Chairman, CEO, CFO: Dr. Glynn Wilson
WSA: Good day from Wall Street. This is Juan Costello, Senior Analyst with the Wall Street Analyzer. Joining us today is Glynn Wilson, Chairman and CEO of TapImmune, Incorporated. The company trades on the OTCQB. Ticker symbol is TPIV. Thanks for joining us today again there, Glynn.
Glynn Wilson: Thanks a lot, Juan. It’s a pleasure to be with you.
WSA: Great, so for some of our listeners that didn’t catch our interview from about six months ago, can you provide us with a history and overview of the company?
Glynn Wilson: Yes, the company is involved in one of the most exciting spaces in the pharmaceutical industry currently, that’s called immuno-oncology, and what we’re doing is trying to develop T-cell vaccines stimulating the body’s own immune system to recognize and fight cancer. We’ve successfully completed two phase I clinical trials. One for HER2/neu breast cancer with a product we call TPIV 100 and the second trial is in triple-negative breast and ovarian cancer with a separate product called TPIV 200. Both those trials showed the vaccines to be safe and well-tolerated and the most interesting part of the studies was that they showed that over 90% of the patients showed robust T-cell immune responses against the vaccines, so that’s very encouraging as we move towards phase II studies. So, we’re in the T-cell vaccine field, we think we’re a leader in that field now with our clinical results, and moving into phase II involving ovarian and breast cancer.
WSA: Alright. And in terms of TPIV 200, can you talk about the fast track designation?
Glynn Wilson: Yes, the fast track designation is something that the FDA gives you if you’re working in an area where there is a significant clinical need and if you have an approach that has significant merit. So we received fast track designation for the use of the development of TPIV 200 in ovarian cancer where the patients have been treated with standard of care, that’s surgery and chemotherapy, and also these patients had been given platinum treatments and they had some sensitivity platinum. So, it’s a very specific indication, but there is a clear need for new products in this area. When patients have undergone treatment, they reoccur fairly quickly and the prognosis is not good. The practicality of fast track is it allows you to go to the FDA with data that you have and talk to them about what that data looks like and what the next steps in the process are, so it has the potential to shorten the development process significantly.
WSA: Great. So in terms of some of the key trends in the sector, can you talk to us about checkpoint inhibitors?
Glynn Wilson: Yes. Checkpoint inhibitors are on the television most nights now. OPDIVO, for example, from Bristol-Myers Squibb, these are compounds that inhibit the T and regulatory cells. Cancer cells have a variety of mechanisms for avoiding detection by the immune system and one of them is by putting out signals which suppress the immune system. The checkpoint inhibitors essentially take that brake off and allow the immune system to work better and so there are a number of products that are on the market and will be coming onto the market for the treatment of melanoma and non-small cell lung cancer. We believe that the use of a vaccine such as TPIV 100 or TPIV 200 is perfect in combination with the checkpoint inhibitor. You take the brakes off the immune system and use the vaccine to stimulate the components of the immune system. It’s like a one-two punch and we hope to announce shortly a combination trial, a phase II clinical trial, with a pharmaceutical partner. That will be in ovarian cancer, it will be done at a cancer institute in New York, and it will be looking into the combination of a checkpoint inhibitor from the pharma partner and TPIV 200. That is scheduled to start before the end of this quarter, so we’re very excited about that trial.
WSA: Well, great! So what are some of the key factors that you feel make your pipeline unique from that of some of the players in the sector?
Glynn Wilson: Well, I think really it starts with the phase I results, where we’ve shown that our approach, with the approach of our collaborator at the Mayo Clinic, Dr. Keith Knutson, broadly stimulates the immune system and we showed that over 90% of the patients that received a vaccine in phase I responded with significant immune responses. That is a unique result and so the key thing for moving forward is to get that into multiple phase II programs, both in triple-negative breast and ovarian cancer, including the combination trial I just mentioned. We announced in September last year that the U.S. Department of Defense has put a $13.3 million grant into our collaborators at the Mayo Clinic for a large phase II study in triple-negative breast cancer using TPIV 200. We of course will provide the vaccine for that study, so that was a major validation, I believe, of our technology.
