Marker Therapeutics, Inc. (MRKR) Q3 2017 Earnings Report, Transcript and Summary

Good afternoon. And welcome to the TapImmune Third 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] Please note this event is being recorded. I would now like to turn the conference over to Josh Drumm with Investor Relations. Please go ahead.

Thanks Afton [ph]. Good afternoon. And welcome to the TapImmune’s third 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 yesterday, November 14, 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. Joining us on call today will be Mr. Peter Hoang, President and Chief Executive Officer of TapImmune; Dr. Richard Kenney, Head of Clinical Development and Mr. Michael Loiacono, the Company’s CFO. At this time, it is now my pleasure to turn the call over to Mr. Peter Hoang, President and Chief Executive Officer of TapImmune. Peter please go ahead.

Thanks Josh. Good afternoon and thanks for joining us today. I’m pleased to host this quarterly update call which is my first as CEO of TapImmune. As you know I joined the company at the end of September. So at the end of the third quarter. It’s my pleasure to be able to report on the progress that TapImmune has made in the quarter, which, I think, puts us in a good position to achieve the important milestones we intend to meet this quarter, my first full quarter with the company. I think that TapImmune is well-positioned with differentiated cancer vaccine candidates and proprietary technologies and the indications and the treatment studies that we targeted. I hope that you’ve all had a chance to look at my letter to our shareholders. As I said in that letter I see a real opportunity for TapImmune to lead our industry, delivering potentially life-changing therapeutic outcomes for our patients. Broadly speaking, immune therapy approaches have had a tremendous impact on the treatment of certain cancers, delivering for the first time a glimmer of hope that patients can achieve durable and complete remissions, but only in some patients. The industry is currently led by checkpoint inhibitors, the metamorphically remove the breaks for the immune system to enable the body to target tumor cells. These approaches have been limited to date by their reliance on cancers that have high rates of tumour mutation rates. And also we’ve seen significant advances by cell-based approaches CAR-T and TCR therapies, which are highly targeted for certain cancers in patients. Recent clinical experience highlights the significant promise of these approaches, but also exposes many of their limitations. Based on what we've learned in the past few years what’s needed in order to advanced cancer immune therapies are new approaches that can stimulate patients’ endogenous immune systems, the more efficiently detect and destroyed cancer cells, especially against cold tumors, meaning those with low rates of DNA mutation, which continue to evade detection and elimination even when the breaks are fluid. So in our indications ovarian and breast cancer, these indications have been particularly difficult indications for those therapies because of their respective low mutational burdens and difficult tumor micro environments. Particularly in remission settings it's difficult to justify the cost of a potential toxicity related to the use of a checkpoint or cell therapy. In order to drive improved patient outcomes in our therapeutic settings, we now recognize the need to generate consistent and durable immune responses. Generally speaking, we need to pursue approaches that generate immune memory by targeting multiple target epitopes, particularly those that have demonstrated the greatest potential to break immune tolerance. We have to find a way to develop therapies that are usable off-the-shelf for the vast majority of the population versus a single individual patient. And we have to make it affordable. In the treatment settings that we currently target, that is for patients who responded to first line cancer therapies, like surgery and chemotherapy, TapImmune is in a unique position to fulfill important treatment gaps with our novel technologies. And I think that that presents an exciting opportunity for the company and its share holders. For example, women in their first remission for ovarian cancer currently have no approved therapies that have been shown to help patients avoid relapse following initial therapy. Therapies that are currently seeking approval in this area like PARP inhibitors tend to work best in a limited subset of patients, like those who have BRCA mutations, but performed relatively poorly in patients who do not. And furthermore, these therapies are further complicated by significant toxicities. Our clinical investigators have personally expressed their excitement about being able to offer a treatment like ours for those patients. Unlike most cancer vaccine approaches our off-the-shelf T cell vaccines are designed to elicit a broad based T-cell response and maybe used with the vast majority of the population without respect to HLA restrictions. In our early clinical trials we've seen powerful immune responses generated in more than 90% of vaccinated patients with most patients generating responses against several of the epitopes