Full Year 2023 Matinas BioPharma Holdings Inc Earnings Call

Speaker Change: [music].

Operator: Welcome everyone to the Matinas Biopharma 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. To ask a question at that time, please press the star key followed by the number 1 on your telephone.

Welcome everyone to the <unk> Biopharma 2023 financial results Conference call.

All participants are in a listen only mode.

Following managements 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 telephone keypad.

Operator: If anyone has difficulty hearing the conference, please press star zero for operator. As a reminder, this conference is being recorded. I would now like to turn the conference over to Jody Cain. Please do so.

If anyone has difficulty hearing the conference. Please press star zero for operator assistance.

A reminder, this conference is being recorded.

I'd 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. Terry Matkovits, Chief Development Officer, Dr. Terry Ferguson, Chief Medical Officer, and Keith Kucinski, Chief Financial Officer. I'd like to remind listeners that remarks made during this call may state management's future intentions. These are forward-looking statements that involve risk and uncertainty. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on Matinas BioPharm's current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statement. 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 investor relations section of the company's website and on sec.gov.

This is Jody Cain with L E K Investor Relations. Thank you perfect as stated in today's call joining me from Machinist Biopharma, Jerry Jabbour, Chief Executive Officer, Dr. Terry <unk>, Chief Development Officer, Dr. Terry Ferguson, Chief Medical Officer, and Keith Kucinski Chief.

Actual office there.

Jody Cain: I'd like to remind listeners that remarks made during this call may state managements future intentions hopes beliefs expectations or projections. These forward looking statements and involve risks and uncertainties forward looking statements are made pursuant to the safe Harbor provisions of the Federal Securities Law.

Jody Cain: These forward looking statements are based on machine, that's filed for Atlas current expectations and actual results could differ materially.

Jody Cain: As a result, you should not place undue reliance on any forward looking statements.

Jody Cain: 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, but chinas Biopharma files with the Securities and Exchange Commission. These documents are available in the Investor Relations section of the company's website and on SEC.

Jody Cain: Oh gosh.

Jerome D. Jabbour: Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, March 27, 2024. Matinas Biopharma undertakes no obligation to revise or update any statements to reflect events or circumstances except as required by law.

Jody Cain: Furthermore, the content of this conference call contains information that is accurate only as of the day. That's a live broadcast March 27th 2020 for Latinos 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.

Jody Cain: Call over to Jerry Jabbour Jerry.

Jerome D. Jabbour: Thank you, Jody. Good afternoon, everyone, and thank you for joining us. This has been an extremely eventful period at Matinas, with multiple positive developments advancing the progress of our L&T platform program. One of the most important of these was reaching final agreement with the FDA on the trial design for the Uralto Phase 3 study of MAT-2203 in patients with invasive aspergillosis and limited treatment options. In many ways, the value-generating power of our LNC platform is epitomized by this progress with MAT-2203, where we have taken the most potent, broad-spectrum antifungal drug amfotericin B, which conventionally suffers from severe toxicity issues and intravenous administration, and created a new, safer oral drug candidate that allows physicians to maximize the benefit of this powerful drug for longer-term treatment. It's quite literally a life-saving and life-changing drug.

Jerome D. Jabbour: Thank you Jody good afternoon, everyone and thank you for joining us.

This has been an extremely eventful period at <unk> with multiple positive developments advancing the progress of our LNC platform programs.

Jerome D. Jabbour: One of the most important of these was reaching final agreement with the FDA on the trial design for the Euro Alto Phase III study of map 22, or three in patients with invasive aspergillosis and limited treatment options.

Jerome D. Jabbour: In many ways the value generating power of our LNG platform is epitomize by this progress with map 22, or three where we have taken the most potent broad spectrum antifungal drug amphotericin, b, which conventionally suffers from severe toxicity issues and inconvenient in intravenous administration and created a.

Jerome D. Jabbour: New paper oral drug candidate that allows physicians to maximize the benefits of this powerful drug for longer longer term treatments, it's quite literally a lifesaving or life changing drugs.

Jerome D. Jabbour: Even more importantly, with alignment on the Phase 3 Errato trial design, we now have a clear registration pathway. This is a critical milestone toward advancing MAT-2203 into Phase 3 and closer to potential approval for this initial indication. We project that the market for MAT-2203 and the treatment of invasive aspergillosis in patients with limited treatment options could reach peak sales in the U.S. alone of over $400 million annually, with opportunities to increase that amount both through territory expansion outside the U.S. and also through indication expansion into the treatment of other invasive fungal infections, such as mucormycoses, cryptococcal meningitis, and endemic myco We view MAT-2203 as a pipeline and a product, and the Aralto trial and initial indication are an important and commercially valuable first step.

Jerome D. Jabbour: Even more importantly, with alignment on the phase III or Alto trial design, we now have a clear registration pathway there.

Jerome D. Jabbour: This is a critical milestone toward advancing that 'twenty, two or three into phase III and closer to potential approval for this initial indications.

Jerome D. Jabbour: We project that the market for about 22 or three in the treatment of invasive aspergillosis in patients with limited treatment options could reach reach peak sales in the U S alone of over $400 million annually with opportunities to increase that amount both through territory expansion outside the U S and also through <unk>.

Jerome D. Jabbour: Occasion expansion into the treatment of other invasive fungal infections, such as Mucormycosis, He's cryptococcal meningitis and the endemic Mitoses given that those are approved indications for amphotericin b today.

Jerome D. Jabbour: We view, Matt 22, or three as a pipeline in a product and they are alto trial and initial indications are an important and commercially valuable first step as.

Jerome D. Jabbour: As we have previously reported, we are actively engaged in partnership discussions and seeking to consummate a transaction which would allow us to advance MAT2203 into Phase 3 as quickly as possible, while also securing the right commercial partner for this important drug in multiple territories. Dr. Matkovits will provide a brief overview of the Oralto Phase 3 trial and an update on our Compassionate Use program in a few minutes. And I will have additional comments on our potential MET 2203 partnership at the end of the call.

Jerome D. Jabbour: As we have previously guided we are actively engaged in partnership discussions and seeking to consummate a transaction, which would allow us to advance them at 22 or three into phase III as quickly as possible.

Jerome D. Jabbour: I'll also securing the right commercial partner for this important drug in multiple territories.

Jerome D. Jabbour: Doctor Mac events will provide a brief overview of the Irrelative phase III trial, and an update on our compassionate use program in a few minutes and I will have additional comments on our potential Matt 22, or three partnership at the end of the call.

