Welcome, everyone, to the Matinas BioPharma 2023 Financial Results Conference Call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to Jody Cain. Please go ahead.

This is Jody Cain with LHA Investor Relations. Thank you for participating in today's call. Joining me from Matinas BioPharma are Jerry Jabbour, Chief Executive Officer; Dr. Terri Matkovits, Chief Development Officer; Dr. Terry Ferguson, Chief Medical Officer; and Keith Kucinski, Chief Financial Officer. 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 that involve risks and uncertainties. Forward-looking statements 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 files with the Securities and Exchange Commission. These documents are available in the Investor Relations section of the company's website and on sec.gov. Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, March 27, 2024. Matinas 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 Jabbour. Jerry?

Thank you, Jody. Good afternoon, everyone, and thank you for joining us. This has been an extremely eventful period at Matinas with multiple positive developments advancing the progress of our LNC platform programs. One of the most important of these was reaching final agreement with the FDA on the trial design for the ORALTO Phase III study of MAT2203 in patients with invasive aspergillosis and limited treatment options. In many ways, the value-generating power of our LNC platform is epitomized by this progress with MAT2203, where we have taken the most potent broad spectrum antifungal drug amphotericin B, which conventionally suffers from severe toxicity issues and inconvenient intravenous administration and created a new safer oral drug candidate that allows physicians to maximize the benefit of this powerful drug for longer-term treatments. It's quite literally a life-saving and a life-changing drug. Even more importantly, with alignment on the Phase III ORALTO trial design, we now have a clear registration pathway. This is a critical milestone toward advancing MAT2203 into Phase III and closer to potential approval for this initial indication. We project that the market for MAT2203 in the treatment of invasive aspergillosis in patients with limited treatment options could reach peak sales in the U.S. alone of over $400 million annually, with opportunities to increase that amount, both through territory expansion outside the U.S. and also through indication expansion into the treatment of other invasive fungal infections, such as mucormycosis, cryptococcal meningitis and the endemic mycoses given that those are approved indications for amphotericin B today. We view MAT2203 as a pipeline in a product, and the ORALTO trial and initial indication are an important and commercially valuable first step. As we have previously guided, we are actively engaged in partnership discussions and seeking to consummate a transaction, which would…

Thanks, Jerry, and good afternoon, everyone. As Jerry mentioned, we achieved a major milestone in reaching final agreement with the FDA on the design of a single Phase III registration trial of oral MAT2203 in patients with invasive aspergillosis who have limited treatment options. We have named this the ORALTO trial, which is an acronym for oral amphotericin in patients with limited treatment options. This Phase III registrational trial is designed as a randomized, multicenter, open-label, adjudicator blinded non-inferiority study that will evaluate the efficacy and safety of MAT2203 as an oral step-down treatment following two days of treatment with AmBisome or liposomal IV-amphotericin B, compared with the standard of care in patients with invasive aspergillosis who have limited treatment options. The primary efficacy endpoint is all-cause mortality at study day 42. Key secondary objectives include the demonstration of superiority for treatment-related toxicities leading to changes in treatment, long-term survival benefit of MAT2203 using all-cause mortality at study day 84 and the impact of MAT2203 and healthcare resource utilization and quality of life. We expect to include approximately 65 clinical sites in the U.S., Europe, South America, the Middle East and Asia Pacific with enrollment of approximately 216 adults. Participating patients will have a recent diagnosis of proven or probable invasive aspergillosis and have been treated with AmBisome due to an inability to receive an IV mold-active azole and thus have limited alternative longer-term treatment options. Following up to two days of treatment with AmBisome, eligible participants will then be randomized 2:1 to receive either oral MAT2203 or continued AmBisome treatment followed by standard of care. All study participants will receive up to 12 weeks of treatment starting from the first day with AmBisome and are expected to be hospitalized during the initial treatment period. After step down to oral…

Thanks, Terri, and good afternoon, everyone. As Jerry mentioned, we are very encouraged by the progress we have made with our oral LNC formulation of docetaxel, a well-known chemotherapeutic agent routinely used in the management of multiple metastatic and unresectable tumors. But unfortunately, also an agent that comes with a number of well-recognized side effects and toxicities. Having already shown that oral LNCs can not only deliver docetaxel to tumor cells but can do so in a way that reduces tumor volumes to an extent comparable to IV docetaxel with no indications of toxicity, we sought to further explore the potential safety advantages of LNC docetaxel. Recognizing how well the crystalline structure of LNC encapsulates and protects cargo and building on our successes with MAT2203 in reducing the renal toxicity of amphotericin, we theorize that we could maintain and perhaps even increase the antitumor efficacy of docetaxel while markedly reducing systemic exposure and thereby avoiding one of the primary drivers of docetaxel toxicity. Earlier this week, we reported new in vivo safety data from a more comprehensive study with higher doses of oral LNC docetaxel and longer treatment duration. In this study, 24 healthy mice received either weekly IV docetaxel, daily oral LNC docetaxel or daily oral saline over a 22-day period with change in body weight as the primary endpoint indicating toxicity. The total amount of docetaxel administered in the oral LNC group was more than 8x higher than with IV docetaxel. Over the 22-day treatment period, the oral LNC docetaxel group showed no weight loss as opposed to an average 20% peak weight loss in mice treated with IV docetaxel. In fact, the average weight of the mice treated with oral LNC docetaxel was not significantly different from the weight of the control mice treated with saline. Compared…

