Q3 2023 Matinas BioPharma Holdings Inc Earnings Call

To all sites on hold we appreciate your patience and please continue to standby.

Speaker 1: To all sites on hold, we appreciate your patience and please continue to stand by.

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Speaker 2: I.

Uh-huh.

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Hum.

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Speaker 5: Please stand by. The program is about to begin.

Speaker 6: Welcome to the Martinez Biopharma Third Quarter 2023 Financial Results Conference call. Currently, all participants are in a listen-only mode.

Welcome to the Mattina Biopharma third quarter 2023 financial results Conference call.

Currently all participants are in a listen only mode.

Following management's prepared remarks, we will hold a Q&A session.

Speaker 7: Following management's prepared remarks, we will hold a Q&A session.

I'll ask a question at that time. Please press the star key followed by the number one on your Touchtone phone.

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As a reminder, this conference is being recorded.

Speaker 10: As a reminder, this conference is being recorded. I would now like to turn the conference over to Jody Kane. Please go ahead.

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

Speaker 11: This is Cody Kane with LHA Investor Relations. Thank you for participating in today's call. Joining me from Martinez-Bial Pharma are Jerry Jibor, Chief Executive Officer, Dr. Terry Mattikovic, Chief Development Officer, Dr. Terry Ferguson, Chief Medical Officer, and Keith Kaczynski, Chief Financial Officer.

This is Jody Cain with L. A to Investor relations. Thank you for participating in today's call. Joining me from my penis Biopharma are Jerry Jabbour, Chief Executive Officer, Dr. Terri <unk> Chief Development Officer Dr.

Terry Ferguson, Chief Medical Officer, and Keith Kucinski, Chief Financial Officer, Tom Cooper, The company's Chief business Officer will be available to answer questions. During the Q&A session.

Speaker 12: Tom Hoover, the company's chief business officer, will be available to answer questions during the Q&A session. If you have any questions, please feel free to contact me.

Speaker 13: I'd like to remind listeners that remarks made during this call may state management's future intentions, hopes, beliefs, expectations and projections.

Like to remind listeners that remarks made during this call may state managements future intentions hopes beliefs expectations and projections. These are forward looking statements and involve risks and uncertainties.

Speaker 14: These are forward-looking statements that involve risks and uncertainties. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements are based on Martinez-Pial Farmers' current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements.

Looking statements are made pursuant to the safe Harbor provisions.

Federal Securities laws.

Forward looking statements are based on mckinnis, Biopharmacy current expectations and actual results could differ materially as a result, you should not place undue reliance on any forward looking statements.

Speaker 15: 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 report.

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.

My penis 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 16: Martinez BioPharma files with the Securities and Exchange Commission. These documents are available in the investors section of the company's website and on SEC.gov.

Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast November eight 2023, the two newest biopharma undertakes no obligation to revise or update any statements to reflect defensive circumstances.

Speaker 17: Furthermore, the content of this conference call contains information that is accurate only as of the date of the live broadcast, November 8, 2023. 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 Gebor. Jerry?

As required by law and now I'd like to turn the call over to Jerry Jabbour Jerry.

Thank you Jody good afternoon, everyone and thank you for joining us.

Speaker 18: Thank you, Jody. Good afternoon, everyone, and thank you for joining us.

Speaker 19: There's been a tremendous amount of activity and industry attention on our company during the past few months.

Been a tremendous amount of activity and industry attention on our company during the past few months.

Speaker 20: Much of this attention has been rightly focused on our lead asset, Matt 2203.

This attention has been rightfully focused on our lead asset <unk> 22 or three.

Speaker 21: We are very excited about the consistent, positive clinical results for MAT 2203 and our compassionate expanded use access program and the demonstration that MAT 2203 can be a life-saving drug in patients with limited or no treatment options.

We are very excited about the consistent positive clinical results for about 20, 203, and our compassionate expanded access program and the demonstration that Matt 22, or three it can be a life saving drug in patients with limited or no treatment options.

Speaker 22: Our L&C platform has afforded the opportunity to take Ampitaricin B, the most powerful and broad spectrum antifungal drug that has historically been saddled with severe toxicity issues and inconvenient administration, and create a safe and convenient product that has the potential to change the treatment paradigm for invasive fungal infections.

Our LNG platform has afforded the opportunity to take amphotericin b, the most powerful and broad spectrum antifungal drug that has historically been saddled with severe toxicity issues and inconvenient administration and create a safe and convenient product. It has the potential to change the treatment paradigm for invasive fungal infections.

Speaker 23: whether it has been saving the life of a young girl with AML, suffering from both mu-core and aspergeralosis, or achieving complete clinical resolution of a Candida Crusade infection in a 61-year-old male for the history of diabetes, kidney disease, lung disease, and heart disease, after just two weeks of treatment, Matt 22 or three has become an invaluable lifeline for patients.

Whether it is been saving the life of a young girl with AML suffering from both new core in aspergillosis or achieving complete clinical resolution of a candidate Crusade infection, and a 61 year old male with a history of diabetes kidney disease lung disease and heart disease. After just two weeks of treatment, Matt 22, or three has become an invaluable.

Lifeline for patients.

Speaker 24: The patients in our Compassionate Expanded Use Access program are very similar to those we're intending to treat in Phase 3.

Patients in our compassionate and expanded use access program are very similar to those were intended to treat and phase III.

Speaker 25: Each patient successfully treated with MAT 2203 increases our confidence for our proposed Phase III clinical trial.

Each patient successfully treated with Matt 22, or three increases our confidence for our proposed phase III clinical trial.

Speaker 26: Earlier today, we announced that our recent FDA meeting was very successful in three key areas. First, FDA supported our intended target patient population with a step-down study design.

Earlier today, we announced that our recent FDA meeting was very successful in three key areas first FDA supported our intended target patient population with a step down study design.

Speaker 27: Second, FDA formally acknowledged that MAT 2203 is a potential candidate for registration under the LPAD pathway. And third, FDA expressed a willingness to accept a superiority composite primary implant for the

Second F D. A formally acknowledged that map 22 or three as a potential candidate for registration under the <unk> pathway.

And third FDA expressed a willingness to accept a superiority composite primary endpoint.

