Executive Chairman: Dr. Robert Wills
About: 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.
WSA: Good day from Wall Street this is Juan Costello, Senior Analyst with the Wall Street Analyzer. Joining us today is Dr. Robert Wills, the Executive Chairman for GTx Incorporated. The Company trades on NASDAQ, ticker symbol is GTXI. Thanks for joining us today Robert.
Robert Wills: My pleasure Juan. It’s good to be here.
WSA: So, starting off please give us a history and overview of the company?
Robert Wills: Sure, the company was founded in 1997 and I believe it went public in 2004. The science and the focus behind the company has not changed, the technology is based on nuclear hormone receptor biology. However, the technology that we currently have today has been greatly expanded since the founding. I joined the company in March of 2015 and I can tell you that the company has two major programs. One is identified under the acronym SARM or Selective Androgen Receptor Modulators and the other great program we have is under an acronym SARD, which are Selective Androgen Receptor Degraders.
And within the SARMs we’ve been focused in two areas, breast cancer and more recently stress urinary incontinence, which I’ll be happy to go through with you. We had a recent press release announcing some key developments. We were selected to be on the podium for the International Continence Society annual meeting, which will be held in Florence, Italy in September—this is very good news for us. This selection for presentation was a positive validation of our data, so that was great.
WSA: Certainly, so yeah bring us up to speed on some of your most recent news and activities including your Q1 update.
Robert Wills: So we have an ongoing trial in breast cancer, we’re looking at two forms of breast cancer. One is a very debilitating and end stage of the breast cancer space; it’s called triple-negative breast cancer. We are evaluating enobosarm at 18 milligrams in this population of patients over a treatment period of four months and the data from that is expected to readout sometime in the late third or early fourth quarter.
The patients in this study have a high-risk profile, and our expectation on that study is not as great because there are no current therapies approved to treat them. We felt that there was a potential to look at enobosarm as a treatment based on the science that we have with our SARMs
The other program, which we’ve already announced positive data on is in another form of breast cancer. The most common form of breast cancer is in the estrogen receptor positive populations. We only require that in that population patients also have a positive androgen receptor, which we agonize and by doing that we compete with estrogen to slowdown or stop the proliferation of that form of breast cancer. We did announce positive news back in January regarding that study at 9 milligrams.
We will also have the readout from that study both at 9 and 18 milligrams at the same time with the other breast trial in the late third, early fourth quarter. I think in addition to those programs we’re also in the clinic, which was the subject of the press release, looking at an indication of stress urinary incontinence. And this is a pelvic floor muscle weakening that women become affected by when they become pregnant and/or if they’ve had babies. In addition, when they reach menopause, there is also weakening in this pelvic floor muscle structure, which leads to daily leaks of urine that are induced by stress. So, if they cough, sneeze, or do any activity that would move the muscles around the pelvic floor. If they jump or exercise, they can have an incontinent episode, and it requires women to wear pads and they do the Kegel exercises to try to strengthen the muscle. There is no pharmaceutical agent approved or being used in this space. It’s almost all devices or surgical intervention.
And so, we’re excited about this study because this would be a daily dose given to women where the drug actually strengthens the pelvic floor, leading to them reducing if not eliminating their leaks all together. So that’s the focus of the program. We are in a proof-of-concept phase 2 trial right now where we dose women for 12 weeks and we have them keep a diary about how many leaks per day they have from baseline when they start, and then we measure it at four, eight and twelve weeks. Twelve weeks being the endpoint. We compare the leaks per day at twelve weeks compared to their baseline to look at the overall effect of the drug.
We did submit the abstract to the International Continence Society and they awarded us with a podium presentation in September at their annual meeting in Florence, Italy, which we are excited about. It’ll be the first time the data will be released. There is an embargo required here unfortunately, so we’re not allowed to talk about the data in detail until it’s presented, but what I can tell you is we’re very bullish on the outcome–from the key opinion leaders that we have shared the information with–in a confidential manner.
They are encouraging us to move forward, so we plan on taking the next step after this trial, which we believe will be successful. We would go into a definitive, well-controlled placebo-controlled trial. That would look at two doses of the drug and placebo and would serve as the basis for moving forward with one other pivotal trial hopefully, and then to registration, so we’re excited about this opportunity.
UPDATE SINCE WSA INTERVIEW:
After this interview was conducted, the International Continence Society has published the stress urinary incontinence abstract on their website and, therefore, the Company has summarized the data in the abstract and noted this data, as well as more current data from the ongoing study, will be presented at the International Continence Society meeting in September. The company press release can be found here. The abstract can be found here.
