Matinas BioPharma Holdings, Inc. (MTNB) Q1 2019 Earnings Report, Transcript and Summary

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, Jenene Thomas with Investor Relations. Thank you. You may begin.

Thank you, Jessy. Good morning, everyone and thank you for joining the Matinas BioPharma quarterly update conference call and webcast. 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 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 Securities and Exchange Commission's website. We encourage you to review these documents carefully. Following the Company's prepared remarks, the call will be opened up for a question-and-answer session. Joining me on the call today are Jerry Jabbour, Chief Executive Officer; Dr. Terry Ferguson, Chief Medical Officer; Dr. Terry Matkovits, Chief Development Officer; and Keith Kucinski, Chief Financial Officer. It is now my pleasure to turn the call over to Jerry.

Thank you, Jenene. Good morning to all those dialed in to our call today. I am extremely pleased with all of the progress we have made since the start of 2019. Highlighted by a recently successful million $32 million financing led by well-respected fundamental healthcare institutional investors. We are now well-positioned with a cash runway extending into the first quarter of 2021. Across all areas of our organization, we are intently focused on execution, and our team is working diligently to advance our products into exciting and important clinical studies. Despite the relatively short period of time since our April 2nd Investor Call, I believe it's important to take a few minutes to review our strategy and call out a few highlights which demonstrate the progress we've been able to make during 2019. Put simply, we are actively moving forward in advancing our two potential best-in-class assets MAT9001 and our LNC platform technology. We strongly believe that our lead asset MAT9001, a prescription only omega-3 fatty acid can be a tremendous value driver. The omega-3 landscape within the cardiovascular world is rapidly evolving. And we believe MAT9001 through its differentiated profile is well-positioned to assume a leadership role in this developing class of drugs. As we have outlined on previous calls, we are aggressively advancing MAT9001 toward an initial indication for the treatment of severe hypertriglyceridemia. Of course, given the profile of MAT9001 and with additional clinical study MAT9001 could be positioned to potentially address a much larger patient population. We believe that the reduced data generated by Vascepa, as well as the ongoing strength outcomes trial being conducted by AstraZeneca with its Epanova are laying a strong foundation for the growth of the class of omega-3 drugs and the opportunity to provide a tolerated, highly effective and affordable therapeutic option for tens of millions of cardiovascular patients. Based upon preliminary FDA feedback under our 505B2 streamlined development pathway, we plan to conduct a comparative PK in a bridging talk study, following an end of phase 2 meeting with the FDA to review these data which we expect to occur in the first half of 2020. We will conduct one single phase 3 study in patients with triglyceride levels of 500 and above, very similar to the design of trials conducted with every currently approved omega-3 drug. We have also been clear that our strategy involves conducting those studies required for an approval to treat severe hypertriglyceridemia in parallel to conducting those studies which we believe will highlight the differentiated profile of our potential best-in-class drug. Fundamentally focused on enhanced bioavailability and stronger efficacy across a variety of well-established and important biomarkers for increased cardiovascular risk. Having recently reactivated our IND and also having secured enough supply of MAT9001 to conduct all planned studies leading up to our phase 3 program, we are now ready to initiate two studies in the coming months, and are also actively preparing for the commencement of an additional head-to-head study against the Vascepa beginning early in 2020. We are proud of the great progress we have made in a short period of time with our lead compound, and look forward to providing additional updates as these studies commence and then following data readout from these trials. Now on to a few key highlight on MAT2203, our lead internal drug based upon our LNC platform technology. MAT2203 is an orally administered formulation of amphotericin B, which is usually an IV only drug with significant toxicity relating to its administration. Utilizing RN LNC platform technology, we have now made amphotericin B orally bioavailable and well tolerated without the toxicity seen with ID administration. amphotericin B historically had potent activity against most of the serious deadly fungal infections. We announced during our last conference call that based upon impressive preclinical data generated by the NIH, and with their continued financial support we are now pursuing cryptococcal meningitis, a severe life-threatening brain fungal infection as our lead clinical indication for MAT2203 Our team has been working diligently alongside the NIH and Dr. David Boulware where the principal investigator of this phases two studies. Dr. Boulware is a professor of the division of infectious disease and internal medicine at the University of Minnesota. With his guidance, we have designed a protocol that we believe will demonstrate the potential of our oral MAT2203 to treat a deadly infectious disease such as cryptococcal meningitis for which the only currently effective standard of care is IV amphotericin. We will be discussing this protocol and our overall development program