Purple Biotech (PPBT) ehemals KTOV (Mkap $16 M) ( Cash $17 M) US Zulassungsantrag diesen Quartal (Seite 29)
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Antwort auf Beitrag Nr.: 67.266.012 von Sven_Bonn am 02.03.21 13:49:17Consensi gefällt mir nicht
Auch nichts zu Collabs
Medium würde ich sagen...
Auch nichts zu Collabs
Medium würde ich sagen...
Trading halt in Israel an der TASE...
Meldung sieht gut aus... alles wie erwartet.. keine Probleme mit den Produkten.. Muss mir das nachher mal in Ruhe anschauen...
LG
Sven
Meldung sieht gut aus... alles wie erwartet.. keine Probleme mit den Produkten.. Muss mir das nachher mal in Ruhe anschauen...
LG
Sven
https://www.globenewswire.com/news-release/2021/03/02/218512…
and Full Year 2020 Financial Results
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March 02, 2021 07:00 ET | Source: Purple Biotech Ltd.
Rehovot, Israel, March 02, 2021 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective, and durable therapies by overcoming tumor immune evasion and drug resistance, today provided a corporate update and announced financial results for the six and 12-months ended December 31, 2020.
“We have recently achieved substantial progress in multiple key aspects of our business,” said Isaac Israel, Chief Executive Officer. “Most importantly, our promising anti-cancer product development pipeline continues to advance our Phase 1/2 clinical studies for NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3. We completed patient recruitment of the second dose level in the single agent dose-escalation phase, demonstrating the drug to be safe and well tolerated in the treated patients. We expect to begin imminently our Phase 1b/2 studies for CM24, our monoclonal antibody drug candidate blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Our robust clinical development activities are supported by a strong balance sheet, as we raised $68.5 million in 2020, ended the year with $60.8 million in cash, and we believe we are well-funded to support our currently planned corporate initiatives until 2024.”
“As part of the completion of our transformation to a corporate mission dedicated to developing first-in-class oncology therapies, we were honored to ring the Nasdaq stock market opening bell on January 5, 2021 to commemorate the successful evolution of our business and the Company’s name change to Purple Biotech. We are firmly committed to improving the lives of cancer patients globally, and look forward to executing on the opportunities that lie ahead of us in 2021 and beyond,” concluded Mr. Israel.
Recent Corporate Highlights
CM24:
Expanded the planned Phase 1b/2 clinical trial evaluating CM24 in combination with nivolumab in advanced non-small cell lung cancer (NSCLC) with a new cohort that will evaluate CM24 in combination with both nivolumab and nab-paclitaxel (Abraxane®) in patients with pancreatic cancer under a clinical collaboration agreement with Bristol Myers Squibb.
Advanced preparations to initiate the Phase 1b/2 study, which is expected to begin imminently.
Received notifications from the U.S. Patent and Trademark Office, European Patent Office and the Chinese Patent Office to grant the patent application entitled "Humanized antibodies against CEACAM1," covering the humanized antibodies capable of specific binding to human CEACAM1 molecules, pharmaceutical compositions and methods of their use in treating and diagnosing cancer and other condition.
Presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program positive results of a Phase 1 study consisting of a monotherapy dose escalating of CM24, as CM24 was found to be safe and well tolerated in all patients. In the study of efficacy evaluable patients (n=24), subjects were highly refractory to prior therapy, having received between two and eight prior therapies (with a median of four). Eight of the evaluable patients (33%) achieved stable disease, with most of these patients treated at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested that a higher dose level is required to achieve full saturation of CEACAM1 receptors.
NT-219:
Initiated and dosed the first patient in the Phase 1/2 clinical trial of NT219.
Presented new data supporting the mechanism of action of NT219 at the Epigenetics and Metabolism AACR Special Virtual Conference by researchers at Tel-Aviv University.