Jerome D. Jabbour: In addition to the progress with MAT2203, we are excited about the expansion of the LNC platform into oncology and inflammation, where in vivo animal studies have generated foundational data in support of identifying our next product candidate in areas where we believe there is a significant unmet medical need, while at the same time generating data which we believe will be of interest to partners looking for a safe, oral, and targeted delivery solution for their own complex molecule Following Dr. Matkovits' comments, Dr. Ferguson will provide more details on our LNT oncology work, as well as give an update on our progress with orally administered small oligonucleotides. Turning finally to a corporate update, last Thursday, we received notification from the NYSE American that Matinas has regained compliance with the exchange's continued listing standards by resolving the deficiency with respect to the low selling price of our common stock. We attribute our ability to regain compliance organically to our thoughtful and patient execution and meaningful clinical, regulatory, and preclinical progress with MAT-2203 and our LNC platform, respectively. Our NYSE listing is important to our company and to our investors, and we are grateful for our ongoing relationship with the New York Stock Exchange.

Jerome D. Jabbour: In addition to the progress with Matt 22, all three we are excited about the expansion of the LNC platform into oncology and inflammation, where in vivo animal studies have generated foundational data and supportive identifying our next product candidate in areas, where we believe there to be a significant unmet medical need while at the same time genera.

Jerome D. Jabbour: <unk> data, which we believe will be of interest to partners looking for a safe oral and targeted delivery solution for their own complex molecules.

Jerome D. Jabbour: Following Dr. <unk> comments, Dr. Ferguson will provide more details on our LNG oncology work as well as giving an update on our progress with orally administered small oligonucleotides.

Jerome D. Jabbour: Turning finally to our corporate update.

Jerome D. Jabbour: Thursday, we received notification from the NYSE American that Mathias has regained compliance with the exchange's continued listing standards by resolving the deficiency with respect to the low selling prices of our common stock.

Jerome D. Jabbour: We attribute our ability to regain compliance organically to our thoughtful and patient execution and meaningful clinical regulatory and preclinical progress with Matt 22, or three and our LNC platform respectively.

Jerome D. Jabbour: Our NYSE listing is important to our company and to our investors and we are grateful for our ongoing relationship with the New York Stock Exchange.

Theresa Matkovits: I'll have additional comments on our outlook later in the call following Keith Kucinski's review of our 2023 financial results. For now, I would like to turn the call over to Dr. Matkovits to provide the MAT 2203 update. Harry?

Dr. unknown: I'll have additional comments on our outlook later in the call. Following Keith Kucinski. His review of our 2023 financial results for now I would like to turn the call over to Dr. <unk> to provide them at 'twenty to 'twenty, two or three update Harry.

Theresa Matkovits: Thanks, Jerry, and good afternoon, everyone. As Jerry mentioned, we achieved a major milestone in reaching final agreement with the FDA on the design of a single Phase III registration trial of OralMath 2203 in patients with invasive aspergillosis who have limited treatment options. We have named this the ARELTO trial, which is an acronym for Oral Amphotericin in Patients with Limited Treatment Options. This Phase III Registrational Trial is designed as a randomized, multi-center, open-label, adjudicator-blinded, non-inferiority study that will evaluate the efficacy and safety of MAT-2203 as an oral step-down treatment following two days of treatment with ambisome or liposomal IV amphotericin B compared with the standard of care in patients with invasive aspergillosis who have limited treatment options.

Dr. unknown: Thanks, Jerry and good afternoon, everyone.

Dr. Harry: Jerry mentioned, we achieved a major milestone and reaching final agreement with the FDA and the design of a single phase III registration trial of oil in that 'twenty, two or three in patients with invasive aspergillosis, who have limited treatment options. We have named this be around her trial, which is an acronym for oral amphotericin.

Dr. Harry: Patients with limited treatment options.

Dr. Harry: This phase III Registrational trial is designed as a randomized multi center open label adjudicated blinded non inferiority study that will evaluate the efficacy and safety of Mad 'twenty, two or three as an oral step down treatment. Following two days of treatment with Amazon or like the summer IV Amphotericin B.

Dr. Harry: Third with the standard of care in patients with invasive aspergillosis, who have limited treatment options.

Dr. Harry: The primary efficacy endpoint is all cause mortality study day 42.

Dr. Harry: Key secondary objectives include the demonstration of superiority for treatment related toxicities, leading to changes in treatment.

Theresa Matkovits: The primary efficacy endpoint is all-cause mortality at study day 42. Key secondary objectives include the demonstration of superiority for treatment-related toxicities leading to changes in treatment, the long-term survival benefit of MAT-2203 using all-cause mortality at study day 84, and the impact of MAT-2203 on healthcare resource utilization and quality of life. We expect to include approximately 65 clinical sites in the U.S., Europe, South America, the Middle East, and Asia Pacific with enrollment of approximately 216 adults. Participating patients will have a recent diagnosis of proven or probable invasive aspergillosis and have been treated with ambisome due to an inability to receive an IV mold-active azole and thus have limited alternative longer-term treatment options. Following up to two days of treatment with Ambisome, eligible participants will then be randomized 2 to 1 to receive either Oral MAT 2203 or Continued Ambisome Treatment followed by Standard of Care. All study participants will receive up to 12 weeks of treatment starting from the first day of treatment with Ambizome and are expected to be hospitalized during the initial treatment period.

Dr. Harry: Long term survival benefit in that 'twenty two on suite using all cause mortality study day 84, and the impact of map 22, or three and how can resource utilization and quality of life.

Dr. Harry: We expect to include approximately 65 clinical sites in the U S. Europe, South America, the Middle East and Asia Pacific with enrollment of approximately 216 adults practice.

Dr. Harry: Participating patients will have a recent diagnosis, a proven or probable invasive aspergillosis and had been treated with ambisone due to an inability to be see even IV mold activase huh, and thus have limited alternatives longer term treatment options.

Dr. Harry: Blowing up to two days of treatment with Ambisone eligible participants will then be randomized two to one to receive either oral mat 22, or three what continued ampersand treatment followed by standard of care.

Dr. Harry: Study participants will receive up to 12 weeks of treatment starting from the first day with Amazon and I expect it to be hospitalized during the initial treatment period.

Dr. Harry: After stepped down to oral mat 22, or three study participants may be discharged to continue treatment on an outpatient basis as clinically appropriate.

Dr. Harry: An independent data review committee, which will be blinded to treatment will adjudicate primary and secondary endpoints, including clinical and radiological and Mycological response.

Theresa Matkovits: After step-down to OralMAT2203, study participants may be discharged to continue treatment on an outpatient basis as clinically appropriate. An independent data review committee, which will be blinded to treatment, will adjudicate primary and secondary endpoints, including clinical, radiological, and mycological response. Once approximately 75% of participants are enrolled, an independent data safety monitoring board will review the pooled all-cause mortality rate in a blinded fashion to ensure that sample size assumptions are reasonable and that the study is adequately powered without any statistical penalty. Should the pooled event rate differ substantially from expected levels, a sample size adjustment can be made to the trial.

