Greetings and welcome to Matinas BioPharma's Third Quarter 2021 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. It is now my pleasure to introduce your host, Peter Vozzo, Investor Relations representative for Matinas BioPharma. Thank you, you may begin.

Thank you, Doug. Good morning, everyone and thank you for joining the Matinas BioPharma third quarter 2021 results conference call. Earlier this morning, we issued a press release with our financial results along with business updates. The release is available on the Matinas BioPharma website under the Investors section. Speaking on today's call will be Jerry DeBoer, Chief Executive Officer; Dr. Terry Matkovits, Chief Development Officer; and Dr. Raphael Mannino, Chief Scientific Officer. We also have Dr. Terry Ferguson, Chief Medical Officer and Keith Kucinski, Chief Financial Officer available to answer questions during our Q&A session. At this time, I would like to remind our listeners that remarks made during this call may state Management's intentions, hopes, beliefs, expectations, or projections of the future. These 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 may differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports, Matinas BioPharma files with the Securities and Exchange Commission. These documents are available in the Investors section of the Company's website and on the SEC's website. An archive of this call will be posted to the Company's website, also in the Investors section. Following the Company's prepared remarks, we will open the call for a question-and-answer session. I will now turn the call over to Jerry.

Thank you, Peter. Good morning, everyone and thank you for taking the time to join us today as we review our 2021 third quarter financial results and provide a business update. For Matinas the third quarter of 2021 was transformational. In September, we announced efficacy and safety data from the first half of our EnACT trial of MAT2203 in patients with cryptococcal meningitis. As outlined on that call, MAT2203 performed impressively in cohort two, exceeding the primary endpoint threshold while at the same time demonstrating an impressive overall safety profile supporting the longer term use of oral MAT2203 up to six weeks and eliciting considerable enthusiasm from Dr. David Bower, the principal investigator. These are incredibly impressive data and provide a great deal of optimism as we continue into the second half of the EnACT trial. Our goal in cohorts 3 and 4 is to demonstrate that MAT2203 can be utilized not only as a step down from IV amphotericin for induction therapy and for extended use in consolidation, but also as part of an all oral regimen for the treatment of cryptococcal meningitis. Thus our oral formulation of amphotericin could significantly limit and even potentially eliminate altogether the need for an IV infusion of amphotericin B. This when combined with eventual potential additional indications for the treatment of other invasive fungal infections similar to those contained in the AmBisome label and the potential extension of treatment to include prevention in highly vulnerable immuno-compromised patients could position MAT2203 to become one of the most important and commercially successful options for the treatment and prevention of invasive fungal disease. Dr. Matkovits will go into more detail on our MAT2203 program including our upcoming FDA meeting as part of her remarks this morning. We intentionally chose to use the word transformational to…

Thanks Jerry and good morning everyone. For MAT2203, our oral amphotericin product, we have made significant progress. As Jerry mentioned earlier, during our last call, we announced positive data from the first two cohorts of the EnACT trial. Since then we have moved on to cohort 3, where we are ahead of schedule and I'm happy to report that as of this morning we have fully enrolled the cohort of 14 patients. Before I outline the specifics of what we expect to see in cohort 3, I'd like to briefly walk you through the bigger picture view of our overall regulatory strategy for MAT2203. As you'll recall, we are working towards filing an NDA for three indications for MAT2203. First, we are pursuing an indication as induction therapy for the treatment of cryptococcal meningitis to be used with Flucytosine as a step down treatment following just two days of IV amphotericin. Second, we are pursuing a novel indication for consolidation treatment for cryptococcal meningitis for up to a total of six weeks of treatment. This would represent the first long-term use indication for any currently available amphotericin B product. Third and especially relevant for cohorts 3 and 4, is an indication for an all oral induction treatment for cryptococcal meningitis administered with Flucytosine potentially eliminating the need for any intravenous amphotericin B treatment. This overall potential registration package for cryptococcal meningitis will be discussed with the FDA next month and we plan to share their official feedback early next year. Importantly, the initial registration of MAT2203 for the treatment of cryptococcal meningitis as step down, consolidation, and/or oral induction is only the beginning. Leveraging the 505 (b)(2) pathway and Orphan Disease designations, with the potential for Breakthrough designation in cryptococcal meningitis, we are preparing for additional discussions with the agency…

