Repros Therapeutics Inc. Reports First Quarter 2009 Financial Results and Provides Clinical Program Update
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First Chronic Uterine Fibroid Phase 3 Pivotal Clinical Trial Fully Enrolled
THE WOODLANDS, Texas--(Business Wire)--
Repros Therapeutics (NasdaqGM:RPRX) today announced financial results for the
first quarter ended March 31, 2009 and provided a clinical program update.
Clinical Program Update
Proellex
Our Proellex clinical programs are progressing well and according to plan. We
have completed enrollment of our first Pivotal Phase 3 clinical trial (ZPU-303)
for the chronic treatment of uterine fibroids and expect the first Pivotal Phase
3 clinical trial for the treatment of anemia associated with uterine fibroids
(ZPU-301), to be fully enrolled mid-2009, which would then lead to top-line
results in each study by the end of this year. We expect top-line results from
our other two complementary Pivotal Phase 3 studies, ZPU-302 (anemia) and
ZPU-304 (chronic symptoms), during Q1 of next year. All of these target
reporting times are in line with previous guidance provided.
The two New Drug Applications ("NDA") for anemia associated with uterine
fibroids and chronic symptoms of uterine fibroids are scheduled to be submitted
to the Food & Drug Administration ("FDA") during the second half of 2010.
Our endometriosis program for Proellex has reached the end of Phase 2, and it is
our intent to discuss the results of our study ZPE-201 with the FDA during an
End-of-Phase II Meeting, mid-2009. Taking the feedback and input from the FDA
into account, we will then initiate two well-controlled Pivotal Phase 3 studies
for the endometriosis indication during the second half of this year. Although
it is difficult to provide firm guidance for the timing of a NDA filing for
endometriosis, we expect this filing to occur during the second half of 2011.
Androxal
Our comparative Phase 2b study (ZA-201) of Androxal versus Testim1%
(Testosterone Gel - Auxilium Pharmaceuticals, Malvern, PA) for the treatment of
men with low testosterone that want to improve or maintain their fertility and
sperm number and function is progressing well, and we expect to report top-line
results during Q3 of 2009. Also, based on feedback from the FDA`s Metabolic
Division, we expect to submit an IND to the Agency during the second half of
this year, for the use of Androxal as a treatment for type 2 diabetes.
Financial Results
Net loss for the three month period ended March 31, 2009, was ($6.8) million or
($0.45) per share as compared to a net loss of ($6.7) million or ($0.52) per
share for the same period in 2008. The increase in loss for the three month
period ended March 31, 2009 as compared to the same period in 2008 was primarily
due to an increase in our general and administrative expenses partially offset
by decreased expenses in clinical development activities for Androxal.
Research and development ("R&D") expenses decreased 8% or approximately $468,000
to $5.7 million for the three month period ended March 31, 2009 as compared to
$6.2 million for the same period in 2008. Our primary R&D expenses for the three
month periods ended March 31, 2009 and 2008 are shown in the following table (in
thousands):
Research and Development Three Months Three Months Variance Change (%)
Ended Ended
March 31, 2009 March 31, 2008
Proellex clinical development $ 4,717 $ 4,640 $ 77 2 %
Androxal clinical development 347 970 (623 ) (64 )%
Payroll and benefits 416 235 181 77 %
Operating and occupancy 218 321 (103 ) (32 )%
Total $ 5,698 $ 6,166 ($468 ) (8 )%
The decrease in R&D expenses for the three month period ended March 31, 2009 is
due primarily to the decrease in clinical activities in the development of
Androxal which is no longer being developed for the treatment of secondary
hypogonadism. We are currently developing Androxal as a treatment for men with
low testosterone that want to maintain or improve their fertility and sperm
function. In addition, we are exploring the feasibility of developing Androxal
for Type 2 diabetes.
General and administrative expenses ("G&A") increased 33% to approximately $1.1
million for the three month period ended March 31, 2009 as compared to $797,000
the same period in 2008. Our primary G&A expenses for the three month periods
ended March 31, 2009 and 2008 are shown in the following table (in thousands):
General and Administrative Three Months Three Months Variance Change ( %)
Ended Ended
March 31, 2009 March 31, 2008
Payroll and benefits $ 475 $ 346 $ 129 37 %
Operating and occupancy 585 451 134 30 %
Total $ 1,060 $ 797 $ 263 33 %
G&A payroll and benefit expense increased to $475,000 for the three month period
ended March 31, 2009 as compared to $346,000 for the same period in 2008 and
includes a non-cash charge relating to stock option expense of $192,000 for the
three month period ended March 31, 2009 as compared to $124,000 for the same
period in the prior year. Additionally, salaries for the three month period
ended March 31, 2009 were $238,000 as compared to $192,000 for same period in
the prior year. G&A operating and occupancy expenses increased 30% or
approximately $134,000 to $585,000 for the three month period ended March 31,
2009 as compared to $451,000 for the same period in the prior year primarily due
to an increase in professional services of $126,000.
