Zonagen - 500 Beiträge pro Seite

[blb]

Empfehlung kam mit dem Börse Inside-Newsletter.

Kling ganz interessant, Marketcap 50 Millionen, Cash rund 20 Millionen $.

[blb]

Kurzfristig etws heißgelaufen:



Langfristig wär noch Platz!

[blb]

Zonagen Reports Second Quarter 2005 Financial Results and Provides Update on Clinical Trial Programs and Androxal Related Patents

FRIDAY, JULY 29, 2005 6:00 AM
- BusinessWire

THE WOODLANDS, Texas, Jul 29, 2005 (BUSINESS WIRE) -- Zonagen, Inc. (ZONA) (PCX:ZONA) today reported financial results for the three-month and six-month periods ended June 30, 2005 and provided an update on its clinical development efforts for Proellex(TM) (formerly called Progenta) and Androxal(TM), and the patent proceeding related to its Androxal product candidate.

"We continue to make progress toward our goal of initiating three clinical trials by year end 2005 which include a U.S. Phase III trial of Androxal for male testosterone deficiency, a U.S. efficacy trial of Proellex for uterine fibroids and a European Phase II trial of Proellex for endometriosis," said Joseph Podolski, President and CEO of Zonagen, Inc. He continued, "We anticipate initial study data from these three trials in mid-year 2006."

Zonagen is in the process of preparing a Special Protocol Assessment ("SPA") to submit to the FDA regarding our proposed U.S. Phase III clinical study of Androxal. In order to begin this clinical study by year end 2005, three-month data from two animal studies, in different species, must be submitted to the FDA and approval from the FDA to begin the study must first be obtained. The Company also hopes to receive approval of the SPA related to this trial. The Company is currently conducting a six-month dog study and a nine-month rat study and has used some of the animals in each study, known as peel-offs, for three-month data. The three-month dosing peel-off portion was completed in July 2005, and that data is being analyzed for submission to the FDA.

In May 2005 the Company held a pre-IND meeting with the FDA regarding the next clinical study to be conducted in the U.S. using Proellex for the treatment of uterine fibroids. The Company believes that the meeting with the FDA constructively identified the requirements that must be completed before the Company can file an IND and begin a clinical study by year end 2005. The Company is addressing these requirements which include three-month safety data from two animal studies, in different species and the FDA`s review of the data from the prior European Phase Ib study. The appropriate end points for the proposed clinical trial were also discussed with the FDA.

"One of the largest challenges ahead of any biopharmaceutical company is not only making significant clinical development progress with its product candidates but also conveying that progress accurately and effectively to our shareholders," said Joseph Podolski. He continued, "During the second quarter, we hired an investor relations firm to assist us in getting our message out to the public and in setting up meetings with existing and potential investors."

Financial Results

Total revenues and other income for the three-month period ended June 30, 2005 increased to $173,000 as compared with $75,000 for the same period in the prior year and increased to $285,000 for the six-month period ended June 30, 2005 as compared to $200,000 for the same period in the prior year. The primary increase in revenues is due to an increase in interest rate yields and an increase in cash reserves which the Company received from its public offering in February 2005 offset by a reduction in SBIR grant revenue which is due to its anticipated conclusion and is essentially depleted.

Research and development ("R&D") expenses include contracted research, regulatory affairs activities and preclinical and clinical study development expenses. R&D expenses increased 167% to $1.4 million for the three-month period ended June 30, 2005 as compared to $508,000 for the same period in the prior year and increased 163% to $2.6 million for the six-month period ended June 30, 2005 as compared to $985,000 for the same period in the prior year. The increase in R&D expenses for the three-month period ended June 30, 2005 as compared to the same period in the prior year is primarily due to an increase of $440,000 and $480,000 related to the Company`s clinical development programs for Proellex and Androxal, respectively, partially offset by a decrease of $52,000 in costs associated with the Company`s SBIR grant funded R&D. The increase in R&D expenses for the six-month period ended June 30, 2005 as compared to the same period in the prior year is primarily due to an increase of $939,000 and $772,000 related to the Company`s clinical development programs for Proellex and Androxal, respectively, partially offset by a decrease of $112,000 in costs associated with the Company`s SBIR grant funded R&D.

General and administrative expenses increased 58% to $465,000 for the three-month period ended June 30, 2005 as compared to $294,000 for the same period in the prior year and increased 23% to $896,000 for the six-month period ended June 30, 2005 as compared to $728,000 for the same period in the prior year. Expenses for the first quarter 2005 were $431,000 as compared to $465,000 for the second quarter. The increase in expenses for the three-month period ended June 30, 2005 as compared to the same period in the prior year are primarily due to an increase in costs associated with increased investor relations activities, legal and accounting services and non-cash stock option compensation expense. The increase in expenses for the six-month period ended June 30, 2005 is primarily due to an increase in costs associated with strategic administrative costs, increased investor relations activities, legal and accounting services and non-cash stock option compensation expenses partially offset by a decrease in directors` and officers` insurance.

