XTL: Explosionsgefahr !!! - 500 Beiträge pro Seite
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Die Aktie kann gunstig bei Cortal Consors unter
WKN: 578488 XTL BIOPHARMACEUTICALS LTD. REGISTERED SHARES O.N.
oder direkt in London geordert werden, es ist auch die Listung an der NYSE geplant.
Die in Israel ansässige Firma (z.B. über London bei Cortal Consors handelbar) ist auf die Entwicklung von Antikörpern zur Behandlung von Hepatitis B und Hepatitis C spezialisiert. Ein gewaltiges Marktpotential, vermutlich höher als bei HIV !
Das Testprinzip der Antikörper ist sehr innovativ. Mäusen wird das Knochenmark radioaktiv abgetötet, dann wird ihnen Knochenmark von Immun-defizienten Mausstämmen transplantiert. Dadurch kann diesen Mäusen dann menschliches (mit Hepatitisviren infiziertes) Lebergewebe transplantiert werden, das nicht mehr vom Immunsystem der Mäuse abgestossen wird, und es können Antikörper im sehr großen Maßstab auf ihre Wirksamkeit hin getestet werden. Das hört sich kompliziert an, ist aber technisch recht einfach und man kann viele tausend solcher Mäuse ‚erzeugen’.
Das ist deshalb so wichtig, weil es nur schlechte und teure Tiermodelle für diese Krankheiten gibt, man aber gleichzeitig seit einiger Zeit die Möglichkeit hat, menschliche monoklonale Antikörper in jeglicher Art und Anzahl zusammenzustellen und zu „verfeinern“ (siehe z.B. Morphosys). Ausgangspunkt sind dabei oft Antikörper von infizierten Menschen, die also das menschliche Immunsystem selbst als Waffe entwickelt hat.
Kann das Patent nicht einfach umgangen werden ? Offenbar scheint dies nicht ganz so einfach zu sein, da große Pharmafirmen wie Lilly Nutzungsvereinbarungen mit XTL ausgehandelt haben.
Der Ansatz, sich zunächst auf Hepatitis B und C zu beschränken ist sehr klug. In den USA haben etwa 1 Million Menschen chronische Hepatitis B und 4 Millionen chronische Hepatitis C, sehr viele dieser Patienten sterben daran (weit mehr übrigens als an HIV !!!, das wird sehr oft vergessen bzw. nicht so publik gemacht. Dasi ist insofern erstaunlich als die Infektionsdosis für diese Krankheiten weit geringer ist als bei HIV).
Der potentielle Markt ist also gewaltig.
Die bereits entwickelten und im Tierversuch getesteten Antikörper scheinen recht wirksam zu sein (1000 mal wirksamer als die Antikörper, die man vorher hatte), und auch bei Menschen gut die Virenzahl zu reduzieren. Da sowohl die Antikörper für Hepatitis B und C bereits in der klinischen Phase II sind, kann ich mir nicht vorstellen, dass es noch großartige Probleme mit Nebenwirkungen gibt, da man bei Antikörpern nicht mit so einem großen Spektrum an Nebenwirkungen rechnen muß wie bei klassischen Pharmaka (bei dem Imclone-Präparat war das ja auch kein Problem, sondern nur der mangelnde Beweis der besseren Wirsamkeit als ein klassisches Mittel allein). Sicher ist das natürlich nicht. Wenn sich z.B. herausstellt, dass die Antikörper mit anderen menschlichen Geweben kreuzreagieren oder systemische Reaktionen provozieren, wäre das nicht gut. So hat ein kürzlich erfolgter Todesfall eines Studienpatienten zu einem gewaltigen Kurssturz der Aktie geführt. Meiner Ansicht nach handelt es sich dabei jedoch mit hoher Wahrscheinlichkeit um einen nicht Antikörper-bedingten Todesfall, wie er bei einer so schweren Erkrankung bei frisch Transplantierten leider sehr oft vorkommt (z.B. durch Sepsis o.ä. bedingt) was ja offenbar auch von der FDA so gesehen wurde (siehe Latest News, xtlbio.com). Ein Restrisiko bleibt natürlich.
Eine wichtige Zielgruppe sind natürlich auch Ärzte und Pfleger. Bei Stichverletzungen ist die Gefahr bei HIV nicht so groß (da braucht es schon recht viele Viren zur Infektion), im Gegensatz zu HCV/HBV und man muss dann sehr genau abwägen, ob die mit vielen Nebenwirkungen behaftete Kombi-Prophylaxe wirklich notwendig ist. Ich denke, Antikörper wären da bestimmt eine Bereicherung bzw. Alternative.
Das Prinzip der Antikörper-Testung hat Potential. Es sind sicher weitere Antikörper gegen menschliche Tumore (die man ja auch den Mäusen einpflanzen kann) usw. in Arbeit. HIV ist schwieriger, weil das Virus so ungeheuer wandlungsfähig ist.
Der wissenschaftliche Leiter war vorher bei ImClone. Andere wissenschaftliche Kooperationspartner kommen aus guten Unis (Stanford). Es sind nicht die ganz großen Nobelpreisträger dabei (vielleicht sogar ein Vorteil, weil dann der Aktienkurs sicher schon höher wäre), aber solide Publikationen.
Andere Firmen werden dauernd in irgendwelchen Internetforen erwähnt, bei XTL habe ich da jetzt auf Anhieb nicht viel gefunden. Aber egal, vielleicht ist es das ja gerade. Insgesamt denke ich, das Risiko hält sich im Rahmen und das Potential ist sehr groß.
Fazit: Momentan (noch) eine sehr gute Einstiegsmöglichkeit eines Hoffnungsträgers, mit absoluter Explosionsgefahr !!!
WKN: 578488 XTL BIOPHARMACEUTICALS LTD. REGISTERED SHARES O.N.
oder direkt in London geordert werden, es ist auch die Listung an der NYSE geplant.
Die in Israel ansässige Firma (z.B. über London bei Cortal Consors handelbar) ist auf die Entwicklung von Antikörpern zur Behandlung von Hepatitis B und Hepatitis C spezialisiert. Ein gewaltiges Marktpotential, vermutlich höher als bei HIV !
Das Testprinzip der Antikörper ist sehr innovativ. Mäusen wird das Knochenmark radioaktiv abgetötet, dann wird ihnen Knochenmark von Immun-defizienten Mausstämmen transplantiert. Dadurch kann diesen Mäusen dann menschliches (mit Hepatitisviren infiziertes) Lebergewebe transplantiert werden, das nicht mehr vom Immunsystem der Mäuse abgestossen wird, und es können Antikörper im sehr großen Maßstab auf ihre Wirksamkeit hin getestet werden. Das hört sich kompliziert an, ist aber technisch recht einfach und man kann viele tausend solcher Mäuse ‚erzeugen’.
Das ist deshalb so wichtig, weil es nur schlechte und teure Tiermodelle für diese Krankheiten gibt, man aber gleichzeitig seit einiger Zeit die Möglichkeit hat, menschliche monoklonale Antikörper in jeglicher Art und Anzahl zusammenzustellen und zu „verfeinern“ (siehe z.B. Morphosys). Ausgangspunkt sind dabei oft Antikörper von infizierten Menschen, die also das menschliche Immunsystem selbst als Waffe entwickelt hat.
Kann das Patent nicht einfach umgangen werden ? Offenbar scheint dies nicht ganz so einfach zu sein, da große Pharmafirmen wie Lilly Nutzungsvereinbarungen mit XTL ausgehandelt haben.
Der Ansatz, sich zunächst auf Hepatitis B und C zu beschränken ist sehr klug. In den USA haben etwa 1 Million Menschen chronische Hepatitis B und 4 Millionen chronische Hepatitis C, sehr viele dieser Patienten sterben daran (weit mehr übrigens als an HIV !!!, das wird sehr oft vergessen bzw. nicht so publik gemacht. Dasi ist insofern erstaunlich als die Infektionsdosis für diese Krankheiten weit geringer ist als bei HIV).
Der potentielle Markt ist also gewaltig.
Die bereits entwickelten und im Tierversuch getesteten Antikörper scheinen recht wirksam zu sein (1000 mal wirksamer als die Antikörper, die man vorher hatte), und auch bei Menschen gut die Virenzahl zu reduzieren. Da sowohl die Antikörper für Hepatitis B und C bereits in der klinischen Phase II sind, kann ich mir nicht vorstellen, dass es noch großartige Probleme mit Nebenwirkungen gibt, da man bei Antikörpern nicht mit so einem großen Spektrum an Nebenwirkungen rechnen muß wie bei klassischen Pharmaka (bei dem Imclone-Präparat war das ja auch kein Problem, sondern nur der mangelnde Beweis der besseren Wirsamkeit als ein klassisches Mittel allein). Sicher ist das natürlich nicht. Wenn sich z.B. herausstellt, dass die Antikörper mit anderen menschlichen Geweben kreuzreagieren oder systemische Reaktionen provozieren, wäre das nicht gut. So hat ein kürzlich erfolgter Todesfall eines Studienpatienten zu einem gewaltigen Kurssturz der Aktie geführt. Meiner Ansicht nach handelt es sich dabei jedoch mit hoher Wahrscheinlichkeit um einen nicht Antikörper-bedingten Todesfall, wie er bei einer so schweren Erkrankung bei frisch Transplantierten leider sehr oft vorkommt (z.B. durch Sepsis o.ä. bedingt) was ja offenbar auch von der FDA so gesehen wurde (siehe Latest News, xtlbio.com). Ein Restrisiko bleibt natürlich.
Eine wichtige Zielgruppe sind natürlich auch Ärzte und Pfleger. Bei Stichverletzungen ist die Gefahr bei HIV nicht so groß (da braucht es schon recht viele Viren zur Infektion), im Gegensatz zu HCV/HBV und man muss dann sehr genau abwägen, ob die mit vielen Nebenwirkungen behaftete Kombi-Prophylaxe wirklich notwendig ist. Ich denke, Antikörper wären da bestimmt eine Bereicherung bzw. Alternative.
Das Prinzip der Antikörper-Testung hat Potential. Es sind sicher weitere Antikörper gegen menschliche Tumore (die man ja auch den Mäusen einpflanzen kann) usw. in Arbeit. HIV ist schwieriger, weil das Virus so ungeheuer wandlungsfähig ist.
Der wissenschaftliche Leiter war vorher bei ImClone. Andere wissenschaftliche Kooperationspartner kommen aus guten Unis (Stanford). Es sind nicht die ganz großen Nobelpreisträger dabei (vielleicht sogar ein Vorteil, weil dann der Aktienkurs sicher schon höher wäre), aber solide Publikationen.
Andere Firmen werden dauernd in irgendwelchen Internetforen erwähnt, bei XTL habe ich da jetzt auf Anhieb nicht viel gefunden. Aber egal, vielleicht ist es das ja gerade. Insgesamt denke ich, das Risiko hält sich im Rahmen und das Potential ist sehr groß.
Fazit: Momentan (noch) eine sehr gute Einstiegsmöglichkeit eines Hoffnungsträgers, mit absoluter Explosionsgefahr !!!
Hi
Ich bin vor paar wochen hier eingestiegen ,die Aktie hat letzte woche das 52w Hoch durchbrochen somit ist der Weg nach oben frei.
Einige Infos Zu XTL:
6th September 2004 - XTL Biopharmaceuticals Ltd - Interim Results for the Six Months Ended 30th June 2004
Key Highlights
Commercial agreement with Cubist Pharmaceuticals Inc. for the licensing
and development of HepeX-B, for the prevention of HBV re-infection following transplantation
Agreement reached with FDA to reopen enrollment into the phase II Hepex-C trial, 240mg cohort, in patients with HCV who are undergoing liver transplants. Enrollment was halted voluntarily in May.
Successful completion of $17.8 million fundraising in July.
Financial Highlights
Net loss for period was $10. R&D expenses rose to $8.4 million reflecting spend on continued development of clinical trials. G&A costs for the period ending 20th June 2004 decreased to US$ 1.2 million from US$ 1.7 million for the first half of 2003. Business Development expenses increased as a result of negotiations in both of the company’s two lead programs. The expected reduction in cash outflow as a result of the deal with Cubist will be reflected in future financials. As at 30th June 2003, the Company`s cash short and long-term investments were US $13.3 million (31st December 2003: US $22.4 million).
Commenting on the results, Dr Martin Becker, Chief Executive Officer, said "The past six months have been a time of significant progress for the Company, with the achievement of several milestones. With our recent key alliance, a strengthened balance sheet, focused clinical programs and a strategy to penetrate the US capital markets, XTLbio is well-placed for growth."
2nd August 2004 - XTL Biopharmaceuticals Ltd - EGM Statement and Announcement of successful Fundraising of £9.8 million
XTL Biopharmaceuticals Ltd today held its Extraordinary General Meeting. All resolutions were passed in connection with the Company`s fundraising to raise $17.8 million (£9.8 million) through an Open Offer
incorporating a UK Placing, an Israeli Private Placement and a US Private Placement.
These shares are expected to be admitted to the Official List of the London Stock Exchange at 8.00am tomorrow, 3rd August 2004, and will rank pari passu with the existing class of Ordinary shares.
Dr Martin Becker, Chief Executive Officer of XTLbio, said, "Given current market conditions, we are delighted that this fundraising has been successful and that we have received the endorsement of an impressive group of international investors. We remain strongly committed to the expeditious development of our lead clinical programmes currently in phase 2 trials, as well as progressing our highly promising programme for chronic HCV."
28th July 2004 - XTL Biopharmaceuticals Ltd - Result of Open Offer
XTL Biopharmaceuticals Ltd announces that its Open Offer to Qualifying Shareholders closed at 3.00 pm on Tuesday 27th July 2004. On 1st July 2004, XTLbio announced its intention to raise proceeds of $17.8 million (£9.8 million) through an Open Offer incorporating a UK Placing, an Israeli Private Placement and a US Private Placement.
Of the 56,009,732 New Ordinary Shares offered to Qualifying Shareholders pursuant to the Open Offer, valid applications in respect of 12,262,332 New Ordinary Shares (21.9 per cent) have been received. The remaining New Ordinary Shares have been conditionally subscribed by placees under the UK Placing and subscribers under the US Private Placement and the Israeli Private Placement. The Fundraising remains conditional upon the passing of the resolutions to be proposed at the extraordinary general meeting of the Company to be held at 10.00 a.m. on 2nd August 2004 and upon admission of the New Ordinary Shares to listing on the Official List of the UK Listing Authority and to trading on the London Stock Exchange`s market for listed securities.
The New Ordinary Shares are expected to be admitted to the Official List at 8.00 am on 3rd August 2004.
8th June 2004 – XTL Biopharmaceuticals Ltd - Board change
XTL Bio announced today that Dr. Hadar Ron, Managing Director of Israel Healthcare Ventures (IHCV), is to stand down from the Company`s Board of Directors. Today`s announcement follows a policy decision by IHCV to cease representation on the boards of public companies in which IHCV invests.
Dr. Ron stated, "During my tenure on the Board, the Company has achieved significant milestones including the recently announced collaboration with Cubist Pharmaceuticals which is of major strategic importance for XTLbio. I wish XTLbio all the best for its future growth and have enjoyed being a member of its Board of Directors."
3rd June 2004 - XTL Biopharmaceuticals - License Agreement with Cubist Pharmaceuticals for Worldwide Rights to Hepatitis B Product
XTL Biopharmaceuticals and Cubist Pharmaceuticals, Inc. today announced the completion of a license agreement for the worldwide development and commercialisation of XTLbio’s investigational monoclonal antibody product currently known as HepeX-B™. HepeX-B, currently in phase a II study, is for the prevention of re-infection by the Hepatitis B virus (HBV) in liver transplant patients.
The companies will continue the ongoing international Phase 2b study and, if successful, will continue late-stage clinical development of the product candidate. Cubist will fund the development costs of HepeX-B and will be solely responsible for registration and commercialisation of the product worldwide. The market for this type of product is currently estimated to be about $100 million worldwide.
Under the terms of the agreement, Cubist will pay XTLbio collaboration support and an up-front payment totalling $3.0 million over the next two years, and may pay an additional $3.0 million upon the achievement of certain regulatory milestones. Cubist has also committed to pay XTLbio a tiered royalty on any sales generated from HepeX-B that ranges from 10–17% of net sales.
“This commercial agreement represents a significant achievement for XTLbio,” said Dr. Martin Becker, XTLbio’s President and Chief Executive Officer. “Cubist’s focus on antiinfectives and their proven ability to get a product registered and launched in the U.S. through a seasoned, hospital-focused sales team made the company a very attractive partner to us. We feel this agreement not only validates our proprietary technology, but also would provide us with a revenue stream should HepeX-B ultimately be approved. This agreement is also consistent with our strategy to leverage our technology through the establishment of licensing or co-development agreements on candidates that have achieved clinical proof of principle, and enables us to allocate significant resources to our ongoing hepatitis C development programs.”
10th May 2004 - XTL Biopharmaceuticals Ltd - Dose Ranging Study of HepeX-C in Liver Transplant Patients
XTL Biopharmaceuticals Ltd (XTLbio) reports that, as a precautionary measure, one of its dosing arms in a Phase 2a study of HepeX-C in hepatitis C virus (HCV) infected liver transplant recipients, has been voluntarily halted after a patient suffering from complications associated with both HCV and hepatocellular carcinoma did not survive the transplant operation. Patients in all other cohorts will continue to receive drug at all participating centres.
Although there were a number of specific high risk factors in this particular case that could have contributed to this event, XTLbio has immediately postponed any further patient recruitment at this dosing arm until full analysis of the facts. XTLbio has consulted with the FDA, which is in agreement that this study (Study 2002-09) should be placed on partial clinical hold, this means halting recruitment in this highest dose cohort whilst continuing dosing patients scheduled in the other cohorts. No drug related severe adverse events (SAEs) have been reported to date in other cohorts of HepeX-C in liver transplant patients. In addition, HepeX-C has been administered to 40 chronic HCV patients with no drug related SAEs.
XTLbio is now awaiting further information on this case and is continuing its discussions with the FDA. All other cohorts currently receiving HepeX-C are on track for trial completion and report prior to year-end.
Dr Neil Graham, MD, XTLbio`s Chief Medical Officer, said "From our review of this case so far and discussions with the clinicians involved, we consider it unlikely that HepeX-C will have been a contributory cause. However, we will be working closely with the investigators to review the data pertaining to this event."
8th April 2004 – XTL Biopharmaceuticals - Grant of HCV Human Monoclonal Antibody Patent
XTL Biopharmaceuticals Ltd. announces the issuance of US Patent No. 6,692,908 (the 908 patent) entitled, "Prevention and treatment of HCV infection employing antibodies that inhibit the interaction of HCV virions with their receptor“. The patent covers human monoclonal antibodies (MAbs) directed against the envelope glycoprotein 2 (E2) of the hepatitis C virus (HCV). The patent was recently licensed from Stanford University.
The Mabs disclosed in the patent include a potent neutralizing antibody that could potentially enhance XTLbio’s treatment candidate, HepeX-C, which is currently in phase 2 clinical studies in liver transplant patients. HepeX-C, also a human MAB, has shown anti-viral activity in phase 1 studies in chronic HCV patients. In line with XTLbio’s previously announced strategy in HCV liver transplant, XTLbio intends to submit an IND for a combination of HepeX-C with one of the newly licensed antibodies later this year. The addition of a second antibody could increase the potency of the product by minimizing emergence of viral escape mutants and /or enhancing anti-viral activity.
The human monoclonal anti HCV antibodies covered by the 908 patent, bind to E2 epitopes common to multiple HCV genotypes. The antibodies were developed in the laboratory of Dr Steven Foung at Stanford University, and were extensively evaluated by XTLbio using the Company’s proprietary HCV in vitro and in vivo validation systems to assess anti-viral activity.
Mirit Lotan, PhD, Senior Director of Patents and Technology Assessment for XTLbio commented "The grant of the 908 patent strengthens our intellectual property presence in the area of human monoclonal antibody therapeutics directed against hepatitis C," stated. "The 908 patent is XTLbio’s first issued patent in the area of HCV antibodies and will provide a strong intellectual property base for the company’s enhanced HepeX-C product in the US”.
1st March 2004 - XTL Biopharmaceuticals Ltd - HepeX-B Receives Orphan Drug Designation from the European Agency for the Evaluation of Medicinal Products (EMEA)
XTL Biopharmaceuticals Ltd. (XTLbio) reported today that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted its investigational therapeutic product, HepeX-BTM, Orphan Drug Designation for prevention of hepatitis B infection in liver transplant patients.
Hepatitis B is the most common form of hepatitis and one of the world`s leading causes of death. About 5% of chronic hepatitis B patients will develop end-stage liver disease, a condition, which necessitates liver transplantation. Following a liver transplant, the newly transplanted liver can become re-infected by residual virus in the patient`s serum , leading to rapid disease progression and graft failure in many cases. The current market for prevention of hepatitis B infection following liver transplant is estimated to be worth $100 million.
HepeX-B is a combination of two fully human monoclonal antibodies acting on the hepatitis B virus surface antigen. In a recently reported study, HepeX-B maintained serum levels similar to or higher than the current first-line treatment (polyclonal preparation of hepatitis B immunoglobulin), while using 1,000 times less drug.
Dr. Martin Becker, XTLbio`s Chief Executive Officer, commented "The granting of Orphan Drug Designation in Europe complements well our pre-marketing efforts for HepeX-B, with a similar status having been granted in the US last year. HepeX-B is progressing well through Phase II trials and, as disclosed at our results last week, we are in discussions with potential
partners in order to take the product through to registration."
25th February 2004 - XTL Biopharmaceuticals Ltd - Preliminary Results for the Year Ended 31st December 2003
XTLbio`s principal focus is to develop the HepeX product line for liver transplant prophylaxis. With significant unmet clinical need, the liver transplant market franchise is an ideal target for XTLbio to pursue. During the year, the Company took major steps to focus its efforts on the development of its most advanced products while discontinuing the discovery research activities.
Key Highlights
HepeX-B - Phase 2b trial initiated in patients with hepatitis B for the prevention of infection following liver transplantation
Received Orphan Drug Designation from the US FDA for HepeX-B
HepeX-C - Demonstrated activity against the hepatitis C virus (HCV) in Phase1b trial in patients with chronic HCV
Completed first part of the phase 2 dose escalating trial with HepeX-C in patients with HCV for the prevention of infection following liver transplantation. The safety profile of the lower doses tested allowed the initiation of higher dose cohorts.
Exercised option to develop small molecule compounds against HCV and advanced two candidates to preclinical development
Acquired exclusive rights from Stanford University to a broad panel of HCV antibodies
Financial Highlights
Loss for the year of US$14.3 million (2002: US$17.1 million) was in line with expectations. XRTL received reinstatement of funding and $3.2 million grant from Israel`s Office of the Chief Scientist. R&D costs were US$0.5 million to US$13.8 million (2002: US$13.3 million) reflecting the company’s advancement of it’s product pipeline activities (HepeX-B and HepeX-C) into Phase 2 clinical trials. General and administrative expenses decreased by US$0.5 million to US$3.1 million. During 2003, the Company put on hold early stage research activities, and consequently, decided to sell an asset used in one of these activities. As a result, an impairment charge in an amount of US$0.4 million was recorded. At 31st December 2003 XTLbio had a cash, short and long term investments of $22.4 million (2002: $35.8 million)
Dr. Martin Becker, Chief Executive Officer, said "During the past 12 months XTLbio has been extremely active on a number of fronts. We have achieved important clinical milestones with our lead drug candidates and we have acquired potential new products to further develop our pipeline of hepatitis treatments. Our strategic review, undertaken in July, saw us focus on our clinical products while carefully managing cash resources."
16th December 2003 - XTL Biopharmaceuticals Ltd - R&D and Business Development Update
XTL Biopharmaceuticals Ltd today announces an update on recent clinical progress and corporate developments to investors
and analysts.
HepeX(TM)-B Update: dosing commenced in Phase 2b trial
XTLbio has commenced dosing in a Phase 2b trial with HepeX-B for the prevention of re-infection in hepatitis B patients following liver transplant. The trial is being conducted in the US, Europe and Israel and involves 45 patients. Patients receiving the current first-line preventative treatment, blood derived polyclonal hepatitis B immune globulin (HBIg) solution together with lamivudine, will be randomised to three cohorts; one cohort will continue on the standard preventative treatment and two cohorts will receive different doses of HepeX-B together with lamivudine.
The aim of the study is to demonstrate that replacement of HBIg with HepeX-B in the current prophylaxis protocol in HBV liver transplant patients is effective in preventing HBV re-infection. Patients will be treated over a six-month period, with a 12-month follow-up observation period. Primary endpoints will be HBV DNA and HBV antigen levels. Secondary endpoints will be anti-HBV antibody blood levels and the safety of HepeX-B compared to the current drug.
HepeX-B is a combination of two fully human monoclonal antibodies acting on the hepatitis B virus surface antigen, which were selected based on their strong activity against the virus in XTLbio`s pre-clinical Trimera(TM) model. In a recently reported study, HepeX-B maintained serum levels similar to or higher than the current first-line treatment (HBIg), while using 1,000 times less drug. In August this year, HepeX-B was granted Orphan Drug Designation from the US Food and Drug Administration, giving the product exclusive marketing rights in the US for seven years following marketing approval.
Dr Neil Graham, Chief Medical Officer of XTLbio, said "Chronic hepatitis B is the most common serious liver infection in the world and can be fatal for patients whose disease progression necessitates a liver transplant. In the phase 2 trial announced today, we hope to be able to confirm the beneficial effects of HepeX-B seen in earlier studies and show a meaningful benefit to patients who have undergone liver transplant."
HepeX(TM)-C Update: Interim clinical results from dose escalation trial
XTLbio discloses preliminary clinical results from its Phase 2a randomised placebo controlled dose-escalation / safety study on HepeX-C. The interim results involved 12 HCV associated liver transplant patients who received the low dose regimens of HepeX-C for three months after their transplants.
Based on the absence of drug related severe adverse events on these initial twelve patients together with amendments to include additional cohorts, the FDA has permitted the higher dosing regimen. XTLbio is now proceeding with completing the higher dose cohorts in the 24 patient study.
HepeX-C is a fully human high-affinity monoclonal antibody, which was shown to reduce viral levels of the HCV virus in chronic HCV patients in a Phase 1b dose ranging safety study. Based upon safety data generated in that study, XTLbio decided to clinically evaluate HepeX-C in liver transplant patients infected with HCV. The study is aimed at achieving the minimum dose necessary of HepeX-C to bind all free HCV virus in the blood stream and thereby prevent or delay re-infection of the transplanted liver with HCV, known as "antibody excess". It is believed antibody excess could potentially prevent or significantly delay re-infection of patients with HCV after their transplant. The continuation of the dose escalation study in 12 additional patients is designed to find the minimum dose necessary to achieve antibody excess while demonstrating safety.
Dr. Shlomo Dagan, XTLbio`s Chief Scientific Officer, stated "As reported at the recent AASLD liver meeting in Boston, one of the most critical needs for liver transplant specialists today is to find an approach to limit the devastating effects of HCV re-infection. The prognosis for such patients begs for a solution. Our strategy to achieve antibody excess is fully justified based upon our review of the data. Therefore we look forward to completing this trial in HepeX-C in transplant recipients."
Business Development Update
XTLbio is making progress to secure an alliance on its HepeX programs. Securing a partner for one or more of our products remains the key priority for XTLbio.
Glenn Kazo, Chief Business Officer of XTLbio, said "We are encouraged by the high level of interest shown in our pipeline and are in discussions of various stages with a number of potential partners. It is our intention to conclude a value enhancing partnership at the earliest possible opportunity and we are working continuously to achieve this."
13th October 2003 – XTL Biopharmaceuticals - Acquires Broad Rights From Stanford University to Antibodies Directed Against Hepatitis C Virus (HCV)
XTL Biopharmaceuticals Ltd. (XTLbio) announces that it has acquired an exclusive license to develop and commercialize a series of neutralizing human monoclonal antibodies to the hepatitis C virus developed in the laboratory of Dr. Steven Foung at Stanford University. The agreement, which commits XTLbio to certain future milestones and royalty payments, grants XTLbio exclusive worldwide development and marketing rights for prevention and treatment of HCV except for certain limited rights in China. Financial terms were not disclosed.
XTLbio has conducted extensive pre-clinical evaluation on the licensed antibodies using the Company’s proprietary HCV in vitro and in vivo validation systems to assess anti-viral activity. From these studies the company has identified a potent neutralizing antibody as a treatment candidate to be used in the prevention of HCV re-infection in liver transplant patients. This candidate could potentially enhance XTLbio’s treatment candidate, HepeX-C, also a human monoclonal antibody based product, currently in phase 2 clinical studies in liver transplant patients. HepeX-C has shown anti-viral activity in phase 1 safety studies in chronic HCV patients. The addition of a second antibody could increase the potency of the product by minimizing viral escape mutants and /or enhancing anti-viral activity. As part of the broad arrangement, Dr. Foung will be assisting XTLbio with the clinical development of this product.
Dr. Neil Graham, Chief Medical Officer of XTLbio, said “The exclusive license from Stanford University is the result of a long standing collaboration with the laboratory of Dr. Steven Foung in the area of HCV. Our initial clinical work with HepeX- C is very encouraging and, to enhance our ability to treat HCV, we have always felt that the optimal marketed product may contain a combination of two antibodies. Dr. Foung’s work with human monoclonal antibodies at Stanford provides us with a number of choices to develop complementary antibody therapies that can benefit patients and provide a strong competitive position in the marketplace.”
4th September 2003 - XTL Biopharmaceuticals Ltd - Interim Results for the Six Months Ended 30th June 2003
Following a strategic review XTL has put on hold all early stage research activities to focus on the development of their most advanced clinical products in order to optimize the use of cash resources.
Key Highlights
Completed strategic review of the business which resulted in increasing the focus on the most advanced clinical development programs for liver transplant in hepatitis;
HepeX-C enrolment for the phase 2 study is progressing well with interim results expected towards the year end - as previously reported Hepex-C showed encouraging safety and biological activity in a phase 1 study;
HepeX-B showed encouraging pharmacokinetic results in a dose-ranging study - phase 2 trials are expected to start later this year;
HepeX-B was granted Orphan Drug Designation by the US Food and Drug Administration - an application is being submitted for similar status in Europe;
Exercised an option to develop and commercialise compounds developed by Korea-based B&C Biopharm aimed at inhibiting Hepatitis C virus replication - lead compounds are being selected and toxicology studies are proceeding;
Cash balance of $28 million as of 30 June 2003 (31 December 2002: $36 million).
Commenting on the results, Dr Martin Becker, Chief Executive Officer, said "In the first six months of 2003, we took significant steps to realign our business to concentrate on those areas offering greatest potential value. We have focused our resources on niche, hepatitis-related products with near-term commercial opportunities and we have implemented a Company-wide cost-reduction programme. With these changes in place and a strong cash position, we believe that XTLbio is well-placed for future growth and success."
17th July 2003 - XTL Biopharmaceuticals Ltd. - Purchase of 14% Stake by Israel Healthcare Ventures
XTLBio confirm today that it has been informed by Israel Healthcare Ventures (IHCV) has acquired a 14% shareholding in XTLbio. IHCV is a venture capital fund committed to investing in Israeli-based companies in the life sciences and medical technology field.
IHCV was founded in March 2001 by UK and US private investors with pharmaceutical and financial backgrounds - Isaac Kaye Family Trust, Harvey Kruger, Steven Kaye and Warren Roiter. Since its launch, it has invested in a number of innovative Israeli companies that have the potential for rapid market penetration and profitability.
Hadar Ron, Managing Director of IHCV, said: "XTLbio exactly fits our strict investment criteria. It is a company focused on innovative science in an area of significant and increasing unmet medical need. We are enthusiastic about its prospects."
Martin Becker, Chief Executive of XTLbio, added: "We are very pleased to have the support from investors of the calibre of IHCV. Their commitment highlights the promise of XTLbio and our work in finding drugs to overcome hepatitis."
15th July 2003 - XTL Biopharmaceuticals Ltd. – Strategy Update
XTL Biopharmaceuticals announces that as part of its continuing review of the business, the Board has agreed on a plan to further focus the Company`s efforts on the development of its most advanced products in order to optimise the use of its cash resources.
Key points arising from the review are as follows:
All discovery research activities are to be put on hold with immediate effect. This will involve a reduction in the Company`s headcount from 74 to 54.
Cash conservation, including recently-announced waivers of remuneration by Executive Directors, will enable previously reported cash resources of $36m as of 31st December 2002 to last at least until the first quarter of 2006. As a result, the average monthly burn rate will decrease from approximately $1.4M to approximately $0.9M. Any revenues that may be generated through planned outlicensing/co-development agreements will further augment the Company`s resources.
A new licensing committee of experienced Non-Executive Directors has been established to help management drive forward the partnering of its most advanced programmes.
The strategy for commercialising HepeX-B for prevention of hepatitis B reinfection following liver transplant is unchanged. Negotiations for outlicensing the product have resumed and Phase II trials are planned to start later this year.
The HepeX-C antibody programme for prevention of hepatitis C reinfection following liver transplant will continue through to the end of Phase II trials, during which time XTLbio will seek a co-development partner to share future development costs. Current Phase II trials are expected to be completed by the end of 2003.
The HepeX-C antiviral small molecule programme for chronic hepatitis C will complete preclinical studies and XTLbio will take the product through clinical trials in chronic hepatitis C patients, to test safety and efficacy. These trials are expected to commence in 2004. XTLbio will then actively seek to outlicense the product.
Commenting on the review, Dr Martin Becker, Chief Executive Officer of XTLbio, said "By focusing on our core expertise in hepatitis and implementing this cost-optimisation programme, we are accelerating the Company`s route to profitability. With both of our lead products advancing well through clinical development, we are confident of delivering increased value for shareholders."
25th June 2003 - XTL Biopharmaceuticals Plc - Board Takes Action Following AGM
XTL Biopharmaceuticals Ltd. announces actions following the Annual General Meeting (AGM) held on 19 June 2003:
A programme, which will focus the Company`s efforts on its late stage products and extend cash resources until the first quarter of 2006, will be presented at the July Board of Directors meeting and actions to implement this programme will be taken by the Board thereafter.
The Chairman and the Executive Directors have advised the Company that they have voluntarily decided to take a 10% reduction in salaries for a period of one year.
In addition to the above, a grant of options to Executive Directors was voluntarily withdrawn as a resolution at the Annual General Meeting.
Dr. Geoffrey Vernon, Chairman of the Board of XTLbio, commented, "As promised, both management and the Board have taken a number of decisive actions to respond to concerns raised by our shareholders. Our clear objective is the realisation of maximum shareholder value through the most productive utilisation of the Company`s cash resources. I am confident that the actions taken today will achieve this."
19th June 2003 – XTL Biopharmaceuticals - AGM Statement
XTL Biopharmaceuticals Ltd. (XTLbio) announced that at its Annual General Meeting (AGM) held today, resolutions 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 16 were passed and the existing Directors were reappointed. Resolutions 12, 13, 14 and 15, relating to the grant of options to the Executive Directors, and resolution 17, relating to the amendment of pre-emptive rights, were withdrawn.
Dr. Geoffrey Vernon, Chairman of the Board of XTLbio, said, `We are grateful to shareholders for the support they have shown at today`s meeting. Having met with a large number of the Company`s shareholders in recent weeks, the Board has taken note of a number of concerns raised and intends to take early action to address those concerns, including the Company`s current rate of expenditure.`
4th June 2003 - XTL Biopharmaceuticals Ltd – Encouraging PK Results for HepeX(tm)-B
XTL Biopharmaceuticals Ltd. reported today results from a pharmacokinetics (PK) study of the absorption, distribution, metabolism and excretion of HepeX-B, which is being developed by the company to prevent re-infection by the hepatitis B virus (HBV) in transplanted livers. The PK study was conducted in the UK earlier this year, in 12 healthy volunteers who received a single, intravenous infusion of either 10 mg or 40 mg of HepeX-B. No serious adverse events were reported. Phase 2 clinical trials of HepeX-B on HBV-related liver transplant patients are scheduled to commence during 2003.
