Marker Therapeutics, Inc. (MRKR) Q4 2017 Earnings Report, Transcript and Summary

Good day everyone and welcome to the TapImmune Fourth Quarter and Full Year 2017 Corporate 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 and please note today’s event is being recorded. I would now like to turn the conference over to Josh Drumm. Please go ahead.

Thank you. Good afternoon and welcome to the TapImmune’s fourth quarter and year end 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 [Audio Gap] limited to any of the following. Any statements other than 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, and 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 annual report on Form 10-K filed, March 23, 2018, 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, Chief Medical Officer; and Dr. Michael Loiacono, Chief Financial Officer. 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.

Thank you. Good afternoon and thanks for joining us today. It's my pleasure to host this update call to highlight the progress that TapImmune has made in terms of advancing our clinical cancer vaccine programs and building additional values through data publication and non-dilutive funding for our clinical studies. Before I hand the call to Dr. Richard Kenney, our Chief Medical Officer, for a clinical update, let me go over some recent company highlights. First of all, I’d like to say that I think we have had an absolutely fantastic quarter. Since our last quarterly call, we have made significant advances towards achieving our goals and reaching our milestones. We recently announced the publication of clinical data from the Phase 1 trial of TPIV200, our multi-epitope T-cell vaccine targeting folate receptor alpha in patients with ovarian and breast cancer. That data published in a leading peer reviewed oncology journal in clinical cancer research shows that TPIV200 vaccination was well tolerated by all patients and over 90% developed robust and durable and antigen specific immune responses against folate receptor alpha, without regard for HLA type. All patients remained alive at the last follow-up at least two years following initial and initiation of immunization and a large majority of vaccinated patients developed lasting immune responses against multiple folate receptor alpha epitopes. This evidence of lasting anti-tumor immunity aligns with the intended mechanism of action for the vaccine. These results are very promising and demonstrate clear proof-of-concept for TPIV200. What’s even more encouraging is that although the safety trial was not designed to evaluate clinical efficacy outcomes, we reported a potential progression free survival benefit based on a subset of women with ovarian cancer in their first remission to progress during the study during the follow-up period. While the population of 10 patients does not rise to the level of statistical significance, the observed median progression free survival of 520 days for women who received our vaccine compares very favorably to historical data where women receiving standard of care in this setting had a median progression free survival of only 313 days. This clear trend towards potentially prolonged progression free survival was certainly intriguing the TapImmune and our clinical investigators. And it highlights the value of our multi-epitope vaccine in the first remission setting where patients have gone through effective chemotherapy and surgery and still have healthy immune systems that may well -- that may respond well to an effective vaccine. Should we see similar results in our larger ongoing randomized double-blind controlled Phase 2 study which is currently enrolling patients at the same stage of disease, we believe the TPIV200 could have a very viable pathway for its potential approval in this indication. Enrollment in the Phase 2 study remains on track and we expect to conduct an interim analysis by mid-2019, which is when we expect to have collected data from the first half of patients enrolled. Last year, we were pleased to achieve full patient enrollment in our first TapImmune sponsored Phase 2 dosing study for TPIV in triple negative breast cancer as well. This milestone would achieve almost two months ahead of schedule as a result of a concerted effort to improve the efficiency of our clinical operations. In fact, we were able to accomplish this milestone [Audio Gap] months in the last two quarters of 2017 versus 0.2 patients [indiscernible] through all the 26 and the first two quarters of 2017. I'd like to thank our investigators and their teams for their diligence as well as our patients for contributing to the development of this vaccine. In addition, we announced late last year that the Mayo Clinic had vaccinated the first patient in our 280 patient Phase 2 trial of TPIV200 for the prevention of cancer recurrence in women with advanced triple negative breast cancer who completed their first line surgery and radiotherapy or chemotherapy. As a reminder, this large efficacy study is fully funded by a $13.3 million grant from the U.S. Department of Defense. While the study will take some time to complete, it represents a tremendous opportunity for us to demonstrate the potential of TPIV200 vaccination to prevent cancer recurrence in a large patient population, all the while incurring essentially no direct cost to TapImmune. In fact, in the fourth quarter the Department of Defense expressed interest in fully funding yet another Phase 2 clinical study to evaluate our five peptide HER2 vaccine, TPIV110, in combination with Herceptin in HER2 new positive breast cancer patients. In conjunction with the Mayo Clinic, this potential study would supplant our smaller previously planned Phase 1/2 study in the same indication. I am particularly encouraged by the recent results seen by Sellas Pharma with statistically significant results using NeuVax their single peptide vaccine for HER2neu combination with Herceptin. I know that there is single peptide shares a high degree of immunology was one of the five peptides embedded in our TPIV110 product. And so I believe this bodes very well for TPIV110. Given that our approach is multi-peptide and build upon the single NeuVax peptide approach, I’m very optimistic that TPIV110 maybe able to drive even better results for patients. We are extremely optimistic and pleased that the Department of Defense has taking such a strong interest in funding this larger study of TPIV110. Should be ongoing discussions which in the Mayo Clinic, the DoD happy to improve successful. The larger Phase 2 study may receive full funding from the U.S. Department of Defense. It would obviously be a very favorable outcome for TapImmune as it would be deferred program essentially half of our clinical trial pipeline that would be fully funded by non-dilutive capital from the Department of Defense. We look to updating you if and when these discussions are complete and the study is ready to begin; so in addition to where vaccine pipeline, I’m pleased to announce a significant enhancement of our intellectual property for our novel PolyStart technology. In the last quarter, the U.S. Patent and Trade office reasonably allowed our patent application that expands coverage with different types of peptide sequences comprising poly-antigen arrays or PAAs. While, our previously issue patents covered PPA portions directly target to other folate receptor alpha or HER2neu peptide epitopes, the molecular targets of our current vaccine candidates. The new allowance covers PPAs composite of any polypeptide portion. In absence, this broadens our ability to replay PolyStart to any tumor antigen or pathogen allowing us to freedom to work with any outside parties or develop new proprietary nucleic acid-based vaccines with commercial exclusivity until 2035. We believe that this new patent adds substantial value to what is already a significant future value driver for TapImmune. As we continue to demonstrate pre-clinical proof-of-concept for PolyStart, we expect to be in a position to leverage this important asset. Moreover, before I turn it over to Dr. Kenney, I believe that we have the opportunity to drive enhance shareholder value through strategic opportunities. Given my view of this strategic landscape and immuno-oncology, I believe that we have a significant opportunity to advance strategic initiatives that can be immediately and significantly approve it to shareholder value. I’m pleased to report that we continue to have discussions to advance these opportunities and I’m very hopeful that we’ll have the chance to execute on some strategic opportunities in the near-term. With that, I’ll hand the call to Rick Kenney, our Chief Medical Officer to provide greater detail on our clinical programs. Rick?

