Marker Therapeutics, Inc. (MRKR) Q2 2017 Earnings Report, Transcript and Summary

Good day everyone and welcome to the TapImmune Second Quarter 2017 Business Update Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] And please do note that today’s event is being recorded. I would now like to turn the conference over to Josh Drumm with Investor Relations. Please go ahead.

Thank you, William. Good afternoon. And welcome to the TapImmune second 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 candidates, 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 the 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 report on Form 10-Q filed August 7, 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 these 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.

Thank you Josh. And good afternoon everyone. And thank you for joining us today. During the second quarter we continue to focus on advancing our robust clinical development pipeline, both our internally funded programs and in collaboration with our clinical partners. Our primary objective for the next several quarters is to continue enrolling patients into our three active Phase 2 trials as efficiently as possible, in order to reach many meaningful value inflection points for our shareholders. In parallel we expect to launch additional clinical studies for each of our novel cancer vaccine candidates later this year, to generate even more value for the company. Adding to this clinical strength is our proprietary PolyStart antigen expression technology platform, for which we continue to generate encouraging data that we believe will support multiple potential business development opportunities, as well as the development of few future vaccines for our internal oncology pipeline. And consistent with the technologies that we're developing, we’ve continued to advance our patent position on both the technology license from the Mayo and the PolyStart technology with new patent approvals and new patent filings. As we highlighted on our last quarterly calls, we expect to deliver on multiple substantive clinical milestones across our entire pipeline over the next 18 months. We've already started to achieve some of these milestones, including hitting the 50% enrollment benchmark in our company-sponsored Phase 2 dosing study off TPIV 200 in women with triple-negative breast cancer. This occurred slightly ahead of our expectations during the second quarter. And we're on track to complete full recruitment for this study by the end of the year. As we continue to deliver on these clinical milestones, we anticipate that this steady flow of meaningful company news will help drive additional interest in the company. And that will help support the valuation that more accurately reflects a significant potential of our product candidates. I'm joined today on the call by our Head of Clinical Development, Dr. Richard Kenny, who will provide further detail on our exciting clinical programs and our PolyStart technology. But before I hand the call to Rick, I want to highlight the other major developments occurred during the second quarter, which was our successful capital raise. This field involves continued investment from several of our existing shareholders. In a private placement transaction, which was done at market price, it also involves the exercise of warrants by existing Series E Warrant holders for aggregate gross proceeds of around $6.8 billion. This infusion of cash helps fund the company through several additional clinical milestones in the advancement of our novel T-cell vaccines for breast and ovarian cancer. We’re thankful for the continued support of our investors and their confidence in our ability to move the programs forward. With that I will hand the call to Rick to provide greater detail on our clinical programs. Rick, over to you.

