GTx Provides Corporate Update and Reports Fourth Quarter and Year-End 2015 Financial Results
Thursday, March 03, 2016 7:00:01 AM ET -- Lead SARD candidates have been selected for additional preclinical studies necessary to initiate first in human clinical trials --
-- Patient enrollment underway in Phase 2 proof-of-concept clinical trial of enobosarm in women with Stress Urinary Incontinence; anticipate top-line data in 2016 --
-- Conference call today at 9:00 a.m. Eastern Time --
GTx, Inc. (GTXI ) today reported financial results for the fourth
quarter and year ended December 31, 2015, and highlighted recent
accomplishments and upcoming milestones. The Company is currently
enrolling patients in three clinical trials: two trials evaluating
enobosarm as a potential treatment for women with advanced breast
cancer, and another assessing enobosarm as a potential treatment for
stress urinary incontinence in postmenopausal women.
"In 2015, we continued to make important progress across our pipeline
assets, and while our primary focus continues to be the development of
enobosarm to potentially treat advanced breast cancer and our SARD
technology, we have diversified our therapeutic opportunities to include
SARMs for stress urinary incontinence and Duchenne muscular dystrophy,"
said Dr. Robert J. Wills, Executive Chairman of GTx.
Corporate Highlights and Anticipated Milestones
Enobosarm in Breast Cancer: The Company’s lead product
candidate, a selective androgen receptor modulator (SARM), is being
developed as a targeted treatment for two advanced breast cancer
indications: (i) estrogen receptor positive (ER+) and androgen receptor
positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer
(TNBC). For both clinical trials, the primary efficacy endpoint will be
clinical benefit, which is defined as a complete response, partial
response or stable disease.
--
ER+/AR+ breast cancer: currently expect to enroll the first stage of
the open-label, Phase 2 clinical trial of enobosarm in women with
metastatic or locally advanced, ER+/AR+ breast cancer by mid-year in
order to report preliminary results by the end of 2016. While the
first stage of the trial will evaluate 18 patients for each of the two
dosing arms, 9 mg and 18 mg of enobosarm, the trial is designed to
enroll up to 118 patients to obtain data from 44 evaluable patients in
each study arm (a total of 88 evaluable patients) to assess the
primary efficacy objective of clinical benefit response following 24
weeks of treatment.
--
AR+ TNBC: currently expect to enroll the first stage of the
open-label, proof-of-concept Phase 2 clinical trial of 18 mg of
enobosarm in women with advanced AR+ TNBC by mid-year in order to
report preliminary results by the end of 2016. While the first stage
will include 21 evaluable patients, the trial is designed to enroll up
to 55 patients in total in order to obtain data from 41 evaluable
patients to assess the primary efficacy objective of clinical benefit
response following 16 weeks of treatment.
SARMs in Non-Oncologic Indications: The Company is exploring
SARMs as potential treatments for both stress urinary incontinence (SUI)
and Duchenne muscular dystrophy (DMD), a rare disease characterized by
progressive muscle degeneration and weakness.
--
SUI: enrolled first patient in a Phase 2 proof-of-concept clinical
trial of 3 mg of enobosarm to treat up to 35 postmenopausal women with
SUI, the first clinical trial to evaluate a SARM for SUI. Top-line
data from the Phase 2 clinical trial is anticipated by the end of 2016.
--
DMD: the Company’s preclinical studies have continued to confirm
beneficial effects from SARMs in mice genetically altered to simulate
DMD, compared to control groups.
--
DMD mice were treated with one of three different SARM compounds,
including enobosarm, and each SARM cohort demonstrated increases
in body weight, muscle mass, muscle performance (grip strength)
and cardiac function, compared to control groups;
--
Histologically, in SARM-treated mice, skeletal muscles
demonstrated a reduction in necrosis, fibrosis, and centrally
nucleated cells, which are accepted markers of skeletal muscle
atrophy; and
--
A SARM also markedly reduced the fibrosis of cardiac muscle, which
is relevant since most DMD patients will develop cardiomyopathy as
the disease progresses.
SARDs in Prostate Cancer: Selective Androgen Receptor Degrader
(SARD) technology is being evaluated as a potentially novel treatment
for men with castration-resistant prostate cancer (CRPC), including
those who do not respond or are resistant to currently approved
therapies. The Company believes that its SARD compounds will degrade
multiple forms of the androgen receptor, including AR splice variants,
such as AR-V7.
--
CRPC: lead SARD compounds are currently being evaluated in additional
preclinical studies to select the best SARD compounds for continued
development, as well as to develop data necessary to initiate first in
human clinical trials in 2017.