contained in tumor vaccine. Unlike previous vaccine approaches that have failed, our approach uniquely targets helper T-cells, which we now know is essential to generating immune memory and enabling killer T-cells to continually seek and destroy cancer cells. To further enhance these augments, our proprietary PolyStart platform is designed to help drive antigen presentation and make all kinds of tumors both hot and cold more visible to the immune system. So I hope that you can understand and appreciate my enthusiasm and my conviction that our technologies can help save and extend lives, as well as the deliver potentially improved quality of life for affected patients. As we continue to advance our deep clinical pipeline, I am determined to drive TapImmune to explore potential from discovery, through tribulation [ph] development into clinical execution, regulatory approval and commercialization. As a company, I expect us to execute more crisply from an organizational, operational, regulatory and commercial standpoint that we ever had, as well as to drive an enhanced appreciation and support for the efforts of TapImmune by the investor and financial community. Before I hand the call to Dr. Richard Kenney, our Head of Clinical Development for clinical update, I'll go over our overall strategy and some recent Company highlights. Our primary objective is to continue executing our active Phase 2 trials as efficiently as possible. In parallel we expect a lot of additional clinical studies for each of our novel cancer vaccine candidates in order to further highlight their potential and generate even more value for the company. My goal is to ensure that we're executing efficiently in our clinical trials so that we achieve every milestone we set for the company. Something that I believe is necessary in increasing the competitive immuno-oncology landscape. I believe that this goal is achievable and I’m committed to making it a reality. Since our last quarterly call, we have continued to deliver recently achieving full patient enrollment in our Phase 2 triple-negative breast cancer study for TPIV 200, done in collaboration with the Mayo Clinic. This milestone was achieved almost a two months ahead of schedule. So I want to thank our investigators and the team’s due diligence, as well as the patients who are contributing to the development of this vaccine. With enrollment not completed we are looking forward to continuing patient vaccination in this comprehensive four-arm study which is designed to help determine the optimal vaccine dose and regimen to maximize patients’ immune responses. Patients in this study will receive administered dose of the TPIV 200 every six months but they remain progression-free. So in addition to immune response this study will look at disease-free survival as a secondary endpoint. Later this quarter we hope to announce when the Mayo Clinic vaccinates their first patient in the large Phase 2 efficacy trial that is planned for TPIV 200 in the same indication. This 280-patient randomized, double-blind, and placebo-controlled trial will evaluate disease-free survival in women with advanced triple-negative breast cancer. As a reminder, this study is sponsored by the Mayo Clinic and is fully funded by a $13.3 million grant from the U.S. Department of Defense. While this study will take some time to complete, it represents a tremendous opportunity for us to demonstrate the potential of TPIV 200 vaccination to prevent cancer recurrence in a very large patient population at virtually no cost to TapImmune. We’re excited for Mayo to start patient enrollment in this important study. Before the end of the year, we also expect to complete the filing requirements for TPIV 110 which will allow us to use the five-peptide vaccine in future critical studies of women with HER-2+ breast cancer. This program is based on a successful completion – on a successfully completed Phase 1 study by predecessor vaccine and is a nice complement to another Phase 2 study that the Mayo Clinic is planning to initiate in ductal carcinoma in situ or DCIS in breast cancer. The Mayo study is also covered by U.S. DoD grant and may enable us to expand the types of cancers targeted by our HER2neu vaccine. Based upon guidance from our collaborators at Mayo, we expect the DCIS study to being enrolling patients in early 2018. Conducting new studies helps to run that our vaccine pipeline building greater value from the company. Additionally, we expect to publish the results of our completed Phase 1 study of TPIV 200 in the coming weeks. The description is currently under review by a high impact, peer reviewed oncology journal, pending certain revisions. As soon as the final manuscript is made available by the journal, we will make an announcement to highlight the key findings. As a final comment I'd like to say that I do believe that we had a significant opportunity to bolster our pipeline and portfolio through corporate and business development initiatives. And we intend to focus significantly effort into pursuing some of these opportunities to expand the market opportunity and drive share holder value for TapImmune. With that I’ll hand the call to Rick to provide greater detail on our clinical programs. Rick?

