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Edited Transcript of MTNB earnings conference call or presentation 13-Aug-19 12:00pm GMT

Q2 2019 Matinas BioPharma Holdings Inc Earnings Call

BEDMINSTER Aug 23, 2019 (Thomson StreetEvents) -- Edited Transcript of Matinas BioPharma Holdings Inc earnings conference call or presentation Tuesday, August 13, 2019 at 12:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* James J. Ferguson

Matinas BioPharma Holdings, Inc. - Chief Medical Officer

* Jerome D. Jabbour

Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director

* Keith A. Kucinski

Matinas BioPharma Holdings, Inc. - CFO

* Theresa Matkovits

Matinas BioPharma Holdings, Inc. - Chief Development Officer

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Conference Call Participants

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* Chad Jason Messer

Needham & Company, LLC, Research Division - Senior Analyst

* Jason Wesly McCarthy

Maxim Group LLC, Research Division - Senior MD

* Robert Cummins Hazlett

BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst

* Peter Vozzo

Westwicke Partners, LLC - MD

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Presentation

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Operator [1]

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Greetings and welcome to the Matinas BioPharma quarterly update conference call and webcast. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Peter Vozzo of Westwicke, Investor Relations for Matinas BioPharma. Please go ahead, Peter.

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Peter Vozzo, Westwicke Partners, LLC - MD [2]

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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, Chief Executive Officer; Dr. Terry Ferguson, Chief Medical Officer; Dr. Terri 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 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 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.

Please note that we are also providing slides to 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 a question-and-answer session.

I will now turn the call over to Jerry.

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [3]

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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 product. 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 toward initiation of a very interesting and important Phase II study in 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 2 clinical programs.

I also believe, we will benefit from 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. Terri Matkovits who will discuss MAT2203, and provide an overview of our upcoming study in cryptococcal meningitis. Finally, Keith Kucinski will provide a brief overview of our second quarter financial results.

Regarding MAT9001, I am extremely pleased to report that we are ahead of schedule in guiding MAT9001 back into the clinic, focused on the treatment of cardiovascular and metabolic conditions. This is an exciting time for this class, and data continue to emerge on the benefits seen with prescription-only omega-3s in the larger world of hypertriglyceridemia and reducing cardiovascular risk. Because this field is still evolving, we have been careful to put into place an adaptive development strategy focused on generating clinical data, we believe could differentiate this product from the leading approved prescription-only omega-3 products. We completed the in-life portion for our required bridging toxicology study ahead of schedule and remain on track to initiate a comparative bioavailability study of MAT9001.

Importantly, we have finalized the protocol and anticipate beginning to prescreen patients in our second head-to-head PK and PD study against Vascepa, and are scheduled to begin dosing patients early in 2020. This study builds on the positive head-to-head data already generated versus Vascepa, which is currently considered the best-in-class drug in a potential $10 billion-plus market. Topline data from this study are anticipated in Q4 2020. This could be ideal timing in advance of the announcement of the topline data from AstraZeneca's strength trial.

Turning now to MAT2203, our lead candidate based upon a lipid nano-crystal delivery platform. We recently had a positive meeting with the FDA, focused on our development program for this drug in cryptococcal meningitis, where we received important feedback in moving forward with our NIH-funded Phase I/II EnACT study. This feedback underscored the critical unmet medical need that MAT2203 could address. This was further demonstrated with our recent receipt of our fourth qualified infectious disease product designation with Fast Track status from the FDA for MAT2203 for the treatment of cryptococcal meningitis.

We are preparing to initiate a combined Phase I/II study with MAT2203 for the treatment of HIV-infected patients suffering from cryptococcal meningitis. Known as the EnACT study, this open-label sequential cohort study will be conducted pursuant to a grant from the National Institutes of Health, which fully funded the study. Dr. Matkovits will provide more details on the study design, study objectives and conclusions that may be drawn over the course of the study a bit later in the call.

I would now like to turn the call over to Dr. Terry Ferguson to provide additional details on our MAT9001 program and some commentary on developments in the cardiovascular space.

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James J. Ferguson, Matinas BioPharma Holdings, Inc. - Chief Medical Officer [4]

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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 Terry discussed earlier, in addition to the studies, we are currently undertaking in support of our regulatory strategy for MAT9001. We're excited about initiating an additional head-to-head study versus Vascepa. We begin prescreening 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 and 499 milligrams per deciliter, similar to those patients included in REDUCE-IT, who will be randomized to either MAT9001 or Vascepa. The initial treatment period will be 28 days, with a washout phase of approximately 1 month. Each patient will then be crossed over to the other therapy for an additional 28 days of treatment. Each patient will receive 2 capsules of studied drug 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, ApoC3 and PCSK9.