Received notifications from the U.S. Patent and Trademark Office and the Chinese Patent Office to grant a patent application entitled "Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer,” covering the various combinations of NT219 with multiple EGFR inhibitors, including cetuximab (Erbitux®), which will be administrated in combination with NT219 for the treatment of recurrent or metastatic squamous cell carcinoma of the head as well as for neck cancer as part of our ongoing Phase 1/2 study, and osimertinib (TAGRISSO®), a 3rd generation EGFR inhibitor approved in the U.S. for first-line treatment of EGFR-mutated non-small-cell lung carcinoma (NSCLC).
CONSENSI®:
Growth of sales of Consensi® in the U.S. has been slow primarily due to the COVID-19 environment, with minor sales of the drug in the second half of 2020. In addition, our distribution partner has not fulfilled all of its obligations as per the distribution agreement. We are currently evaluating a re-launch program that will be designed to boost sales and maximize the value of Consensi® post-COVID-19. At this time, we are not able to provide revenue projections for the rest of 2021 and beyond.
Financial Results for the Six Months Ended December 31, 2020
Research and Development Expenses were $4.4 million, an increase of $3.4 million, or 342%, compared to $1.0 million in the same period of 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.
Selling, General and Administrative (SG&A) Expenses were $4.1 million, compared to $2.8 million in the same period of 2019, an increase of $1.3 million. The increase was due mainly to a $0.9 million increase in expenses related to stock options granted to directors and employees in the second and third quarters of 2020 and a $0.3 million increase in director and officer insurance expenses.
Operating Loss was $8.3 million, an increase of $4.7 million, or 131%, compared to $3.6 million in the same period of 2019.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $6.4 million, an increase of $3.6 million, compared to $2.8 million in the same period of 2019.
Net Loss for the second half of 2020 was $0.3 million, or $0.48 per diluted share, compared to a net loss of $3.3 million, or $1.70 per diluted share, in the second half of 2019. The decrease in net loss was due to $7.5 million in income from a change in the fair value of derivatives, partially offset by an increase of $4.5 million in operating expenses.
Financial Results for the Full Year Ended December 31, 2020
Revenues were $1.0 million for the year ended December 31, 2020, unchanged from the $1.0 million reported for the year ended December 31, 2019.
Research and Development Expenses were $7.5 million, an increase of $4.8 million, or 180%, compared to $2.7 million for the year ended December 31, 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.
SG&A Expenses were $6.3 million, compared to $6.1 million for the year ended December 31, 2019.
Operating Loss was $12.6 million, an increase of $5.5 million, or 76%, compared to $7.2 million for the year ended December 31, 2019.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $10.0 million, compared to $5.9 million, an increase of $4.1 million, for the year ended December 31, 2019.
Net Loss for the year ended December 31, 2020, was $28.1 million, or $2.44 per diluted share, compared to a net loss of $5.9 million, or $3.00 per diluted share, in the same period of 2019. The increase was due to $17.1 million increase in expenses on account of warrants mainly from a change in the fair value of derivatives and an increase of $4.8 million in R&D expenses.
As of December 31, 2020, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $60.8 million, compared to $4.4 million at December 31, 2019. Purple Biotech believes that its cash position will provide sufficient resources for its currently anticipated ongoing needs until fiscal year 2024.
and Full Year 2020 Financial Results
Email Print Friendly Share
March 02, 2021 07:00 ET | Source: Purple Biotech Ltd.
Rehovot, Israel, March 02, 2021 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective, and durable therapies by overcoming tumor immune evasion and drug resistance, today provided a corporate update and announced financial results for the six and 12-months ended December 31, 2020.
“We have recently achieved substantial progress in multiple key aspects of our business,” said Isaac Israel, Chief Executive Officer. “Most importantly, our promising anti-cancer product development pipeline continues to advance our Phase 1/2 clinical studies for NT219, a dual inhibitor, novel small molecule targeting IRS1/2 and STAT3. We completed patient recruitment of the second dose level in the single agent dose-escalation phase, demonstrating the drug to be safe and well tolerated in the treated patients. We expect to begin imminently our Phase 1b/2 studies for CM24, our monoclonal antibody drug candidate blocking CEACAM1, a novel immune checkpoint that supports tumor immune evasion and survival through multiple pathways. Our robust clinical development activities are supported by a strong balance sheet, as we raised $68.5 million in 2020, ended the year with $60.8 million in cash, and we believe we are well-funded to support our currently planned corporate initiatives until 2024.”