Speaker 28: Dr. Makovits will go into more detail on all these areas in a moment.

Dr. <unk> will go into more detail on all of these areas in a moment.

But it's important to emphasize that the potential to move away from a non inferiority endpoint to a composite superiority endpoint is a significant win and something that could position about 22 or three for a much stronger label.

Speaker 29: But it's important to emphasize that the potential to move away from a non-inferiority endpoint to a composite superiority endpoint is a significant win and something that could position Matt 20203 for a much stronger label. And the stronger label brings with it a much more significant commercial market up.

And a stronger label brings with it a much more significant commercial market opportunity.

Speaker 30: We're grateful for our ongoing constructive dialogue with the FDA and look forward to finalizing the composite superiority endpoint as soon as possible.

We're grateful for our ongoing constructive dialogue with the FDA and look forward to finalizing the composite superiority endpoint as soon as possible.

Speaker 31: Earlier this week, we reported new in vivo data demonstrating the therapeutic efficacy of an oral L&T formulation of dose attacks.

Earlier this week, we reported new in vivo data demonstrating the therapeutic efficacy of an oral LNC formulation of Docetaxel.

Speaker 32: building on successful in vitro demonstrations that our LNCs get taken up by tumor cells, these in vivo results were a big step forward for our delivery platform.

Building on successful in vitro demonstrations that are <unk> get taken up by tumor cells.

In vivo results were a big step forward for our delivery platform.

taking us beyond our clinical success in infectious diseases, and providing proof of principle that orally administered LNCs can effectively target large tumors and successfully deliver small molecule therapeutics.

Taking us beyond our clinical success in infectious diseases, and providing proof of principle that orally administered L. N cheese can effectively target large tumors and successfully deliver small molecule therapeutics.

We have also advanced our internal oral L&C small oligonucleotide program, and are excited to have documented biological activity in the form of cytokine knockdown, and some early evidence of tangible clinical benefits in an amyclumod-induced neurine psoriasis disease month.

We have also advanced our internal World L. N C. Small oligonucleotide program and are excited to have documented biological activity in the form of cytokine knockdown and some early evidence of tangible clinical benefit and then the nickel might induce nearing psoriasis disease model.

We have additional ongoing in vivo studies of LNC-formulated small oligonucleotides in inflammatory disease models, and we expect data later in the fourth quarter.

We have additional ongoing in vivo studies of LNG formulated small oligonucleotides in inflammatory disease models and we expect data later in the fourth quarter.

Dr. Ferguson will provide more details on our LNC platform work a bit later in the call.

Dr. Ferguson will provide more details on our LNC platform work a bit later in the call.

Overall the team is very pleased with our recent progress we are energized by the continued clinical validation with map 22, all three and FDA dialogues.

Overall, the team is very pleased with our recent progress. We are energized by the continued clinical validation with MAT 2203 and FDA dialogue, and excited by the potential expansion of the LNC platform into areas such as inflammation, and perhaps most interestingly cancer.

And excited by the potential expansion of the LNG platform into areas, such as inflammation and perhaps most interestingly cancer.

I'll have additional comments on the financial picture and outlook later in the call following our CFO's review of our Q3 financial results. For now, I would like to turn the call over to Dr. McAdance to expand on our MAT-223 update. Terry.

I'll have additional comments on the financial picture and outlook later in the call. Following our CFO to review of our Q3 financial results for now I would like to turn the call over to Dr. <unk> to expand on our map 22 or three update Terry.

Thanks, Jerry and good afternoon, everyone as Jerry mentioned, we held a highly productive and collaborative meeting with the division of anti Infectives of FDA last month that included attendance by the director of the office of infectious diseases, John Farley and his deputy director.

Thanks, Jerry, and good afternoon, everyone. As Jerry mentioned, we held a highly productive and collaborative meeting with the Division of Anti-Infectives of FDA last month that included attendance by the Director of the Office of Infectious Diseases, John Farley, and his Deputy Director. Their participation is highly unusual at the division level, and we believe that it is a direct reflection of the FDA's interest in Advancing Mad-203 towards registration.

Their participation is highly unusual at the division level and we believe that it is a direct reflection of the fda's interest in advance and may of 'twenty, two or three towards registration.

As in previous meetings with the agency, the FDA agreed that MAT-20203 was most likely to be used in ASAL resistant or ASAL intolerant patients or in patients with limited treatment options.

As in previous meetings with the agency.

Do you agree that Matt 22, or three with my most likely to be used as a resistant or as all intolerant patients or in patients with limited treatment options.

Clinical success in this target patient population continues to be supported by the clinically meaningful outcomes seen in patients receiving MAT 2203.

Clinical success in this target patient population continues to be supported by the clinically meaningful outcomes seen in patients receiving that 'twenty, two or three and our compassionate use expanded access program in which patients with no. Other treatment options are receiving that 'twenty, two or three for treatment of multiple fungal infection in multiple different.

in our Compassionate Use Expanded Access program, in which patients with no other treatment options are receiving MAT 2203 for treatment of multiple fungal infections in multiple different tissues.

Tissues, highlighting the ability of map 22, or three to safely target and effectively eradicate a variety of severe and potentially deadly invasive fungal infection in the most challenging clinical circumstances.

highlighting the ability of MAT-20203 to safely target and effectively eradicate a variety of severe and potentially deadly invasive fungal infection in the most challenging clinical circumstances.

During our meeting with the FDA There was general agreement on the main elements of the Phase III study design for the treatment of invasive aspergillosis in patients with limited treatment options.

During our meeting with the FDA, there was general agreement on the main elements of the Phase III study design for the treatment of invasive aspergillosis in patients with limited treatment options.

The FDA confirms that MAT-2203 may be a candidate for the limited population pathway for antifungal and antibacterial drugs or L-PAD.

FDA confirmed that Matt 22, or three may be a candidate for the limited population pathway for antifungal and antibacterial drugs or El pen.

Labeling for drugs under the L-pad pathway conveys that the approval is based on a benefit risk assessment that more flexibly considers the severity, rarity, or prevalence of the particular infection that drugs intended to treat, and the lack of alternatives available for the patient population.

