-- Clinically significant reduction in
incontinence episodes outlined in preliminary results from ongoing
Phase 2 proof-of-concept clinical trial in stress urinary
incontinence --
-- Additional data from ongoing SUI clinical
trial to be released in conjunction with podium presentation at
International Continence Society meeting in September 2017 --
GTx, Inc. (Nasdaq: GTXI) today reported financial results for
the second quarter of 2017 and highlighted recent accomplishments
and upcoming milestones.
During the quarter, GTx announced positive preliminary clinical
data from an ongoing, open-label, Phase 2 proof-of-concept clinical
trial of enobosarm in postmenopausal women with stress urinary
incontinence (SUI). The Company also has continued to advance two
additional R&D programs which are outlined below.
“We are impressed with the positive results in the first seven
patients dosed in the SUI study. Stress urinary incontinence is a
serious and often embarrassing condition which can have a
significant negative impact on a patient’s quality of life. We are
focused on potentially addressing this prevalent condition with a
first-in-class, orally-administered therapy,” said Robert J. Wills,
Ph.D., Executive Chairman of GTx.
Corporate Highlights and Anticipated Milestones
Enobosarm in Stress Urinary Incontinence: The Company has
an ongoing Phase 2 proof-of-concept clinical trial of enobosarm 3
mg in postmenopausal women with SUI. This open-label, non-placebo
controlled proof-of-concept clinical trial is the first of its kind
to evaluate an orally-administered selective androgen receptor
modulator (SARM) for SUI.
- In June 2017, the Company announced
preliminary results from the first seven women in the ongoing
trial, in which all of the women treated with enobosarm showed a
clinically significant reduction (50 percent or greater) in
incontinence episodes per day, as measured by mean stress leaks
from baseline to week 12 of the trial.
- Mean stress leaks decreased by 80.9
percent overall; stress leaks dropped from 5.7 to 1.1 leaks per
day.
- These results, as well as data from
additional patients, will be presented at the International
Continence Society (ICS) annual meeting in September 2017. The
results from the first seven patients can be found here.
- Encouraged by the results to date from
its SUI proof-of-concept clinical trial, the Company is planning to
initiate in the second half of 2017 a randomized, double-blinded
Phase 2 clinical trial to assess the efficacy and safety of two
doses of enobosarm (3 mg and 1 mg) per day against placebo with the
expectation that top-line data from this trial will be available by
the end of 2018.
Enobosarm in Breast Cancer:
The Company has an ongoing Phase 2 clinical trial of enobosarm
in estrogen receptor positive (ER+) and androgen receptor positive
(AR+) breast cancer.
- The Company reported in November 2016
that the pre-specified threshold for success of the trial was
already attained in the 9 mg cohort, with nine patients achieving a
clinical benefit response (CBR) at 24 weeks among the first 22
evaluable patients in that cohort.
- CBR is defined as a complete response,
partial response or stable disease, as measured by Response
Evaluation Criteria in Solid Tumors (RECIST) at 24 weeks of
treatment.
- The Phase 2 clinical trial is fully
enrolled with at least 44 evaluable patients enrolled in each of
the 9 mg and 18 mg cohorts of the trial, and the Company expects to
report top-line results in the third quarter of 2017.
- The independent Safety Monitoring
Committee established to monitor the safety of this clinical trial
met on August 11, 2017, and recommended that the trial continue as
planned.
The Company’s Phase 2 clinical trial of enobosarm in AR+ triple
negative breast cancer completed the first stage of the two stage
trial. Since there was insufficient CBR demonstrated among patients
enrolled in the first stage of the trial, the Company has
determined that the second and final stage of the trial will not
continue.
- One patient who achieved stable disease
remains on study for approximately 10 months from the initiation of
treatment.
Enobosarm in Duchenne muscular dystrophy (DMD): The
Company has conducted preclinical studies evaluating SARMs in DMD.
In preclinical models of DMD, GTx SARMs have increased body weight,
lean mass and physical function.
- The Company is pursuing a potential
strategic collaboration with biopharma companies experienced in
orphan drug development to continue the development of a SARM for
the treatment of DMD.
SARDs in Prostate Cancer: The Company has a Selective
Androgen Receptor Degrader (SARD) preclinical program to evaluate
its novel SARD technology in castration-resistant prostate cancer
(CRPC).
- The Company has ongoing preclinical
studies to select the most appropriate compound to advance into a
first-in-human clinical trial.