“As part of the completion of our transformation to a corporate mission dedicated to developing first-in-class oncology therapies, we were honored to ring the Nasdaq stock market opening bell on January 5, 2021 to commemorate the successful evolution of our business and the Company’s name change to Purple Biotech. We are firmly committed to improving the lives of cancer patients globally, and look forward to executing on the opportunities that lie ahead of us in 2021 and beyond,” concluded Mr. Israel.
Recent Corporate Highlights
CM24:
Expanded the planned Phase 1b/2 clinical trial evaluating CM24 in combination with nivolumab in advanced non-small cell lung cancer (NSCLC) with a new cohort that will evaluate CM24 in combination with both nivolumab and nab-paclitaxel (Abraxane®) in patients with pancreatic cancer under a clinical collaboration agreement with Bristol Myers Squibb.
Advanced preparations to initiate the Phase 1b/2 study, which is expected to begin imminently.
Received notifications from the U.S. Patent and Trademark Office, European Patent Office and the Chinese Patent Office to grant the patent application entitled "Humanized antibodies against CEACAM1," covering the humanized antibodies capable of specific binding to human CEACAM1 molecules, pharmaceutical compositions and methods of their use in treating and diagnosing cancer and other condition.
Presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program positive results of a Phase 1 study consisting of a monotherapy dose escalating of CM24, as CM24 was found to be safe and well tolerated in all patients. In the study of efficacy evaluable patients (n=24), subjects were highly refractory to prior therapy, having received between two and eight prior therapies (with a median of four). Eight of the evaluable patients (33%) achieved stable disease, with most of these patients treated at the higher dose levels of 3mg/kg and 10mg/kg. Pharmacokinetic analysis revealed non-linearity, and modeling suggested that a higher dose level is required to achieve full saturation of CEACAM1 receptors.
NT-219:
Initiated and dosed the first patient in the Phase 1/2 clinical trial of NT219.
Presented new data supporting the mechanism of action of NT219 at the Epigenetics and Metabolism AACR Special Virtual Conference by researchers at Tel-Aviv University.
Received notifications from the U.S. Patent and Trademark Office and the Chinese Patent Office to grant a patent application entitled "Combinations of IRS/STAT3 Dual Modulators and Anti-Cancer Agents for Treating Cancer,” covering the various combinations of NT219 with multiple EGFR inhibitors, including cetuximab (Erbitux®), which will be administrated in combination with NT219 for the treatment of recurrent or metastatic squamous cell carcinoma of the head as well as for neck cancer as part of our ongoing Phase 1/2 study, and osimertinib (TAGRISSO®), a 3rd generation EGFR inhibitor approved in the U.S. for first-line treatment of EGFR-mutated non-small-cell lung carcinoma (NSCLC).
CONSENSI®:
Growth of sales of Consensi® in the U.S. has been slow primarily due to the COVID-19 environment, with minor sales of the drug in the second half of 2020. In addition, our distribution partner has not fulfilled all of its obligations as per the distribution agreement. We are currently evaluating a re-launch program that will be designed to boost sales and maximize the value of Consensi® post-COVID-19. At this time, we are not able to provide revenue projections for the rest of 2021 and beyond.
Financial Results for the Six Months Ended December 31, 2020
Research and Development Expenses were $4.4 million, an increase of $3.4 million, or 342%, compared to $1.0 million in the same period of 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.
Selling, General and Administrative (SG&A) Expenses were $4.1 million, compared to $2.8 million in the same period of 2019, an increase of $1.3 million. The increase was due mainly to a $0.9 million increase in expenses related to stock options granted to directors and employees in the second and third quarters of 2020 and a $0.3 million increase in director and officer insurance expenses.