We’ll be doing smaller open-label phase II studies sponsored by the company in both ovarian and in triple-negative breast cancer to complement the large study that’s funded by the Department of Defense. Some other milestones that we’ll see this year: we’re planning to do an uplisting from the Bulletin Board to the major exchange and we’ll be progressing the development of our in-house developed technology called PolyStart, the DNA vector that has potential to provide a much greater stimulation of the immune system than is being conventionally possible. So, a combination of our clinical entry this quarter and starting next quarter, together with our [possible] uplisting to a major exchange and our pharma partnership, and development of our own in-house technology, I think provides a very good set of milestones for 2016.
WSA: Definitely. Perhaps you can talk a little bit about the key management there, you know, the background and experience behind the scenes?
Glynn Wilson: Yes, you know we’ve been adding management as we’ve gone along. My own background is in big pharma, both in Europe and in United States, in product development, involvement in at least $1 billion growth. My colleague, who has come on board as a Medical Director, Dr. Patrick Yeramian, is coordinating the clinical trials from our side. He has a 25-year history in the industry, including small biotech companies, and my new directors in the company, Strategic Advisor Dr. John Bonfiglio, has run multiple biotech companies such as Immune Response Corporation, Peregrine, Argos, and others. So, we have a wealth of experience in both corporate management and in product development, including clinical development. And we’re adding on to the management team and board as we speak, so again, if we look at additional milestones this year, we’ll be looking at additions to the management team and for the board.
WSA: Certainly. So in terms of investors and the financial community, Glynn, what are some of your key drivers that you wish perhaps they better understood about either your company or about the sector?
Glynn Wilson: Well, I think the key driver is the sector itself. I think there is a general appreciation now that cancer treatments in the future will revolve around immunotherapy, the type of thing we’re doing, and particular combinations. We have a platform in T-cell vaccines that makes the perfect combination with things like either monoclonal antibodies or checkpoint inhibitors. So I think we’re well positioned there. The sector is growing very, very rapidly. There is a lot of opportunity. One of our vaccines, for example, the HER2/neu vaccine, the standard of care in the marketplace is Herceptin from Roche. It can only effectively treat about 20% of the patients, the HER2/neu target, but it’s still a $6 billion product. We have the potential to treat about 85% of that population, so the markets are enormous. In terms of our own market cap, currently around $40 or $42 million, it’s significantly undervalued if you look at the space and the comparables with, probably, pipelines that are not as good as ours. So there is plenty of room for us to grow. There is a huge opportunity for investors to get involved in, I think, a leading company in the leading space in the pharmaceutical business.
WSA: Great. So once again, joining us today is Glynn Wilson, Chairman and CEO of TapImmune, Incorporated. The company trades on the OTCQB, ticker symbol TPIV, currently trading at 57 cents a share. As mentioned, market cap around $42 million. Before we conclude here, Glynn, to recap some of your key points, why do you believe investors should consider the company as a good investment opportunity today?
Glynn Wilson: Well, immuno-oncology, or immunotherapy, is the fastest growing space in the pharmaceutical business. We have a leading set of technologies in that space, which have been successful in phase I, moving into multiple phase IIs this year. So we have multiple, I think, catalysts or inflection points for the growth of the company and we’re addressing huge markets and clinical needs. So I think at the end of the day, we have a real advantage to deliver two things: one, new therapies for women in great need, and secondly, value for investors.
WSA: Well, we certainly look forward to continue to track the company’s growth and report on the upcoming progress. I would like to thank you for taking the time to join us again, Glynn, and update our investor audience on TapImmune. It’s always great to have you on.
Glynn Wilson: Thanks, Juan. It was a pleasure to talk to you. Thanks a lot.