Net loss for the three-month period ended June 30, 2005 was ($1.6) million or ($0.16) per share as compared to a net loss of ($727,000) or ($0.15) per share for the same period in the prior year. Net loss for the six-month period ended June 30, 2005 was ($3.2) million or ($0.35) per share as compared to a net loss of ($1.5) million or ($0.29) per share for the same period in the prior year. The increase in loss per share for the three-month and six-month periods ended June 30, 2005 was primarily due to an increase in clinical research activities relating to the Company`s two products, Proellex and Androxal.

The Company had cash, cash equivalents and marketable securities of approximately $21.1 million at June 30, 2005 as compared to $5.5 million at December 31, 2004 and had 10,079,601 shares of common stock outstanding on June 30, 2005.

Androxal Related Patents

In its prior filings with the SEC, the Company has described its request to the U.S. Patent and Trademark Office ("PTO") for re-examination of a third party`s patent related to the use of an anti-estrogen for use in the treatment of androgen deficiency and disorders related thereto. The third party has since amended the claims in the reexamination proceedings, which may lead to the PTO finding that the claims are patentable in view of the publications under consideration. We believe that the amended claims are invalid based on, among other things, additional prior publications not yet considered by the PTO. We intend to seek further reexamination of the other party`s patent in light of a number of these publications. There is no assurance that the third party`s patent ultimately will be reversed.

Zonagen, Inc. is engaged in the development of pharmaceutical products that address diseases and conditions associated with the treatment of hormonal and reproductive system disorders.

A copy of this press release may be obtained via facsimile by dialing 1-888-329-0920 or via the internet by accessing www.zonagen.com.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Zonagen`s ability to have success in the clinical development of its technologies, Zonagen`s ability to raise additional capital on acceptable terms or at all, Zonagen`s ability to have success in meeting governmental regulations and the costs and time required to meet such regulatory requirements, manufacturing uncertainties related to Proellex(TM), uncertainty relating to Zonagen`s patent portfolio and such other risks which are identified in Zonagen`s Annual Report on Form 10-K for the year ended December 31, 2004. The Form 10-K is available at the Company`s web site at www.zonagen.com, at the SEC`s web site at www.sec.gov or is available by request made to Zonagen`s Corporate Secretary. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ZONAGEN, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)

CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share amounts)

Three Months Ended Six Months Ended
----------------------- -----------------------
June 30, June 30,
2005 2004 2005 2004
----------- ----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenues and other
income
Research and
development grants $- $53 $4 $117
Interest income 173 22 281 48
Other Income - - - 35
----------- ----------- ----------- -----------
Total revenues 173 75 285 200
----------- ----------- ----------- -----------

Expenses
Research and
development 1,355 508 2,590 985
General and
administrative 465 294 896 728
----------- ----------- ----------- -----------
Total expenses 1,820 802 3,486 1,713
----------- ----------- ----------- -----------

Net loss $(1,647) $(727) $(3,201) $(1,513)
=========== =========== =========== ===========

Net loss per share -
basic and diluted $(0.16) $(0.15) $(0.35) $(0.29)
=========== =========== =========== ===========

Shares used in loss
per share
calculation:
Basic 10,080 4,993 9,208 5,242
Diluted 10,080 4,993 9,208 5,242


CONSOLIDATED BALANCE SHEETS

June 30, December 31,
2005 2004
-------------- --------------
(Unaudited)

Cash and cash equivalents $2,358 $736
Marketable securities 18,764 4,800
Other currents assets 222 34
Fixed assets (net) 22 18
Other assets 485 1,018
-------------- --------------
Total assets $21,851 $6,606
============== ==============

Accounts payable and accrued expenses $730 $614
Stockholders` equity 21,121 5,992
-------------- --------------
Total liabilities and stockholders`
equity $21,851 $6,606
============== ==============


SOURCE: Zonagen, Inc.

Zonagen, Inc., The Woodlands
Joseph S. Podolski, 281-719-3447


Copyright Business Wire 2005

[blb]

Pipeline

Proellex™ (formerly know as Progenta)

We are developing Proellex™ to alleviate adverse symptoms associated with both uterine fibroids and endometriosis by selectively blocking the progesterone receptor in women. The National Uterine Fibroid Foundation estimates that possibly as many as 80% of all women in the United States have uterine fibroids, and one in four of these women have symptoms severe enough to require treatment. According to The Endometriosis Association, endometriosis affects 5.5 million women in the United States and Canada and millions more worldwide. The current standards of care for uterine fibroids and endometriosis include surgery and treatment with drugs. The most effective drugs on the market are gonadotropin releasing hormone agonists, or GnRH agonists, such as Lupron® (leuprolide acetate). GnRH are hormones that play an important role in the human reproductive function, and GnRH agonists block the production of these hormones. Lupron is marketed by TAP Pharmaceuticals, a joint venture between Abbott Laboratories and Takeda Chemical Industries, Ltd. Abbott reported total Lupron sales of $787.8 million in 2003 in the United States and Canada for all indications.

