Matinas BioPharma Holdings, Inc.
Q1 2020 Earnings Call Transcript

Published: 12 May 2020

[Operator:]

Welcome to the Matinas BioPharma First Quarter 2020 Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded.I would now like to turn the conference over to Peter Vozzo, Investor Relations representative from Matinas BioPharma. Thank you may begin.

[Peter Vozzo:]

Thank you, Diago. Good afternoon, everyone and thank you for joining the Matinas BioPharma first quarter and 2020 results conference call. Just after the market close today, we issued a press release with our first quarter 2020 financial results along with business update. The release is available on the Matinas BioPharma website under the Investors section.Speaking on today's call will be Jerry Jabbour, Chief Executive Officer. We also have Dr Terry Ferguson, Chief Medical Officer; Dr. Terri Matkovits, Chief Development Officer who will be available to answer questions during our Q&A session. At this time I would like to remind our listeners that remarks made during this call may state management's intentions, hopes, beliefs, expectations or projections of the future.These are forward-looking statements and involve risks, uncertainties; forward-looking statements on this call are made pursuant to the Safe Harbor provisions of Federal Securities Laws. These forward-looking statements are based on the Matinas BioPharma's current expectations and actual results could differ materially. As a result you should not place undue reliance on any forward-looking statements.Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Matinas BioPharma files with the Securities and Exchange Commission. These documents are available in the Investors Section of the company's website and on the SEC's website.An archive of this call will be posted to the company's website also in the Investor Relations Section, on the companies prepare remarks we'll open up the call for a question and answer session.I'll now turn the call over to Jerry.

[Jerry Jabbour:]