Labeling for drugs under the iPad pathway can phase that the approval is based on the benefit risk assessment that more flexibly consider is the severity rarity of prevalence of the particular infection. The drug is intended to treat and the lack of alternatives available for the patient population.

Under the LPAD registration and approval pathway, MAT 2203 would continue to qualify for QIDP incentives under the FDA priority review and fast-track designation, as well as orphan drug exclusivities that could allow for 12 years of exclusivity protection in the U.S. and possibly 10 years in the EU. MAT 2203 could also potentially still be eligible for consideration for breakthrough designation.

Under the El pen registration and approval pathway, Matt 2012, we would continue to qualify for Q I D. P incentives under the FDA priority review and fast track designation as well as the orphan drug exclusivity that could allow for 12 years of exclusivity protection in the U S and possibly 10 years in the EU.

<unk> 22, or three could also potentially still be eligible for consideration for breakthrough designation.

A significant discussion point during the meeting with F. D. A centered around the statistical assumptions regarding the primary endpoint for the phase III study in a non inferiority trial design.

A significant discussion point during the meeting with FDA centered around the statistical assumptions regarding the primary endpoint for the Phase III study in a non-inferiority trial design.

Particularly important was having the FDA spontaneously express openness to an alternative superiority composite endpoint.

Particularly important was having the F D. A spontaneously expressed openness to an alternative superiority composite endpoint.

One proposal we are considering for a composite endpoint includes therapeutic success, consisting of mortality, partial or complete global response, and the ability to complete study treatment with no discontinuations or changes in dosing due to adverse events at day 42 that are treatment-related.

One proposal, we are considering for composite endpoint includes therapeutic success, consisting of mortality partial or complete global response, and the ability to complete study treatment with no discontinuation or changes in dosing due to adverse events at day 42 that are treatment related.

We believe that with this new composite superiority endpoint, MAT-202 or three could be optimally positioned for favorable regulatory and commercial outcomes, given the clinical data that has been generated to date in our compassionate use program, as well as the clinical experience from our completed in-act trial. The study protocol with the new composite endpoint is being finalized and will be submitted to FDA for alignment in the final in the next few weeks.

We believe that with this new composite superiority endpoint, Matt 22, or three could be optimally positioned for favorable regulatory and commercial outcome given the clinical data that has been generated to date and our compassionate use program as well as the clinical experience from our completed <unk> trial.

The study protocol with the new composite endpoint is being finalized and will be submitted to FDA for alignment and the final in the next few weeks.

The company believes that a superiority composite endpoint would not change the projected study size, which we believe will be less than 200 patients, or enrollment timeline, which we believe could be 22 to 24 months.

The company believes that a superiority composite endpoint would not change the projected study size, which we believe will be less than 200 patients or enrollment timeline, which we believe could be 22 to 24 months.

Given the substantially better safety profile of our oral med 22, or three compared with IV administered amphotericin b seen to date, including the rate of toxicity seen with IV administered amphotericin b in the published literature.

Given the substantially better safety profile of our Oral Mad 202.03 compared with IV administered amphoteric and B seen to date, including the rate of toxicity seen with IV administered amphoteric and B in the published literature.

The FDA has communicated its commitment to work with mid teens on an up cycle basis to finalize the phase III protocol as soon as possible.

The FDA has communicated its commitment to work with Martinez on an off-cycle basis to finalize the base 3 protocol as soon as possible.

Overall, the positive outcome of our meeting with the agency was driven by FDA's desire to put forth the best possible study-designed position for regulatory and commercial success with the goal of ultimately making MAT-223 widely available to patients.

Overall, the positive outcome of our meeting with the agency was driven by Fda's desire to put forth. The best possible study design position for regulatory and commercial success with the goal of ultimately, making that 'twenty, two or three widely available to patients.

We are confident that FDA stands on this design, puts us or a partner in a position of strength to launch our product with a much stronger label which can also be built upon during the subsequent life cycle of this product. An optimal initial label at launch, not unexpectedly, has increased partner interest in this asset.

We are confident that F. D. A stance on this design puts us or a partner and a position of strength to launch our product with a much stronger label, which can also be built upon during the subsequent lifecycle of this product.

Optimal initial label at launch not unexpectedly has increased partner interest in this asset.

Given that we plan on addressing the highest need patients, most of whom have limited or no treatment options, we believe that our case for BARDA to assist with the funding of further clinical development of MAT-20203 is quite strong. We are preparing a white paper and anticipates submitting this to BARDA, following alignment with the FDA and our Phase III program.

Given that we plan on addressing the highest need patients most of whom have limited or no treatment options. We believe that our case for BARDA to assist with the funding of further clinical development of map 22, or three is quite strong we are preparing a white paper and anticipate submitting this to BARDA following alignment with the FDA in our phase III.

Ram.

The challenge with BARDA and any non dilutive government funding can be the processing associated timelines for making a decision in funding and award.

The challenge with BARDA and any non-delutive government funding can be the process and associated timelines for making a decision in funding an award. However, we remain hopeful that the compelling unmet need in this patient population might accelerate this process.

However, we remain hopeful that the compelling unmet need in this patient population might accelerate this process.

Circling back to our compassionate use X an expanded access program since instituting this program over a year ago. We have received inbound requests from physicians at the NIH University of Michigan at nationwide Children's Hospital, and Johns Hopkins amongst others there.

Circle and back to our compassionate use X and expanded access program. Since instituting this program over a year ago, we have received inbound requests from physicians at the NIH University of Michigan, nationwide children's hospital, and Johns Hopkins, amongst others. They've contacted us on behalf of patients who have experienced significant renal toxicity while receiving IV amphitheateris and B, and or have not responded to or are unable to tolerate ASALs or other classes of antipongals.

They've contacted us on behalf of patients have experienced significant renal toxicity, while receiving IV amphotericin b Android have not responded to or unable to tolerate asos or other classes of antifungals.

A total of 12 patients had been enrolled in this program to date in October we announced that a 61 year old male with a challenge and medical history achieved complete clinical resolution of a candidate Cruceta infection. Following only two weeks of treatment with Matt 22 O suite.

