Henry Doggrell - VP & Chief Legal Officer Rob Wills - Executive Chairman Marc Hanover - CEO Mayzie Johnston - VP of Clinical Operations.

Analysts:.

Welcome to the GTx Fourth Quarter and Yearend 2015 Corporate Update and Financial Results Conference Call. My name is Candice, and I will 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 call is being recorded for replay purposes.

I would now like to turn the conference over to Henry Doggrell, Vice President and Chief Legal Officer and Secretary of GTx. Please proceed..

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

Joining me on the call today are Dr. Robert Wills, our Executive Chairman of the Board; Marc Hanover, our Chief Executive Officer; Dr. Mayzie Johnston, Vice President, Clinical Development; and Dr.

Ramesh Narayanan, Associate Professor in the Department of Medcine and the Director of the Center of Cancer Drug Discovery at the University of Tennessee Health Science Center. 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 with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed with the SEC for the period ending December 31, 2014, and our Quarterly Report filed for the period ending September 30, 2015.

You're cautioned not to place undue reliance on these forward-looking statements and GTx disclaims any obligations 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, March 03, 2016.

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'll now turn the call over to Dr. Wills..

Thank you, Henry. And thank all of you for being on the call today. I am sure it's a busy end-of-year earnings season for everyone. So I'll keep my remarks brief today.

I joined GTx as its Executive Chairman a year ago in early March 2015 and I believe this is an appropriate time for me to review with you the company's accomplishments over the last year and summarize the milestones that we expect during 2016. Since joining GTx, our strategy has been to proceed along two tracks.

Track one is focusing on development activities for our SARMs to treat advanced breast cancer and our SARD technology in castration resistant prostate cancer.

Given that we have limited resources, we feel it is important to focus our capital and personnel on developing those assets where we believe we have a high probability of delivering attractive return on investment in the near term.

Therefore, our second track is designed to create additional opportunities by monetizing select pipeline assets to bring in new capital that can be deployed against our primary programs in track one.

Let me begin with our first track and summarize for you what we've accomplished through the continued development of our core clinical product candidate enobosarm, a selective androgen receptor modulator or SARM as a potential treatment for advanced breast cancer.

In the second half of 2015, we initiated two Phase 2 open-label multinational clinical trials to evaluate the safety and efficacy of enobosarm as a treatment for two different populations of patients with advanced breast cancer.

One study is evaluating enobosarm in women with androgen receptor positive and estrogen receptor positive breast cancer, and the other is assessing enobosarm's ability to treat women with androgen receptor positive triple negative breast cancer.

The androgen receptor and ER receptor positive breast cancer trail was evaluating two doses, 9 milligrams and 18 milligrams. The trail was enrolling and we expect to have the results of Stage 1, which is the first 18 invaluable patients per each dose by yearend.

Our other clinical trial is evaluating enobosarm and androgen receptor triple negative breast cancer at a dose of 18 milligram. The trail is also enrolling and we expect to have the results from Stage 1 of this trail, which is the first 21 invaluable patients by yearend.

In addition to the clinical trials, I mentioned women with androgen receptor positive advanced breast cancer. We also have continued to support preclinical studies, which further fortifies our therapeutic approach of using an androgen receptor agonist to treat advanced breast cancer. We expect this data to be published later this year.

I will now move on to our SARD Program and exciting technology that has the potential to provide a treatment option for men suffering from castration resistant prostate cancer. This cancer is resistant or unresponsive to current therapies.

We've demonstrated scientifically that our SARD components will degrade multiple forms of the androgen receptor including androgen receptors splice variants, such as AR-V7. We also have retained -- obtained results of independently reproduced assays that validate the science.

I’m now absolutely confident that our SARD Program compounds degrade the full length and variant forms of the androgen receptor. Since our third quarter financial results call, we have selected lead preclinical compounds and have initiated our preclinical development program.

We hope to have several IND-ready compounds that could be taken into the clinic in 2017. To help guide the clinical strategy with additional insight for our development programs, we're pleased to announced that Dr.

Myles Brown, Professor of Medicine, Harvard Medical School and Director of Center for Functional Cancer Epigenetics is now advising the company. Dr. Brown is a recognized authority on the treatment of hormonal dependent breast cancer and prostate cancer.

Now let me update you on the progress of our second track efforts with regard to our non-oncology assets. We initiated a proof-of-concept clinical trial in stress urinary incontinence or SUI to evaluate a Novus arm as a potential treatment of SUI in up to 35 postmenopausal women. The first patient was enrolled earlier this week.

This study is being conducted at Beaumont Hospital in Royal Oak, Michigan under the direction of Dr. Ken Peters, a leading expert in female urologic conditions and disorders. There are no orally available effective treatment options for SUI.

As such we view this as an unique opportunity given the enrichment of the pelvic floor muscles with the androgen receptors and the known effects that our SARMs have on building muscle. We expect to have results from this trial in the second half of this year.

At our recent meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction held last week, Dr.

Ramesh Narayanan who is with me today, presented preclinical data demonstrating that both SARMs tested enobosarm and GTx-027 were able to increase pelvin floor muscle mass as well as turn on genes that are associated with muscle degradation in an over [authorized] [ph] mouse model, a well accepted model that simulates a postmenopausal condition.

Ovariectomy reduced the pelvic floor muscles in preclinical models by approximately 50%, demonstrating the importance of hormones and maintaining muscle integrity. This decrease was significantly reversed by our SARMs.

We've continued to evaluate our SARM compounds as potential for treatment for the orphan indication Duchenne muscular dystrophy of DMD. Our preclinical efforts have shown the beneficial effects from SARMs in mice genetically altered to simulate DMD, including the following.

In DMD mice, which were treated with one of three different SARM compounds, including enobosarm, each SARM cohort demonstrated increases in body weight, muscle mass, muscle performance i.e. grip strength and cardiac function, compared to control groups.

Histologically, in SARM-treated mice, skeletal muscles demonstrated a reduction in necrosis, fibrosis, and centrally nucleated cells, which are accepted markers of skeletal muscle atrophy.

And finally, a SARM also markedly reduced the fibrosis of cardiac muscle, which is relevant since most DMD patients will develop cardiomyopathy as the disease progresses.

We continue to believe that a SARM maybe a viable therapeutic option for the treatment of DMD, including a combination with therapy effect and potentially modify the underlying genetic defect. We now have a sufficient preclinical data package that we are using in discussions with potential collaboration partners.

In summary, we've been able to move all programs forward along each of our two tracks and I’m very pleased with the progress we have made to date. We recognize that data is needed to maximize shareholder value and we're optimistic that our ongoing efforts will allow us to achieve key data milestones across several programs in 2016.

Before concluding our remarks, let me ask Marc to give you a brief update on our financial results for 2015..

Thank you, Rob. Our financial results for the fourth quarter and year ended December 31, 2015, are more fully outlined in our press release issued earlier today. We reported $29.3 million in cash and short-term investments at the end of 2015.

We believe 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 our ongoing Phase 2 breast cancer clinical trials and topline results from our Phase 2 proof-of-concept clinical trial in SUI. We're encouraged by the multiple opportunities ahead of us for this year.

We look forward to updating you on additional progress regarding our two track strategy in the coming months. Operator, we're now ready to take our first question..

[Operator Instructions].

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And I am showing no questions at this time. I would like to turn the conference back over to Dr. Wills for closing remarks..

Thank you, Candice. I would like to thank all of you again for your interest in GTx..

Ladies and gentlemen, thank you participating in today's conference. This does conclude the program and you may all disconnect. Have a great day everyone..