We believe Proellex™ may have advantages over treatment with GnRH agonists. Unlike Proellex™, GnRH agonists induce a low estrogen, menopausal-like state in women, and estrogen is necessary for the maintenance of bone mineral density. Therefore, GnRH agonists tend to promote bone loss and cannot be used for more than six months at a time. When women cease treatment with GnRH agonists, fibroids rapidly regenerate and symptoms associated with endometriosis quickly reappear. We believe Proellex™ may have advantages over treatment with GnRH agonists because, in our animal research to date, Proellex™ does not appear to induce a low estrogen state and therefore should not promote bone loss, which could make Proellex™ a better treatment option for patients prior to surgery. In addition, we believe Proellex™ may provide an attractive alternative to surgery because of its potential to treat these conditions in a long-term, or chronic, fashion, resolving the symptoms that most commonly lead to surgical treatment.

We currently are conducting a Phase Ib clinical trial on Proellex™ in Poland for the treatment of uterine fibroids, in which dosing has been completed. This trial is of a small sample size of 28 people. All clinical trial results are subject to review by the U.S. Food and Drug Administration, or FDA, and the FDA may disagree with our conclusions about safety or efficacy. Preliminary observations from our Phase Ib clinical trial for Proellex™ for the treatment of uterine fibroids have shown some reduction in fibroid size numerically equivalent to or superior to GnRH agonists, as measured by ultrasound. Because the effects of a GnRH agonist are best evaluated after at least three months of dosing, these preliminary results may be reversed by the final results of this clinical trial or from later stage clinical trials with significantly larger and more diverse patient populations treated for longer periods of time. We intend to begin a Phase II clinical trial for Proellex™ in the United States for the treatment of uterine fibroids during 2005, subject to the review of our Phase Ib data by the FDA. We have not yet filed an investigational new drug application, or IND, for Proellex™ with the FDA. If the FDA approves our IND, only then would we be permitted to conduct a clinical trial in the United States for Proellex™.

We also plan to conduct a Phase II clinical trial in Poland on Proellex™ for endometriosis in 2005. We believe Proellex™ may have advantages over current therapies because it is non-invasive, has, to date, shown a positive side effect profile compared to GnRH agonists, and has the potential for chronic use. However, we have not yet conducted any clinical trials for Proellex™ for the treatment of endometriosis, and any clinical trials we conduct may not produce positive results.


Androxal™

Testosterone deficiency in men is linked to several negative physical and mental conditions, including loss of muscle tone, reduced sexual desire, and deterioration of memory and certain other cognitive functions. Testosterone production normally decreases as men age, sometimes leading to testosterone deficiency in a condition commonly referred to as andropause. According to the Urology Channel, recent estimates show that approximately 13 million men in the United States experience testosterone deficiency. Current therapies focus on testosterone replacement by delivering testosterone to the blood stream either through the skin or via injection. The current gold standard in the industry is Androgel®, a topical gel marketed by Solvay Pharmaceuticals, which reported Androgel sales of approximately $283 million in 2003 in North America.

We believe Androxal may have advantages over current therapies because it is being designed as an oral therapy that acts centrally to restore normal testosterone function in the body, rather than simply replacing diminished testosterone. The administration of replacement testosterone has been linked to numerous potential adverse effects, including shrinkage of the testes. In addition, a safe and effective oral treatment for testosterone deficiency has to date been unavailable.

We recently completed a Phase I/II clinical trial for Androxal in the United States for the treatment of men with testosterone deficiency and submitted final data to the FDA. All clinical trial results are subject to review by the FDA, and the FDA may disagree with our conclusions about safety and efficacy; however, we believe these clinical trial results indicate that the safety and efficacy of Androxal compare favorably to the current market leader, Androgel. We caution that these results may be reversed by the results of later stage clinical trials with significantly larger and more diverse patient populations treated for longer periods of time. We met with FDA staff members on November 10, 2004 to review our clinical plan for the approval of Androxal. We are awaiting the written record of this meeting, but based on our discussions, we believe that the FDA will require an additional endpoint, for example, improved libido or increased muscle mass, associated with the primary endpoint of increased testosterone levels. The FDA has agreed to review our protocols for our trials in a timely fashion under a special protocol assessment, or SPA. The FDA deems Androxal to be a new chemical entity, and additional lengthy animal studies will be required before long term human studies may be initiated and before an NDA may be filed.

[seeensation]

Börse Inside schreibt von ca. 1 bis 1,75 Dollar Gewinn PRO AKTIE von 2003 bis 2005.....

Aber im Bericht steht doch deutlich das hier VERLUST gemacht wurde.....

Lt. BI ein niedriges KGV, aber das widerspricht sich ja. Irgendetwas ist hier falsch oder verstehe ICH etwas falsch??

[StRAS]

Pipeline überzeugt mich nicht! Würde Finger davon lassen! Kann schnell mal 50% abschmieren. Völlig heißgelaufen!

[blb]

Genau wie Hana, nicht wahr StRAS?

[miristegal]

[posting]17.469.006 von blb am 06.08.05 23:25:43[/posting]@blb
Interessant ist es zwar allemal.
Meine Frage:
Haste vom Homer oder Homer von Dir???

Deine Beiträge weiss ich zu schäztzen.

MFG

[xxHeribertxx]

oje, schon wieder so ein scheiss....

machen ja tolle umsätze in farnkfurt -- im schnitt so 2.500 stück. is ja irre

haben nix greifbares in der pipeline, alles in phase 1 oder 2, das kann ja jahre dauern, bis da was wird. herrlich, auf der homepage ist nur zu lesen: "wenn das eintritt, dann könnte man" usw......