A total of 12 patients have been enrolled in this program to date. In October , we announced that a 61-year-old male with the challenging medical history achieved complete clinical resolution of a Candid Acrocia infection following only two weeks of treatment with MAT-202-03.

Treatment with IV amphotericin B deoxycholate was discontinued due to renal toxicity, and the patient was transitioned to MAT 2203, which was well tolerated with no adverse effects.

Treatment with IV Amphotericin B Deoxycholate was discontinued due to renal toxicity and the patient was transitioned to <unk> 22, or three which was well tolerated with no adverse effects.

Treatment with <unk> 20, 203 also led to improvement of his kidney function to baseline.

Creteman with MAD-202-03 also led to improvement of his kidney function to baseline.

Earlier this month another patient was enrolled in this program at Vanderbilt University Medical Center. This patient is suffering from a CNS-based fusarium infection and required transition from IV amphitheateris due to significant electrolyte abnormalities.

Earlier this month another patient was enrolled in this program at Vanderbilt University Medical Center.

This patient is suffering from CNS space fusari them infection and require transition from IV amphotericin due to significant electrolyte abnormalities.

Once electrolytes are stabilized, this patient should be able to be discharged from the hospital to receive treatment at home.

Once electrolyze to stabilize this patient should be able to be discharged from the hospital to receive treatment at home.

We continue to evaluate requests for access where the compassionate use of MAT-202-03 may help patients without other treatment options.

We continue to evaluate requests for access where the compassionate use of <unk> 22 O suite may help patients without other treatment options.

Overall, we have a drug we believe has the potential to enact a paradigm shift in the treatment of invasive fungal infections. We are focused on submitting and gaining final agreement with FDA and our Phase III study, and the potential for an advantageous composite primary endpoint is a significant development for this drug. Once aligned, we look forward to progressing into our Phase III trial as quickly as possibly thereafter.

Overall, we have a drug we believe has the potential to enact a paradigm shift in the treatment of invasive fungal infections.

We are focused on submitting and gaining final agreement with F. D. A N. Our phase III study and the potential for an advantageous composite primary endpoint is a significant development for this drug once aligned we look forward to progressing into our phase III trial as quickly as possibly thereafter.

I'd like to now turn the call over to Dr. Ferguson, our Chief Medical Officer, Terry.

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

Thanks, Terry, and good afternoon, everyone. Today, I'll provide an update on initial results from our work in two important therapeutic areas, oncology and inflammation.

Thanks, Terry and good afternoon, everyone.

Today I'll provide an update on initial results from our work in two important therapeutic areas oncology and inflammation.

Specifically, I'll review our InVivo results with an LNC small molecule formulation in oncology.

Specifically I'll review, our in vivo results with an L. N C small molecule formulation in oncology.

and share recent additional in-vivo data highlighting our LNC platform capabilities for the oral delivery of small oligonucleotides.

And share recent additional in vivo data highlighting our LNC platform of capabilities for the oral delivery of small oligonucleotides.

First, we've progressed from earlier in vitro studies that confirmed the efficacy of an LNC formulation of dose ataxyl in inhibiting tumor cell growth in cell culture to our recently announced positive in vivo results with oral LNC dose ataxyl in a syngineic?

First we've progressed from earlier in vitro studies that confirmed the efficacy of an L. A N C formulation of Docetaxel and inhibiting tumor cell growth and cell culture to our recently announced positive in vivo results with oral LNC Docetaxel and ascension.

Murine melanoma model.

DOSA taxil is a well-known chemotherapy agent widely used in the management of malignant disease.

Docetaxel is a well known chemotherapeutic agent widely used in the management of malignant diseases.

These in vivo results showed successful oral delivery.

These Envibo results showed successful oral delivery, dose of taxil to tumors, and a therapeutic response that was comparable to that of conventional IV dose of taxil.

<unk> taxable to tumors.

And a therapeutic response that was comparable to that of conventional IV docetaxel.

In this study mice, who developed melanoma tumors in response to injected mirroring tumor cells oral LNC docetaxel given daily showed significant reductions in tumor volume compared with untreated controls with mean reductions at least two weeks.

In this study, mice who developed melanoma tumors in response to injected merine tumor cells, oral LNC dose of taxil, given daily, showed significant reductions in tumor volume compared with untreated controls, with mean reductions at least two weeks, at two weeks, of 63% with high dose oral LNCs, and 57% with lower dose oral LNC.

At two weeks of 63% with high dose oral L N CS and 57% with lower dose oral LNC.

This compares favorably with 68% reductions with IV dose attacks.

This compares favorably with 68% reductions with IV docetaxel.

Similar significant reductions in tumor rate tumor weight, where noted with the oral L N cheese.

Similar significant reductions in tumor rate, tumor weight were noted with the oral LNC.

Importantly, no systemic toxicities were noted with nine days of daily oral treatment with LNC Docetaxel.

Importantly, no systemic toxicities were noted with nine days of daily oral treatment with LNC dose attacks.

Body weight was stable over the treatment duration, and hematologic parameters were similar to untreated control.

Body weight was stable over the treatment duration and hematologic parameters were similar to untreated controls.

These encouraging results confirm our belief that phosphatutyl serine expression on the outer surface of tumor cells presents a targeting opportunity for potential future oncology applications with our LNC platform.

These encouraging results confirm our belief that phosphate title serene expression on the outer surface of tumor cells presents a targeting opportunity for potential future oncology applications with our LNC platform.

Next, I'd like to highlight recent data from our oral small oligonucleotide proof.

Next I'd like to highlight recent data from our oral small oligonucleotide program.

Building on previously shared work and human whole blood that showed avid uptake of lncs by macrophages dendritic cells neutrophils and some T cell subtypes, we have been investigating a variety of LNC formulations of two small oligonucleotide.

building on previously shared work in human whole blood that showed avid uptake of LNCs by macrophages, dendritic cells, neutrophils, and some T cell subtypes. We have been investigating a variety of LNC formulations of two small oligonucleotides designed to knock down the production of the inflammatory cytokines IL-17A and TNF-alpha.

It's designed to knock down the production of the inflammatory cytokines, IL 17, a and TNF alpha.

Similar to our work with Docetaxel initial in vitro studies verified that LNP formulations of these two oligonucleotides, we're able to consistently knocked down IL 17, and TNF Alpha in cell culture.