Based on an expected first patient in, in Q1 of 2020, we anticipate the topline data from this 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 its most recent updated guidelines. And the nonprofit group ICER, 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 Terri Matkovits.

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Theresa Matkovits, Matinas BioPharma Holdings, Inc. - Chief Development Officer [5]

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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 preclinical 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 need 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. This 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 its 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 2 distinct parts, with part 1a of the study involving a Phase I 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 determine longer-term safety and tolerability. This portion of the study will commence in September and progress over the next several months.

Once the optimal dose has been selected from Phase I and approved by the Independent Data Monitoring Committee, or DMC, the Phase II portion of the study will commence in or around Q1 of 2020. Phase II is an 18-week perspective open label 4 sequential stage cohort trial to evaluate safety, tolerability and efficacy of MAT2203 among approximately 100 HIV-infected patients with cryptococcal meningitis, compared with standard IV administered amphotericin B. There will be scheduled enrollment pauses for DMC safety reviews between stages, with progression to the next cohort of patients viewed as a positive signal for the drug in terms of both efficacy and patient safety. Cohort 1 will begin the induction phase in 10 patients with 5 days of IV amphotericin B, followed by MAT2203 for the next 9 days, for the balance of the induction phase. Consolidation or maintenance therapy will then continue for the remaining portion of the overall 10-week treatment period. Upon review of the data by the DMC which will occur after each induction phase, a decision will be made to move to commence the next cohort of patients.

Cohort 2 will consist of 40 patients in the induction phase, where 2 days of IV amphotericin will be administered, followed by 12 days of MAT2203. At this point, the third cohort of 10 patients will begin the induction phase with MAT2203 for 5 days, followed by IV amphotericin B administration for 9 days.

Finally, the fourth cohort of 40 patients will receive MAT2203 for the entirety of the 14-day induction period. The primary endpoint in this study is the rate of fungal clearance in the cerebral spinal fluid. Multiple secondary endpoints include 18-week survival and hospital-free survival and multiple safety markers.

We are pleased with the design of this study and the collaborative nature of our work with the University of Minnesota and the National Institutes of Health. We believe we have come up with a patient-first study design, which properly focuses on patient safety, while allowing for the generation of important data, demonstrating the impact MAT2203 can have on this deadly fungal infection, which requires crossing the blood-brain barrier with an oral therapy. This is an unusual and challenging but highly promising study design, which we believe could position MAT2203 for both induction and maintenance indications in the treatment of cryptococcal meningitis. While the full results from this study will likely be available in 2021, we believe that progression from cohort to cohort in this study may be viewed positively, and a sign that MAT2203 is having the desired impact. We will plan to comment as appropriate during our quarterly update calls.

I will now turn the call over to Keith for a brief overview of our second quarter financial results.

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Keith A. Kucinski, Matinas BioPharma Holdings, Inc. - CFO [6]

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Thanks, Terri, 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 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 cost, 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 offering 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.

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [7]

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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 prescreening for our head-to-head study against Vascepa.

Finally, our head-to-head study is expected to begin dosing in Q1 of 2020, with topline 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.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question today comes from Bert Hazlett from BTIG.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [2]

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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-day crossover study, could you talk about additional important secondary endpoints that you might be looking for? What's important now to this study beyond triglycerides that you've already seen with MAT9001? And I have a couple of other ones as well.

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James J. Ferguson, Matinas BioPharma Holdings, Inc. - Chief Medical Officer [3]

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Yes. 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 are highlighted are going to be non-HDL, ApoC3, PCSK9 and to validate the prior observations that LDL levels don't increase. There are 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?

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [4]

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That does. That's very clear. So the -- 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 considerations for broadening a label with 2203?

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Theresa Matkovits, Matinas BioPharma Holdings, Inc. - Chief Development Officer [5]

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Yes. Thank you for the question. Our expectation and in conversations with the agency, we do expect to leverage our 505 (b) (2) pathway to allow us to further expand the potential indications for MAT2203. We have already started discussions with FDA on 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.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [6]

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Look forward to that as well. Just a quick question on LNC. And Jerry, there's been some focus on business development and potential additional licensing with that. Is that still underway? And is there potential events upcoming there?

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [7]

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Yes. Thanks, Bert for the questions. First and foremost, obviously, on this call, we 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 2 different collaborations this year. One on the oligo space and then 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 different 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. And sometimes in biotech, it's a fine line between focusing on what is immediately at hand and then thinking forward to what may be 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 progress over the next few quarters and the next year or so.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [8]

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That makes sense. And one last one. And this is regarding an ad com with a competitor for omega-3. Obviously, really difficult to determine what program-specific questions might come out of that discussion that's been announced. But what do you think that -- if anything might come out of that would portend for the class? Just interested in your thoughts.