4th June 2003 - XTL Biopharmaceuticals Ltd - Advances New Drug Candidate to Treat Chronic HCV
XTL Biopharmaceuticals Ltd. announced today pre-clinical progress with HepeX(tm)-C SM1, a small-molecule drug candidate developed to inhibit replication of the hepatitis C virus (HCV). The molecule is one of a series of compounds licensed exclusively to XTLbio.
HepeX(tm)-C SM1 has recently undergone preliminary toxicity testing with promising results. The compound is now to be advanced to the next level of pre-clinical development. As previously announced, this family of HCV polymerase inhibitors exhibited biological activity using XTLbio`s proprietary HCV in vitro and in vivo pre-clinical drug validation systems. HepeX(tm)-C SM1 is being developed to treat chronic HCV patients by targeting viral replication the company’s other HCV product, HepeX-C, is a fully human monoclonal antibody which targets HCV-related liver transplant patients and is currently in phase II.
The existing first-line chronic HCV therapy is often associated with a 50-60% chance of success but is limited by severe side effects, including anaemia, fatigue, hair loss and depression. Due to the relatively limited efficacy and toxicity of this treatment, chronic HCV is still considered an unmet medical need. Financial analysts estimate that worldwide annual sales for all products treating chronic hepatitis C could reach US$4 billion in 2004.
Shlomo Dagan, PhD, Chief Scientific Officer of XTLbio said, `We are pleased with the preliminary toxicity profile of HepeX-C SM1, and feel confident in advancing the compound into full pre-clinical development.`
21st May 2003 - XTL Biopharmaceuticals Ltd – Chief Scientist Grant to XTLbio Deferred
XTL Biopharmaceuticals Ltd. announced that it has received a letter from the Office of the Chief Scientist, Ministry of Industry, Trade and Employment, State of Israel indicating that certain grants that were due to be made available to the Company would be withheld. XTLbio was to have received US$1.9 million this month and a further US$1.5 million at a later date to support its product development.
An English translation of the Hebrew text of the letter from the Office of the Chief Scientist follows:
`From the news items published in the media, we are fearful that, as a result of the purchase of shares of your company by Shore Capital, their intention, among others, is to sell off the intellectual property of the Company.
As a long-standing supporter of the intellectual property, we are concerned about this development and intend to withhold funds due to the Company until the situation is clarified.
Regards,
Deputy Chief Scientist`
XTLbio President and Chief Executive Officer, Martin Becker, PhD, said, `This is a serious development, showing that the uncertainty regarding the Company`s future direction is already starting to have an effect on our partner relationships.`
15th May 2003 - XTL Biopharmaceuticals Ltd. – Cancels June 3rd AGM
XTL Biopharmaceuticals Ltd. announced today that following a request by certain shareholders to raise resolutions on the agenda of a general meeting of the Company, the Board has decided to cancel the Annual General Meeting (AGM) originally scheduled for 3 June 2003 and expects to convene the AGM for no later than 30 June 2003.
13th May 2003 - XTL Biopharmaceuticals Ltd - Update on Request for New Resolutions at AGM
XTL Biopharmaceuticals Ltd. reports an update in relation to a previous request on 8th May 2003 by a group of shareholders holding approximately 11.3% of the current issued share capital of the Company. The request required XTLbio either to alter the agenda for its annual general meeting (AGM) scheduled for 3rd June 2003 incorporating two new proposed resolutions or to convene an extraordinary general meeting at which time the two new resolutions would be considered. The Company has now concluded that the request to alter the agenda for the existing AGM is not legally possible. As a result, the Board of Directors of the Company is now considering alternatives for proposing the new resolutions to shareholders.
The Board will announce its decision by the end of the week.
9th May 2003 - XTL Biopharmaceuticals Ltd. – Receives Request To Convene Special Meeting
XTL Biopharmaceuticals Ltd. Reported today that on 8th May 2003 it received a request to convene a Special Meeting of Shareholders from a group of shareholders holding 11.3% of the current issued share capital of the Company (requestors). The request requires the Board of XTLbio to convene a Special Meeting for the purpose of considering and, if thought fit, passing the following separate ordinary resolutions:
That other than Rusi K. Kathoke and Patricia A. Smith (being the External Directors of the Company for the purposes of the Israeli Companies Law - 1999) each of the current directors will not be re-appointed and that in their place Mr. Eli Pery, Dr. Zvi Marom, Mr. Simon Jaffa, Professor Roni Aloni and Mr. Adam Teeger be appointed as directors on the Board until the closing of the next Annual General Meeting of the Company
That the Articles of Association be amended to reduce the minimum number of directors on the Board from seven to five.
Brief information in relation to Messrs. Pery, Marom, Jaffa, Aloni and Teeger has been supplied to the Company.
The Board of XTLbio is examining the validity of this request and expects to seek additional information and further clarification from the requestors in order to keep shareholders fully informed. The Board`s understanding of the identity of the shareholders who have requested the Special Meeting, based on documents presented by the requestors, is as follows:
Pershing Keen Nominees Limited (Designation: SHCLT) hold 6,300,000 ordinary shares in XTLbio (representing 5.7% of the existing issued share capital of the Company) as custodian for various clients of Shore Capital Stockbrokers Limited and Puma Nominees Limited holds 6,212,339 ordinary shares in XTLbio (representing 5.6% of the existing issued share capital of the Company) as nominees on behalf of Shore Capital Stockbrokers Limited.
27th February 2003 – XTL Biopharmaceuticals - Acquires Broad Rights to Synthetic Compounds for Potential Treatment of the Hepatitis C Virus (HCV)
XTL Biopharmaceuticals Ltd. (XTLbio) announced today that it exercised an option to develop and commercialise a series of compounds developed by Korea-based B&C Biopharm aimed at inhibiting HCV replication. Based on preliminary efficacy studies using XTLbio`s proprietary HCV in vitro and in vivo pre-clinical validation systems, the Company intends to pursue further pre-clinical development and toxicology testing of these small molecule HCV polymerase inhibitors.
The terms of the agreement commit XTLbio to certain future milestones and royalty Payments and grants XTLbio exclusive development and marketing rights in every
continent besides Asia, which is shared between the two companies. B&C Biopharm retains exclusive rights in Korea itself. Financial terms of the agreement were not disclosed.
Shlomo Dagan, PhD, Chief Scientific Officer of XTLbio commented `With our proprietary validation systems, we have identified a series of synthetic compounds showing strong anti-HCV activity that warrant further development. These compounds will form the core of our efforts to complement our human monoclonal antibody therapeutics with small molecules, a long-standing ambition of the Company.`
27th February 2003 – XTL Biopharmaceuticals - Proof of Principle for Hepex(Tm)-C as Potential Hepatitis C Virus (HCV) Prophylactic on Post Liver Transplant Patients
XTL Biopharmaceuticals Ltd. (XTLbio) announced today clinical results from its Phase 1b dose-ranging/safety study on HepeX-C involving 20 chronic HCV patients undergoing one month`s treatment. Results from the trial were as folows;
No drug-related significant adverse events were observed - good interim safety data provided to the US regulatory authorities allowed XTLbio to proceed with its Phase 2 study on post liver transplant patients
Biological activity was confirmed - in 9 out of 20 patients a one-log (90%), or greater, reduction in viral load was seen at one or more dosing time points.
Data supports rationale for HepeX-C as an HCV prophylactic after a liver transplant, when the major source of viral replication has been removed.
Hepatitis C is a major public health concern and the WHO estimates that 170 million people worldwide are chronic carriers of the hepatitis C virus (HCV) with 3 to 4 million people newly infected each year. It is expected that 25 to 35% of these chronic patients will develop progressive liver disease including cirrhosis and liver cancer.
Hepatitis C is the single leading cause of liver transplantation. Approximately 5% of chronic HCV patients will develop end-stage liver disease, and ultimately may require liver transplantation. The liver is the major source of replication for the virus and is removed during liver transplantation, however there is also free-floating virus in the patient`s serum, which can re-infect a healthy transplanted liver in a matter of weeks. Disease progression in re-infected patients is several times faster and, in many cases, a re-transplant becomes necessary. At present, there is no available solution to this problem. The Company estimates worldwide annual sales potential for HCV liver transplant prophylaxis at US$400 million.
The existing first-line chronic HCV therapy is often associated with a 50-60% chance of success but is limited by severe side effects, including anaemia, fatigue, hair loss and depression. Due to the relatively limited efficacy and toxicity of this treatment, chronic HCV is still considered an unmet medical need. Financial analysts estimate that worldwide annual sales for all products treating chronic hepatitis C could reach US$4 billion in 2004.
Martin Becker, PhD, President and Chief Executive Officer of XTLbio commented `If HepeX-C is capable of preventing or delaying re-infection in patients undergoing liver transplant, it could become a standard therapy. In this case, annual sales potential of such a therapeutic could reach US$400 million. HCV prophylaxis is also a more accessible niche for us, where we have the best chance of taking a product all the way to market. In the United States 20 medical centres perform more than 50% of the transplants, with a similar scenario in Europe.`
27th February 2003 - XTLbio Reports Preliminary Results For The Year Ended 31st December 2002
XTL Biopharmaceuticals Ltd. (XTLbio) reported today preliminary results for the year ended 31 December 2002.
Key Highlights
Primary focus shifted to US$500 million market for viral hepatitis associated with liver transplantation
Clinical trials held in 2001 and 2002 on chronic hepatitis B virus (HBV); foundations laid for Phase 2 studies of HepeX(tm)-B as an HBV prophylactic on transplant patients, scheduled to begin later this year
Rationale for initiated studies of hepatitis C virus (HCV) prophylaxis on transplant patients supported by safety results and bioactivity from Phase 1 studies of HepeX-C on chronic HCV patients
Longer-term strategy activated, targeting the chronic hepatitis C market estimated at US$4 billion in 2004
Proprietary anti-HCV compounds licensed after pre-clinical validation -- see details in a separate announcement dated today
High-value anti-bacterial programmes scaled back, with development contingent on securing collaborative agreements or additional funding
Chief Medical Officer recruited and clinical development team established in the US
Ability of XTLbio`s Trimera(tm) model and cell-based assays to predict biological activity repeatedly confirmed in clinical studies
Financial Highlights
Loss for the year was US$17.1 million (2001: US$12.7m), reflecting an increase in R&D costs of US$0.9 million to US$12.7 million (2001: US$11.8m) due to the development of HepeX-B and HepeX-C. There was also an increase in general and administrative expenses of US$0.7 million to US$5.1 million (2001: US$4.4m). At 31 December 2002, XTLbio had a cash balance (including short and long term investments) of US$35.8 million (2001: US$52.3m).
Martin Becker, PhD, President and Chief Executive Officer of XTLbio, commented, `Our primary focus on the high-value niche market for viral hepatitis associated with liver transplantation received a boost from safety and bioactivity data generated from our clinical studies of HepeX-C and HepeX-B on chronic HCV and HBV patients... Another piece of good news came from our R&D department, which, over the course of last year, validated a synthetic drug showing strong anti-HCV activity. We have recently exercised our option to license this class of small molecules, developed by Korea-based B&C Biopharm. This news catapults XTLbio to the forefront of drug development by adding synthetic drugs to our existing portfolio of fully human monoclonal antibodies. We believe that this combination of products puts us on the road to realising our ultimate vision of conquering hepatitis C in our time.`
9th December 2002 - XTL Biopharmaceuticals Ltd - Restructures to Extend Resources Until 2005
XTL reported today that the board of directors has approved the restructure of the Company to maximise shareholder value by extending resources until 2005 and by changing the focus of its two Phase 2 products, HepeX(tm)-B and HepeX-C, from chronic viral hepatitis to liver transplant prophylaxis markets. Management intends to accomplish these objectives by discontinuing a number of early-stage projects and reducing headcount and related expenses.
Following this restructuring decision XTL has announced that a Phase 2 clinical trial of HepeX-C would commence when the first appropriate candidate at a participating site becomes available. The phase II clinical trial will focus on the currently unmet medical need of preventing Hepatitis C virus (HCV) re-infection in transplanted livers. The patients in the trial will be treated with various doses of HepeX-C or placebo in a multi-centre, double-blind, dose-escalation study of safety and efficacy. Twenty patients will be enrolled in one of four dose groups (five patients each) for a period of twelve weeks.
Regulatory approval for the liver transplant trial was granted based on interim safety data from the Phase 1b study on chronic HCV patients, now nearing completion. Full results of the chronic study are scheduled for release during the first quarter of 2003.
"Infusion of human monoclonal antibodies to prevent HCV re-infection in liver transplant patients is a novel approach," said Dr. Thomas Schiano, a liver specialist and the principal investigator for the HepeX-C research study at New York`s Mount Sinai Medical Center. "With no existing therapy available today, transplanted livers are generally re-infected by hepatitis C in a matter of weeks. Previous studies have shown that HepeX-C has a very good safety profile. Preventing or delaying re-infection in even a small percentage of transplant patients would certainly be viewed as a breakthrough."
In line with its new strategic focus XTL plans to commence a HepeX-B Phase 2 clinical trial in 2003 to study safety and efficacy in the prevention of HBV re-infection in transplanted livers and plans to discontinue the study on chronic HBV. Earlier this year, the Company announced interim results from a Phase 2a dose-ranging study of HepeX-B, in combination with lamivudine, on chronic HBV patients. The interim data indicated no significant adverse events and confirmed biological activity upon frequent dosing. This data will form the basis for the phase 2 study in liver transplant patients.
Martin Becker, PhD, President and CEO of XTL commenting on the restructuring said "Given current market conditions, we have redirected approximately 80 percent of our resources to our lead products in clinical trials and the remaining 20 percent to pre-clinical programmes. By prioritising the high-value, niche liver transplant markets over chronic viral hepatitis markets we intend to generate maximum value to our shareholders in the shortest period of time. We believe that HepeX-B and HepeX-C have a strong competitive advantage, representing the only product line in clinical trials with the potential to capture both HBV and HCV liver transplant prophylaxis markets."
10th September 2002 - XTL Biopharmaceuticals Ltd., - Interim Results for Six Months Ended 30th June 2002
XTL Biopharmaceuticals Ltd today announced interim results for the six months ended 30 June 2002.
Key Highlights
· Three-month interim results of a year long Phase 2a dose-ranging/safety study of HepeX-B (formerly XTL-001), for the treatment of hepatitis B, indicated no significant adverse events and confirmation of biological activity after one month of weekly dosing
· Monthly maintenance dosing in HepeX-B study not adequate - investigation of more effective dosing underway
· HepeX-C (formerly XTL-002), for the treatment of hepatitis C, began a one-month Phase 1b dose-ranging/safety study involving 20 patients
· Initiated option/license agreement with B&C Pharma, Korea
· Continued collaborations with; AVI Biopharma, Inc., USA; Hybrigenics SA, France; Biostapro AB, Sweden; Inotek Corporation, USA
· Discontinued collaboration with iviGene Corporation, USA
· Cash as at 30 June 2002 of US$44 million
Financial Review
As of 30th June 2002 the Company`s cash, short-term and long-term investments was US$44 million. R&D expenses rose from US$6 million (first half 2001) to US$6.4 million for the same period this year. G&A costs for the period ending 30th June 2002 increased to US$2.8 million, up from US$2.3 million for the first half of 2001.
Martin Becker, PhD, President and Chief Executive Officer of XTL, remarked, "During the next six months, we look forward to results of the HepeX-C Phase 1b study and initiating a Phase 2a trial in HCV-associated liver transplant, as well as the selection of an anti-HCV drug candidate for clinical development. Despite the continued poor state of global capital markets in general, and in the biotech sector in particular, we continue to steer the company on a steady course through a combination of responsible fiscal management and renewed focus."
4th September 2002 - XTL Appoints Chief Medical Officer And Launches Second US Office
XTL Biopharmaceuticals Ltd. announced today the appointment of Neil Graham, MD, as Chief Medical Officer. Dr. Graham was formerly Vice President, Clinical Research and Medical Affairs at Tibotec-Virco NV, a subsidiary of Johnson and Johnson Corporation, involved in the development of treatments for HIV. Prior to that, Dr. Graham worked at GlaxoWellcome Inc., now GlaxoSmithKline, as Director of HIV Programs in the US, where he helped design and implement clinical trials for Combivir, Trizivir, Agenerase, Fosamprenavir, Ziagen and Epivir QD. Dr. Graham and his staff will be working in the newly established XTL office in Research Triangle Park, Durham, North Carolina.
5th June 2002 - XTL Biopharmaceuticals Ltd – Board Appointment
XTL Biopharmaceuticals Ltd today announced developments resulting from its annual general meeting, held yesterday. Glenn Kazo, General Manager and Chief Business Officer, has been appointed to the board of directors as an Executive Director. He will continue to take responsibility for corporate development of XTL. The company also announced that Jeffrey Sollender, currently Non-Executive Director at XTL, will step down from the board. Both changes will take place immediately.
Glenn Kazo joined XTL in 1999 to establish the company`s U.S. operations and to head corporate development. Mr. Kazo has over 18 years` experience in product development, corporate development, strategic planning and general management for public biopharmaceutical companies. Prior to XTL, Mr. Kazo was a founding member of Enzon, Inc. (Nasdaq: ENZN), a drug delivery company where he spent 12 years in a variety of senior management positions. Subsequently, he joined Focal, Inc., a medical device company (now a unit of Genzyme Corporation as a Corporate Officer. He currently serves on the board of directors of iviGene Corporation, a private target discovery company in the U.S. (in which XTL is a 20% stockholder), and Prolong Pharmaceuticals, a development-stage biogeneric pharmaceutical company also based in the U.S.
26th February 2002 - XTL Biopharmaceuticals Ltd - Preliminary Results for the Year Ended 31 December 2001
XTL Biopharmaceuticals today announces preliminary results for the year ended 31 December 2001.
Highlights
Results in line with expectations with a loss for the year of $12.7 million (2000: $5.5 million)
Continued progress in clinical development and business development activities reflected in increased R&D costs of $11.8 million (2000: $6.0 million)
Cash balances of $52.3 million and selective investments in technology and infrastructure maintain ability to move development programs forward at a rapid pace
Advanced lead products through clinical development:
-XTL-001 for hepatitis B entered multi-centre, Phase 2 combination studies with standard therapy; showed encouraging interim data
- XTL-002 for hepatitis C entered a Phase 1/2 trial with promising results
- Formed new drug discovery collaborations with Dyax Corp., Dong Wha, Biostapro and AM Pharma
- Extended a collaboration with AVI BioPharma, Inc. following positive preliminary results with AVI`s novel compounds for the treatment of hepatitis C
Acquired a 20% stake in iviGene Corporation to identify novel drug targets for treating a broad range of infectious diseases
Financial Review
The results are in line with expectations with a loss for the year of $12.7 million (2000: $5.5 million). This reflects increases in Research and Development (R&D) costs of $5.8 million to $11.8 million (2000: $6.0 million) and an increase in general and administrative expenses of $1.6 million to $4.4 million (2000: $2.8 million). R&D costs have doubled as XTL has advanced its product pipeline activities. This is mainly attributable to the following factors:
- Clinical costs - XTL has two distinct products in the clinic, XTL-001 for treating chronic hepatitis B patients (Phase 2) and XTL-002 for treating chronic hepatitis C patients (Phase 1)
- An increase in the number of employees in R&D by 30% to 67 employees
- Investment in iviGene Corporation as detailed below
The rise in general and administrative expenses is due to the general increase in business activities, including the formation of five additional co-development and in-licensing agreements. Financial income has increased to $2.4 million (2000: $1.5 million). This is mainly due to the higher average cash balance during the year following the Initial Public Offering in September 2000.
In March 2001, XTL made a $1 million acquisition of 20% of the shares of US based iviGene Corporation, and XTL is funding certain research activities. The investment and the ongoing funding were charged to R&D costs in the Statement of Operations. During the next 12 months XTL has the option to continue funding these activities and has the rights to in-license targets discovered by iviGene. In addition, XTL has an exclusive option to acquire the remaining shares of iviGene for $4 million in cash and $16 million in XTL shares.
At 31 December 2001, XTL had a cash balance (including short and long term investments) of $52.3 million (2000: $65 million). Net cash outflow from operating activities in the year was $11.8 million (2000: $4.1 million). The net outflow of cash from operating activities is due principally to the Company`s operating loss. As a result of progressing the products through clinical trials, it is expected that operating cash outflow will continue to increase in 2002.
14th January 2002- XTL Biopharmaceuticals Ltd - Positive clinical data for the treatment of hepatitis C virus
XTL Biopharmaceuticals Ltd. today announces positive clinical data on the antiviral activity and safety of XTL-002, being developed for the treatment of hepatitis C virus (HCV) infections. Results of the Phase Ia study, which included 15 chronic HCV patients, indicate that HCV viral RNA levels were reduced in over half the patients following a single dose. No serious adverse events were reported.
The single-centre study, under the regulation of the United States Food and Drug Administration (FDA) and Ministry of Health, Israel, was designed to test safety, tolerability and efficacy of a single-dose of XTL-002 in chronic HCV patients. The 15 patients were divided into 5 groups, with each group receiving 0.25, 1.0, 2.5, 10 or 40mg of XTL-002 in a single intravenous infusion. HCV viral RNA levels were measured pre-infusion and at multiple time intervals following infusion of XTL-002. In 8 out of 15 patients, significant reduction of HCV viral RNA, ranging from 2 to 100 fold, was demonstrated following XTL-002 administration. XTL-002 is a fully human high-affinity monoclonal antibody which was shown to reduce viral levels of the HCV virus in XTL`s proprietary in vivo model, the HCV TrimeraXTL model. This model is being used in conjunction with a variety of corporate and academic partners to screen and evaluate novel compounds to treat HCV. A peer reviewed scientific article on XTL`s HCV TrimeraXTL model was recently published in the Journal of Infectious Disease.
Professor Eithan Galun, Director, Goldyne Savad Institute of Gene Therapy, Hadassah University Hospital and a principal investigator in the study,commented: "XTL-002 is a promising new therapeutic modality for treating chronic HCV patients. In addition, XTL-002 could be employed to prevent HCV re-infection in HCV-associated liver transplant patients, where no drug currently exists."
Martin Becker, Ph.D., President and Chief Executive Officer of XTL, said: "XTL is the first company to initiate clinical trials with a monoclonal antibody against HCV. We are pleased that the clinical results with XTL-002, though early-stage, suggest that XTL-002 is active against the HCV virus. XTL-002 is the most advanced drug in our broad HCV program, which includes multiple drug candidates that are either fully owned by XTL or co-developed with corporate partners."
Hepatitis C is a major public health concern. The World Health Organization estimates that 170 million people worldwide are chronic carriers of the hepatitis C virus, with 4 million carriers in the United States alone. It is estimated that 25-35% of these chronic patients will develop progressive liver disease including cirrhosis and liver cancer. Hepatitis C is the leading cause of liver transplantation. The Center for Disease Control estimates that in the
year 2000, about 10,000 people died in the US as a result of HCV. It is predicted that by the end of this decade, the number of deaths in the US as a result of HCV will surpass the number of deaths from AIDS.
17th December 2001- XTL Biopharmaceuticals Ltd - Update on lactoferrin-derived peptide program
XTL Biopharmaceuticals Ltd announced today that its human lactoferrin peptide research program, originally initiated with Pharming Group NV in November 2000, has been extended with AM-Pharma BV, a recently established Dutch biopharmaceutical company focused on novel anti-microbial products. Under the original agreement, XTL and Pharming were jointly evaluating and potentially co-developing recombinant human lactoferrin and its derivatives as potential treatments for hepatitis C virus (HCV) infection. Earlier this year, AM-Pharma acquired the ownership of the peptide technology from Pharming. The new agreement with AM-Pharma grants XTL an option to take up an exclusive worldwide license to the lactoferrin peptide for the HCV indication, pending further studies in XTL`s proprietary in-vivo testing system. The peptide program focuses on the development of a human lactoferrin-derived peptide as an anti-HCV therapeutic. This peptide is an active derivative of lactoferrin - a natural protein with known antibiotic and immune modulating properties.
Dr. Martin Becker, XTL`s President and CEO said: "The lactoferrin peptide represents a novel approach to treating HCV. We are encouraged by the results it has achieved in our Trimera in-vivo system, and look forward to confirming these results in further preclinical studies. This peptide program further broadens XTL`s hepatitis franchise, with antibody therapeutics against hepatitis B and C in clinical development and multiple collaborations with HCV drug discovery companies."
Ewald Keijser, AM Pharma`s CEO commented: "For AM-Pharma this is an excellent opportunity to enter into a new therapeutic area, with a partner that has an established track record in developing antiviral therapies. This collaboration also leverages our efforts and investments in other anti-infective programs in the areas of viral, bacterial and fungal systemic infections. "
10th December 2001- XTL Biopharmaceuticals - Positive Results in Chronic Hepatitis B Study
XTL Biopharmaceuticals Ltd announces interim results from a phase 2a clinical study of XTL-001 in chronic hepatitis B (HBV) patients in combination with lamivudine, the standard treatment. The preliminary data indicates that XTL-001 in combination with lamivudine resulted in a significant lowering of viral DNA and antigen levels after only one week of treatment. This effect appears to be sustained for at least one month (the limit of the data analysed). Patients in the study were treated with a combination of various doses of XTL-001 or placebo on a background of the standard treatment regimen of lamivudine. The multi-centre, double-blind, dose ranging study is expected to enroll a total of 60 patients in five dosing regimens of XTL-001. Patients receive the combination drug therapy for up to 12 months. Interim results from 15 patients receiving the combination at 4 weeks indicated that HBV viral DNA was reduced to undetectable levels in 9 out of 15 patients (60%). A greater than 50% reduction in HBV viral surface antigen levels was seen in 7 out of 15 of the patients (47%).
Professor Eithan Galun, Director, Goldyne Savad Institute of Gene Therapy, Hadassah University Hospital and a principal investigator in this study, said: "While the data set is preliminary, the decreased levels of viral antigen as well as the accelerated reduction in viral DNA is consistent with an enhanced effect on eliminating the HBV virus when using XTL-001 compared with standard therapy alone."
Dr. Martin Becker, Ph.D., President and CEO of XTL, said: "These encouraging interim results provide initial validation of our combination therapy strategy for HBV, a chronic disease affecting over 300 million people worldwide. We look forward to seeing continued progress with this and other products in our portfolio during 2002."
XTL-001 consists of two high affinity human monoclonal antibodies that act at multiple sites on the HBV surface antigen. These antibodies were discovered and developed using XTL`s Trimera system, a proprietary technology for generating high affinity human monoclonal antibodies and for creating in vivo systems for bio-validating therapeutics using functional human tissue.
Hepatitis B is one of the most common potentially fatal infectious diseases in the world. The hepatitis B virus is up to 100 times more infectious than HIV, the virus that causes AIDS. Modes of transmission include blood transfusions, contaminated needles, sexual contact, breast milk and open sores. Most people infected with acute hepatitis B have no symptoms and are able to fight off the infection themselves. According to the American Liver Foundation, 5% to 10% of those infected with hepatitis B will become chronic carriers of the virus. The World Health Organization estimates that approximately 350 million individuals worldwide, or 5% of the world`s population, are long-term carriers of hepatitis B in their blood. In the United States, there are over 1 million carriers of hepatitis B and an estimated 200,000 people contract acute hepatitis B each year. Most are unaware that they are infected or have minimal disease with no clinically evident symptoms. However, carriers of the hepatitis B virus have a 200-fold increased chance of developing primary liver cancer, the most common cancer in the world, and a significant number develop cirrhosis of the liver. A safe and effective vaccine against hepatitis B is available. However, the vaccine is a preventative in that it only benefits those who have not yet been infected by the hepatitis B virus. It is not indicated for the treatment of chronic infection. Most approved treatments only benefit a limited proportion of patients and can have serious adverse side effects.
12th October 2001- XTL Biopharmaceuticals Ltd - Sign License and Collaboration Agreement for Development of Monoclonal Antibodies Against Staphylococcal Infections with Biostapro
XTL Biopharmaceuticals Ltd and Biostapro AB, a privately-held biopharmaceutical company based in Sweden, announced today that they have entered into a collaboration to develop fully human monoclonal antibodies (hMAbs) against Staphylococcal infections.
As part of the agreement, XTL will license from Biostapro two protein targets on the cell surface of two major staphylococcal bacteria, S. Aureus, and S. Epidermidis. These targets have previously undergone significant validation processes at Biostapro. The companies will collaborate on the development of hMAbs against these targets using XTL`s proprietary TrimeraXTL technology. XTL will also be responsible for clinical trials and further commercialization of these antibodies. Biostapro will receive a license fee, milestone payments and royalties on future sales.
Staphylococcal infections (mainly caused by S. Aureus and S. Epidermidis) are frequent hospital acquired infections, with S. Aureus responsible for over 400,000 infections each year in the US, Europe and Japan and at least a similar number associated with S. Epidermidis infection. These bacteria are characterized by a high and increasingly growing rate of antibiotic-resistance. Thus, they pose a significant threat to the lives of patients and a significant burden to healthcare systems due to their very high cost of treatment.
Dr. Martin Becker, CEO of XTL, said: "Staphylococcal infections are a key therapeutic area in which there is a clear need for therapeutics with a novel mechanism of action. Monoclonal antibodies represent a powerful and innovative therapeutic approach to these life-threatening diseases. This collaboration with Biostapro is an important step in XTL`s ongoing strategy of developing fully human monoclonal antibodies against infectious disease."
11th September 2001 - XTL Biopharmaceuticals Ltd. – XTL Interim Results for the Six Months Ended 30th June 2001
XTL announce their interim Results for the Six Months Ended 30th June 2001
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6th September 2004 - XTL Biopharmaceuticals Ltd - Interim Results for the Six Months Ended 30th June 2004
Key Highlights
Commercial agreement with Cubist Pharmaceuticals Inc. for the licensing
and development of HepeX-B, for the prevention of HBV re-infection following transplantation
Agreement reached with FDA to reopen enrollment into the phase II Hepex-C trial, 240mg cohort, in patients with HCV who are undergoing liver transplants. Enrollment was halted voluntarily in May.
Successful completion of $17.8 million fundraising in July.
Financial Highlights
Net loss for period was $10. R&D expenses rose to $8.4 million reflecting spend on continued development of clinical trials. G&A costs for the period ending 20th June 2004 decreased to US$ 1.2 million from US$ 1.7 million for the first half of 2003. Business Development expenses increased as a result of negotiations in both of the company’s two lead programs. The expected reduction in cash outflow as a result of the deal with Cubist will be reflected in future financials. As at 30th June 2003, the Company`s cash short and long-term investments were US $13.3 million (31st December 2003: US $22.4 million).
Commenting on the results, Dr Martin Becker, Chief Executive Officer, said "The past six months have been a time of significant progress for the Company, with the achievement of several milestones. With our recent key alliance, a strengthened balance sheet, focused clinical programs and a strategy to penetrate the US capital markets, XTLbio is well-placed for growth."
2nd August 2004 - XTL Biopharmaceuticals Ltd - EGM Statement and Announcement of successful Fundraising of £9.8 million
XTL Biopharmaceuticals Ltd today held its Extraordinary General Meeting. All resolutions were passed in connection with the Company`s fundraising to raise $17.8 million (£9.8 million) through an Open Offer
incorporating a UK Placing, an Israeli Private Placement and a US Private Placement.
These shares are expected to be admitted to the Official List of the London Stock Exchange at 8.00am tomorrow, 3rd August 2004, and will rank pari passu with the existing class of Ordinary shares.
Dr Martin Becker, Chief Executive Officer of XTLbio, said, "Given current market conditions, we are delighted that this fundraising has been successful and that we have received the endorsement of an impressive group of international investors. We remain strongly committed to the expeditious development of our lead clinical programmes currently in phase 2 trials, as well as progressing our highly promising programme for chronic HCV."
28th July 2004 - XTL Biopharmaceuticals Ltd - Result of Open Offer
XTL Biopharmaceuticals Ltd announces that its Open Offer to Qualifying Shareholders closed at 3.00 pm on Tuesday 27th July 2004. On 1st July 2004, XTLbio announced its intention to raise proceeds of $17.8 million (£9.8 million) through an Open Offer incorporating a UK Placing, an Israeli Private Placement and a US Private Placement.
Of the 56,009,732 New Ordinary Shares offered to Qualifying Shareholders pursuant to the Open Offer, valid applications in respect of 12,262,332 New Ordinary Shares (21.9 per cent) have been received. The remaining New Ordinary Shares have been conditionally subscribed by placees under the UK Placing and subscribers under the US Private Placement and the Israeli Private Placement. The Fundraising remains conditional upon the passing of the resolutions to be proposed at the extraordinary general meeting of the Company to be held at 10.00 a.m. on 2nd August 2004 and upon admission of the New Ordinary Shares to listing on the Official List of the UK Listing Authority and to trading on the London Stock Exchange`s market for listed securities.
The New Ordinary Shares are expected to be admitted to the Official List at 8.00 am on 3rd August 2004.
8th June 2004 – XTL Biopharmaceuticals Ltd - Board change
XTL Bio announced today that Dr. Hadar Ron, Managing Director of Israel Healthcare Ventures (IHCV), is to stand down from the Company`s Board of Directors. Today`s announcement follows a policy decision by IHCV to cease representation on the boards of public companies in which IHCV invests.
Dr. Ron stated, "During my tenure on the Board, the Company has achieved significant milestones including the recently announced collaboration with Cubist Pharmaceuticals which is of major strategic importance for XTLbio. I wish XTLbio all the best for its future growth and have enjoyed being a member of its Board of Directors."
3rd June 2004 - XTL Biopharmaceuticals - License Agreement with Cubist Pharmaceuticals for Worldwide Rights to Hepatitis B Product
XTL Biopharmaceuticals and Cubist Pharmaceuticals, Inc. today announced the completion of a license agreement for the worldwide development and commercialisation of XTLbio’s investigational monoclonal antibody product currently known as HepeX-B™. HepeX-B, currently in phase a II study, is for the prevention of re-infection by the Hepatitis B virus (HBV) in liver transplant patients.
The companies will continue the ongoing international Phase 2b study and, if successful, will continue late-stage clinical development of the product candidate. Cubist will fund the development costs of HepeX-B and will be solely responsible for registration and commercialisation of the product worldwide. The market for this type of product is currently estimated to be about $100 million worldwide.
Under the terms of the agreement, Cubist will pay XTLbio collaboration support and an up-front payment totalling $3.0 million over the next two years, and may pay an additional $3.0 million upon the achievement of certain regulatory milestones. Cubist has also committed to pay XTLbio a tiered royalty on any sales generated from HepeX-B that ranges from 10–17% of net sales.
“This commercial agreement represents a significant achievement for XTLbio,” said Dr. Martin Becker, XTLbio’s President and Chief Executive Officer. “Cubist’s focus on antiinfectives and their proven ability to get a product registered and launched in the U.S. through a seasoned, hospital-focused sales team made the company a very attractive partner to us. We feel this agreement not only validates our proprietary technology, but also would provide us with a revenue stream should HepeX-B ultimately be approved. This agreement is also consistent with our strategy to leverage our technology through the establishment of licensing or co-development agreements on candidates that have achieved clinical proof of principle, and enables us to allocate significant resources to our ongoing hepatitis C development programs.”
