Q2 2024 Matinas BioPharma Holdings Inc Earnings Call

Matinas BioFarma: Welcome to the Matinas Biopharma Second Quarter 2024 Financial Results Conference Call.

Unknown Executive: 2020-24 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 touch-tone telephone.

Operator: 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.

Speaker Change: Currently, all participants are in a listen-only mode.

Speaker Change: 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.

Unknown Executive: If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference is being recorded.

Operator: 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 do so.

Speaker Change: 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.

Jody Cain: I would now like to turn the conference over to Jody Cain. Please go ahead.

Jody Cain: This is Jody Cain with LHA. Thank you for participating in today's call.

Jody Cain: This is Jody Cain with L.A.J. Thank you for participating in today's call. Too many me from Matinas Biopharma, Archery Jabbour, Chief Executive Officer, and Keith Kucinski, Chief Financial Officer, Dr. Kerry Matkovits, Chief Development Officer, and Dr. Kerry 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.

Speaker Change: This is Jody Cain with LHA. Thank you for participating in today's call.

Jody Cain: Too many of me from Matinas Biopharma, Archery, J4, Chief Executive Officer, and Keith Kucinski, Chief Financial Officer, Dr. Kerry Maccabits, Chief Development Officer, and Dr. Kerry 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 recent uncertainties. Forward-looking statements may pursue it 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.

Speaker Change: Tune me from Matinos by El Pharma, her Jerry Jabbour, Chief Executive Officer, and Keith Kucinski, Chief Financial Officer.

Speaker Change: Dr. Terry Matkovits, Chief Development Officer, and Dr. Terry Ferguson, Chief Medical Officer, will be available during the question and answer session.

Jody Cain: Forward-looking statements may be made pursuant to the safe harbor provisions of federal securities laws. However, 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 that 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.

Speaker Change: I'd like to remind listeners that remorse may during this call, may state management's future intentions, hopes, police, expectations, or projections. These are forward-looking statements in a voluntary and uncertainties.

Jody Cain: Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, August 14th, 2024. Matinas BioFarma undertakes no obligation to revise or update any statements to reflect these changes in circumstances, except as required by law. Now, I'd like to turn the call over to Jerry Jabbour. Jerry?

Speaker Change: Forward-looking statements may pursue it 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.

Jody Cain: Some of the factors that could cause actual results to differ materially from those contemplated by such forwardly 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.

Speaker Change: 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.

Speaker Change: These documents are available in the investors section of the company's website and on sec.gov.

Jody Cain: Furthermore, the content of this conference call contains information that is accurate only as of the day that the live broadcast, August 14, 2024. Matinas Biopharma undertakes no obligation to revise or update any statements to reflect these answer circumstances, except as required by law.

Speaker Change: Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast.

Jerry Jabbour: August 14, 2024, 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?

Jerry Jepor: And now I'd like to turn the call over to Jerry Jepor. Jerry?

Jerry Jepor: Thank you, Jodi.

Jerome Jabbour: 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 cover not only the initial indication of patients with invasive aspergillosis with limited or no treatment options but potentially all future treatment indications.

Jerry Jepor: 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 Mat203. Our ongoing constructive dialogues to partner this oral formulation of the potent yet toxic antifungal amphotericin B 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 Mat203'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.

Jerry Jabbour: Thank you, Jody. Good afternoon, everyone, and thank you for joining us.

Jerry Jabbour: 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.

Speaker Change: Our ongoing constructive dialogues to partner this oral formulation of the potent yet toxic antifungal amputericin B cover not only the initial indication of patients with invasive aspergillosis with limited or no treatment options, but potentially all future treatment indications.

Jerome Jabbour: We believe we have identified the right partner to maximize MAT-2203'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 interests of our company and our shareholders.

Speaker Change: We believe we have identified the right partner to maximize MAT-2203's value in multiple territories.

Speaker Change: 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.

Jerry Jepor: We should state that this is a non-binding term sheet and there is no guarantee that it will result in the 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 O'Raltto Phase 3 Registration Trial with MAT-2203 to initiate as soon as possible following the consummation of a partnership agreement.

Speaker Change: 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.

Speaker Change: Parking this life-changing asset has been our top priority, and we've now taken a significant step forward in that process.

