Matinas Biopharma Holdings, Inc.

Welcome to the Martinez Biopharma Second Quarter 2024 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. To ask a question at that time, please press the star key followed by the number one on your touchtone telephone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. 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. Thank you for participating in today's call. Joining me from Martinez Biopharma are Jerry Jabbour, Chief Executive Officer, and Keith Kosinski, Chief Financial Officer. Dr. Kerry Matkiewicz, Chief Development Officer, and Dr. Terry Ferguson, Chief Medical Officer, will be available during the question and answer 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 made pursuant to the safe harbor provisions of federal securities laws. These forward-looking statements are based on 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 Matinus 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, August 14, 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 Jappour. Jerry?

Thank you, Jody. Good afternoon, everyone, and thank you for joining us. We're pleased to begin today's call by reporting that we have signed a non-binding term sheet for the licensing of global rights to develop, manufacture, and commercialize MAT2203. Our ongoing constructive dialogues to partner this oral formulation of the potent yet toxic antifungal amphotericin B are cover not only the initial indication of patients with invasive aspergillosis with limited or no treatment options, but potentially all future treatment indications. We believe we have identified the right partner to maximize MAT2203's value in multiple territories. Our discussions have been quite productive and have covered a wide range of topics, from development strategy and commercial manufacturing to regulatory and commercial positioning. We should state that this is a non-binding term sheet and there is no guarantee that it will result in a definitive agreement, but we are very encouraged by this progress. Partnering this life-changing asset has been our top priority and we've now taken a significant step forward in that process. We have confidence that we are on a path to placing this asset in highly capable hands, which is in the best interest of our company and our shareholders. Referrations are ongoing to enable the Oralto Phase III registration trial with MAT2203 to initiate as soon as possible following the consummation of a partnership agreement. In the meantime, we continue to build real-world clinical evidence supporting MAT2203 in a variety of challenging and life-threatening fungal infections through our Compassionate Expanded Use Access programs. In this program, MAT2203 has continuously demonstrated its potential to achieve positive clinical outcomes, even in critically ill patients, and to do so safely. Since our last public update on June 24, seven additional patients ranging in age from 15 to 71 have gained access to oral MAT2203 through this program. This brings total enrollment to 31, with an additional six patients currently under evaluation. These latest patients were afflicted with a variety of serious and life-threatening invasive fungal infections. To date, 15 patients in the Compassionate Expanded Use Access Program have completed a full course of treatment with MAT2203. The median treatment time was 16 weeks, with a range of 2 to 49 weeks. Of these 15 patients, 8 had a complete response, and the other 7 were dramatically improved. Response to treatment for all patients was assessed by the treating physician. Nine additional patients are continuing to receive longer term treatment with positive ongoing effects, and five have just recently initiated treatment. As of now, only two patients have discontinued MAT2203 under this program, both during the first week. One discontinued due to intolerance secondary to underlying and unrelated GI conditions, and the other due to a terminal condition unrelated to their fungal infection. Notably, seven patients with invasive aspergillosis have been or are being treated, and all of them have shown positive clinical results. The positive outcomes in this program highlight the significant value of MAT2203 and bolster our confidence in the success of the Oralto Phase III trial. It's no surprise that given MAT2203's consistently positive clinical impact and highly favorable safety profile in patients with a variety of deadly invasive fungal infections, we're experiencing a dramatic increase in requests by physicians seeking access for their patients. Turning now to updates with our LNC platform. Recent studies have increased our understanding of its potential in delivering both small oligonucleotides and small molecule oncology drugs. This includes LNC cellular uptake and cargo delivery. We also continue to build our knowledge base with this technology in the areas of oncology and inflammation. We believe that there are significant unmet needs and a potential opportunity for the LNC mechanism of action to play a meaningful role in combination with effective treatments plagued by inefficient or nonspecific delivery and or significant safety and toxicity concerns. Regarding our LNC formulation of the widely used chemotherapeutic agent, docetaxel, following the success in melanoma that we've discussed on past calls, recent studies in animal models of breast, prostate, and lung cancer have all demonstrated varying degrees of tumor growth inhibition with daily oral dosing of LNC docetaxel. We have also expanded our in vivo studies to include daily oral LNC docetaxel in combination with IV docetaxel. These studies have demonstrated an even greater degree of tumor inhibition, but also resulted in added weight loss. We are continuing to evaluate several strategies intended to further improve the therapeutic index of this widely used chemotherapeutic agent. We have also begun evaluating the capabilities of our LNC platform with other chemotherapeutic agents. In vitro testing of an LNC formulation of miroplatin, which is a highly toxic agent only approved outside the U.S. for intra-arterial use, demonstrated strong cellular uptake and tumor cell killing capabilities. More recent in vivo testing indicated that while the oral LNC formulation of miroplatin was very effective in inhibiting tumor growth, It was also associated with weight loss, especially at higher doses, which may relate to the overall toxicity of the agent itself. We continue to evaluate the potential causes of this weight loss. In today's update announcement, we also highlighted a recently completed series of in vitro studies that investigated the potential relationship between the expression of surface phosphatidylserine, or PS, and the extent of LNC uptake into certain tumor cells. we previously observed a relationship between tumor cell surface PS and our LNC platform in preferential tumor targeting. Based upon these studies, surface PS expression appears to be one, but not the only driving factor for cellular uptake. Additional work is ongoing to better understand and predict the efficacy of LNC delivered chemotherapeutics. Lastly, in reviewing our parallel work in inflammation, Following encouraging in vivo data demonstrating the successful oral delivery, biological activity, and potential therapeutic efficacy of two different LNC-formulated small oligonucleotides targeting the inflammatory cytokines IL-17A and TNF-alpha, the findings from more recent follow-up in vivo studies have been less consistent. As such, additional optimization is required prior to identifying a potential product candidate. Overall, we believe good progress has been made in better understanding the potential for the L&C platform, but there is significant time and additional work ahead for us to be able to identify additional potential product candidates. We expect to be in a better position to provide additional guidance following the consummation of a MAT2203 partnership. With those comments, I'll turn the call over to our CFO, Keith Kosinski. Keith?