Acer Therapeutics Inc. (ACER) Q2 2016 Earnings Call Transcript
Published at 2016-08-11 23:02:15
Camilla Zuckero - Marketing Communications Manager Neil Warma - President and Chief Executive Officer Don Healey - Chief Scientific Officer
Jason McCarthy - Maxim Group Keay Nakae - Chardan David Bouchey - IFS Securities Robert LeBoyer - Aegis Capital Corp Nathaniel Calloway - Edison Group
Greetings, and welcome to the Opexa Therapeutics Second Quarter Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Ms. Camilla Zuckero. Thank you, Ms. Zuckero. You may begin.
Thank you, Tim. Good afternoon, everyone, and welcome to the Opexa Therapeutics second quarter conference call. During today’s call, members of our senior management team will review Opexa’s financial performance and business highlights for the quarter ending June 30, 2016. Before turning the call over to senior management, I would like to remind everyone that this call includes forward-looking statements, including financial projections and expectations of progress in our clinical development programs, that are subject to risks and uncertainties, that could cause actual results to differ materially from those projected, including the risks set forth in Opexa’s annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, as well as specific risks and uncertainties noted in our 2016 second quarter financial results news release. With us today, are Neil Warma, President and CEO and Acting CFO; Don Healey, Opexa’s Chief Scientific Officer, Donna Rill, Opexa’s Chief Development Officer and other members of the Opexa management team. I would now like to turn the call over to our CEO, Neil Warma.
Thanks, Camilla. Thanks, Tim, for hosting us well. Thanks everybody for joining us today. On behalf of Opexa’s management team we welcome you to this earnings update. It’s an exciting earnings update this time around as it could be the last earnings release before the top-line data from our Phase 2b clinical trial read out. So certainly it’s an exciting for us. As many of you know, who are expecting key data from the Phase 2b Abili-T trial in patients with secondary progressive multiple sclerosis in early Q4 2016. We are now very close to that time-point. Everyone in the company is working diligently to complete the remaining activities and close out the study in a timely manner. Just to back up a little bit, many of you know this, but for the new folks on the line. The Abili-T study is Opexa’s landmark study in individuals with a later form or progressive form of multiple sclerosis. We have enrolled 190 patients in the study, all of whom were diagnosed with secondary progressive multiple sclerosis or SPMS. Trail is being conducted in 35 leading MS centers across the United States and Canada. And while we’ll be analyzing numerous endpoints as part of this study, probably the two most important for the top-line analysis are related to whole-brain atrophy and disease progression. This trial result could impact the lives of MS patients significantly, as there are no approved treatments for individuals with progressive form of MS. Tcelna, which is Opexa’s lead product could be the hope that many patients are seeking. Previous clinical studies with Tcelna in patients with secondary progressive MS have demonstrated encouraging efficacy and clean safety and tolerability. If we see similar results in this ongoing Phase 2b study, then a significant hurdle will have been overcome and this could unlock hope for patients and substantial value for our shareholders. We estimate the overall market potential in SPMS, secondary progressive MS, to be roughly $7 billion. If Tcelna is proven safe and effective it could open the way for it to become the therapy of choice for patients with progressive form of MS and possibly enable us, we would hope, to capture much of this market. Additionally with the positive results in the Abili-T study we should have a streamlined path to a Phase 3 pivotal trial in secondary progressive MS. This would involve working closely with our partner, Merck Serono. Again, as many of you know in 2013 we signed an option and license agreement with Merck Serono, one of the top pharma companies in the world and also one of the top MS companies in the world, those companies that have been involved with multiple sclerosis. With positive Phase 2 data, we believe Merck would exercise their option that they have with Opexa and advance Tcelna into a Phase 3 trial and through clinical development in MS. If they exercise their option, Merck would gain worldwide rights to all MS indications for Tcelna excluding Japan. And with this, they would fund all of the remaining developments in commercialization activities of Tcelna. And Opexa could also benefit through the receipt of milestone payments, potentially totaling $220 million and additional royalty payments from 8% to 15% of net sales. And in this scenario Opexa could potentially recognize a significant revenue stream well into the future. The next milestone payment from this agreement would be upon the execution of the option agreement by Merck, which potentially could come at the end of this Abili-T study. And if that were to happen and advanced into a Phase 3 clinical trial, Opexa could receive a $25 million milestone payment. The remaining activities, as I mentioned, the trial is approaching completion and then remaining activities associated with the completion of the trial are finalizing or completing a few remaining patient visits that are left, this will be followed by database lock, scrubbing of the data, as the terminology goes in clinical trials, and then compiling the top-line tables and figures. Once