Marker Therapeutics, Inc. (MRKR) Q1 2017 Earnings Report, Transcript and Summary

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.

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.

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 and emerging viral threats. We look forward to exploring opportunities to monetize this exciting and 100% proprietary technology platform. At over the most significant drivers for TapImmune would be advancing our current clinical programs. I'm pleased to say that we are now entering a period where we expect to reach multiple substantive clinical milestones across our entire pipeline over the next 18 months. We anticipate that this steady flow of clinical news will help drive additional interest in the company. Particularly among recognized institutional investors, to add credibility and validation to TapImmune, that could help us achieve valuation that more accurately reflects the significant potential of more candidates. I'm joined on the call today by Dr. Richard Kenney, our new Head of Clinical Development, who will provide further detail on the milestones investors can expect over the coming several quarters. We are very pleased to have Rich joined us. His extensive experience in designing and implementing successful clinical development programs in immunotherapy including those for DNA vaccines will be a tremendous benefit to TapImmune. We are confident in his ability to manage our current and planned clinical studies, as well as oversee the continued development to our PolyStart technology. Rich's appointment follows the resignation of John Bonfiglio, our Chief Operating Officer, President and Director. John played a significant role in advancing our programs in Phase 2 and successfully helping us up list our stock to NASAQ. We thank him and wish him good luck in his future endeavors. Before I hand the call to Rick for clinical highlights, I’d like to quickly reiterate what sets TapImmune's vaccine apart from other immunotherapy approaches and why we firmly believe we have focused on clinical efforts on indications where our vaccines are most likely to have a significant impact. Our initial focus is on addressing the unmet needs in women’s cancers, specifically ovarian breast cancers, where reoccurrence rates are high following surgery and initial therapy and in some indications the time to reoccurrence is relatively short. Unfortunately, survival prognosis is extremely poor once the cancer recurs. These cancers also tend to be resistant to most immunotherapies, including immune checkpoint inhibitors, which is why we believe we have a significant opportunity to improve the lives of these patients. Our next generation vaccines are ideally suited to actually prevent cancer recurrence in these patients following initial therapy. As well as offer a needed treatment option for patients with refractory tumors that have already proven to be resists through all available chemotherapy. Our vaccines can be used as standalone therapy against a variety of cancer both primary tumors and metastatic disease, as well as a component of combination therapy due to the distinct mechanism of action and of favorable safety profile of our vaccines. From a product perspective, our vaccines are being developed as off the shelf immunotherapies. As such, we’ve taken steps to ensure that they will be effective from high majority, it’s not all cancer patients in our target indications. We’ve done despite carefully choosing molecular targets of our vaccine, as well as selecting a group of antigens against that target to cover the widest possible range of human genotypes. Furthermore, our vaccines or the design of our vaccines are derived from human immune responses in cancer patients, not animals. Exploiting the body's natural immunity against tumors. In our Phase 1 study vaccination with our peptide based products, resulted in lasting immune responses against our molecular targets. We believe this immunity directed against key proteins that are expressed in abundance on the surface accounts of cells. Molecules that are -- that correlates with disease reoccurrence improve prognosis will lead to sustained anti-tumor responses in patients with the potential to impactful both progression-free survival and overall survival. I’ll now hand the call over to Rick to provide greater detail on our clinical programs. Rick?

