Acer Therapeutics Inc.

Acer Therapeutics Inc.

$0.66
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Biotechnology

Acer Therapeutics Inc. (ACER) Q1 2016 Earnings Call Transcript

Published at 2016-05-13 01:08:26
Executives
Camilla Zuckero - Marketing Communications Manager Neil Warma - President, CEO and Acting CFO Don Healey - Chief Scientific Officer Donna Rill - Chief Development Officer
Analysts
Jason McCarthy - Maxim Group Keay Nakae - Chardan Capital Markets Ted Tenthoff - Piper Jaffray
Operator
Greetings, and welcome to the Opexa Therapeutics First Quarter 2016 Financial Results Conference 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. It is now my pleasure to introduce your host, Camilla Zuckero, Marketing Communication Manager for Opexa Therapeutics. Thank you, Ms. Zuckero. You may begin.
Camilla Zuckero
Thank you, Claudia. Good afternoon, everyone, and welcome to the Opexa Therapeutics first 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 March 31, 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 first 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 Opexa's management team. I would now like to turn the call over to our CEO, Neil Warma.
Neil Warma
Thank you very much, Camilla, and thanks everybody for joining this afternoon. We appreciate your continued interest in Opexa. We filed the Form 10-Q and the earnings release went off few minutes before this call, so there is access there if you want to follow along with our earnings release. I’m pleased to be here with the members of the management team here today representing Opexa. I am also very pleased to say that we are continuing to forge ahead with the completion of our Phase 2b clinical trial and we’re advancing on our second indication through preclinical development. Opexa continues to be one of the leaders in the developments of personalized T-cell immunotherapies for the treatment of autoimmune diseases. We want to be able to deliver the first phase and effective therapy to treat secondary progressive multiple sclerosis, and we remain determined in our efforts to advance Tcelna, our leading therapy candidate, towards the pivotal Phase 3 trial in secondary progressive MS and ideally to market. Opexa’s platform technology, we believe, has the ability to address unmet medical needs and diseases across multiple indications. Through the administration of personalized tailored therapies, we are aiming to restore the function of the body’s immune system in those patients with autoimmune diseases. These are truly personalized therapies, as each individual receives a tailored immune therapy that is matched to his or her disease profile. To our knowledge, no other company has anything similar to Opexa’s proprietary assay that allows us to detect the immunodominant peptides that are driving disease progression and build that into the manufacturing process in order to treat what is the root cause of the autoimmune disease. As I stated, adverse disease target, many of you know this is multiple sclerosis, we have conducted several clinical trials in MS over the years and have invested well over $100 million into the T-cell platform to develop a safe and potentially effective treatment for individuals with multiple sclerosis. Probably the most important trial we have conducted for multiple sclerosis’ patients is the one we are running now, the Abili-T trial. This trial is expected to read out in the coming months, specifically early in the fourth quarter of 2016. The trial is important for several reasons, the most important being that Tcelna is a treatment that could bring significant hope to patients with secondary progressive MS, and hope is certainly something these patients need. Currently there are no treatments available for patients with secondary progressive MS. The unmet medical need is significant as you can imagine. There are no drugs approved for the late-stage progressive form of this chronic neurological disease. The trial is also important in that if this Phase 2b study is successful, as we’ll find out in the new few months, we have a path defined to advance this product into a Phase 3 pivotal trial in secondary progress MS. This path would involve working closely with our partner, Merck Serono. Again, many of you know, in 2013, we signed an option and license agreement with Merck, who are one of the top MS companies in the world. They’ve been involved with multiple sclerosis now for many, many years. So with positive Phase 2 data, we believe Merck would exercise their option and advance Tcelna into a Phase 3 trial, and then continue through clinical developments in MS and to market. And if they did exercise this option, Merck would gain worldwide rights to call MS indications for Tcelna excluding Japan. With this they would then fund all the remaining developments and commercialization of Tcelna and Opexa could benefit through the receipt of milestone payments potentially totaling $220 million and then top of that additional royalty payments tiered from 8% to 15% of net sales. So in this scenario, Opexa could potentially recognize a significant revenue stream into the future. The next milestone payment from this agreement would be upon execution of the option agreement by Merck, which potentially could come at the completion of the Abili-T study. If that were to happen, and Tcelna did advance into a Phase 3 clinical trial, Opexa could then be in the position