Thank you, Terry, and good morning, everyone. As we have announced previously, Matinas, Gilead and the National Institutes of Health have an ongoing collaborative research program utilizing our proprietary LNC delivery platform to develop an orally bioavailable formulation of remdesivir. Before providing an update on the status of this project, I'd like to briefly review some of the background work that has led up to this exciting collaboration. The pre-clinical development programs for MAT2203, our orally bioavailable amphotericin and MAT2501 our orally bioavailable amikacin, both included a number of preclinical studies that demonstrated the efficacy of oral LNC formulated antimicrobials in the treatment of severe lung infections. Oral MAT2203 has proved to be very effective in the treatment of both Candida and Aspergillus lung infections in preclinical studies. PK and PD studies in mouse models of systemic candidiasis demonstrated that when compared to parentally delivered amphotericin B, MAT2203 demonstrated more rapid tissue penetration and more controlled drug levels over the entire course of therapy. In addition, in a systemic controlled, in a systemic aspergillosis mouse model oral MAT2203 provided almost complete eradication of lung infection and enhanced survival when compared to parental amphotericin B. Similarly, MAT2501 has been evaluated in a number of studies looking at the treatment of non-tuberculosis mycobacterial infections in preclinical studies involving mouse models of disseminated infection, biofilm related infections and mouse models of cystic fibrosis. In all these settings orally administered MAT2501 demonstrated efficacy that was at least as good as or even slightly better than that of the parental amikacin. It is important to remember that unlike other nanoparticle delivery platforms, the LNC formulation and manufacturing process allows for significant flexibility in creating new formulations with the ability to customize parameters such as lipid to drug ratio, the specific solvents, excipients and buffers used…

Thanks Raphael. To briefly address our financial results; cash, cash equivalents and marketable securities at September 30, 2021 were approximately $53.8 million, compared to $58.7 million at December 31, 2020. Research and development expenses were approximately $4.6 million in the third quarter of 2021 compared to approximately $3.3 million in the same quarter of 2020. General and administrative expenses were approximately $2.3 million in the third quarter of 2021, essentially unchanged compared to $2.4 million in the same period in 2020. The company reported a net loss attributable to common shareholders of approximately $6.8 million or $0.03 per basic and diluted share, compared to a net loss attributable to common shareholders of $5.7 million or a net loss of $0.03 per share basic and diluted for the same period in 2020. Based on current projections, we continue to believe that cash on hand is sufficient to fund operations into 2024. To summarize and conclude our prepared remarks, I am extremely pleased with how we have been able to progress our LNC platform during 2021. And we now have two product candidates in clinical development, both in areas of significant medical need, with large potential markets, both domestically and globally. Infectious disease continues to pose a significant threat to human life and we believe that the LNC platform and our targeted products can become a valuable solution for patients. As we head toward the end of this year, we expect that DSMB evaluation and progression assessment for MAT2203, which would be a very good sign that our drug has great potential for oral induction therapy. We also are looking forward to our meeting with FDA in December to evaluate all available data and discuss a potential early approval pathway for MAT2203 a step down therapy. We continue to advance MAT2501 with…

Thank you. Our first question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

Hi, team. This is Juan on for Mayank. Thank you for taking our questions. So we'll dive-in here. What's the development plan for LNC remdesivir after the NIH and the UNC started? Do you think there's a possibility that the formulation could improve the drug efficacy, so that it can potentially reduce the viral load? Thank you.