KAUFEN, leute, wenn ihr nur in 100 päkchenstücken wieder verkauft, kriegt ihr das zeug vielleicht auch wieder los

ach nee, ich werd nicht mehr. ist ja der hammer.

[blb]

Deswegen haben andere Leute auch einen Ami-Broker. Im übrigen kannst du über jede Onlinebank direkt im Ausland ordern.

Klar ist das eine spekulative Aktie, aber der Kursanstieg sieht schon nicht übel aus. Zudem mit 20 Millionen Cash erstmal abgesicher!

Man kann den Thread ja einfach mal weiterführen wie sich das Teil so entwickelt...

Grüße
blb

[StRAS]

Für mich ist Zonagen eine absolute Luftnummer...!

[xxHeribertxx]

vielleicht entwickeln die sich ja wie deine amylin....

wer da im jänner rein ist, hat heute genau null dazuverdient. wenn er nicht eh schon vorher beim absturz geschmissen hat

du, auf dich hör ich, da ist ja ein konservatives Sparbuch noch besser

oder hast du den thraed eh nur als selbstzweck, damit du dich mit dir selber unterhalten kannst???

nene, bin schon wieder weg. ist ja unglaublich was hier für dreck angeboten wird

[blb]

Ich mag diese konstruktive Kritik!

PS: Wenn du dir die letzten Zahlen von AMLN mal zur Gemüte führen würdest, würdest du nicht so nen Schmarrn verzapfen.

Ich hab hier Zonagen nur aufgeführt, weil kein Thread eröffnet worden ist. Diskussionen sind erwünscht, aber dann bitte ein paar Argumente und nicht "die sind scheiße"!


Danke
blb

[blb]

Im übrigen:

Username: xxHeribertxx
Registriert seit: 06.08.2005
User ist momentan: Offline
Letztes Login: 07.08.2005 10:40:38
Threads: 0
Postings: 15 [ Durchschnittlich 13,4489 Beiträge/Tag ]
Postings der letzten 30 Tage anzeigen
Interessen: keine Angaben

[kurttilly]

Zanogen, wurde sie nicht schon am 01.08.05 im Global Biotech Investing vorgestellt?!

mfg kurttilly

[xxHeribertxx]

[posting]17.469.865 von blb am 07.08.05 12:40:45[/posting]jaja, die abstufung hat mich wirklich überzeugt bei amylin. und erst diese Performance

gib mir bitte deinen nächsten tipp, am besten per BM, dann wirds nicht so öffentlich peinlich.

ich weiss nicht, wie du das siehst, aber ICH will an der börse geld verdienen und nicht wie bei einem sparbuch einfach herumliegen lassen......

aber viel glück mit deiner tollen strategie.

mann, mann, mann

[blb]

Die Abstufung kam VOR der Veröffentlichung der Zahlen. Die Zahlen waren aber über den Erwartungen. Somit war die Abstufung die reinste Anlegerverarsche! Sie haben im 1.Monat mit beiden Medikamenten über 8 Millionen umgesetzt, was aufs Jahr hochgerechnet ohne Wachstumsrate (also viel zu konservativ) schon allein 96 Millionen $ wären. Ich bin nicht in AMLN investiert und habe die Aktie schon VOR den beiden Zulassungen vorgestellt, was natürlich immer mit Risiken behaftet ist. Im übrigen ist die Aktie im Tief von 15$ auf 24$ gestiegen, woran nicht zuletzt die hohe Shortquote mitgeholfen hat.

Wenn jetzt nicht bald mal was Gescheites von deiner Stelle aus kommt, kann ich w:o nur raten deinen gestern geöffneten Account baldmöglichst wieder zu sperren.

Auf inhaltlose Postings von dir werde ich auf jetzt nicht mehr antworten, die Leute können sich selbst ein Bild drüber machen. Ich habe in keinem meiner Postings zum Thema Biotech irgendeinen in eine Aktie getrieben, sondern nur Informationen reingestellt.

Schönen Sonntag noch!

[blb]

Das ist bis Ende des Jahres zu erwarten, Ergebnisse der Studien sollen dann nächstes Jahr kommen!

" We continue to make progress toward our goal of initiating three clinical trials by year end 2005 which include a U.S. Phase III trial of Androxal for male testosterone deficiency, a U.S. efficacy trial of Proellex for uterine fibroids and a European Phase II trial of Proellex for endometriosis," said Joseph Podolski, President and CEO of Zonagen, Inc. He continued, " We anticipate initial study data from these three trials in mid-year 2006."