to receive a $25 million milestone payment. So we’re excited about having Merck as a potential partner and we’re certainly excited about the potential of Tcelna in multiple sclerosis. The Abili-T trial has been completely on schedule, disclosing out well. As we said, we’re in the remaining months. We have enrolled over 180 patients in the Abili-T trial. To-date 98% of all patients have been completed, the final dose having been administered last February. So all is on track here. We’ll take the next few months to complete the remaining few patients follow-up visits and collect and aggregate the data. Then we are expecting to present top line data early in the fourth quarter 2016 and we’re certainly looking forward to that event. The top line data will focus on the two - really the two key endpoints. There is multiple endpoints we’ll be looking out, but there is really two that are of critical importance, those being the whole-brain atrophy and disease progression. The physicians, the principal investigators in this study and the study coordinators have performed exceptionally well during the trial, and for that we thank them tremendously. We’re also grateful to the patients who are involved in this trial for believing in our therapy. So MS, specifically the results of the Abili-T trial may drive short-term valuation, certainly over the next few months as this landmark trial reads out, we believe that Opexa’s proprietary platform should also generate substantial growth and value in the medium to long-term. With our aim to restore the function of the disabled immune system, we believe our platform technology has broad applications to treat other autoimmune diseases. Many of you know we’ve moved ahead into a second disease indication as well, and over the past few months, we have made progress in the second indication, neuromyelitis optica or NMO. That is really truly pioneering work being done at Opexa in NMO. We believe we’re the only company coming at NMO with a different treatment strategy. Our unique mechanism of action selectively targets the harmful T-cell and we believe eliminates it from the body, thereby potentially treating the root cause of this disease. Similar to multiple sclerosis, our treatment for multiple sclerosis, Opexa’s therapy for NMO patients, we believe, is expected to be a personalized T-cell immunotherapy that should deliver a favorable benefit risk profile to the patients. If we can retrain the body’s immune system, we believe it should have a profound effect on treating the disease. NMO results in the demyelination of the optic nerve and the spinal cord, and there are currently no treatments for this disease in the U.S. or anywhere in the world. It is a rare disease or orphan disease that could affect up to 10,000 individuals in the United States alone. As we move forward with our development of OPX-212, Opexa’s therapy candidate for NMO, we will keep you appraised as we hit the key milestones, but we’re pleased we’re making progress in this our second indication. And then jump over to the financial health of the company. Give a brief overview of the financial numbers. As I said, everything has been filed and presented with the SEC on our Form 10-Q for the quarter ending March 31, 2016. So looking at a few key categories just to read are: we recognized revenues of approximately $726,000 for the three months ending March 31, 2016. This compares with approximately $377,000 for the three months ending March 31, 2015. The revenues were related to the recognized portion of the $5 million upfront payment received from Merck Serono in conjunction with the option and license agreements, and then the additional $3 million payment we received from Merck Serono in connection with their 2015 investments. The net loss reported for the three months, first quarter was approximately $2.2 million, which represents a loss of $0.31 per share, and this compares with a net loss of $3.4 million or $0.95 per share for first quarter 2015. So importantly our cash balance at the end of the first quarter was approximately $10 million. No debt on the balance sheet. Our operating cash burn during the three months was approximately $849,000 per month. Based on our current activity projected burn, we believe we have sufficient liquidity to support the current clinical activities of the Phase 2b Abili-T study in secondary progressive MS and the preclinical activities for OPX-212 in NMO through the first quarter of 2017. So really just to summarize: $2 million in the bank at the end of Q1. This takes us through Q1 2017. Over those three months, we burned roughly $850,000 a month. No debt on the balance sheet. And nicely we’re generating revenue through our partnership with Merck Serono. So it’s a good place to be relatively healthy balance sheet. So before I jump on a few questions from the group, I am very pleased with how the first quarter and even the past couple of months have progressed. We’ve done well as a team and I could give lot of credit to our Opexa team here. We also had a significant privilege to join some of the world’s leading scientist and researchers in the field of cell therapy. At the Vatican last month, I was able to present the Opexa platform to a very broad audience which included the members of the Vatican Pontifical Council for Culture and various heads of the regulatory authorities around the world including Japan’s PMDA, Europe’s