Henry Doggrell - VP, Chief Legal Officer and Secretary Marc Hanover - Chief Executive Officer Dr. Rob Wills - Executive Chairman of the Board Dr. Mayzie Johnston - VP, Medical Affairs and Clinical Operations.

Analysts:.

Good day, ladies and gentlemen, and welcome to the GTx First Quarter 2015 Corporate Update and Financial Results Conference Call. My name is Tania, and I’ll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will facilitate a question-and-answer session.

As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to Henry Doggrell, Vice President, Chief Legal Officer and Secretary of GTx. Please proceed..

Thank you. Good morning, and welcome to the GTx first quarter 2015 financial results conference call. This morning we issued a press release providing financial results and company highlights for the quarter ended March 31, 2015. The press release is available on our website at www.gtxinc.com.

Joining me on the call today are Marc Hanover, our Chief Executive Officer; Dr. Rob Wills, our Executive Chairman of the Board; and Dr. Mayzie Johnston, Vice President, Medical Affairs and Clinical Operations, who oversees our enobosarm breast cancer clinical studies.

As a reminder, during today’s call, we will be making certain forward-looking statements.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

These risks are described in our filings made with the Securities and Exchange Commission, including our Annual Report on Form 10-K, filed with the SEC for the period ended December 31, 2014. You’re cautioned not to place undue reliance on these forward-looking statements. And GTx disclaims any obligation to update such statements.

In addition, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 08, 2015. GTx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. I will now turn the call over to Marc Hanover..

Thank you, Henry. And thanks all of you for being on the call today. I would like to begin by outlining the considerable progress we have made this quarter. Dr. Rob Wills, our Executive Chairman of the Board joined the team in early March and is providing valuable input and oversight to the team.

We will soon commence enrolling our Phase 2 enobosarm clinical trial in patients with advanced AR+ triple negative breast cancer and shortly thereafter we’ll begin enrolling patients in our Phase 2 AR+/ER+ advanced breast cancer study.

As we recently announced, we have in-licensed worldwide exclusive rights to a novel Selective Androgen Receptor Degrader or SARD program from the University of Tennessee Research Foundation. We plan to initially develop SARDs in patients with castration resistant prostate cancer who are not responsive or are resistant to currently approved therapies.

We have completed enrollment in our Phase 2 Capesaris clinical trial in metastatic and non-metastatic castration resistant prostate cancer and data received from this open label study has shown an increase in SHBG, a reduction in free testosterone and a reduction in PSA, thus confirming the drug’s mechanism of action.

And with right leadership, we have completed an evaluation of our pipeline assets and are executing on the following plan.

We have two distinct tracks for our R&D assets, those that we will continue to develop and those whose value we will attempt to monetize more quickly through our business development efforts where Rob has already begun targeted outreach.

Regarding those assets we intend to develop, our primary focus continues to be of course enobosarm, our selective androgen receptor modulator for the treatment of advanced breast cancer. This program remains our highest priority. Also we are excited about our in-licensing of the SARD technology.

We are currently conducting research to optimize clinical candidates to move forward towards first in human clinical studies.

We believe this program provides us an opportunity to develop novel compounds to treat castration resistant prostate cancer in patients who are not responsive or resistant to currently approved therapies and perhaps other indications.

With the growing interest within the pharmaceutical and investment community for hormonal receptor degradation, this program together with our SARM portfolio may drive near-term value and provide additional catalysts for stock appreciation.

With regard to our second track, we believe we have a portfolio of assets which we may be able to monetize in order to create near-term shareholder value and add cash to our balance sheet.

For example, we are evaluating other compounds in our SARM portfolio for indications outside of oncology where unmet medical needs in muscle related diseases may benefit from building muscle. There are several interesting opportunities including orphan indications that we are assessing and hope to be able to discuss in more detail later this year.

We believe GTx-758, the compound known as Capesaris and our other estrogen receptor alpha agonist compounds in our library also offer us an opportunity to add to capital to our balance sheet, which Rob will summarize shortly.

Before turning the call over to Rob, let me conclude with a brief update on our financial results for the quarter ending March 31, 2015, which are more fully outlined in our press release issued earlier today. I would like to point out that we reported $44.6 million in cash and short-term investments at the end of the quarter.

Our cash should be sufficient to carry us through calendar year 2016 and allow us to see, at a minimum, preliminary results from each of the Phase 2 breast cancer studies that we soon will be initiating. Now, I’d like to turn the call over to Rob..

Thank you, Marc. As I mentioned during the last conference call, my role as Executive Chairman of the Board of GTx includes serving as Chairman of the Board Scientific and Development Committee as well as overseeing GTx clinical development programs and strategic business development efforts.

Since officially joining GTx in early March, I’ve reviewed the company’s assets and now have a more complete understanding of the compounds and indications that might best maximize shareholder value. I’ve been extremely pleased with the assets we have within our portfolio and the potential outlook for the company.

The company’s strategy is to develop Enobosarm for the treatment of advanced breast cancer and pursue preclinical development of our newly in-licensed SARD technology to bring clinical candidates into Phase 1 clinical testing.