Thanks a lot Peter. As many of you know our lead candidate vaccine TPIV 200 is currently being evaluated in four active Phase 2 clinical studies. TPIV 200 is a multi epitope CD4 peptide vaccine targeting a cancer biomarker called folate receptor alpha. The first study of those products is a combination of TPIV 200 with AstraZeneca's PD-L1 checkpoint inhibitor called durvalumab, which is being conducted by the Memorial Sloan Kettering Cancer Center in women with recurrent or persistent ovarian cancer who have failed at least one prior platinum-based therapy. This is a first study to evaluate the combination of a peptide vaccine with a checkpoint inhibitor in this population of women with platinum-resistant ovarian cancer, who typically have a very poor survival prognosis and no real treatment options that are FDA approved. Enrollment in this single-arm study was suspended as required by the Simon two-stage trial design, while the first 27 patients who are currently enrolled complete their treatment and the planned interim analysis is conducted. Based on the discussion with the studies clinical investigators at MSKCC, the data are currently being analyzed. We anticipate reporting results based on these patients in the first half of next year. If the safety profile remains positive and there are sufficient signs of tumor response with the combination therapy enrollment may be resumed and the study can be completed as designed. We look forward to providing an update as soon as the data are available and can be disclosed publically. The second study is a TapImmune sponsored randomized, controlled, double-blind Phase 2 study to evaluate TPIV 200 as a vaccination – as maintenance therapy to reduce the rate of recurrence. In this case in women with platinum-sensitive ovarian cancer as opposed to the study I just mentioned. We made a strategic commitment to the study’s enrollment criteria in the second quarter. To shift the focus of this study to dose TPIV 200 at a point that is earlier in the treatment paradigm where no approved therapies currently exist, namely to give TPIV 200 to women in their first remission following the initial round of a successful platinum-based chemotherapy. Enrollment in the amended study was started in August and it is on track. We expect to conduct a blinded interim safety and futility analysis in early 2019 once the data from the first half of enrollment is achieved and responses mature. As Peter highlighted, we recently completed enrollment in our other TapImmune-sponsored Phase 2 study in women with triple-negative breast cancer. This multicenter randomized Phase 2 study will help determine the optimal vaccine dose and regimen that can maximize the anti-tumor immune response in women with maintenance-phase triple-negative breast cancer. With enrollment now complete, we can expect to report top line interim data in the first half of 2018, which will be focused on patient immune responses following vaccination with varying doses of TPIV 200 after treatment with or without cyclophosphamide. Peter also mentioned that our collaborators at the Mayo Clinic have open enrollment for patients in the fourth study of TPIV 200, also in women with advanced triple-negative breast cancer. We remain grateful to the Mayo Clinic for their plans to advance TPIV 200 on our behalf in this large 280 patients study, which is completely funded by the $13.3 million grant from the DoD. Similar to our TapImmune sponsored study it will enroll women who have completed standard of care surgery chemotherapy and radiation for triple-negative breast cancer. Between these two studies we hope to begin to correlate anti-folate receptor alpha immune responses that are generated by the vaccine with prolonged disease free survival. For our second peptide vaccine candidate that targets the HER-2+ breast cancers, we’re completing the FDA filing requirement that will allow us to begin enrolling patients into a Phase 1b/2a study next year, with the updated product. This immense IMD is required for TPIV 110, a five peptide version of its predecessor vaccine, which is now called TPIV 100 that's already been studied in Phase 1. In parallel the Mayo Clinic is also planning to start Phase 1b/2a clinical study of that four peptide vaccine in women with the DCIS breast cancer. And they secured a grant funding from the DOD to do this as well. DCIS is as an early stage breast cancer indication that accounts for about one fourth of new breast cancers each year in the U.S. If successful, our vaccine could one day be positioned to complement standard surgery and chemotherapy in this setting, as well which is an exciting proposition and underscores the potential for effective chemotherapies. The timing of the study is driven by Mayo Clinic. And we look forward to providing an update as soon as patient dosing begins. Finally, completing our deep clinical stage pipeline is our proprietary DNA vaccine technology that we call PolyStart. We are continuing to develop this platform opportunity which we believe can generate significant value for TapImmune both through internal pipeline development as well as strategic out licensing to other vaccine developers. In the last studies we've been able to enhance antigen expression up to ten-fold with this product and further show that they express antigens are presented in greater quantity on a surface of immune cells enabling them to more effectively direct the cytotoxic activity of CDA T-cells. Results are quite compelling. As we continue to validate this platform with additional studies, our goal be to demonstrate the value of PolyStart to a potential out licensing partners and to pursue additional intellectual property to cover broad uses of our technology to enhance vaccines within oncology and infectious diseases. With that, I'll turn the call over to our CFO, Michael Loiacono for an update on our financials.

