Matinas Biopharma Holdings, Inc.

Welcome to the Matinas Biopharma second quarter 2023 financial results conference call. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star 1 on your telephone keypad. If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this conference is being recorded. I would now like to turn the conference over to Jody Kane. Please go ahead.

This is Jody Kane with LHA. Thank you for participating in today's call. Joining me from Martinez Biopharma are Jerry Jabbour, Chief Executive Officer, Dr. Terry Matkiewicz, Chief Development Officer, and Keith Kaczynski, Chief Financial Officer. We also have Dr. Terry Ferguson, Chief Medical Officer, available to answer questions during the 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 that involve risks and uncertainties. Forward-looking statements are made pursuant to the safe harbor provision of the federal securities laws. These forward-looking statements are based on Matinus 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 cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Matinus Biopharma files with the Securities and Exchange Commission. These documents are available in the investor 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. August 9th, 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 Jabbour. Jerry?

Thank you, Jodi. Good afternoon, everyone, and thank you for joining us. I'm pleased to report that we now have received important feedback from FDA and additional clarity on the development path forward to position MAT2203 for approval as quickly and efficiently as possible. As you know, MAT2203 is our oral formulation of amprotericin B. I'll begin today's call with an overview of the feedback we've recently received from the FDA regarding a study for invasive fungal infections, or IFIs. I'll also provide a brief update on our LNC platform for the delivery of nucleic acid. Following my initial remarks, Dr. Makovits will provide more detail on the FDA's feedback and our plans with MAT2203, and will highlight an additional and highly compelling compassionate use case under our expanded Compassionate Use Access Program. Keith Kosinski will follow with a review of our financial results for the second quarter and year to date. We are appreciative of the very recent feedback provided by FDA toward helping us to design a study for the regulatory advancement of MAT2203 in the treatment of IFIs. During a meeting held earlier this year, the FDA acknowledged the need for a therapy like MAT2203 and recently commented that the patients most likely to use our drug would be those patients with limited or no treatment options who require longer-term treatment for a variety of fungal infections which are susceptible to therapy with Amphotericin B. Also, in their most recent feedback, FDA informed us that consideration of MATH2203 as a novel first-line therapy with an unrestricted label would require an extremely high bar to demonstrate non-inferiority, which presents significant challenges for a smaller company like Metimus. Approval as a first-line therapy for just the treatment of aspergillosis, for example, would require an adequately powered study with an active, rigorously defined comparator group and an all-cause mortality non-inferiority margin of 10%. similar to that used in prior first-line approvals for new chemical entities. The FDA instead highlighted and provided additional feedback on alternative trial designs, which could include the patient population likely to use MAT2203, specifically patients in need of long-term treatment for deadly IFI, such as azole intolerant or azole-resistant patients. We believe that these alternative study designs could ultimately position MAT2203 for registration under the limited population pathway for antifungals, or LPAD pathway. This pathway was originally established to provide a streamlined approach to clinical development of certain antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs, and could involve smaller, shorter, or fewer clinical studies than would be required for more broadly used first-line therapy. Enrollment would be focused on the highest-need patients, which is where both we and FDA already believe our drug will be most appropriately used. Furthermore, the LPAD regulatory pathway and relevant study design aligns well with our compassionate use cases and recent clinical experience, which have shown the life-changing potential of MAT2203. We continue to believe that MAT2203 can play a meaningful role in treating the highest-need patients and believe that an approval for MAT2203 pursuant to the LPAD pathway could present a cost-effective approach for pursuing approval. The impressive compassionate use data that we continue to accumulate from our ongoing expanded access program underscores the positive clinical impact of MAT2203 and provides powerful, real-world examples of the life-changing potential of this drug. In just a moment, Dr. Makovits will provide additional details and next steps. But looking beyond MAT2203, We continue to be extremely encouraged by the in vitro data with our LNC oral formulations of various RNAi therapies. We are pushing forward into in vivo studies later this quarter to evaluate the biological activity of these formulations. And these could potentially represent the first successful oral delivery of functional small oligonucleotides that we are aware of. And we continue to believe that our technology has the potential to provide truly differentiated delivery in this rapidly evolving area of medicine. With those comments, I'd like to turn the call over to Dr. Makovits. Teri?