Thank you, Peter. Good afternoon and welcome everyone and thanks for taking the time to join us today as we provide a business update and discuss our 2020 first quarter results. We hope you and your families are safe and healthy during these challenging times. The first and second quarters of 2020 will be remembered as very trying times in light of the unexpected personal and business interruptions brought on by this global pandemic.In the early March we, along with the rest of the country and the rest of the world for that matter, were thrust into uncharted waters. I have to say I am incredibly proud of how the Matinas team has responded to this crisis, recognizing the seriousness of Covid-19 and acting early and decisively to address any operational challenges. Thanks to our agile structure, we adapted very quickly to minimize disruption and prioritize the well-being of our employees, study participants and research partners.During the first quarter, we implemented a variety of mitigation strategies to reduce risk and ensure business continuity. In line with the guidance from the US Center of Disease Control and Prevention as well as the state of New Jersey, we implemented work from home measures for all employees and suspended all business travel. We also implemented processes to ensure the advancement of all of our development programs while continuing to emphasize the safety of our team and research and development partners.Our lab employees recently returned to our Bridgewater facility. And we have prioritized certain lab and manufacturing activities in the interest of safety and efficiency. From a clinical study perspective, the Covid-19 pandemic is an ongoing challenge for all clinical sites and hospitals throughout the world. As you know, late in the first quarter, we made the correct decision to temporarily pause enrollment in each of our key clinical trials.This decision was taken to ensure the health and well-being of trial participants and clinical site employees while ensuring the integrity of our clinical trials, as well as capturing all clinically meaningful data. Since that time and as we have seen gradual improvement in many areas throughout the country and across the globe, we have been working closely with our clinical trial sites and study investigators on plans to resume enrollment of patients in our important clinical trials with the appropriate assessment and safety monitoring protocols in place.I will speak more directly to this in the context of each of our clinical stage candidates in a few moments. For those of us at Matinas the challenges posed by Covid-19 serve to highlight the critical needs of patients dealing with serious diseases. We remain as committed as ever to our mission of serving these patients as well as the health care providers who care for them. We believe we are pursuing this mission from a position of strength and our solid balance sheet will enable us to stay the course with several meaningful inflection points anticipated over the coming quarters.Our enhanced trial, the head-to-head crossover comparative study of MAT9001 versus Vascepa remains an important and compelling study for our next generation prescription-only omega-3 therapy. We are thankful to be able to announce today that enrollment for ENHANCE-IT is expected to resume in June. And working closely with Dr. Kevin Maki, our Study Director as well as the teams from each of our eight clinical trial locations we are implementing all reasonable and necessary safety procedures for subjects and study monitors.With ENHANCE-IT expected to resume in June, we are modestly revising our guidance for the delivery of top line data from the fourth quarter of 2020 to the first quarter of 2021, while it certainly remains possible that top line data could be available sooner depending on enrollment. We believe that this slight revision in guidance is appropriate under the circumstances given some of the uncertainties around Covid-19. Importantly, we remain on track for our end of phase meeting with the FDA in the third quarter of this year.We are in the final stages of preparing both the meeting request and our briefing package which will focus on the results from our comparative toxicology and human pharmacokinetic studies as well as our planned phase 3 protocol for the study of MAT9001 in patients with severe hypertriglyceridemia. The team has continued to do an excellent job of maintaining our supply chain for our MAT9001 clinical trials without disruption while taking steps to prepare actively for phase 3.We continue to believe that MAT9001 has best-in-class potential in the prescription omega 3 class with clear differentiation in pharmacokinetics, EPA levels, impact on lipid markers such as triglycerides and PCSK9 and convenience of administration without the need to split dosing to more than once a day and having to be taken with meals.We look forward to resuming ENHANCE-IT and reporting the results from this trial as soon as possible. I would like to turn now to MAT2203, our lead drug candidate applying our lipid nanocrystal or LNC platform delivery technology, before I get into specifics however, I would like to spend a moment talking about infectious disease generally and the impact of the global pandemic on this area.An interesting and unintended feature of Covid-19 is the increased attention being given to the treatment and prevention of infectious disease. Dealing with these hidden enemies and the potential health and economic threats they pose to society has been thrust into the spotlight. We are unfortunately seeing the impact that Covid-19 has had on the emergence of other deadly infections including in phase of fungal infections. Emerging reports suggest that as many as one-third of patients with severe Covid-19 infections requiring intensive care may also be battling life-threatening invasive fungal infections.In addition, we are also seeing the importance of drug delivery takes center stage as a critical element of effectiveness is ensuring that enough of a therapy can get to the afflicted area of the body at the right time. We believe that our LNC platform is well positioned to not only become a solution for repurposed drugs like amphotericin B and amikacin but potentially for a variety of new complex molecules in development which require delivery in a direct and targeted manner with the convenience of oral administration allowing for outpatient treatment options and improved Pharmacoeconomics.In MAT2203, our oral LNC formulation of the broad spectrum and potent antifungal drug amphotericin B, we believe we have the potential gold standard and drug of choice for the treatment and perhaps ultimately the prevention of deadly invasive fungal infections. Building on extensive impressive preclinical data in the treatment of invasive fungal infections and two phase two studies conducted in the treatment of mucosal fungal infections.MAT2203 is currently positioned to investigate the treatment of cryptococcal meningitis a deadly and face of fungal infection of the central nervous system. As we have previously announced at the end of March, our EnACT trial of MAT2203 which is financially supported by the National Institutes of Health was temporarily suspended by mandate of the Uganda National Drug Authority.Today based on the latest available guidance, we announced that we anticipate resuming EnACT enrollment in June. The significant unmet medical need of HIV patients in Uganda suffering from cryptococcal meningitis is a key factor in restarting this clinical trial as soon as possible. Following discussion with our clinical site in Uganda we are planning