Dr. Harry: Once approximately 75% of participants are enrolled and independent data safety monitoring Blake will review the pools, all cause mortality rate in a blinded fashion to ensure that sample size assumptions are reasonable and that the study is adequately powered without any statistical penalty.

Dr. Harry: Should the pooled event rate differ substantially from expected levels of sample size adjustment can be made to the trial.

Dr. Harry: We are actively preparing for this study and our goal now is to move to phase III program execution as quickly as possible.

Dr. Harry: Turning now to updates for our compassionate expanded use access program <unk> 22 or three.

Dr. Harry: Since we launched this program approximately 18 months ago, we've enrolled and treated patients with multiple different kinds of fungal infections and a wide variety of different tissues.

Theresa Matkovits: We are actively preparing for this study, and our goal now is to move to phase 3 program execution as quickly as possible. Turning now to updates for our Compassionate Expanded Use Access Program for MAT 2203. Since we launched this program approximately 18 months ago, we've enrolled and treated patients with multiple different kinds of fungal infections in a wide variety of different tissues. The success of this program highlights the ability of MAT-2203 to safely target and effectively eradicate a variety of severe and potentially deadly invasive fungal infections, even in the most challenging clinical circumstances.

Dr. Harry: The success of this program highlights the ability of map 22 O suite to safely target and effectively eradicate a variety of severe and potentially deadly invasive fungal infections, even in the most challenging clinical circumstances.

Dr. Harry: We have now enrolled 20 patients with few if any treatment options for their severe and even life threatening fungal infections with two additional new patients currently under evaluation for the program and awaiting approval from the F. D. A.

Dr. Harry: The program continues to generate compelling real world clinical evidence of Matt 22, or three success in a variety of other difficult to treat invasive deadly fungal infections.

Theresa Matkovits: We have now enrolled 20 patients with few, if any, treatment options for their severe and even life-threatening fungal infections, with two additional new patients currently under evaluation for the program and awaiting approval from the FDA. The program continues to generate compelling, real-world clinical evidence of MAT-2203's success in a variety of other difficult-to-treat invasive deadly fungal infections. The consistent efficacy and safety of MAT2203 across such a broad spectrum of fungal infections reinforces our belief in our product and increases our confidence that Arelto will meet its endpoints as well as strongly supports the commercial potential for what could become a new treatment paradigm for addressing the ever-increasing unmet medical needs for invasive fungal infections. As we reported last week, 7 of these 20 patients achieved a complete clinical response, and we added an 8th patient achieving complete clinical resolution just this week.

Dr. Harry: Consistent efficacy and safety of map 22, or three across such a broad spectrum of fungal infections reinforces our belief in our product and increases our confidence that <unk> will meet its endpoints as well as strongly supports the commercial potential for what could become a new treatment paradigm.

Dr. Harry: For addressing the ever increasing unmet medical needs within basic fungal infections.

As we reported last week seven of these 20 patients have achieved a complete clinical response, and we added an eighth patient achieving complete clinical resolution just this week.

Dr. Harry: Furthermore, all of the patients who transition to <unk> 22, or three after developing treatment limiting renal toxicity with IV Amphotericin B has had a return of the renal function to baseline levels after initiating treatment with Matt 22 three.

Dr. Harry: Use of all of them at 22 or three has also allowed a majority of patients to be discharged from the hospital and treated effectively at home with significantly improved quality of life and ultimately a favorable pharmacodynamic impact, which we believe to be a key component of the potential future commercial success for them at 22.

Theresa Matkovits: Furthermore, all of the patients who transitioned to MAD-2203 after developing treatment-limiting renal toxicity with IV amphotericin B have had a return of their renal function to baseline levels after initiating treatment with MAD-2203. The use of oral MAT-2203 has also allowed a majority of patients to be discharged from the hospital and treated effectively at home with significantly improved quality of life and ultimately a favorable pharmacoeconomic impact, which we believe is a key component of the potential future commercial success of MAT-2203. We recently highlighted three cases of patients with invasive Fusarium infection, which can be very difficult to treat as clinically relevant Fusarium species are resistant to almost all currently used antifungals, including azoles and echinocandins.

Dr. Harry: Three.

Dr. Harry: We recently highlighted three cases of patients with invasive fusari them infection, which can be very difficult to treat as clinically relevant <unk> species are resistant to almost all currently used antifungals, including ease off any kind of camden's.

Dr. Harry: Active treatment of Presario also generally requires even higher concentrations of amphotericin b than invasive aspergillosis.

Successful, Matt 'twenty trophy treatment outcomes in patients treated in our expanded compassionate youth access program, including those suffering from invasive aspergillosis adds to our confidence for positive outcomes in the upcoming around till registration trial.

We are grateful to all of the patients participating in our program and we will continue to evaluate patients for inclusion inclusion in this program on an ongoing basis.

Dr. Harry: Given that 22 of threes life changing impact to date.

Dr. Harry: Overall, we believe with the support of existing clinical data that if approved and oral effective and safe Mad 'twenty, two or three could represent a new treatment paradigm addressing the significant challenges and unmet medical needs in the treatment of invasive fungal infections.

James J. Ferguson: The successful MAT-2203 treatment outcomes in patients treated in our expanded Compassionate Use Access Program, including those suffering from invasive aspergillosis, adds to our confidence for positive outcomes in the upcoming Oralto registration trial. We are grateful to all of the patients participating in our program and will continue to evaluate patients for inclusion in this program on an ongoing basis given MAT-2203's life-changing impact to date. Overall, we believe with the support of existing clinical data that if approved, an oral, effective, and safe MAD2203 could represent a new treatment paradigm addressing the significant challenges and unmet medical needs in the treatment of invasive fungal infections. I'd like to now turn the call over to Dr. Ferguson, our Chief Medical Officer. Terry?

Dr. Harry: I'd like to now turn the call over to Dr. Ferguson, Our Chief Medical Officer Perry.

James J. Ferguson: Thanks, Terry and good afternoon, everyone.

James J. Ferguson: As Terry mentioned, we're very encouraged by the progress we have made with our oral LNC formulation of Docetaxel, a well known chemotherapeutic agent routinely used in the management of multiple metastatic and unresectable tumors, but unfortunately also an age that comes with a number of well.

James J. Ferguson: Recognize side effects and toxicities.

James J. Ferguson: Having already shown that oral lnc's can not only deliver docetaxel to tumor cells.

James J. Ferguson: But can do so in a way that reduces tumor volumes to an extent comparable to IV docetaxel with no indications of toxicity, we sought to further explore the potential safety advantages of L. A N C docetaxel.