we have those, the analysis of those top-line figures and then reporting of those top-line results. So with all those activities we remain on track to report top-line results as we’ve indicated over the past several quarters in early fourth quarter 2016. And then, as I just mentioned earlier, to reiterate, if the trial reads out positively, we would then expect Merck to exercise this option, which would possibly unlock a $25 million payment to Opexa at that time and allow us with Merck, our partner, to move towards a pivotal Phase 3 trial. And this is obviously subject to FDA support as well. So over the next months, it could be certainly an exciting time with us with potentially a positive top-line data coming and an option exercised by Merck and then a subsequent milestone payments into Opexa as well. And if this sort of takes place, if this sort of happen in this manner, we believe it would unlock the enormous potential of Opexa’s platform and could allow us to move into new disease areas off our proprietary platform. We’ve said all along that we believe that we have a proprietary platform that is applicable across numerous autoimmune diseases. So the validation that will come with a Phase 2 positive result would unlock that potential of our platform. Our second program is already underway. OPX-212, the name designated for our second therapy candidate is currently undergoing pre-clinical development for the possible treatment of the rare disease neuromyelitis optica or NMO. With the entire company, as you can imagine, focused on the effective and the efficient completion of the Phase 2b MS trial, the Abili-T trial, the activities associated with the NMO program have lessened over the past few months somewhat. However, we would envision that with positive Abili-T data and then sufficient resources we would ramp up to fully support the NMO program and then move rapidly to position that product for IND submission and a Phase 1 study. And beyond NMO there are numerous possibilities in diseases we believe for Opexa to consider with its technology. So the future could see Opexa, in the not too distant future, I might add, could see Opexa dominate the T-cell immunotherapy landscape in autoimmune diseases. So following the introduction, I’d now like review the key second quarter financial figures and report on the financial health of the company. The form 10-Q for the second quarter was filed about 30 minutes ago after market close today. So the numbers are there and you may have those in front you. But they’re filed with the SEC and in our website as well. So for the second quarter ending June 30, 2016, we recognized revenues of approximately $726,000. For both the three months ended June 30, 2016 and also for the three months ended June 30, 2015. These revenues were related to the recognized portion of the $5 million upfront payment received from Merck Serono in conjunction with the option and license agreement executed in 2013 and revenues also related to the additional $3 million payment we received from Merck Serono in connection with the March 2015 amendment. Overall, the net loss reported for the three months ended June 30, 2016 was approximately $2.1 million or $0.30 per share. And that compares with a net loss of approximately $3.5 million or $0.56 per share for the three months ended June 30, 2015. The cash balance as of June 30, 2016 was approximately $7.8 million. There is no debt on our balance sheet, so a clean balance sheet. Our operating cash burn rate during the six months ended June 30 2016 was reduced to approximately $763,000 per month. So as the Abili-T activities are winding down towards completion our burn rate has come down to about $763,000 per month based on historical past six months. So based on the current activities and projected burn, we believe we have sufficient liquidity to support the current clinical activities around the Phase 2 of the Abili-T study, of Tcelna in patients with secondary progressive MS, the pre-clinical activities for OPX-212 in NMO and for general operations of the company into the first quarter of 2017. So just to kind of summarize before we get to Q&A, I’d just like to highlight several, what we believe are Opexa’s strengths or points of differentiation. So we’ve become a leader in the development of immunotherapies for autoimmune diseases, having conducted over five clinical trials in multiple sclerosis, including the large Phase 2b Abili-T Clinical study, we are currently in the process of completing. Our lead therapeutic area, secondary progressive MS, is a $7 billion market opportunity, we believe with currently no approved treatments. We have a significant value of inflection coming in approximately two to three months. The top-line results from the Phase 2b study as we mentioned in SPMS are expected in early Q4 2016. We have a partnership with Merck Serono, one of the leading pharma companies in the world, which could pave the way for Phase 3 and market introduction of our lead therapy. We have received Fast Track designation from the FDA for Tcelna in secondary progressive MS. Our patent estate boasts over 160 issued patents. Opexa currently own its scalable GMP manufacturing facility and we believe we have a true platform technology which is poised to target numerous diseases with our second program already in pre-clinical development. So really in other words, we believe we built a leading proprietary platform with significant potential that indeed could be validated within a few short months. So with that, Tim, maybe we could open up for question from our listeners and we’re happy to take a few questions from the audience, please.