Thanks Glynn and good afternoon. As Glynn mentioned, our lead vaccine candidate, TPIV 200, is currently being evaluated in three active Phase 2 clinical studies, with the fourth study planned to be initiated in 2017. The first study is the combination therapy with Astra Zeneca’s PD-L1 checkpoint inhibitor, called durvalamab, which is being conducted by the Memorial Sloan Kettering Cancer Research Center at multiple clinical sites in women with platinum-resistant ovarian cancer. This is the first study to evaluate the combination of a peptide vaccine with a checkpoint inhibitor in women with platinum-resistant ovarian cancer, who typically have a very poor survival prognosis and no FDA-approved treatment options. As we mentioned on our last call, enrollment in the single-arm study was suspended according to the Simon two-stage design. While the 27 patients who are currently enrolled complete their treatment and the planned interim analysis is conducted. We continue to anticipate reporting the results of the interim analysis later this quarter. If the safety profile remains positive and there are sufficient signs of tumor response from the combination therapy, enrollment will resume and the study will be completed as designed. We look forward to providing an update as soon as the interim data are available. TapImmune sponsored, randomized, blinded, controlled Phase 2 study is also underway to evaluate TPIV 200 vaccination as a maintenance therapy to reduce the rate of recurrence in women with platinum-sensitive ovarian cancer. We recently announced that TapImmune has instituted a strategic amendment to the enrollment criteria for this study to account for a changing treatment landscape for this high, unmet need indication. Originally the study was set to enroll women who had undergone two or more rounds of platinum-based chemotherapy for which no FDA approved therapies had been available at the time the protocol was written. However, given the successful approval of Tesaro's PARP inhibitor, niraparib, for women in their second disease remission, we thought to amend our study protocol to shift the focus of TPIV 200 earlier in the treatment paradigm, where no approved therapies currently exist, namely women in their first remission following the first round of successful platinum-based chemotherapy. It's useful at this point to say that these women are likely to have healthier immune systems, having not gone through multiple rounds of chemotherapy and cancer recurrence in their first remission. So they may be better positioned to benefit from our immunotherapy approach. Additionally, should TPIV 200 demonstrate a significant benefit in prolonging disease-free survival on this population, TapImmune will be well-positioned from a competitive standpoint with the potential to address a unique niche within the ovarian cancer treatment landscape. Enrollment in this study is currently ongoing and we expect to conduct an interim analysis in early 2019, once the data from the first half of the enrollment is achieved. The slight shift from our original expectation of late 2018 for the interim analysis is due to the amended patient population that will be enrolled in this study. Shifting gears now to our other lead cancer indication, triple-negative breast cancer or TNBC. As Glynn mentioned, we recently achieved 50% enrollment in our Company sponsored, multicenter, randomized, Phase 2 study, which is designed to determine the optimal vaccine dose and regimen that can maximize the anti tumor response in women with maintenance phase TNBC. We are encouraged by the rate of enrollment in the study to date and remain on track to complete enrollment by the end of the calendar year, with top line data expected in the second half of 2018. Finally, as we've discussed, our collaborators at the Mayo Clinic are preparing to initiate a fourth study of TPIV 200, also in women with advanced TNBC. This study is completely funded by a grant from the U.S. Department of Defense of approximately $13 million, which was awarded back in September 2015. While we were hopeful that this study would be well on its way by now, the fact is that Mayo Clinic, as a primarily academic institution, is not beholden to TapImmune or its shareholders in terms of meeting our expectations on study start. Clearly they and the Department of Defense recognize the need for new therapies for TNBC. And we remain grateful to the Mayo Clinic for their willingness to advance TPIV 200 on our behalf in this large 280-patient study. Based on our most recent discussions, we expect the study to begin enrolling patients later this year. As a reminder, this study will evaluate the efficacy of TPIV 200 in prolonging disease-free survival after standard-of-care chemotherapy and radiation for TNBC. We look forward to updating the market once again once the study starts. In addition TPIV 200, we also expect to initiate two clinical studies for our second peptide vaccine, which is designated to target HER-2+ breast cancer. First, a company-sponsored Phase 1b/2a trial of our enhanced HER2/neu vaccine, TPIV 110, which now includes an additional HER2 peptide, compared to our original vaccine TPIV 100. As we mentioned on our last call, we expect to file the amended investigational new drug application for TPVI 110 later this year. And upon FDA acceptance we will initiate the study to evaluate TPVI 110 for treating women with Her2neu+ breast cancer. In parallel, our collaborators at the Mayo Clinic have secured a second DoD grant to fund another Phase 1b/2a clinical study in Her2neu+ breast cancer, this time focusing on women with a much earlier stage ductal carcinoma in situ, or DCIS breast cancer. This is actually a very exciting study. If our vaccine is successful in this early stage breast cancer indication, it could one day be positioned to compliment standard surgery and chemotherapy and potentially become part of a routine innovation schedule to prevent breast cancer in healthy women. Again timing of the study is driven by the Mayo Clinic, but we look forward to providing an update as soon as patient enrollment begins. Last but certainly not least, complementing our deep clinical stage pipeline is our proprietary PolyStart technology, which we believe represents a significant platform opportunity for the company to build additional value, both through internal pipeline development, as well as strategic out licensing to other vaccine developers. All of the data that we've generated to date for PolyStart continue to indicate that our unique protein expression technology may be able to significantly improve antigen expression and therefore enhance the potency of any nucleic acid-based vaccine. Using proprietary vectors, we've been able to enhance the expression of several functional protein antigens across multiple cell lines by at least four-fold, compared to traditional vectors. In some cases six-fold to ten-fold or more. In laboratory studies we've also shown that these antigens are effectively presented on the surface of immune cells and are able to direct the cytotoxic activity of CDA T-cells, which is still important for an effective immune response. As we continue to validate our unique approach with additional studies, our goal will be to demonstrate the value of PolyStart to potential out licensing partners. We remain very pleased with our progress and look forward to exploring multiple opportunities to monetize this platform technology both within oncology, as well as in other areas where vaccines are used, of course infectious disease as the primary. With that, I'll turn the call to Glynn for some closing remarks.