to resume enrollment and treatment of the first cohort of ten patients in the next month.Given this updated timing we would expect to be in position to make an announcement as to the progression from the first cohort of patients to the second cohort of patients later this year. We continue to believe that cohort progression is significant with this drug in this patient population and an important potential value inflection point for this therapy.We view cryptococcal meningitis as an important and potentially valuable gateway indication for MAT2203. In the United States alone where we believe MAT2203 could be eligible for a limited population pathway for antifungal drugs or LPAD approval, there are more than 5000 cases annually with potential pricing of more than 50,000 per course of therapy according to peer companies who have performed market research in this area.In the US, a drug approved under the LPAD pathway is an antibacterial or antifungal drug approved to treat a serious or life-threatening infection in a limited population of patients with unmet needs. Of course, the incidence of invasive fungal infections including cryptococcal meningitis is even greater around the world thereby expanding the commercial opportunity potentially significantly.Following approval and cryptococcal meningitis, we believe that MAT2203 is well suited for streamlined 505-b2 approvals and other indications. This could position MAT2203 to become the antifungal drug of choice for the treatment of many invasive fungal infections.Total sales for drugs treating invasive fungal infections amount to several billion dollars which speaks to the great potential for MAT2203 which we believe could capture a very large share of this market. If approved MAT2203 would give physicians for the first time the ability to safely utilize the most broad spectrum and highly potent antifungal drug currently available to treat invasive fungal infections with an oral formulation.In the first quarter of 2020, we also made progress with another clinical stage asset supported by our LNC platform delivery technology. MAT2501 is our oral formulation of amikacin, a broad-spectrum aminoglycoside commonly used to treat chronic and acute bacterial infections.Important work on MAT2501 which was supported by a grant made by the Cystic Fibrosis Foundation yielded promising preclinical data which now potentially positions this drug candidate for further development. We are in an ongoing dialogue with the Cystic Fibrosis Foundation to support development through phase 2. And in the first quarter received a small bridge grant commitment to continue important preclinical work on this product.Given our currently allocated resources, we would rely upon the Cystic Fibrosis Foundation and its support to advance this drug. We are optimistic given our discussions to date and look forward to hearing back on our application in the second half of this year.We believe that MAT2501 has significant clinical and financial potential. We are keenly aware of the value that Insmed, a $2.4 billion market cap company has been able to create with an inhaled version of allocation which was approved in 2018 under the LPAD program but with a very limited approval accompanied by significant black box warnings related to safety.We believe the profile for MAT2501 suggests it could be far better tolerated than Insmed's Arikayce where most of the serious adverse events are caused by having to inhale that product. As the treatment and prevention of infectious disease continues to receive overdue attention, we look forward to the potential to advance MAT2501 which would provide a much needed and much better tolerated solution for patients battling pulmonary bacterial infections.We are frequently asked about the progress we are making on some of the collaborations with big pharma that we announced during 2019. I am pleased to report that all three of these announced projects remain ongoing. Albeit with some interruption from Covid-19. We have advanced our ViiV healthcare collaboration to the point where we are preparing to provide formulations for preclinical investigation. We are also in the process of working on a variety of projects with Genentech just to provide a few examples. Our hope is that early data from these relationships could be available later this year.Furthermore, now that there have been demonstrations of efficacy for IV or injectable therapeutic options for the treatment of Covid-19, our discussions with the National Institute of Allergy and Infectious Disease at the NIH and others have intensified as we identify opportunities to apply our proprietary LNC platform to these compounds. Our goal would be to formulate well tolerated and viable oral therapies for patients confronting Covid-19.While these discussions are ongoing, there is obviously a sense of urgency on all sides. And we look forward to potentially playing a very active role and providing appropriate updates as they materialize and become available.Turning now to our financial results, for the first quarter of 2020 the company reported a net loss attributable to common shareholders of approximately $5.2 million or $0.03 per basic and diluted share compared to a net loss attributable to the common shareholders of approximately $4.3 million or $0.04 basic and diluted share for the same quarter the previous year.Research and development expenses were approximately $4.1 million in the first quarter of 2020 compared to approximately $2.3 million in the same quarter last year. The increase was due primarily to higher clinical development expenses related to the development of MAT9001 and MAT2203. General and administrative expenses were approximately $2.3 million in the first quarter of 2020 compared to the previous year's first quarter G&A expenses of approximately $1.8 million. The increase was primarily due to higher employee compensation costs.Turning to our balance sheet, we ended the first quarter of 2020 with approximately $71.2 million of cash, cash equivalents and marketable securities compared to approximately $27.8 million at year-end 2019. This increase includes net proceeds of approximately $46.7 million from the company's public offering completed in January. Based on current projections we believe that cash on hand is sufficient to fund operations into the first half of 2023.This is extremely important as we advance our products toward potentially significant inflection points. A cash runway that extends almost three full years and well beyond these inflection points provides great security during an otherwise significant period of uncertainty for many companies. We are extremely pleased that we were able to be opportunistic in the first quarter and conclude an important financing to protect the company and drive our business strategy.In summary, overall we are in a strong position from a business continuity standpoint and I thank my teammates for this and commend them for their continued dedication and drive as we all work together to get through these uncertain times. We remain committed to achieving the milestones we laid out at the beginning of the year and reaching our overarching goal of developing important therapies for areas of critical need. I am proud of the tremendous progress we have made in these uncertain times. And I am confident that we will continue to adapt as circumstances evolve.We all remain very excited about what lies ahead for the company for the remainder of 2020 and beyond. With that we have reached the conclusion of our prepared remarks and I will turn the call over to the operator for our question-and-answer session.