Speaker Change: 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.

Jerome Jabbour: Reparations are ongoing to enable the O'Raltto Phase 3 Registration Trial with Matt 20203 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 MAP2203 in a variety of challenging and life-threatening fungal infections through our Compassion Expanded Use Access Program. In this program, MAT-2203 has continuously demonstrated its potential to achieve positive clinical outcomes, even in critically ill patients, and to do so safely.

Speaker Change: Reparations are ongoing to enable the Oralto Phase III registration trial with MAT-2203 to initiate as soon as possible following the consummation of a partnership agreement.

Jerry Jepor: In the meantime, we continue to build real-world clinical evidence supporting MAT-2203 in a variety of challenging and life-threatening fungal infections through our Compassion and Expanded Use Access program. In this program, MAT-2203 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 MAT-2203 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.

Speaker Change: In the meantime, we continue to build real-world clinical evidence supporting MAT-2203 in a variety of challenging and life-threatening fungal infections through our Compassion Expanded Use Access Program.

Speaker Change: In this program, MAT-2203 has continuously demonstrated its potential to achieve positive clinical outcomes, even in critically ill patients, and to do so safely.

Jerome Jabbour: Since our last public update on June 24th, seven additional patients ranging in age from 15 to 71 have gained access to Oral MAT 2203 through this program. This brings Disprings 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 conditions and days of fungal interaction. To date, 15 patients in the Compassionate Expanded Use Access Program have completed a full course of treatment with MAT-2203.

Speaker Change: Since our last public update on June 24th, seven additional patients ranging in age from 15 to 71 have gained access to Oral MAT 2203 through this program.

Speaker Change: Disbrings Total Enrollment to 31, with an additional six patients currently under evaluation.

Speaker Change: These latest patients were afflicted with a variety of serious and life-threatening invasive fungal infections.

Jerry Jepor: To date, 15 patients in the Compassion and Expanded Use Access program have completed a full course of treatment with MAT-2203. The median treatment time was 16 weeks, with a range of 2 to 49 weeks. Of these 15 patients, eight had a complete response, and the other seven 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 MAT-2202 or 300 in this program, both during the first week.

Jerome Jabbour: 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 5th have just recently initiated treatment. As of now, only two patients have discontinued MAT-2203 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.

Speaker Change: Today's 15 patients in the compassion that expanded use access program have completed a full course of treatment with Matt 20203. The median treatment time was 16 weeks with a range of 2 to 49 weeks.

Speaker Change: 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.

Speaker Change: Nine additional patients are continuing to receive longer-term treatment with positive ongoing effects, and five have just recently initiated treatment.

Speaker Change: As of now, only two patients have discontinued MAT-2203 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.

Jerry Jepor: 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 within base of 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 MAT-2203, and bolster our confidence in the success of the Oralto Phase 3 trial. It's no surprise that, given MAT-2203's consistently positive clinical impact and highly favorable safety profile, patients with a variety of deadly invasive fungal infections are experiencing a dramatic increase in request-by-position seeking access for their patients.

Jerome Jabbour: 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 MAT-2203 and bolster our confidence in the success of the Oralto Phase III trial. It's no surprise that given MAT-2203'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. Now, we turn now to updates with our LNC platform.

Speaker Change: Notably, seven patients with invasive aspergillosis have been or are being treated, and all of them have shown positive clinical results.

Speaker Change: The positive outcomes in this program highlight the significant value of MAT-2203 and bolster our confidence in the success of the Oralto Phase III trial.

Speaker Change: It's no surprise that given MAT-2203's consistently positive clinical impact and highly favorable safety profile in patients with a variety of deadly invasive fungal infections, we are experiencing a dramatic increase in requests by physicians seeking access for their patients.

Jerry Jepor: 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. According to our L.N.C. formulation of the wisely used chemo therapeutic agent, Dosa Taxel. 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 L.N.C.

Jerome Jabbour: 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 balancing mechanism of action to play a meaningful role in combination with effective treatments plagued by inefficient or non-specific delivery or significant safety and toxicity concerns.

Speaker Change: 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.

Speaker Change: We also continue to build our knowledge base with this technology in the areas of oncology and inflammation.