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 Phase 2 study is being conducted by the oncology groups at Memorial Sloan Kettering Cancer Center in multiple clinical sites. And it's been conducted in women with platinum-resistant ovarian cancer. We are evaluating TPIV200 vaccination in combination with AstraZeneca's PD-L1 checkpoint inhibitor, which is called Durvalumab. The primary endpoint in this single-arm study is overall response rate. This study would be our first opportunity to see Phase 2 immunogenicity and tumor response data for TPIV200. It's also the first study to evaluate the combination of the Folate Receptor Alpha cancer vaccine with the checkpoint inhibitor. Women was platinum-resistant ovarian cancer have a very poor survival prognosis, and no other treatment options. So there is potential for this novel combination regiment to be a breakthrough therapy in this extremely difficult to treat patient population if it's proven to be successful. With respect to Durvalumab, we were very encouraged to see AstraZeneca and MedImmune's announcement of favorable interim Phase 3 results in patients with non-small cell lung cancer, although their study is in a platinum-sensitive patient population, the patients tumors were advance and unrespectable, so the fact that treatment with Durvalumab was able to held disease progression compared to placebo in this difficult population is an encouraging result that makes us hopeful for our ongoing combination study. Enrollment in the TapImmune study has now reached 27 patients and as per the study protocol Memorial Sloan Kettering has extended patient enrollment pending a planned interim analysis. Based on favorable enrollment in the study we now expect the reported results of this analysis earlier than we had originally anticipated in the third quarter of this year. If the safety profile remains positive and there are efficient signs of tumor response to the combination therapy, enrollment will resume and we expect the study to be completed as planned in 2018. A second Phase 2 study which is TapImmune sponsored is ongoing in women with platinum-sensitive ovarian cancer. This blinded randomized controlled trial is design to evaluate TPIV200 vaccination as maintenance therapy to reduce the times of reoccurrence compared to placebo the primary endpoints in this study is progression free survival. This is the first randomize controlled study of TPIV200, and it benefits from both Orphan drug and FDA Fast Track designations. This enables the potential for ongoing development advice from the FDA and priority review of the TPIV200 Biologics License Application, as well as seven additional years of marketing exclusivity upon potential approval for this indication. Enrollment is currently ongoing this 120 patient's studies and we expect to conduct an interim analysis once 50% enrollment is achieving, which is currently expected in the second half of next year. Moving on now to triple-negative breast cancer, TapImmune is evaluating TPIV200 in a multicenter study that's currently enrolling women with triple-negative breast cancer. These patients are advanced patients who have completed surgery to remove the tumor as well as chemotherapy and radiation. This randomize Phase 2 study is design to determine the optimal vaccine dosing and regimen that can maximize the anti-tumor immune response in this maintenance phase patients. This trial has four-arms, it will evaluate both high-dose and low-dose of TPIV200 either with immune priming with [indiscernible]. The study will also apply vaccine booster strategy after the initial regimen. One boost will be given every six months as long as the patient has no recurrence. The primary endpoint in this study is a generation of an immune response against Folate Receptor Alpha. Last quarter, we announced the TapImmune have received a positive safety recommendation from an independent Data Safety Monitoring Board based on the 25% patients being enrolled. The study has since continued to enroll additional patients and we remain on track to achieve 50% enrollment in the second half of this year. And to complete enrollment by the end of the calendar year. Top-line data for the full study is expected to be available in the second half of 2018. Finally, TPIV200 will be evaluated in a larger randomized control Phase 2 study, also enrolling women with triple-negative breast cancer, which will be conducted by our collaborators at the Mayo Clinic. This is 280 patients study, which is planned to treating patients in the third quarter of this year and is completely funded by grand from a U.S. Department of Defense of approximately $13 million. The study is design to determine the efficacy of TPIV200 in prolonging disease free survival in women with advanced triple-negative breast cancer. We look forward to updating the market when this study begins enrolling patients later this year. Turning to our second vaccine candidate, which is against HER2/neu. We expect to initiate two clinical studies in the near future. First, we’re currently designing a company project Phase 1b, 2a trial in HER2/neu positive breast cancer. Since completing our Phase 1 study, we’ve enhance the vaccine composition by adding another peptide TPIV100 to create the current product TPIV110. This requires that we submit an amendment to the IND prior to beginning any new clinical studies of TPIV110 and we expect to file that later this year. Upon FDA acceptance for this amended IND TapImmune will initiate the study to evaluate TPIV110 for treating women was HER2/neu positive breast cancer. In another study, our collaborators at the Mayo Clinic are also planning to initiate the Phase 1b, 2a study of our HER2/neu vaccine based on our second DoD grant. This study will enroll women with ductal carcinoma in situ or DCIS breast cancer. If successful in this very early breast cancer indication, our vaccine could one-day be positioned to complement standard surgery and chemotherapy, and potentially could even become part of a routine immunization schedule for preventing breast cancer in healthy women. We look forward to providing update on this study once Mayo Clinic enrolling patients. In addition to generating value from our clinical stage pipeline or PolyStart technology represents a significant opportunity for the company to build additional value both in terms of our internal pipeline and through strategic partnerships, PolyStart is a protein expression technology designed to enhance the potency of nucleic acid based vaccines. By enhancing the expression of antigens is in proprietary vectors we're able to potentially enhance the effectiveness of a given vaccine, which gives TapImmune multiple opportunities to monetize this asset both within oncology as well as in other areas where vaccines are used, of course infectious diseases. By Glynn mentioned this technology was invented and is owned by TapImmune. We're continuing to advance the platform in preclinical studies. We've successfully demonstrated that we can increase antigen expression by at least four fold compared to traditional vectors. In some cases, six to ten-fold. We have done this in multiple cell lines and have shown that the antigens are fully functional and our presented on a surface of antigen presenting cells in vitro. We've also shown that this antigen presentation mediates cell curing in vivo very efficiently by CDA T-cells. Additional studies are underway and have been planned in an effort to fully validate our approach to demonstrate that the value that PolyStart may offer to potential partners. But so far we are pleased with our progress to date and look forward to developing it further. I'll just say once again quickly as I'm very happy to join TapImmune and to be able to help carry this exciting program forward. Glynn and I will be at ASCO later this week and we'll be meeting with some of our collaborators and the clinical investigator to discuss our current and future programs. We're all hopeful that through continued execution we can demonstrate the significant potential of our vaccine technologies. With that I'll turn the call back to Glynn for some closing remarks.

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.

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.

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?

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.

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?

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.

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?

And may I ask Rick to answer that one.

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.

The next question comes from Eric Anderson with 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?

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.

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

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.

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