EMA. And really it’s gratifying to see that Opexa is gaining further recognition as a leading company in the field of immunotherapy. It’s a very exciting and important year for the company. We expect to report on the Phase 2b trial early in the fourth quarter or really in the next few months. The market for secondary progressive multiple sclerosis could be substantial possibly up to $7 billion. If the Abili-T trial is successful and Tcelna is ultimately the treatment of choice for secondary progressive MS, we believe our immunotherapy could capture a sizable portion of the potential multibillion dollar market opportunity. And importantly, it could mark a significant contribution for patients with the progressive form of MS. And with Merck Serono lined up as our potential partner at the completion of this Phase 2 trial, with our second indication in NMO advancing and the platform that could mark significant value for the company, we expect this year to contribute positively to shareholder value. So maybe, Claudia, now to questions from the group. We’ll take a few questions from the audience if there are any, and then I’ll going to circle back at the end. But maybe open up to audience. Questions please.
Operator
Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] The first question comes from Jason McCarthy with Maxim Group. Please go ahead.
Jason McCarthy
Hi, Neil. Congratulations on all the success. The T-cell study has been long awaited to data. Lot of work has gone in into this from Opexa and Merck Serono with their support. Can you discuss any of the communications you’ve had with Merck Serono? Are the two companies discussing plans for potential Phase 3 designs, and maybe what that landscape looks like as you do approach data in 4Q, and what does it look like going forward with Merck?
Neil Warma
Yes, thanks Jason. Thanks for calling. Thanks for the question. Thanks for your kind words. Yes, we’ve been really in continuous dialog with Merck Serono since the very beginning a couple of years ago when we inked the deal. They’ve been very supportive. I don’t want to say they’ve been more enthusiastic in Opexa because we’re pretty darn enthusiastic over here, but it’s really encouraging to see them being extremely motivated enthusiastic. You know they’ve been in the area of multiple sclerosis for years. They’ve got one of the leading products on their market with Rebif. So they certainly understand multiple sclerosis. They understand the markets very much in Europe and also in the U.S., so an ideal partner to have. They’ve been very public in their belief and commitment to multiple sclerosis as well. So kind of building up their arsenal of MS products is something they look forward to, and I think they’ve again said publicly that they are excited about the potential of Tcelna. So without going into anything confidential, the discussions have continued and are ongoing. We have setup a joint steering committee between the two companies that’s been ongoing for quite some time now. And really the goal of that joint steering committee is to project forward - planning on success around the Abili-T trial. How are we going to move Tcelna forward to get access to the market as quickly as well, so very much as you suggest part of those discussions are around potential clinical path, regulatory path, how would the clinical picture look moving forward. So as I said, there has been a lot of scenarios that have been built. Certainly what we might envision I think both sides are fairly positive on this that we probably would expect a single Phase 3 pivotal study in secondary progressive MS, obviously as we’ve - what we’ve talked about earlier today and most people know, the unmet medical need in secondary progressive MS is enormous. So knowing that and certainly the FDA knows that. They granted Opexa Fast Track designation for Tcelna in secondary progressive a number of years ago. So there is obviously this recognition to execute on unmet medical need in secondary progressive MS. So the idea that we could forge ahead with one pivotal study in Phase 3 rather than the typical two-study could require early in the stage of MS. I think that’s something that we look forward to the idea of submitting to the FDA for accelerated approval and breakthrough designation is something that holds our company just spoken about and we certainly envision with strong data to be able to apply for those two designations with the FDA and even ramp more rapid movements through Phase 3 to commercial. So all that to say that the two companies, we talk regularly. We’re known throughout their company. They know us well. We know them well. It’s a fairly broad extensive joint steering committee and the commitment runs from the very top of that company throughout the worker bees in the company as well and those out in the sales force. So it’s a terrific relationship. As I said, I’m looking forward to hopefully getting that exercise of the option. Certainly the milestone payment coming in, but I think important for us moving the product closer to market, closer to these patients as we interact with secondary progressive MS patients out on some of these activities we do. It’s such a desperate situation for many of them. So I think the commitment for Merck Serono is certainly there and for certain that it’s there on the part of Opexa as well. So it’s a great team that’s come together in Merck and Opexa.