10th May 2004 - XTL Biopharmaceuticals Ltd - Dose Ranging Study of HepeX-C in Liver Transplant Patients
XTL Biopharmaceuticals Ltd (XTLbio) reports that, as a precautionary measure, one of its dosing arms in a Phase 2a study of HepeX-C in hepatitis C virus (HCV) infected liver transplant recipients, has been voluntarily halted after a patient suffering from complications associated with both HCV and hepatocellular carcinoma did not survive the transplant operation. Patients in all other cohorts will continue to receive drug at all participating centres.
Although there were a number of specific high risk factors in this particular case that could have contributed to this event, XTLbio has immediately postponed any further patient recruitment at this dosing arm until full analysis of the facts. XTLbio has consulted with the FDA, which is in agreement that this study (Study 2002-09) should be placed on partial clinical hold, this means halting recruitment in this highest dose cohort whilst continuing dosing patients scheduled in the other cohorts. No drug related severe adverse events (SAEs) have been reported to date in other cohorts of HepeX-C in liver transplant patients. In addition, HepeX-C has been administered to 40 chronic HCV patients with no drug related SAEs.
XTLbio is now awaiting further information on this case and is continuing its discussions with the FDA. All other cohorts currently receiving HepeX-C are on track for trial completion and report prior to year-end.
Dr Neil Graham, MD, XTLbio`s Chief Medical Officer, said "From our review of this case so far and discussions with the clinicians involved, we consider it unlikely that HepeX-C will have been a contributory cause. However, we will be working closely with the investigators to review the data pertaining to this event."
8th April 2004 – XTL Biopharmaceuticals - Grant of HCV Human Monoclonal Antibody Patent
XTL Biopharmaceuticals Ltd. announces the issuance of US Patent No. 6,692,908 (the 908 patent) entitled, "Prevention and treatment of HCV infection employing antibodies that inhibit the interaction of HCV virions with their receptor“. The patent covers human monoclonal antibodies (MAbs) directed against the envelope glycoprotein 2 (E2) of the hepatitis C virus (HCV). The patent was recently licensed from Stanford University.
The Mabs disclosed in the patent include a potent neutralizing antibody that could potentially enhance XTLbio’s treatment candidate, HepeX-C, which is currently in phase 2 clinical studies in liver transplant patients. HepeX-C, also a human MAB, has shown anti-viral activity in phase 1 studies in chronic HCV patients. In line with XTLbio’s previously announced strategy in HCV liver transplant, XTLbio intends to submit an IND for a combination of HepeX-C with one of the newly licensed antibodies later this year. The addition of a second antibody could increase the potency of the product by minimizing emergence of viral escape mutants and /or enhancing anti-viral activity.
The human monoclonal anti HCV antibodies covered by the 908 patent, bind to E2 epitopes common to multiple HCV genotypes. The antibodies were developed in the laboratory of Dr Steven Foung at Stanford University, and were extensively evaluated by XTLbio using the Company’s proprietary HCV in vitro and in vivo validation systems to assess anti-viral activity.
Mirit Lotan, PhD, Senior Director of Patents and Technology Assessment for XTLbio commented "The grant of the 908 patent strengthens our intellectual property presence in the area of human monoclonal antibody therapeutics directed against hepatitis C," stated. "The 908 patent is XTLbio’s first issued patent in the area of HCV antibodies and will provide a strong intellectual property base for the company’s enhanced HepeX-C product in the US”.
1st March 2004 - XTL Biopharmaceuticals Ltd - HepeX-B Receives Orphan Drug Designation from the European Agency for the Evaluation of Medicinal Products (EMEA)
XTL Biopharmaceuticals Ltd. (XTLbio) reported today that the European Agency for the Evaluation of Medicinal Products (EMEA) has granted its investigational therapeutic product, HepeX-BTM, Orphan Drug Designation for prevention of hepatitis B infection in liver transplant patients.
Hepatitis B is the most common form of hepatitis and one of the world`s leading causes of death. About 5% of chronic hepatitis B patients will develop end-stage liver disease, a condition, which necessitates liver transplantation. Following a liver transplant, the newly transplanted liver can become re-infected by residual virus in the patient`s serum , leading to rapid disease progression and graft failure in many cases. The current market for prevention of hepatitis B infection following liver transplant is estimated to be worth $100 million.
HepeX-B is a combination of two fully human monoclonal antibodies acting on the hepatitis B virus surface antigen. In a recently reported study, HepeX-B maintained serum levels similar to or higher than the current first-line treatment (polyclonal preparation of hepatitis B immunoglobulin), while using 1,000 times less drug.
Dr. Martin Becker, XTLbio`s Chief Executive Officer, commented "The granting of Orphan Drug Designation in Europe complements well our pre-marketing efforts for HepeX-B, with a similar status having been granted in the US last year. HepeX-B is progressing well through Phase II trials and, as disclosed at our results last week, we are in discussions with potential
partners in order to take the product through to registration."
25th February 2004 - XTL Biopharmaceuticals Ltd - Preliminary Results for the Year Ended 31st December 2003
XTLbio`s principal focus is to develop the HepeX product line for liver transplant prophylaxis. With significant unmet clinical need, the liver transplant market franchise is an ideal target for XTLbio to pursue. During the year, the Company took major steps to focus its efforts on the development of its most advanced products while discontinuing the discovery research activities.
Key Highlights
HepeX-B - Phase 2b trial initiated in patients with hepatitis B for the prevention of infection following liver transplantation
Received Orphan Drug Designation from the US FDA for HepeX-B
HepeX-C - Demonstrated activity against the hepatitis C virus (HCV) in Phase1b trial in patients with chronic HCV
Completed first part of the phase 2 dose escalating trial with HepeX-C in patients with HCV for the prevention of infection following liver transplantation. The safety profile of the lower doses tested allowed the initiation of higher dose cohorts.
Exercised option to develop small molecule compounds against HCV and advanced two candidates to preclinical development
Acquired exclusive rights from Stanford University to a broad panel of HCV antibodies
Financial Highlights
Loss for the year of US$14.3 million (2002: US$17.1 million) was in line with expectations. XRTL received reinstatement of funding and $3.2 million grant from Israel`s Office of the Chief Scientist. R&D costs were US$0.5 million to US$13.8 million (2002: US$13.3 million) reflecting the company’s advancement of it’s product pipeline activities (HepeX-B and HepeX-C) into Phase 2 clinical trials. General and administrative expenses decreased by US$0.5 million to US$3.1 million. During 2003, the Company put on hold early stage research activities, and consequently, decided to sell an asset used in one of these activities. As a result, an impairment charge in an amount of US$0.4 million was recorded. At 31st December 2003 XTLbio had a cash, short and long term investments of $22.4 million (2002: $35.8 million)
Dr. Martin Becker, Chief Executive Officer, said "During the past 12 months XTLbio has been extremely active on a number of fronts. We have achieved important clinical milestones with our lead drug candidates and we have acquired potential new products to further develop our pipeline of hepatitis treatments. Our strategic review, undertaken in July, saw us focus on our clinical products while carefully managing cash resources."
16th December 2003 - XTL Biopharmaceuticals Ltd - R&D and Business Development Update
XTL Biopharmaceuticals Ltd today announces an update on recent clinical progress and corporate developments to investors
and analysts.
HepeX(TM)-B Update: dosing commenced in Phase 2b trial
XTLbio has commenced dosing in a Phase 2b trial with HepeX-B for the prevention of re-infection in hepatitis B patients following liver transplant. The trial is being conducted in the US, Europe and Israel and involves 45 patients. Patients receiving the current first-line preventative treatment, blood derived polyclonal hepatitis B immune globulin (HBIg) solution together with lamivudine, will be randomised to three cohorts; one cohort will continue on the standard preventative treatment and two cohorts will receive different doses of HepeX-B together with lamivudine.
The aim of the study is to demonstrate that replacement of HBIg with HepeX-B in the current prophylaxis protocol in HBV liver transplant patients is effective in preventing HBV re-infection. Patients will be treated over a six-month period, with a 12-month follow-up observation period. Primary endpoints will be HBV DNA and HBV antigen levels. Secondary endpoints will be anti-HBV antibody blood levels and the safety of HepeX-B compared to the current drug.
HepeX-B is a combination of two fully human monoclonal antibodies acting on the hepatitis B virus surface antigen, which were selected based on their strong activity against the virus in XTLbio`s pre-clinical Trimera(TM) model. In a recently reported study, HepeX-B maintained serum levels similar to or higher than the current first-line treatment (HBIg), while using 1,000 times less drug. In August this year, HepeX-B was granted Orphan Drug Designation from the US Food and Drug Administration, giving the product exclusive marketing rights in the US for seven years following marketing approval.
Dr Neil Graham, Chief Medical Officer of XTLbio, said "Chronic hepatitis B is the most common serious liver infection in the world and can be fatal for patients whose disease progression necessitates a liver transplant. In the phase 2 trial announced today, we hope to be able to confirm the beneficial effects of HepeX-B seen in earlier studies and show a meaningful benefit to patients who have undergone liver transplant."
HepeX(TM)-C Update: Interim clinical results from dose escalation trial
XTLbio discloses preliminary clinical results from its Phase 2a randomised placebo controlled dose-escalation / safety study on HepeX-C. The interim results involved 12 HCV associated liver transplant patients who received the low dose regimens of HepeX-C for three months after their transplants.
Based on the absence of drug related severe adverse events on these initial twelve patients together with amendments to include additional cohorts, the FDA has permitted the higher dosing regimen. XTLbio is now proceeding with completing the higher dose cohorts in the 24 patient study.
HepeX-C is a fully human high-affinity monoclonal antibody, which was shown to reduce viral levels of the HCV virus in chronic HCV patients in a Phase 1b dose ranging safety study. Based upon safety data generated in that study, XTLbio decided to clinically evaluate HepeX-C in liver transplant patients infected with HCV. The study is aimed at achieving the minimum dose necessary of HepeX-C to bind all free HCV virus in the blood stream and thereby prevent or delay re-infection of the transplanted liver with HCV, known as "antibody excess". It is believed antibody excess could potentially prevent or significantly delay re-infection of patients with HCV after their transplant. The continuation of the dose escalation study in 12 additional patients is designed to find the minimum dose necessary to achieve antibody excess while demonstrating safety.
Dr. Shlomo Dagan, XTLbio`s Chief Scientific Officer, stated "As reported at the recent AASLD liver meeting in Boston, one of the most critical needs for liver transplant specialists today is to find an approach to limit the devastating effects of HCV re-infection. The prognosis for such patients begs for a solution. Our strategy to achieve antibody excess is fully justified based upon our review of the data. Therefore we look forward to completing this trial in HepeX-C in transplant recipients."
Business Development Update
XTLbio is making progress to secure an alliance on its HepeX programs. Securing a partner for one or more of our products remains the key priority for XTLbio.
Glenn Kazo, Chief Business Officer of XTLbio, said "We are encouraged by the high level of interest shown in our pipeline and are in discussions of various stages with a number of potential partners. It is our intention to conclude a value enhancing partnership at the earliest possible opportunity and we are working continuously to achieve this."
13th October 2003 – XTL Biopharmaceuticals - Acquires Broad Rights From Stanford University to Antibodies Directed Against Hepatitis C Virus (HCV)
XTL Biopharmaceuticals Ltd. (XTLbio) announces that it has acquired an exclusive license to develop and commercialize a series of neutralizing human monoclonal antibodies to the hepatitis C virus developed in the laboratory of Dr. Steven Foung at Stanford University. The agreement, which commits XTLbio to certain future milestones and royalty payments, grants XTLbio exclusive worldwide development and marketing rights for prevention and treatment of HCV except for certain limited rights in China. Financial terms were not disclosed.
XTLbio has conducted extensive pre-clinical evaluation on the licensed antibodies using the Company’s proprietary HCV in vitro and in vivo validation systems to assess anti-viral activity. From these studies the company has identified a potent neutralizing antibody as a treatment candidate to be used in the prevention of HCV re-infection in liver transplant patients. This candidate could potentially enhance XTLbio’s treatment candidate, HepeX-C, also a human monoclonal antibody based product, currently in phase 2 clinical studies in liver transplant patients. HepeX-C has shown anti-viral activity in phase 1 safety studies in chronic HCV patients. The addition of a second antibody could increase the potency of the product by minimizing viral escape mutants and /or enhancing anti-viral activity. As part of the broad arrangement, Dr. Foung will be assisting XTLbio with the clinical development of this product.
Dr. Neil Graham, Chief Medical Officer of XTLbio, said “The exclusive license from Stanford University is the result of a long standing collaboration with the laboratory of Dr. Steven Foung in the area of HCV. Our initial clinical work with HepeX- C is very encouraging and, to enhance our ability to treat HCV, we have always felt that the optimal marketed product may contain a combination of two antibodies. Dr. Foung’s work with human monoclonal antibodies at Stanford provides us with a number of choices to develop complementary antibody therapies that can benefit patients and provide a strong competitive position in the marketplace.”
4th September 2003 - XTL Biopharmaceuticals Ltd - Interim Results for the Six Months Ended 30th June 2003
Following a strategic review XTL has put on hold all early stage research activities to focus on the development of their most advanced clinical products in order to optimize the use of cash resources.
Key Highlights
Completed strategic review of the business which resulted in increasing the focus on the most advanced clinical development programs for liver transplant in hepatitis;
HepeX-C enrolment for the phase 2 study is progressing well with interim results expected towards the year end - as previously reported Hepex-C showed encouraging safety and biological activity in a phase 1 study;
HepeX-B showed encouraging pharmacokinetic results in a dose-ranging study - phase 2 trials are expected to start later this year;
HepeX-B was granted Orphan Drug Designation by the US Food and Drug Administration - an application is being submitted for similar status in Europe;
Exercised an option to develop and commercialise compounds developed by Korea-based B&C Biopharm aimed at inhibiting Hepatitis C virus replication - lead compounds are being selected and toxicology studies are proceeding;
Cash balance of $28 million as of 30 June 2003 (31 December 2002: $36 million).
Commenting on the results, Dr Martin Becker, Chief Executive Officer, said "In the first six months of 2003, we took significant steps to realign our business to concentrate on those areas offering greatest potential value. We have focused our resources on niche, hepatitis-related products with near-term commercial opportunities and we have implemented a Company-wide cost-reduction programme. With these changes in place and a strong cash position, we believe that XTLbio is well-placed for future growth and success."
17th July 2003 - XTL Biopharmaceuticals Ltd. - Purchase of 14% Stake by Israel Healthcare Ventures
XTLBio confirm today that it has been informed by Israel Healthcare Ventures (IHCV) has acquired a 14% shareholding in XTLbio. IHCV is a venture capital fund committed to investing in Israeli-based companies in the life sciences and medical technology field.
IHCV was founded in March 2001 by UK and US private investors with pharmaceutical and financial backgrounds - Isaac Kaye Family Trust, Harvey Kruger, Steven Kaye and Warren Roiter. Since its launch, it has invested in a number of innovative Israeli companies that have the potential for rapid market penetration and profitability.
Hadar Ron, Managing Director of IHCV, said: "XTLbio exactly fits our strict investment criteria. It is a company focused on innovative science in an area of significant and increasing unmet medical need. We are enthusiastic about its prospects."
Martin Becker, Chief Executive of XTLbio, added: "We are very pleased to have the support from investors of the calibre of IHCV. Their commitment highlights the promise of XTLbio and our work in finding drugs to overcome hepatitis."
15th July 2003 - XTL Biopharmaceuticals Ltd. – Strategy Update
XTL Biopharmaceuticals announces that as part of its continuing review of the business, the Board has agreed on a plan to further focus the Company`s efforts on the development of its most advanced products in order to optimise the use of its cash resources.
Key points arising from the review are as follows:
All discovery research activities are to be put on hold with immediate effect. This will involve a reduction in the Company`s headcount from 74 to 54.
Cash conservation, including recently-announced waivers of remuneration by Executive Directors, will enable previously reported cash resources of $36m as of 31st December 2002 to last at least until the first quarter of 2006. As a result, the average monthly burn rate will decrease from approximately $1.4M to approximately $0.9M. Any revenues that may be generated through planned outlicensing/co-development agreements will further augment the Company`s resources.
A new licensing committee of experienced Non-Executive Directors has been established to help management drive forward the partnering of its most advanced programmes.
The strategy for commercialising HepeX-B for prevention of hepatitis B reinfection following liver transplant is unchanged. Negotiations for outlicensing the product have resumed and Phase II trials are planned to start later this year.
The HepeX-C antibody programme for prevention of hepatitis C reinfection following liver transplant will continue through to the end of Phase II trials, during which time XTLbio will seek a co-development partner to share future development costs. Current Phase II trials are expected to be completed by the end of 2003.
The HepeX-C antiviral small molecule programme for chronic hepatitis C will complete preclinical studies and XTLbio will take the product through clinical trials in chronic hepatitis C patients, to test safety and efficacy. These trials are expected to commence in 2004. XTLbio will then actively seek to outlicense the product.
Commenting on the review, Dr Martin Becker, Chief Executive Officer of XTLbio, said "By focusing on our core expertise in hepatitis and implementing this cost-optimisation programme, we are accelerating the Company`s route to profitability. With both of our lead products advancing well through clinical development, we are confident of delivering increased value for shareholders."
25th June 2003 - XTL Biopharmaceuticals Plc - Board Takes Action Following AGM
XTL Biopharmaceuticals Ltd. announces actions following the Annual General Meeting (AGM) held on 19 June 2003:
A programme, which will focus the Company`s efforts on its late stage products and extend cash resources until the first quarter of 2006, will be presented at the July Board of Directors meeting and actions to implement this programme will be taken by the Board thereafter.
The Chairman and the Executive Directors have advised the Company that they have voluntarily decided to take a 10% reduction in salaries for a period of one year.
In addition to the above, a grant of options to Executive Directors was voluntarily withdrawn as a resolution at the Annual General Meeting.
Dr. Geoffrey Vernon, Chairman of the Board of XTLbio, commented, "As promised, both management and the Board have taken a number of decisive actions to respond to concerns raised by our shareholders. Our clear objective is the realisation of maximum shareholder value through the most productive utilisation of the Company`s cash resources. I am confident that the actions taken today will achieve this."
19th June 2003 – XTL Biopharmaceuticals - AGM Statement
XTL Biopharmaceuticals Ltd. (XTLbio) announced that at its Annual General Meeting (AGM) held today, resolutions 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 16 were passed and the existing Directors were reappointed. Resolutions 12, 13, 14 and 15, relating to the grant of options to the Executive Directors, and resolution 17, relating to the amendment of pre-emptive rights, were withdrawn.
Dr. Geoffrey Vernon, Chairman of the Board of XTLbio, said, `We are grateful to shareholders for the support they have shown at today`s meeting. Having met with a large number of the Company`s shareholders in recent weeks, the Board has taken note of a number of concerns raised and intends to take early action to address those concerns, including the Company`s current rate of expenditure.`
4th June 2003 - XTL Biopharmaceuticals Ltd – Encouraging PK Results for HepeX(tm)-B
XTL Biopharmaceuticals Ltd. reported today results from a pharmacokinetics (PK) study of the absorption, distribution, metabolism and excretion of HepeX-B, which is being developed by the company to prevent re-infection by the hepatitis B virus (HBV) in transplanted livers. The PK study was conducted in the UK earlier this year, in 12 healthy volunteers who received a single, intravenous infusion of either 10 mg or 40 mg of HepeX-B. No serious adverse events were reported. Phase 2 clinical trials of HepeX-B on HBV-related liver transplant patients are scheduled to commence during 2003.
4th June 2003 - XTL Biopharmaceuticals Ltd - Advances New Drug Candidate to Treat Chronic HCV
XTL Biopharmaceuticals Ltd. announced today pre-clinical progress with HepeX(tm)-C SM1, a small-molecule drug candidate developed to inhibit replication of the hepatitis C virus (HCV). The molecule is one of a series of compounds licensed exclusively to XTLbio.
HepeX(tm)-C SM1 has recently undergone preliminary toxicity testing with promising results. The compound is now to be advanced to the next level of pre-clinical development. As previously announced, this family of HCV polymerase inhibitors exhibited biological activity using XTLbio`s proprietary HCV in vitro and in vivo pre-clinical drug validation systems. HepeX(tm)-C SM1 is being developed to treat chronic HCV patients by targeting viral replication the company’s other HCV product, HepeX-C, is a fully human monoclonal antibody which targets HCV-related liver transplant patients and is currently in phase II.
The existing first-line chronic HCV therapy is often associated with a 50-60% chance of success but is limited by severe side effects, including anaemia, fatigue, hair loss and depression. Due to the relatively limited efficacy and toxicity of this treatment, chronic HCV is still considered an unmet medical need. Financial analysts estimate that worldwide annual sales for all products treating chronic hepatitis C could reach US$4 billion in 2004.
Shlomo Dagan, PhD, Chief Scientific Officer of XTLbio said, `We are pleased with the preliminary toxicity profile of HepeX-C SM1, and feel confident in advancing the compound into full pre-clinical development.`
21st May 2003 - XTL Biopharmaceuticals Ltd – Chief Scientist Grant to XTLbio Deferred
XTL Biopharmaceuticals Ltd. announced that it has received a letter from the Office of the Chief Scientist, Ministry of Industry, Trade and Employment, State of Israel indicating that certain grants that were due to be made available to the Company would be withheld. XTLbio was to have received US$1.9 million this month and a further US$1.5 million at a later date to support its product development.
An English translation of the Hebrew text of the letter from the Office of the Chief Scientist follows:
`From the news items published in the media, we are fearful that, as a result of the purchase of shares of your company by Shore Capital, their intention, among others, is to sell off the intellectual property of the Company.
As a long-standing supporter of the intellectual property, we are concerned about this development and intend to withhold funds due to the Company until the situation is clarified.
Regards,
Deputy Chief Scientist`
XTLbio President and Chief Executive Officer, Martin Becker, PhD, said, `This is a serious development, showing that the uncertainty regarding the Company`s future direction is already starting to have an effect on our partner relationships.`
15th May 2003 - XTL Biopharmaceuticals Ltd. – Cancels June 3rd AGM
XTL Biopharmaceuticals Ltd. announced today that following a request by certain shareholders to raise resolutions on the agenda of a general meeting of the Company, the Board has decided to cancel the Annual General Meeting (AGM) originally scheduled for 3 June 2003 and expects to convene the AGM for no later than 30 June 2003.
13th May 2003 - XTL Biopharmaceuticals Ltd - Update on Request for New Resolutions at AGM
XTL Biopharmaceuticals Ltd. reports an update in relation to a previous request on 8th May 2003 by a group of shareholders holding approximately 11.3% of the current issued share capital of the Company. The request required XTLbio either to alter the agenda for its annual general meeting (AGM) scheduled for 3rd June 2003 incorporating two new proposed resolutions or to convene an extraordinary general meeting at which time the two new resolutions would be considered. The Company has now concluded that the request to alter the agenda for the existing AGM is not legally possible. As a result, the Board of Directors of the Company is now considering alternatives for proposing the new resolutions to shareholders.
The Board will announce its decision by the end of the week.
9th May 2003 - XTL Biopharmaceuticals Ltd. – Receives Request To Convene Special Meeting
XTL Biopharmaceuticals Ltd. Reported today that on 8th May 2003 it received a request to convene a Special Meeting of Shareholders from a group of shareholders holding 11.3% of the current issued share capital of the Company (requestors). The request requires the Board of XTLbio to convene a Special Meeting for the purpose of considering and, if thought fit, passing the following separate ordinary resolutions:
That other than Rusi K. Kathoke and Patricia A. Smith (being the External Directors of the Company for the purposes of the Israeli Companies Law - 1999) each of the current directors will not be re-appointed and that in their place Mr. Eli Pery, Dr. Zvi Marom, Mr. Simon Jaffa, Professor Roni Aloni and Mr. Adam Teeger be appointed as directors on the Board until the closing of the next Annual General Meeting of the Company
That the Articles of Association be amended to reduce the minimum number of directors on the Board from seven to five.
Brief information in relation to Messrs. Pery, Marom, Jaffa, Aloni and Teeger has been supplied to the Company.
The Board of XTLbio is examining the validity of this request and expects to seek additional information and further clarification from the requestors in order to keep shareholders fully informed. The Board`s understanding of the identity of the shareholders who have requested the Special Meeting, based on documents presented by the requestors, is as follows:
Pershing Keen Nominees Limited (Designation: SHCLT) hold 6,300,000 ordinary shares in XTLbio (representing 5.7% of the existing issued share capital of the Company) as custodian for various clients of Shore Capital Stockbrokers Limited and Puma Nominees Limited holds 6,212,339 ordinary shares in XTLbio (representing 5.6% of the existing issued share capital of the Company) as nominees on behalf of Shore Capital Stockbrokers Limited.
27th February 2003 – XTL Biopharmaceuticals - Acquires Broad Rights to Synthetic Compounds for Potential Treatment of the Hepatitis C Virus (HCV)
XTL Biopharmaceuticals Ltd. (XTLbio) announced today that it exercised an option to develop and commercialise a series of compounds developed by Korea-based B&C Biopharm aimed at inhibiting HCV replication. Based on preliminary efficacy studies using XTLbio`s proprietary HCV in vitro and in vivo pre-clinical validation systems, the Company intends to pursue further pre-clinical development and toxicology testing of these small molecule HCV polymerase inhibitors.
The terms of the agreement commit XTLbio to certain future milestones and royalty Payments and grants XTLbio exclusive development and marketing rights in every
continent besides Asia, which is shared between the two companies. B&C Biopharm retains exclusive rights in Korea itself. Financial terms of the agreement were not disclosed.
Shlomo Dagan, PhD, Chief Scientific Officer of XTLbio commented `With our proprietary validation systems, we have identified a series of synthetic compounds showing strong anti-HCV activity that warrant further development. These compounds will form the core of our efforts to complement our human monoclonal antibody therapeutics with small molecules, a long-standing ambition of the Company.`
27th February 2003 – XTL Biopharmaceuticals - Proof of Principle for Hepex(Tm)-C as Potential Hepatitis C Virus (HCV) Prophylactic on Post Liver Transplant Patients
XTL Biopharmaceuticals Ltd. (XTLbio) announced today clinical results from its Phase 1b dose-ranging/safety study on HepeX-C involving 20 chronic HCV patients undergoing one month`s treatment. Results from the trial were as folows;
No drug-related significant adverse events were observed - good interim safety data provided to the US regulatory authorities allowed XTLbio to proceed with its Phase 2 study on post liver transplant patients
Biological activity was confirmed - in 9 out of 20 patients a one-log (90%), or greater, reduction in viral load was seen at one or more dosing time points.
Data supports rationale for HepeX-C as an HCV prophylactic after a liver transplant, when the major source of viral replication has been removed.
Hepatitis C is a major public health concern and the WHO estimates that 170 million people worldwide are chronic carriers of the hepatitis C virus (HCV) with 3 to 4 million people newly infected each year. It is expected that 25 to 35% of these chronic patients will develop progressive liver disease including cirrhosis and liver cancer.
Hepatitis C is the single leading cause of liver transplantation. Approximately 5% of chronic HCV patients will develop end-stage liver disease, and ultimately may require liver transplantation. The liver is the major source of replication for the virus and is removed during liver transplantation, however there is also free-floating virus in the patient`s serum, which can re-infect a healthy transplanted liver in a matter of weeks. Disease progression in re-infected patients is several times faster and, in many cases, a re-transplant becomes necessary. At present, there is no available solution to this problem. The Company estimates worldwide annual sales potential for HCV liver transplant prophylaxis at US$400 million.
The existing first-line chronic HCV therapy is often associated with a 50-60% chance of success but is limited by severe side effects, including anaemia, fatigue, hair loss and depression. Due to the relatively limited efficacy and toxicity of this treatment, chronic HCV is still considered an unmet medical need. Financial analysts estimate that worldwide annual sales for all products treating chronic hepatitis C could reach US$4 billion in 2004.
Martin Becker, PhD, President and Chief Executive Officer of XTLbio commented `If HepeX-C is capable of preventing or delaying re-infection in patients undergoing liver transplant, it could become a standard therapy. In this case, annual sales potential of such a therapeutic could reach US$400 million. HCV prophylaxis is also a more accessible niche for us, where we have the best chance of taking a product all the way to market. In the United States 20 medical centres perform more than 50% of the transplants, with a similar scenario in Europe.`
27th February 2003 - XTLbio Reports Preliminary Results For The Year Ended 31st December 2002
XTL Biopharmaceuticals Ltd. (XTLbio) reported today preliminary results for the year ended 31 December 2002.
Key Highlights
Primary focus shifted to US$500 million market for viral hepatitis associated with liver transplantation
Clinical trials held in 2001 and 2002 on chronic hepatitis B virus (HBV); foundations laid for Phase 2 studies of HepeX(tm)-B as an HBV prophylactic on transplant patients, scheduled to begin later this year
Rationale for initiated studies of hepatitis C virus (HCV) prophylaxis on transplant patients supported by safety results and bioactivity from Phase 1 studies of HepeX-C on chronic HCV patients
Longer-term strategy activated, targeting the chronic hepatitis C market estimated at US$4 billion in 2004
Proprietary anti-HCV compounds licensed after pre-clinical validation -- see details in a separate announcement dated today
High-value anti-bacterial programmes scaled back, with development contingent on securing collaborative agreements or additional funding
Chief Medical Officer recruited and clinical development team established in the US
Ability of XTLbio`s Trimera(tm) model and cell-based assays to predict biological activity repeatedly confirmed in clinical studies
Financial Highlights
Loss for the year was US$17.1 million (2001: US$12.7m), reflecting an increase in R&D costs of US$0.9 million to US$12.7 million (2001: US$11.8m) due to the development of HepeX-B and HepeX-C. There was also an increase in general and administrative expenses of US$0.7 million to US$5.1 million (2001: US$4.4m). At 31 December 2002, XTLbio had a cash balance (including short and long term investments) of US$35.8 million (2001: US$52.3m).
Martin Becker, PhD, President and Chief Executive Officer of XTLbio, commented, `Our primary focus on the high-value niche market for viral hepatitis associated with liver transplantation received a boost from safety and bioactivity data generated from our clinical studies of HepeX-C and HepeX-B on chronic HCV and HBV patients... Another piece of good news came from our R&D department, which, over the course of last year, validated a synthetic drug showing strong anti-HCV activity. We have recently exercised our option to license this class of small molecules, developed by Korea-based B&C Biopharm. This news catapults XTLbio to the forefront of drug development by adding synthetic drugs to our existing portfolio of fully human monoclonal antibodies. We believe that this combination of products puts us on the road to realising our ultimate vision of conquering hepatitis C in our time.`
9th December 2002 - XTL Biopharmaceuticals Ltd - Restructures to Extend Resources Until 2005
XTL reported today that the board of directors has approved the restructure of the Company to maximise shareholder value by extending resources until 2005 and by changing the focus of its two Phase 2 products, HepeX(tm)-B and HepeX-C, from chronic viral hepatitis to liver transplant prophylaxis markets. Management intends to accomplish these objectives by discontinuing a number of early-stage projects and reducing headcount and related expenses.
Following this restructuring decision XTL has announced that a Phase 2 clinical trial of HepeX-C would commence when the first appropriate candidate at a participating site becomes available. The phase II clinical trial will focus on the currently unmet medical need of preventing Hepatitis C virus (HCV) re-infection in transplanted livers. The patients in the trial will be treated with various doses of HepeX-C or placebo in a multi-centre, double-blind, dose-escalation study of safety and efficacy. Twenty patients will be enrolled in one of four dose groups (five patients each) for a period of twelve weeks.
Regulatory approval for the liver transplant trial was granted based on interim safety data from the Phase 1b study on chronic HCV patients, now nearing completion. Full results of the chronic study are scheduled for release during the first quarter of 2003.
"Infusion of human monoclonal antibodies to prevent HCV re-infection in liver transplant patients is a novel approach," said Dr. Thomas Schiano, a liver specialist and the principal investigator for the HepeX-C research study at New York`s Mount Sinai Medical Center. "With no existing therapy available today, transplanted livers are generally re-infected by hepatitis C in a matter of weeks. Previous studies have shown that HepeX-C has a very good safety profile. Preventing or delaying re-infection in even a small percentage of transplant patients would certainly be viewed as a breakthrough."
In line with its new strategic focus XTL plans to commence a HepeX-B Phase 2 clinical trial in 2003 to study safety and efficacy in the prevention of HBV re-infection in transplanted livers and plans to discontinue the study on chronic HBV. Earlier this year, the Company announced interim results from a Phase 2a dose-ranging study of HepeX-B, in combination with lamivudine, on chronic HBV patients. The interim data indicated no significant adverse events and confirmed biological activity upon frequent dosing. This data will form the basis for the phase 2 study in liver transplant patients.
Martin Becker, PhD, President and CEO of XTL commenting on the restructuring said "Given current market conditions, we have redirected approximately 80 percent of our resources to our lead products in clinical trials and the remaining 20 percent to pre-clinical programmes. By prioritising the high-value, niche liver transplant markets over chronic viral hepatitis markets we intend to generate maximum value to our shareholders in the shortest period of time. We believe that HepeX-B and HepeX-C have a strong competitive advantage, representing the only product line in clinical trials with the potential to capture both HBV and HCV liver transplant prophylaxis markets."
10th September 2002 - XTL Biopharmaceuticals Ltd., - Interim Results for Six Months Ended 30th June 2002
XTL Biopharmaceuticals Ltd today announced interim results for the six months ended 30 June 2002.
Key Highlights
· Three-month interim results of a year long Phase 2a dose-ranging/safety study of HepeX-B (formerly XTL-001), for the treatment of hepatitis B, indicated no significant adverse events and confirmation of biological activity after one month of weekly dosing
· Monthly maintenance dosing in HepeX-B study not adequate - investigation of more effective dosing underway
· HepeX-C (formerly XTL-002), for the treatment of hepatitis C, began a one-month Phase 1b dose-ranging/safety study involving 20 patients
· Initiated option/license agreement with B&C Pharma, Korea
· Continued collaborations with; AVI Biopharma, Inc., USA; Hybrigenics SA, France; Biostapro AB, Sweden; Inotek Corporation, USA
· Discontinued collaboration with iviGene Corporation, USA
· Cash as at 30 June 2002 of US$44 million
Financial Review
As of 30th June 2002 the Company`s cash, short-term and long-term investments was US$44 million. R&D expenses rose from US$6 million (first half 2001) to US$6.4 million for the same period this year. G&A costs for the period ending 30th June 2002 increased to US$2.8 million, up from US$2.3 million for the first half of 2001.
Martin Becker, PhD, President and Chief Executive Officer of XTL, remarked, "During the next six months, we look forward to results of the HepeX-C Phase 1b study and initiating a Phase 2a trial in HCV-associated liver transplant, as well as the selection of an anti-HCV drug candidate for clinical development. Despite the continued poor state of global capital markets in general, and in the biotech sector in particular, we continue to steer the company on a steady course through a combination of responsible fiscal management and renewed focus."
4th September 2002 - XTL Appoints Chief Medical Officer And Launches Second US Office
XTL Biopharmaceuticals Ltd. announced today the appointment of Neil Graham, MD, as Chief Medical Officer. Dr. Graham was formerly Vice President, Clinical Research and Medical Affairs at Tibotec-Virco NV, a subsidiary of Johnson and Johnson Corporation, involved in the development of treatments for HIV. Prior to that, Dr. Graham worked at GlaxoWellcome Inc., now GlaxoSmithKline, as Director of HIV Programs in the US, where he helped design and implement clinical trials for Combivir, Trizivir, Agenerase, Fosamprenavir, Ziagen and Epivir QD. Dr. Graham and his staff will be working in the newly established XTL office in Research Triangle Park, Durham, North Carolina.