Thank you, Terry. In reviewing our financial performance, this afternoon, we reported revenue for 2023 of $1.1 million, which was generated from our research collaborations with BioNTech and Genentech. This compares with revenue for 2022 of $3.2 million, which was generated exclusively from our research collaboration with BioNTech. Total costs and expenses for 2023 were $24.9 million, which compares with $27.8 million for 2022. The decrease was primarily attributable to a decrease in clinical trial expenses and lower professional and consulting fees. We reported income from selling unused New Jersey net operating losses and research and development tax credits of $0.5 million in 2023 which compares with $3.5 million for 2022. Our net loss for 2023 was $22.9 million or $0.11 per share. This compares with a net loss for 2022 of $21.0 million or $0.10 per share. The company's cash, cash equivalents and marketable securities as of December 31, 2023, were $13.8 million. With that, I'll turn the call back to Jerry.

Thanks, Keith. In summary, over these past few months, momentum continues to build at Matinas as we advance both MAT2203 and the LNC platform. Clarity on the regulatory and clinical path from MAT2203 along with support from the robust clinical data and patient successes and our Compassionate/Expanded Use Access Program has favorably positioned us for more meaningful discussions with development and commercial partners. Our primary objective is to secure the right strategic partner for MAT2203 and advance into Phase III as quickly as possible. We envision a multi-territory partnership and one that can maximize the value of this life-changing asset. Discussions are ongoing, and we are moving as quickly as possible towards finalizing a transaction. Given this timing, we have prioritized securing our partner over other non-dilutive funding opportunities like BARDA. Our progress in expanding the LNC platform into oncology and inflammation gives us the opportunity to become an active participant in two of the most clinically important areas in medicine. The unique attribute of the LNC platform enabled the development and advancement of differentiated and proprietary oral therapies with the ultimate goal of creating a portfolio of internal and external pipeline drug candidates. The potential for oral, less toxic chemotherapeutics could be a big step forward for patients and our demonstrated ability to orally deliver small oligonucleotides with biological activity and therapeutic effects could be transformative in the inflammation space, where there are many companies looking for oral, targeted and extrahepatic delivery of nucleic acids. Our objectives are clear, and we are committed to our mission. Developing life-changing and life-saving therapies for patients with the help of our LNC platform technology. We are grateful to our dedicated and hard-working team as we advance multiple projects simultaneously and grateful to our supportive investors who have clearly embraced the potential and clinical validation demonstrated by MAT2203. While the past year has been challenging, we are emerging from that and prepared to take advantage of the data we have generated to take the next step in our evolution as a company. We've secured our place on the NYSE American without having to complete a reverse split and look forward to taking advantage of that derisking to support some of the announcements and milestones we have planned for the second quarter of 2024 and beyond. With that review, I'll turn the call over to the operator for Q&A. Joe?

Thank you. [Operator Instructions] Our first question comes from the line of Julian Harrison with BTIG. Please proceed.

This is Rei on for Julian. Thank you for taking our question. You mentioned your recent LNC data with IL-17 and TNF alpha. Where do you see opportunities to inhibit cytokine expression that could prove more advantageous than inhibiting cytokines themselves?

Sure. Rei, thanks for joining and a great question. Dr. Ferguson, this gives us an opportunity to really talk about not just oral delivery with LNCs but a differentiated approach to knocking down cytokines. Why don't you expand a little bit on that without giving away too much in terms of how we're positioning this in the inflammatory space?

Okay. Thanks, Jerry. I think that the advantage to knocking down cytokine synthesis is the specificity that you can achieve in terms of being able to knock down very specific cytokines. And as I mentioned during the discussion, the opportunity to synergize with other direct cytokine targeting things so that you can go after cytokines in multiple mechanistic kinds of ways. So I think that this creates an opportunity to, as Jerry said, differentiate ourselves for what is possible out there. This is not an antibody directed at a specific cytokine. This interferes with a synthesis and lower levels of cytokines. So I think that this creates multiple opportunities in the inflammatory space. I mentioned that on the chemotherapy side that docetaxel was just for proof of principle. Our work as we have moved into the inflammatory space with IL-17 was along the proof of principle line, although IL-17 obviously plays a role in diseases like psoriasis, TNF alpha has a lot more potential applicability. But again, we're at the early stages, and there are other cytokines that we are potentially targeting that with the ability to knock down synthesis creates opportunities to very specifically knock things out and probably avoid some of the other off-target effects. Does that help?