Hi, thank you very much for your question and it's a good one because people are very curious about our LNC remdesivir program and what steps lie beyond this in vivo efficacy study with the NIH and Gilead and a lot of attention has been given recently to the development and advancement of oral antivirals and we believe we're positioned to become a meaningful member of that group. We have to wait to see what the exact data looked like from this in vivo study in order to then aggressively plan to go into a Phase 1 study, based upon our knowledge of how our technology works and our unique ability to get these molecules delivered in an efficient manner intracellularly. Of course, we believe there's a possibility that we could improve upon the efficacy already demonstrated by Remdesivir in clinical trials, but that's going to be data dependent. What we have seen in terms of our ability to deliver other antimicrobials in a similar fashion in terms of encapsulating them in our LNC platform and delivering them to sites of infection, we have seen that ability to improve upon efficacy, and doing that, at the same time, we are significantly improving the safety profile of the drug. So our expectation is that these data to be generated at UNC are very, very important for Gilead, very, very important from a Matinas and the NIH has always been the driver of this program. And we expect that depending on the evaluation of those data, we would then very aggressively move forward into the clinic, into human studies in 2022, but we have to wait to see what the data are.

Thank you for the helpful color. And another question is, in addition to the oral delivery, would you, would like to hear your thoughts on direct delivery of LNC to the lung given the challenges in the field with other like small molecule viral vectors and I think, for example, what -- will it be possible to deliver remdesivir via the lung delivery with your LNC formulation? Thank you.

Sure. Thank you for the question and I'll ask Dr. Mannino to address this one.

Yes, thank you for the question. One of the things we didn't touch upon today, but is another very positive aspect of the LNC technology is just to make it short, LNC are anhydrous. There's no water within the inside layers of this. That allows us not only to give suspensions, which are stable, but also to make dry powders, including lyophilization, fluid bed drying and spray drying. We already have been able to make formulations of other types of molecules, including fluorescent dies within the LNC and deliver them by inhalation, not only in mouse, but mice, but also in dog models. And we were able to then see material in the lung coming out that was taken up by cells. In addition, we were able to do an siRNA study -- siRNA in LNCs in a mouse model of influenza infection. And with a single dose delivered intranasally, we were able to knock down the viral load three days later by 200-fold when in this model about tenfold is considered therapeutic. So we do have early data suggesting that the ability to deliver directly into the lung is compatible with the LNC technology.

Thank you. That’s all we have. Thank you.

Our next question comes from the line of Bert Hazlett with BTIG. Please proceed with your question.

Thank you and congratulations on the progress. Thank you for taking the question. I've got one or two specific ones and then maybe a bigger picture one, Jerry as well. Can you just characterize the Gilead relationship in the remdesivir studies? Is there some further development contemplated with Gilead and just, again general characterization of the relationship at this point.

Yes. Thanks, Bert. So this is a relationship that was directly driven by the NIH. They essentially brought two groups together that they thought could benefit in a symbiotic way. And over the course of really 2020, that relationship deepened in terms of really focusing on a scientific understanding of our technology and then what remdesivir brought to the table. And when we determined to sort of enter into this collaboration with the NIH, we wanted to continue to preserve as much flexibility as we could with our technology and not tie it down until we were able to better demonstrate value. As we advance a platform technology, you do need to be careful about setting an early precedent on value. And so our goal was to get into these in vitro and in vivo studies as quickly as we could, get our hands on the remdesivir and work with it. As we've progressed and particularly because of the impressive nature of the early in vitro data, our conversations with Gilead have advanced. And that's a very important aspect of this, but it will take the in vivo data for us to really then be able to cement this and know where we are. So right now, I would characterize our relationship as one of flexibility. It's one of the reasons why we of course, view remdesivir as potentially a very important drug in the fight against COVID-19. But if you look at this relationship through the Matinas lens, this is about proof-of-concept in a well-established model about the intracellular delivery of antivirals. So we want to preserve our flexibility to go in a number of different directions with antivirals. If one of those ends up being remdesivir, that's a great thing. But the benefit of this in vivo model paid for by the NIH is it gives us that proof-of-concept and then we preserved our flexibility to sort of either cement our relationship with Gilead, go in a direction on our own or investigate the delivery of another antiviral, which could have even more promise clinically than a drug like remdesivir. So I would characterize it as flexibility.