Jason McCarthy
Right. And thanks for that answer. And I remember back at the R&D Investor Day few months ago, some of the physicians - and forgive me I forgot their names off the top of my head, showed really interesting data and presented their views on using brain atrophy as an endpoint. And I’m curious, what do you gone - or Neil, what do you think about using brain atrophy as an endpoint and what do you think the FDA and regulators are going through or how they are going to view that once you get the data?
Neil Warma
Yes, good question. I’ll let Don answer that. I mean, back in the R&D Day, yes, we were very fortunate to have Dr. Clyde Markowitz from UPenn there, presenting on the MS program. Very fortunate Dr. Greenberg presenting on the NMO program as well, and Dr. Markowitz is noted for years. He was in the earlier trial with us and this trial with us. So he spoke very knowledgeably about our therapies, the T-cell therapy in MS and its potential but also about the critical endpoints, brain atrophy being one. So actually he has been very supportive in recognizing brain atrophy as our primary endpoint in this study. Don, maybe scientifically you want to speak about a little bit.
Don Healey
Certainly, yes. Hi Jason. Yes, to the concept of atrophy being predictive of progression is obviously the point in issue or question here. There certainly has been a lot more meant over the last sort of two or three years where trails that are mapping atrophy progressive endpoints are studying cohorts of patients over time and looking at cohort variation. The level of pathology there is pretty evidence of atrophy being linked to the gray matter destruction or loss which then ultimately translates to cognition issues and also to physical disability. So yes, at the moment we believe there is of course in fact relationship of predicting value of atrophy to progression and endpoint. The fun discussion with FDA though is over the context of progression as defined by the EDSS scale. There are a lot of physicians out there who feel that EDSS is an insensitive tool for looking for drug therapies that may have activity in terms of actually improving the quality of life for the patients, and as we probably know companies like Biogen have been looking at composite endpoints that look at subset essentially of EDSS score, so look for more sensitive endpoints to predict potential efficacy activity in patients that may have improvement in quality of life measures with maybe smothered or estimated by the EDSS scale itself. And so yes, it’s somewhat of a moving landscape and we do think atrophy has value. We will certainly be in discussion with FDA and others will as well, how you translate endpoints and the fact that EDSS and the concept of introducing composite endpoints or other measures as registration requirements to get the product to market for a very much unmet medical need for MS community.
Jason McCarthy
Great. And just one more quick one. When do you think NMO objectives will get into the clinic? Thank you.
Neil Warma
Yes, we remember days, as we’re careful not to give specific guidance around NMO. We’re pleased with the progress that we’ve really gone and the whole team here has made in NMO over the few months. We’ve been taken guidance off the table as far as expectations on IND submission moving into the clinics. You suggested rather it’s kind of a better place for us to be at this to kind of inform the market as we move forward and as we hit those milestones. So right now we’re not going to make predictions. As I said, it’s a novel approach and we’re one of the pioneers out there with this approach to NMO targeting the T-cell. So as I said, trying to throw our hurdles every now and then than we have knockdowns. We’ve been doing well in doing that, but we want to - I’d say, we don’t want to put any expectations out there just we’ll inform as we make good progress.
Keay Nakae
Great. Thank you guys for taking the questions.
Neil Warma
Sure.
Operator
The next question comes from Keay Nakae with Chardan. Please go ahead.
Keay Nakae
Yes, thanks. Neil, as we look forward to announcing the data how that would [indiscernible]. What’s the window of time they have to exercise their option?