Thanks Rick. I want to acknowledge the work of you, and the clinical development team image [ph] keeping us competitive with respect to protocol amendments and also meeting our recruitment targets. That's a great achievement, certainly in the second quarter. So in conclusion, TapImmune is focused on treating women's cancers, because this large and un-served patient population deserves better treatment opportunities. We are very active in valuating our novel immunotherapies through multiple ongoing and planned clinical studies. So our shareholders can expect many upcoming milestones in the months and years to come. In the remainder of 2017 alone we expect to complete patient enrollment in our ongoing Phase 2 dosing study of TPIV 200 for treating triple-negative breast cancer. We expect Mayo Clinic, together with ourselves, to publish the long-term safety data, immune response data and progression free survival data from our completed Phase 1 study of TPIV 200. A manuscript is ready to go for submission to a peer-review journal. And soon as it’s accepted it's in electronic form we will make the data available to all our shareholders. We also expect Sloan Kettering to complete the interim analysis from Phase 2 combination study of TPIV 200 with AstraZeneca’s durvalumab for ovarian cancer, which we can then report out. We also plan to file amended IND for TPIV 110 for treating HER-2+ breast cancer and begin the Phase 1b/2a study upon FDA acceptance. And finally, we are hopeful that the Mayo Clinic will initiate the 280-patient at Department of Defense funded Phase 2 study of TPIV 200 in women with triple-negative breast cancer. We're very optimistic that our continued clinical execution should lead to several catalysts for the company and its shareholders over the coming quarters. We look forward to building this long-term value with your continued support. And we thank you again for joining us on call today. Operator you may open the lines for questions.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And the first questioner today will be Travis Walker, a Private Investor. Please go ahead with your question.

Hey Glynn and Rick. Thanks so much for the update, there was a lot of great information in there. There are few questions. The first is around the design of the DCIS study, the one you mentioned was funded by the Department of Defense starting with the Mayo Clinic. Can you just talk a little bit about the design of that study?

We actually don't have the details of that design, that’s a Mayo-sponsored study, we are providing the TPIV 200 – TPIV 100. And that study is as far as I know fairly far along, but they've not yet shared those details with us.

Yes let me let me answer Rick.

Okay.

Ductal carcinoma in situ is really the earliest stage of what could become a breast cancer, but it's confined to the milk ducts in breast. And so the standard of treatment is lumpectomy or mastectomy after diagnosis. What we’re doing is in what will be a 40-patient to 45-patient study we’ll be looking at the use of the HER2neu vaccine given to these patients about six weeks ahead of surgery. So we will have the ability to look at the effect of the vaccine and the immune system on the lumps in the breast ahead of surgery. We will also be able to look at the infiltration of immune cells into the site. And the precedence that this will work. And so it’s a very exciting study which will give us a lot of information.

And that’s quite elaborative [ph], thank you. So my next question is about the purpose of the protocol amendment you made to the ovarian cancer study. Can you talk about why you didn’t design a study to enroll the patient population at the beginning?

You want to answer that Rick?

Well I can try. Actually that was designed long before I joined the company. And so I wasn’t part of those discussions. So the why is a little bit difficult. But I can tell you that those patients in the second remission were seen as the next target for a creative approach. Patients in the first remission were not yet seen as available for a novel technology. And this was still considered to be a novel technology. Given that we’ve got a lot of experience now with the TNBC subpopulation, we have an opportunity to go into this healthier population in first remission. And so we’ve essentially flipped into a space that both has no other medications available during that first remission and can benefit from having a larger population that has a healthier substrate. So we expect great things actually from that study. And the PIs, we talked a lot with the PIs in making this change and they are very excited about the opportunities that sort of presented themselves with this.

Great thanks. Thanks for the clarifying that. And one final question before I let you go. Can you talk about when you expect to see partnership for Polystart?

We’re looking all the time. What we’re focusing on now is really completing our dataset with Polystart to show that the increased expression from Polystart correlates with increased immune response. So we’re just dotting the i's and crossing the t's at the moment. But we’re already starting to have discussions.

Fantastic. Thank you again for answering those questions.

You’re welcome.

[Operator Instructions] And we do have another questioner, it is from Mark Taylor, a Private Investor. Please go ahead with your questions sir. Mark Taylor your line is open for questions. And our next questioner today will be Monish Paul with MHP Capital [ph]. Please go ahead.

Hey good afternoon. I was wondering if can give me an idea to burn rate for the next couple of quarters given all the activity from a clinical trial perspective. Thank you.

Yes hi Monish [ph]. The burn rate we’ve capped below $1 million a month, at $800,000 a month. So based on that burn rate we have sufficient capital to advance our programs over the next 12 months. Some of the cash outflow is – we do get some money back in from the Department of Defense grounds when we provide material to the Mayo Clinic for the clinical trials and have done that a couple of times now. So that non-diluted financing certainly helps us.

Okay, great. Thank you so much. I appreciate it.

Welcome.

[Operator Instructions] And it looks to be no further questions today. So this will conclude the question-and-answer session. I would like to turn the conference back over to Glynn Wilson, CEO for any closing remarks.

Thank you. And thank you all for joining us today. We look forward to speaking with you again soon. And please look at our website, www.tapimmune.com where we try and keep that site updated. And that includes our presence on social media, which we’ve certainly enhanced over the last three months. So thank you all.

And the conference has now concluded. Thank you all for attending today’s presentation. You may now discontent your lines.