Operating Loss was $8.3 million, an increase of $4.7 million, or 131%, compared to $3.6 million in the same period of 2019.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $6.4 million, an increase of $3.6 million, compared to $2.8 million in the same period of 2019.
Net Loss for the second half of 2020 was $0.3 million, or $0.48 per diluted share, compared to a net loss of $3.3 million, or $1.70 per diluted share, in the second half of 2019. The decrease in net loss was due to $7.5 million in income from a change in the fair value of derivatives, partially offset by an increase of $4.5 million in operating expenses.
Financial Results for the Full Year Ended December 31, 2020
Revenues were $1.0 million for the year ended December 31, 2020, unchanged from the $1.0 million reported for the year ended December 31, 2019.
Research and Development Expenses were $7.5 million, an increase of $4.8 million, or 180%, compared to $2.7 million for the year ended December 31, 2019. The increase was due to expenses related to the NT219 clinical trials initiated in 2020 and the preparation for the anticipated initiation of the CM24 clinical trials, including manufacturing costs.
SG&A Expenses were $6.3 million, compared to $6.1 million for the year ended December 31, 2019.
Operating Loss was $12.6 million, an increase of $5.5 million, or 76%, compared to $7.2 million for the year ended December 31, 2019.
On a non-IFRS basis (as reconciled below), adjusted operating loss was $10.0 million, compared to $5.9 million, an increase of $4.1 million, for the year ended December 31, 2019.
Net Loss for the year ended December 31, 2020, was $28.1 million, or $2.44 per diluted share, compared to a net loss of $5.9 million, or $3.00 per diluted share, in the same period of 2019. The increase was due to $17.1 million increase in expenses on account of warrants mainly from a change in the fair value of derivatives and an increase of $4.8 million in R&D expenses.
As of December 31, 2020, Purple Biotech had cash and cash equivalents and short- and long-term deposits of $60.8 million, compared to $4.4 million at December 31, 2019. Purple Biotech believes that its cash position will provide sufficient resources for its currently anticipated ongoing needs until fiscal year 2024.
Hi zusammen,
zugegebermaßen on STocktwits geklaut.. aber sehr viel Zutreffendes....
LG
Sven
https://www.griproom.com/fun/10-signs-your-company-is-about-…
zugegebermaßen on STocktwits geklaut.. aber sehr viel Zutreffendes....
LG
Sven
https://www.griproom.com/fun/10-signs-your-company-is-about-…
Ich glaube, dass Isaac aufgrund seiner Erfahrungen aus der Vergangenheit viel vorsichtiger geworden ist, was seine Kommunikation an die Öffentlichkeit angeht.
Gerade das Management von Biotechunternehmen sollte sich mit überzogenen optimistischen Aussagen zurückhalten. Das betrifft insbesondere Produkte, die noch in der klinischen Erprobung sind.
Das Wort cure sollte man erst in den Mund nehmen, wenn der Beweis erbracht ist, dass das Medikament wirklich so toll wirkt.
Wir als kleine Aktionäre wissen über die Produkte in der klinischen Erprobung nicht viel. Wir setzen große Hoffnung auf CM24 und NT219. Aber was wissen wir schon wirklich. Beide Produkte können auch floppen und dann sieht es schnell sehr düster aus. Das bitte nie vergessen, weil das ist Biotech. Wenn’s gut geht winken andererseits mehre 100% Kurssteigerung. Daher nie in eine Aktie zu sehr verlieben und nicht zu viel auf eine Karte setzen.
Good luck!
Gerade das Management von Biotechunternehmen sollte sich mit überzogenen optimistischen Aussagen zurückhalten. Das betrifft insbesondere Produkte, die noch in der klinischen Erprobung sind.
Das Wort cure sollte man erst in den Mund nehmen, wenn der Beweis erbracht ist, dass das Medikament wirklich so toll wirkt.