Thanks for the additional color. Just one or two specifics, with regard to 2501 and the program, and progression to Phase 2, do you have a Phase 2 program kind of mapped out at this point? And is there potential for that to be a registrational study?

Sure. I'll ask Dr. Matkovits to comment on that, and I may add some things at the end.

Yes. Thanks for the question, Bert. So as with MAT2203, MAT2501 has the unique opportunity to leverage two regulatory pathways that we believe would allow us to streamline the development program. The first is the orphan pathway for the treatment of NTM infections and the second is the 505(b)(2) registration pathway. Since amikacin is approved and is part of the regimen for the current treatment of NTM, we can rely upon that efficacy data that's already been demonstrated with ARIKAYCE as well as with IV amikacin products for the treatment and we believe that will contribute to streamlining the development as will the orphan indication. So we expect that as FDA has done so with MAT2203, they will allow us to work in a streamlined fashion to bring this treatment to patients. And this is all of course, with the assumption that we'll be able to continue to see a clean safety profile of our drug.

Okay. Thank you for that additional color. And then just with regard to 2203, as you mentioned in your comments, just with regard to what you would need to see in cohort 4 to really give you a strong hand as you interact with FDA, I believe you made some comments earlier. Could you just clarify, I guess, in cohort 4 what would really drive, you think, a positive interaction with the agency? And then I just have one big picture question.

So we believe we already have the data that will allow us to have a very meaningful discussion with the agency for our drug as a step-down therapy. So we believe that we have the data. We've already exceeded the primary endpoint. We've seen excellent survival in the patients with step-down therapy. So our focus for the FDA engagement will be based on data that's already available for cohorts 1 and 2. For cohort 3 and 4, those data will be to support the all-oral induction treatment indication. And as with the data from the first 2 cohorts, we'll want to see excellent survival as we have seen with the first 2 cohorts. We'll want to see that the EFA exceeds that threshold of 0.2 that's been tied to improvements in clinical outcome and mortality. We'll want to ensure that we continue to see sterilization of culture in the patients without any rebound or relapse. And of course, very importantly, a continued strong safety package that shows no evidence of renal toxicity.

Terrific, thank you for that additional clarity. And then just on kind of big picture structurally, as you -- Jerry, I think in your opening comments, you alluded to interactions with those in the industry. I know it's difficult to characterize partnerships, development efforts, things like that. But where do you think you are in terms of recognition with other players in the industry? Again, we've mentioned Gilead here, we've mentioned NIH. And do you think that there are other potential partnerships, is something that can be achieved in 2022 or is that a goal of the company or just kind of in general terms, how do you think about this technology and interactions with other players in the industry?

Yes. It's a good question, Bert, and one we get asked a lot. And obviously, on the call, we were specific today to Gilead and to others. We didn't mention Genentech, for example, who we continue to work with. We've extended that relationship again for another year and there's a lot of interest on that side. But of course, there especially following EnACT, there's a lot of inbound interest in our technology. It's no -- it shouldn't come as a surprise to anyone that in these areas of innovative medicine, like the delivery of messenger RNA, like the delivery of gene therapy, there continue to be real delivery, intracellular delivery challenges, either highlighted by inefficiency or highlighted by unwanted immunogenicity, toxicity, things like that. We're actively engaged in those sorts of discussions and for us, it's a balancing act. We have 25 employees in Matinas. We have a lot of ongoing projects. We would like to be able to continue to further validate this technology with a collaboration in one of those areas, and those discussions are ongoing. There's a timeliness to those. And so that is a goal of the company to further broaden the use of this technology beyond small molecules, beyond antivirals. And I would characterize those discussions as robust and ongoing. It absolutely is a goal for 2022, something may happen before 2022. So this is one of the ways that we are looking at increasing the utilization of this technology, but we remain intently focused on controlling our own destiny. So advancing 2203 and 2501 are key for us, because through those two drugs, we can control our own destiny, and those are drugs that can be hopefully approved and then commercialized with less than what would be a customary commercialization effort for other drugs. So we have a lot of flexibility here. I would say we're careful about the collaborations we choose to engage in because it's great to say you want to be partners with everyone, but then relationship management can overwhelm a small organization like ours. So we're concentrating our discussions in a few key areas, which we have a sense of urgency around and we'll continue to drive those until they're at a point where it makes sense to finalize those.

