GTx Reports Third Quarter 2018 Financial Results and Provides Corporate Update
“During the quarter, we turned our focus to the ongoing selective androgen receptor degrader program and the potential of our novel selective androgen receptor degrader to treat castration-resistant prostate cancer. We expect to select the most appropriate development compounds by year-end, which we plan to take into IND-enabling studies next year,” said Robert J. Wills, Ph.D., Executive Chairman of GTx. “Additionally, we are exploring other strategic options for the company with the goal of optimizing the full potential of our development pipeline.”
Corporate Development Update
Selective Androgen Receptor Degrader (SARD): Prostate Cancer
The Company has an ongoing preclinical program to evaluate its novel selective androgen receptor degrader (SARD) technology in castration-resistant prostate cancer (CRPC). In some men with CRPC, current prostate cancer therapy is not effective or subject to emerging resistance. The Company believes that its SARDs may be first-in-class dual-interacting androgen receptor (AR) antagonists and degraders, and may therefore potentially treat CRPC in men who are non-responsive to current androgen targeted therapies. Going forward, the Company plans to:
- Complete ongoing mechanistic preclinical studies by year-end or early in the first quarter of 2019;
- Select the most appropriate SARD compounds to move forward with IND-enabling studies in 2019; and
- Potentially advance one of its SARD compounds into a first-in-human clinical trial in 2020
Selective Androgen Receptor Modulator (SARM): Stress Urinary Incontinence (SUI), Breast Cancer
SUI: Enobosarm, a SARM, was evaluated in post-menopausal women with SUI compared to placebo. During the quarter, the Company announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with SUI, did not achieve statistical significance on the primary endpoint for the trial. Enobosarm was generally safe and well tolerated, and reported adverse events were minimal and similar across all treatment groups. The Company is conducting a comprehensive review of all the ASTRID data and is consulting with key experts to fully understand the study outcomes.
Advanced Breast Cancer: Enobosarm was also evaluated as a hormonal therapy for women with estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer in a Phase 2 clinical trial. The trial met the primary efficacy endpoint in the trial; there are three women in the study who continue to respond to treatment after almost two years on enobosarm (two have stable disease, one now has a partial response). Approximately one year ago, the Company determined that treatment paradigms had shifted to immunotherapies and/or combination therapies, and that it was no longer feasible for GTx to conduct further development of enobosarm in breast cancer.
Enobosarm has been evaluated in more than two dozen clinical trials enrolling over 2,200 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.
Third Quarter 2018 Financial Results
September 30, 2018, cash and short-term investments were $38.1 millioncompared to $43.9 millionat December 31, 2017.
Research and development expenses for the quarter ended
September 30, 2018were $7.5 millioncompared to $5.9 millionfor the same period of 2017.
General and administrative expenses for the quarter ended
September 30, 2018were $2.2 millioncompared to $2.6 millionfor the same period of 2017.
The net loss for the quarter ended
September 30, 2018was $9.4 millioncompared to a net loss of $8.5 millionfor the same period in 2017.
Net loss for the nine months ended
September 30, 2018was $33.0 millioncompared to a net loss of $21.2 millionfor the same period in 2017.
GTx had approximately 24.1 million shares of common stock outstanding
September 30, 2018. Additionally, there are warrants outstanding to purchase approximately 5.3 million shares of GTx common stock at an exercise price of $8.50per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon
GTx’s current expectations. Forward-looking statements involve risks and
uncertainties, and include, but are not limited to, statements relating
to GTx’s ongoing preclinical development of its selective androgen
receptor degrader (SARD) technology; GTx’s plans to move forward with
IND-enabling studies for its SARD technology and to potentially advance
one of its SARD compounds into a first-in-human clinical trial, and the
anticipated timing of such activities; statements related to the
therapeutic potential of GTx’s SARD technology, including to potentially
treat CRPC in men who are non-responsive to current androgen targeted
therapies; and statements related to optimizing the full potential of
GTx’s development pipeline. GTx’s actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties,
which include, without limitation, the risks (i) that the SARDs
preclinical research being conducted and planned to be conducted by GTx
may not be completed on schedule or at all; (ii) that additional
preclinical development of GTx’s SARD compound will be required beyond
anticipated IND-enabling studies, whether to enable the submission of an
IND application to the
Condensed Balance Sheets
(in thousands, except share data)
|September 30,||December 31,|
|Cash and cash equivalents||$||23,089||$||15,816|
|Prepaid expenses and other current assets||2,071||2,178|
|Total current assets||40,144||46,077|
|Property and equipment, net||28||51|
|Intangible assets, net||97||108|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||6,184||5,371|
|Total current liabilities||9,305||7,975|
|Commitments and contingencies|
|Common stock, $0.001 par value: 60,000,000 shares authorized at September 30, 2018 and December 31, 2017; 24,051,844 and 21,541,909 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively||24||22|
|Additional paid-in capital||625,580||599,876|
|Total stockholders’ equity||30,964||38,261|
|Total liabilities and stockholders’ equity||$||40,269||$||46,236|
Condensed Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development expenses||$||7,467||$||5,914||$||26,429||$||14,555|
|General and administrative expenses||2,160||2,617||7,044||6,701|
|Loss from operations||(9,627||)||(8,531||)||(33,473||)||(21,256||)|
|Other income, net||196||27||470||94|
|Net loss per share -- basic and diluted||$||(0.39||)||$||(0.53||)||$||(1.43||)||$||(1.32||)|
|Weighted average shares outstanding:|
|Basic and diluted||24,045,992||16,115,835||23,108,442||16,059,383|
Red House Consulting
Denise Powell, 510-703-9491