Yes, it does. Thank you very much.

Our next question comes from the line of Robert LeBoyer with Noble Capital Markets. Please proceed.

Good afternoon and congratulations on all of the progress that you've made. My question has to do with the ORALTO study and the timeframes that you're looking at to start the study as well as the mention of a collaboration and what your objectives in that might be as far as anyone can tell at this point?

Great. Robert, it's good to hear your voice again, and thanks for dialing in today. We're really happy to have now cleared the road with an agreement with FDA. And so alignment with them on the design of the ORALTO trial, there's a couple of different things. One, it does give us the opportunity to begin to plan for Phase III. And we are expecting to be in the Phase III trial by the end of this year. But what it really does is unlock the opportunity to come to a final agreement with a partner because you understand where the goalposts are. And so I'll ask Terri Matkovits to talk a little bit about time to enrollment and duration, which we have looked at very closely here. It looks to be about a 24-month trial. But this is a Phase III trial, which is being set up, not just for initial indication in the U.S., but something that can then be extrapolated into the EU and beyond. That's how important this Phase III trial is. If you think about the right strategic partner for the ORALTO trial and the interest that we have received, it's from companies who specialize in anti-infectives who have an idea of how to create essentially a SWAT team sales force or have already created those SWAT team sales forces and done it on a domestic and global basis. And you want somebody that understands market access that understands how to price at a premium when you're dealing with a niche orphan indication when patients have no options that becomes an important piece. So how to navigate clearly on a first-line indication basis, the antifungal market is a challenging one. But as you create an opportunity to use amphotericin longer term and in patients who…

Sure. Yes. So the ORALTO trial, as I mentioned, is 216 patients. We plan to enroll that across 65 sites in 11 countries. And we're working with one of the world-renowned CROs who are experts in running these types of trials in invasive fungal infections. And we're already having a lot of inbound interest in clinical sites of excellence to participate in our global trial. And we know the centers of excellence based on the track record of the CRO we're working with. We'll be targeting transplant centers and centers of excellence running trials in oncology patients as well since they're a key cohort of immunocompromised patients. Based on the detailed experience of our CRO, we're expecting enrollment to take approximately 22 to 24 months across these sites. We expect to have topline data based on starting our first patients at the end of this year in the February 27 timeframe, which would allow us to support an NDA filing in the middle of 2027 and with our appropriate designation, fast track and such, we think that an NDA approval could be seen in the early part of 2028 in the first quarter. We believe that also given that our drug delivery of amphotericin B, the known gold standard for the treatment of invasive aspergillosis in patients with limited treatment options would be a great benefit from an enrollment perspective because that risk of not being a new chemical entity from a patient perspective, we believe will also be an important enhancement for the recruitment of patients in this trial.

Okay. Great. Thank you very much. And if I could just ask a second question. You had mentioned some of the primary and secondary endpoints in the trial. Are there any other things in terms of reduction in comorbidity or hospital stays or any of the other things outside of the requirements for approval that is being executed? Or is that – is it too early to expect that? You certainly have plenty of endpoints to support the NDA, anything else that might come out of the trial to justify cost or pricing or anything like that?

Absolutely, great question. So one of the key secondary endpoints will be pharmacoeconomic endpoints that we'll be evaluating the health economic impact of being able to discharge a patient on oral treatment. So exactly to your point, we'll be looking at the number of days of hospitalization, requirements for rehospitalization. For example, for the standard of care arm. We'll be also looking at infusion days as well as the cost associated with managing a patient on an IV-administered product relative to an orally delivered amphotericin B. So all of those measures will be evaluated and collected and will support the value proposition from a commercial perspective. Additionally, we will be evaluating quality of life of patients. So as patients are being able to be treated in the home setting, we have seen already in our compassionate use patients that they're able to return to work, they're able to return to daily living activities. So we expect that both on the pharmacoeconomic as well as the quality of life part of our data that we will further support the value proposition from a commercial perspective for the product.

Okay. Great. That sounds like a very well thought-out design. Looking forward to hearing those.

Thank you.

Thanks, Robert.

Ladies and gentlemen, there are no further questions at this time. I'd like to hand the call back to Jerry Jabbour for closing remarks.

Thank you, Joe. Thanks to everyone for joining us today and for your continued interest in Matinas. As I hope we conveyed during the call, we remain very excited and very optimistic about the company's future. We look forward to reporting further progress during our first quarter conference call in May, and the second quarter is going to be a very big quarter for this company. Thank you again, and have a great evening.

This concludes today's conference. You may now disconnect your lines at this time. Enjoy the rest of your day.