Thank you for the additional color. I look forward to the progress. Congrats on it so far, and again look forward to more. Thanks.

Thanks, Bert.

Our next question comes from the line of Greg Fraser with Truist. Please proceed with your questions.

Good morning, both. Thanks for taking the questions. On MAT2501, I know it's early in the development program, but I'm curious how you're thinking about the initial target patient population, whether it's patients with NTM, MAC who could benefit from oral delivery versus the current inhaled drug. It sounds like, obviously yes, but do you think that 2501 might also be effective for more difficult-to-treat patients like those with mycobacterium abscessus?

Yes. I'll let Terry -- I'll just comment briefly at the beginning. Absolutely, we're not going to be limited, I think, to the -- I would characterize as poor demonstration of efficacy and significant toxicity of the available therapy. So we've shown the ability to have an impact both on MAC and on M-abscessus preclinically. We've also -- one of the reasons we've attracted the attention of the Cystic Fibrosis Foundation, which actually has not worked with these competitive products because of their inability to be an effective treatment for patients with cystic fibrosis is our unique ability to get drug right to the lung in a nontoxic way. We believe that this drug preclinically is set up to go well beyond MAC. And NTM really is also just the first indication for this drug. And that's because that's where the NIH really put its attention because of the significant need there. But unlike that competitive drug, which would be limited to the treatment of pulmonary infections, if at all, we can go after disseminated infections. And so I think you're going to see sort of a laddered indication approach here, a stacked indication approach, similar to what we would look to do with 2203. But initially, in terms of NTM disease, we plan and the data support going far beyond MAC. But anything to add there, Terry?

Yes. No, exactly to Jerry's point, we've really seen remarkable preclinical data in the cystic fibrosis mouse model, data that has been generated at the University of Colorado by Dr. Diane Ordway. The data are very, very compelling, compelling in the support that we are receiving from the Cystic Fibrosis Foundation. So we have clinical and preclinical validation from experts in the field, including experts such as Dr. Daly who is our key advisor on our program. What we can now do is, look at how we leverage this strong safety profile that we're able to see with an oral product that utilizes our platform and see how we can leverage that to the benefit of patients where they can be treated in an outpatient setting and potentially even with the monotherapy of our oral amikacin product. So for us, the preclinical validation has been critically important, and we intend to convene the clinical experts to see how we can leverage this unique preclinical efficacy profile that we've seen, coupled with the safety to look at potentially treating NTM with monotherapy and looking at how we better optimize the current treatment regimens for these patients. So we're in the early phases of mapping out the clinical program, but we are looking to be as broad as we can, leveraging the strong safety that we've seen to date.

And as we approach the Cystic Fibrosis Foundation, actually, they approached us and as we responded to that inquiry, we had to submit sort of an outline of what Phase 2 would look like. And one of the benefits of working with a patient advocacy group like the Cystic Fibrosis Foundation is you get the benefit of their experience and expertise and access to patients. So we've been collaborating already on sort of outlining what a Phase 2 program would look like. It's one of the reasons why we're conducting all of these long-term tox studies, because the course of treatment for NTM can be as long as 18 months and even longer. And so that's why we are entering into a lot of these studies during 2022. But with the support of the Cystic Fibrosis Foundation and other patient advocacy groups and the lineup of KOLs we've established, our goal is to sort of put together as comprehensive but also a streamlined Phase 2 development program as we can so that we can address what continues to be a significant unmet need.

Great. Thanks for all the color and congrats on the progress.

Thanks, Greg.

There are no further questions in the queue. I'd like to hand the call back to Mr. Jabbour for closing remarks.

Thank you, Doug, and thank you all for joining us today. We appreciate your continued interest in Matinas, and our entire team here looks forward to providing you with updates on our future progress. Have a great day.

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