Recognizing how well the crystal structure of Ellen sees encapsulates and protect cargo.

James J. Ferguson: And building on our successes with Matt 22, or three in reducing the renal toxicity of amphotericin we.

James J. Ferguson: Thanks, Terry, and good afternoon, everyone. As Jerry mentioned, we're very encouraged by the progress we have made with our oral LNC formulation of docetaxel, a well-known chemotherapeutic agent routinely used in the management of multiple metastatic and unresectable tumors, but unfortunately, also an agent that comes with a number of well-recognized side effects and toxicities. We have already shown that oral LNCs can not only deliver docetaxel to We sought to further explore the potential safety advantages of LNC docetaxel, recognizing how well the crystalline structure of LNCs encapsulates and protects cargo, and building on our successes with MAT2203 in reducing the renal toxicity of amphotericins.

James J. Ferguson: We theorized that we could maintain and perhaps even increase the anti tumor efficacy of docetaxel, while markedly reducing systemic exposure and thereby avoiding one of the primary drivers of Docetaxel toxicity.

James J. Ferguson: Earlier this week, we reported new in vivo safety data from a more comprehensive study with higher doses of oral LNC docetaxel and longer treatment duration.

James J. Ferguson: In this study 24 healthy mice received either weekly IV docetaxel.

James J. Ferguson: Daily oral LNC docetaxel or daily oral safely over a 22 day period with change in body weight as the primary endpoint, indicating toxicity.

James J. Ferguson: The total amount of Docetaxel administered in the oral LNC group with more than eight times higher than with IV docetaxel.

James J. Ferguson: Over the 22 day treatment period, the oral LNC Docetaxel group showed no weight loss as opposed to an average 20% peak weight loss in mice treated with IV Docetaxel in fact, the average weight of the mice treated with oral LNC docetaxel.

James J. Ferguson: We theorized that we could maintain and perhaps even increase the anti-tumor efficacy of dose attacks while markedly reducing systemic exposure, and thereby avoiding one of the primary drivers of docetaxel toxicity. Earlier this week, we reported new in vivo safety data from a more comprehensive study, with higher doses of oral LNC docetaxel and longer treatment duration. In this study, 24 healthy mice received either weekly IV doses of Taxol, daily oral LNC dosotaxel, or daily oral saline over a 22-day period, with change in body weight as the primary endpoint indicating toxicity.

James J. Ferguson: Was not significantly different from the weight of the control mice treated with ceiling.

James J. Ferguson: Compared to the previous efficacy study that demonstrated anti tumor activity comparable to IV docetaxel in this engineered mouse melanoma model.

James J. Ferguson: The daily administered oral LNC docetaxel dose in this study was 50% higher than the total amount of drug administered was three five times greater.

James J. Ferguson: These safety data lay a foundation for further work in two main areas first of all improving the therapeutic index of Docetaxel with data, suggesting opportunities to enhance both safety and efficacy.

James J. Ferguson: The total amount of dosetaxel administered in the oral LNC group was more than eight times higher than with IV dosetaxel. Over the 22-day treatment period, the oral LNC dosetaxel group showed no weight loss, as opposed to an average 20% peak weight loss in mice treated with IV dose attack. In fact, the average weight of the mice treated with oral LNC docetaxel was not significantly different from the weight of the control mice treated with saline.

James J. Ferguson: And secondly, expanding the application of the LNC platform to other toxic chemotherapeutic agents.

James J. Ferguson: To dive a little deeper improving the therapeutic index of Docetaxel provides not only an opportunity to treat docetaxel responsive tumors with less toxicity.

James J. Ferguson: Compared to a previous efficacy study that demonstrated anti-tumor activity comparable to IV docetaxel in a syngeneic mouse melanoma model. The daily administered oral LNC docetaxel dose in this study was 50% higher, and the total amount of drug administered was 3.5 times greater. These safety data lay the foundation for further work in two main areas. First of all, improving the therapeutic index of docetaxel with data suggesting opportunities to enhance both safety and efficacy, and secondly, expanding the application of the LNC platform to other toxic chemotherapeutic agents. To dive a little deeper, improving the therapeutic index of docetaxel provides not only an opportunity to treat docetaxel-responsive tumors with less toxicity. But it also broadens the scope of potential applications for dose attacks; if you can improve efficacy as well as safety and give it daily for longer periods of time, there could be multiple opportunities to expand the use of docetaxel to tumors that heretofore have not been viewed as docetaxel responses.

James J. Ferguson: But it also broadens the scope of potential applications for Docetaxel.

James J. Ferguson: If you can improve efficacy as well as safety and give it daily for longer periods of time, there could be multiple opportunities to expand the use of docetaxel.

James J. Ferguson: <unk> that hereto for have not been viewed as docetaxel responsive.

James J. Ferguson: Taking it even a step further from a tennis Docetaxel was originally intended primarily as proof of principle for L. N C oncology applications there.

James J. Ferguson: If there are any number of other very potent but also very toxic chemotherapeutic that could benefit from a more favorable therapeutic index.

Evaluating the opportunities to reduce the toxicity of Docetaxel is just the first step in what looked to be very exciting opportunities for L. N season oncology.

James J. Ferguson: In support of the oncology program. We've also looked at uptake in other tumor cells and recently demonstrated very rapid uptake of lncs by her two positive human breast cancer cells, which creates opportunities for differentiation from other delivery platforms and treat.

James J. Ferguson: Taking it even a step further, for Matinas, dosetaxel was originally intended primarily as proof of principle for LNC oncology applications. There are any number of other very potent but also very toxic chemotherapeutics that could benefit from a more favorable therapeutic index. Evaluating the opportunities to reduce the toxicity of docetaxel is just a first step in what look to be very exciting opportunities for LNCs and

James J. Ferguson: <unk> tumors with specific cell surface markers.

James J. Ferguson: And as Gerry mentioned earlier, we're currently measuring LNC uptake and cargo delivery across a number of different tumor cell lines looking more closely at the role of tumor cell surface phosphatide serene on uptake and delivery.

James J. Ferguson: In support of the oncology program, we've also looked at uptake in other tumor cells and recently demonstrated very rapid uptake of LNCs by HER2-positive human breast cancer cells, which creates opportunities for differentiation from other delivery platforms in treating tumors with specific cell surface marks. And as Jerry mentioned earlier, we're currently measuring LNC uptake and cargo delivery across a number of different tumor cell lines, looking more closely at the role of tumor cell surface phosphatidylserine on uptake and delivery. Turning now to progress in our small oligonucleotide program. Late last year, we reported results from a series of in vivo studies demonstrating successful oral delivery and biological activity of two LNC-formulated small single-strand oligonucleotides that specifically target the key inflammatory cytokines TNF-alpha and IL-17A in well-established and validated animal models that mimic the acute inflammatory responses seen in human disease. These studies showed reductions in tissue cytokine mRNA in both colitis and psoriasis models, along with significant reductions in serum TNF-alpha levels in colitis, and demonstrated how our LNC platform could be used for the oral delivery of functional small oligonucleotides with potential therapeutic applications.

