Henry Doggrell - Vice President, Chief Legal Officer Marc Hanover - CEO Rob Wills - Executive Chairman of the Board Mayzie Johnston - VP, Head of Enobosarm Clinical Program Ramesh Narayanan - Associate Professor.

Hugo Ong - Jefferies.

Good day, ladies and gentlemen, and welcome to the GTx Fourth Quarter and Fiscal Year End 2014 Corporate Update and Financial Results Conference Call. My name is Anna, 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 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 fourth quarter and fiscal year end 2014 financial results conference call. This morning we issued a press release providing financial results and Company highlights for the quarter ended December 31, 2014, and for the fiscal year 2014. The press release is available on our Web site at www.gtxinc.com.

Joining me on the call today are, Marc Hanover, our Chief Executive Officer, Dr. Rob Wills, our newly appointed Executive Chairman of the Board, Dr. Mayzie Johnston, Vice President and Head of our Enobosarm Clinical Program; and Dr.

Ramesh Narayanan, Associate Professor in the Department of Medicine and 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 Quarterly Report on Form 10-Q, filed with the SEC for the period ending September 30, 2014 and on our Annual Report, which will be soon filed on Form 10-K. 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, March 04, 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 thank all of you for being on the call today. I would like to officially welcome Rob Wills to the GTx team. Rob is a veteran pharmaceutical executive who brings to us more than 35 years of industry experience in the areas of clinical and preclinical development and business development. As an active Executive Chairman Dr.

Wills will dedicate his efforts to these key priorities, our clinical development programs and strategic business development efforts. Investors and research analysts will also interact with Rob since he and I will be primarily responsible for our external communications.

On the call today I will provide a corporate update while summarizing our key accomplishments and financial highlights. Rob will then review important upcoming milestones related to our clinical development activities. Now I will begin with our recent accomplishments.

Last quarter, I outlined our redefined corporate focus to treat two populations of patients with advanced breast cancer with our selective androgen receptor modulator, Enobosarm.

In December 2014, we presented clinical data at the San Antonio Breast Cancer Symposium from our ongoing Phase 2 open-label trial evaluating a 9 milligram daily dose of Enobosarm as a treatment for women with both estrogen and androgen receptor positive metastatic breast cancer who had previously responded to hormonal therapy and subsequently progressed.

These results demonstrated that six of the 17 evaluable AR positive patients or 35% demonstrated clinical benefit at six months of treatment, exceeding our predefined statistical threshold requiring that at least three of our 14 AR positive patients or 21% demonstrate clinical benefit.

After meeting duration on study of 81 days, 41% of all patients, nine out of 22, achieved clinical benefit as best overall response. One patient with measurable disease having 27% reduction in target lesions in the lever. Another patient remains on study with stable disease after 500 days of treatment.

Enobosarm continues to be well tolerated with a majority of adverse events being grade one. The median time to progression for all patients was 86 days and median duration of response for those patients with clinical benefit as best overall response was 255 days.

Since one patient remains on study, the trial is ongoing and we will provide updated results once the study is completed. We have now turned out our focus to initiating two new Phase 2 breast cancer clinical trials; one, in the estrogen/androgen receptor positive population; and another, in the AR positive, triple negative breast cancer population.

Next, let me provide an update on our Capesaris or GTx-758 our oral estrogen receptor alpha agonist that is being developed to treat advanced prostate cancer. GTx-758 is being tested in two daily doses, 125 milligrams and 250 milligrams, in men with metastatic and high risk non-metastatic castrate resistant prostate cancer.

The 125 milligram cohort of 38 patients was fully enrolled last year and we expect a 250 milligram cohort of an additional 38 patients to be fully enrolled by the end of this month. We have reported that in a 125 milligram cohort, four of the 38 men were observed to have PSA reductions of greater than or equal to 50% by day 90.

The drug was well tolerated in this cohort with no reported SAEs pertaining to the drug. In the patients receiving 250 milligrams of GTx-758 that have reached day 90 seven of the 25 men had PSA reductions of greater than or equal to 50%. GTx-758 has been generally well tolerated.

However, one patient on the 250 milligram dose did experienced venous thromboembolic event or VTE which has been determined as possibly drug related. The reported VTE was subsequently resolved.

The intent of this Phase 2 is to demonstrate that the doses of GTx-758 we are currently testing confirm the mechanism of action of drug and have an acceptable safety profile for the treatment of men with advanced castrate resistant prostate cancer. As the study nears completion, the safety profile of the doses being tested appears to be acceptable.

In the mechanism of action of GTx-758 which has been observed in both dosing arms has shown that the drug works to increase Sex Hormone Binding Globulin or SHBG and thereby decreases serum testosterone levels.

Across both cohorts median SHBG levels have increased from a 158% to 268% of baseline resulting in decreased levels of serum free testosterone. Also we're seeing changes in bone turnover markers which indicate there maybe improvements in bone health.

Data on hot flashes suggests that treatment with GTx-758 may improve this known estrogen deficiency side effect. Before I turn the call over to Rob let me conclude with a brief update on our financial results. The financial results for the quarter and year ending December 31, 2014 are included in the press release issued earlier today.

I would like to point out that we reported $49.3 million in cash and short-term investments at December 31, 2014 which includes the $42.8 million in net proceeds we raised from the financing we announced in November of last year.

Our cash should be sufficient to carry us through calendar year 2016 and allow us to see at a minimum preliminary result from each of the two new breast cancer studies that we will be initiating this year. I will now turn the call over to Rob to discuss our ongoing clinical development priorities. .