5th June 2002 - XTL Biopharmaceuticals Ltd – Board Appointment
XTL Biopharmaceuticals Ltd today announced developments resulting from its annual general meeting, held yesterday. Glenn Kazo, General Manager and Chief Business Officer, has been appointed to the board of directors as an Executive Director. He will continue to take responsibility for corporate development of XTL. The company also announced that Jeffrey Sollender, currently Non-Executive Director at XTL, will step down from the board. Both changes will take place immediately.
Glenn Kazo joined XTL in 1999 to establish the company`s U.S. operations and to head corporate development. Mr. Kazo has over 18 years` experience in product development, corporate development, strategic planning and general management for public biopharmaceutical companies. Prior to XTL, Mr. Kazo was a founding member of Enzon, Inc. (Nasdaq: ENZN), a drug delivery company where he spent 12 years in a variety of senior management positions. Subsequently, he joined Focal, Inc., a medical device company (now a unit of Genzyme Corporation as a Corporate Officer. He currently serves on the board of directors of iviGene Corporation, a private target discovery company in the U.S. (in which XTL is a 20% stockholder), and Prolong Pharmaceuticals, a development-stage biogeneric pharmaceutical company also based in the U.S.
26th February 2002 - XTL Biopharmaceuticals Ltd - Preliminary Results for the Year Ended 31 December 2001
XTL Biopharmaceuticals today announces preliminary results for the year ended 31 December 2001.
Highlights
Results in line with expectations with a loss for the year of $12.7 million (2000: $5.5 million)
Continued progress in clinical development and business development activities reflected in increased R&D costs of $11.8 million (2000: $6.0 million)
Cash balances of $52.3 million and selective investments in technology and infrastructure maintain ability to move development programs forward at a rapid pace
Advanced lead products through clinical development:
-XTL-001 for hepatitis B entered multi-centre, Phase 2 combination studies with standard therapy; showed encouraging interim data
- XTL-002 for hepatitis C entered a Phase 1/2 trial with promising results
- Formed new drug discovery collaborations with Dyax Corp., Dong Wha, Biostapro and AM Pharma
- Extended a collaboration with AVI BioPharma, Inc. following positive preliminary results with AVI`s novel compounds for the treatment of hepatitis C
Acquired a 20% stake in iviGene Corporation to identify novel drug targets for treating a broad range of infectious diseases
Financial Review
The results are in line with expectations with a loss for the year of $12.7 million (2000: $5.5 million). This reflects increases in Research and Development (R&D) costs of $5.8 million to $11.8 million (2000: $6.0 million) and an increase in general and administrative expenses of $1.6 million to $4.4 million (2000: $2.8 million). R&D costs have doubled as XTL has advanced its product pipeline activities. This is mainly attributable to the following factors:
- Clinical costs - XTL has two distinct products in the clinic, XTL-001 for treating chronic hepatitis B patients (Phase 2) and XTL-002 for treating chronic hepatitis C patients (Phase 1)
- An increase in the number of employees in R&D by 30% to 67 employees
- Investment in iviGene Corporation as detailed below
The rise in general and administrative expenses is due to the general increase in business activities, including the formation of five additional co-development and in-licensing agreements. Financial income has increased to $2.4 million (2000: $1.5 million). This is mainly due to the higher average cash balance during the year following the Initial Public Offering in September 2000.
In March 2001, XTL made a $1 million acquisition of 20% of the shares of US based iviGene Corporation, and XTL is funding certain research activities. The investment and the ongoing funding were charged to R&D costs in the Statement of Operations. During the next 12 months XTL has the option to continue funding these activities and has the rights to in-license targets discovered by iviGene. In addition, XTL has an exclusive option to acquire the remaining shares of iviGene for $4 million in cash and $16 million in XTL shares.
At 31 December 2001, XTL had a cash balance (including short and long term investments) of $52.3 million (2000: $65 million). Net cash outflow from operating activities in the year was $11.8 million (2000: $4.1 million). The net outflow of cash from operating activities is due principally to the Company`s operating loss. As a result of progressing the products through clinical trials, it is expected that operating cash outflow will continue to increase in 2002.
14th January 2002- XTL Biopharmaceuticals Ltd - Positive clinical data for the treatment of hepatitis C virus
XTL Biopharmaceuticals Ltd. today announces positive clinical data on the antiviral activity and safety of XTL-002, being developed for the treatment of hepatitis C virus (HCV) infections. Results of the Phase Ia study, which included 15 chronic HCV patients, indicate that HCV viral RNA levels were reduced in over half the patients following a single dose. No serious adverse events were reported.
The single-centre study, under the regulation of the United States Food and Drug Administration (FDA) and Ministry of Health, Israel, was designed to test safety, tolerability and efficacy of a single-dose of XTL-002 in chronic HCV patients. The 15 patients were divided into 5 groups, with each group receiving 0.25, 1.0, 2.5, 10 or 40mg of XTL-002 in a single intravenous infusion. HCV viral RNA levels were measured pre-infusion and at multiple time intervals following infusion of XTL-002. In 8 out of 15 patients, significant reduction of HCV viral RNA, ranging from 2 to 100 fold, was demonstrated following XTL-002 administration. XTL-002 is a fully human high-affinity monoclonal antibody which was shown to reduce viral levels of the HCV virus in XTL`s proprietary in vivo model, the HCV TrimeraXTL model. This model is being used in conjunction with a variety of corporate and academic partners to screen and evaluate novel compounds to treat HCV. A peer reviewed scientific article on XTL`s HCV TrimeraXTL model was recently published in the Journal of Infectious Disease.
Professor Eithan Galun, Director, Goldyne Savad Institute of Gene Therapy, Hadassah University Hospital and a principal investigator in the study,commented: "XTL-002 is a promising new therapeutic modality for treating chronic HCV patients. In addition, XTL-002 could be employed to prevent HCV re-infection in HCV-associated liver transplant patients, where no drug currently exists."
Martin Becker, Ph.D., President and Chief Executive Officer of XTL, said: "XTL is the first company to initiate clinical trials with a monoclonal antibody against HCV. We are pleased that the clinical results with XTL-002, though early-stage, suggest that XTL-002 is active against the HCV virus. XTL-002 is the most advanced drug in our broad HCV program, which includes multiple drug candidates that are either fully owned by XTL or co-developed with corporate partners."
Hepatitis C is a major public health concern. The World Health Organization estimates that 170 million people worldwide are chronic carriers of the hepatitis C virus, with 4 million carriers in the United States alone. It is estimated that 25-35% of these chronic patients will develop progressive liver disease including cirrhosis and liver cancer. Hepatitis C is the leading cause of liver transplantation. The Center for Disease Control estimates that in the
year 2000, about 10,000 people died in the US as a result of HCV. It is predicted that by the end of this decade, the number of deaths in the US as a result of HCV will surpass the number of deaths from AIDS.
17th December 2001- XTL Biopharmaceuticals Ltd - Update on lactoferrin-derived peptide program
XTL Biopharmaceuticals Ltd announced today that its human lactoferrin peptide research program, originally initiated with Pharming Group NV in November 2000, has been extended with AM-Pharma BV, a recently established Dutch biopharmaceutical company focused on novel anti-microbial products. Under the original agreement, XTL and Pharming were jointly evaluating and potentially co-developing recombinant human lactoferrin and its derivatives as potential treatments for hepatitis C virus (HCV) infection. Earlier this year, AM-Pharma acquired the ownership of the peptide technology from Pharming. The new agreement with AM-Pharma grants XTL an option to take up an exclusive worldwide license to the lactoferrin peptide for the HCV indication, pending further studies in XTL`s proprietary in-vivo testing system. The peptide program focuses on the development of a human lactoferrin-derived peptide as an anti-HCV therapeutic. This peptide is an active derivative of lactoferrin - a natural protein with known antibiotic and immune modulating properties.
Dr. Martin Becker, XTL`s President and CEO said: "The lactoferrin peptide represents a novel approach to treating HCV. We are encouraged by the results it has achieved in our Trimera in-vivo system, and look forward to confirming these results in further preclinical studies. This peptide program further broadens XTL`s hepatitis franchise, with antibody therapeutics against hepatitis B and C in clinical development and multiple collaborations with HCV drug discovery companies."
Ewald Keijser, AM Pharma`s CEO commented: "For AM-Pharma this is an excellent opportunity to enter into a new therapeutic area, with a partner that has an established track record in developing antiviral therapies. This collaboration also leverages our efforts and investments in other anti-infective programs in the areas of viral, bacterial and fungal systemic infections. "
10th December 2001- XTL Biopharmaceuticals - Positive Results in Chronic Hepatitis B Study
XTL Biopharmaceuticals Ltd announces interim results from a phase 2a clinical study of XTL-001 in chronic hepatitis B (HBV) patients in combination with lamivudine, the standard treatment. The preliminary data indicates that XTL-001 in combination with lamivudine resulted in a significant lowering of viral DNA and antigen levels after only one week of treatment. This effect appears to be sustained for at least one month (the limit of the data analysed). Patients in the study were treated with a combination of various doses of XTL-001 or placebo on a background of the standard treatment regimen of lamivudine. The multi-centre, double-blind, dose ranging study is expected to enroll a total of 60 patients in five dosing regimens of XTL-001. Patients receive the combination drug therapy for up to 12 months. Interim results from 15 patients receiving the combination at 4 weeks indicated that HBV viral DNA was reduced to undetectable levels in 9 out of 15 patients (60%). A greater than 50% reduction in HBV viral surface antigen levels was seen in 7 out of 15 of the patients (47%).
Professor Eithan Galun, Director, Goldyne Savad Institute of Gene Therapy, Hadassah University Hospital and a principal investigator in this study, said: "While the data set is preliminary, the decreased levels of viral antigen as well as the accelerated reduction in viral DNA is consistent with an enhanced effect on eliminating the HBV virus when using XTL-001 compared with standard therapy alone."
Dr. Martin Becker, Ph.D., President and CEO of XTL, said: "These encouraging interim results provide initial validation of our combination therapy strategy for HBV, a chronic disease affecting over 300 million people worldwide. We look forward to seeing continued progress with this and other products in our portfolio during 2002."
XTL-001 consists of two high affinity human monoclonal antibodies that act at multiple sites on the HBV surface antigen. These antibodies were discovered and developed using XTL`s Trimera system, a proprietary technology for generating high affinity human monoclonal antibodies and for creating in vivo systems for bio-validating therapeutics using functional human tissue.
Hepatitis B is one of the most common potentially fatal infectious diseases in the world. The hepatitis B virus is up to 100 times more infectious than HIV, the virus that causes AIDS. Modes of transmission include blood transfusions, contaminated needles, sexual contact, breast milk and open sores. Most people infected with acute hepatitis B have no symptoms and are able to fight off the infection themselves. According to the American Liver Foundation, 5% to 10% of those infected with hepatitis B will become chronic carriers of the virus. The World Health Organization estimates that approximately 350 million individuals worldwide, or 5% of the world`s population, are long-term carriers of hepatitis B in their blood. In the United States, there are over 1 million carriers of hepatitis B and an estimated 200,000 people contract acute hepatitis B each year. Most are unaware that they are infected or have minimal disease with no clinically evident symptoms. However, carriers of the hepatitis B virus have a 200-fold increased chance of developing primary liver cancer, the most common cancer in the world, and a significant number develop cirrhosis of the liver. A safe and effective vaccine against hepatitis B is available. However, the vaccine is a preventative in that it only benefits those who have not yet been infected by the hepatitis B virus. It is not indicated for the treatment of chronic infection. Most approved treatments only benefit a limited proportion of patients and can have serious adverse side effects.
12th October 2001- XTL Biopharmaceuticals Ltd - Sign License and Collaboration Agreement for Development of Monoclonal Antibodies Against Staphylococcal Infections with Biostapro
XTL Biopharmaceuticals Ltd and Biostapro AB, a privately-held biopharmaceutical company based in Sweden, announced today that they have entered into a collaboration to develop fully human monoclonal antibodies (hMAbs) against Staphylococcal infections.
As part of the agreement, XTL will license from Biostapro two protein targets on the cell surface of two major staphylococcal bacteria, S. Aureus, and S. Epidermidis. These targets have previously undergone significant validation processes at Biostapro. The companies will collaborate on the development of hMAbs against these targets using XTL`s proprietary TrimeraXTL technology. XTL will also be responsible for clinical trials and further commercialization of these antibodies. Biostapro will receive a license fee, milestone payments and royalties on future sales.
Staphylococcal infections (mainly caused by S. Aureus and S. Epidermidis) are frequent hospital acquired infections, with S. Aureus responsible for over 400,000 infections each year in the US, Europe and Japan and at least a similar number associated with S. Epidermidis infection. These bacteria are characterized by a high and increasingly growing rate of antibiotic-resistance. Thus, they pose a significant threat to the lives of patients and a significant burden to healthcare systems due to their very high cost of treatment.
Dr. Martin Becker, CEO of XTL, said: "Staphylococcal infections are a key therapeutic area in which there is a clear need for therapeutics with a novel mechanism of action. Monoclonal antibodies represent a powerful and innovative therapeutic approach to these life-threatening diseases. This collaboration with Biostapro is an important step in XTL`s ongoing strategy of developing fully human monoclonal antibodies against infectious disease."
11th September 2001 - XTL Biopharmaceuticals Ltd. – XTL Interim Results for the Six Months Ended 30th June 2001
XTL announce their interim Results for the Six Months Ended 30th June 2001
K
XTLbio.com 1000% per year
Rehovot, Israel, 18 November 2004 - XTL Biopharmaceuticals Ltd. (LSE: XTL) (“XTLbio” or the “Company” reports progress in developing HepeX-C as a combination of two human monoclonal antibodies (MAb’s) for prevention of re-infection with HCV following liver transplantation (LT):
* FDA formally releases clinical hold on Phase 2a trial with single MAb (AbXTL68) product;
* Following analysis of results available from the above trial, XTLbio can now estimate target dosing regimen range required to achieve a therapeutic effect in LT patients without the need to continue this trial; and
* Following a positive Pre-IND meeting with FDA, XTLbio to file an IND for HepeX-C as a dual MAb product in the first half of 2005.
Rehovot, Israel, 18 November 2004 - XTL Biopharmaceuticals Ltd. (LSE: XTL) (“XTLbio” or the “Company” reports progress in developing HepeX-C as a combination of two human monoclonal antibodies (MAb’s) for prevention of re-infection with HCV following liver transplantation (LT):
* FDA formally releases clinical hold on Phase 2a trial with single MAb (AbXTL68) product;
* Following analysis of results available from the above trial, XTLbio can now estimate target dosing regimen range required to achieve a therapeutic effect in LT patients without the need to continue this trial; and
* Following a positive Pre-IND meeting with FDA, XTLbio to file an IND for HepeX-C as a dual MAb product in the first half of 2005.
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XTL Biopharmaceuticals Ltd
18 February 2005
XTL Biopharmaceuticals Ltd
Preliminary Results for the Year Ended 31 December 2004
Rehovot, Israel, 18 February 2005 - XTL Biopharmaceuticals Ltd (LSE: XTL) today
announces its financial results for the year ended 31 December 2004.
Highlights
Hepatitis B:
• Major worldwide licensing agreement signed with Cubist Pharmaceuticals for
the development and commercialisation of HepeX-B.
• Independent Data & Safety Monitoring Board (DSMB) recommended continuation
of the ongoing Phase 2b trial of Hepex-B and enrolment continues.
• Orphan Drug Designation received from the European Medicines Evaluation
Agency (EMEA).
• Fourth patent issued in July 2004.
Hepatitis C:
• Data presented at American Association for the Study of Liver Diseases
(AASLD) and the European Association for the Study of Liver Diseases (EASL)
showed complementary activity in the dual-antibody approach and subsequent
neutralisation of the Hepatitis virus in serum from patients with chronic HCV.
• Pre-IND meeting held with the FDA on the dual-antibody approach. Preparation
now underway of an IND for the dual-antibody product to be submitted to the FDA
in 2005.
• FDA approval to continue specific dose cohort in Phase II clinical trial,
after a dosing arm in the trial had been voluntarily halted due to a patient not
surviving a transplant operation.
• Two clinical candidates, both small molecules, identified for the treatment
of chronic HCV and preparation of INDs is underway.
Financial:
• $17.8 million raised in an equity offering to investors
• Net loss increased to $16.5 million (2003: $14.3 million)
• Cash, short and long term investments of $23 million (2003: $22.4 million)
Elkan Gamzu, Interim Chief Executive Officer, said:
`We made good progress on a number of fronts in 2004, in particular the signing
of our commercial agreement with Cubist Pharmaceuticals Inc for the licensing,
development and commercialisation of Hepex-B, our most advanced program for
which we are recruiting patients for an ongoing Phase 2b trial.
Alongside the progress made with our development programs, we raised $17.8
million from a number of new international institutional investors and with the
support from them and our existing investors, we look forward to furthering our
development programs and advancing our plans to seek a listing on NASDAQ. We
believe that a solid presence in the US market will assist us in growing the
business going forward.`
CONTACTS
XTLbio
Dr. Elkan Gamzu
Interim Chairman and CEO
+972-8-930-4440
Financial Dynamics
Julia Phillips
+44 (0) 20 7831 3113
Dear Shareholder,
As the Interim Chairman and Chief Executive Officer, I am pleased to update you
on the achievements of XTLbio during 2004. It has been a year of success and
also one of change.
HepeX-B commercial and clinical progress
A major achievement on the business front was the establishment in June of a
commercial agreement with Cubist Pharmaceuticals, Inc. for the licensing,
development and commercialisation of HepeX-B, our most advanced program. HepeX-B
is targeted for the prevention of hepatitis B virus (HBV) re-infection in
patients who have received a liver transplant for end-stage hepatitis B
infection. Not only does this agreement lend continuing validation to our
various hepatitis programs, but it also allowed us to reallocate resources to
our higher-value development programs targeted at the hepatitis C virus (HCV).
We are proud to be working with Cubist, a company that has proven its ability to
develop and launch a novel anti-infective product. During 2004, Cubist
successfully raised over $100M, indicating that some of those funds would be
dedicated to the development of HepeX-B.
In November, we announced, together with Cubist that an independent Data and
Safety Monitoring Board (DSMB) recommended continuation of the ongoing Phase IIb
trial of HepeX-B to prevent hepatitis B reinfection in patients who have
received a liver transplant, and who have been maintained on hepatitis B immune
globulin (HBIg). We look forward to completing the enrolment into this trial in
2005.
Alongside these business and clinical achievements in our HepeX-B program, was
the issuance to XTLbio of a fourth patent in the area, as well as the EU
designation of HepeX-B as an Orphan Drug, which complemented a similar
designation by the US FDA in 2003.
HepeX-C clinical and research
The Company also made important progress toward the goal of developing a
combination of two human monoclonal antibodies (MAbs) AbXTL65 and AbXTL68 for
the prevention of HCV re-infection in liver transplant patients. Based on the
biological activity measured in samples from patients in our Phase IIa trial of
the single MAb (AbXTL68), we can now estimate the target dosing range required
to achieve a therapeutic effect in these patients.
During 2004, the Company voluntarily halted enrolment into one of the dosing
arms in that trial, after a patient did not survive the transplant operation.
Subsequently, the Medical Examiner concluded that the cause of death was
pulmonary emboli and expert consultant reviews did not reveal any evidence of a
drug relationship. Consequently the FDA agreed that entry into the specific dose
cohort could be reopened. However, by that time, the Company had already
obtained the information necessary to estimate the target dosing range and
decided to focus its resources on the combination of the two antibodies.
At the annual meetings of the American Association for the Study of Liver
Diseases (AASLD) and the European Association of the Study of Liver diseases
(EASL), our scientists presented data showing that XTLbio`s two antibodies had
complementary activity and that a mixture of both antibodies effectively
neutralized the hepatitis virus in serum from patients with chronic HCV - a
powerful example of the utility of the dual MAb approach. This presentation and
that of the data from our clinical trial of AbXTL68 were well received and
contributed to growing awareness of XTLbio as an important company in the area
of potential therapeutics for the treatment of hepatitis.
In 2004, the Company had a pre-IND (Investigational New Drug application)
meeting with the FDA at which XTLbio presented data on the dual Mabs - AbXTL68
and AbXTL65 - which had successfully completed pre-clinical development. XTLbio
presented the rationale for developing HepeX-C as a combination product
containing both Mabs (targeting different viral sites). The Company is now
preparing an IND for the dual-MAb product for submission to the FDA in 2005.
Our intellectual property position around the HepeX-C program was further
strengthened by the issuance of a patent for an anti HCV human monoclonal
antibody recently licensed from Stanford University. This is XTLbio`s first
issued patent in the area of HCV antibodies and it will provide a strong
intellectual property base for the Company`s enhanced HepeX-C product in the US.
Small molecule program against chronic HCV
As was reported early in the year, our small molecule program for the treatment
of chronic HCV has yielded two clinical candidates. These are proprietary
synthetic compounds that inhibit the enzyme responsible for the replication of
HCV. Data from this project were also presented at EASL. We are continuing to
move both molecules forward along the development path and hope to submit an IND
to the US FDA later in 2005.
Financing
In July, we significantly strengthened our financial position by closing a $17.8
million financing, through a Placing and Open Offer, approximately 10% of which
was raised in the USA. Given the difficult market we were pleased to have been
able to raise significant new funds for the Company and to have attracted a
number of new top tier institutional investors.
NASDAQ
Early in 2004, we communicated our desire to seek a listing on the US NASDAQ
market which is a dynamic centre for biotechnology investment, innovation and
commercialisation. We believe that a US listing would provide further
opportunity for management to grow the business. In preparation we have
undertaken a number of steps including the restructuring of our Board of
Directors to a US format, whereby the Directors are largely non-executive and a
major part of the Board is comprised of directors with US company experience. To
this end, we appointed Peter Stalker, a former Managing Director of Warburg,
Pincus and Company, in New York. We also reduced the number of Directors on the
Board to render it more efficient and began actively seeking a US-based Chief
Executive Officer with a proven track record. Finally, we have raised awareness
of XTLbio by presentations at various investor conferences.
When market and other conditions are appropriate, XTLbio should be ready to
capitalize on the opportunity.
Personnel Changes
2004 has also been a year of change at the managerial level. To some extent,
these changes have been driven by our successes. With two projects already in
the clinic and a potential third IND submission by late 2005, the clinical,
product development and business activities have taken on a greater importance
as we transition from a purely research based company to a more
commercially-focused business. To lead us through this transition,
business-oriented managerial skills are essential to ensure our continued
success.
To this end, Dr. Martin Becker resigned as CEO to enable us to seek a US-based
CEO with experience, not only in development of pharmaceuticals, but also with a
proven track record in commercialisation, as well as experience in fund raising
and interacting with Wall Street. I agreed to serve as the interim CEO until a
new CEO is appointed.
The Company is extremely grateful to Dr. Becker for the many years of service
and for leading the business through recent years of significant progress
including the Company`s public listing in London, the commercial out-licensing
of one of our lead products and the fundraising this summer which set us up well
for 2005 and beyond. We all wish Martin every success in his future endeavours.
Glenn Kazo resigned as Chief Business Officer toward the end of the year to
pursue other interests. We thank Glenn for his 5 years of service and the
important role he played both in key in-licensing activities, which have
contributed greatly to our current portfolio, as well as for his role in the
alliance with Cubist.
Importantly, two new members were added to the management team. Dr. Clarence
Richard (Rick) Wobbe was named as Senior Director, Program Manager. Rick`s
experience in developing pre-clinical candidates through the clinical stage will
be a valuable asset as he leads the small molecule program targeted for the
treatment of chronic HCV. Craig Shore, was appointed General Manager of the
Israel site. Craig brings with him financial/general manager experience from two
of the world`s largest pharmaceutical companies as well as experience in
managing an IPO on NASDAQ.
As referenced earlier, there has also been change at the Board level. As the
Company grows we wish to tap into the major sources of support for biotechnology
that are located in the US. Not only did we limit Board membership to
non-executive directors (with the exception of the CEO), but we also appointed
two new members: Peter Stalker and Michael Weiss, both US-based. In addition,
Martin Becker, Ehud Geller and Hadar Ron chose to resign. In January 2005,
Geoffrey Vernon informed us that due to family reasons he was stepping down as
non-Executive Chairman and again I agreed to serve in that role until a more
permanent solution was reached. We thank our colleagues for all their efforts on
behalf of the Company.
I would like to thank our staff for their hard work and commitment, and our
shareholders for their ongoing support. We are looking forward to building on
last year`s success during 2005.
Elkan Gamzu, PhD
Interim Chairman and Chief Executive Officer
17 February 2005
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
IN U.S. DOLLARS
31 December
2004 2003
___________ ___________
In thousands
--------------
A s s e t s
CURRENT ASSETS:
Cash and cash equivalents 12,788 4,184
Short-term bank deposits (note 5a) 10,136 17,329
Marketable securities (note 5b) 749
Accounts receivable - trade (note 4) 543
Accounts receivable - other (note 5c) 306 706
__________ ___________
T o t a l current assets 23,773 22,968
___________ ___________
SEVERENCE PAY FUNDS 830 673
___________ ___________
RESTRICTED LONG-TERM DEPOSIT 113 159
___________ ___________
PROPERTY AND EQUIPMENT:
Cost 3,312 3,143
L e s s - accumulated depreciation and
amortization 2,404 2,090
___________ ___________
908 1,053
___________ ___________
T o t a l assets 25,624 24,853
========== ==========
Liabilities and shareholders` equity
CURRENT LIABILITIES:
Accounts payable and accruals (note 5d) 3,134 3,001
Deferred gain 399
___________ ___________
T o t a l current liabilities 3,533 3,001
___________ ___________
LIABILITY FOR EMPLOYEE RIGHTS
UPON RETIREMENT 1,291 1,244
DEFERRED GAIN 1,198
___________ ___________
COMMITMENTS AND CONTINGENCIES
T o t a l liabilities 6,022 4,245
___________ ___________
SHAREHOLDERS` EQUITY (note 6):
Ordinary Shares of NIS0.02 par value (authorized:
300,000,000
as of 31 December 2004 and 2003; issued and
outstanding:
168,079,196 as of 31 December2004 and 112,019,464
as of
31 December 2003) 841 594
Additional paid in capital 104,168 88,966
Deferred share-based compensation 369 337
Accumulated other comprehensive loss 14
Deficit accumulated during the development stage (85,776) (69,303)
___________ ___________
T o t a l shareholders` equity 19,602 20,608
___________ ___________
T o t a l liabilities and shareholders` equity 25,624 24,853
========= ==========
The accompanying notes are an integral part of the financial statements
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
IN U.S. DOLLARS
Period from
9 March 1993*
Year ended 31 December to 31 December
2004 2003 2002 2004
__________ __________ __________ __________
In thousands (except share and per share data)
------------------------------------------------
REVENUES (notes 3 and
4):
Reimbursed
out-of-pockets 3,269 3,269
expenses
License 185 185
__________ __________
3,454 3,454
COST OF REVENUES (notes
3 and 4):
Reimbursed
out-of-pockets 3,269 3,269
expenses
License with respect to
royalties 32 32
__________ __________
3,301 3,301
RESEARCH AND
DEVELOPMENT
COSTS (note 5e) 11,985 13,668 13,231 75,223
L E S S - PARTICIPATIONS - 3,229 75 10,950
__________ _________ __________ __________
11,985 10,439 13,156 64,273
GENERAL AND
ADMINISTRATIVE
EXPENSES (note 5f) 4,134 3,105 3,638 23,555
BUSINESS DEVELOPMENT
COSTS 810 664 916 4,286
(note 5g)
IMPAIRMENT OF ASSET HELD
FOR
SALE 354 354
__________ __________ __________ _________
OPERATING LOSS 16,776 14,562 17,710 92,315
FINANCIAL INCOME - net
(note 5h) 352 352 597 6,700
__________ __________ __________ _________
LOSS BEFORE TAXES ON
INCOME 16,424 14,210 17,113 85,615
TAXES ON INCOME 49 78 27 161
_________ _________ _________ _________
NET LOSS FOR THE YEAR 16,473 14,288 17,140 85,776
========= ========= ========= ========
BASIC AND DILUTED PER
SHARE DATA:
Loss per ordinary share $( 0.12) $( 0.13) $( 0.15)
========= ======== =========
Weighted average number
of
shares used to compute
loss per
ordinary share 134,731,766 111,712,916 111,149,292
========= ========= =========
* Incorporation date, see note 1a.
The accompanying notes are an integral part of the financial statements
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
IN U.S. DOLLARS
Period from
9 March 1993 (b)
Year ended 31 December to 31 December
2004 2003 2002 2004
________ ________ ________ ________
In thousands
--------------
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss for the period (16,473) (14,288) (17,140) (85,776)
Adjustments to reconcile loss
to net cash used in
operating activities:
Depreciation and amortization 319 440 470 2,587
Capital loss (gain) on sale of
property and equipment 1 2 (1) 12
Change in liability for
employee 30 129 333 1,469
rights upon retirement
Impairment of asset held for 354 354
sale
Loss (gain) from marketable
securities, net 13 (27) 41 (410)
Stock based compensation 32 515
expenses
Loss (gain) on amounts funded
in (4) 5 (1) (85)
respect of employee
Changes in operating asset and
liability items:
Increase in accounts receivable
- (543) (543)
trade
Decrease (increase) in accounts
receivable - other 400 (440) 606 (259)
Increase (decrease) in accounts
payable and accruals 133 499 (20) 3,087
Increase in deferred gain 1,597 1,597
________ ________ _______ ________
Net cash used in operating
activities (a) (14,495) (13,326) (15,712) (77,452)
________ ________ _______ ________
CASH FLOWS FROM INVESTING
ACTIVITIES:
Short-term deposits, net 7,193 14,724 1,058 (10,136)
Long-term deposits, net 46 (20) 2 (113)
Investment in available for
sale (71) (1,219) (3,363)
securities
Proceeds from sales of
available 722 1,048 716 3,773
for sale securities
Severance pay funded (136) (112) (97) (841)
Purchase of property and (180) (81) (659) (3,983)
equipment
Proceeds from sale of property
and 5 2 8 122
equipment
________ ________ _______ ________
Net cash provided by (used in)
investing activities -
brought
forward 7,650 15,490 (191) (14,541)
_________ ________ _______ ________
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
IN U.S. DOLLARS
Period from
9 March 1993 (b)
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ _________ _________
In thousands
--------------
Net cash provided by (used
in) investing activities -
brought
forward 7,650 15,490 (191) (14,541)
________ _________ _________ _________
CASH FLOWS FROM FINANCING
ACTIVITIES:
Issuance of share capital
- 15,430 104,371
net of share issuance
expenses
Exercise of share warrants
and 19 4 20 492
employee stock options
Proceeds from long-term 399
debt
Proceeds from short-term 50
debt
Repayment of long-term (399)
debt
Repayment of short-term (50)
debt
_________ _________ _________ _________
Net cash provided by
financing 15,449 4 20 104,863
activities
________ _________ _________ _________
NET INCREASE (DECREASE) IN
CASH AND
CASH EQUIVALENTS 8,604 2,168 (15,883) 12,788
BALANCE OF CASH AND CASH
EQUIVALENTS AT
BEGINNING OF PERIOD 4,184 2,016 17,899
_________ _________ _________ _________
BALANCE OF CASH AND CASH
EQUIVALENTS AT
END OF PERIOD 12,788 4,184 2,016 12,788
======== ======== ======== ========
Supplementary information
on financing activity
not
involving cash flows -
conversion of convertible
subordinated debenture
into 1,700
shares
========
Supplemental disclosures
of cash flow information:
Income taxes paid (mainly
- tax advance in respect
of
excess
expenses) 107 161 79 321
======== ======== ======== ========
Interest paid 350
========
(a) Including
effect of
changes in the
exchange rate
on cash (73) (9) (709) (1,839)
======== ======== ======== ========
(b) Incorporation date, see note 1a.
The accompanying notes are an integral part of the financial statements
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. GENERAL
Through 31 December 2004, the Company has incurred losses in an aggregate
amount of US$86 million. Such losses have resulted from the Company`s
activities as a development stage company. It is expected that the Company
will be able to finance its operations from its current reserves for the
coming year. Continuation of the Company`s current operations after
utilizing its current cash reserves during 2006, is dependent upon the
generation of additional financial resources either through agreements for
the commercialisation of its product portfolio or through external
financing.
2. RESEARCH AND DEVELOPMENT COSTS AND PARTICIPATIONS
Research and development costs are expensed as incurred and consist
primarily of personnel, payments to sub-contractors, facilities, equipment
and supplies for research and development activities.
Participations from government (and from others) for development of approved
projects are recognized as a reduction of expense as the related costs are
incurred.
3. REVENUE RECOGNITION
The Company recognizes the revenue from the licensing agreement with Cubist
under the provisions of the EITF 00-21 entitled `Revenue Arrangements with
Multiple Deliverables` and SAB 104 entitled `Revenue Recognition`. Under
those terms, companies are required to defer all revenue from
multiple-element arrangements if sufficient objective and reliable evidence
of fair value does not exist for the allocation of revenue to the various
elements of the arrangement. Since the Company does not have the ability to
determine the fair value of each unit of accounting, the agreement was
accounted for as one unit of accounting, after failing the separation
criteria, and the Company recognizes revenue on the abovementioned agreement
ratably over the life of the arrangement.
In addition, Cubist has requested the Company to provide development
services that are reimbursed by Cubist. As required by EITF 01-14 `Income
Statement Characterization of Reimbursements Received for `Out-of-Pocket`
Expenses Incurred`, amounts paid by the Company, as a principal, as an
`out-of-pocket` costs are included in the cost of revenues as reimbursable
out-of-pocket expenses and the reimbursements the Company receives as a
principal are reported as reimbursed out-of-pocket revenues.
4. LICENSE AGREEMENT WITH CUBIST
The Company entered into a licensing agreement with Cubist in June 2004,
under which the Company granted to Cubist an exclusive, worldwide license
(with the right to sub-license) to commercialise HepeX-B and any other
product containing a hMAb or humanized monoclonal antibody or fragment
directed at the hepatitis B virus owned or controlled by the Company. See
also note 3 for the revenue recognition treatment.
Cubist paid the Company an initial up front non-refundable payment of US$1
million upon the signing of the agreement, and a payment of US$1 million
(out of which $185 thousands was recorded as revenue in the year ended 31
December 2004) out of an aggregate amount of US$2 million as collaboration
support to be paid in instalments until the end of 2005 and an additional
amount of US$3 million upon achievement of certain regulatory milestones
till 2007 or an amount of US$2 million upon achievement of the same certain
regulatory milestones till 2008.
The company accounts for the payments resulting from the agreement, as
follows (i) the $1 million up front fee and the instalment payments
aggregating $2 million are recorded as deferred revenue upon receipt and
amortized through 2008 or date regulatory approval obtained, if earlier, and
(ii) the milestone contingent payments will be recorded as revenue upon
regulatory approval milestones obtained.
Under the agreement, the Company is entitled to receive royalties from net
sales by Cubist, if any, generally ranging from 10% to 17%, depending on
levels of net sales achieved by Cubist, subject to certain deductions based
on patent protection of HepeX-B in that territory, total costs of HepeX-B
development, third party license payments and indemnification obligations.
The agreement expires on the later of the last valid patent claim covering
Hepex-B to expire, or 10 years after the first commercial sale of Hepex-B on
a country by country basis.
Under a research and license agreement, the Company paid during 2004, $250
thousands with respect to the $1 million up front fee received in June 2004,
out of which $32 thousands was recorded as cost of revenues in 2004.
