Welcome to the Matinas BioPharma Third Quarter 2022 Results Conference Call. At this time, all participants are in a listen only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Dr. Ankit Bhargava, Investor Relations Representative for Matinas BioPharma. You may begin.

Thank you, Dagmar. Good afternoon, everyone. And thank you for joining the Matinas BioPharma third quarter 2022 results conference call. Earlier this afternoon, we issued a press release with our financial results along with business updates. The release is available on the Matinas BioPharma Web site under the Investors section. There are slides accompanying today’s presentation, which are available by joining the webcast through the Investor section of the Company Web site. Speaking on today’s call will be Jerry Jabbour, Chief Executive Officer; Dr. Terry Matkovits, Chief Development Officer; Dr. Terry Ferguson, Chief Medical Officer; and Keith Kucinski, Chief Financial Officer. We also have Mr. Thomas Hoover, Chief Business Officer, available to answer questions during our Q&A section. At this time, I would like to remind our listeners that the 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 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 Web site and on the SEC’s Web site. An archive of this call will be posted to the company’s Web site also in the Investors section. Following the company’s prepared remarks, we will open the call for a question-and-answer session. Now I will turn the call over to Jerry.

Thank you, Ankit. Good morning, everyone, and thank you for taking the time to join us today. This afternoon, we will review our 2022 third quarter financial results and provide some highlights of our recent progress. We have departed from our normal filing schedule and call timing for this quarter. So I thought I would begin by providing some quick color to explain this change. First, we have seen that there is a lot of competition for analyst and investor attention with the early morning calls. We wanted to provide an opportunity in a more convenient time for our analysts and valued investors to be able to participate in a meaningful way. Second, Dr. Matkovits and I had been planning to travel to Uganda tomorrow in preparation for our Phase 3 trial and not returning until our Annual Meeting of stockholders set for Monday, November 14th. Despite that trip being postponed temporarily, we thought it best to stay on the schedule we had laid out for our analysts earlier this fall. So now let's get into it. During the third quarter and through today, we have achieved significant milestones for our company. We are a company which prides itself on being able to set and accomplish goals, and we are very proud of the list of boxes we have been able to check during 2022. At the very top of that list was the announcement of the interim results from Cohort 4 of our Phase 2 EnACT trial of MAT2203 in cryptococcal meningitis. Overall, EnACT was a highly successful Phase 2 trial with patient survival results that are simply unprecedented for an oral therapy in this vulnerable patient population. Dr. Matkovits and her team working closely with Dr. David Boulware from the University of Minnesota delivered something many never thought…

Thanks, Jerry and good afternoon, everyone. I won't go into detail on the design of EnACT since by now everyone is familiar with our Phase 2 randomized open label sequential cohort study evaluating MAT2203 in the treatment of cryptococcal meningitis. We announced data from Cohort 2 in September of 2021 and just recently at ID Week where interim data from the all oral Cohort 4 were presented by one of the principal investigators of this study. EnACT received the outstanding abstract and IDSA Award from the Infectious Diseases Society of America and we believe is reflective of the impressive nature of the data and the unprecedented survival rates achieved with our oral therapy. Turning now to data from Cohort 4. Slide 9 depicts a survival scene with MAT2203 treatment in both Cohorts 2 and 4 versus the survival scene with standard of care IV amphotericin throughout the entire 18 week trial. Ultimately, survival is what infectious disease doctors and FDA care about in this patient population. At each time point in EnACT, MAT2203 outperformed standard of care on survival. Importantly, EnACT was not powered or designed for noninferiority but these data provided great deal of confidence heading into our Phase 3 trial where the primary endpoint will be two weak all cause mortality or survival with a key secondary endpoint of 10 week survival. As Jerry mentioned earlier, these are unprecedented survival rates within all oral therapies. The primary endpoint in EnACT was early fungicidal activity, or ESA, which is the rate of use clearance in cerebrospinal fluid. This is a direct measurement of the quantitative rate of antifungal activity at the site of infection and has become a well recognized surrogate marker for survival. The prespecified target EFA threshold in EnACT was 0.2, which is clinically meaningful and represents…