[xxHeribertxx]

sollen kommen, können kommen, mitte nächstes Jahr....

naja, viel spass damit

[StRAS]

Our capital requirements will depend on many factors, including the costs and timing of seeking regulatory approvals of the Company’s products; the problems, delays, expenses and complications frequently encountered by development stage companies; the progress of the Company’s preclinical and clinical activities; the costs associated with any future collaborative research, manufacturing, marketing or other funding arrangements; the Company’s ability to obtain regulatory approvals; the success of the Company’s potential future sales and marketing programs; the cost of filing, prosecuting and defending and enforcing any patent claims and other intellectual property rights; changes in economic, regulatory or competitive conditions of the Company’s planned business; and additional costs associated with being a publicly-traded company. Estimates about the adequacy of funding for the Company’s activities are based on certain assumptions, including the assumption that the development and regulatory approval of the Company’s products can be completed at projected costs and that product approvals and introductions will be timely and successful. There can be no assurance that changes in the Company’s research and development plans, acquisitions or other events will not result in accelerated or unexpected expenditures. To satisfy its capital requirements, the Company may seek to raise additional funds in the public or private capital markets. The Company may seek additional funding through corporate collaborations and other financing vehicles. There can be no assurance that any such funding will be available to the Company on favorable terms or at all. If the Company is successful in obtaining additional financing, the terms of such financing may have the effect of diluting or adversely affecting the holdings or the rights of the holders of the Company’s common stock.

[blb]

Um die 4$ kann man jetzt durchaus mal auf eine Gegenreaktion spekulieren. Die Überkauftheit wurde komplett abgebaut.

[RLD]

Ich schau ende des jahres noch mal rein.
Vielleicht läuft Zonagen ja mal wie Viropharma 903906!

[blb]

Zonagen Awards Clinical Study Contracts for Next U.S. Trials of Proellex(TM) and Androxal(TM)
MONDAY, SEPTEMBER 12, 2005 6:00 AM
- BusinessWire

THE WOODLANDS, Texas, Sep 12, 2005 (BUSINESS WIRE) -- -Zonagen, Inc. (ZONA) (PCX:ZONA) today announced that the Company has awarded contracts for its next planned US studies for both Proellex(TM) and Androxal(TM). Pending review by the FDA this fall, Zonagen intends to conduct a 150 patient Phase II trial of Proellex(TM) for the treatment of uterine fibroids and a 210 patient Phase III trial of Androxal(TM) for the treatment of testosterone deficiency. The Company currently plans on using up to 20 clinical sites for each study. Upon successful completion of three month preclinical safety studies, Zonagen hopes to submit the IND for a Phase II trial of Proellex(TM) and the IND update and Special Protocol Assessment (SPA) for the Androxal(TM) trial over the next several weeks. Assuming the submissions are acceptable to the FDA, dosing should commence for both studies before the end of 2005.

Pharm-Olam International Ltd ("POI") has been awarded the contracts for both of the planned studies. POI is a privately owned, full service, multi-national CRO with corporate headquarters in Houston, Texas. POI was founded in 1994 and now has clinical services in over 40 countries including the United States, Eastern Europe, Western Europe, Russia, South Africa and Latin America. POI has a proven track record in conducting trials at all stages of the drug development process, from pre-clinical up to and including phase IV studies. POI`s clients include both large pharmaceutical companies as well as biotech organizations. Investigators and patients interested in participating in either of the studies should contact Dr. Fred Lowrey, Director of Clinical Affairs for POI. Dr. Lowrey`s number at POI is 713-463-8075.

The 150 patient Proellex(TM) study is designed to assess both improvement of symptoms associated with uterine fibroids as well as effects on the fibroid itself. The study will test two doses of Proellex(TM) versus placebo in a double-blind design. The study is of 12 week duration, and pending outcomes from both six month rodent and nine month dog studies, results from this Phase II study and subsequent FDA review, patients may be rolled over into a long term open label trial in order to assess the continued safety and efficacy of Proellex(TM). Doses to be used in this trial were previously tested in a 30 patient, 12-week study of Proellex(TM) in women with uterine fibroids. That study was conducted in Europe. In the study, Proellex(TM) exhibited positive effects on fibroid size, bleeding and pain associated with the condition. The drug was well tolerated over the course of the study. Proellex(TM) is a once-a-day oral therapy.

The 210 patient Androxal(TM) study is designed to assess both the improvement in testosterone levels and certain symptoms associated with low testosterone in men diagnosed with secondary hypogonadism. The study will test two doses of Androxal(TM) versus placebo in a double-blind design. The study is of 12 week duration, and pending outcomes from both six month rodent and nine month dog studies, results from this Phase III study and subsequent FDA review, patients may be rolled over into a long term open label trial in order to assess the continued safety and efficacy of Androxal(TM). Doses to be used in this trial were previously tested in a 52 patient, 2-week study of Androxal(TM) in men with secondary hypogonadism. That study was conducted in the US. In the study, Androxal(TM) exhibited positive effects on inducing restoration of normal testicular function as evidenced by achievement of normal testosterone levels. The drug was well tolerated over the course of the study. Androxal(TM) is a once-a-day oral therapy.

ABOUT ZONAGEN

Zonagen is a clinical stage biopharmaceutical company engaged in the development of new drugs to treat hormonal and reproductive system disorders.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including Zonagen`s ability to have success in the clinical development of its technologies, Zonagen`s ability to have success in meeting governmental regulations and the costs and time required to meet such regulatory requirements, manufacturing uncertainties related to Proellex(TM), the need for additional funding in order to complete clinical trials for Proellex(TM) and Androxal(TM), our reliance on independent contractors for development and manufacturing needs, and such other risks identified in Zonagen`s Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the Securities and Exchange Commission (SEC) and other SEC filings. These documents are available on request from Zonagen or at www.sec.gov. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: Zonagen, Inc.