Neil Warma
Hi Keay, thanks for joining today. Yes, the contract lease, they’ve got - I believe it’s a 45-day window from receiving data. There is a couple of point to flexibility there that makes them a little bit kind of certain circumstances, but I believe it’s a 45-day window to obtain the data and pass their decision on to us. So that’s why it’s important. Keeping that window as short as possible obviously has many benefits in moving forward getting to Phase 3 and getting this potentially to market. For us getting the milestone payments is obviously critical as well, but that’s why I think it’s been really important to sit down with them and they’ve been very willing to do this over the past year to get a close understanding of each other. We got an intermittent understanding of the trial design.
Keay Nakae
So second question, who decides whether the data is of sufficient quality, so that it’s three...
Neil Warma
Sorry, Keay, you’re cutting out a little bit. The question who decides on…
Operator
Just to interrupt. I guess his line disconnected. We’ll go ahead with the next question and see. One moment please.
Neil Warma
Maybe I’ll just finish up that point. Merck Serono will make the decision on whether they move forward or not. As I was saying it’s important - it’s been very important to have that dialog with them over the past number of months on the trial design that they are looking at and for them to become intermittent with the design and the types of data they will be looking at, such that when the data comes out in a number of months, they’ll be very familiar with the type of reports they are going to be getting, so that will hopefully streamline that decision-making process considerably. So having these joint steering committees should contribute positively to that outcome as well. So next question?
Operator
The next question comes from John Smith [ph], a Private Investor. Please go ahead.
Unidentified Analyst
Hi. Thanks for taking the question. At the R&D Day last year, one of the things that was talked about was how in secondary progressive a lot of the information is compartmentalized and perhaps behind this closed blood brain barriers. So can you walk through for us how your - these kind of unofficial regulatory sales are making their way from the periphery into the CNS, and my general understanding is that at one point that we’re in relapse remitting scenario, have trouble working in secondary progressive because of this issue. So is this a potential issue for your, I guess, drug? Is it - kind of how it gets into the brain when you’re dealing with this secondary progressive MS?
Don Healey
Hi there, John [ph]. It’s Don Healey speaking. Thanks very much for your question. It’s an interesting observation in that the induced immune responses as a consequence of treatment with Tcelna primes what’s called a T-cell subset or a T regulatory population. Now this T regulatory population can actually traverse through the peripheral blood interlink and even across the blood brain barrier into central nervous system. And there are all sorts of different what we call key note tractions that are put that by inflammatory slides that designed to recruit cells into those locations. So they essentially are guided by those signals. So kind of primes that a new response. It’s called the natural cause of immune recirculation and immune surveillance. People often ask, are you sure they can actually get into the central nervous system? Well, obviously we were hesitant to share positive clinical benefit, but just remembering that T-cell enters the normal healthy brain as a consequence of immune surveillance. If you fail to do that, then you end up with complications such as PML for instance or a drug such as [indiscernible] designed to specifically prevent those cells from harming the central nervous system itself. And so yes, we believe because we’re in both community that could imply the close blood brain barrier is not an impediment to our mechanism of action. The issue with lot of other drugs that work in the [indiscernible] field is that primary mechanism of action is that it impacts the T-cell response in the periphery whether it’s in a link mode or in the blood itself and have no impact within the CNS simply because they are excluded, specifically excluded by the blood brain barrier from entering the target issue. We do not think our mechanism of action is impeded by that event. As a consequence we believe we can get local regulation of inflammation particularly within the brain.
Neil Warma
And I think the big question John [ph], a very big question. We did a lot of work on this. We were actually just chatting just before the call around the table here about exactly that and kind of commenting about the pervious or the Biogen study in secondary progressive MS and why that trial read out negatively. And again coming back at this blood brain barrier and most likely we've seen failure with other relapse remitting drugs in secondary progressive MS because those products, those drugs are just not able to decide. They are not able to cross that blood brain barrier. So I think one of our clearly distinguishing features of our therapy is that these healthy T-cells are able to, as Don said, traverse freely across the blood brain barrier and get into that CNS where the inflammation is more centralized in secondary progressive MS. So it’s a big advantage for us and we believe, as we said, kind of a few minutes ago around the table that makes us the only game in town right now for individual to secondary progressive MS. It’s great for Opexa and unfortunate very much for the patients so, but we differentiate it pretty significantly from some of the - from most of the other drugs that are out there for multiple sclerosis.