Speaker Change: 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 non-specific delivery and or significant safety and toxicity concerns.

Jerome Jabbour: Regarding our LNC formulation of the wisely used chemotherapeutic agent, Dosa Taxel, 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 LNT dose attacks. We have also expanded our in vivo studies to include daily oral LNT docetaxel in combination with IV docetaxel. These studies demonstrated an even greater degree of tumor inhibition but also resulted in added weight loss.

Speaker Change: Regarding our LNC formulation of the widely used chemotherapeutic agent docetaxel

Speaker Change: 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 LNG docetaxel.

Jerry Jepor: Dosa Taxel. We have also expanded our N.V.V.O. studies to include daily oral L.N.C. Dosa Taxel in combination with I.V.O. Dosa Taxel. These studies have demonstrated an even greater degree of tumor inhibition, but also resulted in an 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 L.N.C. platform with other chemotherapeutic agents in vitro testing of an L.N.C. Formulation of mirror platen, 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.

Speaker Change: We have also expanded our in vivo studies to include daily oral LNC docetaxel in combination with IV docetaxel.

Speaker Change: 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.

Jerome Jabbour: 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 meroplatin, 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. However, more recent in vivo testing indicated that while the oral LNC formulation of mirrorplatin was very effective in inhibiting tumor growth, it was also associated with weight loss, especially at higher doses, which may relate to the overall We continue to evaluate the potential causes of this weight loss.

Speaker Change: We have also begun evaluating the capabilities of our LNC platform with other chemotherapeutic agents.

Speaker Change: In vitro testing of an LNC formulation of meroplatin, 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.

Jerry Jepor: More recent N.V.O. testing indicated that while the oral L.N.C. formulation of mirror platen 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.

Speaker Change: More recent in vivo testing indicated that while the oral LNC formulation of mirror platinum was very effective in inhibiting tumor growth, it was also associated with weight loss especially at higher doses.

Speaker Change: which may relate to the overall toxicity of the agent itself. We continue to evaluate the potential causes of this weight loss.

Jerry Jepor: In today's update announcement, we also highlighted a recently completed series of N.V.O. studies that investigated the potential relationship between the expression of surface fossil title steering or PS and the extent of L.N.C. uptake into certain tumor cells. We previously observed a relationship between tumor cell surface PS and our L.N.C. 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 F.

Jerome Jabbour: 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 fossil tidal steering or PS and the extent of, 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 surface PS.

Speaker Change: 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 fossil title serine, or PS, and the extent of LNC uptake into certain tumor cells.

Speaker Change: We previously observed a relationship between tumor cell surface PS and our LNC platform in preferential tumor targeting.

Speaker Change: 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.

Speaker Change: Lastly, in reviewing our parallel work in inflammation,

Speaker Change: Following encouraging in vivo data demonstrating the successful oral delivery, biological activity, and potential therapeutic efficacy of two different LNT-formulated small oligonucleotides targeting the inflammatory cytokines IL-17A and TNF-alpha,

Speaker Change: 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.

Speaker Change: Overall, we believe good progress has been made in better understanding the potential for the LNC platform, but there is significant time and additional work ahead for us to be able to identify additional potential product candidates.

Keith Kucinski: We expect to be in a better position to provide additional guidance following the consummation of a MAT-2203 partnership. With those comments, I'll turn the call over to our CFO , Keith Kucinski. Keith?

Keith Kucinski: Thank you, Jerry, and good afternoon.

Keith Kucinski: Today, the company reported its financial results for the second quarter of 2024, which reflected a net loss of $5.7 million, or $0.02 per share.

Keith Kucinski: This compares to a net loss of $6.1 million or $0.03 per share for the second quarter of 2023.

Keith Kucinski: The company did not report any revenue during either of these periods.

Keith Kucinski: Total costs and expenses for the second quarter of 2024 were $5.8 million, compared with $6.2 million for the second quarter of 2023.

Keith Kucinski: The year-over-year decrease was primarily due to lower clinical development expenses, personnel costs, and administrative expenses.

Keith Kucinski: Turning to our six months results.

Keith Kucinski: Our net loss for the six months of 2024 were $11.5 million or five cents per share compared with the net loss for the first six months of 2023 of $11.6 million, also five cents per share.

