Henry Doggrell - VP, Chief Legal Officer & Secretary Rob Wills - Executive Chairman Marc Hanover - CEO Diane Young - VP, CMO Mayzie Johnston - VP, Clinical Operations Ramesh Narayanan - Associate Professor, Department of Medcine.

Analysts:.

Good day ladies and gentlemen, and thank you for standing by. We apologize for technical difficulties that we have experienced this morning. Welcome to the GTx Third Quarter 2015 Corporate Update and Financial Results Conference Call. My name is Christine, and I will be your lead 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 introduce your conference call over to Mr. Henry Doggrell, Vice President, Chief Legal Officer and Secretary of GTx. Please proceed..

Thank you. Good morning, and again, we apologize for obviously the technical difficulties that NASDAQ phones are experiencing right now. This morning we issued a press release providing financial results and company highlights for the quarter ended September 30, 2015. The press release is available on the website at www.gtxinc.com.

Joining me on the call today are Dr. Rob Wills, our Executive Chairman of the Board; Marc Hanover, our Chief Executive Officer; Dr. Diane Young, Vice President, Chief Medical Officer; Dr. Mayzie Johnston, Vice President, Clinical Operations; and Dr.

Ramesh Narayanan, Associate Professor in the Department of Medcine and the Director of the Center for 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 made 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 Reported filed for the period ending June 30, 2015.

You are 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, October 29, 2015.

GTx undertakes no obligation to revise or update any forward-looking statements to reflect events and circumstances after the date of this conference call. I would now like to turn the call over to Marc Hanover..

Thank you, Henry. And thanks all of you for being on the call today. We have made a great deal of progress over the last few months in advancing our clinical programs. And to begin, I will share few of the highlights with you and then turn the call over to Rob for more detail.

During the quarter we announced that we have dosed the first patient with Enobosarm in each of our Phase 2 advanced breast cancer clinical trials. One in women with ER+ and AR+ breast cancer, and another in women with AR+ triple negative breast cancer. We continue to evaluate other interesting opportunities for our SARM portfolio.

Recently we announce that we have received clearance from FDA to initiate a proof-of-concept clinical trial evaluating enobosarm in post-menopausal women with stress urinary incontinence or SUI. We are also evaluating our SARM compounds as a potential treatment for the orphan indication Duchenne muscular dystrophy or DMD.

By extending our SARM development efforts to indications outside of oncology, we are increasing muscle mass may prove beneficial. We believe that we can create near term value if we are able to monetize assets through licensing or collaboration opportunities.

Regarding our SARD technology, we believe that SARDs may provide a novel treatment for men suffering from castration resistant prostate cancer.

During the quarter we continue to make progress towards identifying and optimizing potential lead compounds to advance to the next phase of preclinical testing so that if all goes as planned we may bring the most appropriate SARD candidate into clinical trials.

Before turning the call over to Rob, let me provide a brief update on our financial results for the quarter ending September 30, 2015 which are more fully outlined in our press release issued earlier today. We reported $34.5 million in cash and short-term investments at the end of the quarter.

We believe our cash should be sufficient to carry us through calendar year 2016 and allow us to see at minimum preliminary results from each of our ongoing Phase 2 breast cancer clinical trials.

In addition, our current cash will allow us to see top line results from a proof-of-concept study in SUI, completion of our ongoing DMD preclinical data package, and selection of lead SARD compounds to move into preclinical work necessary for human trials.

We reported net income for the third quarter of $34.9 million which included a non-cash gain of $40.7 million due to the change in fair value of the company's warrant liability.

The warrant liability was recorded in conjunction with our November 2014 private placement, and we anticipate continuing to recognize the related non-cash gains or losses through the earlier of December 2016 or the exercise of these warrants.

Excluding the non-cash warrant gain, the actual operating loss for the third quarter of 2015 was approximately $5.9 million. Now I would like to turn the call over to Rob Wills..

Thank you, Mark. Now that we are well into the last quarter of 2015 that reflects on everything the team at GTx has accomplished this year, I'm very pleased with the progress we've made. With regard to the two track strategy we announced earlier this year that we are pursuing, we have been able to move all programs forward along each track.

Let me first address our primary track. Developing and advancing our breast cancer program and our selective androgen receptor to greater technology. As Mark mentioned, we are now enrolling patients in our two Phase 2 clinical trials of enobosarm to treat advanced breast cancer.

Our Phase 2 trial in the androgen receptor positive and androgen receptor positive breast cancer is evaluating the efficacy and safety of both, 9 milligram and 18 milligram daily doses of enobosarm in two cohorts of patients for up to 24 months of treatment.

The first 18 patients in each cohort will receive either at 9 milligram or 18 milligram dose, and if at least three of the 18 patients achieve clinical benefit at week 24 then the trial will proceed to the second stage of enrollment for that dosing arm to assess clinical benefits in a total of 44 invaluable patients per arm.

Clinical benefit is defined as a complete response, partial response, or stable disease as measured by the response evaluation criteria in solid tumors at 24 weeks. The lead investigator for the trials is Dr. Beth Overmoyer from the Dana Farber Cancer Institute and the Harvard Medical School.

