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.

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.

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…

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

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?

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.

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.

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…

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

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.

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.

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

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

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.

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…

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

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?

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.

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?

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?

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.

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.

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

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.

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

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?

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.

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

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.

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