Fourth Quarter and Year-End 2015 Financial Results
--
As of December 31, 2015, cash and short-term investments were $29.3
million compared to $49.3 million at December 31, 2014.
--
Research and development expenses for the quarter ended December 31,
2015 were $3.9 million compared to $3.3 million for the same period of
2014. Research and development expenses for the year ended December
31, 2015 were $13.6 million compared to $20.9 million for the year
ended December 31, 2014.
--
General and administrative expenses for the quarter ended December 31,
2015 were $2.1 million compared to $2.2 million for the same period of
2014. General and administrative expenses for the year ended December
31, 2015 were $8.2 million compared to $9.5 million for the year ended
December 31, 2014.
--
The net loss for the quarter ended December 31, 2015 was $3.2 million
compared to a net loss of $14.5 million for the same period in 2014.
The net loss for the quarters ended December 31, 2015 and December 31,
2014 included a non-cash gain of $2.7 million and a non-cash loss of
$8.8 million, respectively, related to the change in the fair value of
the Company’s warrant liability. The net loss for the year ended
December 31, 2015 was $18.7 million compared to a net loss of $39.4
million for the year ended December 31, 2014. The net loss for the
years ended December 31, 2015 and December 31, 2014 included a
non-cash gain of $3.1 million and a non-cash loss of $8.8 million,
respectively, related to the change in the fair value of the Company’s
warrant liability.
--
GTx had approximately 140.4 million shares of common stock outstanding
as of December 31, 2015. Additionally, there remain warrants
outstanding to purchase approximately 64.3 million shares of GTx
common stock at an exercise price of $0.85 per share.
Conference Call and Webcast
There will be a conference call today at 9:00 a.m. Eastern Standard
Time. To listen to the conference call, please dial 877-930-8288 from
the United States or Canada or 253-336-8703 from other international
locations. The access code for the call is 35776523. A playback of the
call will be available from approximately 12:00 p.m. Eastern Standard
Time today through March 10, 2016 and may be accessed by dialing
855-859-2056 from the United States or Canada or 800-585-8367 from other
international locations and referencing reservation number 35776523.
Additionally, you may access the live and subsequently archived webcast
of the conference call from the Investor Relations section of the
Company’s website at http://www.gtxinc.com .
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical
company dedicated to the discovery, development and commercialization of
small molecules for the treatment of cancer, including treatments for
breast and prostate cancer, and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon
GTx’s current expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements relating
to the enrollment and conduct of GTx’s ongoing Phase 2 proof-of-concept
clinical trial of enobosarm (GTx-024) to treat stress urinary
incontinence (SUI) and its Phase 2 clinical trials of enobosarm for the
treatment of advanced breast cancer, as well as the potential
preclinical and other future development of GTx’s licensed SARD
technology and the development of selective androgen receptor modulators
(SARMs) for the treatment of Duchenne muscular dystrophy (DMD) and the
timing thereof, including the anticipated identification of clinical
SARD candidates and the potential evaluation thereof in clinical
studies; the potential therapeutic applications for, and potential
benefits of SARM (including enobosarm) and SARD technology. GTx’s actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, the risks
(i) that GTx’s evaluation of the licensed SARD technology or a SARM for
the treatment of DMD are at very early stages and it is possible that
GTx may determine not to move forward with any meaningful development of
one or both programs; (ii) that if GTx determines to move forward with
additional development of enobosarm for the treatment of advanced breast
cancer or for the treatment of SUI or if GTx does determine to move
forward with meaningful development of its SARD program or a SARM for
the treatment of DMD, GTx will require additional funding, which it may
be unable to raise, in which case, GTx may fail to realize the
anticipated benefits from its SARM and/or SARD technology; (iii) that
GTx may not be successful in developing a clinical SARD product
candidate or a SARM for the treatment of DMD to advance into clinical
studies or the clinical product candidate may fail such clinical
studies; (iv) that the clinical trials of enobosarm to treat advanced
breast cancer or SUI being conducted by GTx may not be completed on
schedule, or at all, or may otherwise be suspended or terminated; (v)
related to the difficulty and uncertainty of pharmaceutical product
development, including the time and expense required to conduct
preclinical and clinical trials and analyze data, and the uncertainty of
preclinical and clinical success; and (vi) related to issues arising
during the uncertain and time-consuming regulatory process, including
the risk that GTx may not receive any approvals to advance the clinical
development of one or more potential clinical SARM or SARD candidates.
