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Marker Therapeutics, Inc. (MRKR)

Q1 2017 Earnings Call· Wed, May 31, 2017

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Transcript

Operator

Operator

Good afternoon and welcome to the TapImmune First Quarter 2017 Business Update Conference Call. All participants will be listen-only mode. [Operator Instructions]. After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions]. Please note this event is being recorded. I would now like to turn the conference over to Joshua Drumm, Investor Relations. Please go ahead.

Joshua Drumm

Analyst

Thank you. Good afternoon and welcome to the TapImmune first quarter 2017 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, we will make forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties that include but are not limited to any of the following. Any statements other than the statements of historical fact regarding management’s expectations, beliefs, goals and plans about the company’s prospects including its clinical studies for its cancer vaccine candidate's advancement of its PolyStart technology, future financial position, future revenues and projected costs and market acceptance of the company’s product candidates. Forward-looking statements include any statements about our clinical development plans, and the timing cost and results thereof, projections as to the company’s future spending and cash position, expectations as to the timing and nature of anticipated regulatory action, possible product licensing or other business development transactions, any commercial plans and expectations, market projections for our product candidates and expectations as to manufacturing and product component costs. Our actual results may differ materially from these projections or estimates due to a variety of important factors including but not limited to uncertainties related to clinical development, regulatory approvals and commercialization. These risks are described in greater detail in TapImmune's filings with the Securities and Exchange Commission, including the company’s quarterly on Form 10-Q filed May 5, 2017, which is available at tapimmune.com as well as the SEC’s website. TapImmune may not actually achieve the goals or plans described in these forward-looking statements and investors should not place undue reliance on these statements. Please note that TapImmune does not intend to update forward-looking statements except as required by law. At this time, it is now my pleasure to turn the call over to Dr. Glynn Wilson, Chief Executive Officer of TapImmune. Glynn please go ahead.

Glynn Wilson

Analyst

Thanks Josh and good afternoon everybody and thank you for joining us today. During the weeks and our last investor call we and are clinical partners have continued to run multiple active Phase 2 clinical trials of our lead cancer vaccine TPIV200. Our efforts and resources remained focused on enrolling patients into these trials as efficiently as possible, as well as preparing to initiate in a Phase 1b/2a trial on our second vaccine candidate TPIV110 later this year. In parallel, we anticipate two additional Phase 2 clinical studies to commence in the second half of 2017. One involving each of our cancer vaccine candidates and covering two distinct breast cancer indications. These studies will be conducted by the Mayo Clinic and are free funded by approximately $17 million in grants distributed to the Mayo Clinic from the U.S. Department of Defense. We believe that the breast and advance stage of our clinical pipeline, as well as the caliber of our clinical collaborators positions TapImmune as a clear leader in the immunotherapy of women's cancers, in the indications of higher clinical need. We've also secured Orphan designation and FDA Fast Track status for certain of our programs, which further highlight the need for new treatment modalities in ovarian cancer, all of which enhance the value of our pipeline. Adding to these clinical sciences are off earlier stage PolyStart technology platform, which is designed to improve antigen presentation from DNA and RNA base vaccines. We continue to generate very encouraging data demonstrating how PolyStart may be able to enhance the potency of virtually any expression based vaccine. This gives us multiple opportunities to leverage our technology to develop future vaccines and to add to our oncology pipeline as well as our out license PolyStart through strategic partners developing vaccines for infectious disease…

Richard Kenney

Analyst

Thanks Glynn. I really delighted to have joined TapImmune and I look forward to supporting the company as the Head of Clinical Development. There are a number of great opportunities for TapImmune vaccine candidates in both ovarian and breast cancers. As Glynn mentioned, we expect to begin validating these prospects over the next several quarters as the ongoing Phase 2 clinical studies advanced. First, I’ll briefly introduce our vaccines. The target for our lead vaccine candidate called TPIV200 is Folate Receptor Alpha, which is protein that is over expressed by about 90% of ovarian cancers and in more than 80% of triple-negative breast cancers. Folate Receptor Alpha is associated with the likelihood of cancer recurrence, and it tends to remain highly expressed when that recurrence occurs. The vaccine itself consists of five peptides, they are design to illicit those helper T-cell and the killer T-cell responses. The composition of such that we expect to cover that 85% of human genotypes worldwide. Our second lead vaccine candidate is TPIV110, which also consists of five peptides. They are design to stimulate a robust T-cell response. In this case the target is HER2/neu, which is overexpressed by about 38% of breast cancer patients. The unique mix of epitopes that make-up TPIV 110 are expected to cover a much larger HER2/neu patient population than blockbuster drugs like Herceptin, which is a single antibody that shares the same molecular target. Based on genetic variances we expect up to 90% coverage for TPIV110 versus 15% to 20% for Herceptin. And TPIV110 can might remained effective significantly quite longer. Now I'll dive into study highlights staring to TPIV200. As Glynn mentioned the Folate Receptor Alpha vaccine is currently being evaluated in three Phase 2 clinical studies. With the fourth study being initiated in 2017. The first ongoing…

