Greetings, and welcome to the Matinas BioPharma Quarterly Update Conference Call and Webcast. 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, Peter Buzzel [ph] of Westwood, Investor Relations from Matinas BioPharma. Please go ahead, Peter.

Thank you, Kevin. Good morning everyone and thank you for joining the Matinas BioPharma second quarter results conference call.Earlier this morning we issued a press release with our second quarter 2019 financial results along with business updates. The release is available on the Matinas BioPharma website under the Investors section. Joining me on the call today are Jerry Jabbour, our Chief Executive Office; Dr. Terry Ferguson, Chief Medical Officer; Dr. Terry Matkovits, Chief Development Officer; and Dr. Raphael Mannino, Chief Scientific Officer; and Keith Kucinski, Chief Financial Officer.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 forward-looking statements involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws. These forward-looking statements are based on 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 filed 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.Please note, that we are also providing slides that will accompany this morning's call. These slides which can be found in the Investors section of the company's website, summarize some of the key updates discussed on today's call. Finally, an archive of this call will be posted to the company's website, also in the Investor Relations section. Following the company's prepared remarks, we will open up the call for question-and-answer session.I will now turn the call over to Jerry.

Thank you, Peter. Good morning and welcome everyone. Thanks for taking the time to join us today as we discuss our 2019 second quarter results and provide a business update.In Q2, Matinas made important progress on a number of key objectives that now set up our company and our product candidates for an exciting next 12 to 18 months. We have continued to focus on advancing our lead product candidate, MAT9001, further into development and on securing necessary supply of intermediate and final drug products. We are set to begin what will be a very busy and we believe a value creating period for this differentiated and highly promising prescription-only omega-3 product. We have also been extremely busy moving MAT2203, our oral formulation of amphotericin B, and our lead LNC platform drug candidate towards initiation of a very interesting and important phase 2 study cryptococcal meningitis, an area of significant unmet medical need. As we initiate and conduct these studies, we expect to continue to build on this momentum through the second half of 2019 and throughout 2020.We are well positioned to begin a period of what we believe will be compelling news flow with multiple studies getting underway across our two clinical programs. I also believe we will benefit from the increasing activity in our space, specifically with the continued emergence of this new class of omega-3 drugs which could potentially benefit tens of millions of patients without some of the side-effects that have traditionally plagued cardiovascular medicines and at an affordable cost.This morning I will provide a few high level comments on both, MAT9001 and MAT2203. Then turn the call over to Dr. Terry Ferguson to further discuss MAT9001. We'll then hand things off to Dr. Terry Matkovits, who will discuss MAT2203 and provide an overview of our…

Thanks Jerry, and good morning everyone. As we've outlined on previous calls, we continue to advance the MAT9001 program to treat patients with hypertriglyceridemia. This pathway involves careful consideration of not only where the clinical and regulatory environments currently stand but also how they are likely to evolve over the next few years.As Jerry discussed earlier, in addition to the studies we are currently undertaking in support of our regulatory strategy for MAT900, we're excited about initiating an additional head-to-head study versus Vascepa. We begin pre-screening patients in the next month and plan to begin enrollment early in the first quarter of 2020. The design of the study builds on prior head-to-head data for MAT9001 versus Vascepa providing experience in a larger number of patients treated for a longer period. We plan to enroll approximately 70 patients with elevated triglycerides between 150 milligrams and 499 milligrams per deciliter, similar to those patients included and reduce it. We'll be randomized to either MAT9001 or Vascepa.The initial treatment period will be 28 days with a washout phase of approximately one month. Each patient will then be crossed over to the other therapy for an additional 28 days of treatment. Each patient will receive two capsules of study drugs twice daily with food. Our expectation is that MAT9001 will have greater bioavailability versus Vascepa, and we also look to confirm the prior observations in reducing triglycerides, total cholesterol, VLDL-C, non-HDL-C, Apo C-3 and PCSK9. Based on an expected first patient in, in Q1 of 2020, we anticipate the top line data from the study will be available in early Q4 of 2020.More generally, the enthusiasm for the emerging class of prescription omega-3 drugs continues to build. I believe that the strength trial will also be an important contributor to the evolution of prescription omega-3 therapies. The expectation is that this trial, which is being done in an even higher risk patient population than reduce it, will also be positive. The ADA has included Vascepa in it's most recent updated guidelines and the non-profit group ICER [ph] recently concluded that Vascepa is a cost-effective solution for patients. These are all positive indicators of the growing acceptance of prescription-only omega-3 therapy and create positive momentum for other similar drugs in development including MAT9001.I'm proud of the progress we have made in a relatively short period of time with MAT9001 and we look forward to providing additional updates as these studies progress and as data from these trials become available.With that, I'll turn the call over to Theresa Matkovits.