Similar to our work with DOSA taxil, initial in vitro studies verified that LNC formulations of these two oligonucleotides were able to consistently knock down IL-17A and TNF-Alpha in cell culture.

More recently, we have evaluated the in vivo biologic activity of orally administered LNC formulations of these oligonucleotides and a series of studies in a murine model using both high potency and lower potency lipopolysaccharide or L. P. S.

<unk> stimulation.

The LPS model is an acute inflammatory model in which healthy animals are injected with LPS resulting in a severe acute inflammatory response.

The O P. S model is an acute inflammatory model in which healthy animals are injected with L. P. S, resulting in a severe acute inflammatory response. This model is commonly used to evaluate the biologic effect of therapies targeting cytokines in the inflow.

This model is commonly used to evaluate the biologic effect of therapies targeting cytokines in the inflammatory cascade. Biologic activity is usually measured by reductions in the levels of the targeted cytokine.

Amatory Cascade.

Biologic activity is usually measured by reductions in the levels of the targeted cytokines.

Initial L. P. S studies of varying doses of an IL 17, a targeted L. N C using lower potency stimulation documented substantial IL 17, a knockdown with about 40% of animals showing complete knocked out.

Initial LPS studies of varying doses of an IL-17A targeted LNC using lower potency stimulation documented substantial IL-17A knockdown with about 40% of animals showing complete knockdown.

More recent studies with more potent LPS stimulation have shown lesser degrees of knockout.

More recent studies with more potent L. P. S stimulation have shown lesser degrees of lockdown.

Similar studies with an oral LNC formulation of an oligonucleotide blocking the formation of TNF-alpha are ongoing.

Similar studies with an oral LNC formulation of an oligonucleotide blocking the formation of TNF Alpha are ongoing.

These preliminary studies provide evidence supporting biological activity of orally administered L. P formulations of small oligonucleotides. However, additional work will be necessary to clarify the strength and time course of cytokine inhibition for both IL.

These preliminary studies provide evidence supporting biological activity of orally-administered LHC formulations of small oligonucleotides. However, additional work will be necessary to clarify the strength and time course of cytokine inhibition for both IL-17A and TNF-alpha.

17, a and TNF Alpha <unk>.

and to determine whether the level of cytokine knockdown achievable with orally administered small oligos will be sufficient to provide clinical benefit in disease models where targeting these cytokines can play a meaningful therapeutic role.

And to determine whether the level of cytokine knocked down achievable with orally administered small oligos will be sufficient to provide clinical benefit in disease models. We're targeting these cytokines can play a meaningful therapeutic role.

To this end we have recently conducted preliminary in vivo studies with an oral LNC formulation in a murine and Nicola Mod induced psoriasis model.

To this end, we have recently conducted preliminary in vivo studies with an oral LNC formulation in a murine emichuomod induced psoriasis morph.

In this model, an irritant, imiquimod, was applied daily to the skin of healthy mice, resulting in a pathological picture closely resembling human psoriatic.

In this model an irritant in nickel Mod was applied daily the skin of healthy mice, resulting in a pathological picture closely resembling.

Human Psoriatic lesions.

Importantly, blocking IL-17A with monoclonal antibodies has been associated with improvement in the severity of skin lesions in both this model and in human psoriasis.

<unk> blocking IL 17, a with monoclonal antibodies has been associated with improvement in the severity of skin lesions in both this model and in human psoriasis.

Similar to the LPS model, the severity of the response is proportional to the amount and duration of a Michel mod exposure.

Similar to the L. P. S model the severity of the response is proportional to the amount and duration of <unk> exposure.

An initial pilot study evaluated our oral LNC formulation of the anti-IL-17A oligonucleotide in a high dose in miquamod model, and identified reductions in skin IL-17A mRNA expression in comparison to treatment with a miquamod alone.

An initial pilot study evaluated our oral LNC formulation of the anti IL 17, a oligonucleotide and a high dose of <unk> model and identified reductions in skin IL 17, a mrna expression.

In comparison to treatment with <unk> alone.

Thus confirming the biological activity of an orally administered small oligonucleotide in a disease model more recent studies and a lower dose and eco Mod model have provided additional evidence of associated clinical benefit with qualitative improvements in skin.

thus confirming the biological activity of an orally administered small oligonucleotide in a disease model. More recent studies in a lower dose imiquimod model have provided additional evidence of associated clinical benefit with qualitative improvements in skin lesion appearance such as redness and scaling of the lesion.

<unk> lesion appearance, such as redness and scaling of lesions.

Additional in vivo studies evaluating the therapeutic potential of oral LNC knockdown of both IL-17A and TNF-alpha are ongoing in other disease models, with data readouts expected in the fourth quarter of this year.

Additional in vivo studies evaluating the therapeutic potential of oral LNC knockdown of both IL 17, a and TNF Alpha are ongoing in other disease models with data Readouts expected in the fourth quarter of this year.

With those comments I'd like to turn the call over to Keith Kucinski, Our Chief Financial Officer to review our financial performance Keith.

With those comments, I'd like to turn the call over to Keith Kaczynski, our Chief Financial Officer, to review our financial performance.

Yeah.

Thank you, Terry. Starting today with our third quarter results.

Thank you Terry.

Starting today with our third quarter results.

We reported zero revenue for the third quarter of 2023, whereas in the third quarter of 2022 we reported revenue of $1.1 million, which was generated from our research collaboration with BioNTech.

We reported zero revenue for the third quarter of 2023, whereas in the third quarter of 2022, we reported revenue of $1 $1 million, which was generated from our research collaboration with bio <unk> Tec.

Total costs and expenses for the third quarter of 2023 were $6.1 million, which compares with $6.5 million for the third quarter of 2022.

Total costs and expenses for the third quarter of 2023 were $6 $1 million, which compares with $6 $5 million for the third quarter of 2022.

The decrease was primarily attributable to lower manufacturing costs of clinical trial materials, lower clinical consulting fees, and lower headcount-related expenses.

The decrease was primarily attributable to lower manufacturing costs of clinical trial materials.

Lower clinical consulting fees and lower head count related expenses.