The balance of the deferred gain, related to the revenue from Cubist, as of
31 December 2004, was presented in the balance sheet, net of the above
mentioned payment, as follows:
31 December
2004
_____________
$ in thousands
_____________
Deferred revenue 1,815
Less - Deferred expenses related to Yeda 218
_____________
Deferred gain 1,597
============
5. SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION
a. Short-term bank deposits
The deposits are denominated in dollar and bear a weighted average annual
interest rate of 1.81 % as of 31 December 2004 (as of 31 December 2003 - 1.17%).
b. Marketable securities:
1) As of 31 December 2004, there are no marketable securities. The balance as
of 31 December 2003 composed as follows:
31 December 2003
Amortized Unrealized holding gains Unrealized holding Estimated
Cost ___________ losses Fair market
___________ ___________ value
___________
$ in thousands
----------------
Debentures:
Link to the
Israeli CPI 71 (2) 69
Unlinked 561 19 (17) 563
___________ ___________ ___________ ___________
632 19 (19) 632
___________ ___________ ___________ ___________
Sort-term
treasury
notes
and bonds:
Link to the
USD 10 10
Unlinked 93 14 ___________ 107
___________ ___________ ___________
103 14 ___________ 117
___________ ___________ ___________
735 33 (19) 749
========= ========= ========= =========
2) Changes in marketable securities held for sale are as follows:
2004 2003 2002
_______ _______ _______
$ in thousands
----------------
Balance at beginning of year 749 1,637 1,178
Investments 71 1,219
Proceeds from sales (722) (1,048) (716)
Reclassifications into earnings (loss) from
other
comprehensive income (loss) (14) 62 (3)
Realized gain (loss) from sales (13) 27 (41)
_______ _______ _______
-,- 749 1,637
======= ======= =======
31 December
2004 2003
_______ _______
$ in thousands
----------------
Office of the Chief Scientist of
the Israeli Ministry of Industry (`OCS`) - 537
Prepaid expenses 165 119
Employees 24 36
Value Added Tax authorities 101 6
Sundry 16 8
__________ __________
306 706
======== =========
c. Accounts receivable - other:
d. Accounts payable and accruals:
31 December
2004 2003
__________ __________
$ in thousands
----------------
Suppliers 1,108 1,334
Accrued expenses 1,337 1,077
Institutions and employees in respect of salaries
and related benefits 294 280
Provision for vacation pay and recreation pay 385 300
Sundry 10 10
_________ __________
3,134 3,001
======== =========
Statements of operations:
e. Research and development costs:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Wages, salaries
and
related
benefits 2,776 3,450 3,958 20,945
Sub-contractors expenses 6,430 6,799 5,575 33,856
Laboratories supplies 754 1,128 1,653 8,406
Consulting 549 494 396 3,194
Rent and maintenance 725 866 926 4,004
Depreciation and 277 369 415 2,717
amortization
Other 474 562 308 2,101
________ _________ ________ _________
11,985 13,668 13,231 75,223
======== ========= ======= ========
f. General and administrative expenses:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Wages, salaries and related
benefits 1,890 1,244 1,704 11,080
Corporate communications 289 228 598 2,210
Professional fees 647 564 662 3,515
Director fees 243 183 181 1,387
Rent and maintenance 90 104 135 865
Communication 34 33 43 195
Depreciation and amortization 42 70 55 589
Patent registration fees 271 125 71 1,017
Other 628 554 189 2,697
_________ _________ ________ _________
4,134 3,105 3,638 23,555
======= ======= ======= =======
g. Business development costs:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Wages, salaries
and related
benefits 410 408 567 2,501
Travel 36 136 140 742
Professional
fees 364 120 209 1,043
_________ _________ ______ ________
810 664 916 4,286
======== ======== ===== =======
h. Financial income, net:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Financial income:
Interest received 297 458 1,360 8,725
Foreign exchange
differences
gain 67 203
Gain from available for
sale
securities 13 62 (13)
Other _________ _________ ________ 156
_________
377 520 1,360 9,097
________ _________ ________ _________
Financial expenses:
Foreign exchange
differences
loss 148 733 1,921
Interest paid 374
Loss from available for
sale
securities 3 14
Other 25 20 27 88
________ _________ ________ _________
25 168 763 2,397
_________ _________ ________ _________
Financial income, net 352 352 597 6,700
======== ======== ======= ========
Gruss
B.M.
XTL Biopharmaceuticals Ltd
18 February 2005
XTL Biopharmaceuticals Ltd
Preliminary Results for the Year Ended 31 December 2004
Rehovot, Israel, 18 February 2005 - XTL Biopharmaceuticals Ltd (LSE: XTL) today
announces its financial results for the year ended 31 December 2004.
Highlights
Hepatitis B:
• Major worldwide licensing agreement signed with Cubist Pharmaceuticals for
the development and commercialisation of HepeX-B.
• Independent Data & Safety Monitoring Board (DSMB) recommended continuation
of the ongoing Phase 2b trial of Hepex-B and enrolment continues.
• Orphan Drug Designation received from the European Medicines Evaluation
Agency (EMEA).
• Fourth patent issued in July 2004.
Hepatitis C:
• Data presented at American Association for the Study of Liver Diseases
(AASLD) and the European Association for the Study of Liver Diseases (EASL)
showed complementary activity in the dual-antibody approach and subsequent
neutralisation of the Hepatitis virus in serum from patients with chronic HCV.
• Pre-IND meeting held with the FDA on the dual-antibody approach. Preparation
now underway of an IND for the dual-antibody product to be submitted to the FDA
in 2005.
• FDA approval to continue specific dose cohort in Phase II clinical trial,
after a dosing arm in the trial had been voluntarily halted due to a patient not
surviving a transplant operation.
• Two clinical candidates, both small molecules, identified for the treatment
of chronic HCV and preparation of INDs is underway.
Financial:
• $17.8 million raised in an equity offering to investors
• Net loss increased to $16.5 million (2003: $14.3 million)
• Cash, short and long term investments of $23 million (2003: $22.4 million)
Elkan Gamzu, Interim Chief Executive Officer, said:
`We made good progress on a number of fronts in 2004, in particular the signing
of our commercial agreement with Cubist Pharmaceuticals Inc for the licensing,
development and commercialisation of Hepex-B, our most advanced program for
which we are recruiting patients for an ongoing Phase 2b trial.
Alongside the progress made with our development programs, we raised $17.8
million from a number of new international institutional investors and with the
support from them and our existing investors, we look forward to furthering our
development programs and advancing our plans to seek a listing on NASDAQ. We
believe that a solid presence in the US market will assist us in growing the
business going forward.`
CONTACTS
XTLbio
Dr. Elkan Gamzu
Interim Chairman and CEO
+972-8-930-4440
Financial Dynamics
Julia Phillips
+44 (0) 20 7831 3113
Dear Shareholder,
As the Interim Chairman and Chief Executive Officer, I am pleased to update you
on the achievements of XTLbio during 2004. It has been a year of success and
also one of change.
HepeX-B commercial and clinical progress
A major achievement on the business front was the establishment in June of a
commercial agreement with Cubist Pharmaceuticals, Inc. for the licensing,
development and commercialisation of HepeX-B, our most advanced program. HepeX-B
is targeted for the prevention of hepatitis B virus (HBV) re-infection in
patients who have received a liver transplant for end-stage hepatitis B
infection. Not only does this agreement lend continuing validation to our
various hepatitis programs, but it also allowed us to reallocate resources to
our higher-value development programs targeted at the hepatitis C virus (HCV).
We are proud to be working with Cubist, a company that has proven its ability to
develop and launch a novel anti-infective product. During 2004, Cubist
successfully raised over $100M, indicating that some of those funds would be
dedicated to the development of HepeX-B.
In November, we announced, together with Cubist that an independent Data and
Safety Monitoring Board (DSMB) recommended continuation of the ongoing Phase IIb
trial of HepeX-B to prevent hepatitis B reinfection in patients who have
received a liver transplant, and who have been maintained on hepatitis B immune
globulin (HBIg). We look forward to completing the enrolment into this trial in
2005.
Alongside these business and clinical achievements in our HepeX-B program, was
the issuance to XTLbio of a fourth patent in the area, as well as the EU
designation of HepeX-B as an Orphan Drug, which complemented a similar
designation by the US FDA in 2003.
HepeX-C clinical and research
The Company also made important progress toward the goal of developing a
combination of two human monoclonal antibodies (MAbs) AbXTL65 and AbXTL68 for
the prevention of HCV re-infection in liver transplant patients. Based on the
biological activity measured in samples from patients in our Phase IIa trial of
the single MAb (AbXTL68), we can now estimate the target dosing range required
to achieve a therapeutic effect in these patients.
During 2004, the Company voluntarily halted enrolment into one of the dosing
arms in that trial, after a patient did not survive the transplant operation.
Subsequently, the Medical Examiner concluded that the cause of death was
pulmonary emboli and expert consultant reviews did not reveal any evidence of a
drug relationship. Consequently the FDA agreed that entry into the specific dose
cohort could be reopened. However, by that time, the Company had already
obtained the information necessary to estimate the target dosing range and
decided to focus its resources on the combination of the two antibodies.
At the annual meetings of the American Association for the Study of Liver
Diseases (AASLD) and the European Association of the Study of Liver diseases
(EASL), our scientists presented data showing that XTLbio`s two antibodies had
complementary activity and that a mixture of both antibodies effectively
neutralized the hepatitis virus in serum from patients with chronic HCV - a
powerful example of the utility of the dual MAb approach. This presentation and
that of the data from our clinical trial of AbXTL68 were well received and
contributed to growing awareness of XTLbio as an important company in the area
of potential therapeutics for the treatment of hepatitis.
In 2004, the Company had a pre-IND (Investigational New Drug application)
meeting with the FDA at which XTLbio presented data on the dual Mabs - AbXTL68
and AbXTL65 - which had successfully completed pre-clinical development. XTLbio
presented the rationale for developing HepeX-C as a combination product
containing both Mabs (targeting different viral sites). The Company is now
preparing an IND for the dual-MAb product for submission to the FDA in 2005.
Our intellectual property position around the HepeX-C program was further
strengthened by the issuance of a patent for an anti HCV human monoclonal
antibody recently licensed from Stanford University. This is XTLbio`s first
issued patent in the area of HCV antibodies and it will provide a strong
intellectual property base for the Company`s enhanced HepeX-C product in the US.
Small molecule program against chronic HCV
As was reported early in the year, our small molecule program for the treatment
of chronic HCV has yielded two clinical candidates. These are proprietary
synthetic compounds that inhibit the enzyme responsible for the replication of
HCV. Data from this project were also presented at EASL. We are continuing to
move both molecules forward along the development path and hope to submit an IND
to the US FDA later in 2005.
Financing
In July, we significantly strengthened our financial position by closing a $17.8
million financing, through a Placing and Open Offer, approximately 10% of which
was raised in the USA. Given the difficult market we were pleased to have been
able to raise significant new funds for the Company and to have attracted a
number of new top tier institutional investors.
NASDAQ
Early in 2004, we communicated our desire to seek a listing on the US NASDAQ
market which is a dynamic centre for biotechnology investment, innovation and
commercialisation. We believe that a US listing would provide further
opportunity for management to grow the business. In preparation we have
undertaken a number of steps including the restructuring of our Board of
Directors to a US format, whereby the Directors are largely non-executive and a
major part of the Board is comprised of directors with US company experience. To
this end, we appointed Peter Stalker, a former Managing Director of Warburg,
Pincus and Company, in New York. We also reduced the number of Directors on the
Board to render it more efficient and began actively seeking a US-based Chief
Executive Officer with a proven track record. Finally, we have raised awareness
of XTLbio by presentations at various investor conferences.
When market and other conditions are appropriate, XTLbio should be ready to
capitalize on the opportunity.
Personnel Changes
2004 has also been a year of change at the managerial level. To some extent,
these changes have been driven by our successes. With two projects already in
the clinic and a potential third IND submission by late 2005, the clinical,
product development and business activities have taken on a greater importance
as we transition from a purely research based company to a more
commercially-focused business. To lead us through this transition,
business-oriented managerial skills are essential to ensure our continued
success.
To this end, Dr. Martin Becker resigned as CEO to enable us to seek a US-based
CEO with experience, not only in development of pharmaceuticals, but also with a
proven track record in commercialisation, as well as experience in fund raising
and interacting with Wall Street. I agreed to serve as the interim CEO until a
new CEO is appointed.
The Company is extremely grateful to Dr. Becker for the many years of service
and for leading the business through recent years of significant progress
including the Company`s public listing in London, the commercial out-licensing
of one of our lead products and the fundraising this summer which set us up well
for 2005 and beyond. We all wish Martin every success in his future endeavours.
Glenn Kazo resigned as Chief Business Officer toward the end of the year to
pursue other interests. We thank Glenn for his 5 years of service and the
important role he played both in key in-licensing activities, which have
contributed greatly to our current portfolio, as well as for his role in the
alliance with Cubist.
Importantly, two new members were added to the management team. Dr. Clarence
Richard (Rick) Wobbe was named as Senior Director, Program Manager. Rick`s
experience in developing pre-clinical candidates through the clinical stage will
be a valuable asset as he leads the small molecule program targeted for the
treatment of chronic HCV. Craig Shore, was appointed General Manager of the
Israel site. Craig brings with him financial/general manager experience from two
of the world`s largest pharmaceutical companies as well as experience in
managing an IPO on NASDAQ.
As referenced earlier, there has also been change at the Board level. As the
Company grows we wish to tap into the major sources of support for biotechnology
that are located in the US. Not only did we limit Board membership to
non-executive directors (with the exception of the CEO), but we also appointed
two new members: Peter Stalker and Michael Weiss, both US-based. In addition,
Martin Becker, Ehud Geller and Hadar Ron chose to resign. In January 2005,
Geoffrey Vernon informed us that due to family reasons he was stepping down as
non-Executive Chairman and again I agreed to serve in that role until a more
permanent solution was reached. We thank our colleagues for all their efforts on
behalf of the Company.
I would like to thank our staff for their hard work and commitment, and our
shareholders for their ongoing support. We are looking forward to building on
last year`s success during 2005.
Elkan Gamzu, PhD
Interim Chairman and Chief Executive Officer
17 February 2005
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
IN U.S. DOLLARS
31 December
2004 2003
___________ ___________
In thousands
--------------
A s s e t s
CURRENT ASSETS:
Cash and cash equivalents 12,788 4,184
Short-term bank deposits (note 5a) 10,136 17,329
Marketable securities (note 5b) 749
Accounts receivable - trade (note 4) 543
Accounts receivable - other (note 5c) 306 706
__________ ___________
T o t a l current assets 23,773 22,968
___________ ___________
SEVERENCE PAY FUNDS 830 673
___________ ___________
RESTRICTED LONG-TERM DEPOSIT 113 159
___________ ___________
PROPERTY AND EQUIPMENT:
Cost 3,312 3,143
L e s s - accumulated depreciation and
amortization 2,404 2,090
___________ ___________
908 1,053
___________ ___________
T o t a l assets 25,624 24,853
========== ==========
Liabilities and shareholders` equity
CURRENT LIABILITIES:
Accounts payable and accruals (note 5d) 3,134 3,001
Deferred gain 399
___________ ___________
T o t a l current liabilities 3,533 3,001
___________ ___________
LIABILITY FOR EMPLOYEE RIGHTS
UPON RETIREMENT 1,291 1,244
DEFERRED GAIN 1,198
___________ ___________
COMMITMENTS AND CONTINGENCIES
T o t a l liabilities 6,022 4,245
___________ ___________
SHAREHOLDERS` EQUITY (note 6):
Ordinary Shares of NIS0.02 par value (authorized:
300,000,000
as of 31 December 2004 and 2003; issued and
outstanding:
168,079,196 as of 31 December2004 and 112,019,464
as of
31 December 2003) 841 594
Additional paid in capital 104,168 88,966
Deferred share-based compensation 369 337
Accumulated other comprehensive loss 14
Deficit accumulated during the development stage (85,776) (69,303)
___________ ___________
T o t a l shareholders` equity 19,602 20,608
___________ ___________
T o t a l liabilities and shareholders` equity 25,624 24,853
========= ==========
The accompanying notes are an integral part of the financial statements
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
IN U.S. DOLLARS
Period from
9 March 1993*
Year ended 31 December to 31 December
2004 2003 2002 2004
__________ __________ __________ __________
In thousands (except share and per share data)
------------------------------------------------
REVENUES (notes 3 and
4):
Reimbursed
out-of-pockets 3,269 3,269
expenses
License 185 185
__________ __________
3,454 3,454
COST OF REVENUES (notes
3 and 4):
Reimbursed
out-of-pockets 3,269 3,269
expenses
License with respect to
royalties 32 32
__________ __________
3,301 3,301
RESEARCH AND
DEVELOPMENT
COSTS (note 5e) 11,985 13,668 13,231 75,223
L E S S - PARTICIPATIONS - 3,229 75 10,950
__________ _________ __________ __________
11,985 10,439 13,156 64,273
GENERAL AND
ADMINISTRATIVE
EXPENSES (note 5f) 4,134 3,105 3,638 23,555
BUSINESS DEVELOPMENT
COSTS 810 664 916 4,286
(note 5g)
IMPAIRMENT OF ASSET HELD
FOR
SALE 354 354
__________ __________ __________ _________
OPERATING LOSS 16,776 14,562 17,710 92,315
FINANCIAL INCOME - net
(note 5h) 352 352 597 6,700
__________ __________ __________ _________
LOSS BEFORE TAXES ON
INCOME 16,424 14,210 17,113 85,615
TAXES ON INCOME 49 78 27 161
_________ _________ _________ _________
NET LOSS FOR THE YEAR 16,473 14,288 17,140 85,776
========= ========= ========= ========
BASIC AND DILUTED PER
SHARE DATA:
Loss per ordinary share $( 0.12) $( 0.13) $( 0.15)
========= ======== =========
Weighted average number
of
shares used to compute
loss per
ordinary share 134,731,766 111,712,916 111,149,292
========= ========= =========
* Incorporation date, see note 1a.
The accompanying notes are an integral part of the financial statements
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
IN U.S. DOLLARS
Period from
9 March 1993 (b)
Year ended 31 December to 31 December
2004 2003 2002 2004
________ ________ ________ ________
In thousands
--------------
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss for the period (16,473) (14,288) (17,140) (85,776)
Adjustments to reconcile loss
to net cash used in
operating activities:
Depreciation and amortization 319 440 470 2,587
Capital loss (gain) on sale of
property and equipment 1 2 (1) 12
Change in liability for
employee 30 129 333 1,469
rights upon retirement
Impairment of asset held for 354 354
sale
Loss (gain) from marketable
securities, net 13 (27) 41 (410)
Stock based compensation 32 515
expenses
Loss (gain) on amounts funded
in (4) 5 (1) (85)
respect of employee
Changes in operating asset and
liability items:
Increase in accounts receivable
- (543) (543)
trade
Decrease (increase) in accounts
receivable - other 400 (440) 606 (259)
Increase (decrease) in accounts
payable and accruals 133 499 (20) 3,087
Increase in deferred gain 1,597 1,597
________ ________ _______ ________
Net cash used in operating
activities (a) (14,495) (13,326) (15,712) (77,452)
________ ________ _______ ________
CASH FLOWS FROM INVESTING
ACTIVITIES:
Short-term deposits, net 7,193 14,724 1,058 (10,136)
Long-term deposits, net 46 (20) 2 (113)
Investment in available for
sale (71) (1,219) (3,363)
securities
Proceeds from sales of
available 722 1,048 716 3,773
for sale securities
Severance pay funded (136) (112) (97) (841)
Purchase of property and (180) (81) (659) (3,983)
equipment
Proceeds from sale of property
and 5 2 8 122
equipment
________ ________ _______ ________
Net cash provided by (used in)
investing activities -
brought
forward 7,650 15,490 (191) (14,541)
_________ ________ _______ ________
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
IN U.S. DOLLARS
Period from
9 March 1993 (b)
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ _________ _________
In thousands
--------------
Net cash provided by (used
in) investing activities -
brought
forward 7,650 15,490 (191) (14,541)
________ _________ _________ _________
CASH FLOWS FROM FINANCING
ACTIVITIES:
Issuance of share capital
- 15,430 104,371
net of share issuance
expenses
Exercise of share warrants
and 19 4 20 492
employee stock options
Proceeds from long-term 399
debt
Proceeds from short-term 50
debt
Repayment of long-term (399)
debt
Repayment of short-term (50)
debt
_________ _________ _________ _________
Net cash provided by
financing 15,449 4 20 104,863
activities
________ _________ _________ _________
NET INCREASE (DECREASE) IN
CASH AND
CASH EQUIVALENTS 8,604 2,168 (15,883) 12,788
BALANCE OF CASH AND CASH
EQUIVALENTS AT
BEGINNING OF PERIOD 4,184 2,016 17,899
_________ _________ _________ _________
BALANCE OF CASH AND CASH
EQUIVALENTS AT
END OF PERIOD 12,788 4,184 2,016 12,788
======== ======== ======== ========
Supplementary information
on financing activity
not
involving cash flows -
conversion of convertible
subordinated debenture
into 1,700
shares
========
Supplemental disclosures
of cash flow information:
Income taxes paid (mainly
- tax advance in respect
of
excess
expenses) 107 161 79 321
======== ======== ======== ========
Interest paid 350
========
(a) Including
effect of
changes in the
exchange rate
on cash (73) (9) (709) (1,839)
======== ======== ======== ========
(b) Incorporation date, see note 1a.
The accompanying notes are an integral part of the financial statements
XTL BIOPHARMACEUTICALS LTD.
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. GENERAL
Through 31 December 2004, the Company has incurred losses in an aggregate
amount of US$86 million. Such losses have resulted from the Company`s
activities as a development stage company. It is expected that the Company
will be able to finance its operations from its current reserves for the
coming year. Continuation of the Company`s current operations after
utilizing its current cash reserves during 2006, is dependent upon the
generation of additional financial resources either through agreements for
the commercialisation of its product portfolio or through external
financing.
2. RESEARCH AND DEVELOPMENT COSTS AND PARTICIPATIONS
Research and development costs are expensed as incurred and consist
primarily of personnel, payments to sub-contractors, facilities, equipment
and supplies for research and development activities.
Participations from government (and from others) for development of approved
projects are recognized as a reduction of expense as the related costs are
incurred.
3. REVENUE RECOGNITION
The Company recognizes the revenue from the licensing agreement with Cubist
under the provisions of the EITF 00-21 entitled `Revenue Arrangements with
Multiple Deliverables` and SAB 104 entitled `Revenue Recognition`. Under
those terms, companies are required to defer all revenue from
multiple-element arrangements if sufficient objective and reliable evidence
of fair value does not exist for the allocation of revenue to the various
elements of the arrangement. Since the Company does not have the ability to
determine the fair value of each unit of accounting, the agreement was
accounted for as one unit of accounting, after failing the separation
criteria, and the Company recognizes revenue on the abovementioned agreement
ratably over the life of the arrangement.
In addition, Cubist has requested the Company to provide development
services that are reimbursed by Cubist. As required by EITF 01-14 `Income
Statement Characterization of Reimbursements Received for `Out-of-Pocket`
Expenses Incurred`, amounts paid by the Company, as a principal, as an
`out-of-pocket` costs are included in the cost of revenues as reimbursable
out-of-pocket expenses and the reimbursements the Company receives as a
principal are reported as reimbursed out-of-pocket revenues.
4. LICENSE AGREEMENT WITH CUBIST
The Company entered into a licensing agreement with Cubist in June 2004,
under which the Company granted to Cubist an exclusive, worldwide license
(with the right to sub-license) to commercialise HepeX-B and any other
product containing a hMAb or humanized monoclonal antibody or fragment
directed at the hepatitis B virus owned or controlled by the Company. See
also note 3 for the revenue recognition treatment.
Cubist paid the Company an initial up front non-refundable payment of US$1
million upon the signing of the agreement, and a payment of US$1 million
(out of which $185 thousands was recorded as revenue in the year ended 31
December 2004) out of an aggregate amount of US$2 million as collaboration
support to be paid in instalments until the end of 2005 and an additional
amount of US$3 million upon achievement of certain regulatory milestones
till 2007 or an amount of US$2 million upon achievement of the same certain
regulatory milestones till 2008.
The company accounts for the payments resulting from the agreement, as
follows (i) the $1 million up front fee and the instalment payments
aggregating $2 million are recorded as deferred revenue upon receipt and
amortized through 2008 or date regulatory approval obtained, if earlier, and
(ii) the milestone contingent payments will be recorded as revenue upon
regulatory approval milestones obtained.
Under the agreement, the Company is entitled to receive royalties from net
sales by Cubist, if any, generally ranging from 10% to 17%, depending on
levels of net sales achieved by Cubist, subject to certain deductions based
on patent protection of HepeX-B in that territory, total costs of HepeX-B
development, third party license payments and indemnification obligations.
The agreement expires on the later of the last valid patent claim covering
Hepex-B to expire, or 10 years after the first commercial sale of Hepex-B on
a country by country basis.
Under a research and license agreement, the Company paid during 2004, $250
thousands with respect to the $1 million up front fee received in June 2004,
out of which $32 thousands was recorded as cost of revenues in 2004.
The balance of the deferred gain, related to the revenue from Cubist, as of
31 December 2004, was presented in the balance sheet, net of the above
mentioned payment, as follows:
31 December
2004
_____________
$ in thousands
_____________
Deferred revenue 1,815
Less - Deferred expenses related to Yeda 218
_____________
Deferred gain 1,597
============
5. SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION
a. Short-term bank deposits
The deposits are denominated in dollar and bear a weighted average annual
interest rate of 1.81 % as of 31 December 2004 (as of 31 December 2003 - 1.17%).
b. Marketable securities:
1) As of 31 December 2004, there are no marketable securities. The balance as
of 31 December 2003 composed as follows:
31 December 2003
Amortized Unrealized holding gains Unrealized holding Estimated
Cost ___________ losses Fair market
___________ ___________ value
___________
$ in thousands
----------------
Debentures:
Link to the
Israeli CPI 71 (2) 69
Unlinked 561 19 (17) 563
___________ ___________ ___________ ___________
632 19 (19) 632
___________ ___________ ___________ ___________
Sort-term
treasury
notes
and bonds:
Link to the
USD 10 10
Unlinked 93 14 ___________ 107
___________ ___________ ___________
103 14 ___________ 117
___________ ___________ ___________
735 33 (19) 749
========= ========= ========= =========
2) Changes in marketable securities held for sale are as follows:
2004 2003 2002
_______ _______ _______
$ in thousands
----------------
Balance at beginning of year 749 1,637 1,178
Investments 71 1,219
Proceeds from sales (722) (1,048) (716)
Reclassifications into earnings (loss) from
other
comprehensive income (loss) (14) 62 (3)
Realized gain (loss) from sales (13) 27 (41)
_______ _______ _______
-,- 749 1,637
======= ======= =======
31 December
2004 2003
_______ _______
$ in thousands
----------------
Office of the Chief Scientist of
the Israeli Ministry of Industry (`OCS`) - 537
Prepaid expenses 165 119
Employees 24 36
Value Added Tax authorities 101 6
Sundry 16 8
__________ __________
306 706
======== =========
c. Accounts receivable - other:
d. Accounts payable and accruals:
31 December
2004 2003
__________ __________
$ in thousands
----------------
Suppliers 1,108 1,334
Accrued expenses 1,337 1,077
Institutions and employees in respect of salaries
and related benefits 294 280
Provision for vacation pay and recreation pay 385 300
Sundry 10 10
_________ __________
3,134 3,001
======== =========
Statements of operations:
e. Research and development costs:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Wages, salaries
and
related
benefits 2,776 3,450 3,958 20,945
Sub-contractors expenses 6,430 6,799 5,575 33,856
Laboratories supplies 754 1,128 1,653 8,406
Consulting 549 494 396 3,194
Rent and maintenance 725 866 926 4,004
Depreciation and 277 369 415 2,717
amortization
Other 474 562 308 2,101
________ _________ ________ _________
11,985 13,668 13,231 75,223
======== ========= ======= ========
f. General and administrative expenses:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Wages, salaries and related
benefits 1,890 1,244 1,704 11,080
Corporate communications 289 228 598 2,210
Professional fees 647 564 662 3,515
Director fees 243 183 181 1,387
Rent and maintenance 90 104 135 865
Communication 34 33 43 195
Depreciation and amortization 42 70 55 589
Patent registration fees 271 125 71 1,017
Other 628 554 189 2,697
_________ _________ ________ _________
4,134 3,105 3,638 23,555
======= ======= ======= =======
g. Business development costs:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Wages, salaries
and related
benefits 410 408 567 2,501
Travel 36 136 140 742
Professional
fees 364 120 209 1,043
_________ _________ ______ ________
810 664 916 4,286
======== ======== ===== =======
h. Financial income, net:
Period from
9 March 1993
Year ended 31 December to 31 December
2004 2003 2002 2004
_________ _________ ________ _________
$ in thousands
----------------
Financial income:
Interest received 297 458 1,360 8,725
Foreign exchange
differences
gain 67 203
Gain from available for
sale
securities 13 62 (13)
Other _________ _________ ________ 156
_________
377 520 1,360 9,097
________ _________ ________ _________
Financial expenses:
Foreign exchange
differences
loss 148 733 1,921
Interest paid 374
Loss from available for
sale
securities 3 14
Other 25 20 27 88
________ _________ ________ _________
25 168 763 2,397
_________ _________ ________ _________
Financial income, net 352 352 597 6,700
======== ======== ======= ========
Gruss
B.M.
XTL Biopharmaceuticals Ltd. (XTLbio) announced today
the convening of an Extraordinary General Meeting (EGM) at 12:00 pm (Israel
time) on 24 February 2005 in response to a requisition from a shareholder (the
`Requisitioner`). A circular concerning the upcoming EGM is being posted to
shareholders today and will be made available on the Company`s website at
www.xtlbio.com
.
The Requisitioner`s resolutions propose that three (3) new individuals should be
appointed as Non-executive Directors of the Company, that three (3) current
Non-executive Directors should be removed from their office as Directors of the
Company, that two (2) Non-executive Directors should be granted options and that
the Articles of Association of the Company should be amended to enable new
shares to be issued without the current pre-emptive requirement. In addition,
the Board proposes two (2) further resolutions: that the Articles of Association
of the Company should be amended as to reduce the minimum number of directors on
the Board from seven (7) to five (5) and that the remuneration of Elkan Gamzu in
his capacity as the Interim Chief Executive Officer be approved.
The circular to shareholders includes the following letter from the external
directors of XTLbio:
LETTER FROM THE EXTERNAL DIRECTORS OF XTL BIOPHARMACEUTICALS LTD
To holders of ordinary shares in XTL Biopharmaceuticals Ltd (`XTLbio` or the
`Company`) and, for information only, to participants in the Company`s share
option schemes
Dear Shareholder,
CONVENING OF AN EXTRAORDINARY GENERAL MEETING:
REQUISITION TO APPOINT THREE NEW MEMBERS TO THE BOARD;
REMOVAL OF THREE CURRENT DIRECTORS;
GRANT OF SHARE OPTIONS TO TWO NON EXECUTIVE DIRECTORS AND AMENDMENT OF THE
ARTICLES
On 5 January 2005, Alex Rabinovitch (the `Requisitioner`), under authority from
Roy Nominees Limited, a holder of 10.11% of the Company`s issued share capital,
wrote to the Board requiring the Company to convene an Extraordinary General
Meeting (`EGM`) at which certain resolutions be proposed to shareholders. On 11
January 2005 the Requisitioner wrote to the Board requesting one (1) additional
resolution be proposed at the EGM.
The Requisitioner`s resolutions state that three (3) new individuals should be
appointed as Non-executive Directors of the Company, that three (3) current
Non-executive Directors should be removed from their office as Directors of the
Company, that two (2) Non-executive Directors should be granted options and that
the Articles of Association of the Company (`the Articles`) should be amended to
enable new shares to be issued without the current pre-emptive requirement.
On the basis of various recent interviews given by the Requisitioner and
reported in the press, the Requisitioner has indicated that the passing of his
proposed resolutions, among other things, will facilitate the Company`s listing
on NASDAQ.
In keeping with its obligations under the UK Listing Rules (which would equally
apply if the Company was listed on NASDAQ) this letter addresses the
Requisitioner`s proposals. Under the Israeli Company Law, the Company must
appoint two External Directors. Their role is to ensure good corporate
governance of the Company. External Directors have no pre-existing relationship
with the Company prior to their appointment and have a particular responsibility
to fully represent the best interests of all shareholders with no conflicts of
interest. Accordingly, as all other directors of the Board have a personal
interest in one or more resolutions proposed; this letter has been issued by the
External Directors.
The External Directors believe that the Requisitioner`s proposals go beyond the
simple matter of appointment, removal and remuneration of Directors and raise
significant concerns about corporate governance of the Company. The External
Directors are also aware that a significant number of the Company`s shareholders
are resident in Israel and may not have heard the Board`s views on these
proposals although several interviews with the Requisitioner have been published
in the local press. The External Directors therefore urge shareholders to attend
the EGM in person to hear the Requisitioner`s proposals and to provide the Board
with an opportunity to respond directly to shareholders on these proposals
before shareholders cast their votes in respect of each of the proposed
resolutions.
Summary of the External Directors` views
The External Directors oppose the Requisitioner`s proposals for the following
reasons:
•their general concerns regarding corporate governance for a publicly
quoted company and the potential issues for the decision making process of
the Board moving forward;
•significant unnecessary dilution of the Company`s share capital should
the proposal to grant large numbers of options to one (1) existing
Non-executive Director and one (1) proposed Non-executive Director be
agreed;
•removal of experienced and committed Non-executive Directors without
reasonable justification; and
•difficulty in appointing a credible new Chief Executive Officer which the
External Directors believe is an essential pre-requisite for a successful
NASDAQ listing.
These issues and concerns are discussed in greater detail below.
NASDAQ Listing
On 6 September 2004 the Board announced its intention to pursue a NASDAQ listing
of the Company`s securities, and has already taken the following steps to effect
such a NASDAQ listing:
•appointing Peter Stalker III, former Managing Director of E. M. Warburg
Pincus and Co. Inc., New York, as a Non-executive Director in January 2004,
with significant US investment banking experience;
•restructuring the Board to a US format, whereby the Directors are largely
non-executive and a major part of the Board is comprised of US based
directors with US public company experience;
•reducing the total number of Directors on the Board;
•progressing a recruitment process for a US based Chief Executive Officer
with a proven track record; and
•pro-actively raising awareness amongst US investors of the Company`s
profile and impending listing.
Companies do not automatically qualify for a NASDAQ listing. Prior to any
listing a company must satisfy a number of requirements. Some of these relate to
the value of securities to be listed, others relate to the regulatory processes
to be followed. Both of these cannot be completed in a short space of time. The
External Directors believe that the Board is already progressing matters to
obtain such a listing in the shortest reasonable timeframe and the
Requisitioner`s proposals will not add anything to facilitate, accelerate or
improve the processes already underway.
Grant of Options to Directors
The Requisitioner has proposed that Michael Weiss, a Non-executive Director of
the Company, and Ben Zion Weiner, one of the individuals proposed by the
Requisitioner, to be appointed as a new Non-executive Director, be granted
options to purchase 9,250,000 Ordinary Shares and 2,000,000 Ordinary Shares,
respectively, at an exercise price of £0.20 per share. Details of such proposed
grant and their terms are set out below.
The current remuneration of Non-executive Directors of the Company, which has
been approved by shareholders since the listing of the Company`s shares, falls
into one of the following categories:
1. Cash-based Remuneration Package
(a) An annual payment of £10,000 together with a payment of £1,000 for
attendance at each board meeting and £500 for attendance at each
committee meeting.
(b) Reimbursement for any reasonable and out-of-pocket expenses.
2. Cash and Option-based Remuneration Package
(a) An annual payment of US$15,000, payable in four (4) equal quarterly
instalments, for the duration serving as a director.