Keith Kucinski: We reported no revenue for the first six months.

Keith Kucinski: I'm sorry, for the six months ended June 30th.

Keith Kucinski: 2024. This compares with $1.1 million in revenue for the prior year period.

Keith Kucinski: which was generated from research collaborations.

Keith Kucinski: with BioNTech and Genentech.

Keith Kucinski: Total costs and expenses for the first six months of 2024 were $11.7 million, compared with $12.8 million for the first six months of 2023.

Keith Kucinski: This decrease primarily reflects a decline in R&D expenses as well as lower general and administrative expenses.

Keith Kucinski: Cash, Cash Equivalence, and Markable Securities, as of June 30, 2024, were $14.3 million, compared with $13.8 million, as of December 31, 2023.

Keith Kucinski: This increase reflects $10 million in gross proceeds raised through a registered direct offering in April , more than offsetting the company's negative cash flow from operations over the six-month period.

Keith Kucinski: With that, I'll turn the call back to Jerry.

Jerry Jabbour: Thanks, Keith. In closing, we are reporting positive real progress in consuming a partnership transaction with Matt 20203. That we believe will be in the best interest of our company and bring value to our shareholders.

Speaker Change: We have signed a non-binding term sheet with a potential global partner and remain engaged in ongoing constructive discussions with our prospective licensee with the goal of finalizing this transaction as soon as possible.

Speaker Change: Our compassionate expanded use access program continues to highlight the ability of Matt 2023 to safely target and effectively eradicate a variety of severe, potentially deadly and basic thungal infections, even in the most challenging clinical circumstances.

Speaker Change: This program is gaining awareness within the medical community with request for access to Matt 20203 significantly increasing in recent months.

Speaker Change: In fact, just yesterday, we received two additional requests, bringing us close to 40 total enrollees should all current evaluations result in patient admittance and emergency IND approvals.

Speaker Change: This essential program is functioning like a basket study of invasive fungal infections and could position us and or our partner for the support of potential expanded label discussions at the time of NDA filing.

Speaker Change: We continue to expand our knowledge base with our LNC platform. We're evaluating the best next steps for this technology as we determine how to maximize return to shareholders. And look forward to providing additional guidance on next steps once we have secured our Matt 223 partnership, which remains the key focus of the company.

Speaker Change: With that review, I'll turn the call over to the operator for Q&A. Morgan.

Speaker Change: As a reminder, if you wish to register to ask a question in today's Q&A session, you will need to press star, then number one on your telephone.

Speaker Change: If your question has been answered, and you wish to withdraw your request, you may do so by pressing the pound key. If you are using a speaker phone, please pick up your handset before entering your request.

Speaker Change: One moment please for the first question.

Speaker Change: Your first question comes from Scott Henry with Alliance Global Partners. Your line is open.

Scott Henry: Thank you, and good afternoon. Just a couple quick questions. First, uh...

Scott Henry: Good news on the nine binding term sheet. Obviously, you can't get out specifics.

Scott Henry: But, generally speaking, should we be thinking about an upfront payment in as well reimbursement for the around-to-trials, although those kind of key components of what you're looking for in this type of deal through this agreement or another one.

Scott Henry: Hi Scott, thanks for the question, and actually without commenting on it specifically, I do think it's appropriate to say that we would expect.

Speaker Change: you know, not just a non-binding term sheet, but a definitive agreement to be structured similar to what you would typically see and have seen in this area.

Speaker Change: With some combination, you know, of an upfront payment, certainly development and commercial milestones, royalties, and the additional potential elements of how you're going to treat clinical development costs.

Speaker Change: and manufacturing, which we have outlined for investors before, specifically referencing our intended tech transfer of manufacturing from here at Matinos to thermal fisher. So there's a lot of moving parts there, but I think, you know, as investors try to get their arms around, what is the meaning of a non-binding term sheet? It's just that, it's the framework for a deal, but all of those elements have been discussed.

Speaker Change: and I think it's safe to say that any definitive agreement that we arrive at with this intended partner on a global basis would include some combination of those essential elements.