Zonagen, Inc., The Woodlands
Joseph S. Podolski, 281-719-3447


Copyright Business Wire 2005

[blb]

Zonagen Reports Third Quarter 2005 Financial Results and Provides Update on Proellex and Androxal Clinical Development Programs
FRIDAY, NOVEMBER 11, 2005 6:00 AM
- BusinessWire

THE WOODLANDS, Texas, Nov 11, 2005 (BUSINESS WIRE) -- Zonagen, Inc. (ZONA) (PCX:ZONA) today reported financial results for the three-month and nine-month periods ended September 30, 2005 and provided an update on its clinical development efforts for Proellex(TM) and Androxal(TM).

"We continue to move toward our goal of initiating three clinical trials by year end 2005 which include a U.S. Phase III trial of Androxal for male testosterone deficiency, a U.S. efficacy trial of Proellex for uterine fibroids and a European Phase II trial of Proellex for endometriosis," said Joseph Podolski, President and CEO of Zonagen, Inc. He continued, "We anticipate initial data from these three trials during the summer of 2006."

Zonagen is preparing a submission supporting a Phase III study for its drug Androxal. The Company also hopes to submit the documents necessary for initiation of the study to the FDA within the next few weeks and believes that it will commence the study before year end 2005. The study will consist of approximately 200 patients at up to 20 clinical sites in the U.S. and abroad. The Phase III study is being designed to collect additional safety data on Androxal for the treatment of testosterone deficiency in men with secondary hypogonadism. Additional endpoints addressing certain clinical symptoms associated with low testosterone will also be assessed in the trial. The study will also compare Androxal against Androgel, the gold standard for patients suffering from low testosterone. We believe that at least two additional Phase III pivotal studies beyond the currently planned study will be required before an NDA can be submitted. A contract has been awarded to a clinical research organization (CRO) to begin the Phase III study as soon as the FDA has reviewed and accepted the submission.

Initial review of the Company`s special protocol assessment (SPA) filing for its first Phase III pivotal study of efficacy has been completed by the FDA, and the Company is in the process of responding to their comments. The FDA has suggested that certain endpoints suggested by Zonagen in its SPA filing, such as reduced libido, need to be validated as clinical endpoints before being used in a Phase III pivotal study. The Company plans on complying with the FDA`s request, and revising its Phase III pivotal protocol to incorporate the FDA`s suggestions, before continuing under the SPA. A decision on commencement of the SPA protocol is dependent on successful completion or progress on the above described Phase III study.

In May 2005 the Company held a pre-IND meeting with the FDA regarding the next clinical study to be conducted in the U.S. using Proellex for the treatment of uterine fibroids. The Company believes that the meeting with the FDA constructively identified the requirements that must be completed before the Company can file an IND and begin a clinical study by year end 2005. The Company completed its 23 volume IND submission which included extensive preclinical animal data supporting the safety of Proellex as well as a final study report for the previously reported trial of Proellex in women with uterine fibroids and delivered the submission to the FDA on November 10, 2005. The Company can not begin its Proellex Phase II clinical study until the FDA has reviewed and accepted the submission. A contract has been awarded to a CRO to begin the Phase II study as soon as the FDA has reviewed and accepted the submission.

Financial Results

Total revenues and other income for the three-month period ended September 30, 2005 increased to $175,000 as compared to $29,000 for the same period in the prior year and increased to $460,000 for the nine-month period ended September 30, 2005 as compared to $228,000 for the same period in the prior year. The primary increase in revenues is due to an increase in interest rate yields and an increase in cash reserves which the Company received from its public offering in February 2005 offset by a reduction in SBIR grant revenue which is due to its anticipated conclusion and is essentially depleted.

Research and development ("R&D") expenses primarily consist of clinical regulatory affairs activities and preclinical and clinical study development expenses. R&D expenses increased 72% to $1.6 million for the three-month period ended September 30, 2005 as compared to $929,000 for the same period in the prior year and increased 121% to $4.2 million for the nine-month period ended September 30, 2005 as compared to $1.9 million for the same period in the prior year. The increase in R&D expenses for the three-month period ended September 30, 2005 as compared to the same period in the prior year is primarily due to an increase of $732,000 and $274,000 related to our clinical development programs for Androxal and Proellex, respectively, partially offset by a decrease of $281,000 in costs associated with the 2004 write-off of our patent portfolio related to our vaccine adjuvants and prostate cancer vaccines. The increase in R&D expenses for the nine-month period ended September 30, 2005 as compared to the same period in the prior year is primarily due to an increase of $1.5 million and $1.2 million related to our clinical development programs for Androxal and Proellex, respectively, partially offset by a decrease of $337,000 in costs associated with the 2004 write-off of our patent portfolio related to our vaccine adjuvants, prostate cancer vaccines and hCG immuno-contraceptive vaccine.