(b) One time grant of 60,000 options to purchase 60,000 ordinary shares,
nominal value NIS 0.02 of the Company, at an exercise price equal to
the average average price per share quoted on the London Stock
Exchange, in the three (3) days preceding such date of issuance, such
options to vest over three (3) years, so that 1/3 of such options
shall vest on the first, second and third anniversary of the date of
issuance, provided that at such time the individual still continues as
a director.
(c) Reimbursement for any reasonable and out-of-pocket expenses.
The Board (excluding Michael Weiss) considers the aforementioned remuneration to
Non-executive Directors to be fair and reasonable and within the acceptable
corporate governance standards of remuneration of Non-executive Directors,
especially given the relatively small size of the Company.
A summary of the Requisitioner`s proposal is that the options to be granted to
Michael Weiss and Ben Zion Weiner shall be exercisable for a period of five (5)
years from the date of issuance at the Extraordinary General Meeting. The
options will be granted in accordance with the terms and condition governing the
Company`s 2001 Stock Option Plan and will be subject to the terms and conditions
thereof.
The options granted shall vest as follows: (a) 1/3 of the options shall vest and
be exercisable upon the Company achieving a total market capitalization on a
fully diluted basis of more than $150 million, as determined utilizing the
Market Capitalization Formula (defined below); (b) 1/3 of the options shall vest
and be exercisable upon the Company achieving a total market capitalization on a
fully diluted basis of more than $250 million, as determined utilizing the
Market Capitalization Formula; and (c) 1/3 of the options shall vest and be
exercisable upon the Company achieving a total market capitalization on a fully
diluted basis of more than $350 million, as determined utilizing the Market
Capitalization Formula, provided that at each such vesting the relevant grantee
is still a Director of the Company.
The `Market Capitalization Formula` shall be calculated as follows: the fully
diluted shares (including shares attributable to all options, warrants, other
purchase rights and convertible securities, which are in the money and including
shares held by affiliates (collectively `market capitalization shares`))
multiplied by the three (3) consecutive trading day average of the closing price
of the Ordinary Shares as reported by NASDAQ (or such other exchange as such
shares are then listed or in the good-faith determination of the board, if not
then listed or quoted) plus long-term debt (as of any date) minus Working
Capital (as defined below) and minus the aggregate exercise price of all options
and warrants included in the market capitalization shares. The term `Working
Capital` shall mean as of any date, (1) the current assets plus investment
securities or cash equivalents thereof or similar assets that have maturities in
excess of 12 months, minus (2) current liabilities.
The full terms of such options as proposed by the Requisitioner are:
`The Company will grant the Directors (each a `Grantee`) the Options to purchase
Ordinary Shares, of nominal value NIS 0.02 each of the Company (the `Shares`),
which options shall be exercisable for a period of five (5) years from the
date of issuance at the Extraordinary Shareholders meeting. The Options will be
granted in accordance with the terms and condition governing the Company`s 2001
Stock Option Plan (the `Plan`) and will be subject to the terms and conditions
thereof; provided, however, that if any provisions hereunder are inconsistent
with the terms and conditions of the Plan, the terms hereunder shall control.
In accordance with the Plan, should any change be made to the Ordinary
Shares by reason of any stock split, stock dividend, extraordinary cash dividend,
recapitalization, combination of shares, exchange of shares or other change
affecting the outstanding Ordinary Shares as a class without the Company`s
receipt of consideration, appropriate adjustments shall be made to (A) the total
number and/or class of securities subject to such options and (B) the Exercise
Price in order to reflect such change and thereby preclude a dilution or
enlargement under such options.
The Options granted to the Grantees shall vest as follows: (a) 1/3 of the
Options shall vest and be exercisable upon the Company achieving a total market
capitalization on a fully diluted basis of more than $150 million, as determined
utilizing the Market Capitalization Formula (defined below); (b) 1/3 of the
Options shall vest and be exercisable upon the Company achieving a total market
capitalization on a fully diluted basis of more than $250 million, as determined
utilizing the Market Capitalization Formula; and (c) 1/3 of the Options shall
vest and be exercisable upon the Company achieving a total market capitalization
on a fully diluted basis of more than $350 million, as determined utilizing the
Market Capitalization Formula, provided that at each such vesting the Grantees
is still a Director of the Company.
With regard to any Grantee who is a resident of the US for tax purposes, these
Options are intended to qualify as `incentive stock options` under section 422
of the Internal Revenue Code of 1986, as amended, to the extent allowable. The
Grantee`s shall be entitled to pay the exercise price of any or all of the
Options described by any method set forth in the Plan and shall be allowed to
satisfy any withholding obligations incurred on the exercise of such Options
by electing to have option shares withheld upon such exercise. The Company shall
use best efforts to cause all of the shares underlying such Options to be fully
registered and freely tradable, including for resale without any limitations
or restrictions, provided, however, that while the Grantees are Director`s of
the Company, each Grantee shall agree to abide by the trading restrictions that
may be imposed upon such Grantee from time to time pursuant to any laws,
statutes, rules or regulations to which the shares underlying the Options may be
subject from time to time.
The `Market Capitalization Formula` shall be calculated as follows: the fully
diluted shares (including shares attributable to all options, warrants, other
purchase rights and convertible securities, which are in the money and including
shares held by affiliates (collectively `market capitalization shares`))
multiplied by the three (3) consecutive trading day average of the closing price
of the Ordinary Shares as reported by Nasdaq (or such other exchange as such
shares are then listed or in the good-faith determination of the board, if not
then listed or quoted) plus long-term debt (as of any date) minus Working
Capital (as defined below) and minus the aggregate exercise price of all options
and warrants included in the market capitalization shares. The term `Working
Capital` shall mean as of any date, (1) the current assets plus investment
securities or cash equivalents thereof or similar assets that have maturities in
excess of 12 months, minus (2) current liabilities.`
Michael Weiss, who has an interest in one of the two resolutions proposed by the
Requisitioner, has not participated in discussions concerning his own
remuneration. He has however indicated his support for the proposed resolution 6
to grant options to Ben Zion Weiner. The Board, excluding Michael Weiss, have
the following views on proposed resolutions 5 and 6:
•The proposal to grant two (2) Directors significant numbers of options on
the terms proposed by the Requisitioner detracts from the Company`s current
standards of remuneration for Non-executive Directors. These are highly
unusual remuneration packages for Non-executive Directors, amounting to 6.7%
of the issued and outstanding share capital of the Company.
•Directors in receipt of such remuneration may be categorised as
`non-independent` for the purpose of corporate governance codes of practice
in the UK and the US. The combined code for corporate governance in the UK
states that a board should include a balance of executive and Non-executive
Directors and in particular `independent` Non-executive Directors such that
no individual or small group of individuals can dominate. Under NASDAQ
rules, a majority of the directors on a NASDAQ listed company are required
to be `independent` meaning that such directors must not have a substantial
financial interest in the company. If all of the Requisitioner`s resolutions
were approved at the EGM, two (2) out of the six (6) remaining Directors may
not be considered independent. This may have implications for the Company`s
proposed NASDAQ listing and also for the ability of those Directors to
participate in certain Board Committees, which are critical to the efficient
functioning of any Board.
•Although Non-executive Directors have a valuable contribution to make,
company performance and results are largely delivered by executive
management. The granting of such a large number of options to Non-executive
Directors may also act as a disincentive to recruiting a new Chief Executive
Officer to the Company. In particular, the External Directors believe that
the grant of 9,250,000 options to a single Non-executive Director would be
considered to be more in keeping with the level of options for a chief
executive officer than for an individual with a non-executive role on the
Board. In the view of the External Directors such a grant could make it
extremely difficult to hire a qualified US-based Chief Executive Officer. In
addition, the magnitude and the pricing of the proposed option packages
might also be considered unfair to existing senior management executives and
hinder the recruitment of new senior executives.
•The proposed discounting of the exercise price is inconsistent with the
Company`s policy on granting of options to employees and also to
Non-executive Directors. The current Company policy as to the exercise price
is the average price per share in the three (3) days preceding the date of
issuance, as set out in the Company`s employee stock option plan and as is
consistent with UK best practices and substantially similar to US best
practices. The External Directors consider this to be reasonable and
appropriate. The Requisitioner`s proposed exercise price was at a discount
of 24 per cent to the share price of the Company at the date of the
requisition, a level of discount which the External Directors view as highly
favourable to the grantees of the options and highly dilutive to existing
shareholders.
Under the UK Listing Rules the proposals set out in Resolution 5 and, subject to
Resolution 1 being passed, Resolution 6 amount to `related party` transactions.
Accordingly, under the Listing Rules the terms of the proposals require that
prior to the grant of the options the board of the Company provide the UKLA with
written confirmation from an independent adviser acceptable to the UKLA that the
terms of the proposed transactions with the related parties are fair and
reasonable so far as the shareholders of the Company are concerned (the `Related
Party Confirmation`). The UKLA has not been provided with such a Related Party
Confirmation and in the absence of it the grant of the options would be
prohibited under the UK Listing Rules.
Appointment of New Directors and Removal of Current Directors
The Requisitioner has proposed the removal of Elkan Gamzu, Geoffrey Vernon and
Peter Stalker III from the Board, effective as of the date of the EGM. Further
the Requisitioner is requesting that Ben Zion Weiner, William James Kennedy and
Jonathan Spicehandler be appointed as directors of the Company. Copies of the
curriculum vitae of the proposed directors can be found in Part 2 of this
document.
The External Directors believe that the existing board of XTLbio has a broad
combination of skills, including a wealth of pharmaceutical and biotechnology
industry experience, financial and management expertise and knowledge of the
Company`s operations which positions it very well to build on past successes
and, crucially, to deliver real value from the Company`s unique assets to its
shareholders. Significant progress has been made in both the clinic and from a
partnering perspective.
The Board welcomes nominations from shareholders with regard to individuals
whose skills they believe would add value to the Company. However, in coming to
a decision the Board is required to follow a proper selection process. In
seeking to adhere to codes of conduct in the UK and the US, new candidates to be
appointed meet with the Nominations Committee in order to ascertain their
suitability, their potential contribution to the Board and the Company and to
ensure that they have no conflicting interests. The selected candidates then
meet with the remaining members of the Board and are then confirmed. In this
particular instance, the Board first heard of the proposed appointments when the
Requisitioner tabled their appointment as one of the resolutions for this EGM.
Therefore the Board`s knowledge of these individuals extends only to the
information contained within their curriculum vitae, which are attached in the
`Additional Information` section of this document.
The External Directors are very concerned by the proposed process of the
Requisitioner to appoint three (3) new individuals without any prior reference
to the Board or its Nominations Committee. Because Board members carry equal
legal responsibilities with other Directors serving together with them on the
same Board, Nominations Committees are standard in publicly quoted companies.
The Requisitioner has no such responsibilities, nor is accountable to the
shareholders for any appointment. Therefore, the calling of an EGM to
specifically over-ride a standard corporate governance process affecting the
legal responsibilities of the Board is, in the opinion of all members of the
Board other than Michael Weiss, highly irregular and raises concerns with the
External Directors about the way in which such important decisions could be
taken in the future if the Requisitioner`s proposals were allowed to proceed
unchallenged.
Whilst shareholders are entitled at a shareholder meeting to remove directors
from office, the Board has been advised in writing by the Requisitioner that the
current proposal to remove Elkan Gamzu, Geoffrey Vernon and Peter Stalker III as
Directors stems from the Board and the Remuneration Committee`s decision not to
recommend the Requisitioner`s request to the grant of options described above
with the effect that, despite any shareholder vote on this issue, the option
grant would not be valid. Directors` fiduciary duties are to act independently
in the best interests of the Company and all of its shareholders, according to
their own conscience and, based on their own belief, experience and specific
knowledge of the Company. For the reasons stated above, the External Directors
believe that the Board has acted in the best interests of the Company.
Geoffrey Vernon has notified the Company of his intention to resign from the
Board immediately upon the completion of the Extraordinary General Meeting
regardless of the outcome. Elkan Gamzu has a wealth of research and development
experience in both the pharmaceutical and biotechnology industries, is US based,
has served on other publicly quoted US Boards and has an in-depth understanding
of the research and development programmes of XTLbio. Peter Stalker III has
extensive US banking experience. We do not believe that removing these two (2)
Directors from the Board is in the best interests of the Company and its
shareholders.
Requisitioner`s communication with the External Directors
As External Directors of the Company, we have also received a separate letter
from the Requisitioner demanding that we disclose our position regarding the
appointment of the three (3) new Directors and the granting of the proposed
option packages to two (2) Directors. In the same letter he urges us to consider
resignation from the Board prior to the upcoming EGM if we are not in agreement
with his proposals, which he claims are supported by a majority of shareholders.
It is stated that this would enable the proposal and appointment of two (2) new
External Directors at the upcoming EGM and would negate the requirement for a
further EGM to do the same.
In keeping with our fiduciary responsibilities and having special regard for our
duties as External Directors, we do not believe that the appointment of an
entirely new Board of Directors is in the best interests of the Company and its
shareholders at this time. However, the Requisitioner has indicated in a letter
to the current members of the Board that he and other shareholders `shall deem
each and every member of the Board who voted against the grant of options
personally liable for any such additional expenditure and damage to the Company
and, may in the future, request the Company to recover any such damages that
will be incurred from the Board`. Furthermore, in his letter to the External
Directors the Requisitioner says, `...you should consider the ramifications of
any decrease in the share price on the market that may result from your actions
or inactions` in relation to our decision or otherwise to resign at or after the
EGM. In our opinion, this threat of personal litigation is an unnecessary act of
aggression and might be deemed as undue interference with our statutory
responsibilities as Directors. The External Directors also believe that this
approach raises significant issues about the direction of a public company if a
shareholder, who has not otherwise obtained approval of the shareholder body as
a whole, pressurises External Directors into resignation because they do not
agree with him. We also believe that it also does not augur well for the
independent role of Directors in decision-making processes within the Company if
a dissatisfied shareholder seeks to replace an entire Board in this way.
Amendment of the Articles
The Board supports the proposed amendment of the Articles of Association to
enable the issuance of shares without the current pre-emptive requirement so as
to help facilitate a listing on NASDAQ. The effect of such amendment to the
Articles is that the Board will be entitled to issue securities of the Company
without first offering such securities to the shareholders of the Company.
Notwithstanding such amendment to the Articles, the Company shall continue to be
obligated to comply with the UK Listing Rules regarding the issuance of share
capital, while the Company remains listed in the UK, regardless of amendments
made to the Company`s articles.
It is proposed that the following amendments be made to the Company`s Articles
of Association:
That the existing Articles of Association of the Company be amended by the
deletion of the existing Articles 6.1, 6.3 and 6.4 and the replacement
therefore with the following:
`6.1 The shares of the Company shall be under the control of the Board
of Directors, who shall have the power to allot shares or otherwise dispose
of them to such persons, on such terms and conditions, and either at par or
at a premium, or, subject to the provisions of the Companies Law, at a
discount, and at such times, as the Board of Directors may think fit, and
the power to give to any person the option to acquire from the Company any
shares, either at par or at a premium, or, subject as aforesaid, at a
discount, during such time and for such consideration as the Board of
Directors may think fit.`
`6.3 Reserved.`
`6.4 Reserved.
Additional Resolutions proposed by the Board of Directors
In the light of the convening of the EGM and the resolutions proposed by the
Requisitioner, the Board proposes two (2) further resolutions for consideration
by shareholders at the EGM.
1. A further amendment of the Articles of Association so as to reduce the
minimum number of directors on the Board from seven (7) to five (5)
following the Board`s decision that executive directors, excluding the
Chief Executive Officer, should not serve on the Board of Directors. The
reduction of the number of directors on the Board, by way of executive
directors not serving on the Board, brings the Company more in line with a
US style board consistency.
The full text of the proposed amendment is as follows:
`THAT the existing Articles of Association of the Company be amended by the
amendment of Articles 26.1 and the replacement of the word `seven (7)` with
the word `five (5)` so that following such amendment, Article 26.1 shall
state the following:
`26.1 Until such time as the General Meeting decides otherwise, the
number of members of the Board of Directors shall be not less than five (5)
and not more than twelve (12).`
2. To approve the remuneration of Elkan Gamzu, who volunteered to serve as the
interim Chief Executive Officer and Chairman of the Board until such time
as permanent successors are appointed. At present Dr. Gamzu, who is
normally based in the US, is prevented from carrying out his regular full
time consulting role with other companies there and therefore forfeits his
normal income from such consulting activities to address XTLbio`s business
needs, which include frequent travel to Israel. Accordingly, the Board
proposes that Elkan Gamzu should receive a monthly remuneration of
US$25,000 for each month he serves as interim Chief Executive Officer (such
amount to be pro rated for any parts of a month), effective as of 1
December 2004. This is the same as the cash remuneration paid to the former
Chief Executive Officer. Elkan Gamzu will receive no benefits commensurate
with the office and it is not proposed to pay him additional remuneration
for his role as Interim Chairman.
Extraordinary General Meeting / Action to be taken
A notice convening the Extraordinary General Meeting of the Company to be held
at 12.00 p.m. (Israel Time) on 24 February 2005 at The Dan Tel Aviv Hotel, 99
Hayarkon St., Tel Aviv 63432, Israel is set out at the end of this document.
RESOLUTIONS 1 TO 6 ARE OPPOSEDBY THE EXTERNAL DIRECTORS
Resolutions 1 to 3 seek to approve the appointment of Ben Zion Weiner, William
Kennedy, and Jonathan Spicehandler, as Directors to the Board;
Resolution 4 seeks to approve the removal of Elkan Gamzu, Geoffrey Vernon, and
Peter Stalker III from their office as Directors of the Company;
Resolution 5 seeks to approve the grant of certain share options to Michael
Weiss, a Director of the Company; and
Resolution 6 seeks to approve the grant of certain share options to Ben Zion
Weiner, a proposed candidate to be appointed as a Director of the Company.
RESOLUTIONS 7 TO 9 ARE SUPPORTEDBY THE EXTERNAL DIRECTORS
Resolution 7 seeks to amend the Articles of Association of the Company to
exclude the provisions relating to pre-emption rights and to provide a general
authority to the Board to issue shares of the Company so as to provide the
Company with greater flexibility to take advantage of fund-raising opportunities
should they prove necessary;
Resolution 8 seeks to amend the Articles of Association of the Company to reduce
the minimum number of directors from seven (7) to five (5); and
Resolution 9 seeks to approve the grant of certain remuneration to Elkan Gamzu,
a Director of the Company, for the provision of his services as the interim
Chief Executive Officer and Chairman.
Shareholders are urged, where possible, to attend and vote at the meeting in
person. If this is not possible they may vote by proxy and are advised to take
the following course of action to ensure that their views are represented at the
meeting.
You will find enclosed a form of proxy (or Form of Instruction in the case of
holders of Depository Interests) for use at the Extraordinary General Meeting.
Whether or not you intend to be present at the meeting, please complete and
return the form of proxy to Computershare Investor Services (Channel Islands)
Limited, PO Box 83, Ordnance House, 31 Pier Road, St. Helier, Jersey, JE4 8PW,
Channel Islands; the form of instruction to Computershare Investor Service PLC,
POB 1075, The Pavilions, Bridgwater Road, Bristol BS99 3FA, England; (or, by
hand only, at Computershare Investor Services PLC, 68 Upper Thames Street,
Vintners` Place, London, EC4V 3BJ, England) as soon as possible and, in any
event, so as to be received with regard to the form of instruction, no later
than 2.00 p.m. (Israel Time) on 21 February 2005 and with regard to the proxy,
no later than 12.00 p.m. (Israel Time) on 22 February 2005. The Board of
Directors has fixed 11 February 2005 as the `record date` for determining those
shareholders entitled to participate and vote at the Extraordinary General
Meeting. If you need assistance in communicating with your nominee (for nominee
banks that are not a direct shareholder) or in filling out the proxy forms,
please contact Georgeson Shareholder Communications, Inc., a Computershare plc
company, Mr. Stephen Lewis, whose details are provided below.
Phone: +44 (0) 870 703 0307
Fax: +44 (0) 870 703 0158
Email:
stephen.lewis@computershare.co.uk.
Completion and return of a form of proxy will not preclude shareholders from
attending and voting at the Extraordinary General Meeting, should they so wish.
Recommendations
The Directors (excluding Michael Weiss) do not believe that resolutions 1-4 are
in the best interests of shareholders as a whole and therefore recommend that
shareholders:
VOTE AGAINST resolutions 1 to 4
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The Directors (excluding Michael Weiss, who did not participate in the Board
decision on this matter) do not believe that resolution 5 is in the best
interests of shareholders as a whole and therefore recommend that shareholders:
VOTE AGAINST resolution 5
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The Directors (excluding Michael Weiss) do not believe that resolution 6 is in
the best interests of shareholders as a whole and therefore recommend that
shareholders:
VOTE AGAINST resolution 6
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The Directors do believe that resolutions 7-8 are in the best interests of
shareholders as a whole and therefore recommend that shareholders:
VOTE FOR resolutions 7 and 8
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The majority of the Directors (excluding Elkan Gamzu, who did not participate in
the Board decision on this matter) do believe that resolution 9 is in the best
interests of shareholders as a whole and therefore recommend that shareholders:
VOTE FORresolution 9
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to four hundred and seventeen thousand three hundred and twenty
seven shares representing approximately 0.25 per cent of the issued share
capital of the Company.
Geoffrey Vernon has notified the Company of his intention to resign from the
Board immediately upon the completion of the Extraordinary General Meeting
irrespective of the outcome of resolution 4.
Michael Weiss has indicated to the Board that he is highly likely to resign from
the Board if the Requisitioner`s resolutions are not approved.
Elkan Gamzu and Peter Stalker III have indicated to the Board that they shall
consider resigning from the Board even if Resolution 4 seeking to remove them
from office is not approved but resolutions 1-3 and 5-6 are approved by the
shareholders. They feel that these resolutions would undermine the role of the
current Board in managing the Company and would have a significant bearing on
the way in which Board decisions would be made in the future.
Yours faithfully,
Patricia Smith
Rusi Kathoke
the convening of an Extraordinary General Meeting (EGM) at 12:00 pm (Israel
time) on 24 February 2005 in response to a requisition from a shareholder (the
`Requisitioner`). A circular concerning the upcoming EGM is being posted to
shareholders today and will be made available on the Company`s website at
www.xtlbio.com
.
The Requisitioner`s resolutions propose that three (3) new individuals should be
appointed as Non-executive Directors of the Company, that three (3) current
Non-executive Directors should be removed from their office as Directors of the
Company, that two (2) Non-executive Directors should be granted options and that
the Articles of Association of the Company should be amended to enable new
shares to be issued without the current pre-emptive requirement. In addition,
the Board proposes two (2) further resolutions: that the Articles of Association
of the Company should be amended as to reduce the minimum number of directors on
the Board from seven (7) to five (5) and that the remuneration of Elkan Gamzu in
his capacity as the Interim Chief Executive Officer be approved.
The circular to shareholders includes the following letter from the external
directors of XTLbio:
LETTER FROM THE EXTERNAL DIRECTORS OF XTL BIOPHARMACEUTICALS LTD
To holders of ordinary shares in XTL Biopharmaceuticals Ltd (`XTLbio` or the
`Company`) and, for information only, to participants in the Company`s share
option schemes
Dear Shareholder,
CONVENING OF AN EXTRAORDINARY GENERAL MEETING:
REQUISITION TO APPOINT THREE NEW MEMBERS TO THE BOARD;
REMOVAL OF THREE CURRENT DIRECTORS;
GRANT OF SHARE OPTIONS TO TWO NON EXECUTIVE DIRECTORS AND AMENDMENT OF THE
ARTICLES
On 5 January 2005, Alex Rabinovitch (the `Requisitioner`), under authority from
Roy Nominees Limited, a holder of 10.11% of the Company`s issued share capital,
wrote to the Board requiring the Company to convene an Extraordinary General
Meeting (`EGM`) at which certain resolutions be proposed to shareholders. On 11
January 2005 the Requisitioner wrote to the Board requesting one (1) additional
resolution be proposed at the EGM.
The Requisitioner`s resolutions state that three (3) new individuals should be
appointed as Non-executive Directors of the Company, that three (3) current
Non-executive Directors should be removed from their office as Directors of the
Company, that two (2) Non-executive Directors should be granted options and that
the Articles of Association of the Company (`the Articles`) should be amended to
enable new shares to be issued without the current pre-emptive requirement.
On the basis of various recent interviews given by the Requisitioner and
reported in the press, the Requisitioner has indicated that the passing of his
proposed resolutions, among other things, will facilitate the Company`s listing
on NASDAQ.
In keeping with its obligations under the UK Listing Rules (which would equally
apply if the Company was listed on NASDAQ) this letter addresses the
Requisitioner`s proposals. Under the Israeli Company Law, the Company must
appoint two External Directors. Their role is to ensure good corporate
governance of the Company. External Directors have no pre-existing relationship
with the Company prior to their appointment and have a particular responsibility
to fully represent the best interests of all shareholders with no conflicts of
interest. Accordingly, as all other directors of the Board have a personal
interest in one or more resolutions proposed; this letter has been issued by the
External Directors.
The External Directors believe that the Requisitioner`s proposals go beyond the
simple matter of appointment, removal and remuneration of Directors and raise
significant concerns about corporate governance of the Company. The External
Directors are also aware that a significant number of the Company`s shareholders
are resident in Israel and may not have heard the Board`s views on these
proposals although several interviews with the Requisitioner have been published
in the local press. The External Directors therefore urge shareholders to attend
the EGM in person to hear the Requisitioner`s proposals and to provide the Board
with an opportunity to respond directly to shareholders on these proposals
before shareholders cast their votes in respect of each of the proposed
resolutions.
Summary of the External Directors` views
The External Directors oppose the Requisitioner`s proposals for the following
reasons:
•their general concerns regarding corporate governance for a publicly
quoted company and the potential issues for the decision making process of
the Board moving forward;
•significant unnecessary dilution of the Company`s share capital should
the proposal to grant large numbers of options to one (1) existing
Non-executive Director and one (1) proposed Non-executive Director be
agreed;
•removal of experienced and committed Non-executive Directors without
reasonable justification; and
•difficulty in appointing a credible new Chief Executive Officer which the
External Directors believe is an essential pre-requisite for a successful
NASDAQ listing.
These issues and concerns are discussed in greater detail below.
NASDAQ Listing
On 6 September 2004 the Board announced its intention to pursue a NASDAQ listing
of the Company`s securities, and has already taken the following steps to effect
such a NASDAQ listing:
•appointing Peter Stalker III, former Managing Director of E. M. Warburg
Pincus and Co. Inc., New York, as a Non-executive Director in January 2004,
with significant US investment banking experience;
•restructuring the Board to a US format, whereby the Directors are largely
non-executive and a major part of the Board is comprised of US based
directors with US public company experience;
•reducing the total number of Directors on the Board;
•progressing a recruitment process for a US based Chief Executive Officer
with a proven track record; and
•pro-actively raising awareness amongst US investors of the Company`s
profile and impending listing.
Companies do not automatically qualify for a NASDAQ listing. Prior to any
listing a company must satisfy a number of requirements. Some of these relate to
the value of securities to be listed, others relate to the regulatory processes
to be followed. Both of these cannot be completed in a short space of time. The
External Directors believe that the Board is already progressing matters to
obtain such a listing in the shortest reasonable timeframe and the
Requisitioner`s proposals will not add anything to facilitate, accelerate or
improve the processes already underway.
Grant of Options to Directors
The Requisitioner has proposed that Michael Weiss, a Non-executive Director of
the Company, and Ben Zion Weiner, one of the individuals proposed by the
Requisitioner, to be appointed as a new Non-executive Director, be granted
options to purchase 9,250,000 Ordinary Shares and 2,000,000 Ordinary Shares,
respectively, at an exercise price of £0.20 per share. Details of such proposed
grant and their terms are set out below.
The current remuneration of Non-executive Directors of the Company, which has
been approved by shareholders since the listing of the Company`s shares, falls
into one of the following categories:
1. Cash-based Remuneration Package
(a) An annual payment of £10,000 together with a payment of £1,000 for
attendance at each board meeting and £500 for attendance at each
committee meeting.
(b) Reimbursement for any reasonable and out-of-pocket expenses.
2. Cash and Option-based Remuneration Package
(a) An annual payment of US$15,000, payable in four (4) equal quarterly
instalments, for the duration serving as a director.
(b) One time grant of 60,000 options to purchase 60,000 ordinary shares,
nominal value NIS 0.02 of the Company, at an exercise price equal to
the average average price per share quoted on the London Stock
Exchange, in the three (3) days preceding such date of issuance, such
options to vest over three (3) years, so that 1/3 of such options
shall vest on the first, second and third anniversary of the date of
issuance, provided that at such time the individual still continues as
a director.
(c) Reimbursement for any reasonable and out-of-pocket expenses.
The Board (excluding Michael Weiss) considers the aforementioned remuneration to
Non-executive Directors to be fair and reasonable and within the acceptable
corporate governance standards of remuneration of Non-executive Directors,
especially given the relatively small size of the Company.
A summary of the Requisitioner`s proposal is that the options to be granted to
Michael Weiss and Ben Zion Weiner shall be exercisable for a period of five (5)
years from the date of issuance at the Extraordinary General Meeting. The
options will be granted in accordance with the terms and condition governing the
Company`s 2001 Stock Option Plan and will be subject to the terms and conditions
thereof.
The options granted shall vest as follows: (a) 1/3 of the options shall vest and
be exercisable upon the Company achieving a total market capitalization on a
fully diluted basis of more than $150 million, as determined utilizing the
Market Capitalization Formula (defined below); (b) 1/3 of the options shall vest
and be exercisable upon the Company achieving a total market capitalization on a
fully diluted basis of more than $250 million, as determined utilizing the
Market Capitalization Formula; and (c) 1/3 of the options shall vest and be
exercisable upon the Company achieving a total market capitalization on a fully
diluted basis of more than $350 million, as determined utilizing the Market
Capitalization Formula, provided that at each such vesting the relevant grantee
is still a Director of the Company.
The `Market Capitalization Formula` shall be calculated as follows: the fully
diluted shares (including shares attributable to all options, warrants, other
purchase rights and convertible securities, which are in the money and including
shares held by affiliates (collectively `market capitalization shares`))
multiplied by the three (3) consecutive trading day average of the closing price
of the Ordinary Shares as reported by NASDAQ (or such other exchange as such
shares are then listed or in the good-faith determination of the board, if not
then listed or quoted) plus long-term debt (as of any date) minus Working
Capital (as defined below) and minus the aggregate exercise price of all options
and warrants included in the market capitalization shares. The term `Working
Capital` shall mean as of any date, (1) the current assets plus investment
securities or cash equivalents thereof or similar assets that have maturities in
excess of 12 months, minus (2) current liabilities.
The full terms of such options as proposed by the Requisitioner are:
`The Company will grant the Directors (each a `Grantee`) the Options to purchase
Ordinary Shares, of nominal value NIS 0.02 each of the Company (the `Shares`),
which options shall be exercisable for a period of five (5) years from the
date of issuance at the Extraordinary Shareholders meeting. The Options will be
granted in accordance with the terms and condition governing the Company`s 2001
Stock Option Plan (the `Plan`) and will be subject to the terms and conditions
thereof; provided, however, that if any provisions hereunder are inconsistent
with the terms and conditions of the Plan, the terms hereunder shall control.
In accordance with the Plan, should any change be made to the Ordinary
Shares by reason of any stock split, stock dividend, extraordinary cash dividend,
recapitalization, combination of shares, exchange of shares or other change
affecting the outstanding Ordinary Shares as a class without the Company`s
receipt of consideration, appropriate adjustments shall be made to (A) the total
number and/or class of securities subject to such options and (B) the Exercise
Price in order to reflect such change and thereby preclude a dilution or
enlargement under such options.
The Options granted to the Grantees shall vest as follows: (a) 1/3 of the
Options shall vest and be exercisable upon the Company achieving a total market
capitalization on a fully diluted basis of more than $150 million, as determined
utilizing the Market Capitalization Formula (defined below); (b) 1/3 of the
Options shall vest and be exercisable upon the Company achieving a total market
capitalization on a fully diluted basis of more than $250 million, as determined
utilizing the Market Capitalization Formula; and (c) 1/3 of the Options shall
vest and be exercisable upon the Company achieving a total market capitalization
on a fully diluted basis of more than $350 million, as determined utilizing the
Market Capitalization Formula, provided that at each such vesting the Grantees
is still a Director of the Company.
With regard to any Grantee who is a resident of the US for tax purposes, these
Options are intended to qualify as `incentive stock options` under section 422
of the Internal Revenue Code of 1986, as amended, to the extent allowable. The
Grantee`s shall be entitled to pay the exercise price of any or all of the
Options described by any method set forth in the Plan and shall be allowed to
satisfy any withholding obligations incurred on the exercise of such Options
by electing to have option shares withheld upon such exercise. The Company shall
use best efforts to cause all of the shares underlying such Options to be fully
registered and freely tradable, including for resale without any limitations
or restrictions, provided, however, that while the Grantees are Director`s of
the Company, each Grantee shall agree to abide by the trading restrictions that
may be imposed upon such Grantee from time to time pursuant to any laws,
statutes, rules or regulations to which the shares underlying the Options may be
subject from time to time.
The `Market Capitalization Formula` shall be calculated as follows: the fully
diluted shares (including shares attributable to all options, warrants, other
purchase rights and convertible securities, which are in the money and including
shares held by affiliates (collectively `market capitalization shares`))
multiplied by the three (3) consecutive trading day average of the closing price
of the Ordinary Shares as reported by Nasdaq (or such other exchange as such
shares are then listed or in the good-faith determination of the board, if not
then listed or quoted) plus long-term debt (as of any date) minus Working
Capital (as defined below) and minus the aggregate exercise price of all options
and warrants included in the market capitalization shares. The term `Working
Capital` shall mean as of any date, (1) the current assets plus investment
securities or cash equivalents thereof or similar assets that have maturities in
excess of 12 months, minus (2) current liabilities.`
Michael Weiss, who has an interest in one of the two resolutions proposed by the
Requisitioner, has not participated in discussions concerning his own
remuneration. He has however indicated his support for the proposed resolution 6
to grant options to Ben Zion Weiner. The Board, excluding Michael Weiss, have
the following views on proposed resolutions 5 and 6:
•The proposal to grant two (2) Directors significant numbers of options on
the terms proposed by the Requisitioner detracts from the Company`s current
standards of remuneration for Non-executive Directors. These are highly
unusual remuneration packages for Non-executive Directors, amounting to 6.7%
of the issued and outstanding share capital of the Company.
•Directors in receipt of such remuneration may be categorised as
`non-independent` for the purpose of corporate governance codes of practice
in the UK and the US. The combined code for corporate governance in the UK
states that a board should include a balance of executive and Non-executive
Directors and in particular `independent` Non-executive Directors such that
no individual or small group of individuals can dominate. Under NASDAQ
rules, a majority of the directors on a NASDAQ listed company are required
to be `independent` meaning that such directors must not have a substantial
financial interest in the company. If all of the Requisitioner`s resolutions
were approved at the EGM, two (2) out of the six (6) remaining Directors may
not be considered independent. This may have implications for the Company`s
proposed NASDAQ listing and also for the ability of those Directors to
participate in certain Board Committees, which are critical to the efficient
functioning of any Board.
