Matinas BioPharma Holdings, Inc. (AMEX:MTNB) Q3 2023 Earnings Call Transcript

Matinas BioPharma Holdings, Inc. (AMEX:MTNB) Q3 2023 Earnings Call Transcript November 8, 2023

Matinas BioPharma Holdings, Inc. reports earnings inline with expectations. Reported EPS is $-0.03 EPS, expectations were $-0.03.

Operator: Welcome to the Matinas BioPharma Third Quarter 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.

Jody Cain: 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. Tom Hoover, the company’s Chief Business Officer, will be 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, and 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 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 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, November 8th, 2023. 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?

Jerry Jabbour: Thank you, Jody. Good afternoon, everyone, and thank you for joining us. There’s been a tremendous amount of activity and industry attention on our company during the past few months. Much of this attention has been rightfully focused on our lead asset, MAT2203. We are very excited about the consistent positive clinical results for MAT2203 and our Compassionate/Expanded Use Access Program and the demonstration that MAT2203 can be a life-saving drug in patients with limited or no treatment options. Our LNC platform has afforded the opportunity to take amphotericin B, the most powerful and broad spectrum antifungal drug that has historically been settled with severe toxicity issues and inconvenient administration and create a safe and convenient product that has the potential to change the treatment paradigm for invasive fungal infections.

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Q&A Session

Whether it has been saving the life of a young girl with AML suffering from both mucor and aspergillosis or achieving complete clinical resolution of a Candida krusei infection in a 61-year-old male with a history of diabetes, kidney disease, lung disease and heart disease after just two weeks of treatment. MAT2203 has become an invaluable lifeline for patients. The patients in our Compassionate/Expanded Use Access Program are very similar to those who are intending to treat in Phase 3. Each patient successfully treated with MAT2203 increases our confidence for our proposed Phase 3 clinical trial. Earlier today, we announced that our recent FDA meeting was very successful in three key areas; first, FDA supported our intended target patient population with a step-down study design.

Second, FDA formally acknowledged that MAT2203 is a potential candidate for registration under the LPAD pathway. And third, FDA expressed a willingness to accept a superiority composite primary end point. Dr. Matkovits will go into more detail on all these areas in a moment, but it’s important to emphasize that the potential to move away from a non-inferiority endpoint to a composite superiority endpoint is a significant win and something that could position MAT2203 for a much stronger label. And a stronger label brings with it a much more significant commercial market opportunity. We’re grateful for our ongoing constructive dialogue with the FDA and look forward to finalizing the composite superiority endpoint as soon as possible. Earlier this week, we reported new in vivo data demonstrating the therapeutic efficacy of an oral LNC formulation of docetaxel.

Building on successful in vitro demonstrations that our LNCs get taken up by tumor cells. These in vivo results were a big step forward for our delivery platform, taking us beyond our clinical success in infectious diseases and providing proof of principle that orally administered LNCs can effectively target large tumors and successfully deliver small molecule therapeutics. We have also advanced our internal oral LNC small oligonucleotide program and are excited to have documented biological activity in the form of cytokine knockdown, and some early evidence of tangible clinical benefit in an imiquimod induced murine psoriasis disease model. We have additional ongoing in vivo studies of LNC formulated small oligonucleotide in inflammatory disease models, and we expect data later in the fourth quarter.

Dr. Ferguson will provide more details on our LNC platform work a bit later in the call. Overall, the team is very pleased with our recent progress. We are energized by the continued clinical validation with MAT2203 and FDA dialogue and excited by the potential expansion of the LNC platform into areas such as inflammation and perhaps most interestingly, cancer. I’ll have additional comments on the financial picture and outlook later in the call, following our CFO’s review of our Q3 financial results. For now, I would like to turn the call over to Dr. Matkovits to expand on our MAT2203 update. Terri?

Terri Matkovits: Thanks, Jerry and good afternoon everyone. As Jerry mentioned, we held a highly productive and collaborative meeting with the division of Anti-Infectives of FDA last month that included attendance by the Director of the Office of Infectious Diseases, John Farley, and a Deputy Director. Their participation is highly unusual at the division level, and we believe that it is a direct reflection of the FDA’s interest in advance in MAT2203 towards registration. As in previous meetings with the agency, the FDA agreed that MAT2203 was most likely to be used in azole-resistant or azole intolerant patients or in patients with limited treatment options. Clinical success in this target patient population continues to be supported by the clinically meaningful outcome seen in patients receiving MAT2203 in our Compassionate/Expanded Use Access Program in which patients with no other treatment options are receiving MAT2203 for treatment of multiple fungal infections in multiple different tissues highlighting the ability of MAT2203 to safely target and effectively eradicate a variety of severe and potentially deadly invasive fungal infections in the most challenging clinical circumstances.