-- Completed patient enrollment in the ASTRID
Trial, a Phase 2 double-blinded, placebo-controlled clinical trial
of enobosarm in Stress Urinary Incontinence --
-- Top-line results from the ASTRID Trial
expected early in the fourth quarter of 2018 --
-- Podium presentation at the 2018 American
Urological Association (AUA) meeting May 18, 2018, will update
results from Phase 2 proof-of-concept clinical trial of enobosarm
--
GTx, Inc. (Nasdaq:GTXI) today reported financial results for the
first quarter ended March 31, 2018 and highlighted recent
accomplishments and upcoming milestones.
“GTx is off to a strong start in 2018, with data presented at
the SUFU Meeting in March supporting enobosarm’s potential to treat
stress urinary incontinence (SUI). The data included additional
positive results in a subset of women with both SUI and urge
incontinence,” said Robert J. Wills, Ph.D., Executive Chairman of
GTx. “We look forward to presenting additional data from our
open-label, Phase 2 proof-of-concept clinical trial evaluating
enobosarm 3 mg in postmenopausal women with SUI at the upcoming AUA
meeting in May. In addition, we completed patient enrollment in our
placebo-controlled, Phase 2 clinical trial of enobosarm in
postmenopausal women with SUI several months ahead of schedule.
Enrollment exceeded the 400 patients planned per protocol, and we
are eager to report top-line results early in the fourth quarter of
2018.”
Clinical Highlights and Anticipated Milestones
Stress Urinary Incontinence
(SUI):
Enobosarm, a Selective Androgen Receptor Modulator (SARM), is
being evaluated in Phase 2 clinical development for SUI, the
Company’s lead indication. Recent and upcoming important milestones
are summarized as follows:
- At the Society of Urodynamics, Female
Pelvic Medicine, & Urogenital Reconstruction (SUFU) Meeting in
March, positive results were presented from the Company’s Phase 2
proof-of-concept (POC) clinical trial of enobosarm 3 mg
administered orally in post-menopausal women with SUI. Details of
the SUFU presentation can be found here and are summarized below:
- At the end of the 12-week treatment
period, all 18 enobosarm-treated women demonstrated clinically
meaningful (50 percent or greater) reductions in stress urinary
incontinence episodes per day, compared to baseline.
- The reduction in incontinence episodes
was sustained, or durable, well beyond the 12-week treatment
period.
- Additional positive results in a subset
of postmenopausal women suggest a dual treatment effect on both SUI
and urge incontinence (UI).
- Magnetic resonance imaging (MRI)
results showed a statistically significant increase in several
important measurements and support the mechanism of action of
enobosarm on the pelvic floor.
- There were no serious adverse events
reported and reported adverse events were minimal and included
headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness
and acne. Mild transient elevations in liver enzymes that were
within normal limits were observed, except for one patient with
levels greater than 1.5 times the upper limit of normal which
returned to normal following her 12-week treatment period.
Reductions in total cholesterol, LDL-C, HDL-C and triglycerides
were also observed.
- On May 18, 2018, a podium presentation
at the 2018 American Urological Association (AUA) meeting will
update results from the Phase 2 POC clinical trial of
enobosarm.
- The Company has an ongoing randomized,
double-blinded, placebo-controlled, Phase 2 trial to assess the
efficacy and safety of enobosarm administered orally in
post-menopausal women with SUI compared to placebo. More
information about the ASTRID (Assessing Enobosarm for Stress
Urinary Incontinence Disorder) trial can be found here.
- In April, the Company completed patient
enrollment in the ASTRID trial several months ahead of schedule,
enrolling 493 women at over 60 clinical trial centers across the
United States. Top-line results are expected early in the fourth
quarter of 2018.
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 mechanistic preclinical studies designed to select the most
appropriate compound to potentially advance into a first-in-human
clinical trial.
First Quarter 2018 Financial Results
- As of March 31, 2018, cash and
short-term investments were $32.1 million compared to $43.9 million
at December 31, 2017.
- Research and development expenses for
the quarter ended March 31, 2018 were $11.0 million compared to
$4.2 million for the same period of 2017.
- General and administrative expenses for
the quarter ended March 31, 2018 were $2.7 million compared to $2.1
million for the same period of 2017.
- The net loss for the quarter ended
March 31, 2018 was $13.6 million compared to a net loss of $6.3
million for the same period in 2017.
- GTx had approximately 22.5 million
shares of common stock outstanding as of March 31, 2018.
Additionally, there are warrants outstanding to purchase
approximately 5.3 million shares of GTx common stock at an exercise
price of $8.50 per share and approximately 3.3 million shares of
GTx common stock at an exercise price of $9.02.