•Although Non-executive Directors have a valuable contribution to make,
company performance and results are largely delivered by executive
management. The granting of such a large number of options to Non-executive
Directors may also act as a disincentive to recruiting a new Chief Executive
Officer to the Company. In particular, the External Directors believe that
the grant of 9,250,000 options to a single Non-executive Director would be
considered to be more in keeping with the level of options for a chief
executive officer than for an individual with a non-executive role on the
Board. In the view of the External Directors such a grant could make it
extremely difficult to hire a qualified US-based Chief Executive Officer. In
addition, the magnitude and the pricing of the proposed option packages
might also be considered unfair to existing senior management executives and
hinder the recruitment of new senior executives.
•The proposed discounting of the exercise price is inconsistent with the
Company`s policy on granting of options to employees and also to
Non-executive Directors. The current Company policy as to the exercise price
is the average price per share in the three (3) days preceding the date of
issuance, as set out in the Company`s employee stock option plan and as is
consistent with UK best practices and substantially similar to US best
practices. The External Directors consider this to be reasonable and
appropriate. The Requisitioner`s proposed exercise price was at a discount
of 24 per cent to the share price of the Company at the date of the
requisition, a level of discount which the External Directors view as highly
favourable to the grantees of the options and highly dilutive to existing
shareholders.
Under the UK Listing Rules the proposals set out in Resolution 5 and, subject to
Resolution 1 being passed, Resolution 6 amount to `related party` transactions.
Accordingly, under the Listing Rules the terms of the proposals require that
prior to the grant of the options the board of the Company provide the UKLA with
written confirmation from an independent adviser acceptable to the UKLA that the
terms of the proposed transactions with the related parties are fair and
reasonable so far as the shareholders of the Company are concerned (the `Related
Party Confirmation`). The UKLA has not been provided with such a Related Party
Confirmation and in the absence of it the grant of the options would be
prohibited under the UK Listing Rules.
Appointment of New Directors and Removal of Current Directors
The Requisitioner has proposed the removal of Elkan Gamzu, Geoffrey Vernon and
Peter Stalker III from the Board, effective as of the date of the EGM. Further
the Requisitioner is requesting that Ben Zion Weiner, William James Kennedy and
Jonathan Spicehandler be appointed as directors of the Company. Copies of the
curriculum vitae of the proposed directors can be found in Part 2 of this
document.
The External Directors believe that the existing board of XTLbio has a broad
combination of skills, including a wealth of pharmaceutical and biotechnology
industry experience, financial and management expertise and knowledge of the
Company`s operations which positions it very well to build on past successes
and, crucially, to deliver real value from the Company`s unique assets to its
shareholders. Significant progress has been made in both the clinic and from a
partnering perspective.
The Board welcomes nominations from shareholders with regard to individuals
whose skills they believe would add value to the Company. However, in coming to
a decision the Board is required to follow a proper selection process. In
seeking to adhere to codes of conduct in the UK and the US, new candidates to be
appointed meet with the Nominations Committee in order to ascertain their
suitability, their potential contribution to the Board and the Company and to
ensure that they have no conflicting interests. The selected candidates then
meet with the remaining members of the Board and are then confirmed. In this
particular instance, the Board first heard of the proposed appointments when the
Requisitioner tabled their appointment as one of the resolutions for this EGM.
Therefore the Board`s knowledge of these individuals extends only to the
information contained within their curriculum vitae, which are attached in the
`Additional Information` section of this document.
The External Directors are very concerned by the proposed process of the
Requisitioner to appoint three (3) new individuals without any prior reference
to the Board or its Nominations Committee. Because Board members carry equal
legal responsibilities with other Directors serving together with them on the
same Board, Nominations Committees are standard in publicly quoted companies.
The Requisitioner has no such responsibilities, nor is accountable to the
shareholders for any appointment. Therefore, the calling of an EGM to
specifically over-ride a standard corporate governance process affecting the
legal responsibilities of the Board is, in the opinion of all members of the
Board other than Michael Weiss, highly irregular and raises concerns with the
External Directors about the way in which such important decisions could be
taken in the future if the Requisitioner`s proposals were allowed to proceed
unchallenged.
Whilst shareholders are entitled at a shareholder meeting to remove directors
from office, the Board has been advised in writing by the Requisitioner that the
current proposal to remove Elkan Gamzu, Geoffrey Vernon and Peter Stalker III as
Directors stems from the Board and the Remuneration Committee`s decision not to
recommend the Requisitioner`s request to the grant of options described above
with the effect that, despite any shareholder vote on this issue, the option
grant would not be valid. Directors` fiduciary duties are to act independently
in the best interests of the Company and all of its shareholders, according to
their own conscience and, based on their own belief, experience and specific
knowledge of the Company. For the reasons stated above, the External Directors
believe that the Board has acted in the best interests of the Company.
Geoffrey Vernon has notified the Company of his intention to resign from the
Board immediately upon the completion of the Extraordinary General Meeting
regardless of the outcome. Elkan Gamzu has a wealth of research and development
experience in both the pharmaceutical and biotechnology industries, is US based,
has served on other publicly quoted US Boards and has an in-depth understanding
of the research and development programmes of XTLbio. Peter Stalker III has
extensive US banking experience. We do not believe that removing these two (2)
Directors from the Board is in the best interests of the Company and its
shareholders.
Requisitioner`s communication with the External Directors
As External Directors of the Company, we have also received a separate letter
from the Requisitioner demanding that we disclose our position regarding the
appointment of the three (3) new Directors and the granting of the proposed
option packages to two (2) Directors. In the same letter he urges us to consider
resignation from the Board prior to the upcoming EGM if we are not in agreement
with his proposals, which he claims are supported by a majority of shareholders.
It is stated that this would enable the proposal and appointment of two (2) new
External Directors at the upcoming EGM and would negate the requirement for a
further EGM to do the same.
In keeping with our fiduciary responsibilities and having special regard for our
duties as External Directors, we do not believe that the appointment of an
entirely new Board of Directors is in the best interests of the Company and its
shareholders at this time. However, the Requisitioner has indicated in a letter
to the current members of the Board that he and other shareholders `shall deem
each and every member of the Board who voted against the grant of options
personally liable for any such additional expenditure and damage to the Company
and, may in the future, request the Company to recover any such damages that
will be incurred from the Board`. Furthermore, in his letter to the External
Directors the Requisitioner says, `...you should consider the ramifications of
any decrease in the share price on the market that may result from your actions
or inactions` in relation to our decision or otherwise to resign at or after the
EGM. In our opinion, this threat of personal litigation is an unnecessary act of
aggression and might be deemed as undue interference with our statutory
responsibilities as Directors. The External Directors also believe that this
approach raises significant issues about the direction of a public company if a
shareholder, who has not otherwise obtained approval of the shareholder body as
a whole, pressurises External Directors into resignation because they do not
agree with him. We also believe that it also does not augur well for the
independent role of Directors in decision-making processes within the Company if
a dissatisfied shareholder seeks to replace an entire Board in this way.
Amendment of the Articles
The Board supports the proposed amendment of the Articles of Association to
enable the issuance of shares without the current pre-emptive requirement so as
to help facilitate a listing on NASDAQ. The effect of such amendment to the
Articles is that the Board will be entitled to issue securities of the Company
without first offering such securities to the shareholders of the Company.
Notwithstanding such amendment to the Articles, the Company shall continue to be
obligated to comply with the UK Listing Rules regarding the issuance of share
capital, while the Company remains listed in the UK, regardless of amendments
made to the Company`s articles.
It is proposed that the following amendments be made to the Company`s Articles
of Association:
That the existing Articles of Association of the Company be amended by the
deletion of the existing Articles 6.1, 6.3 and 6.4 and the replacement
therefore with the following:
`6.1 The shares of the Company shall be under the control of the Board
of Directors, who shall have the power to allot shares or otherwise dispose
of them to such persons, on such terms and conditions, and either at par or
at a premium, or, subject to the provisions of the Companies Law, at a
discount, and at such times, as the Board of Directors may think fit, and
the power to give to any person the option to acquire from the Company any
shares, either at par or at a premium, or, subject as aforesaid, at a
discount, during such time and for such consideration as the Board of
Directors may think fit.`
`6.3 Reserved.`
`6.4 Reserved.
Additional Resolutions proposed by the Board of Directors
In the light of the convening of the EGM and the resolutions proposed by the
Requisitioner, the Board proposes two (2) further resolutions for consideration
by shareholders at the EGM.
1. A further amendment of the Articles of Association so as to reduce the
minimum number of directors on the Board from seven (7) to five (5)
following the Board`s decision that executive directors, excluding the
Chief Executive Officer, should not serve on the Board of Directors. The
reduction of the number of directors on the Board, by way of executive
directors not serving on the Board, brings the Company more in line with a
US style board consistency.
The full text of the proposed amendment is as follows:
`THAT the existing Articles of Association of the Company be amended by the
amendment of Articles 26.1 and the replacement of the word `seven (7)` with
the word `five (5)` so that following such amendment, Article 26.1 shall
state the following:
`26.1 Until such time as the General Meeting decides otherwise, the
number of members of the Board of Directors shall be not less than five (5)
and not more than twelve (12).`
2. To approve the remuneration of Elkan Gamzu, who volunteered to serve as the
interim Chief Executive Officer and Chairman of the Board until such time
as permanent successors are appointed. At present Dr. Gamzu, who is
normally based in the US, is prevented from carrying out his regular full
time consulting role with other companies there and therefore forfeits his
normal income from such consulting activities to address XTLbio`s business
needs, which include frequent travel to Israel. Accordingly, the Board
proposes that Elkan Gamzu should receive a monthly remuneration of
US$25,000 for each month he serves as interim Chief Executive Officer (such
amount to be pro rated for any parts of a month), effective as of 1
December 2004. This is the same as the cash remuneration paid to the former
Chief Executive Officer. Elkan Gamzu will receive no benefits commensurate
with the office and it is not proposed to pay him additional remuneration
for his role as Interim Chairman.
Extraordinary General Meeting / Action to be taken
A notice convening the Extraordinary General Meeting of the Company to be held
at 12.00 p.m. (Israel Time) on 24 February 2005 at The Dan Tel Aviv Hotel, 99
Hayarkon St., Tel Aviv 63432, Israel is set out at the end of this document.
RESOLUTIONS 1 TO 6 ARE OPPOSEDBY THE EXTERNAL DIRECTORS
Resolutions 1 to 3 seek to approve the appointment of Ben Zion Weiner, William
Kennedy, and Jonathan Spicehandler, as Directors to the Board;
Resolution 4 seeks to approve the removal of Elkan Gamzu, Geoffrey Vernon, and
Peter Stalker III from their office as Directors of the Company;
Resolution 5 seeks to approve the grant of certain share options to Michael
Weiss, a Director of the Company; and
Resolution 6 seeks to approve the grant of certain share options to Ben Zion
Weiner, a proposed candidate to be appointed as a Director of the Company.
RESOLUTIONS 7 TO 9 ARE SUPPORTEDBY THE EXTERNAL DIRECTORS
Resolution 7 seeks to amend the Articles of Association of the Company to
exclude the provisions relating to pre-emption rights and to provide a general
authority to the Board to issue shares of the Company so as to provide the
Company with greater flexibility to take advantage of fund-raising opportunities
should they prove necessary;
Resolution 8 seeks to amend the Articles of Association of the Company to reduce
the minimum number of directors from seven (7) to five (5); and
Resolution 9 seeks to approve the grant of certain remuneration to Elkan Gamzu,
a Director of the Company, for the provision of his services as the interim
Chief Executive Officer and Chairman.
Shareholders are urged, where possible, to attend and vote at the meeting in
person. If this is not possible they may vote by proxy and are advised to take
the following course of action to ensure that their views are represented at the
meeting.
You will find enclosed a form of proxy (or Form of Instruction in the case of
holders of Depository Interests) for use at the Extraordinary General Meeting.
Whether or not you intend to be present at the meeting, please complete and
return the form of proxy to Computershare Investor Services (Channel Islands)
Limited, PO Box 83, Ordnance House, 31 Pier Road, St. Helier, Jersey, JE4 8PW,
Channel Islands; the form of instruction to Computershare Investor Service PLC,
POB 1075, The Pavilions, Bridgwater Road, Bristol BS99 3FA, England; (or, by
hand only, at Computershare Investor Services PLC, 68 Upper Thames Street,
Vintners` Place, London, EC4V 3BJ, England) as soon as possible and, in any
event, so as to be received with regard to the form of instruction, no later
than 2.00 p.m. (Israel Time) on 21 February 2005 and with regard to the proxy,
no later than 12.00 p.m. (Israel Time) on 22 February 2005. The Board of
Directors has fixed 11 February 2005 as the `record date` for determining those
shareholders entitled to participate and vote at the Extraordinary General
Meeting. If you need assistance in communicating with your nominee (for nominee
banks that are not a direct shareholder) or in filling out the proxy forms,
please contact Georgeson Shareholder Communications, Inc., a Computershare plc
company, Mr. Stephen Lewis, whose details are provided below.
Phone: +44 (0) 870 703 0307
Fax: +44 (0) 870 703 0158
Email:
stephen.lewis@computershare.co.uk.
Completion and return of a form of proxy will not preclude shareholders from
attending and voting at the Extraordinary General Meeting, should they so wish.
Recommendations
The Directors (excluding Michael Weiss) do not believe that resolutions 1-4 are
in the best interests of shareholders as a whole and therefore recommend that
shareholders:
VOTE AGAINST resolutions 1 to 4
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The Directors (excluding Michael Weiss, who did not participate in the Board
decision on this matter) do not believe that resolution 5 is in the best
interests of shareholders as a whole and therefore recommend that shareholders:
VOTE AGAINST resolution 5
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The Directors (excluding Michael Weiss) do not believe that resolution 6 is in
the best interests of shareholders as a whole and therefore recommend that
shareholders:
VOTE AGAINST resolution 6
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The Directors do believe that resolutions 7-8 are in the best interests of
shareholders as a whole and therefore recommend that shareholders:
VOTE FOR resolutions 7 and 8
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to five hundred and sixteen thousand seven hundred and
seventy-nine shares representing approximately 0.31 per cent of the issued share
capital of the Company.
The majority of the Directors (excluding Elkan Gamzu, who did not participate in
the Board decision on this matter) do believe that resolution 9 is in the best
interests of shareholders as a whole and therefore recommend that shareholders:
VOTE FORresolution 9
as they intend to do in respect of their own beneficial holdings which amount,
in aggregate, to four hundred and seventeen thousand three hundred and twenty
seven shares representing approximately 0.25 per cent of the issued share
capital of the Company.
Geoffrey Vernon has notified the Company of his intention to resign from the
Board immediately upon the completion of the Extraordinary General Meeting
irrespective of the outcome of resolution 4.
Michael Weiss has indicated to the Board that he is highly likely to resign from
the Board if the Requisitioner`s resolutions are not approved.
Elkan Gamzu and Peter Stalker III have indicated to the Board that they shall
consider resigning from the Board even if Resolution 4 seeking to remove them
from office is not approved but resolutions 1-3 and 5-6 are approved by the
shareholders. They feel that these resolutions would undermine the role of the
current Board in managing the Company and would have a significant bearing on
the way in which Board decisions would be made in the future.
Yours faithfully,
Patricia Smith
Rusi Kathoke
Die Aktie schleicht sich nach oben .Ob da was positives bei dem meeting übermorgen bekannt gegeben wird ?
Hi
Geil diese woche schon über 15% gestiegen und es geht weiter aufwärts
Geil diese woche schon über 15% gestiegen und es geht weiter aufwärts
XTLBio
Man sollte sich gar nicht von den jetzigen Anstiegen oder mgl kurzfristigen Abstürzen irritieren lassen.
Das Konzept der Firma ist vom wissenschaftlichen Ansatz her einfach hervorragend. Diese Aktie sich auch vom jetzigen Niveau aus noch verfielfachen, falls nicht irgend etwas ganz schlimmes dazwischen kommt.
Man sollte sich gar nicht von den jetzigen Anstiegen oder mgl kurzfristigen Abstürzen irritieren lassen.
Das Konzept der Firma ist vom wissenschaftlichen Ansatz her einfach hervorragend. Diese Aktie sich auch vom jetzigen Niveau aus noch verfielfachen, falls nicht irgend etwas ganz schlimmes dazwischen kommt.
Eine tolle performance in den letzten tagen und das ohne nachrichten .
Long and Strong on XTL
Long and Strong on XTL
Hi
Gute Nachrichten XTL wurde ins FTSETM techMARK 100 index aufgenommen.
XTL Biopharmaceuticals joins FTSETM techMARK 100 index
Rehovot, Israel, 4 March 2005 - XTL Biopharmaceuticals Ltd. (XTLbio) announced
today that, following the FTSETM techMARK 100`s recent quarterly review, the
Company`s shares are now included in the FTSETM techMARK 100. The techMARK 100
is a component of the FTSETM techMARK index of the London Stock Exchange. XTLbio
continues to be a constituent member of the FTSETM techMARK All-Share and the
FTSETM techMARK mediscienceTM indices.
Gute Nachrichten XTL wurde ins FTSETM techMARK 100 index aufgenommen.
XTL Biopharmaceuticals joins FTSETM techMARK 100 index
Rehovot, Israel, 4 March 2005 - XTL Biopharmaceuticals Ltd. (XTLbio) announced
today that, following the FTSETM techMARK 100`s recent quarterly review, the
Company`s shares are now included in the FTSETM techMARK 100. The techMARK 100
is a component of the FTSETM techMARK index of the London Stock Exchange. XTLbio
continues to be a constituent member of the FTSETM techMARK All-Share and the
FTSETM techMARK mediscienceTM indices.
Ja, sehr positiv zu bewerten ist, daß die Aktie trotz der brillianten Rahmenbedingungen noch nicht das Aufsehen erregt hat, das ihr aufgrund ihrer Bedeutung eigentlich zusteht.
Die wissenschaftliche/innovative Basis (das wichtigste überhaupt) ist hervorragend, die wirtschaftlichen Aussichten bei Zulassung nur eines der Antikörper sind gigantisch, Geld ist genug da, jetzt muß nur noch der neue Vorstand keine groben Fehler machen...dann steht der Aufnahme in NY nichts mehr im Wege und der Kurs wird in einem Jahr bei 10 Pfund stehen
Die wissenschaftliche/innovative Basis (das wichtigste überhaupt) ist hervorragend, die wirtschaftlichen Aussichten bei Zulassung nur eines der Antikörper sind gigantisch, Geld ist genug da, jetzt muß nur noch der neue Vorstand keine groben Fehler machen...dann steht der Aufnahme in NY nichts mehr im Wege und der Kurs wird in einem Jahr bei 10 Pfund stehen
Achtung: Neue positive Nachricht (s. www.xtlbio.com) in Kürze zu erwarten...
Attention: Positive news in the near future (www.xtlbio.com)..
Attention: Positive news in the near future (www.xtlbio.com)..
Moin
XTL Biopharmaceuticals Ltd
Board Change
Rehovot,Israel 15 March 2005 - XTL Biopharmaceuticals Ltd (`XTLbio`) (LSE: XTL) today
announces the appointment of Michael Weiss as Interim Non-Executive Chairman
with immediate effect. Mr. Weiss became a Non-Executive Director of XTLbio in
November 2004 and is also Chairman and CEO of New York-based Keryx
Biopharmaceuticals, Inc.
`With the new board in place following the successful shareholder requisition, I
felt it was an appropriate time for me to take a leadership role in XTLbio`
stated Mr. Weiss, who continued, `with the new board members we have added
substantial expertise in research and development as well as regulatory affairs
and with particular expertise in hepatitis C. We look forward to transitioning
the Company into a disciplined and focused biotechnology company dedicated to
creating shareholder value. Our early efforts will also focus on commencing the
Nasdaq listing process and identifying a US-based Chief Executive to lead the
Company.`
XTL Biopharmaceuticals Ltd
Board Change
Rehovot,Israel 15 March 2005 - XTL Biopharmaceuticals Ltd (`XTLbio`) (LSE: XTL) today
announces the appointment of Michael Weiss as Interim Non-Executive Chairman
with immediate effect. Mr. Weiss became a Non-Executive Director of XTLbio in
November 2004 and is also Chairman and CEO of New York-based Keryx
Biopharmaceuticals, Inc.
`With the new board in place following the successful shareholder requisition, I
felt it was an appropriate time for me to take a leadership role in XTLbio`
stated Mr. Weiss, who continued, `with the new board members we have added
substantial expertise in research and development as well as regulatory affairs
and with particular expertise in hepatitis C. We look forward to transitioning
the Company into a disciplined and focused biotechnology company dedicated to
creating shareholder value. Our early efforts will also focus on commencing the
Nasdaq listing process and identifying a US-based Chief Executive to lead the
Company.`
Hallo
XTL Biopharmaceuticals Ltd
31 March 2005
XTL Biopharmaceuticals Ltd
Provides Update on Clinical Programs and Planned Operations
XTLbio to focus efforts on advancing lead programs, HepeX(TM)-C and HCV-SM
and supporting HepeXTM-B collaboration
Rehovot, Israel, 31 March 2005 - XTL Biopharmaceuticals Ltd (`XTLbio`) (LSE:
XTL) today announced that the new Board has undertaken a review of the business
and agreed on a re-focusing plan designed to enable the Company to realize value
from its R&D programs.
Integral to the strategy is the Board`s initiative to focus its resources on the
development of its lead programs, HepeX-C and HCV-SM, with the goal of moving
those programs through to clinical proof-of-principle. The plan provides for
cost savings of approximately $6 million over the next two years and will extend
the Company`s cash resources until the end of 2006 or early into 2007. The key
points arising from the review include:
- a reduction in headcount of approximately 20 individuals, primarily
in R&D, as the Company`s programs advance into the clinical stages of
development, and its commercialisation partner for HepeX-B, Cubist
Pharmaceuticals, takes over more responsibility for product development;
- streamlining of operations across the business;
- deferring all R&D activity not supporting the lead clinical programs
until proof-of-principle has been achieved in at least one of the two lead
programs; and
- reduction in cash burn to $0.9M per month from $1.3M
In addition, to diversify the Company`s clinical product portfolio and to
strengthen its franchise in infectious diseases, XTLbio will seek to in-license
or acquire complementary clinical product candidates to broaden its clinical
pipeline.
Michael Weiss, Interim Non-Executive Chairman, commented:
`The Board has agreed to a plan to realize value from XTLbio`s pipeline in what
we believe will be the most efficient, cost effective and timely manner. By
streamlining operations and focusing our research efforts, we believe we can
reach our clinical timelines to proof-of-principle for each of our major
programs more efficiently and, if necessary, do so with our current resources.
Our aim is to re-create XTLbio as a goal driven organization that can thrive in
the US capital markets following our anticipated listing on the NASDAQ.`
Shlomo Dagan, PhD, Chief Scientific Officer, commented:
`While it is always difficult to part with great people, as XTLbio is moving
into the next stage of its scientific and clinical development, we need to focus
our resources on supporting our lead clinical programs.`
Update on Clinical Programs
HepeX-C is being developed to prevent hepatitis C (HCV) re-infection of
transplanted livers as well in the treatment of chronic HCV. Having completed a
phase 2 clinical trial with one monoclonal antibody (MAb), the program is now at
the second stage of the development strategy - evaluation of the dual-MAb
product in clinical trials. The Phase Ia/Ib clinical trial with HepeX-C in
patients with chronic HCV will evaluate safety and preliminary biological
activity of the drug, and is expected to be completed by the end of 2006. XTLbio
is now preparing an IND for the dual-MAb product for submission to the FDA in
2005.
The small molecule development program, HCV-SM, is targeted at treating chronic
hepatitis C. Following the identification of two lead candidates, the Company
plans to select the most promising small molecule in this program to take
forward into clinical development, and assuming the lead candidate passes
pre-clinical toxicology testing, currently on-going, then the Company expects to
make an IND filing to the FDA by the end of 2005. The Company is targeting
completion of a Phase Ia/Ib clinical trial in patients with chronic HCV
establishing proof-of-principle, by the end of 2006.
HepeX-B is being developed to prevent re-infection with Hepatitis B (HBV)
following liver transplantation. HepeX-B is currently in a Phase IIb trial in
patients following liver transplantation. We expect to complete recruitment for
this trial by mid-2005. Worldwide rights for HepeX-B were licensed to Cubist
Pharmaceuticals Inc.
XTL Biopharmaceuticals Ltd
31 March 2005
XTL Biopharmaceuticals Ltd
Provides Update on Clinical Programs and Planned Operations
XTLbio to focus efforts on advancing lead programs, HepeX(TM)-C and HCV-SM
and supporting HepeXTM-B collaboration
Rehovot, Israel, 31 March 2005 - XTL Biopharmaceuticals Ltd (`XTLbio`) (LSE:
XTL) today announced that the new Board has undertaken a review of the business
and agreed on a re-focusing plan designed to enable the Company to realize value
from its R&D programs.
Integral to the strategy is the Board`s initiative to focus its resources on the
development of its lead programs, HepeX-C and HCV-SM, with the goal of moving
those programs through to clinical proof-of-principle. The plan provides for
cost savings of approximately $6 million over the next two years and will extend
the Company`s cash resources until the end of 2006 or early into 2007. The key
points arising from the review include:
- a reduction in headcount of approximately 20 individuals, primarily
in R&D, as the Company`s programs advance into the clinical stages of
development, and its commercialisation partner for HepeX-B, Cubist
Pharmaceuticals, takes over more responsibility for product development;
- streamlining of operations across the business;
- deferring all R&D activity not supporting the lead clinical programs
until proof-of-principle has been achieved in at least one of the two lead
programs; and
- reduction in cash burn to $0.9M per month from $1.3M
In addition, to diversify the Company`s clinical product portfolio and to
strengthen its franchise in infectious diseases, XTLbio will seek to in-license
or acquire complementary clinical product candidates to broaden its clinical
pipeline.
Michael Weiss, Interim Non-Executive Chairman, commented:
`The Board has agreed to a plan to realize value from XTLbio`s pipeline in what
we believe will be the most efficient, cost effective and timely manner. By
streamlining operations and focusing our research efforts, we believe we can
reach our clinical timelines to proof-of-principle for each of our major
programs more efficiently and, if necessary, do so with our current resources.
Our aim is to re-create XTLbio as a goal driven organization that can thrive in
the US capital markets following our anticipated listing on the NASDAQ.`
Shlomo Dagan, PhD, Chief Scientific Officer, commented:
`While it is always difficult to part with great people, as XTLbio is moving
into the next stage of its scientific and clinical development, we need to focus
our resources on supporting our lead clinical programs.`
Update on Clinical Programs
HepeX-C is being developed to prevent hepatitis C (HCV) re-infection of
transplanted livers as well in the treatment of chronic HCV. Having completed a
phase 2 clinical trial with one monoclonal antibody (MAb), the program is now at
the second stage of the development strategy - evaluation of the dual-MAb
product in clinical trials. The Phase Ia/Ib clinical trial with HepeX-C in
patients with chronic HCV will evaluate safety and preliminary biological
activity of the drug, and is expected to be completed by the end of 2006. XTLbio
is now preparing an IND for the dual-MAb product for submission to the FDA in
2005.
The small molecule development program, HCV-SM, is targeted at treating chronic
hepatitis C. Following the identification of two lead candidates, the Company
plans to select the most promising small molecule in this program to take
forward into clinical development, and assuming the lead candidate passes
pre-clinical toxicology testing, currently on-going, then the Company expects to
make an IND filing to the FDA by the end of 2005. The Company is targeting
completion of a Phase Ia/Ib clinical trial in patients with chronic HCV
establishing proof-of-principle, by the end of 2006.
HepeX-B is being developed to prevent re-infection with Hepatitis B (HBV)
following liver transplantation. HepeX-B is currently in a Phase IIb trial in
patients following liver transplantation. We expect to complete recruitment for
this trial by mid-2005. Worldwide rights for HepeX-B were licensed to Cubist
Pharmaceuticals Inc.
!!!EXPLOSIONSGEFAHR !!!
In den nächsten wochen geht es steil bergauf....
In den nächsten wochen geht es steil bergauf....
hallo BioExperte, sieht ganz gut aus. In Berlin wird kein Kurs gestellt, und ich wollte vorerst höchstens 2000 stücke odern. Weißt Du wie ich das am besten mache und hältst Du das für sinnvoll? :-)
hier noch der aktuelle chart:
@all
Hallo, liest hier noch jemand mit?
Ich habe folgende Fragen:
Welche chart-technischen Kriterien gibt es, um den richtigen Einstiegszeitpunkt zu finden.
Wie limitiere ich meine order am besten?
Macht bei einer geringen Ordergröße von 2000 Stück eine Auslands-Order überhaupt Sinn?
:-)
Hallo, liest hier noch jemand mit?
Ich habe folgende Fragen:
Welche chart-technischen Kriterien gibt es, um den richtigen Einstiegszeitpunkt zu finden.
Wie limitiere ich meine order am besten?
Macht bei einer geringen Ordergröße von 2000 Stück eine Auslands-Order überhaupt Sinn?
:-)
XTLBIO:
Der kurs durfte jetzt stark anziehenn wegen in kurze zu erwartender guter neuigkeiten
Der kurs durfte jetzt stark anziehenn wegen in kurze zu erwartender guter neuigkeiten
Hi
@Kalb von Hanau
Bei einer anzahl von 2000stück würde ich direkt in Berlin ordern.
Xtl zieht langsam wieder an ,die 40p ist nach einigen monaten wieder erobert worden.
News Expected for 2005
HepeX-B Phase IIb results (Liver)
HepeX-C Phase IIa results (Liver)
HepeX-C Phase I results (small molecule)
Nasdaq listing
@Kalb von Hanau
Bei einer anzahl von 2000stück würde ich direkt in Berlin ordern.
Xtl zieht langsam wieder an ,die 40p ist nach einigen monaten wieder erobert worden.
News Expected for 2005
HepeX-B Phase IIb results (Liver)
HepeX-C Phase IIa results (Liver)
HepeX-C Phase I results (small molecule)
Nasdaq listing
XTL Biopharma notiert knapp unter jahreshoch.
XTL Biopharmaceuticals Ltd
07 July 2005
XTL Biopharmaceuticals Ltd - the first Israeli company to perform a dual listing
between the London Stock Exchange and Tel-Aviv Stock Exchange
Rehovot, Israel, 7 July 2005: XTL Biopharmaceuticals Ltd (`XTLbio` or the
`Company`) (LSE:XTL) announces that it will file a registration document today
(the `Registration Document`) with the Israel Securities Authority (`ISA`) in
connection with the proposed dual listing of the Company`s shares on the Tel
Aviv Stock Exchange (`TASE`). Trading on TASE is expected to commence on
Tuesday, 12 July 2005. The Company is not conducting an offering in connection
with the listing. The current market capitalisation of the Company will enable
XTLbio to be included in the Tel Aviv 100 Index and the Tel-Aviv Tel-Tech Index.
The dual listing will enable Israeli and international investors, who currently
do not trade shares in the UK because of, inter alia, various restrictions,
costs or time differences, to trade in XTLbio shares.
Dual listing has been available for companies listed on NASDAQ since October
2000. Recently, the dual listing regulations have been expanded to allow
companies that are listed on the UK Official List and traded on the London Stock
Exchange`s market for listed securities to be admitted to trade on TASE. The
Company`s London listing will continue to be the Company`s primary listing and
the Company will continue to report in English and in accordance with the
continuing obligations of, inter alia, the Listing Rules of the Financial
Services Authority in the UK.
Once filed, the Registration Document may be accessed from the ISA website,
located at
XTL Biopharmaceuticals Ltd
07 July 2005
XTL Biopharmaceuticals Ltd - the first Israeli company to perform a dual listing
between the London Stock Exchange and Tel-Aviv Stock Exchange
Rehovot, Israel, 7 July 2005: XTL Biopharmaceuticals Ltd (`XTLbio` or the
`Company`) (LSE:XTL) announces that it will file a registration document today
(the `Registration Document`) with the Israel Securities Authority (`ISA`) in
connection with the proposed dual listing of the Company`s shares on the Tel
Aviv Stock Exchange (`TASE`). Trading on TASE is expected to commence on
Tuesday, 12 July 2005. The Company is not conducting an offering in connection
with the listing. The current market capitalisation of the Company will enable
XTLbio to be included in the Tel Aviv 100 Index and the Tel-Aviv Tel-Tech Index.
The dual listing will enable Israeli and international investors, who currently
do not trade shares in the UK because of, inter alia, various restrictions,
costs or time differences, to trade in XTLbio shares.
Dual listing has been available for companies listed on NASDAQ since October
2000. Recently, the dual listing regulations have been expanded to allow
companies that are listed on the UK Official List and traded on the London Stock
Exchange`s market for listed securities to be admitted to trade on TASE. The
Company`s London listing will continue to be the Company`s primary listing and
the Company will continue to report in English and in accordance with the
continuing obligations of, inter alia, the Listing Rules of the Financial
Services Authority in the UK.
Once filed, the Registration Document may be accessed from the ISA website,
located at
XTL Biopharmaceuticals Ltd
07 July 2005
Annual General Meeting (`AGM`) and Extraordinary General Meeting (`EGM`) notice
posted to shareholders
Rehovot, Israel, 7 July 2005 - The Company has posted to shareholders a notice
convening its AGM and an EGM. The AGM will take place the Company`s offices,
Kiryat Weizmann Science Park, Bldg 3, 3 Hasapir St, Ness Ziona 76100, Israel at
10a.m. (Israel Time) on 1 August 2005 and the EGM will follow at 4p.m. at the
same venue on the same day.
At the AGM it is proposed that:
•the annual reports for the year ended 31 December 2004 be received;
•Kesselman & Kesselman be reappointed as the Company`s auditors;
•Messrs Michael Weiss, Ben Zion Weiner, William Kennedy and Jonathan
Spicehandler be reappointed as Directors of the Company;
•Vered Shany and Ido Seltenreich be appointed as External Directors of the
Company; and
•the Company`s articles be amended.
At the EGM it is proposed that:
•the remuneration for non-Executive Directors be approved;
•the grant of options to William Kennedy and Jonathan Spicehandler be
approve;
•the grant of options to Ben-Zion Weiner be approved;
•the annual fee of Michael Weiss and the remaining terms of remuneration
of Michael Weiss including the grant of options;
•the Company`s purchase of liability insurance be approved; and
•the indemnification to the Board members be approved
Contacts:
XTLbio
Jonathan Burgin, Chief Financial Officer Tel: +972 8 930 4440
Notes to Editors
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing
drugs against hepatitis. Established in 1993, XTLbio became a public company in
2000 and its ordinary shares are listed on the Official List of the UK Listing
Authority and are traded on the London Stock Exchange under the symbol XTL.
07 July 2005
Annual General Meeting (`AGM`) and Extraordinary General Meeting (`EGM`) notice
posted to shareholders
Rehovot, Israel, 7 July 2005 - The Company has posted to shareholders a notice
convening its AGM and an EGM. The AGM will take place the Company`s offices,
Kiryat Weizmann Science Park, Bldg 3, 3 Hasapir St, Ness Ziona 76100, Israel at
10a.m. (Israel Time) on 1 August 2005 and the EGM will follow at 4p.m. at the
same venue on the same day.
At the AGM it is proposed that:
•the annual reports for the year ended 31 December 2004 be received;
•Kesselman & Kesselman be reappointed as the Company`s auditors;
•Messrs Michael Weiss, Ben Zion Weiner, William Kennedy and Jonathan
Spicehandler be reappointed as Directors of the Company;
•Vered Shany and Ido Seltenreich be appointed as External Directors of the
Company; and
•the Company`s articles be amended.