Thanks, Terry. Building off of Jerry and Terry's comments, we are positioning MAT2203 as an ideal antifungal agent with key value propositions of longer term oral administration and avoidance of significant kidney toxicity, the capability of our LNC platform to both preserve the efficacy and fungal killing power of amphotericin B, while at the same time making it convenient and safe for patients is incredibly important. While we are beginning our Phase 3 program with an indication for the treatment of cryptococcal meningitis, we've also developed a protocol outline for a Phase 3 study for the broader treatment of invasive fungal infections and plan to meet with the FDA to discuss this in the first half of 2023. Our ultimate goal is securing multiple orphan indications for MAT2203, maximizing the available regulatory exclusivities while also positioning this drug to be used as broadly as possible in the treatment of those WHO identified priority fungal pathogens. Additionally, we believe MAT2203 has important potential applications for the prevention of invasive fungal infections, especially in immunocompromised patients, such as leukemia patients and transplant patients. Underscoring these plans are data we continue to generate in support of potential broader use of MAT2203. As Jerry mentioned earlier, Dr. Ashraf Ibrahim of the Lundquist Institute of the Harbor-UCLA Medical Center presented MAT2203 data for the treatment of invasive mucormycosis at ID Week. This late breaking study demonstrated impressive in vivo efficacy of MAT2203 in treating two different strains of mucorales in immunosuppressed mice, with a prolonged median survival time, enhanced overall survival and significantly reduced tissue fungal burden of target organs, including lung and brain, comparable to that of ambisome conventional IV amphotericin B, thus positioning MAT2203 as a potentially important clinical option for the treatment of these deadly invasive fungal infections. Overall, MAT2203 is being positioned for global success with significant projected US and global revenues. We've seen more partnership interest in MAT2203 lately, and recent deal activity in this space bodes well for the value we believe we have created in our MAT2203 program. I will now turn the call over to Keith Kucinski, our Chief Financial Officer, who will discuss our financial results.

Thanks, Terry, and good afternoon, everyone. Today, the company reported its financial results for the third quarter of 2022, which reflected a net loss attributable to common shareholders of approximately $5.5 million or $0.03 per basic and diluted share compared to a net loss attributable to common shareholders of $6.8 million, or a net loss of $0.03 per share basic and diluted for the same period of 2021. The reduced loss resulted from the company recording $1.1 million in revenue during the current year period from its research collaboration with BioNTech SE along with a slight decrease in operating expenses year-over-year. Cash, cash equivalents and marketable securities at September 30, 2022 were approximately $33.1 million compared to $49.6 million at December 31, 2021. Based on current projections, we continue to believe that cash on hand is sufficient to fund planned operations through 2023. I will now turn the call back over to Jerry to provide some pipeline updates and concluding thoughts. Jerry?

Thanks, Keith. I did want to provide an update on our pipeline program since I know many of our investors are following these closely. First and most importantly, our licensing discussions with BioNTech remain ongoing. The potential for the oral delivery of nucleic acids is extremely large and we want to make sure we are putting our company and our shareholders in the best position both near and long term. Happily, our research collaboration is progressing well and we have learned a lot about our technology and its application to nucleic acids over these past few months. We are diligently working together with BioNTech to commence in vitro and in vivo studies as soon as possible. Ultimately, we are both looking to increase the overall probability of success for these studies. And for each of us, there are a lot of steps along the way. On the license side, I have stated numerous times publicly that we are looking for the right deal and are prepared to make a fair deal for access to our LNC platform. We look very favorably at the precedents in this space and we are also gratified to see a lot of interest from other third parties. We continue to believe that a deal with BioNTech makes sense for both companies, and are optimistically working toward that goal. We hope to have an update on this prior to year’s end. The other thing I want to highlight is that we have consciously chosen to slow down development of MAT2501 to allocate resources judiciously in these uncertain market times. While we continue to believe in the opportunity for the first oral aminoglycosides, we want to prioritize allowing some of our potential nondilutive and inexpensive financing options to materialize and/or mature prior to moving into a Phase…

[Operator Instructions] Our first question comes from Greg Fraser with Truist.

