Matinas Biopharma Holdings, Inc.

Greetings and welcome to the Martinez Biopharma 2022 fourth quarter and full year conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jody Kane. Thank you, Jody. You may begin.

This is Jody King with LHA. Thank you for participating in today's call. Speaking on today's call from Matinus Biopharma will be Jerry Jabbour, Chief Executive Officer, and Keith Kaczynski, Chief Financial Officer. We also have Dr. Terry Matrovich, Chief Development Officer, and Dr. Terry Ferguson, Chief Medical Officer, available to answer questions during our Q&A session. I'd like to remind listeners that remarks made during this call may state management's future intentions, hopes, beliefs, expectations, or projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities law. These forward-looking statements are based on the team's biofarmers' current expectations and actual results could differ materially. As a result, you should not place undue reliance on 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 investor section of the company's website and on the SEC's website. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, March 15, 2023. Martinez Biopharma undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law. And now I'd like to turn the call over to Jerry Chapoor. Jerry?

Thank you, Jody. Good afternoon, everyone, and thank you for joining us. During our 2023 strategic outlook call in late January, we detailed our strategy of focusing on the non-toxic extrahepatic delivery of nucleic acids and small molecules through our proprietary lipid nanocrystal platform technology, or LNC. This strategy capitalizes on the increasingly sophisticated approaches to targeting the body's genetic machinery to develop highly effective therapeutics, as we believe genetically targeted therapy is the future of medicine. We continue to believe that our LNC technology and our business strategy are putting us on a path to becoming a leader in the ever-evolving world of delivering genetic material. Currently available options for the intracellular delivery of therapeutics include liposomes, lipid nanoparticles, and viral vectors. While these technologies have been widely adopted, each has well-recognized limitations, such as challenges with extrahepatic delivery. undesirable and dangerous toxicity and adverse immunogenicity, and unstable formulations that can necessitate challenging storage conditions. We believe our LNC delivery platform overcomes many of these limitations. Our confidence is significantly bolstered by the success of MAT2203. Results from the Phase II and ACT clinical trial of MAT2203 in a deadly brain fungal infection demonstrated that our LNC platform was able to deliver amphotericin B, in a safe, well-tolerated oral form across the blood-brain barrier with dramatic survival outcomes, in contrast to the currently available formulations of this potent yet highly toxic antifungal, which are only available with shorter-term intravenous administration. We are actively working to further validate and advance development of our LNC platform, with several notable milestones expected during the second quarter. Among these are anticipated data readouts on key differentiating and value-creating aspects of the platform from our internal program with smaller oligonucleotides like siRNA and ASOs and for larger oligonucleotides like messenger RNA and DNA being explored in collaborations with BioNTech and National Resilience, two of the world's leading companies working in the rapidly emerging nucleic acid space. You may recall that we announced our exclusive research collaboration with BioNTech last April involving a combination of our LNC platform technology and BioNTech messenger RNA formats. In addition to meaningful financial support, this collaboration has also provided an opportunity to evaluate the capabilities of our technology for large oligo delivery and even potentially the oral delivery of messenger RNA, widely considered to be the holy grail of RNA delivery. We are extremely pleased with the progress of our in vitro work over the past year and expect to gain additional insights from upcoming in vivo testing. The transition from in vitro demonstration of protein expression to achieving similar results in vivo is a complex one with many physiologic factors that can impact both the success of intracellular delivery in tissues and subsequent protein expression and biological activity in vivo. Importantly, We believe our internal in vivo biodistribution data arising from this collaboration will ultimately set the stage for us to quickly move into therapeutic applications of both smaller and larger oligonucleotides and becomes a key decision point considered for the potential expansion of our biotech collaboration to a licensing agreement. One of the unique aspects of our delivery technology is its flexibility with route of administration. In addition to pursuing the highly challenging oral delivery of messenger RNA, we are also evaluating the use of our technology to deliver messenger RNA intramuscularly, as well as other routes for systemic administration. While the successful oral delivery of messenger RNA would represent a scientific first, our demonstrated ability to also deliver large oligos systemically with the technology that is more stable, less toxic, and can deliver nucleic acids extrahepatically or beyond the liver, would also represent a significant advancement in the field of nucleic acid delivery and position our company to become a leader in this space. We view our technology's versatility and cargo-dependent characteristics as potential advantages, both from design and intellectual property perspectives. We believe we are building a solid foundation underlying our goals, of creating a pipeline of internal and external product candidates in the nucleic acid space. The exclusivity constraints of our current agreement with BioNTech expire next month, allowing us to pursue interest from the many other firms working with messenger RNA. Things that we have learned during our in vitro and in vivo work over the past year, both internal and as part of our BioNTech collaboration, position us to approach potential partners with a compelling data package. We remain in discussions with BioNTech and interested in expanding our collaboration through a license agreement, but flexibility in this area should only benefit those discussions while also allowing us the opportunity to broaden the application of our technology and engage with other leaders in this space who have expressed interest in differentiated delivery. Moving on to our material transfer and evaluation agreement with National Resilience. Since announcing this agreement in January, we and Resilience have been working closely on a comprehensive research program that includes design, formulation, optimization, and delivery of certain nucleic acids applying the LNC platform. We anticipate in vitro testing data during the second quarter, with our collaborative work then advancing to in vivo testing with data potentially available in the second half of 2023. We envision that National Resilience could be a true platform partner for our technologies, bringing CMC expertise, manufacturing scale, and unparalleled industry relationships in the nucleic acid space. In the coming months, we also anticipate results from our internal program for the delivery of smaller oligonucleotides, such as antisense oligos, or ASOs, and short interfering RNA, or siRNAs. We have chosen to focus our internal efforts on these smaller oligos because of the greater ease with which they can be encapsulated their documented successful delivery in prior in vitro and in vivo studies with our technology, and the overall success of the L&T platform in oral delivery of smaller molecules. Following initial in vitro testing with cargos, including newer therapeutic agents, we intend to move forward with multiple in vivo biodistribution and animal efficacy studies in the second half of 2023. These data are expected to be highly useful in identifying the company's next internal product candidate later this year and in positioning MATINAS for developing a broader pipeline of ASO and SARNA therapies. I'd like to turn now to key next steps in the MAT2203 Clinical Development Program. With all of our enthusiasm for potential applications for our technology in the nucleic acid space, We have not lost sight of the fact that we have a clinically validated asset in MAT2203, a drug that saves lives and has the potential to become the ideal antifungal agent for the treatment of serious and potentially deadly invasive fungal infections. Preparations are underway for a Type B meeting with the FDA that is scheduled to take place in the second quarter. We will be seeking the agency's guidance and agreement on the design of a Phase III clinical trial to assess the efficacy, safety, and tolerability of oral MAT2203 in patients with life-threatening invasive fungal infections for which there are few treatment options. The meeting will include a discussion of our proposed pivotal study design and overall strategy for achieving MAT2203 marketing approval for a multitude of invasive fungal infection treatment indications. As previously announced, we made the prudent decision to gain important feedback from the FDA on our plans for a phase three study in these invasive fungal infections prior to going into phase three in cryptococcal meningitis. We believe a broader focus on invasive fungal infections positions Smetina to potentially receive non-dilutive funds from BARDA and or the NIH and makes this asset much more attractive to potential partners. Such funding could be sufficient to complete development of MAT2203 through market approval for the targeted IFI indications, as well as to support supply chain and commercial readiness. We believe MAT2203 is a strong candidate for BARDA funding based upon its oral, well-tolerated, and broad-spectrum profile, its recent clinical success in the Phase II ENACT trial in cryptococcal meningitis, and the criteria set forth by BARDA for grants for promising antifungal treatments. We also believe pursuing IFIs provides the best means to maximize MAT2203's commercial potential domestically with the potential for 12 years of exclusivity in the U.S. and will also favorably position this important drug for global expansion where there is additional and significant need and commercial opportunity. Now I'd like to turn the call over to Keith Kosinski to review our 2022 financial performance. Keith?