Thank you, Marc. I am very excited about joining the GTx team and I would to like to begin by sharing with you a few of the things that attracted me to the company.

First the GTx team, not investors make the trip to Memphis and get to meet with team but I can tell you that I have been very impressed with the scientists and clinicians I have met along with the key experts with whom they are collaborating.

This expert list is long and distinguished, to share a few names the team is working with renowned hormonal experts Professor Mitch Dowsett and Dr. Steven Johnson from the United Kingdom and Professor Wayne Tilley from Australia. In addition GTx has secured leading clinical experts as clinical principal investigators for both breast cancer trials Dr.

Hope Rugo from the University of California, San Francisco and Dr. Beth Overmoyer from Dana-Farber. Lastly, I am fortunate to be working closely with Dr. Lee Schwartzberg a nationally recognized expert in breast cancer who resides here in Memphis. Second the science.

I am enthusiastic about Enobosarm as a treatment for breast cancer especially since it's rare to have the opportunity to develop a drug in this space that already has extensive clinical data and acceptable safety profile to date and a valuable intellectual property position.

I have been impressed with the amount and level of pre-clinical and clinical data that have been generated to support the rational for pursuing both breast cancer trials.

In addition to the evidence supporting our current approach for the hormonal treatment of breast cancer there is impressive pre-clinical data to support exploring other indications with GTx compounds. These compounds if successfully developed in and of themselves can create significant value for the company above and beyond breast cancer.

I will be exploring with the team the best ways to maximize the development of these opportunities, capitalizing on my clinical development and business development experience. Third the market, which I call prefer to call the patients, since we don't have a market without patients.

As have been well documented, there is currently no cure for metastatic breast cancer and there are over 3 million women in the United States with a history of the diseases. Unfortunately approximately one-third of these women will relapse from current treatments and will require additional therapies to treat their diseases.

This is where Enobosarm could prove to be very beneficial for patients and GTx. With regard to triple negative breast cancer although these patients represent 20% of the total breast cancer population this is a devastating diseases where treatment is limited to chemotherapy.

Again this presents an important unmet medical need which if Enobosarm can demonstrate success, it will be a significant advance. In summary we believe Enobosarm provides an excellent opportunity to introduce a new hormonal treatment for androgen receptor positive breast cancer patients.

So with this background in mind let me discuss GTX's goals for 2015 with regard to our clinical programs. We plan to start the triple negative breast cancer study during the second quarter of this year subject to appropriate regulatory clearances.

Based on the extensive pre-clinical data the company has generated and given how few therapeutic options are currently available for women with triple negative breast cancer we have received enthusiastic support from the investigators who will be involved in the clinical trial.

And the estrogen receptor breast cancer study should begin within a month or two of the triple negative breast cancer study it is targeted for the third quarter of this year. With regard to Capesaris we believe data from the ongoing study is encouraging and suggest there may be a realistic path forward for future development.

Following our [receipt] of all the data from the clinical trials we will evaluate potential next steps in the clinical development of Capesaris including potentially seeking a partner or collaborative arrangement in order to fund additional clinical development.

I am truly excited to be a member of the GTx team and I am optimistic about our prospects. Operator, we are now ready to take our first question..

(Operator Instructions) So the first question comes from Hugo Ong of Jefferies. Your line is open. Please go ahead..

This is Hugo speaking in for Biren Amin. Thanks for taking my questions.

Just one on the breast cancer program, can you tell us how you are defining AR positivity in your upcoming Phase 2 trial?.

This is Mayzie. Hugo we are defining AR positivity by immunohistochemistry, where we’re acquiring that -- greater than 10% of the cells that are staying positive for the androgen receptor and that will be essentially confirmed..

And on the previous study I think you evaluated 9 milligrams of Enobosarm and can you tell us if you’ve evaluated higher doses and whether a maximum tolerated dose has been identified?.

Yes, we have studied doses up to 30 milligrams; we used the 30 milligram dose in a through [Q2] study where we saw no negative effects in that study. We’ve also studied up to 30 milligrams in our multiple ascending dose study with patients dosed for up to two weeks and again with no major toxicity.

As we increase the dose we do see greater reductions in HDL, cholesterol and potential for increased lever enzymes, but no notable toxicities other than that. We have not done -- if you are asking we’ve done on MTD dose one in toxicity study, we have done one..

And just one last question, the triple negative trials is availing CDR at 16-weeks, why 16 and not say 24 weeks as in some of the other trials?.

Excellent question, we’ve actually discussed that with many of our collaborators and [steering] committee, the standard as you know is at 24 weeks so that is a secondary endpoint but because these patients progress so rapidly and the disease is aggressive we wanted to get -- wanted to make sure we have patients that were going to live long enough to actually achieve an endpoint especially if we received patients who were on third, fourth, fifth rounds of therapy.

So, as our primary endpoint to continue to move them from stage one to stage two, we decided to look at a 16 week endpoint as our primary, which is consistent with other recent triple negative studies targeting androgen receptor. But again so the traditional endpoint of 24 weeks that is our secondary endpoint..

I would now like to turn the call back over to Marc Hanover, CEO for closing remarks..

Thank you, Anna. We would like to thank you all for your interest in GTx and we look forward to updating you on our progress in the future. Thank you..

Thank you for your participation in today’s conference. This concludes the presentation. You may now disconnect. Good day..