The first question on 2203. can you expand on the feedback that you heard from the docs at ID Week with the feedback universally positive? Was there any data that the docs were asking for like the sterility or the relapse status to better understand the clinical profile?

Greg, thanks for your question. I'll turn that right over to Dr. Matkovits and then if he wants to weigh in, Dr. Ferguson. But Terry, go ahead.

So two of the key elements of our clinical data for our crypto study that really resonated with the physicians was survival and safety. So the ability to with an all oral regimen have survival rates that exceeded, far exceeded what has been seen with other -- the available therapies was really resounding and really supported where they saw the benefit of our drug in the clinical setting. Secondly, the safety profile of our drug. So being able to treat patients for the first time with a longer treatment course of an amphotericin B product was really fitting into a high area of unmet need with patients suffering from invasive fungal infection. So those really were key attributes of our drug that really has highlighted the clinical interest. And the opportunities to expand the use of our drug for the treatment of other deadly invasive fungal infections, such as mucor aspergillosis, endemic mycoses and the Candida infections, really is the expanded potential for the first time be able to use an amphotericin product clinically for longer term use in these other deadly infections.

Terry Ferguson, anything else to add there, Terry Ferguson?

Just to add to that, I think, that they were very happy with the data that they saw. There were not additional questions or holes that they found in the data. So they were very excited about it. You saw a lot of people taking pictures of the slides during the presentation. And I think that the general air that I sensed was one of excitement around an opportunity to do things with Amphotericin that hitherto were not really possible to be able to give it orally, to be able to give it without worrying about the nephrotoxicity. So I think that the sense that I saw was a lot of excitement, and very happy with the data that they saw.

And then -- so just to add to that, too. I mean, Greg, the one thing that jumped out at me the most is that the questions instead of talking about the data themselves, they jumped to the how. And it was all about mechanism of action and how our platform works, and trying to understand PK. And that gave us the opportunity to talk about how this LNC platform encapsulates drugs in a solid crystal or keeps drug out of the blood, we access activated cells who go right to the site of infection. So they were so, I think, impressed with the ability to achieve these survival data with an oral therapy that it jumped right to the how, and then it became a platform moment. And so I think that's the other thing that happened at ID Week that had people really interested.

So I'm curious about the Phase 3 study for invasive fungal infections. Will you be enrolling patients with different infections like mucor aspergillosis, and how are you thinking about size and duration, and also costs?

And I would say, we've developed the protocol outline for that. And our plan is to enroll patients who are suffering from a variety of invasive fungal infections. There's precedent in this category for the so-called all comer or basket studies. I think you'll see us focus on the big ones of mucor aspergillosis and maybe some of the more endemic mycosis. We're working on patient numbers now. We don't think it needs to be a huge study based upon precedent in the space and the fact that we have demonstrated success in cryptococcal meningitis, we will obviously prepare well and submit a package to FDA to have those discussions. But that will be something that happens in the first quarter. But Terry Matkovits, anything to add to that?

I think Jerry, you hit it on the head. So we intend to leverage what we've already demonstrated vis-a-vis efficacy in cryptococcal meningitis to then allow us to do a more streamlined basket study for treating invasive fungal infections where we hope FDA would be amenable to a more streamlined design that perhaps would allow us to do a smaller open label study with external comparators, that would not require us to do a significantly sized study.

Can you use the same formulation in the study that you used in EnACT?

Correct, yes.

And would you initiate that study on your own or possibly wait for a partner to help fund it…

I mean, given the interest in this asset and the fact that we're in an active process, our hope and expectation would be that we have a partner on board, particularly given the global nature of that sort of trial, not from a cost perspective, but just from setting this asset up the right way from the beginning to be able to check a lot of the regulatory boxes around the world. So that is -- we anticipate that that would be part of the discussions we're having with third parties.

