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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Gtx, Inc. | NASDAQ:GTXI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.20 | 1.18 | 1.20 | 0 | 01:00:00 |
-- Positive results achieved in all patients after 12-week treatment in the enobosarm Phase 2 proof-of-concept clinical trial in women with stress urinary incontinence (SUI) --
-- Enobosarm Phase 2 proof-of-concept clinical trial for SUI continues to show sustained durability of response --
-- Initiated ASTRID study, a Phase 2 placebo-controlled clinical trial of orally-administered enobosarm for the treatment of SUI --
-- Closed private placement with $45.6 million in net proceeds --
GTx, Inc. (Nasdaq:GTXI) today reported financial results for the third quarter of 2017 and highlighted recent accomplishments and upcoming milestones.
“During the quarter, we achieved a key milestone for the company when we reported positive results from our first clinical trial in stress urinary incontinence,” said Robert J. Wills, Ph.D., Executive Chairman of GTx. “Remarkably, 18 out of 18 women who received enobosarm for 12 weeks responded. These responses also appear to be durable, lasting months after dosing. These exciting results provided the basis for our recently initiated, placebo-controlled clinical trial of enobosarm for the treatment of SUI.”
“Recent data suggests 50 percent of women report SUI, for which there are no FDA-approved pharmaceutical therapies. An orally-available therapy would offer numerous advantages over existing treatments including surgery, and would provide a significant new option that many women would choose in order to address this medical condition,” said Kenneth M. Peters, M.D., Chairman of Urology, Oakland University William Beaumont School of Medicine and the principal investigator in the trial.
Third Quarter 2017 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 important milestones are summarized as follows:
Breast Cancer:
Enobosarm is also being 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 for this advanced breast cancer population. As reported earlier for the 9 mg cohort, the Phase 2 trial pre-specified threshold for success, clinical benefit response (CBR), was attained and therefore met the primary efficacy endpoint. In addition, the 18 mg cohort has also met the primary efficacy endpoint. The trial has now completed enrollment of the predefined number of evaluable patients in both dosage arms with at least 44 patients in each of two cohorts receiving 9 mg or 18 mg daily doses of enobosarm.
Duchenne Muscular Dystrophy (DMD):
SARMs have also been evaluated in preclinical models of DMD, in which GTx SARMs have increased lean muscle 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.
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 advance into a first-in-human clinical trial.
Third Quarter 2017 Corporate Highlights and Financial Results
About GTx
GTx is a biopharmaceutical company dedicated to the discovery, development and commercialization of medicines to treat serious 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 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, as well as 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 SUI or if GTx does determine to move forward with development of its SARD program or a SARM, 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 quarterly report on Form 10-Q for the quarter ending September 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)
September 30, December 31, 2017 2016 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 53,431 $ 8,910 Short-term investments 200 12,959 Prepaid expenses and other current assets 2,049 2,429 Total current assets 55,680 24,298 Property and equipment, net 57 81 Intangible assets, net 112 123 Total assets $ 55,849 $ 24,502 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 2,451 $ 1,220 Accrued expenses and other current liabilities 6,828 3,391 Total current liabilities 9,279 4,611 Commitments and contingencies Stockholders’ equity: Common stock, $0.001 par value: 60,000,000 shares authorized at September 30, 2017 and December 31, 2016; 21,541,909 and 15,919,572 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively 22 16 Additional paid-in capital 598,908 551,073 Accumulated deficit (552,360 ) (531,198 ) Total stockholders’ equity 46,570 19,891 Total liabilities and stockholders’ equity $ 55,849 $ 24,502GTx, Inc.Condensed Statements of Operations(in thousands, except share and per share data)(unaudited)
Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Expenses: Research and development expenses $ 5,914 $ 4,614 $ 14,555 $ 12,643 General and administrative expenses 2,617 2,313 6,701 6,426 Total expenses 8,531 6,927 21,256 19,069 Loss from operations (8,531 ) (6,927 ) (21,256 ) (19,069 ) Other income, net 27 13 94 46 Gain on change in fair value of warrant liability - - - 8,163 Net loss $ (8,504 ) $ (6,914 ) $ (21,162 ) $ (10,860 ) Net loss per share -- basic and diluted $ (0.53 ) $ (0.49 ) $ (1.32 ) $ (0.77 ) Weighted average shares outstanding: Basic and diluted 16,115,835 14,189,226 16,059,383 14,172,177
View source version on businesswire.com: http://www.businesswire.com/news/home/20171114006551/en/
Investors:Argot PartnersKimberly Minarovich or Sam Martin, 212-600-1902orMedia:Red House ConsultingDenise Powell, 510-703-9491denise@redhousecomms.com
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