Speaker Change: Okay, thank you for that color. And then, you know, given the timeline for a partnership is taking a little longer than expected, would you still expect the Oralto trial to start in fourth quarter of 2024 or perhaps we should think about early 2025?

Speaker Change: Yeah, it's a fair question, and I think it's appropriate for us to address, that this has taken, I think, longer than any of us have expected, and I think that speaks to the complexity of these sorts of dialogues, but it also speaks to how important it is to have complete alignment across the board in no surprises. I mean, if you look...

Speaker Change: in this category in the recent past, you know, you had a global big farmer that was surprised by CMC issues, which arose after a definitive agreement was signed. And I think that has caused...

Speaker Change: Certainly, everyone in this category to make sure that all of those boxes are checked. And so, the diligence process around this transaction has been pretty thorough, thorough. And I think that has explained, you know, the passage of time as much as anything else. And why it's taken a little bit longer, I do think it eliminates surprises, you know, post-apartnership announcement and does put you in position to get things started as quickly as possible. Once a transaction is consummated and if a transaction is consummated, in terms of timing.

Speaker Change: We're not sitting on our laurels, so the team here is actively working with a global CRO to sort of put pieces in place. You know, it's a slight excale Scott in terms of, you know, are you going to have product ready? And any time, you know, that you're getting ready to start a phase three trial, there are a number of steps that need to be done and boxes checked before you can have first patient first dose.

Speaker Change: But we do think that we have confidence that the study can initiate in the fourth quarter of this year. But whether or not that results in a first patient, first visit in 2024, that's probably safer for 2025.

Speaker Change: But taking that into account there are a number of steps that we've taken the discussions with the global CRO.

Speaker Change: to take sort of this delay into account, make some some adjustments to how.

Speaker Change: The study has set up the number of sites so that you're not losing sort of enrollment time on the back end. So we've tried to be proactive in addressing that issue so that at the end of the day, not only are we putting ourselves in position to initiate the trial or partner to initiate the trial as soon as we can, but also sort of maximize the time for phase three and sort of get through this quickly as we can. So eventually we can have this. Thank you.

Speaker Change: product be filed under an NDA and be ready for commercialization, you know, as soon as possible. We still project it in Rome, it's going to take about 24 months in this study. So things have lined up, yes, the counter has lit a little bit, but we're working hard to make sure that doesn't have too much of an impact on the back end.

Speaker Change: Okay, great. Final question with regards to the LNC platform in the

Speaker Change: oncology indications

Speaker Change: How should we interpret the additional weight loss we're seeing? Obviously, you know, typically a good thing, but less so in an oncology trial. Would you think that is molecule-related, or would you think it's a lack of thriving? I'm just curious. I saw it in there a couple times, how you would...

Speaker Change: interpret that.

Speaker Change: Yeah, and this is like Scott's a great question, and this is sort of the interesting and challenging part of early stage drug development, right, because at the same time, you know, you're trying to drive and show that you have biological activity and therapeutic efficacy, particularly, I mean, and biological activity would apply more to the knowledge and nucleotides.

Speaker Change: But if we're talking about LNC dose attacks, for example, some of what we're doing is cranking the dose really high.

Speaker Change: And so that, to some degree, when you're talking about dosotaxel, we think can explain some of the weight loss. But we also think, remember, this is...

Speaker Change: in oral therapy that's traditionally been given IV, and when you're giving an oral therapy in animal studies.

Speaker Change: You could have Gavaj issues which could have all sorts of ramifications on how these animals feed or eat which could be contributing to the weight loss.

Speaker Change: and so that's in the case of docetaxel and that's why we're looking for ways to sort of optimize that formulation to not only increase the therapeutic index

Speaker Change: But be able to give as much as we can and even split the dose into two doses and we've even begun to see a dose response there, which is positive.

Speaker Change: When you look at me or a plat and you're dealing with a different animal altogether, it's a highly, much more highly toxic agent and different cargo.

Speaker Change: Sometimes, you know, create different characteristics of the LNCs, in the case of mere platinum, I think.

Speaker Change: without drawing too many conclusions because a lot of work is still ongoing internally.

Speaker Change: We would attribute more of the weight loss we saw on the mirum platen side to the toxicity of the agent.