for MAT2203 with FDA in a face-to-face meeting set for the end of June. As we prepare all of the materials for this important meeting, we believe the degree of interest and optimism in this program within FDA is quite high, given the expert we'll be sending to our meeting and the significant unmet medical need for individuals suffering from cryptococcal meningitis globally. If we are successful in demonstrating efficacy and tolerability of MAT2203 in this very challenging patient population especially given the well-established historical profile of efficacy of amphotericin B, a now oral and well-tolerated amphotericin B could become the drug of choice for physicians and patients in battling a variety of highly invasive and deadly fungal infections. We anticipate that following our FDA meeting, we will be in position to share the full details of this protocol for our phase 2 study, and we are looking forward to commencing this study in late Q3, 2019. We also continue to believe that generating successful data was MAT2203 is a key indicator of the viability and potentially broad applicability of our LNC platform delivery technology, including the potential to treat disease of the central nervous system. Now on to an update on our LNC delivery platform. As you know, we are positioning this technology to hopefully play a meaningful role in solving significant intracellular delivery, challenges with a variety of different molecules, including those in the gene therapy space. We are leveraging our LNT platform as an additional key area of focus for the company. Our ultimate goal is to generate non diluted funding through partnered programs and capitalize on the significant need for improved drug delivery solutions to create a variety of strategic verticals, while limiting financial and clinical development risk. We would like to see how broadly this technology can be applied without taking on the traditional burdens of full drug development. As a reminder, we announced our first evaluation with a large top 10 global pharmaceutical company in January. Strategically, we hope to utilize their expertise in the design of gene therapies and their substantial financial resources to drive this technology forward in their area of focus. We continue to have meaningful ongoing discussions with a number of parties interested in utilizing our unique delivery platform with their molecules. We remain focused on advancing these discussions toward the finish line in the coming months, while also increasing our internal efforts in the application of our LNC technology in the messenger RNA space. We hope to have additional data in areas such as mitigating injection site toxicity and protein expression following oral administration. Each of which could be very important to becoming a valued solution provider in this rapidly developing area. We continue to monitor, learn and understand more about the challenges associated with the delivery of nucleic acid polymers, a unifying challenge for many companies operating in this space, and we are eager to continue to demonstrate our potential here. I am very pleased with the progress of our two potential best-in-class assets and look forward to numerous opportunities over the course of 2019 and beyond to achieve value driving milestones. Before closing, I should mention that a little over a week ago on Monday May 6th, we celebrated an important event. The Matinas team led by our distinguished Chairman Herb Conrad was invited to ring the New York Stock Exchange opening bell. This was our second time in just over two years to be so honored which is very unusual. We are very proud of this opportunity and believe it speaks to all we have recently accomplished in a very short period of time. It was especially appropriate that Herb had the honor of ringing the opening bell. Herb was the first investor in Matinas and has made a significant impact upon the pharmaceutical industry over the course of his career. We are fortunate that Matinas will continue to benefit from his guidance and strategic vision. In closing, I want to stress to all of our listeners that Matinas is not a binary investment. We believe that in MAT9001, we have a potential best-in-class cardiovascular drug in a potential multi-billion dollar market with the advantage of a well-established and clear development plan designed for approval and differentiation. From the platform side led by MAT2203, we believe we have a unique drug delivery solution that can effectively protect molecules, including genetic material and deliver them in a fusogenic non-toxic and non destructive way into cells and then in turn use these cells for targeted delivery to specific tissues. The potential breadth of application could give us the potential to become a delivery partner of choice and puts Matinas in the enviable position to potentially collect licensing fees, milestones and royalties for each of the products on which we choose to partner. Advancing our delivery platform through collaboration during 2019 is a key objective of ours. And we look forward to making announcements in this area in the next few months. From a financial perspective, the company is now well funded to drive clinical development through key data points with cash until 2021. 2019 is and will remain a year of execution for Matinas and I am pleased to say that based upon our progress to date, we are well on our way. Our entire organization from our experienced Board of Directors to each of our individual employees is energized, enthusiastic and optimistic about our future and the opportunities which lie ahead. Thank you for joining today. I will now turn the call over to the operator to facilitate our question-and-answer session.