Thanks, Terry and good morning, everyone. I will provide a few key highlights on MAT2203 and discuss our upcoming study in patients with cryptococcal meningitis.MAT2203 is an orally administered formulation of amphotericin B, a historically IV-only administered drug with fungicidal activity but an overall poor tolerability and toxicity profile. This drug has been in development for some time and is supported by multiple pre-clinical and clinical studies in a variety of target indications. With our most recent qualified infectious disease product designation with fast-track status, supporting our regulatory pathway, we are now focused on the treatment of cryptococcal meningitis with the support of both, the National Institutes of Health, and the FDA, following our most recent interaction in late June.Cryptococcal meningitis is a severe life-threatening fungal infection of the central nervous system and is currently an area of high unmet medical needs with poor treatment alternatives. Our protocol for the EnACT study which stands for Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial was developed with the most important goal being patient safety. The study is designed to explore the use of MAT2203 for both, induction and maintenance therapy in these very sick patients. Current standard-of-care involves a very limited treatment course with IV amphotericin due to it's renal toxicity, followed by an extended maintenance period of fluconazole treatment.Within this patient population, more than 40% of treated patients typically die, underscoring the ineffectiveness of the current treatment options. We have designed this protocol to be split into two distinct parts, with part 1A of the study involving a phase 1, 3-arm single ascending dose design in 9 healthy, meaning without fungal infection, though HIV-positive volunteers to determine the maximum tolerated dose, followed by a multiple-dose portion in 9 additional patients receiving the dose from Part 1A for 7 additional days to…

Thanks, Terry and hello, everyone. This morning we reported a net loss attributable to common shareholders of $3.6 million or $0.03 per basic and diluted share, essentially unchanged from a net loss attributable to the common shareholders of $3.6 million or $0.04 per basic and diluted share for the same quarter last year.Research and development expenses were $2.8 million compared to $1.5 million in the same quarter of 2018. The increase in R&D is due primarily to higher clinical development costs associated with MAT9001. General and administrative expenses were $1.8 million compared to last year's second quarter G&A expenses of $2 million. We ended the second quarter with $36.8 million of cash and cash equivalents compared to $12.4 million at year-end 2018; this increase includes net proceeds of approximately $30.1 million from the company's public offerings completed in March.Based on our current projections, we continue to believe that cash-on-hand is sufficient to fund operations into the first quarter of 2021.I'll now turn the call back over to Jerry for some closing remarks.

Thanks, Keith. Just to provide some key takeaways to the group today following our update. For MAT9001, we're set to initiate our comparative PK trial in the coming weeks. We are also set to begin patient pre-screening for our head-to-head study against Vascepa. Finally, our head-to-head study is expected to begin dosing in Q1 of 2020 with top line data expected a short time thereafter in Q4 of 2020. On MAT2203 supported by recent QIDP and fast-track designations for MAT2203 in the treatment of cryptococcal meningitis, and following a positive FDA meeting and approval to commence the EnACT study which is fully funded by the National Institutes of Health, we are set to initiate the PK portion of that study in the fourth quarter of 2019 and we'll provide updates over the course of 2019 and 2020 as we expect to move from cohort-to-cohort in this important study, demonstrating the impact that MAT2203 can have on the deadly invasive fungal infection cryptococcal meningitis.In summary, it's an extremely exciting time for the company. The next 12 to 18 months we believe will be full of milestones and value creating events. We thank our valued shareholders for following along with us and we look forward to continuing to update you on our progress.With that, I will turn it back over to the operator so we can begin our question-and-answer session.