WSA: And what are some of the key trends that you guys are focusing on in the sector and what makes you uniquely positioned to capitalize?
Robert Wills: First of all, the sector is robust with capital. We know that, and we also know that the sector will reward and recognize novel innovation. We believe that this is the case with the SUI opportunity, being that there is nothing on the market pharmaceutically to treat this. Along with our SARD program, the androgen degraders, which would be useful in potentially treating prostate cancer patients who have become resistant to all existing therapies–that’s a very high unmet need.
So, these types of innovations would be rewarded by the sector if they come to fruition. They have the potential if there are unmet needs. With our SARD program we have not released a lot of data; but we believe that when we do release some of the pivotal data that will come out of these programs that we will get investor and potentially partnering interest in the compounds.
WSA: And what are the key goals and milestones that you’re hoping to accomplish over the course of the next 12 months?
Robert Wills: So we do expect to release what we believe will positive data for SUI, at the podium session I have mentioned in Florence. This will be the first time that the public will see what we are seeing. We think that it’s going to be a significant milestone because the sector reacts to data. I mean you can talk all you want about how good you might be, but they need to see the data; so that will be the next key milestone. We also will be releasing our final top line results from the breast cancer ER/AR positive trial in the fourth quarter. And then for the SARD program, that is for the prostate area, we are currently now running some compounds through the necessary prerequisite IND work with the goal of being able to file an IND sometime in the first half of ’18. That would allow us to go into human trials for the first time and also be another key milestone for the company.
WSA: And perhaps you can talk about your background experience, Dr. Wills, and go over who some of the key management team there is?
Robert Wills: Okay, so my background, I’ve been in the pharmaceutical sector for over 35 years. I was a PhD by training and I started out in science at Hoffmann-La Roche, I spend 10 years there. I then moved to J&J and spent over 25 years at J&J mostly in R&D; but for the last 12 or 15 years I was on the business development side. And then I elected to retire from J&J in February of ’15 to go out and have some fun. And so, I have been serving on boards for small biotech companies for the last two years plus. As I mentioned I’m the Executive Chairman of GTx, which is the subject of this interview, but I am also the Chairman of a company in California called CymaBay and I sit on two other private company boards.
So, like I said most of my experience has been in drug development in a large company and has been on the business side, so coming into the biotech arena, which is the other side of the coin I am hoping to be able to leverage that experience in bringing the technology from a company like GTx to this sector. As far as other members of the management team, the CEO is Marc Hanover. He was one of the founders; he has a finance and banking background.
Our Chief Medical Officer is Dr. Diane Young. She has come out of Roche, J&J and Novartis. She is a Hematologist/Oncologist by training. Our Head of Clinical Development is Mayzie Johnson. She is the one who is running the clinical programs for us and we have our General Counsel, our CFO, and we have our Head of Regulatory who are all part of the management team.
WSA: Sure, so when it comes to investors and the financial community what are some of your key drivers there that you wish perhaps they better understood about you guys?
Robert Wills: Well, I think that the key thing for us is we know that the investment community will react positively to data; but we have not shared that for our two biggest programs, which we think are the value drivers of the company.
I believe we’re severely undervalued because of that, but again what I believe in is bringing your best information forward where you can address most of the questions that will be raised and if we do that properly and correctly we’ll be recognized. So, I think at this point it’s about us delivering on the data and I think the rest of it will take care of itself.
WSA: Sure and once again joining us today is Dr. Robert Wills, Executive Chairman for GTx Incorporated. The company trades on NASDAQ, ticker symbol GTXI, currently trading at $4.44 a share and market cap is north of $70 million. Before we conclude here to recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Robert Wills: Well, largely for what I was stating in that I do think we’re undervalued in this mid to high $4 price range. Part of that is based on, I believe, some of the history of the company and the fact that the lead program, which we have been pursuing for the last two years in breast cancer is probably not viewed as robustly as a program like stress urinary incontinence and prostate cancer would be. And so, I think once that data becomes available we’ll see a change and turnaround in the interest of the investment community.
WSA: Well, we certainly look forward to continuing to track the company’s growth and report on your upcoming progress, and we would like to thank you for taking the time to join us today Dr. Wills and update our investor audience on GTx. It was great having you on.
Robert Wills: Perfect. Thank you very much Juan.