Thank you Rick. I’m pleased to review our Q3 2017 financials. Firstly, right yesterday afternoon you filed our 10-Q for the third quarter and we urge you to read the information in footnotes contained in the 10-Q for a more complete explanation of our results and financial statements. We recorded a net loss for the third quarter of 2017 of approximately $4 million or $0.39 a share. This is compared to a net loss of $1.9 million or $0.22 a share for the second quarter of 2017 and compared to a net loss of $2.1 million or $0.29 per share in the third quarter of last year. our net loss for the quarter was impacted by about $1.1 million of stock compensation charges relating to employment agreements executed during the quarter. Excluding those charges net loss per share for the quarter would have been $0.28 cents a share. Total operating expenses for the third quarter of 2017 were $4.2 million, compared to $2.4 million in the second quarter of 2017 and $2.7 million for the third quarter of 2016. Excluding increased non-cash compensation expenses booked during the quarter, operating expenses would have been $2.9 million or an increase of about 21% from the second quarter of this year. R&D expenses during the quarter were $1.6 million compared to $1.2 million for Q2 of this year and compared to $1.1 million during Q3 2016. the increase in R&D expenses relate to increase spending in our clinical trials as we continue to enroll patients in our triple-negative breast cancer trial and continue preparations for our ovarian cancer trial. G&A expenses for the quarter were $2.5 million, versus $1.2 million in Q2 and $1.6 million in Q3 of last year. Excluding the incremental non-cash stock compensation expenses recorded during the quarter G&A would have increased less than $100,000 from Q2 of this year. With respect to our financial results for the nine-month period ending September 30, 2017, our net loss was approximately $8.3 million or $0.91 a share. This is compared to a net loss of about $900,000 or $0.14 basic and $0.54 diluted loss per share for the same period in 2016. Net loss for the nine months of 2016 was positively impacted by a $5.9 million gain in change in fair value of warrant liabilities. Total operating expenses for the nine months of 2017 were about $9 million, compared with 46.9 million for that nine-month period of 2016, which represents an increase of about 30%. R&D expenses for the nine months of 2017 were $3.8 million, as compared to $3.3 million for 2016. The net increase of $500,000 year-over-year was a result of increased spending relating to our clinical trials paused out by license fees of about $1 million paid to Mayo Clinic during the nine months of 2016. Our cash used in operations for the nine-month period of 2017 was approximately $6 million And that’s compared to $4.8 million for the nine-month period of 2016. The increase in cash used in operations resulted primarily from our increased spending in our Phase 2 clinical trials. With regards to our balance sheet, we are into Q3 2017 with $7.6 million of cash this compares to $7.9 million of cash at December 31, 2016. At September 30 we had $1.7 million of accounts payable and accrued liabilities of which about $1.3 million represents normal operating accounts payable. Lastly, we ended the quarter with $5.9 million of working capital, which compares to $6.2 million of working capital at the end of fiscal 2016. I will now hand the call back over to Peter for some additional and closing remarks. Peter?

Thank you, Michael. In conclusion, TapImmune is a leading clinical-stage immuno-oncology company with multiple ongoing clinical trials in large and underserved cancer indications. We're optimistic that continued clinical execution across our deep pipeline should lead to several important and significant catalysts for the company and its shareholders over the coming quarters and years. We are on the strength of our technologies which I believe to be significant I also believe that our people and our energy can help drive therapies through regulatory approval and commercial success. I'm convinced that the unique approach we're taking will also attract others in the immuno oncology space they want to collaborate with us and develop compelling combinations therapies and potentially improve patient outcomes. In addition to continuing to drive capital efficient clinical execution another critical objective is to better communicate our value proposition in the capital markets, to ensure that TapImmune is appropriately valued by investors who understand it’s the space and will be able to see where the company is headed. We look forward to the next quarterly update and keeping the market up to date on milestones that we're tracking for the rest of 2017 and into new year. I also want to thank our shareholders for your continued support which enables us to continue to pursue our mission and develop what we believe will be nice to immunotherapies by changing the phase of standard of care. Thank you. Operator you can open the line for questions.

Thank you. Can I hear some more about your strategy for improving operational efficiency?