Thank you. [Operator Instructions] Our first question today is come from Bert Hazlett with BTIG. Your line is now live.

Thank you. Congratulations on the progress. I have a couple of questions. Terry, I think you've discussed this previously once or twice but could you -- in the additional 20 days crossover study, would you talk about additional important secondary endpoints that you might be looking for? What's important now that the study beyond triglycerides that you've already seen with MAT9001? And I have a couple of other ones as well.

Thanks for the question. The head-to-head study looking at -- comparing MAT9001 versus Vascepa is an opportunity to build on the information we already have. And in addition to the bioavailability, I think there are opportunities to probe deeper into the lipid markers, and the important lipid markers that I highlighted are going to be non-HDL, Apo C-3, PCSK9; and to validate the prior observations that LDL levels don't increase. There are a variety of other markers that would be of a more exploratory nature but I think that we hope to reinforce and validate the prior observations of what was shown in the head-to-head study. Does that answer the question Bert?

That does, thank you. That's very clear. So shifting to LNC and the -- first of all, the EnACT study; it's really encouraging that that is moving forward rapidly. Assuming success in EnACT, would you expect there to be additional consideration for broadening a label with 2203?

Yes. Thank you for the question. Our expectation and in conversation with the agency, we do expect to leverage 505V2 [ph] pathway to allow us to further expand the potential indications for MAT2203. We have already started discussions with FDA and a bridging strategy that will allow us to leverage the many years of safety data already generated with the amphotericin products already on the market. So our expectation is absolutely as you've indicated to expand our reach beyond just cryptococcal meningitis.

Thank you, look forward to that as well. Just a quick question on LNC; Jerry, there have been some focus on business development and potential additional licensing with that; is that still underway? And is there potential events upcoming there?

Yes, thanks Bert for the questions. First and foremost, obviously on this call we've focused on products and the products that we have in the clinic, but that's not to say that our objectives in terms of advancing the platform have any less importance. And you know that we outlined two different collaborations this year. One in the oligo space, and then and one with ViiV Healthcare in the antiviral space; those are very much ongoing. And specifically, with respect to ViiV, we're already in formulation development working on a number of differing approaches to those antivirals and we expect and look forward to kind of advancing that with ViiV Healthcare over the coming quarters.At the same time we continue to field inbound requests on a variety of different uses for this technology, which has demonstrated such broad applicability. Sometimes in biotech, it's a fine line between focusing on what is immediately at hand and then thinking forward to what maybe additional opportunities. We think in focusing most of our internal attention and resources on 9001 and 2203, we're doing the right thing in terms of placing importance on immediate value creation but we do look forward to continuing to demonstrate how the LNC platform can be utilized more broadly, and certainly making those announcements as those programs progressed over the next few quarters and the next year or so.

Thanks, that makes sense. And one last one. And this is regarding EnACT.com with a competitor for omega-3. Obviously, it's really difficult to determine what programs specific questions might come out of that discussion that's been announced but what do you think that -- if anything that might come out of that would pretend for the class? I'm just interested in your thoughts.

Sure. And obviously I want Dr. Ferguson to comment on that, given his years of experience in the area. But certainly, we think an outcome is something that probably should have been anticipated the entire time and that's not necessarily because of questions specifically with respect to the CPA but let's face reality here. With the data I've reduce it, you now have data which potentially place not only that product but products that promise to follow in a position to treat tens of millions of patients. From an FDA perspective, their obligation is not just an evaluation of the CPA but how do they think about an entire class. And so from our perspective, we certainly think it's an opportunity for the class and something that probably should have been expected all along, notwithstanding kind of the timing and how it may have caught certainly the market and investors by surprise. But overall, as we look forward to how this class may emerge and the potential that it has to treat that many patients with that safety profile and with an affordable cost for patients, this is exactly what we believe the FDA has to and should do if this is really going to set up as a class, but I'll let Dr. Ferguson comment for us.

