Track topics on Twitter Track topics that are important to you
-- Top-line results from the ASTRID trial, a Phase 2 placebo-controlled clinical trial of enobosarm for the treatment of SUI, are expected in the second half of 2018 --
GTx, Inc. (Nasdaq:GTXI) today reported financial results for the fourth quarter and year ended December 31, 2017 and highlighted recent accomplishments and upcoming milestones.
“2017 was a transformational year for GTx, marked by positive results from our Phase 2 proof-of-concept clinical trial in post-menopausal women with stress urinary incontinence and the initiation of the ASTRID trial, a Phase 2 placebo-controlled clinical trial of enobosarm for the treatment of SUI,” said Robert J. Wills, Ph.D., Executive Chairman of GTx. “We believe that there is a significant opportunity for an effective oral therapy to treat SUI and look forward to results from the ASTRID trial in the second half of 2018.”
Clinical Highlights and Anticipated Milestones
Stress Urinary Incontinence (SUI) Phase 2 Proof-of-Concept Trial:
Last week at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction (SUFU) Meeting and at the International Continence Society (ICS) annual meeting in 2017, 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. The results, including additional positive results presented at SUFU in a subset of women with both urge and stress incontinence, are summarized as follows:
At the end of the 12-week treatment period, all of the 18 enobosarm-treated women showed a clinically meaningful reduction in stress urinary incontinence episodes per day (the primary endpoint of the trial).
The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period.
Additional positive results in subset of postmenopausal women suggest dual treatment effect on both urge incontinence and stress urinary incontinence.
While all of the women in the trial had predominant SUI, some also experienced urge incontinence (UI). Eleven of the 18 women completing 12 weeks of treatment were determined to have both SUI and UI at baseline, also known as mixed incontinence.
Magnetic resonance imaging (MRI) was used to quantitatively measure muscle in the pelvic floor of 17 women at 12 weeks compared to their baseline. The 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 during the trial 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.
SUI Phase 2 Placebo-Controlled ASTRID Clinical Trial:
Based on the positive results from the Phase 2 POC trial, the Company initiated a randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of enobosarm administered orally in approximately 400 post-menopausal women with SUI compared to placebo. More information about the ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder) trial, which is ongoing, can be found here. Top-line results from the Phase 2 placebo-controlled clinical trial are expected in the second half of 2018.
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.
Fourth Quarter and Year-End 2017 Financial Results
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 SUI and prostate cancer. For more information, please visit http://www.gtxinc.com.
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 placebo-controlled clinical trial of enobosarm (GTx-024) in post-menopausal women with stress urinary incontinence (SUI), as well as GTx’s plans for its ongoing preclinical research and potential future development of GTx’s licensed selective androgen receptor degrader (SARD) technology, 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 is at a very early stage and it is possible that GTx may determine not to move forward with any meaningful development of the program; (ii) that if GTx determines to move forward with additional development of enobosarm for the treatment of SUI or if GTx does determine to move forward with development of its SARD program, 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 to advance into clinical studies or the clinical product candidate may fail such clinical studies; (iv) that the Phase 2 placebo-controlled clinical trial of enobosarm to treat 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 annual report on Form 10-K for the year ending December 31, 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.
Condensed Balance Sheets
(in thousands, except share data)
|Cash and cash equivalents||$||15,816||$||8,910|
|Prepaid expenses and other current assets||2,178||2,429|
|Total current assets||46,077||24,298|
|Property and equipment, net||51||81|
|Intangible assets, net||108||123|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued expenses and other current liabilities||5,371||3,391|
|Total current liabilities||7,975||4,611|
|Commitments and contingencies|
|Common stock, $0.001 par value: 60,000,000 shares authorized at December 31, 2017 and December 31, 2016; 21,541,909 and 15,919,572 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively||22||16|
|Additional paid-in capital||599,876||551,073|
|Total stockholders’ equity||38,261||19,891|
|Total liabilities and stockholders’ equity||$||46,236||$||24,502|
Condensed Statements of Operations
(in thousands, except share and per share data)
|Three Months Ended||Year Ended|
|December 31,||December 31,|
|Research and development expenses||$||6,912||$||4,585||$||21,467||$||17,228|
|General and administrative expenses||2,487||2,279||9,188||8,705|
|Loss from operations||(9,399||)||(6,864||)||(30,655||)||(25,933||)|
|Other income, net||122||-||216||46|
|Gain on change in fair value of warrant liability||-||-||-||8,163|
|Net loss per share -- basic and diluted:||$||(0.43||)||$||(0.44||)||$||(1.75||)||$||(1.22||)|
Weighted average shares outstanding -- basic and diluted:
Kimberly Minarovich or Sam Martin
Red House Consulting
Denise Powell, 510-703-9491
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...