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GTx Provides Corporate Update and Reports Fourth Quarter and Year-End 2014 Financial ResultsGTx, Inc. (Nasdaq: GTXI) today reported financial results for the fourth quarter and year ended December 31, 2014, and highlighted recent accomplishments and upcoming milestones. The Company remains focused on targeting the androgen receptor in women with advanced breast cancer using enobosarm, the Company's oral nonsteroidal selective androgen receptor modulator. The Company also highlighted clinical progress with GTx-758, its oral nonsteroidal selective estrogen receptor alpha agonist, being studied for secondary hormonal therapy in men with castration resistant prostate cancer. "We are pleased to now be working with Rob Wills, our new Executive Chairman, an industry executive with solid operational experience, to help us execute on our business objectives," said Marc S. Hanover, CEO of GTx. "Initiating and enrolling our two new breast cancer trials is of utmost importance to our Company as we remain dedicated to treating women with advanced breast cancer." Recent Highlights and Upcoming Activities
Enobosarm is the Company's lead product candidate and is being developed for two breast cancer indications: as a targeted treatment for (i) estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and (ii) AR+ triple negative breast cancer (TNBC).
GTx-758 (Capesaris®) is being developed as a secondary hormonal treatment for men with castration resistant prostate cancer (CRPC).
Fourth Quarter and Year-End 2014 Financial Results
Conference Call and Webcast There will be a conference call today at 9:00 a.m. Eastern Standard Time. To listen to the conference call, please dial 866-314-5232 from the United States or Canada or 617-213-8052 from other international locations. The access code for the call is 85796452. A playback of the call will be available from approximately 1:00 p.m. Eastern Standard Time today through March 18, 2015 and may be accessed by dialing 888-286-8010 from the United States or Canada or 617-801-6888 from other international locations and referencing reservation number 56856619. Additionally, you may access the live and subsequently archived webcast of the conference call from the Investor Relations section of the Company's website at http://www.gtxinc.com. About enobosarm (GTx-024) to treat breast cancer Enobosarm, an oral nonsteroidal selective androgen receptor modulator, is being studied for the targeted treatment of androgen receptor positive advanced breast cancer (ER+/AR+ and AR+ TNBC). Prior clinical studies have shown that women with metastatic breast cancer who have been previously treated with tamoxifen and whose cancer has progressed have responded to treatment with steroidal androgens, with overall response rates ranging from 20 to 60 percent. Because steroidal androgens have unwanted virilizing side effects, they have limited widespread clinical use. GTx believes that a selective androgen receptor modulator, like enobosarm, by targeting the androgen receptor in advanced breast cancer, has the potential to provide clinical benefit to women with advanced breast cancer while minimizing these unwanted side-effects associated with steroidal androgens. For more information about enobosarm, please visit www.gtxinc.com. About GTx-758 (Capesaris®) to treat men with castration resistant prostate cancer GTx-758, an oral nonsteroidal selective estrogen receptor alpha agonist, is being studied for secondary hormonal therapy in men with castration resistant prostate cancer (CRPC) and, potentially, as a secondary hormonal treatment for advanced prostate cancer used in combination with androgen deprivation treatment (ADT). GTx is enrolling an open-label, Phase 2 clinical study of GTx-758 to treat men with metastatic and non-metastatic CRPC. Data from the study is expected in the third quarter of 2015. For more information about GTx-758, please visit www.gtxinc.com. 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 GTx's planned clinical trials for enobosarm (GTx-024) and its ongoing clinical trial of GTx-758 (Capesaris®), including the anticipated timing of initiation and expected data from such trials, statements related to the potential to undertake additional development of GTx-758 and GTx's plans or possible plans related thereto, and GTx's expectation that it will recognize non-cash gains or losses resulting from the revaluation of the warrants issued in November 2014 to fair value each reporting period through the earlier of December 31, 2016 or the exercise in full of these warrants. 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 clinical trials being conducted or planned to be conducted by GTx may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (ii) that any additional clinical development of GTx's product candidates beyond the two planned Phase 2 clinical trials of enobosarm in patients with AR positive advanced breast cancer is contingent on GTx entering into new collaborative arrangements with third parties for such development or otherwise obtaining sufficient additional capital to permit such development, which it may be unable to do; (iii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; or (iv) that GTx may be unable to take appropriate action to increase its authorized and unreserved shares of common stock to an amount sufficient to remove GTx's cash settlement obligations under the November 2014 warrants and/or that GTx could otherwise remain subject to liability accounting with respect to these warrants for the full terms of these warrants. 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 ended September 30, 2014 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.
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