Thank you, Jerry, and good afternoon, everybody. Today we reported revenue for 2022 of $3.2 million, which was generated from our research collaboration with BioNTech that we announced in April 2022. This compares with revenue for 2021 of $33,000 from our feasibility study agreement with Genentech. Total costs and expenses for 2022 were $27.8 million, compared with $24.8 million for 2021. The increase was due mainly to higher research and development expenses related to the later stage of our MAT 2203 clinical development program. Net loss attributable to common shareholders for 2022 was $21 million, or 10 cents per share. This compares with the net loss attributable to common shareholders for 2021 of $23.7 million, or 11 cents per share. As of December 31st, 2022, cash equivalents and marketable securities were $28.8 million. Based on current projections, we believe our cash position is sufficient to fund planned operations into the second quarter of 2024. With that, I'll turn the call back to Jerry.

Thanks, Keith. We believe that the Martinez investment thesis has never been stronger, and we could not be more excited about our prospects going forward. We are well positioned with a Phase III ready asset that has produced compelling and unprecedented survival data in the treatment of a deadly fungal infection. MAT2203 has established a solid foundation for our company, and we are taking prudent steps to position that asset for long-term success. With our LNC platform, we have the potential to disrupt the delivery of nucleic acids by providing safe extrahepatic intracellular delivery with enhanced stability with multiple potential routes of delivery, including oral. We are gaining confidence in our technology through internal programs with ASOs and SIRNAs and through collaborations with industry leaders like BioNTech, Genentech, and National Resilience. All of this supports our goal of building robust internal programs and external pipelines with leading pharmaceutical companies. We see tremendous value for our company and our shareholders in establishing a leadership position for Matinas in intercellular delivery. We have many high-value milestones in the near term and throughout this year. And we look forward to reporting on our progress and execution. With that, I will now turn the call over to the operator for a question and answer session.