[Operator Instructions] Our first question comes from the line of Robert Hazlett with BTIG. Please proceed with your question.

Thank you for taking the question and congratulations on the progress Jerry and the crew. Two lines of questioning. First of all, could you talk a little bit about MAT2203? And what are some of your expectations for what might come out of the June meeting with FDA? Is there potential for rapid advancement of 2203 in the setting? Just a little bit more color there would be helpful.

Sure. We're really excited about this meeting because this is really an area that is of high focus not only for FDA, but for physicians who are operating in this area without really a good tool to help patients essentially survive. And so as we head into this meeting, this is really all about getting [buy-in] on a pretty unique protocol. A protocol that's designed to in its first instance get us PK data in this patient population to make sure that we're using the right dose in order to improve our chances to get a therapeutic result. And then it's really all about getting their buy-in on the design of this trial and it's a pretty unique design. Without going too much into detail, it's a combination of step-down therapy from the current standard of care as an initial cohort of patients. And then eventually moving through to where MAT2203 becomes the induction therapy. And that's pretty unique because you're dealing with a patient population which is highly at risk where the level of mortality is extremely high. So finding that right balance between exposing patients to our drug and ensuring that they continue to get access to therapies which give them a chance to save their life is really important. So this meeting with FDA is about buy-in. We think that --we already know that they're enthusiastic in this area. And so we don't expect any real questions or challenges on the protocol itself, but you bring up a good point because we're dealing with really a super orphan patient population here. And we do think there could be opportunities to streamline development. We are already positioning 2203for 505b2 which can streamline development in a lot of ways and rely on historical data generated by amphotericin B that will cut out a lot of things. But this is also an emergent patient population and so there is also we believe and it's our hope that this protocol in and of itself should we demonstrate success in these early cohorts, we could position this to actually kind of transition into almost a pivotal or registration trial. So that's our mindset going into this. Obviously, there's a lot of dialogue which needs to be had around that, but the other unique thing about this patient population is that because of this study design and where it will be conducted enrollment will not be a challenge. We are going to a clinic which is unfortunately full of patients who today have no good option. So unlike a lot of companies who are faced with studying their drugs in a patient population faced with a deadly infection enrollment can take years, that's not the case here. This will be a rapidly enrolled trial where we would expect to move from cohort to cohort in a relatively uniform fashion without having to wait for example three or four years that you would have to one-way to a roll of trial in new core for example. So and the other aspect of our meeting with FDA is their increasing interest in the platform. Our unique ability to take older, highly efficacious drugs but highly toxic drugs and make them a potential option for patients is of great interest to FDA because exposing patients to toxic drugs should be a last alternative. So there will also be a platform aspect to what we discuss with them. And which sets us up for further discussions including what we hope our future discussions on our second anti-infective drug MAT2501 which would be the first oral aminoglycoside and could have the potential to treat not only chronic infections like NTM but also gram-negative bacterial infection. So it's learning for FDA as well.

That's great additional color. And just one quick follow-up before I move into the manufacturing side. But is there ability to --is the study design contemplates something where the endpoint is a long-term endpoint or is it something like a 28-day endpoint or just a little bit more color in terms of what you're contemplating.

Yes. So when you're talking about these studies, it's not really defined to time. So we're going to kind of wait until we go into FDA to talk about how long these studies go. When you're thinking about the use of amphotericin in a patient who is experiencing cryptococcal meningitis, your expectation is that there will be utilization of that drug likely for up to a month. So in 28-days you're looking at it the right way but because of the way this study is being structured, there will be a combination of induction therapy using standard of care initially, and then balanced out with our drug that will eventually flip. But with any deadly fungal infection, you're not looking at long-term chronic use with MAT2203, but the unique thing about our formulation and what has everyone so intrigued is that with the IBM and Patterson not only is it not readily available because of a cost implications and because of the lot of --the inconvenience of IV administration in these patients. But you can't really use it longer than 10 or 14 days without starting to see that irreversible nephrotoxicity. So this protocol is designed to be able to demonstrate that our oral 2203 can be used for a longer period of time and be well tolerated. But there's no magic around 28-days.