General and administrative expenses decreased 15% to $461,000 for the three-month period ended September 30, 2005 as compared to $540,000 for the same period in the prior year and increased 8% to $1.4 million for the nine-month period ended September 30, 2005 as compared to $1.3 million for the same period in the prior year. The decrease in expenses for the three-month period ended September 30, 2005 is primarily due to a decrease in costs associated with potential funding activities in the amount of $117,000, offset by an increase in costs associated with strategic administrative fees in the amount of $25,000. The increase in expenses for the nine-month period ended September 30, 2005 is primarily due to an increase in costs associated with strategic administrative fees in the amount of $86,000, personnel costs in the amount of $47,000, legal and accounting services in the amount of $43,000 and investor relations costs in the amount of $37,000, offset by a decrease in costs associated with potential funding activities in the amount of $117,000 and a $27,000 decrease in directors` and officers` insurance.

Net loss for the three-month period ended September 30, 2005 was ($1.9) million or ($0.19) per share as compared to a net loss of ($1.4) million or ($0.29) per share for the same period in the prior year. Net loss for the nine-month period ended September 30, 2005 was ($5.1) million or ($0.54) per share as compared to a net loss of ($3.0) million or ($0.57) per share for the same period in the prior year. The increase in loss per share for the three-month and nine-month periods ended September 30, 2005 was primarily due to an increase in clinical research activities relating to the Company`s two products, Androxal and Proellex.

The Company had cash, cash equivalents and marketable securities of approximately $19.1 million at September 30, 2005 as compared to $5.5 million at December 31, 2004 and had 10,079,601 shares of common stock outstanding on September 30, 2005.

Zonagen, Inc. is engaged in the development of pharmaceutical products that address diseases and conditions associated with the treatment of hormonal and reproductive system disorders.

A copy of this press release may be obtained via facsimile by dialing 1-888-329-0920 or via the internet by accessing www.zonagen.com.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Zonagen`s ability to have success in the clinical development of its technologies, Zonagen`s ability to raise additional capital on acceptable terms or at all, Zonagen`s ability to have success in meeting governmental regulations and the costs and time required to meet such regulatory requirements, manufacturing uncertainties related to Proellex(TM), uncertainty relating to Zonagen`s patent portfolio and such other risks which are identified in Zonagen`s Annual Report on Form 10-K for the year ended December 31, 2004. The Form 10-K is available at the Company`s web site at www.zonagen.com, at the SEC`s web site at www.sec.gov or is available by request made to Zonagen`s Corporate Secretary. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ZONAGEN, INC. AND SUBSIDIARY
(A DEVELOPMENT STAGE COMPANY)

CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share amounts)

Three Months Ended Nine Months Ended
----------------------- -----------------------
September 30, September 30,
2005 2004 2005 2004
----------- ----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenues and other
income
Research and
development grants $- $2 $4 $118
Interest income 175 27 456 75
Other Income - - - 35
----------- ----------- ----------- -----------
Total revenues
and other income 175 29 460 228
----------- ----------- ----------- -----------

Expenses
Research and
development 1,641 929 4,231 1,914
General and
administrative 461 540 1,357 1,268
----------- ----------- ----------- -----------
Total expenses 2,102 1,469 5,588 3,182
----------- ----------- ----------- -----------

Net loss $(1,927) $(1,440) $(5,128) $(2,954)
=========== =========== =========== ===========

Net loss per share -
basic and diluted $(0.19) $(0.29) $(0.54) $(0.57)
=========== =========== =========== ===========

Shares used in loss
per share
calculation:
Basic 10,080 4,993 9,501 5,159
Diluted 10,080 4,993 9,501 5,159


CONSOLIDATED BALANCE SHEETS

September 30, December 31,
2005 2004
-------------- --------------
(Unaudited)

Cash and cash equivalents $3,000 $736
Marketable securities 16,053 4,800
Other current assets 203 34
Fixed assets (net) 21 18
Other assets 564 1,018
-------------- --------------
Total assets $19,841 $6,606
============== ==============

Accounts payable and accrued expenses $621 $614
Stockholders` equity 19,220 5,992
-------------- --------------
Total liabilities and stockholders`
equity $19,841 $6,606
============== ==============


SOURCE: Zonagen, Inc.

Zonagen, Inc., The Woodlands
Joseph S. Podolski, 281-719-3447


Copyright Business Wire 2005

[blb]

Ausbruch:

[blb]

Zonagen Announces Positive Top-Line Results of Androxal(TM) Study; Androxal(TM) Did Not Produce Supra-Normal Levels of Testosterone in Study Patients
FRIDAY, FEBRUARY 03, 2006 6:00 AM
- BusinessWire

THE WOODLANDS, Texas, Feb 03, 2006 (BUSINESS WIRE) -- Zonagen, Inc. (ZONA) and (PCX:ZONA), a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders, today announced positive top-line results of an open-label study of Androxal(TM), the company`s candidate for the treatment of testosterone deficiency. This study was designed to evaluate the effect of Androxal(TM) on the testosterone levels of 13 men with normal, borderline or low testosterone.

The open-label study enrolled eight patients with normal testosterone levels (greater than 350 and less than 1,100 ng/dL), four with borderline testosterone levels (250-350 ng/dL) and one with low testosterone (less than 250 ng/dL). Study subjects received 25 mg of Androxal(TM) orally for two weeks and were monitored at the end of the dosing period and four weeks after dosing had stopped. After two weeks on Androxal(TM), all study subjects, including those that had normal testosterone levels at the start of the study, exhibited average testosterone levels within the normal range. The average change from baseline was 297.5 ng/dL of testosterone. Four weeks after the dosing period had concluded, all of the study subjects had returned to their baseline testosterone levels.