In addition, GTx will continue to need additional funding and may be
unable to raise capital when needed, which would force GTx to delay,
reduce or eliminate its product candidate development programs and
potentially cease operations. GTx’s actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties.
You should not place undue reliance on these forward-looking statements,
which apply only as of the date of this press release. GTx’s quarterly
report on Form 10-Q for the quarter ended September 30, 2015 contains
under the heading, "Risk Factors", a more comprehensive description of
these and other risks to which GTx is subject. GTx expressly disclaims
any obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to reflect
any change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements are
based.
GTx, Inc.
Condensed Balance Sheets
(in thousands, except share data)
December 31,
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2015 2014
--------------------------------------------------- ---------------------------------------------------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 14,056 $ 17,880
Short-term investments 15,200 31,415
Prepaid expenses and other current assets 2,633 856
-------------------- -------- -------------------- -------------------- -------- --------------------
Total current assets 31,889 50,151
Property and equipment, net 5 29
Intangible and other assets, net 137 471
-------------------- -------- -------------------- -------------------- -------- --------------------
Total assets $ 32,031 $ 50,651
==================== ======== ==================== ==================== ======== ====================
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 382 $ 512
Warrant liability 27,349 30,430
Accrued expenses and other current liabilities 2,441 1,850
-------------------- -------- -------------------- -------------------- -------- --------------------
Total current liabilities 30,172 32,792
Other long-term liabilities - 30
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.001 par value: 400,000,000 and 200,000,000 shares 141 140
authorized at December 31, 2015 and December 31, 2014, respectively;
140,374,112 and 140,325,643 shares issued and outstanding at
December 31, 2015 and December 31, 2014, respectively
Additional paid-in capital 515,192 512,460
Accumulated deficit (513,474 ) (494,771 )
-------------------- -------- -------------------- -------------------- -------- --------------------
Total stockholders’ equity 1,859 17,829
-------------------- -------- -------------------- -------------------- -------- --------------------
Total liabilities and stockholders’ equity $ 32,031 $ 50,651
==================== ======== ==================== ==================== ======== ====================
GTx, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
------------------------------------------------------------------------------------------------------------------------------------------------------ -----------------------------------------------------------------------------------------------------------------------------------------------------
2015 2014 2015 2014
------------------------------------------------------ ------------------------------------------------------ ------------------------------------------------------ -----------------------------------------------------
Expenses:
Research and development expenses $ 3,879 $ 3,254 $ 13,607 $ 20,870
General and administrative expenses 2,079 2,203 8,234 9,478
-------------------- ----------- -------------------- -------------------- ----------- -------------------- -------------------- ----------- -------------------- -------------------- ---------- --------------------
Total expenses 5,958 5,457 21,841 30,348
-------------------- ----------- -------------------- -------------------- ----------- -------------------- -------------------- ----------- -------------------- -------------------- ---------- --------------------
Loss from operations (5,958 ) (5,457 ) (21,841 ) (30,348 )
Other (expense) income, net (4 ) (284 ) 57 (259 )
Gain (loss) on change in fair value of warrant liability 2,729 (8,804 ) 3,081 (8,804 )
-------------------- ----------- -------------------- -------------------- ----------- -------------------- -------------------- ----------- -------------------- -------------------- ---------- --------------------
Net loss $ (3,233 ) $ (14,545 ) $ (18,703 ) $ (39,411 )
==================== =========== ==================== ==================== =========== ==================== ==================== =========== ==================== ==================== ========== ====================
Net loss per share:
Basic $ (0.02 ) $ (0.13 ) $ (0.13 ) $ (0.48 )
==================== =========== ==================== ==================== =========== ==================== ==================== =========== ==================== ==================== ========== ====================
Diluted $ (0.04 ) $ (0.13 ) $ (0.15 ) $ (0.48 )
==================== =========== ==================== ==================== =========== ==================== ==================== =========== ==================== ==================== ========== ====================
Weighted average shares outstanding:
Basic 140,374,112 108,869,121 140,364,684 81,807,706
==================== =========== ==================== ==================== =========== ==================== ==================== =========== ==================== ==================== ========== ====================
Diluted 149,529,197 108,869,121 147,774,040 81,807,706
==================== =========== ==================== ==================== =========== ==================== ==================== =========== ==================== ==================== ========== ====================
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SOURCE: GTx, Inc.
Investors:
GTx, Inc.
Lauren Crosby, 901-271-8622
lcrosby@gtxinc.com
or
Media:
Red House Consulting
Denise Powell, 510-703-9491
denise@redhousecomms.com