[Operator:]

[Operator Instructions]Our first question comes from Bert Hazlett with BTIG. Please state your question.

[BertHazlett:]

Yes thanks. Thank you for the update on 2501. Jerry, would you be kind enough to give a little bit more on the gating items for advancing that program forward?

[JerryJabbour:]

Sure, so just, Bert based upon our cache runway, our projections and our operating plan for MAT9001 and MAT2203 we've allocated our resources to those to lead drugs. So while we have continued to do formulation work and miner work necessary to position that drug to advance, we do believe that advancing 2501 further into the clinic, we've already completed one single ascending dose phase 1 study for that drug but going further into the clinic.I will rely into a great deal upon with the support of the Cystic Fibrosis Foundation. So, we are optimistic given the level of our conversations there the data that was generated using their funds was submitted directly to them and caused them to reach back out to us to invite us to submit a proposal for additional funding. We responded aggressively to that given the interest we have in that product and the potential addressable market.And so we're optimistic that, that will result in something but advancing that product will be dependent upon their support.

[BertHazlett:]

Great. That's very clear, thank you. Just two more for me, you expanded number of sites for ENHANCE-IT could you just talk a little bit about the additional sites you chose and why it clearly makes sense. And then the second one would be what types of data should we be hopefully expecting out of the additional collaborations from Genentech and ViiV. Thanks.

[JerryJabbour:]

Sure, so I'll just first talk about site expansion. So, even pre-Covid-19, one of the things that we looked at as a team was really giving ourselves the best opportunity to deliver data in a timely fashion. We knew the importance of 2020 and the ENHANCE-IT study and being able to use ENHANCE-IT as an opportunity to further differentiate our product from Vascepa. And the importance of adhering to timelines.And so we began even in the first quarter addressing the possibility of adding additional sites mostly as a way to ensure timely delivery. As we began to recognize and realize the risk that Covid-19 provided, we actually accelerated those discussions. And we actually have assessed our sites on the number of different levels, there's a level of sophistication we bring to that obviously we had a number of sites before but we also have taken a look at how the demographics and the epidemiology of this virus is occurring across the country.And so as we evaluated the opportunity to bring on different sites we also tried as much as possible based upon available evidence to select those sites in areas we believe would be less severely impacted than others by Covid-19. For example, we didn't choose an eighth site in Manhattan. So that was one of the reasons we added eight sites was to make delivery more timely and then also to give ourselves some opportunity should there become an issue or challenge with enrollment in any of our eights, any of our six sites that we would have additional sites to pick up the slack.And then so and then you asked a question on the collaboration. So, every one of our collaborations with big pharma is about proof of concept. It is about taking their molecule, developing formulations and then providing those formulations back to big pharma where they can do early preclinical proof of concept studies. So those studies and the type of studies will depend on the molecule and the target. Some of those will be in active disease models; other will be in models to determine things like protein expression.So, when we say that we're team things up with ViiV Healthcare that's what we're doing, we're giving them the formulations where they then will go and do their pre-clinical work. We have not disclosed publicly nor are we at liberty to disclose publicly what those targets are or how those models these those formulations will be evaluated. Same thing with Genentech, there's just a number of molecules that we're looking at but it's that same early stage evaluations.So, we need to be careful, we think there's a great opportunity in partnering with big pharma, we like the ability to utilize their expertise in molecule development and their expertise and financial resources to broaden the application of the technology but we - it's not like we're going to turn around and all of a sudden there's going to be human clinical data, this is early. Now things can happen fast once you have proof of concept but for us it's kind of getting to that first level.And that's what we would hope to see from ViiV Healthcare and or Genentech in the second half of this year, how that timing is disrupted by Covid-19 and how it impacts their operations, we have not seen that yet, there's always the opportunity that, that could impact them but it's that sort of data that we would be looking at from them.