Glynn Wilson

Analyst

Thanks Rich. In conclusion TapImmune is focused on treating women's cancers because this large and underserved patient population deserves better treatment options. We are developing our vaccines to potentially improves the prognosis for about 30,000 ovarian cancer patients and about 40,000 triple-negative breast cancer patients, and in total of 220,000 breast cancer patients, who are diagnose with disease each year in United States. Our success in this and endeavor is currently being evaluated in multiple clinical studies with plenty of milestones upcoming in 2017, 2018 and beyond. In the remainder of 2017 alone, we expect to achieve 50% enrollment in our ongoing Phase 2 dosing study of TPIV200 for treating triple-negative breast cancer. In the coming weeks with enrollment completed I [indiscernible]. We expect Mayo Clinics to publish long-term safety immune response and survival data from the completed Phase 1 study of TPIV in a peer review journal in the next a couple of months. We expect to complete the interim analysis from the ongoing Sloan Kettering sponsor Phase 2 combination of study of TPIV200 with AstraZeneca's Durvalumab for ovarian cancer. We plan to file an amended IND for TPIV110 in treating HER2/neu breast cancer. And finally, the Mayo Clinic is expected to add an additional DoD funded Phase 2 study of TapImmune TPIV200 in triple-negative breast cancer. I think it's important that I thank all the dedicated people, the dedicated team that have been involved in these studies interacting with the different sites, monitoring the trials, supplying the product during the regulatory work and interacting with the FDA. It's a great team effort which has allowed us to come this far. On our projections, we expect the study clinical news to continue for the next several quarters and we are more optimistic than ever that this may lead to multiple cash list [ph] for the company and its shareholders. We look forward to building this long-term value with your continued support and we thank you again for joining us on this call. Operator, you may open the lines for questions.

Operator

Operator

We will now begin the question-and-answer session. [Operator Instructions]. The first question comes from Gary Anderson with Micro Cap Research. Please go ahead.

Gary Anderson

Analyst

Hello, Dr. Wilson and Dr. Kenny. Thank you for today’s corporate update. I actually have three questions, I’ll try to keep in brief. But we all know that TapImmune has collaborative partners with greater organizations like AstraZenica, Sloan Kettering, Mayo Clinic. My question is how will this partnerships impact down the road looking ahead future commercialization? Does TapImmune retain commercialization rights and the ability to make future partnerships beyond the present one, as far as getting the drug to market goes?

Glynn Wilson

Analyst

Gary, thanks for the question. Let me answer that. The key partner here is the Mayo Clinic, because for both vaccines we have a worldwide exclusive licensing agreement with the Mayo Clinic. And that covers royalty, structure and milestone payments for the Mayo. So that is first and foremost, our key interaction. The other interactions are also very important with Memorial Sloan Kettering, because of the potential to work with them on other projects included ovarian cancer. And secondly, with AstraZenica, we deliberately avoided any license lock up or tie up to leave us free to work with others. Because at the time we started this, we were not certain Durvalumab would work out competitive to other checkpoint inhibitors. So our agreement with Sloan Kettering and AstraZenica is a simple clinical trials treatment.

Gary Anderson

Analyst

Okay. Good. That answers that question. So next question, will TapImmune’s management be attending any immunotherapy or oncology conferences or generic investment conferences in the coming weeks and months. And I ask this because it seems like there is far too few people that are aware of the significant of what you’re doing in these patients with high unmet medical situations with breast and ovarian cancers in particular. You’ve got top-tier partners FDA Fast Track designation, research that's bankrolled by the U.S. Department of Defense and yet your market cap is a mere $31 million, which seems absurd to me. So the question is what are you doing to get the word out there? Will you would be attending conferences and the like in the future to help support the share price and I know that there is clinical information coming up, you mentioned that in the call, I appreciate that, over the next 12 or 18 months that will also help garner some support and investor awareness, but beyond that what are you doing?