Thanks a lot Peter. Just to know, I will -- my phone lines being a little touchy, so I will try to get through this and we’ll see what happen. As Peter mentioned earlier, our Phase 1 trial results for our lead vaccine candidates TPIV200 or recently published in the clinical cancer research general. TPIV200 is a multi-epitope peptide vaccine targeting folate receptor alpha, which is a tumor associated membrane protein that is over expressed in ovarian, breast and lung cancers. The initial clinical study was designed to evaluate the safety and long-term immune response of ovarian and breast cancer patients to TPIV200. Patients were immunized over six months' period following pre-treatment type of cyclophosphamide and then monitored for an additional 12 months. Study demonstrated that the TPIV200 vaccine generated strong immune responses and was well tolerated by all patients with only one grade 3 adverse event related vaccination, which was a local alternation the result. Generation of T-cell immunity following immunization was robust and long lasting in the group. Analysis showed 91% of patient had an antigen-specific response without expect HLA type with 89% of those patients responding to multiple epitodes include TPIV200. T-cell responses developed slowly over the course vaccination with the medium kind and maximum immunity of five months. As we hope to achieve with the therapeutic vaccine, the T-cell immunities of the fully receptor was shown to be durable with antigen specific T-cells remaining at high levels throughout the 12-months post immunization monitoring period. These solid and long lasting responses demonstrate the clinical proof of principle for a multi-epitode peptide vaccine approach and suggest the presence of immune memory responses that we expected to achieve in these patients. The sustained immunity against folate receptor alpha could translate to improve, outcome specifically a longer time to disease progression. Finally as Peter mentioned, there was observed that ovarian cancer patients who entered the study in their first emission had a median progression free survival time of 528 days with the 95% confident interval of 110 to 548 days. Despite the small number of patients, which contributes to the wide confidence interval, these results compared quite favorably the data from the largest controlled clinical study conducted in the patient population with ICON7 trial of bevacizumab, which is marketed at the vaccine. The results of this study were published in the New England Journal of Medicine back in 2011. In that large Phase 3 study, 625 patients received standard of care treatment as a control and they had a medium PFS time of 313 days before cancer recurring. Our medium PFS to 528 days is much longer by comparison. While this is historical data and our patients were not randomized, the contrast certainly speaks to the potential of TPIV200 in this patient population. To better understand what our Phase 1 PFS data might look like, if we study the larger number of patient, we ran a statistical multi-parallel simulation where we look at the 1.000 hypothetical outcomes using the distribution of PFS times from our 10 patients. Based on this analysis, the median PFS for 60 simulated patient was still very strong at 521 days with the much improved 95% confidence interval. This is the number of people that will be at our Phase 2 study on treatment. We believe this analysis is helpful for understanding of the potential for our Phase 2 study to produce meaningful insight and the potential impact of TPIV200 on prolonged PFS in ovarian cancer patients in first remission. I encourage you to download the white paper in fact, which is currently available on our website that summarizes our Phase 1 clinical findings in the Phase 2 simulation and includes data figures and additional references. Clearly we're very encouraged by our results, particularly in light of our ongoing Phase 2 clinical study in ovarian cancer that began enrolling women in their first remission following initial sugary and chemotherapy in August of last year. Given the lack of currently available treatment option and the potential PFS benefit we saw in our Phase 1 study, our study protocol focuses on this patient population in hope of demonstrating a statistically significant improvement in PFS. We're continuing to enroll patients as efficiently as possible and as Peter-mentioned, we remained on track to conduct a blinded interim analysis in early 2019, once the data from the first half of enrollment is achieved based on our previous data. We are also studying TPIV200 in women with recurrent or persistent ovarian cancer who have failed at least one prior platinum based therapy. This Phase 2 study is being conducted by the Memorial Sloan Kettering cancer center and is the first to use the combination of a peptide vaccine with a checkpoint inhibitor in these very advanced patients. In this case, the checkpoint inhibitor was AstraZeneca's PD-L1 antagonist to durvalumab. Women with platinum resistant ovarian cancer typically have a very poor survival prognosis and no FDA approved treatment option. Enrollment in this single arm study was suspended as required by the final two stage design, while the first 27 patients were currently