At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Jason McCarthy of Maxim Group. Please proceed with your question, Jason.
Thanks for taking the question. Can we just talk a little about the endpoint of brain atrophy? I know that Roche - ocrelizumab showed some Phase 3 data that was really compelling. They’re likely going to get approved. And one of their endpoints was the 17.5% reduction in brain volume loss. I mean, we interpret that as very similar to what Opexa is doing. Can you give us a sense of the degree or the percent of change in brain volume that you’re looking for, as a signal in Phase 2b study?
Yes, thanks, Jason. Thanks for the question. I’ll pass you to Don Healey, our Chief Scientific Officer in a minute. But that’s a really good question around brain atrophy. I mean, we are encouraged by the ocrelizumab data. We discussed this ourselves. We’ve certainly discussed this with Merck Serono team as well. As you mentioned, they showed a 17% reduction in brain volume. Important to us is that they, similar to us, see a relevance in using whole-brain atrophy brain volume as a valid endpoint. And I know we have had questions about that. You and I have discussed that several times in the past. But their focus on brain atrophy as a valid endpoint certainly validates our approach as well. Their reduction of 17.5% is an interesting threshold. I think clinicians and FDA see this very much as a clinically relevant benefit of their drug over control. And again, this is in primary progressive, so a different indication of MS that we’re going after, but still has relevance. So that threshold of 17.5% is certainly lower than what we believe we could hit going into our trial. Keep in mind that we have powered our study based on our historical data, thinking we might see a 37.5% reduction on brain atrophy. So we set ourselves a high goal or a high target. So again, by having kind of the enthusiasm around Roche’s much lower target at 17.5% that gives us that much more confidence that our high target is that much more achievable. So again, it’s all very supportive for us at selecting an endpoint and a threshold that everybody has gotten excited about over the ocrelizumab data. It’s certainly lower threshold that we believe we’ll see for our data, so that kind of bodes very for us as well. Maybe, I’ll let Don speak a little bit more scientifically about that, about those data.
Yes, hi, Jason, yes, as we’ve discussed in the past, the links between atrophy and progression are gaining more and more momentum. It’s interesting you mentioned that the ocrelizumab study showed a 17.5% distinction between placebo and therapeutic drug treated patients. And of course, that followed on with an improvement in progression of approximately 24%. So again, it’s evidence that atrophy may be an important pointer to potential improvement in progression itself. Why do we think that we can do better than ocrelizumab in terms of how we paired our study? I think we need to think about the mechanism of action of our drug versus those have tried in the progressive phase of disease. Though the ocrelizumab data is certainly encouraging, it’s worth remembering again that antibody therapeutic will have its major activity in the peripheral immune response. So in other words it’s going to try and disrupt immunity entering the central nervous system and then perturbing the central nervous system neurodegeneration. Our mechanism of action only involves impacting the peripheral immune response, but the induced immunity to the product Tcelna will have the capacity of actually entering the CNS itself so thereby providing localized suppression of inflammatory response that translates to brain loss and ultimately obviously a degradation of clinical activity in terms of progression of disease and disability. And so, yes, we think there is a link between atrophy and progression and there is every reason to believe based on the mechanism of action that Tcelna could do even better than ocrelizumab.