Thank you. We'll now be conducting our question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is from Greg Frazier with Truist Securities. Please proceed with your question.

Hey, good afternoon, folks. Thanks for taking the questions. On 2203, will there be any new or incremental data from an act that's presented at the ACMID meeting next month?

Sure. Terry Makovich, you want to handle that one?

Sure, thanks for that question, Greg. So as we've completed enrollment and all patients have completed the entire treatment phase and follow-up, we will be releasing the overall final data set. But I can say that the data that we're seeing in the final data set supports and is very much in line with what we saw with the interim data readout. So very favorable results, both from an efficacy as well as a safety perspective.

I'm not sure if I missed this, but did you already have the meeting with BARDA?

That's a good question. Greg, we have had an initial meeting with BARDA, an enthusiastic meeting, where we reviewed their criteria, our program, and how it aligned with their mission to identify promising antifungal therapies. They're as interested in We Are and FDA's feedback on the Phase III program and IFIs. focus is on IFIs like aspergillosis, mucormycosis, and things like coccidiomycosis, valley fever. So they very much want to see what FDA's feedback there is on program size, length, because it's at that point that we have been invited to submit a white paper seeking. It's essentially a formal proposal. We've skipped a couple of steps with BARDA. But that key piece there for that white paper will come as a result of the FDA meeting in the second quarter. Got it.

And how quickly after that meeting would you expect to have visibility on the study design and FDA's view?

Yeah, I mean, having been through a number, you know, this is now, I think, our fifth or sixth meeting with this division, with this product. So we've developed a very good rapport with this group. You usually get a pretty good sense during our meetings with FDA how they're leaning. They're very collaborative with Matinus. In fact, it was during one meeting last year where they, you know, suggested a tweak to the design of the phase three for cryptococcal meningitis, which, which very much was in our favor. So we expect to have a pretty detailed discussion with them at this meeting. You have to wait typically 30 days for the formal minutes of those meetings, but we'll have a good sense before that. We obviously prepare our own minutes of those meetings, but we will want to wait for the official minutes before we make any comment on that. Got it.

Okay. And then I just had a question on the emergency use I'm curious how many patients have been treated with 2203. Is there a limit to the number that can be treated? And what are your plans to present or publish data related to those patients? Thank you.

Yeah, and I'll let Terry MacVitt handle this. I just want to say that I think this has been one of the most exciting things that has happened over the last six months is the amount of interest we've seen from patients interested in compassionate use. I think there's some confusion between the use, you know, emergency use basis and compassionate use, and I want to be clear that this isn't, you know, an emergency use basis like you see for a global pandemic. This is compassionate use consistent with the intended use of the drug. You know, certainly other routes of administration. Our ability to provide amphotericin in an oral form that can be used longer is a big attraction for these physicians. But Terry, why don't you comment on the number, on what we're seeing, and then some of the exciting things that will be all that with some of these other invasive fungal infections outside crypto.

Sure, I'd be happy to. So we have agreed and supported the compassionate use of MAT2203 for the treatment of five patients. four of whom have had very favorable responses, both from a safety and an efficacy perspective. All of the patients who have been put forward as compassionate use patients have had significant renal toxicity associated with their IV-administered IV amphotericin. And these were patients for whom there were no other treatment options, so they were clinically responding to the IV-administered amphotericin. but had significant renal toxicity, which is why they were coming to us for our support. I'm very happy to be able to share with you that two of the patients have completed treatment and have successfully responded to treatment. The first patient, which will be presented as an oral presentation at ECMID, had an osteomyelitis, so a bone infection in her left foot, and was at risk for amputation. She had a rotatorial infection that was not, she was not able to continue IV amphotericin because she had significant renal failure. Upon transitioning to our oral MAT 2203, she had continued clinical response such that we were able to save her foot. She was able to resume normal weight-bearing activity. And very importantly, the renal dysfunction and toxicity was completely reversed. once she transitioned to our oral MAT 2203. And now after three to four months of treatment, she's completely clinically, her infection is completely clinically resolved. The second patient had a candida infection in his bladder. After only two weeks of transitioning on to oral MAT 2203, he also had complete clinical resolution of his symptoms. The other two patients continue to improve on MAT2203. One of the patients who is severely presented with severe aspergillosis and mucormycosis is continuing to improve on treatment. This is a chemotherapy patient who was, again, significantly had a safety risk with the IV amphotericin that she was receiving. After transitioning to our drug, she has been clinically improving. and has had very favorable response both for her aspergillosis as well as her mucor infection. And the fourth patient who is continuing to receive MET2203 has a mucocutaneous infection who's also responding very well to treatment.

Great. Thanks for all that . Thank you.

As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. Thank you. There are no further questions at this time. I'd like to turn the floor back over to Jerry Jabbour for any closing comments.

Thanks, Paul. Thank you once again for joining us today and for your interest in Matinas Biopharma. We're very excited about our company's future and look forward to reporting progress during our Q1 investor call a short time from now in May. Thanks, and have a great evening.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.