I'll ask one more quick one and get back in the queue. But can you just remind us how long -- what's the standard treatment protocol with ampho for mucor and aspergillosis?

It's different, and I'll let Terry Matkovits fill that one.

So because of the toxicities associated with IV amphotericin use, it's typically restricted to one to two weeks of treatment followed by step down to an azole typically or echinocandins. But those classes of anti fungals have significant liabilities associated with their use, such as resistance and significant complications with drug-drug interactions. And just to remind us that these are immunocompromised patients that have significant underlying comorbidities, and they're on polypharmacy. So the ability to treat with a safe alternative to a class that has significant drug-drug interaction and limitations of use due to those drug-drug interactions really positions our drugs to really expand the opportunity with any amphotericin product.

Our next question comes from Robert Hazlett with BTIG.

I've got one or two. Congrats on the progress as well from me. Just with regard to the harmonization of the EU Phase 3, could you just go into a little bit more detail there? Are there any particular wrinkles in either additional work or work you're doing to make it amenable to an EU filing and acceptance?

I mean, one of the benefits, Bert, of us going early to EMA was that we were able to get their feedback in time to incorporate it into our overall protocol planning for the Phase 3 for cryptococcal meningitis. So even though I would say the majority of their comments were aligned, there are some things that they want to see, which we will be able to incorporate pretty easily. So we think that this is a study that we will be able to use to meet the criteria, both regulatory agencies, which is obviously a huge advantage. So I think that's the benefit of Dr. Matkovits being proactive there, and going and getting that feedback, because then we can align everything at the start of Phase 3, and not find ourselves in the position of having to do smaller studies or other things to appease regulatory agencies.

And then talked about being in an active process with regard to 2203. And I’d love to just get your sense of maybe where you are and what a good deal might look like there. I know there's 1000 different ways to slice this. But is this something where you might consider a geographic carve out, or is it something given this alignment that seems to be in place, you'd like to license the whole thing? But just a little bit more of the status and little bit more of the types of deals that you might be considering.

So Bert, it's a good question. In this business, timing is everything. And I think the fact, there have been parties who have actively been following the development of this drug for some time, obviously, their interest was piqued by Cohort 2 where it's just the first time you really saw the ability of this therapy to effectively treat immunocompromised cryptococcus patients. But that's only increased with the data at ID Week, and now the attention brought by the World Health Organization's call for additional development. We've also seen, over the last year and a half, particularly during the pandemic, the increase in the prevalence of these fungal infections, particularly in immunocompromised patients. So it's a perfect storm. There's a lot of precedent in this space for deals that are done on a regional basis. I mean, you can look pretty recently at least in the last couple of years at things like Sidara or F2G in that space. I think we have a better product. I think we have a product that has a broader spectrum and has the ability to more effectively treat these pathogens. So we want to be smart about it. What we know is we're not going to slow down this train because we have a drug that works really well in these patient populations and has the opportunity to stack indications. But that interest is increasing. We would and are open to regional sort of licensing deals but we have not discounted the possibility that there's a global deal here given the emergence and the attention. So we're focused on execution. We're being smart about how we fund. The NIH’s support of the Phase 3 and cryptococcal meningitis is a big reason why we can be patient. That again, they're going to stand firmly behind supporting a lot of the patient costs in that study. So that's a big variable for us. I know Tom Hoover and Terry Matkovits and others are working hard to inform partners. We have an active data room that's open. So we will be opportunistic. We want to be comprehensive in terms of canvassing all interested parties. But finding that right partner is a key part of our business objective, I would say, over the next two quarters.

And just following on that exact topic with regard to BioNTech. Certainly, don't want to negotiate on a quarterly conference call, but at the same time, I'm interested if there's any particular ask or any particular hurdle that's being considered in order to be able to affect the broader transaction there?

Bert, in which transaction?

A potential broader deal for BioNTech?