Okay, that's very helpful. And you gave some additional color on manufacturing being able to be in place for 9001 through the clinical studies in 2020. Any thinking longer term in terms of manufacturing and if so, if could shed any light on the general strategies there that would be helpful.

Sure. It's something we think about a lot and we plan ahead because we believe we're going to be in position to be able to hopefully get an indication where we can supply a large amount of patients. So as we think about the evolution of our supply chain, obviously, mission critical was ensuring that we could begin the studies that are currently in our plan on time. And we're really happy that in a short period of time, we've secured supply for essentially a year and a half which is good. And then it's just the passage of time with these same suppliers that will put us in position to be able to have product available for Phase 3 pretty quickly. But as you go forward you want to expand your supply chain, so you're not reliant on one or two suppliers and there are different aspects to our supply chain. We buy a variety of intermediates and then kind of bring them together. And we also have a proprietary capsule technology which plays a key role. So whether we're talking about the omega-3 that we're using for the final formulation of MAT9001 over the next 12 to 18months, we would expect and I've already identified and are working with additional suppliers to get our specs right and we will bring additional suppliers on board. And the same with the capsule technology and that does a couple of things. Obviously, it creates important redundancy in your supply chain and removes an over-reliance, so that you are lessening or mitigating any risk of supply interruption. And then the other thing it does it gives you -- give you an opportunity to improve your cost of goods. And we continue to believe cost of goods in this area will be very important. I think there is a general recognition that high purity omega-3 is not an inexpensive endeavor and the price you pay for having this highly refined drug is a higher cost of goods. At the same time, we recognized that our cost of goods is going to be in line with other players in the space, which is really important that will improve our cost of goods just like theirs will improve over time as your volumes increase. So as we move through clinical development and we begin to put together launch forecasts, our cost of goods will come down even further. It's too early to project exactly what those will be, but we are confident when we say we will be in line with the other omega-3 approved products in terms of where our cost of goods eventually will land upon commercialization.

Our next question comes from the line of Jerry Isaacson with ROTH Capital. Please proceed with your question.

Hi. This is Ana on for Jerry Isaacson. If you could just give a little bit of color around the LNC platform and it seems like there's a lot of different applications for which it could be used? And so maybe just give a little bit of color around the technology and other indications that could be expert other than what you had mentioned. Thank you.

Sure. So the technology put simply has a unique ability to nano encapsulated molecule, get oral bioavailability because of the stability of these particles and then a unique ability because of the composition of these particles to get taken up by cells, activated cells. We've also seen them get taken up by monocytes and lymphocytes and that puts you in a pretty unique position. One, there are very few if any delivery technologies which can take these sorts of molecules and make them orally bioavailable. Typically, when you're thinking about lipid nanoparticles or even the traditional method of using something like adenovirus to deliver drug, it must be delivered intravenously. So a key point of differentiation for us is being able to deliver these drugs orally. That's number one. Number two because of the flexibility and formulation and the way we have identified strategies to essentially trap molecules in the lipid bilayer and the flexibility of doing it with small and large molecules, we can work with everything from hydrophilic and hydrophobic small molecules like amphotericin and amikacin, all the way up to large molecules like DNA plasmids, which we have shown the ability to work with. Those are large molecules. They're 11 kilobases. Those are too large for traditional lipid nano particles really to deliver. And our ability to be that flexible is what has the NIH excited about applications for example in the CRISPR area. And then you have to think about the unique way that we get into cells and the fact that we are attracted to cells or we are -- cells like macrophage or dendritic cells are attracted to our particles that makes you think about the type of intracellular disease that we can become a key player in and there I'm really talking about antivirals. And so the ability to actually safely get drug directly into macrophages which is where that disease hides, we believe can be a differentiator. We can take existing antiviral drugs for example and make them more potent because we're getting that drug exactly to the right SPOT, which is really, really exciting. And then when you think about delivering molecules like messenger RNA or small interfering RNA, the challenge is twofold. One how do you protect the genetic material and then how do you get it inside a cell without generating an unintended immune response. And from what we've seen so far in our preclinical work, we do that in a way which we do not get any destruction of the genetic material. We're getting greater than 90% yield when we encapsulate these drugs very important, it's passing intact at least in our animal models and then it's delivering without generating an immune response. And that's a really, really important thing. And so whether it's the first collaboration that we announced in the oligonucleotide area or other collaborations under discussion in areas like antivirals or in the messenger RNA area that is where we want to play. And we're pleased with the interest from companies who are major players in these areas today and wanting to learn more about our technology. And it's really about demonstrating proof of concept. Taking their molecules, creating stable formulations, giving them the ability to even store those at room temperature, and then take those into early animal models where we hope to can continue to demonstrate a lack of immunogenicity and protein expression following oral administration. So there are a large number of areas. I mean obviously our unique ability to take drug out of the blood and keep it in cells and then in tissues does not make us in an ideal solution for a blood-borne disease for example. Because we are taking drug out of the blood that's what allows us for example to eliminate toxicity with amphotericin. So it's uniform solution across the board for every drug, but it does our strengths play to the weaknesses that some companies are experiencing with delivery and we want to capitalize on that.