James J. Ferguson: Turning now to progress in our small oligonucleotide program.

James J. Ferguson: Late last year, we reported results from a series of in vivo studies, demonstrating successful oral delivery.

James J. Ferguson: And biologic activity of two LNC formulated small single strand oligonucleotides that specifically targets the key inflammatory cytokines, TNF Alpha and IL 17, a and well established and validated animal models that mimic the acute inflammatory.

James J. Ferguson: Tori responses seen in human disease.

James J. Ferguson: These studies showed reductions in tissue cytokine mrna in both colitis and psoriasis models, along with significant reductions in serum TNF alpha levels and colitis.

James J. Ferguson: <unk> demonstrated how our LNC platform could be used for the oral delivery of functional small oligonucleotides with potential therapeutic application.

James J. Ferguson: Importantly, the unique nature of the particular oligonucleotides evaluated in these studies, which interfere with cytokines synthesis, rather than simply targeting the cytokine itself.

James J. Ferguson: It's additional opportunities for future applications of LNC delivered therapeutics, either alone or in combination with other agents with different mechanisms of action.

James J. Ferguson: Importantly, the unique nature of the particular oligonucleotides evaluated in these studies, which interfere with cytokine synthesis, rather than simply targeting the cytokine itself, creates additional opportunities for future applications of LNC-delivered therapeutics, either alone or in combination with other agents with different mechanisms of action. We're continuing to explore the delivery of cytokine-inhibiting small oligos for inflammation with additional work in other animal models and other cytokine targets, to advance our mechanistic understanding of LNCs and how they work, and setting the stage for even more potential applications of our technology platform, we've conducted additional in vitro and ex vivo studies looking at the dynamics of LNC uptake and cargo delivery in human blood and in cell culture. We've already reported how avidly empty LNCs are taken up by innate immune cells, neutrophils, monocytes, dendritic cells, and even B cells, and that dual-labeled small oligo-carrying LNCs show similar uptake patterns, with distinct characteristics to the timing and uptake and siRNA cargo delivery in cultured human embryonal kidney cells, new, more recent in vitro dynamic cell imaging has corroborated features of endocytotic LNC uptake with direct cell membrane fusion as an additional potential entry mechanism, as well as documenting delivery of siRNA cargo into the cytosol and providing visual confirmation that LNCs do effectively encapsulate and protect cargo up until the time of intracellular release.

James J. Ferguson: We're continuing to explore the delivery of cytokine inhibiting small oligos for inflammation with additional work in other animal models and other cytokine targets.

James J. Ferguson: To advance for mechanistic understanding of Ellen sees and how they work and.

James J. Ferguson: And setting the stage for even more potential applications of our technology platform. We've conducted additional in vitro and ex vivo studies looking at the dynamics of Ela and see uptake and cargo delivery in human blood and in cell culture.

James J. Ferguson: We've already reported how avidly empty lncs are taken up by innate immune cells neutrophils, monocytes dendritic cells and even b cells.

James J. Ferguson: And that dual labeled small all ago carrying L. N CS show similar uptake patterns with distinct characteristics to the timing and uptake and S IRR or any cargo delivery and cultured human and Brian will kidney cells.

James J. Ferguson: New more recent in vitro dynamic cell imaging is corroborated features of antipsychotic LNC uptake with direct cell membrane fusion as an additional potential entry minute mechanism as well as documenting delivery of S. I arent a cargo into the cytosol.

James J. Ferguson: And providing visual confirmation that lnc's do effectively encapsulate and protect cargo up until the time of intra cellular release.

James J. Ferguson: All of these accumulated data serve to reinforce our belief in the substantial potential of L. N. CS for the intracellular delivery of complex therapeutics in multiple therapeutic areas with our current primary focus on oncology and inflammation.

Keith A. Kucinski: All of these accumulated data serve to reinforce our belief in the substantial potential of LNCs for the intracellular delivery of complex therapeutics in multiple therapeutic areas, with our current primary focus on oncology and inflammation. We will continue to keep you informed as our knowledge advances. With that, I'd like to turn the call over to Keith Kucinski, our CFO, to review our financial performance. Thank you, Terry, for reviewing our financial performance. This afternoon, we reported revenue for 2023 of $1.1 million, which was generated from our research collaborations with BioNTech and Genentech. This compares with revenue for 2022 of $3.2 million, which was generated exclusively from our research collaboration with BioNTech. Total costs and expenses for 2023 were $24.9 million, which compares with $27.8 million for 2022. The decrease was primarily attributable to a decrease in clinical trial expenses and lower professional and consultant fees. We reported income from selling unused New Jersey net operating losses and research and development tax credits of $0.5 million in 2023, which compares with $3.5 million for 2021. Our net loss for 2023 was $22.9 million, or 11 cents per share.

James J. Ferguson: We will continue to keep you informed as our knowledge advances with that I'd like to turn the call over to Keith Kucinski, Our CFO to review our financial performance Keith.

Keith A. Kucinski: Thank you Terry.

Keith A. Kucinski: In reviewing our financial performance.

Keith A. Kucinski: This afternoon, we reported revenue for 2023 of $1 $1 million, which was generated from our research collaborations with bio in tech and Genentech.

Keith A. Kucinski: This compares with revenue for 2022 of $3 $2 million, which was January that generated exclusively from our research collaboration with violent attack.

Keith A. Kucinski: Total costs and expenses for 2023 or $24 $9 million, which compares with $27 $8 million for 2022.

Keith A. Kucinski: The decrease was primarily attributable to a decrease in clinical trial expenses and lower professional and consulting fees.

Keith A. Kucinski: We reported income from selling unused new Jersey, net operating losses, and research and development tax credits.

Keith A. Kucinski: Zero point $5 million in 2023, which compares with $3 $5 million for 2022.

Keith A. Kucinski: Our net loss for 2023 was $22 9 million or <unk> 11 per share.

Jerome D. Jabbour: This compares with a net loss for 2022 of $21.0 million, or $0.10 per share. The company's cash, cash equivalents, and marketable securities as of December 31, 2023 were $13.8 million. With that, I'll turn the call back to Jerry. Thanks, Keith. In summary, over these past few months, momentum continues to build at Matinas as we advance both MAT 2203 and the L&T platform. Clarity on the regulatory and clinical path for MAT-2203, along with support from robust clinical data and patient successes and our compassionate expanded use access program, has favorably positioned us for more meaningful discussions with development and commercial partners. Our primary objective is to secure the right strategic partner for MAT-2203 and advance into phase three as quickly as possible.