About the Phase 2 Proof-of-Concept Clinical Trial
The single-arm, open-label Phase 2 clinical trial is evaluating
enobosarm in postmenopausal women with SUI, and is the first
clinical trial to evaluate an orally-administered selective
androgen receptor modulator (SARM) for SUI. This clinical trial is
closed to enrollment; more information about the clinical trial can
be found here.
About the Phase 2 ASTRID Clinical Trial
In addition to the Phase 2 proof-of-concept clinical trial being
presented at AUA, GTx also has a larger, ongoing,
placebo-controlled Phase 2 clinical trial evaluating enobosarm in
postmenopausal women with SUI. The study, called ASTRID
(Assessing Enobosarm for Stress Urinary
Incontinence Disorder), completed enrollment (n=493)
recently and is being conducted at over 60 clinical trial centers
across the United States. Top-line results are expected early
in the fourth quarter of this year. More information about the
ASTRID clinical trial can be found here.
About Enobosarm and SUI
Enobosarm (GTx-024), a selective androgen receptor modulator
(SARM), has been evaluated in 25 completed or ongoing clinical
trials enrolling over 2,100 subjects, in which approximately 1,500
subjects were treated with enobosarm at doses ranging from 0.1 mg
to 100 mg. At all evaluated dose levels, enobosarm was observed to
be generally safe and well tolerated. The rationale for evaluating
enobosarm as a treatment for SUI is supported by
preclinical in vivo data demonstrating increases in
pelvic floor muscle mass following treatment with GTx’s SARM
compounds, including enobosarm, and the proof-of-concept Phase 2
clinical trial of enobosarm 3 mg for the treatment of
postmenopausal women with SUI.
About Stress Urinary Incontinence
Stress urinary incontinence (SUI) refers to the unintentional
leakage of urine during activities that increase abdominal pressure
such as coughing, sneezing or physical exercise. SUI, the most
common type of incontinence suffered by women, affects up to 35
percent of adult women. There are a variety of treatments that are
used to treat SUI in women, such as behavioral modification and
pelvic floor physical therapy, especially as initial treatment
options. As the condition worsens however, bulking agents and
surgical procedures are often the most widely used treatments.
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a
biopharmaceutical company dedicated to the discovery, development
and commercialization of medicines to treat serious and/or
significant unmet medical conditions, including stress urinary
incontinence and prostate cancer.
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 GTx's ongoing clinical development of its
selective androgen receptor modulator (SARM) compounds. 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 the Phase 2 placebo-controlled
clinical study being conducted by GTx for the treatment of stress
urinary incontinence (SUI) may not be completed on schedule; (ii)
that additional clinical development of GTx’s SARM compound for the
treatment of SUI will be required beyond the ongoing study; and
(iii) any future development of SARMs in SUI is contingent on
obtaining sufficient additional capital to permit such development,
which it may be unable to do. 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 annual
report on Form 10-K for the year ended December 31, 2017, 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)
March 31, December 31, 2018 2017
(unaudited) ASSETS Current assets: Cash and cash
equivalents $ 14,958 $ 15,816 Short-term investments 17,186 28,083
Prepaid expenses and other current assets 2,067
2,178 Total current assets 34,211 46,077 Property and
equipment, net 43 51 Intangible assets, net 105
108 Total assets $ 34,359 $ 46,236
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable $ 1,739 $ 2,604 Accrued expenses and other current
liabilities 7,871 5,371 Total current
liabilities 9,610 7,975 Commitments and contingencies Stockholders’
equity: Common stock, $0.001 par value: 60,000,000 shares
authorized at March 31, 2018 and December 31, 2017; 22,529,690 and
21,541,909 shares issued and outstanding at March 31, 2018 and
December 31, 2017, respectively 23 22 Additional paid-in capital
599,920 599,876 Accumulated deficit (575,194 )
(561,637 ) Total stockholders’ equity 24,749
38,261 Total liabilities and stockholders’ equity $ 34,359
$ 46,236
GTx, Inc.
Condensed Statements of
Operations
(in thousands, except share and per
share data)
(unaudited)
Three Months Ended March 31, 2018
2017 Expenses: Research and development
expenses $ 11,000 $ 4,193 General and administrative expenses
2,688 2,087 Total expenses
13,688 6,280 Loss from operations (13,688 )
(6,280 ) Other income, net 131 27 Net
loss $ (13,557 ) $ (6,253 ) Net loss per share --
basic and diluted $ (0.62 ) $ (0.39 ) Weighted
average shares outstanding -- basic and diluted 21,967,805
16,018,342
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version on businesswire.com: https://www.businesswire.com/news/home/20180515005119/en/
GTx, Inc.Investors:Argot PartnersKimberly Minarovich or
Sam Martin212-600-1902orMedia:Red House ConsultingDenise
Powell, 510-703-9491denise@redhousecomms.com
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