Our net loss for the third quarter of 2023 was $6 $1 million or <unk> <unk> per share.

Our net loss for the third quarter of 2023 was $6.1 million, or $0.03 per share. This compares with a net loss for the third quarter of 2022 of $6.5 million, also $0.03 per share.

This compares with a net loss for the third quarter of 2022 of $6 5 million also <unk> <unk> per share.

Turning now to our nine months results.

Revenue for the first nine months of 2023 was $1 $1 million compared with $2 $1 million for the first nine months of 2022.

Revenue for the first nine months of 2023 was $1.1 million compared with $2.1 million for the first nine months of 2022.

Total costs and expenses for the first nine months of 2023 were $19 million compared with $21.2 million for the first nine months of 2022.

Total costs and expenses for the first nine months of 2023 were $19 million.

Compared with $21 $2 million for the first nine months of 2022.

The company's net loss for the first nine months of 2023 was $17.6 million, or $0.08 per share. This compares with the net loss for the first nine months of 2022 of $17.4 million, also $0.08 per share.

The company's net loss for the first nine months of 2023 was $17 $6 million or <unk> <unk> per share. This compares with a net loss for the first nine months of 2020 to $17 $4 million.

<unk> per share.

Cash cash equivalents and marketable securities as of September 30th 2023 were $18 $2 million.

Cash, cash equivalents, and marketable securities as of September 30, 2023 were $18.2 million.

Based on current projections, we believe our cash is sufficient to fund planned operations into the third quarter of 2024.

Based on current projections, we believe our cash is sufficient to fund planned operations into the third quarter of 2024.

We are actively seeking to extend our cash runway by securing non dilutive funding from potential third party development partners and government grant programs through agency agencies, such as BARDA as well as from potential public or private equity offerings.

We are actively seeking to extend our cash runway by securing non-dilutive funding from potential third-party development partners and government grant programs through agencies such as BARDA, as well as from potential public or private equity offerings. With that, I'll turn it back over to you.

With that I'll turn the call back to Jerry.

Thanks, Keith in summary, this is a very exciting time for our company in Matt 22, or three we have a late stage asset that's positioned to enter phase III.

Thanks Keith. In summary, this is a very exciting time for our company. In Matt 20203, we have a late stage asset that's positioned to enter phase three.

This drug is supported by robust, positive clinical data and a regulatory and clinical trial strategy designed to potentially provide superiority data on a composite endpoint and potentially line up for registration under the advantageous LPAD pathway.

This drug is supported by robust positive clinical data and a regulatory and clinical trial strategy designed to potentially provide superiority data on a composite endpoint and potentially lineup for registration under the advantageous L pad pathway.

combination of focusing treatment with MAT-203 on an orphan patient population.

The combination of focusing treatment with Matt 22, or three on an orphan patient population with a superiority composite primary endpoint is designed to maximize commercial potential while filling but as perhaps the biggest current unmet need in the treatment of deadly invasive fungal infections.

with a superiority composite primary endpoint is designed to maximize commercial potential while filling what is perhaps the biggest current unmet need in the treatment of deadly invasive fungal infection.

Further supported by the potential for 12 years of market exclusivity upon approval should not be a surprise that partner interest in MAT 2203 has increased significantly over the last month or so.

Further supported by the potential for 12 years of market exclusivity upon approval should not be a surprise that partner interest in that 'twenty, two or three has increased significantly over the last month or so.

Our goal is to use the recent FDA dialogue and clarity to accelerate these discussions and identify the ideal partner or partners for this drug, which will allow us to fully fund and commence phase three as soon as possible, and ensure that the right commercial partner is in place to maximize that opportunity.

Our goal is to use the recent FDA dialogue and clarity to accelerate these discussions and identify the ideal partner or partners for this drug.

Which will allow us to fully funding commenced phase III as soon as possible and ensure that the right commercial partner is in place to maximize that opportunity.

Given the uncertain and volatile capital markets, our primary objective is to extend our cash runway in a non-dilutive manner. And we believe the elements are now in place to forge a meaningful partnership.

Given the uncertain and volatile capital markets. Our primary objective is to extend our cash runway in a non dilutive manner.

And we believe the elements are now in place to forge a meaningful partnership.

Also, as we continue to generate potential LNC platform expanding data in areas like inflammation and cancer, both with small molecules and orally available small oligonucleotides, we remain open to the right partnerships with companies looking to apply our unique and proprietary delivery technology to their molecules.

So as we continue to generate potential LNC platform expanding data in areas like inflammation and cancer, both with small molecules orally available small oligonucleotides, we remain open to the right partnerships with companies looking to apply our unique and proprietary delivery technology to their molecules.

Additionally, we will look for opportunities to selectively access to capital markets. If the terms makes sense for our company and our stockholders based upon the expected advancement of our technology and the generation of additional compelling data.

Additionally, we will look for opportunities to selectively access the capital markets if the terms make sense for our company and our stockholders based upon the expected advancement of our technology and the generation of additional compelling data.

Finally, we would like to thank our stockholders for their support at our recent annual meeting of stockholders held on November one and.

Finally, we would like to thank our stockholders for their support at our recent annual meeting of stockholders held on November 1st and for successfully passing each of the four proposals in our proxy state.

And for successfully passing each of the four proposals in our proxy statement.

One of the key proposals for the company was obtaining shareholder approval for authorization of our board of directors to potentially implement a reverse split of our stock over the next year.

One of the key proposals for the company was obtaining shareholder approval for authorization of our board of directors to potentially implement a reverse split of our stock over the next year.

Although in September , we received a notice of noncompliance from MYSC due to our low share price, recent progress and accompanying increase in valuation have positioned us to potentially regain compliance organically.

Although in September we received a notice of noncompliance from NYSE due to our low share price.

Recent progress and accompanying increase in valuation have positioned us to potentially regain compliance organically.

As a result, there are no immediate plans to consider a reverse split of our stock.

As a result, there is no there are no immediate plans to consider a reverse split of our stock.

Moving forward, our board will only consider affecting a reverse split if it's deemed to be in the best interest of our stockholders and our company.

Moving forward, our board will only consider affecting a reverse split if it seemed to be in the best interest of our stockholders and our company.