enrolled completed their treatment, and the planned interim analysis is conducted. Based on discussion with the study’s clinical investigators the data are still being analyzed and we anticipate reporting results as soon as they released by the MSKCC. In 2017, we also completed enrollment in a TapImmune-sponsored phase 2 study at TPIV200 in women with triple negative breast cancer. We are pleased to announce that enrollment in this study was completed two months ahead of schedule of November. The study itself is ongoing. This multicenter randomized Phase 2 study will help determine the optimal vaccine dose and the regimen that can maximize the antitumor immune responses in women with maintenance phase TNBC. We are currently analyzing the data and anticipate reporting top line interim results in the third quarter this year. The interim analysis will focus on patient immune responses following vaccination with varying doses of TPIV200 for patients treated with or without preliminary type of hospital line. Peter also mentioned that in the fourth quarter, the first patient was dosed in the fourth study of TPIV200, which is also in women with advanced triple negative breast cancer and is being done by our collaborators at the Mayo clinic. This 280 patients randomized, double-blind, and placebo controlled trial is completely funded by Mayo's $13.3 million grant from the Department of Defense, and is designed to demonstrate safety as well as efficacy of TPIV200 and prolonging the time the disease progression in women in their first remission from triple negative breast cancer. Between these multiple studies of TPIV200 in breast and ovarian cancer, we expect to begin characterizing anti-folate receptor immune responses that are generated by our vaccine and we will attempt to correlate them with prolonged disease free survival in patients. Our second vaccine program targets HER2neu in breast cancer. We completed a successful Phase 1 study of the vaccine and has since added a fifth HER2 peptide to our vaccine. The Mayo Clinic and TapImmune are very excited about this program and we look forward to studying further in different breast cancer settings. Mayo has already secured a grant funding from BOD to launch Phase 1B/2A clinical study in women with ductal carcinoma in situ or DCIS breast cancer. DCIS is an early stage breast cancer indication that accounts for about one fourth of new breast cancer breast cancers each year in the U.S. is successful, our vaccine could one day be positioned to complement standard surgery and chemotherapy in that setting as well, which is an exciting proposition and underscores the potential for effective chemotherapies. In addition, the DoD, grant may also enable us to expand the types of cancers targeted by our HER2neu vaccine while the timing of this study is driven by Mayo Clinic. We look forward to providing an update as soon as patient enrollment begins. Peter mentioned that we are also in ongoing discussions with Mayo and the DoD regarding funding for our Phase 2 study of our HER2 vaccine candidate, this time in combination with Herceptin. As you might recall TapImmune initially planned to submit FDA filing for our five peptide HER2 vaccine called TPIV110, and to begin a Phase 1/2 clinical study in women with HER2 low breast cancer. However, in the fourth quarter the U.S. DoD expressed interest in fully funding a larger Phase 2 clinical study that uses TPIV110 in combination with Herceptin as trastuzumab in HER2 new positive breast cancer. If these ongoing discussions prove fruitful and we’re able to secure funding for new Phase 2 study, it would then replace our initially planned TapImmune sponsored Phase 1/2 study altogether. While the details of that larger study are not yet final we expect that it could be our largest study to date for our peptide vaccine candidate. We’re looking forward to providing updates on the potential study as the funding is secured and the study protocol is finalized. In addition to our vaccine pipeline, we’ve continued to advance our proprietary PolyStart technology platform as Peter mentioned. The additional patent coverage that Peter highlighted at the start of the call significantly expands the type of molecular target that we can use, and the peptides that we can encode in our poly-antigen arrays or PAA. This opens the door for us to generate value for TapImmune, both through internal pipeline development as well as through strategic outline something to other vaccine developers. In laboratory studies, PolyStart has been able to enhance antigen expression up to tenfold and further shows that the expressed antigens are presented in greater quantity on the surfacing immune cells, enabling them to more efficiently direct the cytotoxic activity of the T-cell. As we continue to validate this platform with additional studies and with the intellectual property now covering a wider array of oncology and infectious disease target we expect to be able to demonstrate the value of PolyStart to potential outlining partners who might be interested in developing nucleic acid based vaccine or enhancing the potency of their existing vaccine. With all that, I'll now turn the call over to our CFO, Michael Loiacono for an update on our 2017 financials. Thank you.