That’s wells said. And I do just want to reiterate those points, because I think it’s important for the audience. Again, the fact that that Roche has picked the two endpoints that we’re looking at, whole-brain volume, brain atrophy and disease progression, they showed results showing brain atrophy improvement at 17.5%. We have shown in our previous study brain atrophy improvement of 37.5%. They showed an improvement in disease progression in this study of 24%, and we’ve shown historically in our previous progressive MS patients, an improvement of 50%. So again, I think that bodes well for us with those data, which are - thinking about it now, probably half of what we’ve already shown in our previous study. And again our previous studies were open label studies, so we need to put that front and center. But their results are about 50% of what we’ve seen in the past. And with those data, looks like they’re set for market approval on one study and they’ve certainly got their breakthrough therapy and everybody is kind of rejoicing at those data. So again, I don’t want to say that that it’s an easier bar for us to cross. But I do want the audience to acknowledge that even at those lower levels I think the community was very much enthusiastic. And certainly those data points were deemed as being very clinically significant. So I think it bodes well for us moving forward. So thanks, Jason, great question.
Great and just one follow-up, and it’s kind of abstract question. And I’m looking kind of for an abstract answer. And maybe the audience would appreciate the discussion. We’re coming across in complex diseases like MS, whether it’s RR, SPMS or pick your point on the spectrum or even heart failure for cell therapies or biologic based therapies, and the new mantra is really we’re treating these diseases all wrong, like trying to treat acutely and then treat symptoms; whereas if we can treat with these therapies and actually alter the course of disease, it might be the more practical approach. And it’s kind of where we’re seeing therapies like Tcelna and even ocrelizumab, you’re looking at the totality of bunch of different measures and really trying to determine if you can change the direction the disease is going in. It’s not actually a cure. Can you guys talk just a little bit about that, because we think that’s really critical, and a piece that Merck is going to look at when they decide to opt in or not if it doesn’t go well?
Yes, that’s not too abstract. I think it’s very real, Jason. And the fact - and we’ve been saying all along that this - this T cell therapy that Opexa is developing certainly does reach through to the root cause of multiple sclerosis. And it certainly does potentially in any autoimmune disease we go after. I mean, what we are trying to do is really to restore the function of the body’s immune system. So if we’re able to do that through our therapy then at the end of the day we’ve altered the history or the course of that disease in that individual. And ideally it provided a cure for that individual. And again, those are - that C word is an important word and we don’t toss it around lightly, because we have to maintain expectations especially to the patients. But when we’re modulating the immune system to try to reboot or re-sensitize or restore the function in that failed system it is a way. This is a certainly not symptomatic treatment that we’re going after, it is altering the cause of that disease to restore the function of that body’s immune system to enable it to treat that disease itself. So I think, it is very - it could be a very dramatic result it’s very true that Merck Serono even back in day one, when we were speaking with these individuals, and they have always said they’re extremely smart and they have some of the world’s best immunologist in that company as we have here as well with Don, but again, they were always very intrigued that this elegant approach to personalize T-cell therapy could impact dramatically the course of MS in individuals, rather than just providing a symptomatic treatment which essentially is what the drugs in the market do today.
Okay. Great. Thanks guys for taking the questions.
Our next question comes from the line of Keay Nakae of Chardan. Please proceed with your question.
Yes. Thank you. We are providing color on what are the discussions with Merck have been like more recently in terms of any kind of forward planning, talk about plans for larger scale manufacturing to produce the therapy that new discussions you may have had?
