Zonagen (NASDAQ:ZONA)
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From Jul 2019 to Jul 2024
Zonagen, Inc. (Nasdaq:ZONA)(PCX:ZONA) today provided an
overview of the status of its Progenta(TM) and Androxal(TM) clinical
programs, reported first quarter financial results for the three-month
period ended March 31, 2005, and announced its 2005 Annual Meeting of
Stockholders to be held in New York City on June 21, 2005.
"We are emerging from our first quarter with a strong clinical
pipeline and are preparing to initiate three clinical trials in 2005.
These trials include a U.S. Phase III trial of Androxal for male
testosterone deficiency, a U.S. clinical trial of Progenta for uterine
fibroids and a European Phase II trial of Progenta for endometriosis,"
said Joseph Podolski, President and CEO of Zonagen, Inc. "We continue
to operate in a streamlined, efficient manner as a near-virtual
company to provide the most value to our stockholders."
Zonagen has been informed by the FDA that it has agreed to review
the Company's Androxal Phase III pivotal trial under a Special
Protocol Assessment ("SPA") pending the FDA's review of the protocol.
The Company's goal is to commence a U.S. Phase III study by year end
2005 and have initial three-month study data by the end of the first
half of 2006.
The Company's recently completed European Phase Ib clinical study
of Progenta, which studied the drug's safety and efficacy when
administered for three months to women diagnosed with uterine
fibroids, indicated that Progenta may be safe and have the potential
to significantly reduce fibroid size. The Company believes it has
sufficient data from this trial to adequately select dose for an
advanced Phase II U.S. trial. Zonagen has scheduled a pre-IND meeting
with the FDA for May 20, 2005 and pending those discussions, the
Company's goal is to commence this Phase II trial by year end 2005.
The Company hopes that this Phase II trial may be the first pivotal
trial of two required pivotal trials. Initial three-month study data
from this trial is expected by the end of the first half of 2006.
Zonagen also intends to conduct a European Phase II clinical study
of Progenta for the treatment of endometriosis. The Company believes
it will begin that study by year end 2005 and have initial study data
by the end of the first half of 2006.
Financial Results
Total revenues and other income for the three-month period ended
March 31, 2005 decreased to $112,000 as compared with $125,000 for the
same period in the prior year. Research and development grant revenue
for the three-month period ended March 31, 2005 were $4,000 as
compared to $64,000 for the same period in the prior year. This grant
revenue relates to a $836,441 Phase II Small Business Innovative
Research ("SBIR") grant that was awarded to the Company in 2002 for
the development of Progenta as an oral treatment for endometriosis.
This SBIR grant has come to its anticipated conclusion and is
essentially depleted. Interest income increased 315% to $108,000 for
the three-month period ended March 31, 2005, as compared to $26,000
for the same period in the prior year. This increase is primarily due
to the increase in marketable securities as a result of the Company
completing its follow-on public offering on February 1, 2005 in which
it received approximately $18.2 million in net proceeds.
Research and development ("R&D") expenses include contracted
research, regulatory affairs activities and general research and
development expenses. R&D expenses increased 159% to $1.2 million for
the three-month period ended March 31, 2005 as compared to $477,000
for the same period in the prior year. The increase in R&D expenses
for the three-month period ended March 31, 2005 as compared to the
same period in the prior year is primarily due to an increase of
$499,000 and $292,000 related to the Company's clinical development
programs for Progenta and Androxal, respectively, partially offset by
a decrease of $60,000 in costs associated with the Company's SBIR
grant funded R&D.
General and administrative expenses remained relatively constant
at $431,000 for the three-month period ended March 31, 2005, as
compared to $434,000 for the same period in the prior year. The slight
decrease in expenses for the three-month period ended March 31, 2005
is primarily due to a decrease in directors' and officers' insurance
expense and professional services, partially offset by an increase in
directors' expense.
Net loss for the three-month period ended March 31, 2005 was
($1,555,000) or ($0.19) per share as compared to a net loss of
($786,000) or ($0.14) per share for the same period in the prior year.
The increase in loss per share for the three-month period ended March
31, 2005 was primarily due to an increase in clinical research
activities relating to the Company's two products, Progenta and
Androxal.
The Company had cash, cash equivalents and marketable securities
of approximately $23.2 million at March 31, 2005 as compared to $5.5
million at December 31, 2004 and had 10,079,601 shares of common stock
outstanding on March 31, 2005.
2005 Annual Meeting of Stockholders
The 2005 Annual Meeting of Stockholders of Zonagen, Inc. will be
held on Tuesday, June 21, 2005, at 5:00 p.m., Eastern Daylight Time,
at the New York Marriott East Side Hotel, 525 Lexington Avenue, New
York, New York. 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.
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 Progenta(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.
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ZONAGEN, INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share amounts)
Three Months Ended
--------------------------
March 31,
2005 2004
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(Unaudited) (Unaudited)
Revenues
Research and development grants $4 $64
Interest income 108 26
Other - 35
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Total revenues 112 125
Expenses
Research and development 1,236 477
General and administrative 431 434
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Total expenses 1,667 911
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Net loss $(1,555) $(786)
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Net loss per share $(0.19) $(0.14)
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Shares used in loss per share calculation:
Basic 8,326 5,492
Diluted 8,326 5,492
CONSOLIDATED BALANCE SHEETS
March 31, December 31,
2005 2004
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(Unaudited)
Cash and cash equivalents $1,620 $736
Marketable securities 21,541 4,800
Other currents assets 238 34
Fixed assets (net) 20 18
Other assets (net) 438 1,018
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Total assets $23,857 $6,606
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Accounts payable and accrued
expenses $1,152 $614
Stockholders' equity 22,705 5,992
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Total liabilities and
stockholders' equity $23,857 $6,606
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