Glynn Wilson

Analyst

I think we are trying to be far more selective in types of meetings we present at to get the best bank for our buck. I think it could be split into three types of meeting. Firstly, clinical meetings as Rick Kenney mentioned with ASCO on Friday and do we tend to talk to clinicians who are actually involving in our trials, and clinical advisors who have been helping us. We are also looking at bio-partnering meetings. I will be presenting at Bio 2017 in San Diego at the end of June and that is still looks specifically at partnerships in the -- with the PolyStart. Than we have something that we've been doing for a long-time now and that is doing retail road shows. Continuously meeting with a retail investors at family offices to get the word out that way. So yes I do believe we really need to do better, but in addition to that we have a new guy in the company called Aaron James Santos [ph], who is our IR guru and social media specialist who is getting the word out daily and so if you have a minute go and look at TapImmune Twitter, go and Google TapImmune Twitter to see the extent of our activities there. So in addition to those sorts of meeting where we are looking at for example at San Antonio Breast Cancer Conference in January and we're looking we've been invited to speak up specifically on PolyStart at the International Vaccine Congress in San Diego, end of November, beginning at December. So yes we are trying to do as much as we can, but at the same time target with right audiences.

Gary Anderson

Analyst

Got it, okay my last question is, I have read that recently the FDA approved a new drug for platinum-sensitive ovarian cancer and I know that's an area that TapImmune is working in. So how will that approval by the FDA effect TapImmune's study in that indication?

Glynn Wilson

Analyst

And may I ask Rick to answer that one.

Richard Kenney

Analyst

Sure. We were very interested to see that approval and in fact in our clinical advisors mentioned that the approval was broader than that expected and it fell directly on our patient population for those one Phase 2 that we are doing in platinum-sensitive ovarian cancer. And so we spend several days trying to figure out what the best approach to do is with that information. And finally decide that maybe the best thing to do would be to shift our indication from the second remission which is what was approved by the FDA for [indiscernible] to a first remission setting, maintenance setting after platinum treatment of the first round of platinum therapy for ovarian cancer patients. This is a space that is not taken up by any approved drugs, is a great space for current clinical trials and is an opportunity for us to go forward with this clinical trial, which was poised to start and I think we’ll actually benefit from this change. The change is now being implemented and we’re excited about being able to show this as a kind of novel approach to the treatment of ovarian cancer.

Operator

Operator

The next question comes from Eric Anderson with Hartford Financial. Please go ahead.

Eric Anderson

Analyst · Hartford Financial. Please go ahead.

Yes. Well, I wonder, could you update us on how much your planned studies over the next couple of years are going to cost the company? And then what are the current capital reserves that are available to you?

Glynn Wilson

Analyst · Hartford Financial. Please go ahead.

I mean, there is two answers for that question. The first is that, we have 70 million allocated from the Department of Defense grants that cover a large Phase 2 study and triple-negative breast cancer and around innovative study in ductal carcinoma in situ, DCIS. So that’s essentially in the bank. So our own studies cost considerably less. And so we’re looking at an increase in burn, but it’s been manageable. So we’ve always maintained sufficient cash in hand to meet our milestones. And we will look at -- I mean, I think more than money, the key issue that we face with all these clinical trials is bandwidth. Our ability to execute demand, we realized how important that is. So we’re looking -- I think we’re looking at 8 million to 9 million a year in burn. We reported it in our 10-Q in May and then we have 12.9 million [ph] in the bank, which will take us through the end of the year and into 2018. So that gives us a lot of flexibility to look at our financing needs for the future. And after that our current and large investors, warrant holders have been particularly supported. And so I think we’re in very good place there to bank what we need for the studies before us.

Operator

Operator

This concludes the question-and-answer session. I would like to turn the conference back over to Glynn Wilson for any closing remarks.

Glynn Wilson

Analyst

Well, thank you again for joining us today. We look forward to speaking with all of you again soon. And with that, we will terminate the conference call. Thank you very much.

Operator

Operator

The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.