Good question. Thanks Keay, thanks for joining. As you know, we’ve been having discussions with Merck Serono ever since we think the deal a couple of years ago, and again, I can’t reiterate enough what a terrific partner they have been, and they are. And hopefully, moving forward it will strengthen even more. We have efficiently formed a joint steering committee and we have that running now for well over a year. And a lot of that was based around the expectations that - the hope the expectations that the data will be positive and we want to be ready to move forward as rapidly as possible, and obviously in designing any Phase 3 study or Post-Phase 2 analysis, there is enough lot of activities that have to be discussed and determined and analyzed and evaluated what is manufacturing clinical regulatory process. So Merck’s been terrific to say let’s get ahead of that curve, let’s get to JSC discussions going, so that we can anticipate and address lot of these concerns before the data comes, because we want to be able to move rapidly. So the discussions certainly as you mentioned here the discussions that are manufacturing and certainly been pretty in-depth, they got a superb person there representing the JSC from their manufacturing side, very knowledgeable and we’ve got Donna Rill in our side is very knowledgeable in that area. So they spoke lot about manufacturing, what needs to be required ramping up for Phase 3, that responsibility rests with Opexa. We have an original agreement with Merck that Opexa is responsible for the manufacturing and there are options to remain responsible for manufacturing Phase 3 into commercialization as well. So that piece of it is obviously we have the expertise, we have the facility here. How we plan to build enrolling the Phase 3 has been very much part of the discussion and I don’t get into the details of what we discussed and how we planned to move forward and a lot has not been - a lot has not been nail down, but the fact we’ve been having these discussions for over years, there is a lot has been put on table, that’s been blueprinted and mapped out. So those discussions have gone very, very well. And Donna certainly knows her role and her function moving forward with positive data [we received] [ph] on manufacturing clinical discussions have also taken place. It’s a Phase 3 trial, if we get there U.S. trial, European trial as well, is it combined, is it starting when enrolled into the next territory. How do we deal with EMA, how do we deal with FDA, are we going to apply for breakthrough designation. All those accelerated approvals, all those points have been raised and discussed and it’s nice to get ahead starting all the stuff. So as I said, without going into too much detail, and rest assures that at both sides and Merck kind of certainly very much at the table as well, have been very excited about the fact that the data is coming in a couple of months, and I think, we’re all pleased with ourselves that we’ve taken the past year to prepare and with that much further ahead now when the data hopefully that we have positively.
Okay. Well, that is encouraging. And then, I know, the development on NMO is in the background, but just anything you can add about resolving prior challenges that you try to optimize, and just any other progress there?
Yes, sure. I mean, NMO was certainly our second program, it plays an important role in this company. They said just kind of in the upfront remarks they said if you can imagine, we’re all kind of - all hands on that, we’re not a large group of people, 20 plus people here in the company. So that’s a small number to focus on finishing up a very important study. So really is a line share, the work is around completion of the Abili-T study and that’s result of the NMO activities as I mentioned, they have been slow down a little bit, but you just don’t have the human resources. But as far as the challenges to which we referred last time, mainly around the manufacturing of those peptides. They have pretty much been overcome, Keay. As I said the Don and Donna here in the rest of the team they kind of overcame those challenges a number of months ago and dealing with the peptide manufacturing groups. So the challenges we believe this is still novel pioneering side. So we’re never 100% share, but we believe the challenges we face before are pretty much been overcome such that when we kind of get the data from Abili-T and get our resources aligned and we can kind of move rapidly we can kind of back in front of NMO and get it back to this into the clinic. So these challenges, I think we’re comfortable having results those we work hard to kind of get those out of the way and understand that peptide manufacturing and hydrophobic natures of the peptides. So those are hopefully behind us now, and we’re just kind of waiting for the next couple of months to finish off the study and get repositioned on the NMO front as well.
Okay, very good. That’s all I have.
Our next question comes from the line of David Bouchey of IFS Securities. Please proceed with your question.
Don, I know you - Don, hi. Don, you and I have had some conversations over the past several weeks about the ASCEND trial, which was done secondary progressive MS, especially looking at their control arm, something that might be predicted for the Abili-T control arm, but as I look at the patients in that trial and compared them to parameters of the inclusion and exclusion criteria for your trial. It looks to me, like the patients in your trial are going to have a little bit more active disease than in the ASCEND trial, was that a correct assumption?
Hi, David. Yes, thanks for your question, obviously the ASCEND referring to Biogen’s experience with TYSABRI. And their inclusion criteria is not that dissimilar from ours I would have to say. The primary element here is that the patients must have evidence of progression in the absence of relapse. But if they patients are active in sense of a relapse event, it does not exclude them from recruitments of the trial. And so, yes, I don’t think we’re that dissimilar. Our EDSS range for procurement is between three to six which we believe is a sensitive area, and which to be out to detect movement in progression over a two-year time period.