I don't think it's an obstacle. I think for them there's a number of things that they need to consider. I think they're quite happy with how the research collaboration is going. And we all know that their intention has been pulled in a number of different directions. The parties are talking about value. And so I think anytime you're trying to wrap your head around valuations and things like exclusivity and things like the opportunity for an oral messenger RNA, I think things get complicated. But these are, I think, mature, pleasant discussions. We always have a sense of urgency in everything that we do. But we are comfortable proceeding on a timeline, which puts us and our shareholders in the position for the right deal. If we would have had the right deal two months ago, we would have done it. I think we're moving closer every day. And both parties I think, believe it makes sense. It's just a question of being able to cross those t’s and dot the i’s.

Our next question comes from Mayank Mamtani from B. Riley Securities.

This is Sahil Kazmi on for Mayank. Congrats on all the progress. And thanks for this really comprehensive update, and some of the interesting data we're seeing from EnACT. So maybe just starting there, as you think about the Phase 3 study. Could you talk about some of your expectations for the different treatment arms in terms of the induction consolidation versus standard of care, and maybe put in context how significant that one week loading dose of amphotericin is?

So a couple of things, that we need to sort of walk back there. There's not going to be a one week loading dose for the Phase 3, at least as far as the MAT2203 arms. We're talking about two loading doses. So over the first two days, patients will receive a loading dose and then it will transition on day two actually to oral MAT2203 for the balance of the 14-day induction period. So it's only in the standard of care arm where they will be getting seven days of IV amphotericin followed by fluconazole. So we don't expect and what we saw, both in Cohort 2 and was validated in Cohort 4 is that the loading dose was not responsible for the antifungal effect of our drug. I think that's one of the benefits of having not stopped at Cohort 2 and gone all the way to an oral regimen and Cohort 4, it takes away the very question that you asked about what is the benefit of the loading dose? I think it's just piece of mind for physicians at the beginning. I think there's big enrollment benefit to doing it that way. And I do think that there's going to be some guideline impact there. But I'll let Terry Matkovits talk specifically about the two treatment arms. I mean, this is approximately a 270 patients study. It'll be randomized two to one to the MAT2203 treatment arms. But Terry, maybe you want to talk about that and what the difference is and the opportunity that FDA gave us, essentially the look at the data and file on what we believe is the strongest indication, either treatment of crypto for two weeks or treatment of crypto for six weeks?

So as Jerry mentioned and as we discussed during the call, our design for Phase 3 is really replicating identically to what we did in Cohort 2, so the two days of IV amphotericin stepping down to our MAT2203 arm. And in the final design of the study, which was collaboratively worked with the FDA, the design will allow us for the first time to potentially get a treatment indication that expands the use of any amphotericin product are specifically for a six week treatment period. And the way that the primary endpoint is positioned, it's focused on two week all cause mortality, which we saw in our Cohort 2 data, we performed better than standard of care, which will be the same comparison that will be tested in our Phase 3 registration trial. So we believe that we are very much positioned for success given that we have now in two independent cohorts of EnACT been able to demonstrate numerically better survival relative to standard of care. And recall that the overall statistical analysis will be one of noninferiority. So we need to demonstrate that we are noninferior to standard of care. It's not a superiority endpoint, which is also a much lower bar from a regulatory perspective. Secondly, the 10 week all cause mortality endpoint will be the key endpoint that will support this longer term treatment indications that will be a first ever indication for any amphotericin product. And there again, based on our Cohort 2 data, we saw numerical benefit of our drug versus the standard of care, where we had 90% survival relative to 85% survival in the standard of care arm. This was also replicated in Cohort 4 of the all oral regimen. So we believe we really are very well positioned to be able to meet the criteria that will be pre-specified as the success of the study for both induction as well as that six week treatment throughout for the label -- final label.