See Clark [ph]. Look, let me be candid about [indiscernible] there are things that we as the company done well, but there are also many things that we're not done effectively historically. Much of my time in these first 50 days of the company has been assessing what’s working well within the company and identifying those things that aren’t. For example, I think that we need to acknowledge the fact that the company historically has not done an exceptional job of hitting the milestones with regarded investor expectations to. But the problem it comes from two major issues. The first is, a failure to properly forecast realistic timeframes, through which we provide guidance. One of the things that I’ve focused on is to analyze our timelines with a lot more rigor, and to align our projected timelines and milestones to be more in line with industry norms. The guidance that we give from this point will be rooted in a very thorough analysis of what needs to be done in order to achieve the goals we set and assess with a realistic expectation of what could be accomplished based upon the industry standards and industry experience. The other side of the problem is frankly rooted in execution. When I say that we have to execute more crispy I mean two things by that. Firstly, we really need to move with more urgency. Historically TapImmune as allied in many cases on the work of our academic partners, which has working well for us in many cases. But academic institutions as you may know tend to work along different timelines and with a different sense of urgency than the other commercially focused organization like TapImmune. So we’ll continue to work with our academic partners, who act like a force multiplier for us in driving the things that we can accomplish with the resources that are available to us. But in cases where we can move faster by doing it ourselves, we will. So broadly speaking, we're not going to be held hostage to developments outside our control and so in cases where times critical, we're going to find ways to accomplish was internally if necessary, so that we can move with the spin that we need to the remain competitive in the marketplace. Secondly, I think that we have to work more efficiently. When you look at clinical operations much of the work that we do in clinical development largely the basic blocking and tackling, the pluses of clinical enrollment is dependent on many cases on our ability to work with individual clinical sites and their primary clinical investigators to get the volume on therapies, motivate them to drive patient enrollment. And then make sure that there are no bureaucratic, administrative, or logistically obstacles that really prevent it from being able to enroll patients effectively. And this is what we intend to do. I’ll give you an example. Yesterday, we announced that we completed full enrollment on the Phase 2 triple-negative breast cancer trial almost two months ahead of schedule. We managed to do that, because we focused on the operational execution. Rick, along with Gerald and his clinical operations team we were able to drive the enrollment rate of our patients in that clinical trial and at our clinical trial sites over the last few months. Almost quadrupling the enrollment rate over that period versus the first quarter of this year that was done despite the fact that we had to go head to head against high profile clinical trials like the Phase 3 pembrolizumab trial by Merck that's what I mean by blocking and tackling and that's how we're going to drive operational efficiency.

Okay, thank you. So if I can go on, I saw SEC filings showing insider selling from both you and Dr. Wilson, can you shed some light on why you would sell shares soon after joining the company?

Sure. I can say categorically. I’ve never sold the single share of TapImmune. I'll also point out that, at my previous company I never sold the share of Bellicum, well, I was an executive there either. I took this position as CEO, which is I think that we've got a significant opportunity ahead of us. So I think what you may be referring to is confusion about the SEC filing about my initial stock grant, which can be confusing to interpret for people who aren’t used to reading SEC documents that is most of us. My initial stock grant upon accepting the position here is CEO is deemed to be compensation and seeing with my salary is. So like any company when your employer pays you, it’s compelled to withhold an appropriate percentage against federal and state taxes associated with it. So I assuming here that what you are referring to is that in the same way that the company withholds my salary that's been twice a month. They was held about 30% of my initial stock grant as standard tax withholding as company has did.

Okay. Thank you. That clarifies. Thanks. So then I guess my last question is, I see that guys have $7.6 million on the balance sheet, so what is your current cash right away?

Hey thanks [indiscernible], this is Michael. Over the last two quarters, we've been using about $2 million a quarter for operations. So if you want to use that as a run rate going forward and adding some incremental spending to our ovarian cancer trial moving forward, that math would put us into Q3 of 2018. While we always have the ability to slow the enrollment in the trials that's certainly not ideal and certainly something that's not planned. We've discussed additional financing activities and we certainly will not be waiting until a late Q2 or early Q3 timeframe to address. So it's on our radar, and it's something that will be actively we’re looking into.

All right. Thanks. That’s all my questions.

Thanks Clara.

Our next question is from Karl Malden [ph] a Private Investor. Please go ahead.

Hey, thank you all so much for the call. You mentioned that you are interested in pursuing opportunities to build out the pipeline. Can you go into any further detail on what types of assets that you're going to look for?

I think that it's premature to talk about any specific sort of asset. I think that what we're looking for are assets that are potentially synergistic to the portfolio and are immediately accretive to shareholder value. As you may know my background is heavily rooted in originating and executing strategic transactions to drive shareholder value. So I actually happen to think that one of the short term benefits of being in the immune oncology space right now is that there’s a actual wealth of opportunities, that cannot prescribe some synergies whether that be through a strategic partnership, or add on opportunities that leverage our technology and our capabilities. So I'm convinced that there are actually many strategic opportunities, strategic development opportunities across the spectrum of IO frankly that are actionable in the short to medium term, that can be immediately and significantly accretive to shareholder value. We're going to continue to assess those opportunities over the course of the short to medium term. And where appropriate we will pursue some of those opportunities.