Yes, building on that a little bit. I think that the -- this in my view is really good for the class because the reduce it data are very robust. All of the endpoints line up in the proper direction and that's one of those things that the more you look at it the more impressive the data are. It's an amazing clinical trial. At the same time, as Jerry mentioned, this is potentially applicable to lots and lots of patients that are out there. So they're -- and it's not just this Omega-3, there are others that are coming behind, including that 9001. And the big questions that arise are simply just who and why and who is the population and the -- is this going to be reparable to the broad reduce it population of high risk cardiovascular patients with elevated triglycerides. And what is it that is driving the outcomes and how much of that relates to the reduction in triglycerides that was observed in reduce it? And I think that those are fundamental questions that have to be addressed not just for the CPA and the reduce it trial but for the Omega-3 class as it comes forward. And I welcome the opportunity for people to take a much closer look at the data because again, as you look at the data, it just continues to look stronger and stronger. So I'm very optimistic about this for the class.

Appreciate the additional color and congratulations again on the progress. Look forward to more.

Thanks, Bert.

Thank you our next question today is coming from Jason McCarthy from Maxim Group. Your line is now live.

Hi, thanks for taking the questions. Jerry, I want to shift back to 2203. I think there's so much focus on 9001 and the Omega-3 space at Amarin [ph] and AstraZeneca. When you look at 2203 in the anti-fungal space which I continue to believe is incredibly underserved, even relative to an underserved antibiotic market. And you look at adding an oral ampho, how do you look at the market in general? Because cryptococcal meningitis and HIV is a large indication, particularly in Africa but it's a very small, fungal community, as you know. And when awareness builds around a drug like ampho that's potentially oral with absolutely no toxicity, IV doctors, in my experience will tend to use whatever is available for any indication. Can you give us like kind of a broad mile-high perspective on that?

Sure. Again, Jason thanks for the question. And thanks for turning the call back to 2203. I think it's one of the things that makes Matinas a unique opportunity. Is that this really isn't a binary investment. We're not a single asset, omega-3 Company. We benefit from a lot of the work that has been done over the last 3 years and certainly even longer than that in advancing MAT 2203. And for us, you're right to focus on the market and you're right to say that this is a small community. And from the very beginning, this acid has been fortunate to be surrounded by some of the leading mycologists in the world. And that caused us to focus on what are the areas of greatest unmet medical need and that's where you started with prophylaxis. But as additional data started to emerge, particularly with Peter Williamson's data, in his really stringent mouse model at the National Institutes of Health, you started to see that treatment could become probably even a more important threshold demonstration than prophylaxis.And you combine that with the fact that we have an opportunity because of the NIH funding to move forward in this demonstration, essentially, without having to use our own dollars. It presented the greatest opportunity and so the combination of great data in those preclinical models, combined with the interest of the NIH and the University of Minnesota and the financial support made crypto a perfect model. And then, it became how do you design the study in a way that gets you to where you want to be in a high-risk patient population without subjecting the product and subsequently the platform to unnecessary risk? And that's why Dr. Matkovits, Dr. Mannino and the entire team spend so much time on this…

And also, just briefly, while we're on this subject, can you talk or somebody that's in your group talk a little bit about something that's different about anti-infective? Whether it's antifungal or antibiotic or otherwise, is that the preclinical models? Well, I think, in use high triglycerides or oncology or gene therapy or whatever, doesn't hold or carry a lot of weight. In infectious disease, it tends to because typically what you see in animal models and Id tends to translate quite nicely into humans. So I think that the preclinical models carry more weight. Can somebody address that just a little bit to work?

Sure. Jason, we think it's a really important point and so I'd like to have Dr. Matkovits comment on that.