Speaker Change: but we're doing some additional work to verify that that is in fact the case. And at the end of the day,

Speaker Change: What we want to be able to do is encapsulate whatever chemotherapeutic agent we're targeting in a way that we can create that oral availability, that we can still have that specific tumor targeting and lower toxicity. And we're just in these early stages, you're optimizing, you're cranking the dose sometimes, you're splitting the dose sometimes. So it's not surprising that in some contexts you're going to see weight loss, but the team is working hard to better understand those. And at least in the case of miroplatin, we think it's agent specific and not related to the platform.

Speaker Change: Okay, great. Thank you for taking the questions.

Speaker Change: God, thanks very much.

Speaker Change: Your next question comes from Jason McCarthy with Maxim Group. Your line is open.

Joanne Lee: Hi, this is Joanne Lee on the call for Jason McCarthy. Thanks for taking the question and congratulations on securing the partnership for RALTO.

Unknown Executive: 2020-24 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 touch-tone telephone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this conference is being recorded.

Joanne Lee: My question on the anticipated timeline for the Phase 3 launch was answered, but just as a follow-up, with the recent milestone achieved, could you just remind us on some of the key design elements and objective measures of the upcoming non-inferiority study?

Speaker Change: Sure. Joanne, thanks very much for the question. And I'm going to turn it over to Dr. Matkovits to talk about the design. But I would say we're really proud of our progress. I wouldn't quite say milestone achieved yet. You know, we don't have, we have not secured the definitive agreement. Obviously, we're working very hard to deliver that as soon as we can.

Jody Cain: I would now like to turn the conference over to Jody Cain. Please go ahead.

Jody Cain: This is Jody Cain with LHA. Thank you for participating in today's call.

Dr. Matkovits: when we'll pop the champagne. But we do think that this is an important, you know, progress toward that milestone, narrowing it down to a single party, working with them to make sure that all of those questions are answered and that we're setting the program up for success as soon as we pass that baton. We don't want to have any drops.

Jody Cain: Too many of me from Matinas Biopharma, Archery, J4, Chief Executive Officer, and Keith Kucinski, Chief Financial Officer, Dr. Kerry Maccabits, Chief Development Officer, and Dr. Kerry 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 recent uncertainties. Forward-looking statements may pursue it to the safe harbor provisions of federal securities laws.

Terry: But that might, we'll consider the milestone achieved when we have a definitive agreement, so just want to be fair about that. But Terry, for a second, why don't you just remind everyone what that design element of the Router study looks like, number of patients, what we're going up against, and what's the key, and what's the key primary and secondary endpoints.

Terry: Yep.

Terry: Sure, thanks Joanne for the question. So to remind everyone, the ARALTO trial is a non-inferiority trial, a two-armed trial.

Jody Cain: 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 forwardly 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.

Terry: Where we are targeting assessing the efficacy of Mat 2012-03 after two-day IV Amphos stepped down to Mat 2012-03 with treatment out to 12 weeks.

Terry: And this non-inferiority trial will be targeting patients with invasive aspergillosis who have no other treatment options. So they either have a toxicity or a lack of tolerance to the azole class.

Jody Cain: Furthermore, the content of this conference call contains information that is accurate only as of the day that the live broadcast August 14, 2024. Matinas Biopharma undertakes no obligation to revise or update any statements to reflect these answer circumstances, except as required by law.

Terry: or they have some significant clinical drug interactions that preclude them from the ability of being treated with an nasal.

Terry: So, the comparator arm will be an arm where patients will receive IV liposomal amphotericin for as long as they are able to tolerate the treatment with the primary endpoint of mortality at six weeks.

Jody Cain: And now I'd like to turn the call over to Jerry Jepor. Jerry? Thank you, Jodi.

Jerry Jepor: 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 Mat203. Our ongoing constructive dialogues to partner this oral formulation of the potent yet toxic antifungal amphoteric and B cover not only the initial indication of patients with invasive aspergillosis with limited or no treatment options, but potentially all future treatment indications.

Terry: Now, we've added some key secondary endpoints to the trial because we believe that one of the key attributes of MAT2203 is the ability to receive the drug longer term without any of the safety sequelae that you see with IV-administered AMFO.