Keith A. Kucinski: This compares with a net loss for 2022 of $21.0 million or <unk> 10 per share.

Keith A. Kucinski: The company's cash cash equivalents and marketable securities as of December 31, 2023 were $13 $8 million.

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

Jerome D. Jabbour: Thanks Keith.

Jerome D. Jabbour: In summary over these past few months momentum continues to build at mid teens as we advance both Matt 22, or three and the LNC platform.

Jerome D. Jabbour: Clarity on the regulatory and clinical path for them at 20 203, along with support from the robust clinical data in pain patient successes and our compassionate expanded use access program.

Jerome D. Jabbour: As favorably positioned us for more meaningful discussions with development and commercial partners. Our primary objective is to secure the right strategic partner for them at 20, 203 and advanced into phase III as quickly as possible.

Jerome D. Jabbour: We envision a multi territory partnership and one that can maximize the value of this life changing asset discussions are ongoing and we are moving as quickly as possible towards finalizing a transaction.

Jerome D. Jabbour: We envision a multi-territory partnership, and one that can maximize the value of this life-changing asset. Discussions are ongoing, and we are moving as quickly as possible towards finalizing a transaction. Given this timing, we have prioritized securing our partner over other non-dilutive funding opportunities like BARDA, our progress in expanding the LNC platform into oncology and inflammation, gives us the opportunity to become an active participant in two of the most clinically important areas in medicine. The unique attributes of the LNC platform enable the development and advancement of differentiated and proprietary oral therapies with the ultimate goal of creating a portfolio of internal and external pipeline drug candidates, the potential for oral, less toxic chemotherapeutics could be a big step forward for patients, and our demonstrated ability to orally deliver small oligonucleotides with biological activity and therapeutic effects could be transformative in the inflammation, where there are many companies looking for oral, targeted, and extrahepatic delivery of nucleic acid.

Jerome D. Jabbour: Given this timing we have prioritized securing our partner over other non dilutive funding opportunities like BARDA.

Jerome D. Jabbour: Our progress in expanding the LNC platform into oncology and inflammation gives.

Jerome D. Jabbour: It gives us the opportunity to become an active participant in two of the most clinically important areas in medicine.

Jerome D. Jabbour: The unique attributes of the LNC platform enabled the development and advancement of differentiated and proprietary oral therapies with the ultimate goal of creating a portfolio of internal and external pipeline drug candidates.

Jerome D. Jabbour: The potential for oral less toxic chemotherapeutic could be a big step forward for patients and our demonstrated ability to orally deliver small oligonucleotides with biological activity and therapeutic effects could be transformative in the inflammation space, where there are many companies looking for oral targeted.

Jerome D. Jabbour: And extra hepatic delivery of nucleic acids.

Jerome D. Jabbour: Our objectives are clear and we are committed to our mission developing life changing and lifesaving therapies for patients with the help of our LNC platform technology.

Jerome D. Jabbour: We are grateful to our dedicated and hard working team as we advance multiple projects simultaneously and.

Jerome D. Jabbour: Our objectives are clear, and we are committed to our mission, developing life-changing and life-saving therapies for patients with the help of our LNC platform technology. We are grateful to our dedicated and hardworking team as we advance multiple projects simultaneously, and grateful to our supportive investors, who have clearly embraced the potential and clinical validation demonstrated by MAT 2203, although the past year has been challenging. We are emerging from that and prepared to take advantage of the data we have generated to take the next step in our evolution as a company. We've secured our place on the NYSE American without having to complete a reverse split and look forward to taking advantage of that de-risking to support some of the announcements and milestones we have planned for the second quarter of 2024 and beyond.

Jerome D. Jabbour: And grateful to our supportive investors, who have clearly embraced the potential and clinical validation demonstrated by Matt 20 203.

Jerome D. Jabbour: While the past year has been challenging we are emerging from that and prepared to take advantage of the data we have generated to take the next step in our evolution as a company.

Jerome D. Jabbour: We've secured our place on the NYSE American without having to complete a reverse split and look forward to taking advantage of that derisking to support some of the announcements and milestones we have planned for the second quarter of 2024 and beyond.

None: With that review I'll turn the call over to the operator for Q&A Joe.

Joe: Thank you.

None: Ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad and a confirmation tone will indicate your line is in the question queue.

None: You May press Star two if you would like to remove your question from the queue.

Jerome D. Jabbour: With that review, I'll turn the call over to the operator for Q and A. Joe? Thank you. Ladies and gentlemen, if you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in question. You may press star 2 if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.

None: For participants using speaker equipment.

It may be necessary to pick up your handset before pressing the star keys.

None: One moment, please when we pull for questions.

None: And our first question comes from the line of Julian Harrison with BTG. Please proceed.

Good afternoon. This is ray on for Joe.

Ray: Julien. Thank you for taking my question you mentioned here recently.

Ray: Yeah.

Julian Reed Harrison: Where do you see opportunities to inhibit cytokine.

Julian Reed Harrison: That could prove more advantages than inhibiting cytokines themselves.

Sure Ray Thanks for joining and have great question Doctor purchasing this gives us the opportunity to really talk about not just oral delivery with Ellen sees but a differentiated approach to knocking down cytokine why don't you expand a little bit on that without giving away too much in terms of how we're positioning this.

Operator: One moment, please, while we pull. Our first question comes from the line of Julian Harrison with BTIG. I appreciate it; that could prove to have more advantages. Sure. Ray, thanks for joining us and for a great question. Dr. Ferguson, this gives us an opportunity to really talk about not just oral delivery with LNCs but a differentiated approach to knocking down cytokines. Why don't you expand a little bit on that without giving away too much in terms of how we're positioning this in the inflammatory? Okay, thanks, Jerry.

Ray: And the inflammatory space.

Ray: Okay. Thanks, Jerry.

Ray: I think that the advantage to knocking down cytokine synthesis.

Ray: Is the specificity that you can achieve in terms of being able to knock down very specific cytokines.

James J. Ferguson: I think that the advantage of knocking down cytokine synthesis is the specificity that you can achieve in terms of being able to knock down very specific cytokines. And, as I mentioned during the discussion, the opportunity to synergize with other direct cytokine targeting things so that you can go after cytokines in multiple mechanistic kinds of ways. So, I think that this creates an opportunity to, as Jerry said, differentiate ourselves from what is possible out there. This is not an antibody directed at a specific cytokine. This interferes with the synthesis and lowers the levels of cytokines.

Doctor Mac: And as I mentioned during the discussion the opportunity to synergize with other direct cytokine targeting things. So that you can go after cytokines.