Very exciting, very exciting. Can you go in any further details at all regarding the status of the Memorial Sloan Kettering trial?

Well, as Rick highlighted in his commentary, the trial at Memorial Sloan Kettering remains open. And so based on our conversations with the primary investigators there. I think that we should get an update based on their data analysis in the first half of 2018.

Fantastic. So can we expect those Phase 1 results to be published and what’s the reason at this point, I guess, for the delay?

So it's interesting. Let me go back to your last question, because coming from the cell therapy field by the way, I think that there's some commentary that I would add to the MSKCC trial, because I think that ovarian cancers are pretty interesting indication for me. And that historically coming from the cell therapy a checkpoint, the ovarian has been an extraordinarily difficult indication for checkpoint therapies and cell therapies. I have yet to see any meaningfully positive outcomes reported from either checkpoints more continued studies. I'm hoping that this even change over time but the difficulties – even gene-modified T cells have seen in that setting like the failure of TapImmune [indiscernible] study in ovarian. Point of the fact that I think the combination studies will probably be only the first step in the dressing primary tumors in an aggressive indication like ovarian. So from my standpoint I’m eagerly waiting for the data analysis coming from our partners over to MSKCC. With respect to the Phase 2 study is that you talked about Phase 1 study right.

Correct.

Okay. So for the Phase 1 study, let me give you an update on the most recent status. So our lead investigator of the Mayo Clinic as you know submitted a manuscript for publication to one of the leading journals in the clinical oncology field. And they have received a reviewer comment on the paper. I have actually seen the comments, and I think that they're reasonable, straightforward and addressable. Our collaborators at the Mayo have addressed the items that have been highlighted by the reviewers, and are addressing the response. Well the subject of the editorial review process there, I think, that personally we should be in a position to announce the results of that data inherently when the paper is published.

Great. Thank you.

The next question is from Jack Roseman a Private Investor. Please go ahead.

Hi, there and thanks for taking the questions. First of all, congrats on completing enrollment in triple-negative breast cancer study. In addition to looking at the mean responses for this interim analysis, are you also going to be tracking the disease-free survival in those patients? And if so, when we would expect to see that data?

That’s a good question. Thank you. The disease-free survival in a breast cancer study is a little bit different than in a study with a faster pace disease like ovarian cancer. In breast cancer you don’t typically do CT scans and these patients have a much less propensity to progress in their natural history. And so you’re mostly depending on their clinical progression and clinical evaluation of that progression. You therefore need much larger patient database to really say, much of anything definitive. And so disease-free progression in this case – in this study is really an exploratory endpoint and won’t be part of the interim analysis. Really what we’re looking for in the interim analysis is whether or not we’ve got a sense that the peptides themselves are causing an immune response in the conditions that we’ve addressed in that the primary design of the study, which is cyclophosphamide either the addition of it or not as well as the high or low dose of the vaccine.

Got it. Thank you. Okay, so my second question is have the 280 patient DOD started enrolling patients yet?

So that’s correct. The Mayo Clinic is currently enrolling patients for the study. We have not yet dosed the first patient. So in the last few weeks they’ve requested that we provide drug for dosing their first patient, and we provided that to them. So as a result I expect that we should be in a position to announce the dosing of that first patient in the trial in the next few weeks.

Okay, great. And my question is what is the next milestone for the Fast Track ovarian cancer study?

So the study of TPIV200 in platinum sensitive patients is, like we said, starting to enroll, we are going to be getting probably a couple of dozen sites and we’ll be enrolling for most of next year. The interim analysis can be done one about half of patients have enrolled and those we get about half of the endpoint which is progression in this disease. We expect that to happen sometime towards the end of 2018 early 2019 and then can do the analysis at that point.

Got it.

That’s really the only milestone. Yes, that’s the only milestone we can predict at this point because it is a blinded study.

Got it. Thanks a lot.

The next question is from Jerry Logan a Private Investor. Please go ahead.