Great, thank you so much .And my second question is based on some of the financing activity that has happened in the first quarter. I wondered if you could give some color on the primary use of funds where you see this taking the company. Thank you.

Thank you for the question. So, obviously, we're thrilled with the financing led by Vivo Capital. It just-- it begins to change the perception of the company within the institutional healthcare world. And so and it gives us firm financing for essentially two years of runway. There was no limitation our use of proceeds from that transaction, but it's clear that our use of proceeds and our main focus with the money raised in this latest round is to drive MAT9001 forward. It essentially takes us through this beginning work to an end of Phase 2 meeting and then a really interesting head-to-head study against the Vascepa which we expect we will read out in August or September of 2020. So the money from this is really designed for that and we have a luxury and the luxury we have is we have a well resourced Big Brother in the National Institutes of Health who continues to pay for our MAT2203 program. And so we have the luxury of having the interest from investors in driving MAT9001 forward into a multi-billion dollar market. And now the capital to do that and we didn't have to make the choice we made three years ago to forego advancing an asset at the expense of another because of the NIH's interest. And then when you layer on the fact that on the platform side the dollars are coming from well-funded Big Pharma's in order to prove the concept, it gives you a sustainable strategy across all areas of our business without having to resort to dilute of fundraisings every six months. So we're well capitalized now, we are utilizing our cash resources to drive MAT9001 forward and then the non dilutive resources of the federal government and our partners to drive the platform forward.

Great and now I'm just going to pivot off of Amarin and Vascepa that you had mentioned its -- the increase hasn't been as expected for Vascepa in the 1Q and I was just wondering can you talk about the trajectory what it could mean from Matinas?

It's a great question. We're noticing the same trends and when you think about the really the revolutionary nature of the reduce it data it's transformational and we believe it puts omega high dose high purity omega-3 on the map. Obviously, we have a lot more work to do but Amarin is now intently focused on expanding the market. And they're looking forward to an interaction with FDA to expand their label which will give them the freedom to promote their drug on label to almost 60 or 70 million patients in this country. So I'm not surprised that over the course of the last six months, you're starting to see the data that they've generated resonate with physicians. Now changing physician prescribing behavior takes time and as good as the uptick has been and had it's almost literally up a 100% quarter-over-quarter. It's going to get bigger because more and more physicians are going to be exposed to this drug to this data to this profile which gives them the opportunity on top of a statin to give a patient a safe drug that bodes well for us. And then you add in the fact that there is a big pharma out there in AstraZeneca who is looking to read out their data from their outcome study in 2020. This is all setting up as a perfect storm for Matinas because as we are advancing development, Ameren and big pharma will be expanding the market. And that's exactly what you want. So we will continue to monitor the prescriptions that Vascepa generates. We will continue to monitor and look forward to data from the strength trial, but our greatest mission is ensuring that we start these studies on time that they're designed in such a way to set us up for an approval and designed in such a way to continue to demonstrate differentiation, we think will be important to position MAT9001 not as a best-in-class product in the now $350 million to $400 million prescription market, but in the soon to come $3 billion to $5 billion and growing prescription omega-3 market. And so the timing for us is perfect. We get to learn from the companies that have gone before us on the development path. And now we get to take advantage, they're plowing the road on the commercialization path. End of Q&A

Thank you. We have reached the end of our question-and-answer session. And this does conclude today's teleconference. Ladies and gentlemen, we thank you for your participation. And you may disconnect your lines at this time.