Thanks, Rick. I am pleased to review our financials for 2017. Firstly as our Josh Drumm indicated we’ve filed our 10-K for 2017 on March 23rd, and we encourage you to read the information and footnotes contained in the 10-K report for more complete explanation of our results and financial statements. With respect to our financial results for fiscal 2017, our net loss was approximately 11 million, or $1.16 per share compared to a net loss of 2.5 million or $0.36 basic and $0.72 diluted loss per share for 2016. As referenced, net loss for 2016 was positively impacted by a $5.9 million gain in a change in fair value of warrant liabilities. Operating expenses for 2017 were 11.7 million, compared with 8.5 million in 2016, an increase of 38%. R&D expenses for the year were 5.3 million as compared to 3.8 million for 2016. This $1.5 million increase year-over-year was due to substantial increased spending related to our Phase 2 clinical trials. G&A expenses increased to 6.4 million during the year from 4.7 million in 2016. The increased expense in G&A was mainly attributable to increased non-cash stock-based compensation expenses. Our cash used in operations for 2017 was approximately $8.4 million, compared to $6.5 in the prior year with the 5.7 million of cash provided by financing activities. Our net decreasing cash for the year was 2.7 million. For the fourth quarter of 2017, we used approximately 2.5 million of cash for operations. We ended 2017 with cash of 5.1 million. As a quarterly cash burn rate similar to out of the fourth quarter, we believe we have sufficient cash to get into Q3 of 2018. We also believe that cash will be available for financing need as we go forward. I will now hand the call back to Peter for additional and closing remarks. Peter?