[Operator:]

Thank you. Our next question comes from Ed Tenthoff with Piper Sandler, please state your question.

[EdTenthoff:]

Great, thank you very much. Jerry thanks for the update on Amarin and thanks for your comments. I wanted to get a sense just with respect to the recent patent wins with respect to Vascepa, sort of how that changes the dynamics in the market, obviously no direct impact to 9001 - I just wanted to get a kind of high-level sense of how you anticipate that could actually impact the market? Thanks so much.

[JerryJabbour:]

Thanks Ed. I appreciate the question and certainly a lots been made of Amarin's latest challenge with respect to the IP. I mean we've set our piece in terms of it doesn't impact us at all. I think it's too early to tell how if at all it impacts the market. Obviously, there's an appeal process that they will go through. To date this year based upon Amarin’s disclosures of first quarter sales and things like that it hasn't seemed to impact them at all nor has it changed their plans for how they're going to try to continue to expand the market.Maybe there's some reduced DTC costs there but based upon the addressable patient population that is subject to the new labeling of Vascepa, this market is going to continue to expand. And so I think we need to kind of wait to see how that is resolved from a litigation standpoint before you're able to really see how this is going to impact the market but one thing is clear it's not going to impact a product that's differentiated from Vascepa or its opportunity to become a best-in-class drug.So, while we believe that the headwinds that Amarin has faced has had an impact on our stock. Ultimately, the success of MAT9001 will be judged by how it's differentiated from Vascepa that's one of the reasons why ENHANCE-IT is so important, it gives us that other opportunity to distinguish MAT9001 and its unique benefits on things like EPA levels on PCSK9 that would position it as potentially a superior drug to Vascepa and any generic copy.So, for right now the market continues to expand, we do know that people have some concerns but I would say that those concerns really rest with Amarin; it's market cap and its ability to fulfill its analysts’ projections for its sales supporting its valuation. For us we think the pastures are very green and the opportunity to differentiate is still there.

[EdTenthoff:]

Excellent that’s super helpful perspective. And really looking forward to the intensity there now early next year.

[Operator:]

Our next question comes from Jason McCarthy with Maxim Group. Please state your question.

[JasonMcCarthy:]

Hey, Jerry. Thanks for taking the question. I think you would agree that with all the coronavirus activity that's going on, there's not a biggest light shining on infectious disease and there is right now. Can you talk a little bit about how maybe that shifts, some of the fundamental direction of Matinas if it does it all towards 2203? And also help us understand a little bit more about the market opportunity because antifungal is a whole $4 billion but Ambisome is the amphotericin leader. It's $500 million. It's a fraction of that probably because it's not used because of toxicity as much as it should be.And then there's a whole market that's untapped and just prophylaxin and treating patients on different hospital wards when you don't know why they have a fever they use the kind of candidates right? So, there's this whole $4 billion opportunity and all these dynamics behind it. So, maybe first a little bit Matinas’s thinking and then a little bit about the market dynamics.

[JerryJabbour:]