Unidentified Analyst
Thanks. That helps. And then just one follow-up question. With respect to the disease progression, can you help us understand how that’s being - how that’s defined? Is it sort of change in the EDSS for a certain period of time or can you…
Neil Warma
Yes, we look at disease progression typically introduced in the EDSS. And for those out there not familiar, EDSS is really the standardized scale or measurement for determining disease progression in multiple sclerosis. The scale goes from zero to 10; zero being healthy, 10 being death due to MS. And over the life of an MS individual, they typically go from zero to one to three to five to six to seven and progress down that EDSS scale. And there is a number of measurements or observations that go into that when the neurologists gives a determination of what the EDSS value is and that’s related to mobility, cognition, visual acuity. So there is a number of elements that are considered in EDSS.
Unidentified Analyst
Is it there like a one point - how is it specifically being defined during your trial for the one point increase?
Neil Warma
Our trial, it’s a change in EDDSS. A one point change in EDSS is sustained over three months. So how can we sustain over time because it’s a spike, so over three months, a one point change, John [ph].
Unidentified Analyst
Okay. Thank you so much for taking the questions.
Neil Warma
Okay. You’re welcome. Thanks for your questions.
Operator
The next question comes from Ted Tenthoff with Piper Jaffray. Please go ahead.
Ted Tenthoff
Great. Thank you very much, Neil. Great to see you over in Italy. Quick question with respect to the next program, NMO. How quickly could you advance that into the clinic and is that something that you guys internally budget?
Neil Warma
Thanks Ted for the question. Hi, it was a terrific meeting over in Vatican. Yes, that was wonderful. Yes, I mean, it’s hard. NMO we can - again, how quickly can we get into the clinic? Let's say we’re kind of finishing off preclinical studies. What’s involved there? I think we spoke we’ve been getting to in this call the positive data we generated in the preclinical animal model NMO that’s a few months ago now. So we show that statistically significant down regulation of those auto-reactive T-cells in the NMO mouse model. So that was one component we had to do in the preclinical box. What were the other steps that we need to focus on to complete in the preclinical package is the manufacturing of the product. So FDA wants to see product manufacture consistently and robustly in our manufacturing facility. So those are the studies we’re doing now. Once that’s completed, Ted, submit an IND, FDA comments, move that into the clinic. So it could in theory be relatively rapid process. As we announced publicly a number of months ago as well, we were very fortunate to have secured a private investor to fund the Phase 1, 2 study and when we get there. This is an individual who understood the complexity of NMO and how are you proceeding by therapy and stepped up and provided us with a $5 million investment that will be tranched in as we hit certain clinical milestones in that study. The first tranche came in last September and the other tranches will come in as we complete those milestones moving forward. And those are public mixed milestones with either submission of the IND. There is approval of IND. There is initiating dose in the first patient and dosing 30% of patients. Those milestones are out there publicly. So ideally, Ted, when we kind of move through the preclinical program and should we get that IND filed and into the clinics, then the investments could trigger and we would have funding to move that clinical program forward. So we’re setup nicely with NMO, again, as we make progress in getting that towards the clinic. We’ve got that box checked when we get there, so we’re grateful to our private investor for recognizing the potential of our achievement and stepping up and supporting that program as well.
Ted Tenthoff
That’s it. And looking forward to the MS data. Thanks so much, Neil.
Neil Warma
Thanks very much, Ted. Appreciate it.
Operator
The next question comes from Dave Massack [ph], a Private Investor. Please go ahead sir.
Unidentified Analyst
I think you’re talking about me. Anyway, can you elaborate a little bit about when you talk about this is first line therapy, and do you think is this part of the reason why we only have a $15 million market cap because maybe the investment community is thinking that this can't really be marketed to the masses? Can you elaborate a little bit about?