Wir als kleine Aktionäre wissen über die Produkte in der klinischen Erprobung nicht viel. Wir setzen große Hoffnung auf CM24 und NT219. Aber was wissen wir schon wirklich. Beide Produkte können auch floppen und dann sieht es schnell sehr düster aus. Das bitte nie vergessen, weil das ist Biotech. Wenn’s gut geht winken andererseits mehre 100% Kurssteigerung. Daher nie in eine Aktie zu sehr verlieben und nicht zu viel auf eine Karte setzen.
Good luck!
Trading Spotlight
ich frage mich immer noch, was die schlechte Kommunikation bedeutet, unser CEO hat so viele Aktien, dass er ja sicher auch einen hohen Kurs bevorzugen würde.. Warum das Ganze??
Nach wie vor gehen ich nicht von einer Unfähigkeit aus sondern von einem Plan. Dafür ist das Management einfach zu gut...
Nach wie vor gehen ich nicht von einer Unfähigkeit aus sondern von einem Plan. Dafür ist das Management einfach zu gut...
Antwort auf Beitrag Nr.: 67.244.616 von Sven_Bonn am 01.03.21 08:49:31Abgesehen von unserem unfähigen CEO ist alles gut! 😉
Earnings müssen diesen Monat kommen und damit auch Material Events berichtet werden. Ich rechne mit Verkauf Consensi, was bis zu 60 Mio Cash bringen könnte. Ggfs kommt noch was zu CM24 (Vertiefung Collab mit BMY). Dann wären wir "fully funded" und Isaac hätte doch recht behalten. Damit dann auf zu neuen Ufern mit NT219. Buyout für 2 Mrd. ist nicht unrealistisch!
Jetzt bloß nicht verkaufen!
Earnings müssen diesen Monat kommen und damit auch Material Events berichtet werden. Ich rechne mit Verkauf Consensi, was bis zu 60 Mio Cash bringen könnte. Ggfs kommt noch was zu CM24 (Vertiefung Collab mit BMY). Dann wären wir "fully funded" und Isaac hätte doch recht behalten. Damit dann auf zu neuen Ufern mit NT219. Buyout für 2 Mrd. ist nicht unrealistisch!
Jetzt bloß nicht verkaufen!
Antwort auf Beitrag Nr.: 67.223.223 von gosinga430 am 26.02.21 16:49:12Guten Morgen zusammen,
hoffe, Euch geht es gut und die Nerven liegen nicht blank :-)
Insgesamt meinte ich mit meinem letzten Beitrag, dass durch Übernahmen im Sektor oft Phantasie bei diversen Titel reinkommt...
Der März ist bei vielen Oncology-Stocks momentan ziemlich heiss.. Trillium, usw..
Hoffen wir, dass auch wir dazugehören..
Was auch immer bei Isaac der Ausspruch "soon.. very soon" bedeutet.
Hoffen wir auf den März!
Einen schönen Start in die Woche und bleibt gesund
Sven
hoffe, Euch geht es gut und die Nerven liegen nicht blank :-)
Insgesamt meinte ich mit meinem letzten Beitrag, dass durch Übernahmen im Sektor oft Phantasie bei diversen Titel reinkommt...
Der März ist bei vielen Oncology-Stocks momentan ziemlich heiss.. Trillium, usw..
Hoffen wir, dass auch wir dazugehören..
Was auch immer bei Isaac der Ausspruch "soon.. very soon" bedeutet.
Hoffen wir auf den März!
Einen schönen Start in die Woche und bleibt gesund
Sven
Antwort auf Beitrag Nr.: 67.199.463 von Sven_Bonn am 25.02.21 14:51:14Servus Sven, aber das hat ja nichts mit Purple Biotech zu tun? Merck führte 2021 schon eine 2,75-Milliarden-Dollar-Übernahme der privaten Firma VelosBio durch( Krebstherapie)(Phase 3)
Lg
Lg
Geduld... schaut mal:
Merck To Acquire Pandion Therapeutics For $60 Per Share In Cash
https://talkmarkets.com/content/stocks--equities/merck-to-ac…
Merck To Acquire Pandion Therapeutics For $60 Per Share In Cash
https://talkmarkets.com/content/stocks--equities/merck-to-ac…
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