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.

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?

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. 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…

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. During our meeting with the FDA, there was general agreement on the main elements of the Phase 3 study design for the treatment of invasive aspergillosis in patients with limited treatment options. The FDA confirmed that MAT2203 may be a candidate for the limited population pathway for antifungal and antibacterial drugs for LPAD. Labeling for drugs under the LPAD pathway can phase that the approval is based on a benefit risk assessment that more flexibly considers the severity, rarity, or prevalence of the particular infection the drug is intended to treat and the lack of alternatives available for the patient population. Under the LPAD registration and approval pathway, MAT2203 would continue to qualify for QIDP incentives under the FDA priority review and…

Thanks Terri, and good afternoon, everyone. Today, I'll provide an update on initial results from our work in two important therapeutic areas, oncology and inflammation. Specifically, I'll review our in vivo results with an LNC small molecule formulation in oncology, and share recent additional in vivo data highlighting our LNC platform capabilities for the oral delivery of small oligonucleotides. First, we've progressed from earlier in vitro studies that confirm the efficacy of an LNC formulation of docetaxel in inhibiting tumor cell growth in cell culture, to our recently announced positive in vivo results with oral LNC docetaxel in a syngeneic murine melanoma model. Docetaxel is a well-known chemotherapeutic agent widely used in the management of malignant diseases. These in vivo results showed successful oral delivery docetaxel to tumors and a therapeutic response that was comparable to that of conventional IV docetaxel. In this study, mice who developed melanoma tumors in response to injected murine tumor cells, oral LNC-docetaxel given daily showed significant reductions in tumor volume compared with untreated controls with mean reductions at least two weeks -- at two weeks of 63% with high-dose oral LNCs and 57% with lower dose oral LNCs. This compares favorably with 68% reductions with IV docetaxel. Similar significant reductions in tumor rate and tumor weight were noted with the oral LNCs. Importantly, no systemic toxicities were noted with nine days of daily oral treatment with LNC-docetaxel. Body weight was stable over the treatment duration and hematologic parameters were similar to untreated controls. These encouraging results confirm our belief that phosphatidylserine expression on the outer surface of tumor cells presents a targeting opportunity for potential future oncology applications with our LNC platform. Next, I'd like to highlight recent data from our oral small oligonucleotide program. Building on previously shared work in human whole blood,…

Thank you, Terry. Starting today with our third quarter results. We reported 0 revenue for the third quarter of 2023, whereas in the third quarter of 2022, we reported revenue of $1.1 million which was generated from our research collaboration with BioNTech. Total costs and expenses for the third quarter of 2023 were $6.1 million which compares with $6.5 million for the third quarter of 2022. The decrease was primarily attributable to lower manufacturing costs of clinical trial materials, lower clinical consulting fees and lower headcount-related expenses. Our net loss for the third quarter of 2023 was $6.1 million or $0.03 per share. This compares with a net loss for the third quarter of 2022 of $6.5 million, also $0.03 per share. Turning now to our nine-month results. Revenue for the first nine months of 2023 was $1.1 million compared with $2.1 million for the first nine months of 2022. Total costs and expenses for the first nine months of 2023 were $19 million compared with $21.2 million for the first nine months of 2022. The company's net loss for the first nine months of 2023 was $17.6 million or $0.08 per share. This compares with a net loss for the first nine months of 2022 of $17.4 million, also $0.08 per share. Cash, cash equivalents, and marketable securities as of September 30th, 2023, were $18.2 million. Based on current projections, we believe our cash is sufficient to fund planned operations into the third quarter of 2024. We are actively seeking to extend our cash runway by securing non-dilutive funding from potential third-party development partners and government grant programs through agencies such as BARDA, as well as from potential public or private equity offerings. With that, I'll turn the call back to Jerry.

Thanks Keith. In summary, this is a very exciting time for our company. In MAT2203, we have a late-stage asset that's positioned to enter Phase 3. This drug is supported by robust positive clinical data and the regulatory and clinical trial strategy designed to potentially provide superiority data on a composite endpoint and potentially line up for registration under the advantageous LPAD pathway. The combination of focusing treatment with MAT2203 on an orphan patient population, with a superiority composite primary endpoint is designed to maximize commercial potential while filling what is perhaps the biggest current unmet need in the treatment of deadly invasive fungal infections. Further supported by the potential for 12 years of market exclusivity upon approval, should not be a surprise that partner interest in MAT2203 has increased significantly over the last month or so. Our goal is to use the recent FDA dialogue in clarity to accelerate these discussions and identify the ideal partner or partners for this drug, which will allow us to fully fund and commence Phase 3 as soon as possible, ensure that the right commercial partner is in place to maximize that opportunity. Given the uncertain and volatile capital markets, our primary objective is to extend our cash runway in a nondilutive manner. And we believe the elements are now in place to forge a meaningful partnership. Also, as we continue to generate potential LNC platform expanding data in areas like inflammation and cancer, both with small molecules and orally available small oligonucleotides, we remain open to the right partnerships with companies looking to apply our unique and proprietary delivery technology to their molecules. Additionally, we will look for opportunities to selectively access the capital markets, if the terms make sense for our company and our stockholders based upon the expected advancement of…