But just to reiterate that’s obviously very true. I mean, the interest thinking with Biogen and the definition of secondary progressive patients. They’ve broaden their definition more from I think, from a positioning Biogen’s perspective to try to expand their label, whether they thought for sure that they can address the need of truly secondary progressive MS patients, I’m not so sure again, expanding this to include patients who were actively relapsing kind of dilutes down the definition in secondary progressive MS and probably had patients in that study, who were not true secondary progressive MS. But again as allow them potentially for successful, to capture a broader label around relapsing forms of MS. So we think it was probably little bit positioning on Biogen’s part rather than purely going after the secondary progressive MS population. And at the end of the day, the trial failed, and again as we were talking about the data is been around for little bit now, but leading up to that we felt that from a mechanism of action perspective. The trial was probably set up to fail, just given the mechanism of TYSABRI and the fact that the information on secondary progressive MS, as Don commented on it houses the CNS. So they really don’t have a mechanism to get to address that information behind that blood brain barrier. So we - again mechanistically, it was a bit of reach and then the definition was a little bit water down as part of secondary progressive and I think, ours fits the definition that the FDA described too as well a little bit more.
Yes, I agree. And then, any Abili-T trial, you are memorize for a whole brain atrophy they are being done by a centralized group, they are not being done at these individual site, is that correct.
Yes, that’s correct. Not only that, they’re being done by, probably the leading worldwide group that’s top in the world for MRI and imaging that being Dr. Arnold’s group out McGill. And he is generally used for all things imaging and he is superb and it is done, you’re correct, David. But as a central core lab all the reading for the MRI is done essentially by him and his team, not individually. So you kind of minimize the risk of interpreting data differently by different meters by having it all done centrally through his world leading group.
Our next question comes from the line of Robert LeBoyer of Aegis Capital. Please proceed with your question.
Good afternoon, everyone. I was just questioning the Roche trial that was discussed earlier, and there was a mention of 17.5 reductions in that trial and 37.5 reductions in trial that you’re running. Could you just give some data as to what the reduction in brain volume would be expected for a placebo patient, and how and compare these, as well as just elaborating on the milestones and the timeframe of the Merck option.
Yes. So, Robert, thanks. Thanks for joining. As far as I mean, the accepted rate I mean, it’s in the literature and there is a number of publications and there is one that kind of come out recently as well talking about brain atrophy in the placebo in the secondary progressive population, and typically, what we see Robert is brain atrophy at the rate of 0.5% per patient per year. Now, Don, and that seems to be pretty consistent from time of diagnosis through the death due to MS. So again, we patterned our trial or certainly patterned our kind of sample size calculations empower analysis based on the fact that we’ve seen in ours and others have seen in their placebo patients would progressive MS a range of 0.5% per patient per year. So again, in our study power as I mentioned a short 37.5% different between active Tcelna and placebo, which again is a higher threshold than what we saw with the Roche data so it’s a hopefully nicely for that outcome. As far as kind of milestones in Merck, as we know the timelines for Merck that option agreement is such that they see that data from the trial, and then they have the right exercise that option move forward with the further development, so again, they pay for all the cost moving forward in the milestones and royalties into Opexa. So the time and there is a couple of different triggers on that timeline Robert, so you can kind of - it can shift a little bit based on which trigger they pull and additional data inside, but again, in the range of 60 days when they see the data to making the decision, we would hope in that timeframe we will get a decision from Merck, and ideally it’s a positive one they exercise, there is a $25 million payment and then to Opexa and then off you go to Phase 3. So in that kind of 60 day period, well ideally look for something in a good situation.
Okay, yes. That 60 day timeframe was the answer, I was looking for. Okay, great. Well, thanks again, and look forward - looking forward to the data.
Yes, thanks, Robert. I appreciate it.
[Operator Instructions] our next question comes from the line of Nathaniel Calloway of Edison Group. Please proceed with your question.