At the EGM it is proposed that:
•the remuneration for non-Executive Directors be approved;
•the grant of options to William Kennedy and Jonathan Spicehandler be
approve;
•the grant of options to Ben-Zion Weiner be approved;
•the annual fee of Michael Weiss and the remaining terms of remuneration
of Michael Weiss including the grant of options;
•the Company`s purchase of liability insurance be approved; and
•the indemnification to the Board members be approved
Contacts:
XTLbio
Jonathan Burgin, Chief Financial Officer Tel: +972 8 930 4440
Notes to Editors
XTL Biopharmaceuticals Ltd. (XTLbio) is a biopharmaceutical company developing
drugs against hepatitis. Established in 1993, XTLbio became a public company in
2000 and its ordinary shares are listed on the Official List of the UK Listing
Authority and are traded on the London Stock Exchange under the symbol XTL.
Bei XTL scheint etwas im busch zu sein ,volumen und kurs steigen .
Ab Dienstag dürfte wohl noch mehr schwung in den kurs kommen durch die listung in Tel Aviv .
Und in kürze soll auch Nasdaq folgen.
Trading in XTLbio shares on the TASE is expected to start on Tuesday, 12 July 2005. The company is not conducting an offering in connection with the listing.
XTLbio said that its current market capitalization would enable it to be included in the Tel Aviv 100 and Tel-Tech indices.
The company said that dual listing would enable Israeli and international investors who currently do not trade shares in the UK because of restrictions, costs, or time differences, to trade in XTLbio shares.
XTLbio interim chairman Michael Weiss said, "We are delighted to be the first Israeli company to perform a dual listing between London and Tel-Aviv. The listing in Tel-Aviv will provide our Israeli shareholders and potential new investors with the ability to trade our shares locally in their own currency. We look forward to completing our listing on Nasdaq in the near future so as to enable US investors to trade our shares in the US."
Und in kürze soll auch Nasdaq folgen.
Trading in XTLbio shares on the TASE is expected to start on Tuesday, 12 July 2005. The company is not conducting an offering in connection with the listing.
XTLbio said that its current market capitalization would enable it to be included in the Tel Aviv 100 and Tel-Tech indices.
The company said that dual listing would enable Israeli and international investors who currently do not trade shares in the UK because of restrictions, costs, or time differences, to trade in XTLbio shares.
XTLbio interim chairman Michael Weiss said, "We are delighted to be the first Israeli company to perform a dual listing between London and Tel-Aviv. The listing in Tel-Aviv will provide our Israeli shareholders and potential new investors with the ability to trade our shares locally in their own currency. We look forward to completing our listing on Nasdaq in the near future so as to enable US investors to trade our shares in the US."
Hallo
Xtl Bio erreicht neues 3jahreshoch bei 45,25p tendenz steigend.
Damit hat sich meine xtl seit einstieg fast verdoppelt.
Mal sehen was die reichen Israelis morgen machen.
Xtl Bio erreicht neues 3jahreshoch bei 45,25p tendenz steigend.
Damit hat sich meine xtl seit einstieg fast verdoppelt.
Mal sehen was die reichen Israelis morgen machen.
Moin
Guter start in die woche mit Fast Track für HepeX-C !
XTL Biopharmaceuticals Ltd
18 July 2005
XTLbio Receives Fast Track Designation for Hepatitis C Therapy
from US Food and Drug Administration
Rehovot, Israel, 17 July 2005 - XTL Biopharmaceuticals Ltd (`XTLbio`) (LSE: XTL)
today announced that it has received Fast Track designation from the United
States Food and Drug Administration for XTL-6865 (formerly known as HepeX-C).
Fast Track designation is granted to facilitate the development and expedite the
regulatory review of new drugs that are intended to treat serious or life
threatening conditions and that demonstrate the potential to address unmet
medical needs. XTL-6865 is being developed to prevent hepatitis C (HCV)
re-infection following a liver transplant and for the treatment of chronic HCV
disease. The Fast Track designation was limited by the Agency to the
post-transplant indication.
XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and
Ab65) against the hepatitis C virus E2 envelope protein. A single antibody
version of this product was tested in a pilot clinical program that included
both Phase I and Phase II clinical trials. In April 2005, XTLbio submitted a US
investigational new drug application (IND) to the FDA in order to commence a
Phase Ia/Ib clinical trial later this year for XTL-6865, the dual-MAb product.
A Biologics License Application (BLA) is submitted before a drug is approved for
marketing by the FDA. Fast track designation gives XTLbio the opportunity to
submit a BLA for XTL-6865 in sequential sections, and to have these sections
reviewed as they are submitted. Fast track designation also opens the
possibility for receiving a priority review or accelerated approval of the BLA
where the review time at the Agency would be six months, further reducing the
time to market.
Michael Weiss, Interim Non-Executive Chairman, commented:
`The designation of XTL-6865 as a Fast Track programme recognises the need for
new forms of treatment for patients with recurrent HCV following a liver
transplant.`
Guter start in die woche mit Fast Track für HepeX-C !
XTL Biopharmaceuticals Ltd
18 July 2005
XTLbio Receives Fast Track Designation for Hepatitis C Therapy
from US Food and Drug Administration
Rehovot, Israel, 17 July 2005 - XTL Biopharmaceuticals Ltd (`XTLbio`) (LSE: XTL)
today announced that it has received Fast Track designation from the United
States Food and Drug Administration for XTL-6865 (formerly known as HepeX-C).
Fast Track designation is granted to facilitate the development and expedite the
regulatory review of new drugs that are intended to treat serious or life
threatening conditions and that demonstrate the potential to address unmet
medical needs. XTL-6865 is being developed to prevent hepatitis C (HCV)
re-infection following a liver transplant and for the treatment of chronic HCV
disease. The Fast Track designation was limited by the Agency to the
post-transplant indication.
XTL-6865 is a combination of two fully human monoclonal antibodies (Ab68 and
Ab65) against the hepatitis C virus E2 envelope protein. A single antibody
version of this product was tested in a pilot clinical program that included
both Phase I and Phase II clinical trials. In April 2005, XTLbio submitted a US
investigational new drug application (IND) to the FDA in order to commence a
Phase Ia/Ib clinical trial later this year for XTL-6865, the dual-MAb product.
A Biologics License Application (BLA) is submitted before a drug is approved for
marketing by the FDA. Fast track designation gives XTLbio the opportunity to
submit a BLA for XTL-6865 in sequential sections, and to have these sections
reviewed as they are submitted. Fast track designation also opens the
possibility for receiving a priority review or accelerated approval of the BLA
where the review time at the Agency would be six months, further reducing the
time to market.
Michael Weiss, Interim Non-Executive Chairman, commented:
`The designation of XTL-6865 as a Fast Track programme recognises the need for
new forms of treatment for patients with recurrent HCV following a liver
transplant.`
Xtl Bio steigt und steigt anscheinend merken die leute was für potential hier schlummert nur hier in deutschland schläft man noch.
Moin
Xtl Bio startet durch die 50p ist überschritten wow.
Link für die Israelische Börse wo Xtl bio auch gelistet ist:
http://www.tase.co.il/buildpage.cgi
Und in U.K.:
http://uk.finance.yahoo.com/q?d=t&p=&q=q&s=xtl&m=L
Einen schönen Wochenstart wünscht
Xtl Bio startet durch die 50p ist überschritten wow.
Link für die Israelische Börse wo Xtl bio auch gelistet ist:
http://www.tase.co.il/buildpage.cgi
Und in U.K.:
http://uk.finance.yahoo.com/q?d=t&p=&q=q&s=xtl&m=L
Einen schönen Wochenstart wünscht
Interview mit Chairman Michael Weiss
Two-gun Weiss
Michael Weiss, chair of Keryx and XTLbio, is visiting Israel to promote their interests.
Hadass Geyfman 21 Jul 05 13:58
Michael Weiss is chairman of XTL Biopharmaceuticals Ltd. (LSE: XTL; TASE: XTL), which develops drugs for treatment of hepatitis B and C. He is also chairman and CEO of Keryx Biopharmaceuticals Inc. (Nasdaq: KERX, which develops drugs for treatment of cancer and diabetes. Currently visiting Israel for XTL’s listing on the Tel Aviv Stock Exchange (TASE), Weiss was invited to open yesterday’s TASE trading.
Weiss told "Globes", “In addition to listing the share on the TASE, the purpose of my visit to Israel is to meet XTL’s staff, visit the company’s shareholders, and meet with parties connected with Keryx.”
"Globes": Why did you decide to have XTL’s share listed for trading on the TASE?
Weiss: ”The initial motivation for having XTL’s share listed on the TASE was our feeling that the company’s shareholder base was shifting significantly from London to Israel. We thought that it was very important to give the shareholders a chance to trade in the local stock exchange, and in local currency.”
When do you think you’ll have the share listed on Nasdaq?
”The target for Nasdaq listing that we’ve set for ourselves is mid-August. We think the likelihood is very high that it will happen.”
Having the share listed on three stock exchanges involves high management costs, and quite a few headaches investment management.
”Listing in Tel Aviv was a simple and easy process, which didn’t add costs or management complications, thanks to the current reciprocal relations between the stock exchanges in Tel Aviv and London. The decision to have the share listed in Tel Aviv followed the change in the laws for dual listing of shares that are listed in London.
”The London Stock Exchange (LSE) was the first on which XTL was issued. The share currently enjoys fairly good trading volume in London, and its listing there will therefore continue. The next stage in the company’s development should be listing on Nasdaq, because the Wall Street capital market offers the largest and most sophisticated capital base for investments in biotechnology, with the most experienced investors.
”Another reason is that US investors don’t often invest in companies that aren’t listed on US exchanges. Nasdaq listing is expected to bring a new large and high-quality group of investors with expertise in biotechnology to the company.”
In the long term, will you allow the share’s listing in London to continue?
”The decision about continuing the share’s listing in London in the long term will be based on its trading volume. At the moment, volume is good, so there’s no reason to change the listing. If all the trading volume shifts to Nasdaq and the TASE later, we’ll consider changing the share’s status on the LSE.”
What trading volume on Nasdaq do you expect?
”We expect that volume will be modest at first, then grow gradually over 6-18 months. I believe that most of the trading volume will eventually be on Nasdaq.”
What are your plans with investors?
”We’re planning a series of non-financial road shows for XTL, in which we’ll present the company to new investors who focus on biotechnology investments. The purpose is to enable investors to know the company. We’re not looking for investment at the moment. We’ll start with small investors, and gradually move to larger and larger investors.”
What are your plans for the company in the coming year?
”In technology, our plans are to continue developing XTL’s relationship with Cubist Pharmaceuticals, which is investing in financing development of the HepeX-B drug. At the same time, the company will continue its aggressive development of the XTL-6865 drug. Another important element is looking for opportunities to buy licenses or new drugs. We’ll look for an opportunity to acquire a company that has developed new drugs, or to buy the rights to new drugs from companies that for certain reasons wish to stop investing in these drugs.
”For example, there are companies interested in relying on XTL’s accumulated expertise. There are companies that lack resources to continue developing their drugs by themselves, and there are companies that have already developed drugs that are not strategic for them. All these companies have acquisition potential.”
XTL’s CEO resigned a few months ago. Is there already a permanent CEO?
”There’s still no permanent CEO. At the moment, we’re in the process of selecting potential candidates. The goal is to appoint a CEO in the next 30-60 days.”
What kind of CEO are you looking for?
”We’re looking for a CEO with strong connections in the financial community. The ideal situation, of course, is to find a CEO with connections in the financial community in Israel and the US, but our emphasis is on the US. In addition to that, we obviously also need a smart person, who knows how to work hard, and has experience in biotechnology. We currently have several such candidates on our short list.”
Are there still obstacles on the way to appointing a CEO?
”We’ve gotten rid of most of the obstacles. Before appointing a CEO, we wanted to make sure that we had a stable business plan that we could execute. We didn’t want to appoint a CEO in the middle of making changes.”
In mid-November 2004, a new group of investors headed by Apex-Mutavim group joint co-owner Alex Rabinowitz took control of XTL. The share price on the eve of the takeover was £0.225. The share price has since soared 95.6%, reaching £0.44 in London last night.
During his visit to Israel, Weiss also met with parties connected to Keryx. “Keryx works with a large group of doctors in Israel, which participates in the clinical trial of KRX-101, a drug for treating kidney disease caused by diabetes. I had an excellent meeting with a large group of doctors. We’re very excited about their participation in the trial, and we have great hopes that they will constitute a significant part of our clinical program. We’ve developed research centers in each country, in order to work on research,” Weiss explains.
Last week, Keryx scored an impressive financial success by raising $81.2 million from top US investment institutions. “The money raised will be used to continue development of the KRX-101 drug, which is now in Phase III and Phase IV clinical trials,” Weiss says. “We hope to be in the market by the end of 2007. We’ll also use the money raised to continue development of drugs for treating cancer, with an emphasis on development of KRX-0401, which is designed to treat breast cancer, prostate cancer, lung cancer, and sarcoma.”
Two-gun Weiss
Michael Weiss, chair of Keryx and XTLbio, is visiting Israel to promote their interests.
Hadass Geyfman 21 Jul 05 13:58
Michael Weiss is chairman of XTL Biopharmaceuticals Ltd. (LSE: XTL; TASE: XTL), which develops drugs for treatment of hepatitis B and C. He is also chairman and CEO of Keryx Biopharmaceuticals Inc. (Nasdaq: KERX, which develops drugs for treatment of cancer and diabetes. Currently visiting Israel for XTL’s listing on the Tel Aviv Stock Exchange (TASE), Weiss was invited to open yesterday’s TASE trading.
Weiss told "Globes", “In addition to listing the share on the TASE, the purpose of my visit to Israel is to meet XTL’s staff, visit the company’s shareholders, and meet with parties connected with Keryx.”
"Globes": Why did you decide to have XTL’s share listed for trading on the TASE?
Weiss: ”The initial motivation for having XTL’s share listed on the TASE was our feeling that the company’s shareholder base was shifting significantly from London to Israel. We thought that it was very important to give the shareholders a chance to trade in the local stock exchange, and in local currency.”
When do you think you’ll have the share listed on Nasdaq?
”The target for Nasdaq listing that we’ve set for ourselves is mid-August. We think the likelihood is very high that it will happen.”
Having the share listed on three stock exchanges involves high management costs, and quite a few headaches investment management.
”Listing in Tel Aviv was a simple and easy process, which didn’t add costs or management complications, thanks to the current reciprocal relations between the stock exchanges in Tel Aviv and London. The decision to have the share listed in Tel Aviv followed the change in the laws for dual listing of shares that are listed in London.
”The London Stock Exchange (LSE) was the first on which XTL was issued. The share currently enjoys fairly good trading volume in London, and its listing there will therefore continue. The next stage in the company’s development should be listing on Nasdaq, because the Wall Street capital market offers the largest and most sophisticated capital base for investments in biotechnology, with the most experienced investors.
”Another reason is that US investors don’t often invest in companies that aren’t listed on US exchanges. Nasdaq listing is expected to bring a new large and high-quality group of investors with expertise in biotechnology to the company.”
In the long term, will you allow the share’s listing in London to continue?
”The decision about continuing the share’s listing in London in the long term will be based on its trading volume. At the moment, volume is good, so there’s no reason to change the listing. If all the trading volume shifts to Nasdaq and the TASE later, we’ll consider changing the share’s status on the LSE.”
What trading volume on Nasdaq do you expect?
”We expect that volume will be modest at first, then grow gradually over 6-18 months. I believe that most of the trading volume will eventually be on Nasdaq.”
What are your plans with investors?
”We’re planning a series of non-financial road shows for XTL, in which we’ll present the company to new investors who focus on biotechnology investments. The purpose is to enable investors to know the company. We’re not looking for investment at the moment. We’ll start with small investors, and gradually move to larger and larger investors.”
What are your plans for the company in the coming year?
”In technology, our plans are to continue developing XTL’s relationship with Cubist Pharmaceuticals, which is investing in financing development of the HepeX-B drug. At the same time, the company will continue its aggressive development of the XTL-6865 drug. Another important element is looking for opportunities to buy licenses or new drugs. We’ll look for an opportunity to acquire a company that has developed new drugs, or to buy the rights to new drugs from companies that for certain reasons wish to stop investing in these drugs.
”For example, there are companies interested in relying on XTL’s accumulated expertise. There are companies that lack resources to continue developing their drugs by themselves, and there are companies that have already developed drugs that are not strategic for them. All these companies have acquisition potential.”
XTL’s CEO resigned a few months ago. Is there already a permanent CEO?
”There’s still no permanent CEO. At the moment, we’re in the process of selecting potential candidates. The goal is to appoint a CEO in the next 30-60 days.”
What kind of CEO are you looking for?
”We’re looking for a CEO with strong connections in the financial community. The ideal situation, of course, is to find a CEO with connections in the financial community in Israel and the US, but our emphasis is on the US. In addition to that, we obviously also need a smart person, who knows how to work hard, and has experience in biotechnology. We currently have several such candidates on our short list.”
Are there still obstacles on the way to appointing a CEO?
”We’ve gotten rid of most of the obstacles. Before appointing a CEO, we wanted to make sure that we had a stable business plan that we could execute. We didn’t want to appoint a CEO in the middle of making changes.”
In mid-November 2004, a new group of investors headed by Apex-Mutavim group joint co-owner Alex Rabinowitz took control of XTL. The share price on the eve of the takeover was £0.225. The share price has since soared 95.6%, reaching £0.44 in London last night.
During his visit to Israel, Weiss also met with parties connected to Keryx. “Keryx works with a large group of doctors in Israel, which participates in the clinical trial of KRX-101, a drug for treating kidney disease caused by diabetes. I had an excellent meeting with a large group of doctors. We’re very excited about their participation in the trial, and we have great hopes that they will constitute a significant part of our clinical program. We’ve developed research centers in each country, in order to work on research,” Weiss explains.
Last week, Keryx scored an impressive financial success by raising $81.2 million from top US investment institutions. “The money raised will be used to continue development of the KRX-101 drug, which is now in Phase III and Phase IV clinical trials,” Weiss says. “We hope to be in the market by the end of 2007. We’ll also use the money raised to continue development of drugs for treating cancer, with an emphasis on development of KRX-0401, which is designed to treat breast cancer, prostate cancer, lung cancer, and sarcoma.”
In kürze soll XTL auch an der Nasdaq gehandelt werden,vorraussichtlich schon mitte august.
Das wird der aktie sicherlich neuen schwung geben .
When do you think you’ll have the share listed on Nasdaq?
”The target for Nasdaq listing that we’ve set for ourselves is mid-August. We think the likelihood is very high that it will happen.”
Ich denke bis jahresende dürften kurse zwischen 70p und 80p realistisch sein.
Das wird der aktie sicherlich neuen schwung geben .
When do you think you’ll have the share listed on Nasdaq?
”The target for Nasdaq listing that we’ve set for ourselves is mid-August. We think the likelihood is very high that it will happen.”
Ich denke bis jahresende dürften kurse zwischen 70p und 80p realistisch sein.
Hallo
Xtl Biopharma geht heute wieder ab ,ich denke mein kursziel wird schon vorher erreicht.
http://finance.yahoo.com/q?s=xtl.l
Xtl Biopharma geht heute wieder ab ,ich denke mein kursziel wird schon vorher erreicht.
http://finance.yahoo.com/q?s=xtl.l
Hallo
Ist einfach herrlich anzusehen wie XTL fast täglich neue hochs erklimmt.
Ist einfach herrlich anzusehen wie XTL fast täglich neue hochs erklimmt.
Die Israelis kaufen Xtl wie verrückt und jeder weiß das die Israelis gute geschäftsleute sind.
Der Aktuelle stand an der Israelischen Börse
Symbol Last Price % Change Turnover (NIS)
XTL 454.30 +7.30% 3,472,237
Der Aktuelle stand an der Israelischen Börse
Symbol Last Price % Change Turnover (NIS)
XTL 454.30 +7.30% 3,472,237
Hallo
Supernews und Xtl fliegt weiter geilllllllllllll
Über 11% plus xtl macht mich sehrrrrrr glücklich
XTL Biopharmaceuticals Ltd
09 August 2005
XTLbio announces the end of patient dosing in HepeX-B(TM) hepatitis B
Phase 2 trial
XTLbio also announces the accelerated transition of HepeX-B program to
Cubist Pharmaceuticals
Rehovot, Israel, 9 August 2005: XTL Biopharmaceuticals Ltd. (LSE:XTL) (`XTLbio`)
announced today that XTLbio and Cubist Pharmaceuticals (NASDAQ: CBST) have ended
patient dosing in the second of two Phase 2 hepatitis B clinical trials of
HepeX-B. Cubist plans to review data from this trial with the FDA as part of a
discussion of design elements of a Phase 3 trial. A Data Safety Monitoring Board
recently reviewed safety data from all patients in the Phase 2 trial and no
concerns were raised.
XTLbio also announced that the transition of HepeX-B development activities from
XTLbio to Cubist was completed, and that, accordingly, Cubist will not make
collaborative support payments which would otherwise have been due to XTLbio in
2005 of $1 million. The collaborative support payments were established to cover
XTLbio overhead associated with managing the HepeX-B program. Cubist will
reimburse XTLbio for all direct costs associated with the program incurred at
the request of Cubist.
`I am very pleased with the completion of transition of HepeX-B development
activities to Cubist` said Michael Weiss, Chairman of XTLbio, who continued,
`with all further development and commercialization activities of HepeX-B now in
the hands of our partner Cubist, we can focus all of XTLbio`s current resources
on our internal hepatitis C programs.`
Supernews und Xtl fliegt weiter geilllllllllllll
Über 11% plus xtl macht mich sehrrrrrr glücklich
XTL Biopharmaceuticals Ltd
09 August 2005
XTLbio announces the end of patient dosing in HepeX-B(TM) hepatitis B
Phase 2 trial
XTLbio also announces the accelerated transition of HepeX-B program to
Cubist Pharmaceuticals
Rehovot, Israel, 9 August 2005: XTL Biopharmaceuticals Ltd. (LSE:XTL) (`XTLbio`)
announced today that XTLbio and Cubist Pharmaceuticals (NASDAQ: CBST) have ended
patient dosing in the second of two Phase 2 hepatitis B clinical trials of
HepeX-B. Cubist plans to review data from this trial with the FDA as part of a
discussion of design elements of a Phase 3 trial. A Data Safety Monitoring Board
recently reviewed safety data from all patients in the Phase 2 trial and no
concerns were raised.
XTLbio also announced that the transition of HepeX-B development activities from
XTLbio to Cubist was completed, and that, accordingly, Cubist will not make
collaborative support payments which would otherwise have been due to XTLbio in
2005 of $1 million. The collaborative support payments were established to cover
XTLbio overhead associated with managing the HepeX-B program. Cubist will
reimburse XTLbio for all direct costs associated with the program incurred at
the request of Cubist.
`I am very pleased with the completion of transition of HepeX-B development
activities to Cubist` said Michael Weiss, Chairman of XTLbio, who continued,
`with all further development and commercialization activities of HepeX-B now in
the hands of our partner Cubist, we can focus all of XTLbio`s current resources
on our internal hepatitis C programs.`
Führ mich zum Schotterrrrrrrrrr
Toll wie sich XTL entwickelt hat .
XTL Biopharmaceuticals Ltd
22 August 2005
XTLbio Signs License and Asset Purchase Agreement with VivoQuest Inc.
Strengthens Hepatitis C Small Molecule Pipeline and Discovery
Capabilities
Rehovot, Israel, 22 August 2005: XTL Biopharmaceuticals Ltd. (LSE:XTL)
(`XTLbio`) announced today that it signed a license (the `license`) and asset
purchase agreement with VivoQuest Inc. (`VivoQuest`), a privately held
venture-backed biotechnology company based in the U.S.
VivoQuest`s lead program focuses on development of compounds for the treatment
of Hepatitis C virus (HCV) infection, and has identified multiple lead
candidates in this disease area that have shown significant activity in
preclinical model systems, which is equal to or greater than the most promising
molecules in clinical development today.
These HCV compounds emerged from VivoQuest`s proprietary compound library, which
was developed using a breakthrough small molecule chemistry technology known as
Diversity Oriented Synthesis (DOS). Originally developed at the Harvard
Institute of Chemistry and Cell Biology, DOS is the first practical approach to
synthesizing large numbers of chemical compounds that share the complexity of
natural product molecules. Since the vast majority of drugs in the market today
are derived from natural product molecules, DOS generates compounds that are
expected to have a higher probability of being successful drugs.
VivoQuest was formed by a team that includes internationally recognized pioneers
in DOS from the Harvard Institute of Chemistry and Cell Biology. VivoQuest is
one of two companies founded based on DOS technology; the other being Infinity
Pharmaceuticals Inc. For Infinity, DOS was the basis for recent significant
collaborative deals with Amgen, Novartis and Johnson & Johnson.
Under the license, XTLbio has the exclusive worldwide rights to VivoQuest`s
intellectual property and technology, including its HCV compounds and compound
library. XTLbio will be responsible for the further development and
commercialization of VivoQuest`s HCV program.
The terms of the license include an upfront fee of $940,000 to be paid in
XTLbio`s ordinary shares at the time of closing. The agreement also provides for
additional regulatory and sales milestone payments to be paid in cash or XTLbio
shares, at XTLbio`s discretion. These payments total $34.6 million, $25.0
million of which will be due upon or following regulatory approval or actual
product sales. In addition, the license agreement will require that XTLbio make
royalty payments on product
sales.
In addition to the license, XTLbio has signed an asset purchase agreement, under
which XTLbio will acquire from VivoQuest certain assets, including laboratory
equipment, and will assume VivoQuest`s lease of its laboratory space. In
consideration, XTLbio will pay $450,000 to VivoQuest in XTLbio`s ordinary
shares.
Closing of the license and the asset purchase agreement is dependent on meeting
certain closing conditions. Between signing and closing of these agreements,
which will take place no later than September 22, 2005, XTLbio will provide
VivoQuest with up to $400,000 in exclusivity payments.
Michael Weiss, Chairman of XTLbio, commented: `We are very excited to bolster
our HCV pipeline by bringing in the VivoQuest program, which has already
identified a large number of candidates that pre-clinically compare very
favorably with the most promising anti-HCV compounds presently in clinical
development. XTLbio has traditionally been focused on biology with our Trimera
model and has relied on others for chemistry expertise to identify drug
candidates. The VivoQuest program provides us with an exciting complementary,
chemistry-based technology with which to pursue our proprietary drug development
efforts`.
Toll wie sich XTL entwickelt hat .
XTL Biopharmaceuticals Ltd
22 August 2005
XTLbio Signs License and Asset Purchase Agreement with VivoQuest Inc.
Strengthens Hepatitis C Small Molecule Pipeline and Discovery
Capabilities
Rehovot, Israel, 22 August 2005: XTL Biopharmaceuticals Ltd. (LSE:XTL)
(`XTLbio`) announced today that it signed a license (the `license`) and asset
purchase agreement with VivoQuest Inc. (`VivoQuest`), a privately held
venture-backed biotechnology company based in the U.S.
VivoQuest`s lead program focuses on development of compounds for the treatment
of Hepatitis C virus (HCV) infection, and has identified multiple lead
candidates in this disease area that have shown significant activity in
preclinical model systems, which is equal to or greater than the most promising
molecules in clinical development today.
These HCV compounds emerged from VivoQuest`s proprietary compound library, which
was developed using a breakthrough small molecule chemistry technology known as
Diversity Oriented Synthesis (DOS). Originally developed at the Harvard
Institute of Chemistry and Cell Biology, DOS is the first practical approach to
synthesizing large numbers of chemical compounds that share the complexity of
natural product molecules. Since the vast majority of drugs in the market today
are derived from natural product molecules, DOS generates compounds that are
expected to have a higher probability of being successful drugs.
VivoQuest was formed by a team that includes internationally recognized pioneers
in DOS from the Harvard Institute of Chemistry and Cell Biology. VivoQuest is
one of two companies founded based on DOS technology; the other being Infinity
Pharmaceuticals Inc. For Infinity, DOS was the basis for recent significant
collaborative deals with Amgen, Novartis and Johnson & Johnson.
Under the license, XTLbio has the exclusive worldwide rights to VivoQuest`s
intellectual property and technology, including its HCV compounds and compound
library. XTLbio will be responsible for the further development and
commercialization of VivoQuest`s HCV program.
The terms of the license include an upfront fee of $940,000 to be paid in
XTLbio`s ordinary shares at the time of closing. The agreement also provides for
additional regulatory and sales milestone payments to be paid in cash or XTLbio
shares, at XTLbio`s discretion. These payments total $34.6 million, $25.0
million of which will be due upon or following regulatory approval or actual
product sales. In addition, the license agreement will require that XTLbio make
royalty payments on product
sales.
In addition to the license, XTLbio has signed an asset purchase agreement, under
which XTLbio will acquire from VivoQuest certain assets, including laboratory
equipment, and will assume VivoQuest`s lease of its laboratory space. In
consideration, XTLbio will pay $450,000 to VivoQuest in XTLbio`s ordinary
shares.
Closing of the license and the asset purchase agreement is dependent on meeting
certain closing conditions. Between signing and closing of these agreements,
which will take place no later than September 22, 2005, XTLbio will provide
VivoQuest with up to $400,000 in exclusivity payments.
Michael Weiss, Chairman of XTLbio, commented: `We are very excited to bolster
our HCV pipeline by bringing in the VivoQuest program, which has already
identified a large number of candidates that pre-clinically compare very
favorably with the most promising anti-HCV compounds presently in clinical
development. XTLbio has traditionally been focused on biology with our Trimera
model and has relied on others for chemistry expertise to identify drug
candidates. The VivoQuest program provides us with an exciting complementary,
chemistry-based technology with which to pursue our proprietary drug development
efforts`.
Hallo
Ab heute auch an der Nasdaq(sym:XTLB) handelbar ,Xtl steigt aktuell um knapp 6%.
XTL Biopharmaceuticals Ltd
1 September 2005
XTLbio ADRs to Commence Trading on US NASDAQ National Market
Rehovot, Israel, 1 September 2005: XTL Biopharmaceuticals Ltd. (LSE: XTL)
(XTLbio) announced that it has completed the registration process for its shares
with the US Securities and Exchange Commission and that its shares are scheduled
to begin trading today Thursday 1 September 2005 on the US NASDAQ National
Market under the ticker symbol `XTLB`. Trading will be in the form of American
Depository Receipts (`ADRs)`, each ADR representing ten (10) ordinary shares.
Depository bank for the ADR program is the Bank of New York.
Michael S. Weiss, Chairman of XTLbio, commented: `We are very pleased to join
the ranks of the leading biotechnology companies that are traded on the NASDAQ.
We believe that this is a major milestone for the Company and will help us
attract US investors and analysts.`
Ab heute auch an der Nasdaq(sym:XTLB) handelbar ,Xtl steigt aktuell um knapp 6%.
XTL Biopharmaceuticals Ltd
1 September 2005
XTLbio ADRs to Commence Trading on US NASDAQ National Market
Rehovot, Israel, 1 September 2005: XTL Biopharmaceuticals Ltd. (LSE: XTL)
(XTLbio) announced that it has completed the registration process for its shares
with the US Securities and Exchange Commission and that its shares are scheduled
to begin trading today Thursday 1 September 2005 on the US NASDAQ National
Market under the ticker symbol `XTLB`. Trading will be in the form of American
Depository Receipts (`ADRs)`, each ADR representing ten (10) ordinary shares.
Depository bank for the ADR program is the Bank of New York.
Michael S. Weiss, Chairman of XTLbio, commented: `We are very pleased to join
the ranks of the leading biotechnology companies that are traded on the NASDAQ.
We believe that this is a major milestone for the Company and will help us
attract US investors and analysts.`
Hallo
XTL Biopharmaceuticals Ltd announces Interim Results for the Six Months Ended 30 June 2005
Wednesday September 7, 2:01 am ET
Rehovot, Israel--(MARKET WIRE)--Sep 7, 2005 -- XTL Biopharmaceuticals Ltd
Interim Results for the Six Months Ended 30 June 2005
Rehovot, Israel, 7 September 2005: XTL Biopharmaceuticals Ltd. (London:XTL.L - News) ("XTLbio" or the "Company")a biopharmaceutical company developing drugs against hepatitis, today announces interim financial results for the six months ended 30 June 2005.
Highlights:
- Re-focusing plan designed to enable the Company to realize value
from its Research and Development programs and focus its resources
on the development of its lead programs through to clinical proof-
of principle.
- Decrease in the loss for the period by 50% - the loss for the
period was $5 million compared to $10 million during the same
period last year.
- Strengthening the hepatitis C small molecule pipeline and discovery
capabilities - XTLbio signed an in-license and asset purchase
agreement with VivoQuest Inc.
- Transition of HepeX-B development activities from XTLbio to Cubist
was completed.
- FDA granted XTL-6865 "Fast Track" designation for the treatment of
HCV re-infection following a liver transplant.
- Submitted a US investigational new drug application to the FDA in
order to commence a Phase Ia/Ib clinical trial later this year for
XTL-6865, the dual-MAb product.
- Shares listed on two new stock exchanges - Nasdaq and the Tel
Aviv Stock Exchange
Commenting on the results, Michael S. Weiss, Chairman, said: "The Company`s management is taking significant actions to focus its business activities in areas with the highest potential. The financial results for the first half of the year reflect the start of this process. Trading on NASDAQ and the Tel-Aviv Stock Exchanges provides an important milestone for the Company and will help us attract investors and analysts. The Company will continue to develop its various clinical products while at the same time, continue to seek to in-license or acquire additional candidates or complementary technologies."
XTL Biopharmaceuticals Ltd announces Interim Results for the Six Months Ended 30 June 2005
Wednesday September 7, 2:01 am ET
Rehovot, Israel--(MARKET WIRE)--Sep 7, 2005 -- XTL Biopharmaceuticals Ltd
Interim Results for the Six Months Ended 30 June 2005
Rehovot, Israel, 7 September 2005: XTL Biopharmaceuticals Ltd. (London:XTL.L - News) ("XTLbio" or the "Company")a biopharmaceutical company developing drugs against hepatitis, today announces interim financial results for the six months ended 30 June 2005.
Highlights:
- Re-focusing plan designed to enable the Company to realize value
from its Research and Development programs and focus its resources
on the development of its lead programs through to clinical proof-
of principle.
- Decrease in the loss for the period by 50% - the loss for the
period was $5 million compared to $10 million during the same
period last year.
- Strengthening the hepatitis C small molecule pipeline and discovery
capabilities - XTLbio signed an in-license and asset purchase
agreement with VivoQuest Inc.
- Transition of HepeX-B development activities from XTLbio to Cubist
was completed.
- FDA granted XTL-6865 "Fast Track" designation for the treatment of
HCV re-infection following a liver transplant.
- Submitted a US investigational new drug application to the FDA in
order to commence a Phase Ia/Ib clinical trial later this year for
XTL-6865, the dual-MAb product.
- Shares listed on two new stock exchanges - Nasdaq and the Tel
Aviv Stock Exchange
Commenting on the results, Michael S. Weiss, Chairman, said: "The Company`s management is taking significant actions to focus its business activities in areas with the highest potential. The financial results for the first half of the year reflect the start of this process. Trading on NASDAQ and the Tel-Aviv Stock Exchanges provides an important milestone for the Company and will help us attract investors and analysts. The Company will continue to develop its various clinical products while at the same time, continue to seek to in-license or acquire additional candidates or complementary technologies."
Nicht irritieren lassen wegen des kurzlichen kursruckganges.
0.4 konnen zum neueinstieg genutzt werden. Diese Aktie wird stark steigen !
0.4 konnen zum neueinstieg genutzt werden. Diese Aktie wird stark steigen !
Jetzt ist es fast zu spat zum Einsteigen...
Am Montag nachster Woche und auch die Tage zuvor wird die Aktie stark anziehen, vermutlich erstmals uber 1,00 pound, (Prasentation neuer Daten in NY)
Am Montag nachster Woche und auch die Tage zuvor wird die Aktie stark anziehen, vermutlich erstmals uber 1,00 pound, (Prasentation neuer Daten in NY)
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