Doctor Mac: In it in multiple mechanistic kinds of ways. So I think that this creates an opportunity to as Jerry said differentiate ourselves for what is possible out. There. This is not an antibody directed at a specific cytokine this interferes with our synthesis and low.

Doctor Mac: Worse levels of cytokines, so I think that this creates.

James J. Ferguson: So, I think that this creates multiple opportunities in the inflammatory space. I mentioned that, you know, on the chemotherapy side, that docetaxel was just for proof of principle. Similarly, our work as we have moved into the inflammatory space with IL-17 has been along the proof of principle line, although IL-17 obviously plays a role in diseases like psoriasis.

Doctor Mac: Multiple opportunities in the inflammatory space I mentioned that.

Doctor Mac: On the chemotherapy side that Docetaxel was just for proof of principle, our work as we have.

Doctor Mac: Moving to the inflammatory space with IL 17 was along the proof of principle light, although IL 17, obviously plays a role in diseases like psoriasis.

James J. Ferguson: TNF-alpha has a lot more potential applicability. But, again, we're at the early stages, and there are other cytokines that we are potentially targeting that, with the ability to knock down synthesis, create opportunities to very specifically knock things out and probably avoid some of the other off-target occurrences. Does that help?

Doctor Mac: TNF Alpha has a lot more potential applicability, but again, we're at the early stages and there are other cytokines that we are potentially targeting that.

Doctor Mac: With the ability to knock down synthesis creates opportunities too.

Doctor Mac: Very specifically knock things out and probably avoid some of the other off target effects does that help.

Doctor Mac: Yeah.

None: Yes. It does thank you very much.

Robert Michael LeBoyer: And our next question comes from the line of Robert LeBoyer with Noble Capital Markets. Good afternoon and congratulations on all the progress. My question has to do with the Oralto study and the timeframes that you're looking at to start the study, as well as the mention of a collaboration and what your objectives in that might be, as far as anyone can tell. Great.

None: And our next question comes from the line of Robert Leboyer with Noble capital markets. Please proceed.

Robert Michael LeBoyer: Good afternoon, and congratulations on all the progress that you've made my question has to do with the Rialto study.

Robert Michael LeBoyer: And the Timeframes that youre looking at the store.

Robert Michael LeBoyer: Start the study as well as the mention of our collaboration and what your objectives in that might be.

Robert Michael LeBoyer: As far as anyone can tell at this point.

None: Great Robert it's good to hear your voice again, and thanks for dialing in today.

Jerome D. Jabbour: Robert, it's good to hear your voice again, and thanks for dialing in today. We're really happy to have now cleared the road with an agreement with FDA. And so, alignment with them on the design of the ARAUTO trial does a couple of different things. One, it does give us the opportunity to begin to plan for Phase III, and we are expecting to be in the Phase III trial by the end of this year. But what it really does is unlock the opportunity to come to a final agreement with a partner because you understand where the goalposts are. And so, I'll ask Terry Matkovits to talk a little bit about time to enrollment and duration, which we have looked at very closely here. It looks to be about a 24-month trial, but this is a phase 3 trial which is being set up not just for initial indication in the U.S. but something that can then be extrapolated into the EU and beyond.

None: We're really happy to have now cleared the road with our agreement with FDA and so alignment with them on the design of the route to a trial does a couple of different things one it does give us the opportunity to begin to plan for phase III.

None: And and we are expecting to be in the phase III trial by the end of this year, but what it really does is unlock the opportunity to come to a final agreement with a partner because you understand where the goalposts are and so I'll ask Terry Mcevoy hits to talk a little bit about time to enrollment and duration, which we have looked at.

Theresa Matkovits: Very closely here it looks to be about a 24 month trial, but this is a phase III trial, which is being set up not just for initial indication in the U S. But something that can then be extrapolated into the EU and beyond that's how important this phase III trial is if you think about the right strategic.

Jerome D. Jabbour: That's how important this phase 3 trial is. If you think about the right strategic partner for the ARALTO trial and the interest that we have received, it's from companies who specialize in anti-infectives and who have an idea of how to create essentially a SWAT team sales force or have already created those SWAT team sales forces and done it on a domestic and global basis. And you want somebody that understands market access, that understands how to price at a premium when you're dealing with a niche orphan indication when patients have no options. That becomes an important piece. So how to navigate clearly on a first-line indication basis the antifungal market is a challenging one, but as you create an opportunity to use amphotericin longer term and in patients who have no options, that's where the pharmacoeconomic impact becomes big.

Theresa Matkovits: Partner for the <unk> trial, and the interest that we have received from companies.

Theresa Matkovits: Who specialize in anti Infectives, who have an idea of how to create essentially a swat team salesforce or have already created those Swat team sales forces and done it on a domestic and global basis, and you want somebody that understands market access that understands how to price at a premium when you're dealing with a.

Theresa Matkovits: A niche orphan indication when patients have no.

Theresa Matkovits: Have no options that becomes an important piece of how to navigate them.

Theresa Matkovits: Clearly on the first line indication basis, the antifungal market is a challenging one but as you have created an opportunity to use amphotericin longer term and in patients who have no options, that's where the pharmacodynamic impact becomes big and it's not just about getting patients outside out of the hospital. It's also.

Jerome D. Jabbour: And it's not just about getting patients outside and out of the hospital; it's also about identifying opportunities to reduce costs across the board in terms of managing drug-to-drug interactions and things like this. And in our discussions with payers, including the big PBMs, including the Blues, in all the commercial assessments we've done, which aligns with some of the commercial assessments conducted by partners, there's an opportunity for payers to meaningfully So the right partner for us is not just about reach; it's about maximizing that opportunity and the relationships that exist with payers to put ourselves in position for this to be not just a commercial success in the U.S. but beyond.

Theresa Matkovits: About identifying opportunities to reduce costs across the board in terms of managing drug to drug interactions and things like this and in our discussions with payers, including the big Pbms, including the blues in.

Theresa Matkovits: And all the commercial assessments, we've done which aligns with some of the commercial assessments conducted by partners. There is an opportunity to meaningfully participate in that Pharmacopeia economic impact savings for the right partner for US is not just about reached its about maximizing that opportunity and the relationships that exist with payors to.

Theresa Matkovits: Put ourselves in position for this to be not just a commercial success in the U S but beyond.

Jerome D. Jabbour: And I'm not going to comment much more on the partnership process other than that, but Oralto sets you up for it, you have alignment on what the commercial opportunity is, and so we're moving as fast as we can to get this all wrapped up. But Terry, why don't you talk a little bit about Oralto, time to enrollment, and how we're thinking about it in terms of when we would expect top-line data, you know, if we were to start in the second half of this year, and then, you know, what an NDA filing date could look like. Sure, yes.