Second Quarter 2017 Financial Results
- As of June 30, 2017, cash and
short-term investments were $11.4 million compared to $21.9 million
at December 31, 2016. On August 10, 2017, the Company entered into
a loan agreement (the “Loan Agreement”) with J.R. Hyde, III, the
largest shareholder of the Company and its Lead Director of its
Board of Directors, and The Pyramid Peak Foundation, another large
shareholder of the Company, (the “Lenders”) for the Lenders to make
available to the Company from time to time during the term of the
Loan Agreement up to $15 million at an interest rate of 8% per
annum (the “Loan”). The term of the Loan Agreement is for a period
of nine (9) months and is unsecured. The Lenders have agreed that
they will participate in any “qualified” financing (defined as the
sale of equity by the Company during the term of the Loan Agreement
which equals or exceeds $15 million) at least to the extent of any
outstanding indebtedness under the Loan.
- Research and development expenses for
the quarter ended June 30, 2017 were $4.4 million compared to $4.1
million for the same period of 2016.
- General and administrative expenses
were $2.0 million for both the quarter ended June 30, 2017 and June
30, 2016.
- Net loss for the quarter ended June 30,
2017 was $6.4 million compared to a net loss of $6.1 million for
the same period in 2016.
- Net loss for the six months ended June
30, 2017 was $12.7 million compared to a net loss of $3.9 million
for the same period in 2016. The six months ended June 30, 2016
included a non-cash gain of $8.2 million due to the change in fair
value of the Company’s warrant liability, recorded in the first
quarter of 2016. During the first quarter of 2016, the Company
modified its outstanding warrants with no further adjustment to the
fair value of these warrants being required.
- GTx had approximately 16 million shares
of common stock outstanding as of June 30, 2017. Additionally,
there remain warrants outstanding to purchase approximately 6.4
million shares of GTx common stock at an exercise price of $8.50
per share.
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
trial of enobosarm for the treatment of advanced breast cancer, as
well as GTx’s plans to initiate a Phase 2 placebo-controlled
clinical trial of enobosarm to treat SUI and the potential
preclinical and other future development of GTx’s licensed
selective androgen receptor degrader (SARD) technology and the
development of selective androgen receptor modulators (SARMs) for
the treatment of Duchenne muscular dystrophy (DMD) and the timing
thereof; and 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
its 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 or the Phase 2 placebo-controlled clinical trial GTx plans to
initiate may not be completed or initiated 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 ending June 30, 2017, which is
being filed subsequent to this release, 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)
June 30, December 31, 2017 2016
(unaudited) ASSETS Current assets: Cash and cash
equivalents $ 5,156 $ 8,910 Short-term investments 6,200 12,959
Prepaid expenses and other current assets 2,130
2,429 Total current assets 13,486 24,298 Property and
equipment, net 65 81 Intangible assets, net 116
123 Total assets $ 13,667 $ 24,502
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable $ 603 $ 1,220 Accrued expenses and other current
liabilities 4,582 3,391 Total current
liabilities 5,185 4,611 Commitments and contingencies Stockholders’
equity: Common stock, $0.001 par value: 60,000,000 shares
authorized at June 30, 2017 and December 31, 2016; 16,041,923 and
15,919,572 shares issued and outstanding at June 30, 2017 and
December 31, 2016, respectively 16 16 Additional paid-in capital
552,322 551,073 Accumulated deficit (543,856 )
(531,198 ) Total stockholders’ equity 8,482
19,891 Total liabilities and stockholders’ equity $ 13,667
$ 24,502
GTx, Inc.
Condensed Statements of
Operations
(in thousands, except share and per
share data)
(unaudited)
Three Months Ended Six Months Ended June
30, June 30, 2017 2016
2017 2016 Expenses: Research and
development expenses $ 4,448 $ 4,058 $ 8,641 $ 8,029 General and
administrative expenses 1,997 1,999
4,084 4,113 Total expenses 6,445
6,057 12,725 12,142
Loss from operations (6,445 ) (6,057 ) (12,725 ) (12,142 )
Other income, net 40 5 67 33 Gain on change in fair value of
warrant liability - - -
8,163 Net loss $ (6,405 ) $ (6,052 ) $ (12,658 ) $
(3,946 ) Net loss per share -- basic and diluted $
(0.40 ) $ (0.43 ) $ (0.79 ) $ (0.28 ) Weighted average
shares outstanding: Basic and diluted 16,041,923
14,174,914 16,030,689 14,163,559
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version on businesswire.com: http://www.businesswire.com/news/home/20170814005268/en/
Investors:GTx, Inc.Lauren Crosby,
901-271-8622lcrosby@gtxinc.comorMedia:Red House ConsultingDenise
Powell, 510-703-9491denise@redhousecomms.com
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