Neil Warma
Yes, sure. There is a number of points in there. Thanks Dave [ph] for the question. I think from the first line therapy perspective, I think that should have broad appeal and that’s what we’re hearing with all these immunotherapies these days whether they are cancer-based or autoimmune base. The benefit risk profile that is being projected on these personalized therapies will likely go away what we’ve seen in biologics and small molecules, and I think that’s true for Opexa therapy as well. Essentially what we’re delivering is a truly personalized T-cell vaccine, if you will, to every individual. And the upfront personalization, as I said, we don’t need to get into this specific for the time and we’re happy to follow up with you offline David [ph], if you want to reach out to us. But again we’ve developed a proprietary assay which allows us to evaluate - potentially evaluate the individuals’ disease profile by assessing their episodes read out. I alluded this into the speech at the outset of this call, but we’ve got a proprietary assay that allows us to identify the immunodominant peptides. So the specific peptides to which the T-cells are binding in an individual. And these are unique for individual and they change over time. So what we’re truly developing in expanding of that T-cell population, we’re expanding out those T-cells that are doing the damage in that individual at that point in time. So there truly is personalized and tailored for that individual. We treat that individual without T-cell vaccine, five injections over the course of the year. And then in every subsequent year, we reanalyze his episode profile. We screened 109 episodes that comprised the [indiscernible]. We pick out the two or three that are specific for that individual, manufacture the vaccine, treat again. And as it changes year-on-year, we’re able to keep pace with that evolving peptide profile, if you will. So this is something that no other company can do we believe. So it’s a vaccine year-upon-year for every individual. And as far, I mean, your point your market cap and scalability and that’s clearly an issue I think the entire cell therapy industry needing to - needs to do a better job in the education process. We spend a lot of time educating - certainly educating Merck before we got into our partnership. How we were going to take a 200-patient trial and all of a sudden we have the 10,000 patients in the commercial market. So they’re into the belief that Opexa has a viable commercially attractive process or will have one at launch. So it’s certainly possible to do this at effective cost of goods. I don’t think the cost of goods have to be suffocating at all. They can be attractive. They can yield margins at 80%-plus. A lot of this has been demonstrated by us internally and a lot of this has been demonstrated to investors and to pharmaceutical partners, but again a lot of explanation, we either have - when you have individually tailored products for every individual, obviously the thought about commercialization and scale up is going to be threatening to some. So something the industry kind of breakdown those misperceptions, if you will, and demonstrate that. How this translates to our market cap? I mean, again there is a number of reasons and a number of rationales why this could have effect. I think what we’re trying to do is kind of get out in front of the investors now, talk about the MS program. I think a lot of folks are waiting till we got close to the data to buy into the program so to speak. So we’re moving forward. We’re few months from data. So hopefully we see some enthusiasm and we kind of go as the markets go. Today we see bad days over the past few weeks and it’s not so good, but we believe that as we kind of move closer to data, we can unlock some of this potentially us to explain and demonstrate the potential in the platform. We’ve got Merck Serono standing by. We’ve got Fast Track from the FDA. So we kind of rattle some changes and get out there a little bit more and tell the story. But I think as we do, people start to recognize that this is a huge disconnect between the potential and the company and where we are versus the actual - the valuation that’s been dictated by the market today. But hopefully that all comes together over the next few months as well.
Unidentified Analyst
Okay. Thank you.
Neil Warma
Thanks for the questions, David [ph].
Operator
[Operator Instructions] There are no further questions at this time. I would like to turn the conference over to Mr. Neil Warma for closing comments.
Neil Warma
Thanks, Claudia. Just briefly, so you had great questions and chance to kind of talk to some of our science well. So I appreciate all that from the audience. Again we continue to be a leader in the development of personalized immunotherapies for autoimmune diseases. We have important Phase 2b data expected in the near-term. We’re positioned for the strong potential partnership to advance Tcelna closer towards the market for successful data from the Phase 2b trial. We’ve got an exciting orphan program moving along, potential of that platform to reach out in the several different disease areas. So I’m excited about the potential in the company and until that we - that Opexa continues to be at the forefront in developing these next generation therapies. And thanks so much everybody for your interest this afternoon and listening to the call.
Operator
This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.