Theresa Matkovits: And I'm not going to comment much more on the partnership process other than that but our alto lines you up for it you have alignment on what the commercial opportunity is.

Theresa Matkovits: And so we're moving as fast as we can to get this all wrapped up but Terry why don't you talk a little bit about our roto time to enrollment and how we're thinking about it in terms of when we would expect top line data. If we were to start in the in the second half of this year.

Terry: And then what an NDA filing date could look like.

Theresa Matkovits: So the ERALTO trial, as I mentioned, is 216 patients. We plan to enroll them across 65 sites in 11 countries. And we're working with one of the world-renowned CROs who are experts in running these types of trials in invasive fungal infections. And we're already having a lot of interest from clinical sites of excellence to participate in our global trial. And we know the centers of excellence, based on the track record of the CRO we're working with, will be targeting transplant centers and centers of excellence running trials in oncology patients as well, since they're a key cohort of immunocompromised patients. Based on the detailed experience of our CRO, we're expecting enrollment to take approximately 22 to 24 months across these sites.

Terry: Sure Yeah. So the rocket trial as I mentioned is 216 patients we plan to roll that across 65 sites in 11 countries and we're working with one of the world have announced Sierra owners, who are experts in running these types of trials in invasive fungal infections and we're already having.

Terry: A lot of inbound interest in clinical sites of excellence to participate in that.

Terry: Global trial, and we know the centers of excellence based on the track record. The CIO, we're working with will be targeting transplant centers and centers of excellence running trials in oncology patients as well since there are.

Terry: T cohort of immuno compromised patients based on the detailed experience that I see arrow, we're expecting enrollment to take approximately 22 to 24 months across the sites. We expect to have top line data based on starting our first patients at the end of this year.

Theresa Matkovits: We expect to have top-line data based on starting our first patients at the end of this year, in the February 27 timeframe, which would allow us to support an NDA filing in the middle of 2027. And with our appropriate designations, fast track, and such, we think that an NDA approval could be seen in the early part of 2028, in the first quarter. We believe that also given that our drug delivery of Amphotericin B, the known gold standard for the treatment of invasive aspergillosis in patients with limited treatment options, would be a great benefit from an enrollment perspective because the risk of not being a new chemical entity from a patient perspective will also be an important enhancement for the recruitment of patients in this trial.

Terry: 27 timeframe, which would allow us to support an NDA filing in the middle of 2027.

Terry: With our our appropriate designation fast track and such we think that an NDA approval could be seen in the early part of 2028 and the first quarter.

Terry: We believe that also given that our drug delivery of amphotericin B, the known gold standard for the treatment of invasive aspergillosis in patients with limited treatment options would be a great benefit from an enrollment perspective, because that risk of not being a new kind of.

Terry: Entity from a patient perspective, we believe it will also be an important enhancement for the recruitment of patients in this trial.

Theresa Matkovits: Okay, great. Thank you very much. And if I could just ask one second question.

None: Okay, great. Thank you very much and if I could just ask a second question you had mentioned some of the primary and secondary endpoints in the trial.

Robert Michael LeBoyer: You mentioned some of the primary and secondary endpoints in the trial. Are there any other things in terms of reduction in comorbidity or hospital stays or any of the other things outside of the requirements for approval that are being included, or is that too early to expect that? You know plenty of points to support the NDA. Anything else that might come out of the trial to justify cost or price? Anything like that would be fine.

None: N E.

None: Other things firms or reduction in comorbidity or hospital stays are any of the other things outside of the requirements for approval.

None: Or is that.

None: Is it too early to expect that you know once you kind of points to support the NDA.

None: Anything else that might come out of the trials to justify cost or pricing or anything like that.

Theresa Matkovits: Absolutely, a great question. So one of the key secondary endpoints will be pharmacoeconomic endpoints that will be evaluating the health economic impact of being able to discharge a patient on oral treatment. So exactly to your point, we'll be looking at the number of days of hospitalization, requirements for rehospitalization, for example, for the standard of care arm. We'll also be looking at infusion days, as well as the cost associated with managing a patient on an IV-administered product relative to an orally-delivered amphotericin B.

None: So really great question. So one of the key secondary end points will be farmer economic endpoints that we'll be evaluating the health economic impact of being able to discharge a patient on oral treatment. So exactly to your point, we'll be looking at the number of days of hospitalization requirements for hospitalization for example.

None: Standard of care and we'll be also looking at infusion days as well as the cost associated with managing a patient on an IV administered product relative to an orally delivered amphotericin b. So all of those measures will be evaluated and collected and will support the value proposition from a commercial perspective.

Theresa Matkovits: So all of those measures will be evaluated and collected and will support the value proposition from a commercial perspective. Additionally, we will be evaluating the quality of life for patients. So as patients are being able to be treated in the home setting, we have seen already in our compassionate use patients that they're able to return to work, and they're able to return to daily living activities. So we expect that both on the pharmacoeconomic as well as the quality of life part of our data will further support the value proposition from a commercial perspective for the product. Okay, great. That sounds like a very well thought out design.

None: Additionally, we will be evaluating quality of life of patients. So as patients are being able to be treated in the home setting we have seen already in a compassionate use patients that they're able to return to where they are able to return to daily living activities. So we expect that both on the time o'clock economic as well as the quality of life.

None: Part of our data that we will further support.

None: Support the value proposition from a commercial perspective for the product.

None: Okay, great that sounds like a very well thought out design.

Robert Michael LeBoyer: Looking forward to hearing the results. Thanks, Robert. Ladies and gentlemen, there are no...

None: Looking forward to hearing those.

None: Thanks Robert.

None: Yes.

None: Ladies and gentlemen, there are no further questions at this time I'd like to hand, the call back to Jerry Jabbour for closing remarks.

Jerome D. Jabbour: I'd like to hand the call back to Jerry Jabbour for his closing remarks. Thank you, Joe. Thanks to everyone for joining us today and for your continued interest in Matinas. As I hope we conveyed during the call, we remain very excited and very optimistic about the company's future. We look forward to reporting further progress during our first quarter conference call in May, and the second quarter is going to be a very big quarter for this company. Thank you again, and have a great evening. This concludes today's conference. You may now disconnect your lines at this time. Enjoy the rest of the day.

Jerome D. Jabbour: Thank you Joe Thanks to everyone for joining us today and for your continued interest in <unk> as I hope we conveyed during the call. We remain very excited and very optimistic about the company's future. We look forward to reporting further progress during our first quarter conference call in May.

Jerome D. Jabbour: In the second quarter is going to be a very big quarter for this company. Thank you again and have a great evening.

None: This concludes today's conference you may now disconnect your lines at this time and enjoy the rest of your day.

None: Okay.

None: [music].