Thanks, Michael. In conclusion, TapImmune continues to be a leading clinical stage immuno-oncology company with multiple ongoing clinical trials in large and underserved cancer indications. I believe that we’re on the strongest trajectory, a successful milestone execution and I expect that continued progress will lead to several significant catalysts for the Company coming going forward. I believe that we remain significantly undervalued given the debt and stage of our clinical pipeline. I would argue that no other immuno-oncology company of our size can burst four active Phase 2 studies with two other studies planned. Of these six clinical programs only two were sponsored by TapImmune. Half of our clinical trial pipeline is expected to be fully funded by U.S. Department of Defense grants through the Mayo Clinic. This allows us to advance a deep pipeline of cancer vaccine programs in a very capital efficient matter giving our shareholders a significant potential for return on their investment. We remain great hope to the Mayo Clinic for continuing to support our vaccine candidates and to exploring ways to moving forward in parallel with our internal efforts. As our proprietary PolyStart technology continues to mature, I believe that it can also become a significant value driver for the Company. Thanks to our development team for continuing to validate this exciting platform and to pursuing the intellectual property that allows us to effectively monetize it through strategic partnerships. We look forward to our next quarterly call and continuing to execute on the milestones that we’re attracting towards in our clinical programs. I want to thank our shareholders for your continued support. At this time, I’d like to turn it over for any questions you may have. Operator, you may open the line for questions.

