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GTx Provides Corporate Update and Reports Second Quarter 2018 Financial Results

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-- 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 --

-- Updated results from Phase 2 proof-of-concept (POC) clinical trial
of enobosarm were presented at the 2018 American Urological Association
(AUA) meeting in May --

GTx, Inc. (NASDAQ:GTXI) today reported financial results for the second
quarter ended June 30, 2018 and highlighted recent accomplishments and
upcoming milestones.

"During the second quarter, we achieved a key milestone for the company
when we completed patient enrollment in our placebo-controlled, Phase 2
ASTRID Trial of enobosarm in postmenopausal women with stress urinary
incontinence (SUI)," said Robert J. Wills, Ph.D., Executive Chairman of
GTx. "Due to overwhelming interest from women wanting to participate in
the clinical trial, we completed enrollment several months ahead of
schedule and exceeded the 400 patients planned. We look forward to
reporting 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. Recent and upcoming
important milestones are summarized as follows:

  • 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.
  • On May 18, 2018, a podium presentation entitled "Oral Enobosarm Shows
    Promising Activity in Post-Menopausal Women with Stress Urinary
    Incontinence: Results of a Phase 2 Study," took place at the 2018
    American Urological Association (AUA) annual meeting. The presentation
    updated results from the Phase 2 POC clinical trial of enobosarm.
    Details of the AUA presentation can be found here
    and are summarized below:
    • At the end of the 12-week treatment period, all 18
      enobosarm-treated women showed 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.
    • 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.
  • The ASTRID Trial protocol includes a four-month, off-drug durability
    assessment in the first 225 patients enrolled. These data will be
    announced simultaneously with the ASTRID results. Once the 225-patient
    cohort completes the four-month, off-drug durability assessment, those
    patients will have, at their discretion, the option to enter an
    additional five-month, off-drug extension study to provide a total of
    nine months of off-drug durability assessment.
  • The Company also has initiated an open-label safety extension study.
    Each participating patient will receive 3 mg of oral enobosarm on a
    daily basis.

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.

Second Quarter 2018 Financial Results

  • As of June 30, 2018, cash and short-term investments were $45.7
    million compared to $43.9 million at December 31, 2017.
  • Research and development expenses for the quarter ended June 30, 2018
    were $8.0 million compared to $4.4 million for the same period of 2017.
  • General and administrative expenses for the quarter ended June 30,
    2018 were $2.2 million compared to $2.0 million for the same period of
    2017.
  • The net loss for the quarter ended June 30, 2018 was $10.0 million
    compared to a net loss of $6.4 million for the same period in 2017.
  • Net loss for the six months ended June 30, 2018 was $23.6 million
    compared to a net loss of $12.7 million for the same period in 2017.
  • GTx had approximately 24.0 million shares of common stock outstanding
    as of June 30, 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 that was
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) 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 27 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 quarterly report on Form 10-Q for the period ended
March 31, 2018, 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,
2018 2017
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 16,511 $ 15,816
Short-term investments 29,205 28,083
Prepaid expenses and other current assets   1,864     2,178  
Total current assets 47,580 46,077
Property and equipment, net 35 51
Intangible assets, net   101     108  
Total assets $ 47,716   $ 46,236  
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,473 $ 2,604
Accrued expenses and other current liabilities   6,404     5,371  
Total current liabilities 7,877 7,975
Commitments and contingencies
Stockholders' equity:
Common stock, $0.001 par value: 60,000,000 shares authorized at June
30, 2018 and December 31, 2017; 24,031,191 and 21,541,909 shares
issued and outstanding at June 30, 2018 and December 31, 2017,
respectively
24 22
Additional paid-in capital 625,024 599,876
Accumulated deficit   (585,209 )   (561,637 )
Total stockholders' equity   39,839     38,261  
Total liabilities and stockholders' equity $ 47,716   $ 46,236  
 
   

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,
2018   2017 2018   2017
 
Expenses:
Research and development expenses $ 7,962 $ 4,448 $ 18,962 $ 8,641
General and administrative expenses   2,196     1,997     4,884     4,084  
Total expenses   10,158     6,445     23,846     12,725  
Loss from operations (10,158 ) (6,445 ) (23,846 ) (12,725 )
Other income, net   143     40     274     67  
Net loss $ (10,015 ) $ (6,405 ) $ (23,572 ) $ (12,658 )
 
 
Net loss per share -- basic and diluted $ (0.43 ) $ (0.40 ) $ (1.04 ) $ (0.79 )
 
Weighted average shares outstanding:
Basic and diluted   23,288,691     16,041,923     22,623,601     16,030,689  

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