[Operator Instructions]

While we're waiting for the first question, I would like to mention that we will be holding meetings with investment professionals during the 2024 JPMorgan Healthcare Conference being held January 8 to 11 in San Francisco. If you are interested in schedule a meeting, please contact LHA Investor Relations. Okay. Chloe, I think we're ready for that first question.

Perfect. We'll move first to Julian Harrison with BTIG. Your line is open.

Hi. Congrats on the progress and thank you for taking my question. First, great to hear about the FDA's openness to a SUPERIORITY trial. I'm curious if this maybe will involve any changes to the comparator arm? And if not, can you just remind us of the plan there? And then also, can you just remind us of the corresponding market opportunity here in azole-resistant or intolerant invasive aspergillosis?

Julian, thanks for your question. For the first part of that question, I'll turn it over to Dr. Matkovits to talk about the design and specifically the control arm and how our recent dialogue can impact that. Terri?

Sure. Thanks Julian. So, our fundamental trial design has not changed. The target patient population for the trial will still be patients with invasive aspergillosis with limited treatment options. So, patients who cannot receive azole for reasons of intolerance, drug-drug interactions or issues of resistance. So all of the patients will start with IV amphotericin. And once they are deemed appropriate for oral step down, the patients will be randomized two-thirds to treatment with MAT2203 as step down. The remaining one-third of the patients will continue on IV amphotericin until they are no longer able to tolerate upon which a decision will have to be made by the treating physician to manage the relevant drug-drug interactions if an azole would be the only other treatment option for the patients. So, this very much is reflective of the patients that are currently being treated with IV amphotericin in our Compassionate Use Access Program.

So, -- and just to add to that, Julian, I think one of the benefits is that the control arm is not changing. And that's important when you think about this as a composite endpoint. You would be ordinarily -- you don't see a superiority endpoint certainly in an antifungal trial. And certainly, you wouldn't exercise a superior -- you wouldn't add a superiority endpoint if you were just going head-to-head, for example, on all-cause mortality with IV amphotericin versus oral amphotericin. But what the composite endpoint does, especially being able to define it as therapeutic success and include a change in treatment regimen, for example, you're going to have a control arm in this study where any change from IV amphotericin in the control arm is going to be viewed as a failure potentially. And you're going to contrast that with oral MAT2203, which we've seen in other instances and other patients can be given for long periods of time without the toxicity seen with IV amphotericin, which is exactly what necessitates a change in therapy. So, we'll see how that dialogue goes with FDA, but that's -- this is the unique position that MAT2203 is in. And what we really bring to the table here is that safety element and allowing amphotericin B to be used for long periods of time. That's the goal. And ideally, you wouldn't change the control arm at all. We don't have to. And that's why we think a composite superiority endpoint is really a significant step forward for the program. And then in terms of the market, you're looking at here an orphan population in and of itself with invasive aspergillosis. We're targeting initially patients with limited treatment options. There are about 15,000 to 16,000 patients annually in the US that are…

Okay. Excellent. Very helpful. And then one final question, if I may, the potential LPAD designation. I'm wondering how soon that might be confirmed? Is that something you expect clarity on or around regulatory submission or perhaps earlier?

Yes. No, the way LPAD works is not like getting a special protocol assessment. So, LPAD is the termination made at the time of NDA filing, at the NDA approval. It gives the agency the opportunity to look at the totality of the data and our ability to address that restricted patient population. But there are formal feedback to us that were a potential candidate is consistent with what they've done for other groups. Currently, there's only two products approved on LPAD, but that will be a review issue. But certainly, with the design of the study and the target patient population, we fit well within the criteria outlined by FDA to qualify for that. But you don't expect any sort of declaration in advance. That's not how it works.

Okay, great. Thanks again for taking the question.

Thanks Julian.

And once more -- I will turn the call back to the speakers for any closing remarks.

Thanks Chloe. Thanks to everyone for joining us today. We're thrilled with our FDA update. We're thrilled with our LNC-docetaxel data. We look forward to additional data clinical disease impact from the small oligonucleotide program. We've come a long way in 2023. We're not done. We're excited and optimistic about our company's future and we can't wait to report additional progress over the next few months. In the meantime, we wish all of our investors and anyone listening to the call, a very happy Thanksgiving holiday. Have a great night and thanks for joining us. Take care.

This does conclude today's program. Thank you for your participation. You may disconnect at any time and have a wonderful evening.