Sure, so Jason thanks for those questions. First, there's no fundamental shift to our focus inside this company and even over the last 12 months we have talked about the importance of having two clinical stage assets. The interest in those assets and the markets in which they participate will invariably ebb and flow based upon an investor's view of the upside potential at any one time. But the way we look at MAT9001 is no different today than it was year ago. We continued to believe that the profile of that drug suggests that it's an asset that we should support with a significant amount of our resources.We are in the beneficial position of having a partner in the NIH who to date has underwritten a lot of the expense in developing MAT2203 and that continues with the EnACT trial. So moving forward we are intent on getting to what we view as the potential for transformational data for both MAT9001 and MAT2203 in less than 12-months. So this is not going to be a situation like perhaps investors saw in 2015 where because of the headwinds facing the Omega-3 class and Amarin at that time and due to our available resources, we made a strategic decision to place MAT9001 in our back pocket and advance the platform. In 2020, what you have is a situation where now it's not headwinds which is facing any particular asset, but yes perhaps due to the increased attention on infectious disease, because of something like Covid-19, there are now tailwinds behind assets like MAT2203, behind MAT2501 and behind the potential of our delivery platform to potentially become part of a solution for Covid-19.So this is not going to result in any sort of fundamental shift, but it does give us an opportunity to now instead of driving MAT9001 forward with a lot of investor interest and dragging MAT2203 in the platform behind with governmental support perhaps now because of the need, because of the attention and because of the increased resistance to available therapies and the real threat and scare we have now to public health and to the economy because of infectious disease, it's going to give us we hope an opportunity to drive both of these things forward.In terms of the antifungal market you're exactly right. I mean AmBisome, with its global sales of around four $400 million to $500 million is severely limited because of its toxicity. The broad spectrum nature of that antifungal drug and the fact that as a polyene is uniquely resistant to kind of developing resistance because of the way that it's chemically formed. It's the toxicity and the IV administration that's held that back, but we need to progress development of this lockstep cryptococcal meningitis is a great initial gateway indication for us and should we be able with the EnACT study to follow up on the preclinical data showing that we could cross the blood-brain barrier and effectively treat cryptococcal meningitis should we begin to see that in the first, second, third cohort of patients from EnACT because of physicians familiarity with amphotericin and really the only hesitancy they have is because of that toxicity.I mean we feel with the NIH patients that have been taking this drug for almost three years; we've established a very good safety profile. We obviously need to continue to add to that safety database with EnACT but in amphotericin you do have that potential to take a repurposed medicine and solve its biggest challenges with IV administration and toxicity and make that well and well tolerated. So we do think that it is less of a hurdle for physicians to take a tool that they know really well from a potency and an efficacy perspective, if given the opportunity to show that it's safe and well tolerated they're going to use it.So we do know that the global invasive antifungal market is a multi-billion dollar market. We're beginning with cryptococcal meningitis. We are going to be - we've designed this study very carefully. Dr. Matkovits and her team with that primary goal of patient safety designed as a trial that we think accomplish a number of things. Let's get without putting patients at risk efficacy data and let's get any data set which shows we can cross the blood-brain barrier. So we plan to take that lock step. We do think that the opportunity exists for MAT2203 to be used more broadly, but we need to get through the EnACT study before we can start to really think about how this can blossom.

[Operator:]

Our next question comes from Greg Fraser with SunTrust. Please state your question.

[GregFraser:]

Yes. Thanks. It's Greg Fraser on for Greg Gilbert. I just want to follow up on the bridging study and the comparative talk study. I'm assuming you would have called out if there were any findings that were unexpected. So if you could just comment on that that would be helpful?

[JerryJabbour:]

Sure. So, Greg, we're still - all of the in light portions of those studies have been done. I mean we've seen some preliminary PK data there. We're waiting for final study reports. None of that is eventually will be published in a scientific journal at some point. We really view this really is material that the FDA just wanted to see and its evaluation of the relative profile of MAT9001 to LOVAZA under 505-b2, nothing that we've seen today is surprising to us relative to what we understand the pharmacokinetics of a free fatty acid versus an ethyl ester.We've seen that work having been done in the past for example with EPANOVA having been compared to LOVAZA in the ECLIPSE studies, nothing surprising there but ultimately it will come down to how the FDA evaluates that data in light of LOVAZA and their comfort level with advancing us to Phase 3 based upon that. But based upon our team's significant amount of experience in this space having looked at the data from all the Omega-3s regardless of molecular form over the last 15 years, we're comfortable with what we've seen so far and believe it continues to support our intended regulatory pathway.

[GregFraser:]

Got it. That's helpful. And as you work on the Phase 3 protocols and meet with the agency, you won't yet have data from ENHANCE-IT and I know that you always plan to meet with the agency before you had that data. So it hasn't changed but can you just remind us how ENHANCE-IT could influence your Phase 3, if at all?

[JerryJabbour:]

So it's an interesting question. I mean ENHANCE-IT is really done with an eye towards differentiation from a commercialization perspective. It is not any sort of gateway or item that would impact the well-established pathway to an approval and severe hypertriglyceridemia. What it does provide is an opportunity for an additional discussion with FDA perhaps in connection with the eventual revelation of the strength data for what opportunities outside of severe hypertroglyceridemia would be it - would be appropriate for MAT9001. So and it also gives us additional patients obviously to include in our safety database for submission as part of an approval for severe hypertriglyceridemia. And I'll let Dr Ferguson comment here. There's nothing necessarily per se and ENHANCE-IT that would advance severe hypertriglyceridemia, but it's really important data to reduce it like patient population against the therapy that's delivered compelling data.So from that standpoint it's good for differentiation but Terry Ferguson anything you want to add to that?