Yes, you raise an excellent point. In the anti-infective and antifungal world, absolutely the animal models are highly predictive of efficacy. And that's been borne out in many studies that have been done just in the mouse model alone that was used to test our MAT2203. In Dr. Peter Williamson's hands, amphotericin IV behaved as it does clinically. And that's really what was that the key basis for the investment by the National Institute of Health in this clinical trial because there was such good validation and replication of what is seen clinically with the IV amphotericin. The ability for us to demonstrate in that rigorous animal model that MAT2203 is at least as effective, if not better than the current standard of care was really instrumental in driving the funding decision by the National Institutes of Health.

And Jason, just to add on that just one more thing. I think you've seen this with the development of other anti-infective medicines. That predictive ability of animal models, specifically with respect to efficacy translates really, really well. The unfortunate reality in the anti-infective space over the last few years is that the failures we have seen are centered on safety. They're centered on toxicity. And our reality and the reality of our platform is that is exactly the challenge that this platform is designed to solve. So we like the ability we can rely on the predictive nature of the efficacy demonstrated in our preclinical models, and the fact that the solution we're bringing to bear is about patient safety. So that combination, we think sets this study up to be a very good potential outcome for MAT 2203.

Okay, just real quick, will you -- in the next will you be screening patient samples for any azole resistance or other resistance as part of your data set?

So currently, we have not included that in the protocol. However, we've left the protocol open to future adaptations. So that is something that we can look for in an exploratory fashion as the study progresses.

Okay, great. Thanks for taking the questions.

Thanks, Jason.

[Operator Instructions] Our next question is coming from Chad Messer from Needham & Company. Your line is now live.

Great. Good morning and thanks for taking my question. It seems an important part of the differentiating profile for MAT9001 is your inclusion of proprietary amount of DPA. But it seems like DPA is a little less understood or its contribution to efficacy is a little less understood than EPA and DHA. Can you comment on what the sort of current state of knowledge about DPA and how it's working is and maybe what sort of steps there are to improve our knowledge about how it's working whether that's going on at Matinas or with some academic collaborators?

Great. Now thanks, Chad, for the question. And certainly, differentiation is the key hallmark of why we think MAT9001 can assume a potential best-in-class position. I'll ask Dr. Ferguson to comment on it, and then, perhaps add some color at the end.

Yes, and I think that the DPA in a lot of ways is kind of the new kid-on-the-block. There has been a lot of basic work done in the past and it's clear that all of the omega-3s are not the same, and there is a clear hierarchy of the ability of these different omega-3s to, for instance, reduce triglycerides so that EPA turns out to be the least potent of the triglyceride-lowering drugs, DHA is in the middle, and DPA is actually the most potent of the triglyceride-lowering drugs. They also have a variety of different effects on genetic markers, PCSK9 being one of them, and there is -- we're currently in discussions for additional basic science work relating to how the omega-3s are incorporated into membranes, what they do to membrane fluidity, a lot of this. So we are sort of behind the scenes also continuing to advance the basic science understanding of where the omega-3s fit into this, there has been a lot of work done with DHA and EPA and we are going to be supporting additional work looking at DPA in exactly those same circumstances.

Great, thanks. It's good to hear that the science behind this is important work.

Absolutely, Chad. Thanks for the question.

Thank you. We have reached the end of our question-and-answer session. Ladies and gentlemen, that does conclude today's teleconference. At this point, I'd like to turn the floor back to Jerry for any further or closing comments.

Great, thank you very much. We appreciate everyone's interest in all the different things we're doing here at Matinas. Obviously, this isn't a single asset play, we have -- are about to commence a period of significant activity. At the end of the day, data rules the day, and we are starting studies which are positioning us to be able to show demonstrations that both, MAT9001 and MAT2203 can become effective solutions for patients. That's why we do this, this is a science-driven business, proud of the team we have assembled driving these products forward, and the next 12 to 18 months should be a very exciting time to be a follower of Matinas BioPharma.Thank you for your time today. Enjoy the rest of summer, and we look forward to continuing to update you over the coming months.

Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time, and have a wonderful day. We thank you for your participation today.