And just a follow-up on that, too. I mean, that's one of the benefits of our having multiple interactions with FDA this past year is getting them to agree to be open to that longer indication of up to six weeks. And that's primarily because of the safety data that we were able to generate and that they saw in addition to the efficacy, because that's also what sets you up for the treatment of mucormycosis in the treatment of aspergillosis whose treatment periods are longer than two weeks. So the FDA will be able to see the data from crypto and that should factor in very favorably to how we're thinking about the possibility of longer indications with a streamlined less challenging trial for the invasive fungal infections as well.

And then maybe just a brief question on the BioNTech collaboration. Are you able to discuss in a little more detail kind of some of the ongoing research and diligence that might have been informative of the preclinical models you're thinking as you look to deploy some of the attractive features of the platform here?

Yes, we can't. I mean, we can't -- we're not really at liberty to go into the exact nucleic acids or the targets or things like that. But this is really two parties coming together who have strength and expertise in two unique areas, us with our ability to formulate and create novel formulations and then with their unique messenger RNA format. So there was a lot of learning that had to go on between the two groups in terms of understanding what they had used before to deliver, how -- what challenges that they ran into. And then we also did a lot of work with them on cell identification, cell uptake, basic stuff, to position us then to be able to identify what are going to be the best in vitro and in vivo study. So it was really building it from the foundation for the long term. Other than that, I can't go into many details, but it has been collaborative and back and forth. And so I think both parties have learned a great deal about why it makes sense for the two of us to work together for the long term.

Our next question comes from Matthew [Coffield].

Thanks and congrats guys on the continued LNC progress. So based on the Cohort 4 success and pivotal developments in CM focused on step down therapy. What are your thoughts on future usage of 2203 as a frontline therapy and how relevant you see that ultimately been in terms of treatment benefits and the focus on platform expansion?

It's a really good question, because we get this question a lot from investors. Why are we talking about step down versus just starting with oral therapy, you're giving up prescription days and things like that. And we've looked at all of those issues. We obviously have been able to look at the Cohort 4 data as an open label trial, we obviously have gone over the Cohort 2 data pretty significantly. We've had the opportunity to talk to physicians and payers about how they view all of this and gain a good understanding of what the treatment landscape is like. And we keep coming back to the same place where using MAT2203 as step down therapy just checked a lot of boxes. It allows us to sort of derisk our studies and allows us to align ourselves with what physician practice may be. It allows us to get through these studies faster, it eliminates questions in some physicians’ are patients’ minds about enrolling in the study. We think this is how it will work in practice. And we think that it's not necessarily -- it's obviously after Cohort 4, there's no fear that we couldn't do it. But it's taking every factor into account and positioning the drug for big success. And the reality of starting with IV and transitioning to oral MAT2203 and the beauty of our Phase 3 study design is if we can show that there's a survival benefit in taking therapy out to 10 week survival, the reward you get there and not only showing that you can enhance survival at 10 weeks but you're also going to be able to show that you can use MAT2203 safely for longer, you get a much longer prescription time. And so the length of time that a patient is going to be comfortably on your drug more than makes up for the two days. And from a health economic perspective, the ability to show in both more likely in the invasive fungal infection study than in the crypto study just because of the nature of the design and the location in Uganda, there's going to be a health economic aspect that we're going to be able to measure and show that we're getting patients out of the hospital faster. They are not going to be prone to the resistance you see with azoles and [indiscernible] today, which may cause relapse or hospital readmission. So we think that on balance the economics are going to be better for us, and we're going to be able to get the study done faster and get it in patients’ hands much quicker.

Now I will turn it back over to Jerry for closing remarks.

Great, thank you Dagmar. We appreciate everyone taking the opportunity to join today. We look forward to your feedback. And if this afternoon slot works better for our investors and the analysts, I think judging by our analysts cue today and the participation I'm able to see online and calling in I think this is a good thing. So we look forward to keeping you apprised as to our progress for the balance of '22. We're going to close strong. We thank you for your support. One of the benefits we have as a small biotech company is the strength of our investor base. We have a very passionate informed investor base who follows us closely. We're going to continue to work hard on your behalf and check those boxes for the rest of the year and in 2023. Thanks, everybody.

Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time, and have a great day.