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [9]

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Sure. And obviously, I want Dr. Ferguson to comment on that, given his years of experience in the area. But certainly, we think an ad com is something that, probably, should have been anticipated the entire time. And that's not necessarily because of questions specifically with respect to Vascepa, but let's face reality here, with the data of 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 Vascepa, 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 first.

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James J. Ferguson, Matinas BioPharma Holdings, Inc. - Chief Medical Officer [10]

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Yes. Building on that a little bit, I think that this, in my view, is really good for the class because the REDUCE-IT data are very robust, all the endpoints line up in the proper direction. And it'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 there -- and it's not just this omega-3, there are others that are coming behind, including MAT9001. And the big questions that arise are simply just 'who' and 'why', and 'who' is the population and that -- is this going to be referable to the brought 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 Vascepa 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.

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Robert Cummins Hazlett, BTIG, LLC, Research Division - MD & Biotechnology Equity Research Analyst [11]

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

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James J. Ferguson, Matinas BioPharma Holdings, Inc. - Chief Medical Officer [12]

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Thanks, Bert.

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Operator [13]

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Our next question today is coming from Jason McCarthy from Maxim Group.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [14]

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Jerry, I just want to shift back to 2203. I think there is so much focus on 9001 and the omega-3 space with Amarin and AstraZeneca. When you look at 2203 in the antifungal space, which I continue to believe is incredibly underserved, even relative to an underserved antibiotic market, and you look at having 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. ID 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?

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [15]

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Sure. Again, Jason, thanks for the question. And thanks for the -- turning the call back to 2203. I think it's one of the things that make Matinas a unique opportunity is that -- this really isn't 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 MAT2203. 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 asset has been fortunate to be surrounded by some of the leading mycologists in the world. And that caused us to focus on one of 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 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 spent so much time on this protocol. But it sets up the product. Yes, cryptococcal meningitis is not the largest commercial indication in the U.S. It is an acute orphan patient population, for sure, and a population, unfortunately, where even those patients subjected to treatment, there is a 40% plus mortality rate. So the need is huge. But it's a great demonstration in the -- one of the most difficult to treat invasive fungal infections, that our drug that can operate effectively and safely. And utilizing the 505 (b) (2) pathway, that Dr. Matkovits alluded to, and that we've been in advanced discussions with FDA, we believe, positions this upon a demonstration in the EnACT trial that we can treat these patients to go back after the other invasive fungal infections for which we already have QIDP, invasive candidiasis, the treatment of aspergillosis.

And yes, eventually, we believe the prevention of invasive fungal infections in immunocompromised patients. Those patients who are subjected to additional risk because of advances in medicine rendered them immunocompromised. So this is a great study for us to prove the point, advance MAT2203 and then use that as the bridge that Terri talked about to get us to those indications. And when you think about the opportunity that an oral, safe, well-tolerated amphotericin brings, that's the $1 billion-plus opportunity that people see, given the unmet medical need across the board in the antifungal space and the lack of investment in new therapies there, that's where MAT2203 is going to fit.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [16]

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

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [17]

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

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Theresa Matkovits, Matinas BioPharma Holdings, Inc. - Chief Development Officer [18]

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Yes. You raise an excellent point. In the anti-infective and the 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 the key basis for the investment by the National Institute of Health in this clinical trial because there was such good validation of 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 that -- the funding decision by the National Institutes of Health.

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [19]

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And Jason, just to add on that, just for one second. I mean 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 MAT2203.

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Jason Wesly McCarthy, Maxim Group LLC, Research Division - Senior MD [20]

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Okay. Just real quick. Will you -- in the EnACT study, will you be screening patient samples for any azole resistance or other resistance as part of your data set?

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Theresa Matkovits, Matinas BioPharma Holdings, Inc. - Chief Development Officer [21]

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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.

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Operator [22]

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(Operator Instructions) Our next question is coming from Chad Messer from Needham & Company.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [23]

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Great. It seems an important part of the differentiating profile for MAT9001, is your inclusion of a 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 its 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?

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [24]

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Great. No, 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.

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James J. Ferguson, Matinas BioPharma Holdings, Inc. - Chief Medical Officer [25]

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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's a lot of work done with DHA and EPA, and we are going to -- we are going to be supporting additional work looking at DPA in exactly those same circumstances.

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Chad Jason Messer, Needham & Company, LLC, Research Division - Senior Analyst [26]

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

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [27]

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Absolutely, Chad. Thanks for the question.

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Operator [28]

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

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Jerome D. Jabbour, Matinas BioPharma Holdings, Inc. - Co-Founder, CEO, President & Director [29]

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Great. Thank you very much. We appreciate everyone's interest in all of 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.

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Operator [30]

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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.