Jean Fourcroy, MD, Ph.D., M.P.H., member of the Boards of Zonagen and the U.S. Anti-Doping Agency and a former FDA medical officer noted, "These results are particularly interesting in light of the potential that exists to achieve supra-normal levels of testosterone with currently available exogenous preparations." Dr. Fourcroy further stated, "Not only does Androxal(TM) exhibit the potential to restore normal testosterone levels in men experiencing secondary hypogonadism and consequently all the benefits that normalized male hormones afford, it appears that it does not offer the potential for abuse, although further studies need to substantiate this finding."

Zonagen previously announced the results of a U.S. Phase I/II study comparing Androxal(TM) to Androgel(R), the leading marketed testosterone replacement therapy, in 52 patients with low testosterone. As reported, Androxal(TM) and Androgel(R) were each successful in restoring normal testosterone levels within 2 weeks of treatment. Importantly, the study also showed that Androgel(R), while restoring normal testosterone levels, suppressed normal pituitary secretions; whereas Androxal(TM) was shown to restore normal pituitary signaling to the testes, thereby eliminating the need for testosterone supplementation. Androxal(TM) was well tolerated over the course of the study.

Based on these Phase I/II data, Zonagen is conducting a 200 patient Phase III double-blind trial of Androxal(TM). The study will test two doses of Androxal(TM) versus placebo and will include an open-label arm of the commercially available drug Androgel(R). The dosing is of 24-week duration with an efficacy assessment made at 12 weeks. Initial data after 12 weeks of dosing is anticipated in the third quarter of 2006.

ABOUT ANDROXAL(TM)

Androxal is a proprietary, small molecule, orally active product candidate, being developed for the treatment of testosterone deficiency in men. Androxal is designed to restore normal testosterone production in males versus competitive solutions that externally replace testosterone.

ABOUT ZONAGEN

Zonagen is a clinical stage biopharmaceutical company engaged in the development of new drugs to treat hormonal and reproductive system disorders.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including Zonagen`s ability to have success in the clinical development of its technologies, Zonagen`s ability to have success in meeting governmental regulations and the costs and time required to meet such regulatory requirements, manufacturing uncertainties, the need for additional funding in order to complete clinical trials for Zonagen`s product candidates, reliance on independent contractors, uncertainty relating to Zonagen`s patent portfolio and such other risks identified in Zonagen`s Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the Securities and Exchange Commission (SEC) and other SEC filings. These documents are available on request from Zonagen or at www.sec.gov. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: Zonagen, Inc.

Zonagen, Inc., The Woodlands
Joseph S. Podolski, 281-719-3447
or
Porter Novelli Life Sciences
Aline Schimmel, 212-601-8278


Copyright Business Wire 2006

[blb]

Namensänderung geplant...

Zonagen Announces 2006 Annual Meeting of Stockholders; Shareholder Approval Sought to Change Name to Repros Therapeutics Inc.
WEDNESDAY, FEBRUARY 08, 2006 6:00 AM
- BusinessWire

THE WOODLANDS, Texas, Feb 08, 2006 (BUSINESS WIRE) -- Zonagen, Inc. (ZONA) (PCX:ZONA) announced today that the 2006 Annual Meeting of Stockholders of Zonagen, Inc. will be held on Tuesday, May 2, 2006, at 12:00 p.m., Eastern Daylight Time. The Company will mail a Notice of the Annual Meeting, Proxy Statement and form of Proxy to stockholders of record for the meeting about one month prior to the meeting. The record date for the meeting will be March 10, 2006.

Among other matters, the Company intends to seek stockholder approval at this meeting to change the Company`s name to Repros Therapeutics Inc. to more accurately reflect the Company`s focus on therapeutics for reproductive disorders.

Joseph S. Podolski, President & CEO, noted, "Our Company was founded to commercialize technology originated at Baylor College of Medicine focusing on the reproductive system, and our name Zonagen reflected that focus. With our new focus on the development of drugs to treat hormonal and reproductive system disorders, we feel that the name Repros Therapeutics Inc. better reflects our new strategic focus. We continue to make advances in the development of Proellex(TM) for the treatment of uterine fibroids and endometriosis, and Androxal(TM) for the treatment of testosterone deficiency in men. We urge our shareholders to vote in favor of this change in corporate identity and look forward to continued progress."

ABOUT ZONAGEN

Zonagen is a clinical stage biopharmaceutical company engaged in the development of new drugs to treat hormonal and reproductive system disorders.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including Zonagen`s ability to have success in the clinical development of its technologies, Zonagen`s ability to have success in meeting governmental regulations and the costs and time required to meet such regulatory requirements, manufacturing uncertainties, the need for additional funding in order to complete clinical trials for Zonagen`s product candidates, reliance on independent contractors, uncertainty relating to Zonagen`s patent portfolio and such other risks identified in Zonagen`s Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the Securities and Exchange Commission (SEC) and other SEC filings. These documents are available on request from Zonagen or at www.sec.gov. Zonagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: Zonagen, Inc.

Zonagen, Inc., The Woodlands
Louis Ploth, 281-719-3454


Copyright Business Wire 2006