Overall, we continue to focus our efforts and resources on maximizing the potential for MAT-223, and on generating additional data with our LNC platform in areas where we believe our technology is differentiated and can create distinct advantages over currently available THERICS.

Overall, we continue to focus our efforts and resources on maximizing the potential for Matt 22, or three and on generating additional data with our LNC platform in areas, where we believe our technology is differentiated and can create distinct advantages over currently available therapies.

We are intent on closing 2203 very strong and remain thankful for your ongoing support.

We are intent on closing 22, or three very strong and remain thankful for your ongoing support.

With that review, I'll now turn the call over to the operator for Q&A. Chloe?

With that review I'll now turn the call over to the operator for Q&A.

<unk>.

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 the number one on your telephone.

If you wish to register to ask a question in today's Q&A session, you will need to press star, then the number 1 on your telephone. If your question has been answered and you wish to withdraw your polling request, you may do so by pressing the star, then number 2 on your telephone keypad.

If your question has been answered and you wish to withdraw your pooling request you may do so by pressing the Star then number two on your telephone keypad.

If you are using a speakerphone, please pick up your handset before entering your request. One moment please for the first

If you are using a speakerphone. Please pick up your handset before entering your request one moment. Please for the first question.

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

Yeah.

While we are waiting for the first question I would like to mention that we will be holding meetings with investment professionals. During the 2020 for J P. Morgan Healthcare conference being held January eight to 11 in San Francisco. If you are interested in schedule a meeting please contact <unk> Investor relations Okay Chloe.

We're ready for that first question.

Perfect. We'll move first to Julian Harrison with BTIG.

Perfect well move first to Julian Harrison with B T G I.

Your line is open.

Hi, congrats on the progress and thank you for taking my question.

Hi, Congrats on the progress and thank you for taking my questions first.

First, great to hear about the FDA's openness to a superiority trial. I'm curious if this maybe will involve any changes to the comparator arm, and if not, can you just remind us of the plan there? And then also can you just remind us of the corresponding market opportunity here in azole-resistant or intolerant invasive aspergillus.

First great to hear about the Fda's openness to a superiority trial I'm curious if this maybe it will involve any changes to the comparator arm in and if not can you just remind us of the plan there.

And then also can you just remind us of the corresponding market opportunity here and azole resistant or intolerant invasive spiritual offices.

Sure Julian Thanks for your question for the first part of that question I will turn it over to.

Sure, Julian. Thanks for your question. For the first part of that question, I'll turn it over to Dr. Makovitz to talk about, you know, the design and specifically the control arm and how our recent dialogue can impact that. Terry.

Doctor Mac minutes to talk about the design and specifically the control arm.

And how our recent dialogue can impact that Terry.

Sure. Thanks, Julien So are our fundamental trial design has not changed the target patient population for the trial will still be patients with invasive aspergillosis with limited treatment options for patients who cannot receive the news off for reasons of and tolerance drug drug interactions or.

Sure. Thanks, Julian. So our fundamental trial design has not changed. The target patient population for the trial

will still be patients with invasive aspergillosis with limited treatment options. So patients who cannot receive a nasal for reasons of

intolerance, drug-drug interactions, or issues of resistance.

Issues of resistance. So all of the patients will start with IV amphotericin.

So all of the patients will start with IV amphetiracin.

And once they are deemed appropriate for oral step-down, the patients will be randomized two-thirds to treatment with MAT-2203 as step-down.

And once they are deemed appropriate for oral step down the patient will be randomized two thirds to treatment with Matt 22, or three as step down the remaining one third of the patients will continue on IV amphotericin until they are no longer able to tolerate upon.

The remaining one-third of the patients will continue on IV amphotericin until they are no longer able to tolerate upon which a decision will have to be made by the treating physician to manage the relevant drug-drug interactions if an A-Zall would be the only other treatment option for the patient. So this very much is reflective of the patients that are currently being treated with IV amphotericin in our Compassionate Use Access Program.

<unk> decision will have to be made by the treating physician to manage the relevant drug drug interactions if and as all would be the only other treatment option for the patients. So this is very much is reflective of the patients that are currently being treated with IV amphotericin in our compassionate use access program.

So and just to add to that Julian I think one of the benefits is that the control arm is not changing.

So I'm just to add to that, Julian, I think one of the benefits is that the control arm is not changing. And that's important when you think about this as a composite endpoint.

And that's important when you think about this as a composite endpoint.

You would be ordinarily you don't see a superiority endpoint and then certainly in an antifungal trial and certainly you wouldnt exercise of superior you wouldn't add a superiority endpoint. If you are just going head to head for example, and all cause mortality with IBM for terrorism versus oral amphotericin, but what.

You know, you would be ordinarily, you don't see a superiority end point in certainly in an antifungal trial, and certainly you wouldn't exercise a superior, you wouldn't add a superiority end point if you were just going head to head, for example, in all-cause mortality with IV amputerism versus oral amputerism.

But what the composite endpoint does, especially being able to define it as therapeutic success and include a change in treatment regimen, for example, you're gonna have a control arm in this study where any change from IV amputaricin in the control arm is gonna be viewed as a failure potential.

The composite endpoint does especially being able to define it as therapeutic success and include a change in treatment regimens for example, youre going to have a control arm. In this study were any change from IV amphotericin in the control arm is going to be viewed as a failure potentially.

And you're going to contrast that with oral math 202.03, which we've seen in other instances and other patients.

And Youre going to contrast that with oral mat 22, or three which we've seen in other instances in other patients can be given for long periods of time without the toxicity seen with IV amphotericin, which is exactly what necessitates a change in therapy. So we'll see how that dialogue goes with FDA.

can be given for long periods of time without the toxicity seen with IV amperateurism, which is exactly what necessitates a change in therapy. So we'll see how that dialogue goes with FDA, but this is the unique position that Matt 22 or 3 is in.

That's this is the unique position that that 'twenty, two or three years in and what we really bring to the table here is that safety element in allowing amphotericin b to be used for long periods of time.

And what we really bring to the table here is that safety element and allowing Ampeteris and V to be used for long periods of time.

That's the goal and ideally you wouldn't change the control arm and all. We don't have to. And that's why we think a composite superiority endpoint is really a significant step forward for the program.