Our other Phase 2 breast cancer trial is evaluating the efficacy and safety of a daily dose of 18 milligrams of enobosarm for up to 12 months of treatment and up to 55 women with advanced AR+ triple negative breast cancer.

In at least two of the first 21 patients enrolled in the trial achieved clinical benefit at week 16 then the trial will proceed to the second stage of enrollment of up to 41 invaluable patients. The lead investigator for the trial is Dr. Hope Rugo from the University of California at San Francisco.

Both clinical trials will include investigators from approximately 40 sites in the U.S. and abroad. We currently expect to have preliminary data from both studies by the end of 2016.

Now regarding our selective Androgen Receptor Degrader or SARD program we continue to make progress towards identifying potential clinical SARD candidates with a goal of initiating preclinical studies in the first quarter of 2016. These studies will allow us to reflect the best SARD compound to move into clinical trials.

Now I would like to address our second track. To monetize certain of our of pipeline assets as business development opportunities arise. Let me start with our SARMs, we have several SARM compounds in our portfolio that we can target for the potential treatment of the Duchenne muscular dystrophy or stress urinary incontinence.

Our preclinical studies in Duchenne muscular dystrophy and stress urinary incontinence have confirmed that at least two of our SARM compounds could be developed for these indications. This approach allows for the creation of an incremental value through a diversification of our SARM portfolio.

Last quarter we discussed in detail the rationale for using a SARM Duchenne muscular dystrophy and outlined our approach. Duchenne muscular dystrophy is a genetic disorder characterized by progressive muscle weakness and muscle wasting.

Promising research is ongoing in the areas of modifying or correcting the genetic defect in Duchenne muscular dystrophy with some encouraging results. Other approaches include anti-inflammatory and anti-oxidant therapies, enhancement of utrophin expression in Myostatin inhibitors. We believe there is still room for continued therapeutic advance.

We have completed a battery of preclinical studies and mice genetically altered to simulate the Duchenne muscular dystrophy through the knockout of dystrohpne gene in these mice. We demonstrated the ability of three GTX SARMs to increase body weight, muscle mass and muscle performance in these animals when compared to controlled groups.

These results have been conducted in both castrated animals to deplete normal circulating androgens and intact animals with similar results. In addition we assessed cardiac function and found significant improvements in heart muscle and cardiac functioning.

We are also conducting physiological evolutions on the skeletal and cardiac muscle to assess the integrity and architecture of the muscle.

While we continue to advance the preclinical evaluation of our SARM to treat Duchenne muscular dystrophy including meeting with experts in the field we have also discussed our findings with potential strategic partners and expertise in Duchenne muscular dystrophy.

We believe that a SARM maybe a viable therapeutic option for treatment of this disease including a combination with therapies that can potentially modify the underlying genetic defect. We have been pleased with the earlier reception that we have had and we will continue to move these efforts forward.

We anticipate that we will have a sufficient preclinical data package available by year-end to discuss in more detail with the potential of collaboration partners. We announced earlier this month the FDA's acceptance of IND application for a Phase 2 proof of concept clinical trial to treat postmenopausal women with stress urinary incontinence.

It is anticipated that this clinical trial will roll approximately 35 patients who will be treated with the Novus arm 3 milligrams for 12 weeks.

Stress urinary incontinence which affects up to 35% of adult woman is an involuntary leakage of urine during activities such as coughing, laughing, sneezing, exercising or other movements that increase intra-abdominal pressure and thus increase pressure on the bladder.

In women physical changes resulting from pregnancy, childbirth and menopause often contribute to stress incontinence predominantly through the weakening of the pelvic floor muscles. Currently there are no orally available effective treatment options for stress urinary incontinence.

Treatment is limited to physical therapy to strengthen the pelvic floor muscles, surgery to help augment or support the pelvic floor muscles, bulking agents injected into the urethra of the bladder and implantable device which aims to minimize the leakage of urine under stress.

Other than physical therapy each of these treatment modalities is invasive with risk and complications. There is clearly an unmet need for new safe and effective therapies in this space. We view this as a unique opportunity given the enrichment of the pelvic floor muscles with androgen receptors and the known effect of SARMs have on building muscle.

We have completed a series of preclinical studies to determine the effect of some of our SARMs on the pelvic floor muscle mass.

These studies have shown an over [indiscernible] mice there were [indiscernible] significant increases in pelvic floor muscles compared to the control groups indicating that SARMs may provide a real treatment option for the numerous postmenopausal women suffering from stress urinary incontinence.

We’re in clinical collaborators in the process of completing the final steps to initiate a Phase 2 proof of concept clinical trial and we anticipate initiating the study in the first quarter of 2016. We plan to update more about the results of this clinical trial during our fourth quarter financial results conference Call.

So in summary, we are prudently developing multiple opportunities some that are likely to remain proprietary GTX programs, others that we hope to out license to strategic partners. I look forward to updating you on additional progress of our two track strategy in the coming months. Operator, we are now ready to take our first question..

Operator:.

Thank you for your interest in GTX and we look forward to updating you on our progress in the future. Thank you for being on this call, we apologize for the difficulties..

Ladies and gentlemen, thank you participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day..