Interest income decreased 99% to $3,000 for the three month period ended March
31, 2009 as compared to $269,000 for the same period in 2008. This decrease was
primarily due to lower combined cash, cash equivalents and marketable securities
balances and reduced interest rate yields that have occurred as we moved our
cash investments solely into a money market mutual fund.
As of March 31, 2009 we had 15,174,904 shares of common stock outstanding.
Liquidity and Going Concern Uncertainty
As of March 31, 2009, we had cash, cash equivalents and marketable securities of
approximately $12.4 million as compared to $19.5 million at December 31, 2008.
Based on our current ongoing and planned clinical programs, we will need to
raise additional capital in the third quarter of 2009, which we intend to
accomplish through either a corporate partnership for Proellex or, if we are not
able to complete such partnership on a timely basis, an equity financing. We
intend to complete such a transaction by the end of the 2nd quarter but there
can be no assurances that a partnership will be completed on a timely basis or
such capital will be available to us. Our Annual Report on Form 10-K for the
year ended December 31, 2008 includes an explanatory paragraph about the report
of its independent registered public accounting firm that there is substantial
doubt about Repros` ability to continue as a "going concern." Repros also
received a similar going concern opinion for the year ended December 31, 2007.
About Repros Therapeutics
Repros Therapeutics focuses on the development of oral small molecule drugs for
major unmet medical needs that treat male and female reproductive disorders.
Our lead drug, Proellex, is a selective blocker of the progesterone receptor and
is being developed for the treatment of symptoms associated with uterine
fibroids and endometriosis. We are also developing Proellex as a short course
pre-surgical treatment for anemia associated with excessive menstrual bleeding
related to uterine fibroids. There is no currently approved effective long-term
orally administered drug treatment for uterine fibroids or endometriosis. In the
United States alone, 300,000 women per year undergo a hysterectomy as a result
of severe uterine fibroids.
Our second product candidate, Androxal, is a single isomer of clomiphene citrate
and is an orally active proprietary small molecule compound. We are developing
Androxal for men of reproductive age with low testosterone levels who want to
improve or maintain their fertility and/or sperm function while being treated
for low testosterone. In November 2008, we received guidance from the FDA
suggesting submission of a new IND to the Division of Metabolic and Endocrine
Products, or DMEP, for the investigation of Androxal as a potential treatment
for type 2 diabetes. We plan to submit a new IND for this indication to the DMEP
as soon as practicable.
Any statements that are not historical facts contained in this release are
forward-looking statements that involve risks and uncertainties, including
Repros` ability to have success in the clinical development of its technologies,
the timing of enrollment and release of data in such clinical studies and the
accuracy of such studies, limited patient populations of clinical studies to
date and the possibility that final data may not be consistent with interim
data, Repros' ability to raise additional capital in a timely manner and on
acceptable terms or at all and such other risks which are identified in the
Company's most recent Annual Report on Form 10-K and in any subsequent quarterly
reports on Form 10-Q.These documents are available on request from Repros
Therapeutics or at www.sec.gov.Repros disclaims any intention or obligation to
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
For more information, please visit the Company's website at
http://www.reprosrx.com.
REPROS THERAPEUTICS INC. AND SUBSIDIARY
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share amounts)
Three Months Ended
March 31,
2009 2008
(Unaudited) (Unaudited)
Revenues
Interest income $ 3 $ 269
Total revenues 3 269
Expenses
Research and development 5,698 6,166
General and administrative 1,060 797
Total expenses 6,758 6,963
Net loss $ (6,755 ) $ (6,694 )
Net loss per share - basic and diluted $ (0.45 ) $ (0.52 )
Weighted average shares used in loss per share calculation:
Basic 15,175 12,775
Diluted 15,175 12,775
CONSOLIDATED BALANCE SHEETS
March 31, December 31,
2009 2008
(Unaudited)
Cash and cash equivalents $ 12,402 $ 19,470
Prepaid expenses and other currents assets 2,240 1,392
Fixed assets (net) 23 28
Patents (net) 1,840 1,713
Total assets $ 16,505 $ 22,603
Accounts payable and accrued expenses $ 7,312 $ 6,989
Stockholders' equity 9,193 15,614
Total liabilities and stockholders' equity $ 16,505 $ 22,603
Repros Therapeutics, The Woodlands
Dr. Paul Lammers, 281-719-3402
President
Copyright Business Wire 2009
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