Thank you, sir. And we will now begin the question-and-answer session. [Operator Instructions] And our first question today will be Steve Brozak with WBB. Please go ahead.

And looking over your business model, typically a biotech company would need to go out there and interest clinicians, which they probably would work with already, but it seems like the clinician team actually coming to you or they're advocating with you. And as a result, we’re able to leverage them and different types of non-diluted funding. Can you tell us what is the patient component of this and are they looking to you? Do they call in to see about participation and trials and what kind of feedback? Can you give us there because that the singularly important component when you're dealing with some tried implications. And I've got a follow up question on that as well.

Yes, absolutely, Steve. Thanks for joining in the call today. We appreciate your support. So what I'll tell you is this that I think that as our programs have gathered steam, we're getting more and more word of mouth among the patient population. A note that the first patient who ever received our therapy in our Phase 1 trial is -- has posted a very nice blog through the University of Maryland Medical Center, that's garnered a lot of attention. She continues to continue interim remission ever since receiving our vaccine therapy for HER triple negative breast cancer over three years ago at this point. But what I'll tell you is that, in many ways the vaccines itself to potential patients and clinicians because in ovarian cancer today, as you probably know, there are no currently approved therapies. It was striking to me how much of enthusiasm there was from the population of clinicians for this therapy. Because right now, all that their patients can do is wait. There really is nothing for them. And these are women who know that in all likelihood the disease is coming back within a year. And so I will tell you that shortly after I joined the Company this was in October of last year, we had a national investigator conference in Dallas. And what was striking to me is that we had some of the leading ovarian physicians in the country take time away from the clinic, which as you know is always a challenge for these physicians. Come down to Dallas for two days to help wanted to help discuss with us, clinical trial design and patient enrollment for these trails. So I think that you're right in that and that we've got a significant amount of clinician engagement here and a lot of the enthusiasm. I'll tell you that time and time again I heard these clinicians tell me. They think that this is really important, they're very enthusiastic about enrolling patients. And I think that that is reflected in our ability to enroll clinical trial site. Currently, I believe that we're targeting 24 sites across the country for the TPIV trial in TPIV200 trial in ovarian cancer. To-date, we've enrolled 18 of those sites including three sites at the Mayo Clinic, two sites of Sarah Cannon, two sites of Memorial Sloan Kettering and the [Moffitt] among others. But we really have a national coverage at this point in terms of clinical trial sites. and I think that I've been -- the way that I would characterize is that I've been pleased with the enrollment rate that we're seeing in. There seems to be a lot of interest particularly for women who otherwise would have no therapeutic alternative.

And going back into this getting more detail, you had mentioned during the call that you had 4 programs. And that you obviously have clinician and patient interest. Let's talk about one more component and that would be potential collaborators on the corporate site. Obviously this is something that has all the large pharma biotech interested. How would you see going forward potentially with them, or how would you see any potential collaboration taking place? And also what kind of interest have you seen so far from them in looking at your technology and potentially working with you? And I've got one last question and I'll jump back in the queue. Thank you.

Yes, absolutely. Well you know my background is that. I've spent 16 years on Wall Street doing strategic transaction and then another 7 years in immuno-oncology doing the same thing. I’ll tell you that I think that there is a right time and a less than a perfect time to do strategic collaborations. I think that what we are beginning to see here is a real recognition our therapeutic program has laid. And the first step in terms of establishing that was getting our Phase 1 data published. And I was extraordinarily pleased that we got publication in clinical cancer research, which as you know is a Journal of the American Association of Cancer Researchers and a journal with an impact factor of 9.6. That Phase 1 data readout was the first clear evidence that we could show for efficacy of the vaccine. And I think that it's an extraordinarily important result because even though we haven’t recruited enough patients to reach statistical significance. It’s a very long progression free survival time. And in fact I’d tell you that there's actually some positive noise in those numbers in that. When we measured 520 days what we were measuring was 528 days from the time that those patients had received our therapy. When you look at the Avastin trial in standard of care these patients saw a median progression free survival of 313 days. The 313 actually represents the time that it took between the date that they got surgery and the date that the median patient the 50th percentile patient relaxed. What we know is that there is some time between the time that the patients get surgery and the time to get our therapy. Now, unfortunately that data point was not collected in our phase 1 clinical trial, but you can easily estimate that it was at least 50 days and potentially up to as much as 200 days, but in the time that these patients received surgery and the time that they received our therapy. So the number could conceivably be significantly better than 520 days. That is like I said I think that that is a very important signal of efficacy in our vaccine. And I would argue that it may well be the first signal of efficacy that anyone has ever seen in the cancer vaccine as a standalone therapeutic. And so I think that it's an extremely important result that is going to capture a lot of attention from potential corporate partners. But that Phase 1 readout was really the first opportunity that we have had to share with the world the proof that we think that our therapy is delivering real and meaningful therapeutic results for patients. Now, given where we stand from evaluation standpoint I think it is going to take some time for our evaluation to catch up with the reality of the clinical trial result. And in the middle we are going to be pushing our clinical trials forward in generating a more statistically significant readout that is going to motivate potential corporate partners. Coming from the business development background I’ll tell you that I think that there is an optimal kind a part for these things and I don't think that that time is today. I think that we can have fruitful conversations but that we will not necessarily receive optimal evaluation. Look I can partner it in the short-term but I don’t think that that would generate necessarily the best results for our shareholders. I think that where we will generate the strongest results for the shareholders is to be extent that we engage in partnering negotiations. I think that that comes after the readout from the Phase 2.