That's the goal and ideally you wouldn't change the control arm at all we don't have to.

And that's why we think a composite superiority endpoint.

It's really a significant step forward for the program.

And then in terms of the market.

You know, you're looking at here an orphan population in and of itself within base of aspergillosis. We're targeting initially patients with limited treatment options. There are about 15 to 16,000 patients annually in the US that are in base of aspergillosis patients. About a third of those.

You're looking at here and orphan population in and of itself with invasive aspergillosis. We're targeting initially patients with limited treatment options. There are about 15 to 16000 patients annually in the U S that are invasive aspergillosis patients about a third of those would fall into the category of patients with limited treatment.

would fall into the category of patients with limited treatment options, meaning that they can't, they're resistant to asal therapy. They can't take an asal because of drug to drug interaction, you know, with other medications that they're taking that happens a lot in the cancer arena. And so the value of that population right now is the fact that it's orphaned and they have no their alternative. So you are looking at an opportunity.

Options, meaning that they can't they are resistant to ease off therapy. They can't taken as all because of drug drug interaction with other medications that they're taking that happens a lot in the cancer arena and so the value of that population right. Now is the fact that it's working and they have no. Other alternatives. So you are looking at an.

<unk>, where if you layer on some of the Pharmacodynamic impact that we believe we can bring and getting patients out of the hospital in treating their their fungal infections. It becomes the significant opportunity we estimate conservatively with the help of outside groups that that could be.

where if you layer on some of the pharmacoeconomic impact that we believe we can bring in getting patients out of the hospital in treating their fungal infections.

it becomes a significant opportunity. You know, we estimate, you know, conservatively with the help of outside groups that that could be a, you know, a $300 million market alone in the U.S. just for that limited patient population. A lot of that is, will be dependent upon the data we see in phase three and discussions with payers.

A $300 million market alone in the U S. Just for that limited patient population a lot of that is will be dependent upon the data we see in phase III and discussions with payers.

But that's where the matchup of an orphan patient population and a superiority endpoint, which you haven't seen recently in these antifungal trials, is really the ideal set of circumstances to then have, you know, pretty productive discussions with payers, where in this patient population, they're typically not going to get in the way of the infectious disease doctors.

But that's where the match up.

In orphan patient population in a superiority endpoint, which you havent seen recently in these antifungal trials.

Is really the ideal set of circumstances to then have pretty productive discussions with payers where in this patient population, they're typically not going to get in the way of the infectious disease doctors.

desire to treat these patients and save their lives. So we think it's a big commercial opportunity for this indication alone.

Desire to treat these patients and save their lives. So we think it's a big commercial opportunity for this indication alone and then remember this is a pipeline in a product and there is an opportunity with the Pharmacodynamic bridge established by this phase III program to quickly move into other invasive fungal infections with limited.

three program to quickly move into other invasive fungal infections with limited clinical trials necessary. So, it's important that you start with a strong foundation, and that's why we're so excited by what Dr. Makovic and her team have been able to achieve so far with FDA. We have a little bit further to go to finalize that endpoint, but obviously a big change from non-inferiority to superiority. Okay, excellent. Very helpful. One final question, if I may, that the potential LPAD...

Clinical trials necessary so.

It's important that you start with a strong foundation and that's why we're so excited by what Dr. <unk> and her team have.

<unk> been able to achieve so far with the FDA, we have a little bit further to go to finalize that endpoint, but obviously, a big change from non inferiority to superiority.

Okay, excellent. Very helpful. And then one final question if I made that the potential L-pad designation, I'm wondering how soon that might be confirmed, is that something you expect clarity on.

Okay excellent very helpful. And then one final question if I may the potential El pad designation I'm wondering how soon that might be confirmed is that something you expect clarity on honor.

on our around regulatory submission or perhaps earlier.

On or around regulatory submission or perhaps earlier.

Yeah, no the way <unk> works its not like getting a special protocol assessment. So al pad. His determination made at the time of NDA filing at the time of NDA approval. It gives the agency the opportunity to look at the totality of the data and our ability to address that restricted patient population.

Yeah, no, the way L-PAD works, it's not like getting a special protocol assessment. So L-PAD is a termination made at the time of NDA filing at the time of NDA approval. It gives the agency the opportunity to look at the totality of the data and our ability to address that restricted patient population. But there are formal feedback to us that we're a potential candidate is consistent with what they've done for other groups. Currently, there's only two products approved.

But their formal feedback to us that where a potential candidate is consistent with what they've done for other groups. Currently there's only two products approved.

on L-PAD, but that'll be a review issue. But certainly with the design of this study and the target patient population, we fit well within the criteria outlined by FDA, you know, to qualify for that. But you don't expect, you know, any sort of declaration in advance. That's not how it works. Okay, great. Thanks again for taking-

All pad, but that'll be a review issue.

But certainly with the design of this study in the target patient population.

We fit well within the criteria outlined by FDA to qualify for that but you don't expect.

Any sort of declaration in advance that's not how it works.

Okay, great. Thanks, again for taking the questions.

Thanks Julien.

And once more.

I will turn the call back to the speakers for any closing remarks.

I will turn the call back to the speakers for any closing remarks.

Thanks, Chloe. Thanks to everyone for joining us today. We're thrilled with our FDA update. We're thrilled with our LNC dose of taxal data. We look forward to additional data, clinical disease impact from the small oligonucleotide program. We've come a long way in 2023. We're not done. We're excited and optimistic about our company's future and we can't wait to report additional progress over the next few days.

Thanks Chloe.

Thanks to everyone for joining us today, we're thrilled with our FDA update we're thrilled with our LNC Docetaxel data, we look forward to additional data Clint.

Clinical disease impact from the small oligonucleotide program.

We've come a long way in 2023, we're not done.

We're excited and optimistic about our company's future and we can't wait to report additional progress over the next few months in the meantime, we wish all of our investors and anyone listening to the call a very happy Thanksgiving holiday have a great night and thanks for joining us take care.

In the meantime, we wish all of our investors and anyone listening to the call a very happy Thanksgiving holiday. Have a great night and thanks for joining us. Take care.

Yeah.

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

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

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