Terry: So a key secondary endpoint will be safety, looking at the proportion of patients who have to switch from IV amphotericin in the comparator arm.

Terry: to another treatment regimen, whether that be a drug holiday from IV AMFO or a reduction of dose.

Jerry Jepor: We believe we have identified the right partner to maximize Mat203'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 the definitive agreement, but we are very encouraged by this progress.

Terry: and comparing those toxicity-related dosing changes, if you will, and testing for superiority.

Terry: and that test would be done at the 12-week end point. We'll also be looking at global response to treatment, so looking at clinical radiological and psychological response at 12 weeks.

Terry: and also, importantly, looking at the pharmacoeconomic impact of OralMAT2203 because the value proposition in addition to

Jerry Jepor: 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 O'Raltto Phase 3 Registration Trial with MAT-2203 to initiate as soon as possible following the consummation of a partnership agreement.

Speaker Change: The Safety Benefit is the ability to transition patients as early as possible to the outpatient setting where they have a lower use of health care resources and a higher quality of life. And so we're tracking this in our ongoing Compassionate Use Program where we're seeing that.

Speaker Change: Patients are very quickly transitioned to home care after they're able to switch from IV amphotericin to our OralMed 2203. And of course, throughout the course of the study, we'll be evaluating mortality through the 12-week endpoint.

Jerry Jepor: In the meantime, we continue to build real-world clinical evidence supporting MAT-2203 in a variety of challenging and life-threatening fungal infections through our Compassion and Expanded Use Access program. In this program, MAT-2203 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 MAT-2203 through this program.

Speaker Change: Great, appreciate all those details, looking forward to more upbeat on the program. Thank you. Thank you. Thanks, Joanne.

Speaker Change: i

Speaker Change: At this time, there are no further questions in queue. I'd like to turn the call back over to Jerry Jabbour for any further remarks.

Jerry Jabbour: Thanks Morgan, and thank you for joining us today and for your interest in Martinez. We remain excited and very optimistic about our company's future, and look forward to reporting further progress during our third quarter conference call on November. Thank you again and have a nice evening.

Jerry Jepor: 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 Compassion and Expanded Use Access program have completed a full course of treatment with MAT-2203. The median treatment time was 16 weeks, with a range of 2 to 49 weeks. Of these 15 patients, eight had a complete response, and the other seven were dramatically improved.

Speaker Change: This concludes the Martinez Biopharma second quarter 2024 conference call. Thank you for attending and have a wonderful rest of your day.

Speaker Change: Thanks for watching, see you in the next video.

Jerry Jepor: 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 MAT-2202 or 300 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 within base of aspergillosis have been or are being treated, and all of them have shown positive clinical results.

Speaker Change: Thank you very much for watching this video.

Jerry Jepor: The positive outcomes in this program highlight the significant value of MAT-2203, and bolster our confidence in the success of the Oralto Phase 3 trial. It's no surprise that given MAT-2203's consistently positive clinical impact, and highly favorable safety profile and patients with a variety of deadly invasive fungal infections, we're experiencing a dramatic increase in request-by-position seeking access for their patients.

Jerry Jepor: 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.

Jerry Jepor: According to our L.N.C, formulation of the wisely used chemo therapeutic agent, Dosa Taxel 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 L.N.C. Dosa Taxel.

Jerry Jepor: We have also expanded our N.V.V.O, studies to include daily oral L.N.C. Dosa Taxel in combination with I.V.O. Dosa Taxel.

Jerry Jepor: These studies have demonstrated an even greater degree of tumor inhibition, but also resulted in an added weight loss. We are continuing to evaluate several strategies intended to further improve the therapeutic index of this widely used chemo therapeutic agent. We have also begun evaluating the capabilities of our L.N.C, platform with other chemo therapeutic agents in vitro testing of an L.N.C, formulation of mirror platen, 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.

Jerry Jepor: More recent N.V.O, testing indicated that while the oral L.N.C, formulation of mirror platen 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.

Jerry Jepor: In today's update announcement, we also highlighted a recently completed series of N.V.O, studies that investigated the potential relationship between the expression of surface fossil title steering or PS and the extent of L.N.C, uptake into certain tumor cells. We previously observed a relationship between tumor cell surface PS and our L.N.C, 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 F.