Last question is a more detailed question, as mentioned, I don’t know how you want to answer this that there was a slight reaction on in terms of administration. Now given how the immune system is recruited, would it be fair to say that that's an adverse event or anything else related to that, given how robust the immune response would be after something like that? Or as we've all been conditioned to say well slight site administration reaction is something that we don't want to see, but in this case it's actually intuitive that that’s what you want to see. So how would you describe that? And that's my last question?

Yes, absolutely, I’ll kick it over to Rick to give you a fuller response, but I'll tell you that given the number of patients that we’ve dosed with TPIV200 to-date and given the dosing trial the Phase 1 trial and the ongoing placebo-controlled efficacy trial. I’m going to tell you that we have dosed well over 100 patients and maybe a over a 150 at this point, and that's really talking about one site related reaction is extraordinarily low. You have to remember that our primary competition for this vaccine comes in the form of PARP inhibitors, which have significant toxicities in almost every patient that receives it. And so when you think about the side effect profile, you have to remember that the most common side effect here is not broadly dissimilar to what you get when you get an intradermal injection for a flu shot which is redness and swelling around the injection site. But having said that, let me kick it over to Rick to talk about that one extreme case where you got -- I think is effectively an infusion related reaction.

I have actually set my career doing as we with the vaccines, and the site of injection as an inflammatory site is often considered to be a good thing as you know. The fact that you’ve got a little bit of pain and some redness in many of the patients is reflective simply of infiltration of immune cells, and shows that the body is responding in an immune developing way. In this patient, she had -- I think it was fifth dose, a bit of ulceration of her skin, which by the CTCA criteria her grade was to Grade 3 turns out to have been the only Grade 3, we actually have had that is vaccine related to-date in over a 100 patient that have been dosed. And to some extent was related to the fact that it was given repeatedly on the forearm that you you’d almost call a fixed drug reaction. What we’ve done to avoid this in the future is to rotate the site between skin sites on either arm or either leg and that seems to be working out very well, we’re getting very limited local reactions now, it's very common to have a great one or two thing and some redness at the site. But my job is to actually as a medical monitor to look very carefully at all this, and to identify any possible adverse events. And so, yes, while it’s considered an adverse event, I agree that it's also considered, something I should be considered, something that is demonstrating the affect of the vaccine locally.

And there look to be no further questions at this time. So, this will conclude 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. Once again, I want to thank all of our shareholders, the Mayo Clinic and all of our employees for delivering, what I think is an absolutely fabulous quarter. I think that we have managed to deliver on all of our major meaningful milestones, and we’ve made substantial progress over the last quarter in terms of improving clinical operations, in terms of driving our Phase 2 clinical programs forward in the clinic as well as getting this very significant Phase 1 data published. Going forward, I’m looking very much to reporting back to you as further developments occur with respect to the ongoing negotiations with the U.S. Department of Defense in the Mayo Clinic. We’re very, very excited by the possibility of doing a third clinical trial as Rick said potentially, our largest clinical trial to-date in conjunction with the Mayo and with full funding from U.S. Department of Defense. I’m very optimistic about the prospect going forward and so I look forward to speaking with you all again next quarter. Thank you very much.

And the conference has now concluded. Thank you for attending today’s presentation and you may now disconnect.