We intend to fund these development activities by adding to our current balance sheet through business development efforts to license, partner or sell other portfolio assets.

As Marc stated our in-licensing of the novel SARD technology from the University of Tennessee Research Foundation, explains our platform for developing agents targeting hormonal receptors. The prospects for this technology are exciting.

The SARD technology has the potential to compounds which can degrade multiple forms of the androgen receptor including those resistant to current therapy in patients with progressive castration-resistant prostate cancer. Let me expand on this.

Currently the development of various agents for castration-resistant prostate cancer such as androgen synthesis inhibitors and androgen receptor antagonists, have improved overall survival in these patients.

Despite this, approximately one-third of these patients do not respond to current available treatment due in part to the presence of androgen receptor variance including the variant 7. Splice variants of the androgen receptor have been identified in which the ligand binding domain, necessary for the action of many of the current therapies, is lost.

In addition, most patients who do initially respond to available treatments, eventually progress due to the emergence of resistance. All of the mechanisms which underlie the resistance are not fully understood; it is believed that castration-resistant prostate cancer growth remains highly dependent on androgen receptor activity.

A therapeutic agent that would safely degrade multiple forms of the androgen receptor, including those without the ligand binding domain, may be uniquely positioned to treat this population of patients.

We believe that with a relatively small financial commitment which we’ve already allocated to the SARD program for this year, we can finish the process of evaluating a number of SARD compounds and optimize clinical candidates to move towards Phase 1 clinical testing.

Any additional preclinical or clinical development activities beyond this year will be prior incremental funds which we hope to raise as licensing, partnering or sale of other assets or through a strategic partnerships or collaboration for the development and commercialization of SARDs.

Regarding enobosarm for the treatment of androgen receptor positive advanced breast cancer, next month we expect to enroll our first patient in our Phase 2 open label trial for women with advanced androgen receptor positive triple negative breast cancer. The study is being conducted in approximately 30 sites, in the U.S. and abroad.

The principal investigator for this study is Dr. Hope Rugo from the University of California -- San Francisco of Comprehensive Cancer Center who’s a recognized expert in the treatment women with advanced breast cancer.

She and other clinical investigators we have worked with to get this study initiate have shown a great deal of enthusiasm for the trial. Triple negative breast cancer represents approximately 20% of the total breast cancer population and these women have very limited options beyond chemotherapy, representing a significant unmet medical need.

Shortly after commencing the triple negative breast cancer trial, we will start enrollment in another Phase 2 open label trial in women with advanced androgen and estrogen receptor positive breast cancer. Principal investigator for this trial was Dr. Beth Overmoyer, from the Dana Farber Cancer Institute. Dr.

Overmoyer is a recognized expert in the treatment of breast cancer and also the lead investigator in our ongoing proof-of-concept clinical trial in women with estrogen and androgen receptor positive metastatic breast cancer.

Newer agents targeting the hormone receptors including the androgen receptor may provide significant therapeutic options for patients prior to chemotherapy. Hormone receptor positive breast cancer represents the largest of the breast cancer patients and we believe is an exciting opportunity for GTx.

I look forward to updating you on the progress of both the triple negative breast cancer and ER positive trials in the coming months.

With regard to Capesaris, we do not plan to dedicate any further internal resource to this program, once the ongoing Phase 2 trial has been completed, since as I have stated we are allocating our current financial resources and attention to the enobosarm breast cancer program and our new SARD technology.

We know that data currently available to us that Capesaris can effectively lower testosterone beyond what is being accomplished with androgen deprivation therapy alone and men suffering from castration-resistant prostate cancer.

There appears to be a good opportunity for the right partner in to the advanced prostate cancer space to undertake the remaining clinical development needed to potentially commercialize this product candidate.

Also there are other estrogen receptor agonist compounds that are part of the same patent family, which could potentially be developed as mono-therapy for the first line treatment of advanced prostate cancer. Operator, we are now ready to take our first question..

[Operator Instructions] And our first question comes from Sri Vallepalli [ph] of Jefferies. Your line is open..

Hi, this is Sridhar Vallepalli; [ph] I am picking in for Biren Amin.

I just wanted to get sense of when we could see some data from the TNBC or the ER prostate breast cancer?.

This is Mayzie Johnston. And as we stated before, we’re still on track to see at least preliminary data from both the triple negative trial and the ER+ trial during the second half of 2016. Keep in mind it, is an open label trial, so we will be monitoring each of the patient’s progress as they pass our endpoint..

So, can we expect some data in San Antonio Breast Cancer?.

In San Antonio Breast Cancer for 2015, not likely because we’ll miss any abstract deadline to submit, so that’s next month..

But you will be issuing some press release or giving updates on your earnings call, right?.

Yes. We’ll definitely be updating periodically throughout the trial..

Unfortunately we are out of time. I’d like to hand the call back over to Marc Hanover, CEO..

Thank you, Tanya. We would like to thank you all for your interest in GTx and we look forward to continuing to update you on our progress. Thank you..

Ladies and gentlemen, this concludes today’s conference. We appreciate your participation. Have a great day..