[TerryFerguson:]

Yes. As jerry mentioned, this doesn't affect the severe hypertriglyceridemia strategy at all. That path has been very well trodden is fairly well - is very well laid out. I think that the questions that finally having the strength data will tell us will address other populations other indications and I think that from my own standpoint the most important questions are going to revolve around the populations and subgroups in whom it worked in whom it may have not worked to set the stage for future opportunities.

[GregFraser:]

Got it. Thanks very much for all the color. Just a couple quick ones on EnACT. How will Q203 exposure differ during the induction period for the subsequent cohorts? And is the maintenance treatments phase the same for all the cohorts? Thank you.

[JerryJabbour:]

Yes. I'll let Dr. Makovitz comment on that.

[TerriMatkovits:]

So it's an active control standard of care parallel group comparison of sequential cohort designs in which we are slowly titrating patients off of IV amphitaricin to our oral MAT2203 until ultimately in the fourth cohort we are on an all oral regimen of our oral amphitaricin product. So the active arm will be the standard of care IV amphitaricin plus 5FC with the test arm being our product being administered for longer and longer treatment durations through sequential cohort design in order to manage patient safety. The maintenance phase induction will be a two-week length of treatment time followed by up to six weeks of maintenance treatment during the consolidation phase of treatment.

[Operator:]

Our next question comes from Chad Messer from Needham & Company. Please state your question.

[ChadMesser:]

Great. Good afternoon. Thanks for taking my question. I was just wanting to the upcoming end of phase 2 meeting with the FDA in terms of your discussion of the Phase 3 protocol. You talked about it a little bit to whatever extent is appropriate. Could you maybe discuss a little bit more about what you're hoping to get out of that?

[JerryJabbour:]

So out of the end of Phase 2 meeting there's really two aspects we view with this meeting. One is we're giving FDA the data it asked for before we could advance to phase 3. So based upon the feedback the written feedback that we got from FDA what they wanted to see was a comparative pharmacokinetic study to LOVAZA and a 28-day comparative toxicology study. So what we did is in addition to those two we added a 90-day comparative toxicology study as well. So in the FDA's mind their ability to have us pass to phase 3 is going to be about their evaluation of the safety of our product and have we established enough in order to move forward under 505-b2 relative to LOVAZA. So that's goal number one.And based upon precedent and other products which have pursued a 505-b2 path to LOVAZA in this category, we feel pretty good about that. And then in terms of the review of the phase 3 protocol, this is a protocol which they have seen over and over again in this space in terms of an approval for severe hypertriglyceridemia. So you're looking at a 12-week placebo-controlled trial in patients with triglycerides 500 or above that will be conducted on a global basis versus placebo. And so it is a protocol that will not come as a surprise to them. It's one they've seen very often, in fact, with every other product that has been approved in this space and so those are the two boxes we're hoping to check. The evaluation of that data and then their green light on that protocol. We have already begun sort of outlining preparations for phase 3. We've obviously accumulated the right sort of global talent on our SAB to be able to lead that effort.But that's really the goal going into the meeting, Chad, that's what the briefing book will focus on. And we're hoping to come out of that meeting with an approval to go into phase 3. FDA, for those who have experience in that area, they're not likely to say yay or nay on 505-b2 during this meeting. They always make those sorts of things a review issue. So the green light to go into phase 3 really is the key and our goal and expectation is that we could be in position to enter phase 3 in the first half of 2021.

[Operator:]

Ladies and gentlemen, there are no further questions at this time. I'll turn it back to management for closing remarks. Thank you.

[Jerry Jabbour:]

Great, Diego. Thanks. Thanks to everybody for joining us today. We wish everyone continued good health and safety. And we look forward over the course of 2020 to continue to keep you apprised as to our progress. We're thrilled to be in position to resume both EnACT and ENHANCE-IT in June of this year. And we look forward to the potential clinically meaningful data that each could provide. Thanks for joining us and have a great day.

[Operator:]

Thank you. This concludes today's conference. All parties may disconnect. Have a good day.