Hi, guys. I was just wondering given the recent successful partnering with Merck Serono. If you guys have any plan outside the MS and NMO to be able to license any other indications here in the future or any active discussions about that person.
Yes. Thanks, Nathaniel yes, as far as I mean, as far as the partner we have in place, as you mentioned Merck Serono has that option license agreement. So they have the right MS indications only, MS worldwide excluding Japan. So we have the rights to Japan, which we talked about before is a really interesting market especially in cell therapy. The ability to do small trials and get really access to the market in Japan is something that the health authority in Japan has set up over the past couple of years. So moving rapidly into the Japanese market and through development is something that’s very exciting, which is why we pushed to keep Japan right ourselves in MS. So worldwide MS, the Merck Serono excluding Japan, as far as NMO all the rights to NMO and any other disease at the platform remain with Opexa. So 100% of the rates were NMO, we had some very interesting discussions with pharma companies, with respect to NMO, our second program is ongoing. And we’ve actually also had, Nathaniel, to your point interesting discussions with pharma about the platform capability or the applications, further applications in autoimmune diseases for T-cell platform. I think pharma companies are recognizing certainly the whole area, T-cell immunotherapy is become very, very exciting with the interesting data coming out the cancer immunotherapy side, but even an autoimmune disease, which Opexa is one of the leaders there, we have had some really positive discussions with pharma companies about NMO itself. What potentially life beyond NMO that could be approached off of Opexa T-cell platform. So I think, certainly having a Merck Serono partnership already validate us to certain degree pharma companies like follow their own, so we’ve got one of the best ones onboard already. So that bodes well for us. The fact that we kind of rolled off into the second indication means, we show the people that we actually move off of just the lead indication in go to others specifically. And then the potential to address autoimmune diseases with rogue T-cell is the primary driver of disease progression is something that we’ve demonstrated at least hypothetically and a number of other diseases. So nothing is in yet, but I think certainly if when the data read out possibly in a couple months. I would like to thank, the pharma companies would step up their interest significantly, if we showed a positive result and I’d like to think that they’d be much more aggressive with us, which is why it’s been important over the past year to two to develop and establish relationships with a number of pharma companies, so at least know the potential of the platform. So again I could - that could prove quite interesting with positive result as well. And if want to just, as many of you know it’s a bit of tangent, but we’ve also got that biomarker data that program is running along the Don and his team. And I actually came out of the lab this afternoon. I was talking with Lauren, and Chris, and Jenny who were kind of running a lot of the analysis of that, not biomarker program that were running alongside of the actual clinical trial, it’s a remarkable collection of data. I know, Don and his team has been working tirelessly at collecting those data. Those data will be un-blinded as well with the clinical data as well as the top line un-blinding of the immune program, the immune monitoring program, biomarker data along with the clinical data. I know those data, might tell us a really, really exciting story about the mechanism of action of Tcelna, might give a lot more elucidation around the mechanism of secondary progressive MS itself. And that they have been correlated clinical outcome. This is the first time that any company is going to show any meaningful biomarker data correlated to clinical outcomes, so struck my head in the lab this afternoon, so it’s really remarkable on a scientific level. What we’re pulling off on the biomarker data and then, how it’s going to clinical relevance of the whole industry will be pretty exciting in the couple of months as well.
All right, thanks. That’s really exciting.
Our next - [Operator Instructions] Our next question comes from the line of Peter Madaraz, [ph] a private investor. Please proceed with your question, Peter.
Yes, the question I wanted to ask was that the Lancet had published an article a couple of months ago about stem cell transplant for MS. I was wondering if you could comment as to - how Tcelna could be used as a combination therapy or is a follow through medication, are there any kind of derivatives off T-cell that could be used in combination with other treatment?
