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Share Name | Share Symbol | Market | Type |
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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 | |
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0.00 | 0.00% | 1.20 | 1.18 | 1.20 | 0 | 01:00:00 |
-- Clinically significant reduction in incontinence episodes outlined in preliminary results from ongoing Phase 2 proof-of-concept clinical trial in stress urinary incontinence --
-- Additional data from ongoing SUI clinical trial to be released in conjunction with podium presentation at International Continence Society meeting in September 2017 --
GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2017 and highlighted recent accomplishments and upcoming milestones.
During the quarter, GTx announced positive preliminary clinical data from an ongoing, open-label, Phase 2 proof-of-concept clinical trial of enobosarm in postmenopausal women with stress urinary incontinence (SUI). The Company also has continued to advance two additional R&D programs which are outlined below.
“We are impressed with the positive results in the first seven patients dosed in the SUI study. Stress urinary incontinence is a serious and often embarrassing condition which can have a significant negative impact on a patient’s quality of life. We are focused on potentially addressing this prevalent condition with a first-in-class, orally-administered therapy,” said Robert J. Wills, Ph.D., Executive Chairman of GTx.
Corporate Highlights and Anticipated Milestones
Enobosarm in Stress Urinary Incontinence: The Company has an ongoing Phase 2 proof-of-concept clinical trial of enobosarm 3 mg in postmenopausal women with SUI. This open-label, non-placebo controlled proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI.
Enobosarm in Breast Cancer:
The Company has an ongoing Phase 2 clinical trial of enobosarm in estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer.
The Company’s Phase 2 clinical trial of enobosarm in AR+ triple negative breast cancer completed the first stage of the two stage trial. Since there was insufficient CBR demonstrated among patients enrolled in the first stage of the trial, the Company has determined that the second and final stage of the trial will not continue.
Enobosarm in Duchenne muscular dystrophy (DMD): The Company has conducted preclinical studies evaluating SARMs in DMD. In preclinical models of DMD, GTx SARMs have increased body weight, lean mass and physical function.
SARDs in 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).
Second Quarter 2017 Financial Results
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions.
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 proof-of-concept clinical trial of enobosarm (GTx-024) to treat stress urinary incontinence (SUI) and its Phase 2 clinical trial of enobosarm for the treatment of advanced breast cancer, as well as GTx’s plans to initiate a Phase 2 placebo-controlled clinical trial of enobosarm to treat SUI and the potential preclinical and other future development of GTx’s licensed selective androgen receptor degrader (SARD) technology and 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 advanced breast cancer or for the treatment of SUI or if GTx does determine to move forward with meaningful development of its SARD program or a SARM for the treatment of DMD, 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 or a SARM for the treatment of DMD to advance into clinical studies or the clinical product candidate may fail such clinical studies; (iv) that the clinical trials of enobosarm to treat advanced breast cancer or SUI being conducted by GTx or the Phase 2 placebo-controlled clinical trial GTx plans to initiate may not be completed or initiated 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 June 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)
June 30, December 31, 2017 2016 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 5,156 $ 8,910 Short-term investments 6,200 12,959 Prepaid expenses and other current assets 2,130 2,429 Total current assets 13,486 24,298 Property and equipment, net 65 81 Intangible assets, net 116 123 Total assets $ 13,667 $ 24,502 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 603 $ 1,220 Accrued expenses and other current liabilities 4,582 3,391 Total current liabilities 5,185 4,611 Commitments and contingencies Stockholders’ equity: Common stock, $0.001 par value: 60,000,000 shares authorized at June 30, 2017 and December 31, 2016; 16,041,923 and 15,919,572 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively 16 16 Additional paid-in capital 552,322 551,073 Accumulated deficit (543,856 ) (531,198 ) Total stockholders’ equity 8,482 19,891 Total liabilities and stockholders’ equity $ 13,667 $ 24,502GTx, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended Six Months Ended June 30, June 30, 2017 2016 2017 2016 Expenses: Research and development expenses $ 4,448 $ 4,058 $ 8,641 $ 8,029 General and administrative expenses 1,997 1,999 4,084 4,113 Total expenses 6,445 6,057 12,725 12,142 Loss from operations (6,445 ) (6,057 ) (12,725 ) (12,142 ) Other income, net 40 5 67 33 Gain on change in fair value of warrant liability - - - 8,163 Net loss $ (6,405 ) $ (6,052 ) $ (12,658 ) $ (3,946 ) Net loss per share -- basic and diluted $ (0.40 ) $ (0.43 ) $ (0.79 ) $ (0.28 ) Weighted average shares outstanding: Basic and diluted 16,041,923 14,174,914 16,030,689 14,163,559
View source version on businesswire.com: http://www.businesswire.com/news/home/20170814005268/en/
Investors:GTx, Inc.Lauren Crosby, 901-271-8622lcrosby@gtxinc.comorMedia:Red House ConsultingDenise Powell, 510-703-9491denise@redhousecomms.com
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