Hey, folks I just want to say congratulations. You are doing a marvelous job. I’ve heard that guide for ovarian cancer that’s interesting on cell that’s what got me interested in the investment of few folks. Are they with you prior to the reverse split? And I told you that we’re – what viewing like. I guess my question is, and you said you trade at H&Q, so cash burn is always a problem and I know that CFO just trying to address that with $7.2 million. Your cash burn is about $2 million per quarter that type of thing. Where do you stand with Polystart as far as potentially out licensing to potentially alleviate additional stock dilution? Unfortunately the stock price has kind of disintegrated a little bit.

Thanks, Jerry. Let me address that. So with respect to the cash burn I think that one thing, I’m able to point out is that we do have the ability to modulate the rate of the cash burden by modulating the speed at which we enroll patients. Currently, we are guiding towards that date based on a very aggressive rate of enrollment in the clinical studies because I think it’s a little important here. We expect that with the milestones that we are about to announce our completion that we will be in a – we should be in a good position to help drive shareholder value here and increase investor confidence that we are executing differently and better than we had in the past. With respect to Polystart, I think that’s one of the priority initiatives for the coming quarter. I will tell you that historically the business development, corporate development efforts here are not a priority and that’s one of the things that we intend to change. I think that one of the benefits of coming from a background where I spent the last five years talking with pharma and major biotechs and other space about potential transactions is that we know the people that we need to go to take Polystart to have interesting conversations. I want to mitigate the expectations here in that – my experience with licensing transactions is that they tend to be long lead time. And so while I fully expect to be able to drive the conversations in ways that will help monetize the asset for us. I think we have to look at the capital requirement in isolation from the question of the licensing with Polystart.

Very good answer. I read your bio and it looks like you’ve got a very extensive background in what you do. So I applaud that. As I said, I applauded the ovarian cancer aspect of things. Obviously as an investor under somewhat concern with the cash burn. I’m very happy with the $13 million DOD. Hopefully we’re going to start to see some very positive results in conjunction with Astra, with ovarian cancer that was my initial investment opportunity and why of thought of this and I’m just also not out there as far as, the last thing unfortunately I guess, one of the [indiscernible] on TapImmune in the past was that there was a lot of funky large kind of investing in that type of thing and it kind of its like moved into a lot of people. I try to be long winded, I’m just going to leave at that. I’m sure they broadly win to alleviate a lot of that.

Thank you, Jerry. I think you’ve hit a lot of the issues ahead. I think that I look at the stock price and I think that it is something that we want to address. There are things that we have like I said done well and things that we’ve done poorly. I think that we can do better in the investor communications and making sure people understand what the value proposition is here. The second is that injunction with the investor communication and investor support, look there’s no doubt that overtime we’d like to address the capital structure and help alleviate any difficulties that are involved with the capital structure. But in many ways I look at that question very much the way that it will be looked at terrain or weather which is that you can complain about it all you want but this is the world that we live in – this is the world that we’re prepared to operate in. I recognize that warns are complication in terms of evaluation time. But I’m confident that we can work our way through it.

I have ultimate confident. I want to quote this, we’ve got nothing but individual investors and I know Mr. [indiscernible] and the physicians for a very short period of time. Stock price is about $3 a share. So I understand how difficult it is – how are you getting out there trying to get institutional investment activity going? And to the results kind of people to get this share price going a little bit more.

Well, I think you hit the nail in my head. Actually we have to get out and generate interest from institutional investors. I think that – I love our shareholders for the support that they’ve given us historically and I would love for them to continue to be our shareholders and perpetuate. But, I think the best way for us to drive half investors is to be able to drive a return for them. And the way that we’re going to do that is by getting conventional biotech investors in a mid-cap company to invest in this company. That’s easier said than done because we all recognize that the current market cap makes it difficult for many institutional investors to participate. But I do believe that with the value proposition with our current clinical portfolio alongside the opportunity we can drive some of the strategic opportunities that we have. I think that we have every opportunity to bring in conventional biotech life sciences investors that will be validating to the investment thesis here.

With the 100%, I wish you have 100% success.

Thank you very much.

Thank you for taking my questions.

Absolutely, happy too.

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

Thank you very much guys. Once again, I want to conclude by thanking all of our investors for your support historically and your patients. As I said on our call, we are intensely focused on driving operational efficiency and driving shareholder and investor value for you, our shareholders and to drive towards creating transformative outcomes for our patients. I thank you once again for all of your support and look forward to hearing from you again on our next quarterly conference call.

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