Yes, thank you, Peter. Thanks for that question. We know that study well, people running that study in the certainly kind of world-class leaders running that study out of Dr. Mark Freedman’s group. I’ll let Don speak to that in a minute as well. In that study, I mean 24 individuals with the progressive form of MS, interesting, I mean there is not a lot of activity in secondary progressive MS overall, which again, it’s unfortunate very much for the patients and bodes well for Opexa, because it’s a limited competition. What we are seeing some stem cell programs again early stage stem cell programs looking at kind of restoring the entire immune system. So these are very aggressive approaches for trying to wipe their immune system was some toxic drugs, and then restoring it by rebuilding with stem cell transplant. So right way, just to answer your question, there would be no kind of complementary treatment with what we’re doing in with the stem-cell treatment. They really are standalone different treatments. We see Tcelna being first-line treatment broadly used to really anyone with MS. I mean, our side-effect profile has been absolutely stellar. We have not seen one serious adverse event associated with treatment. And the drugs that are on the market for MS have some very serious side-effects. And even the stem cell program, which we saw, the small study that was reported in Lancet, I think there were - how many deaths were there associated with RR? I think one or two patients actually died from the treatment. So it’s a very aggressive form of trying to restore the function of a failed immune system. Again, as I said, I’m all for encouraging new approaches to treating horrible diseases. That’s a very aggressive approach. Granted, I think some of the efficacy looks interesting. But the side effects, including the death of two individuals out of 24 was pretty dramatic. So as I said, I think there is a lot of work to do in the stem-cell space, before it becomes broadly accepted. And for us, as I said, we’ve done five clinical studies and not one serious adverse event, so a bit of different approach. Don, I know you’ve kind of gone through those data and know them well.
I think the major comments I would make is that obviously it’s a highly invasive technology to completely reset your immune response. But there is some evidence of activity, even in progressive phase of the disease. So that again underpins the direct role of immunity in driving progression in those late stage patients. Our argument is that we want to achieve that same degree of efficacy but on preferred safety profile which Neil has already highlighted. So, on that basis we feel that by just targeting those immune cells associated with neurodegeneration whilst leaving your body’s immune response fully intact to fight third-party infections or pathogens or even cancer for that matter, has to be an advantage to us. Could we envisage combination therapies in principle scientifically? There may be some that we could consider. But as Neil mentioned, our argument will be, well, why do the combination setting will be far better will be to introduce Tcelna into the first line settings, in other words, treat the patient earlier in the clinical disease phases and therefore to reestablish tolerance and control, but with a strong efficacy, but on a strong safety profile. One of the arguments, obviously with doing something like a transplant, it’s unlikely we’d do it in a patient that’s having, say, one or two relapses every other year. That would be considered too higher risk versus the degree of efficacy and the clinical stage of the patient. But a therapy like Tcelna that has such a very clean safety profile, it would make a lot of sense to take such a drug product into that patient base as soon as possible.
Yes, I think the different approaches that they upfront patient the patients with a…
Yes, myeloablation to kind of wipe out their immune system. The idea being, let’s rebuild it in the hopes that we can rebuild a healthy one, so that upfront depletion of the entire immune system is a very risky one to do as opposed to our approach which is let’s take - let’s take immune system that’s faulty and just repair the mechanism that is not working properly. So it’s a far left less risky approach than depleting the entire immune cell population which is the stem-cell folks are looking to do. But again, I give credit to teams and I know Dr. Freedman extremely well. And he is one of the leading guys out there. So I’d give credit to these people that are trying to find novel ways to treat such a horrible disease. But, thanks, Peter, that’s a really good question.
Thank you. Thank you for clarifying that. It’s wonderful, what you’re doing.
You’re welcome. Thank you. Tim, any other questions?
At this time, there are no further questions. I would like turn the conference over to management for closing remarks.
Okay. Thanks, Tim. And thanks, everyone. Just as a final comment, to remind everyone that we believe Opexa continues to be a leader in the development of personalized therapies for autoimmune disease. When next we speak it could be about the exciting results from the Phase 2b of the Abili-T. We’re certainly very, very excited about that. We hope for positive results from this study, especially for the patients who eagerly await a treatment for this disease. And certainly for our shareholders, many who have been supporting us for several years through the course of this very important MS trial. So the few months should be a very exciting time for us as we come to the completion of this, really his landmark study. So thank you again so much. We look forward to updating on our progress as we continue. And thank you specifically for your interest this afternoon in our Q2 earnings call. We appreciate it. Thank you.