Matinas BioPharma Holdings Inc. Q1 2023 Earnings Call
Speaker 1: Thank you for standing by. The conference call will begin momentarily. Please remain on the line.
Speaker 1: At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star-0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Jodi Kane. Thank you, Jodi. You may begin. This is Jodi Kane with LHA. Thank you for participating.
Speaker 2: I would like to remind listeners that remarks made during this call may state management's future intentions, hopes, beliefs, expectations, or projections. These are forward-looking statements that involve risks and uncertainties. Forward-looking statements are made pursuant to the safe harbor provisions of the federal securities laws. For more information, visit www.fema.gov
Speaker 2: These forward-looking statements are based on Martinez-BioFarmist current expectations, and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially.
Speaker 2: from those contemplated by such forward-looking statements are discussed in the periodic reports between this file farm of files with the Securities and Exchange Commission. These documents are available in the investor section of the company's website and on the SEC's website.
Speaker 2: Furthermore, the content of this conference called contains information that is accurate only as of the date of the live broadcast, May 10, 2023. Martinez Biopharma undertakes new obligation to revise or update any statements to reflect the events or circumstances except as required by law.
Speaker 2: And now I'd like to turn the call over to Jerry Chabore. Jerry?
Speaker 1: Carry is your line on mute.
Speaker 3: Thank you, Jody. Good afternoon, everyone, and thank you for joining us.
Speaker 3: We have several recent developments to discuss today.
Speaker 3: First, we are encouraged by the feedback from the FDA that provides us with valuable guidance in developing a Phase III trial design with MAT-2203, our oral amphoteric and B-product, which we believe could position this important and potentially life-saving drug for the broadest label possible for the treatment of numerous invasive fungal infections.
Speaker 3: It's not often that the director of the Division of Infectious Diseases elects to join a type B meeting. And we believe this is a signal of the broad support we are receiving within FDA for the development of MAT-202-03.
Speaker 3: We also announced earlier today that our initial in vivo study of oral messenger RNA delivery
Speaker 3: did not demonstrate preclinical activity, which resulted in the conclusion of our collaboration agreement with Biontech.
Speaker 3: Following a few brief remarks on these developments, I will turn the call over to Dr. Terry Maccametz to provide a more detailed update on the MAT203 and our plans to pursue marketing approval. Followed by Dr. Terry Ferguson to discuss this recent development by on-tack and our other Newt Plague acid programs.
Speaker 3: Finally, Keith Kaczynski will review our financial results for the first quarter. You may have seen findings from a recent government study that was widely covered in the media, discussing the rapid spread of deadly fungal infections in U.S. healthcare facilities.
Speaker 3: This disturbing news provides us with an even greater motivation to advance our MAT-223 program through late-stage development for broad treatment of these often deadly invasive fungal infections and toward commercialization.
Speaker 3: we have continued to amass impressive compassionate use data through our expanded access program.
Speaker 3: One particularly compelling case was even highlighted during the recent European Congress of clinical microbiology and infectious diseases or ECMID, which was held last month.
Speaker 3: This growing body of clinical evidence played a meaningful role in our recent FDA meeting held in April .
Speaker 3: During our March Investor call, we announced that preparations were underway for a type B meeting seeking the FDA's guidance and agreement on the design of a Phase III clinical trial to assess the efficacy safety and tolerability of Matt-22-03 in patients with life threatening invasive fungal infections or IFIs.
Speaker 3: Strategically, we believe that the treatment of these IFIs with our broad spectrum and early administered anti-fungal agent MAT-202-03 represents an important unmet medical need. It also aligns with the commercial interests of potential partners and sources of non-deludive government funding to support the complete development.
Speaker 3: and hopefully ultimate approval of MAT-2203. We are diligently working to finalize and submit a protocol and accompanying statistical package for FDA review in the next few weeks. Once we have agreement with FDA on the design and endpoints to this space three study in Asperger-Gelosis and other IFIs, hopefully in June ,
Speaker 3: transformative biomedical and healthcare breakthroughs.
Speaker 3: On the partnership front, we remain in dialogue with multiple potential global and regional partners and are prepared to accelerate those discussions with this important FDA feedback in hand.
Speaker 3: Turning now to biantech, we were disappointed to learn that our initially vivo study of oral messenger RNA delivery, which was based upon encouraging early and vitro results, did not demonstrate preclinical activity. We recognized that this was an ambitious goal for a first in vivo study of a new unique messenger RNA formulation.
Speaker 3: especially where to date no delivery technology has been successful in achieving oral delivery of messenger RNA. We are pleased to report that in other studies conducted by Martinez, similar messenger RNA formulations have shown activity when administered both intramuscularly and intraperitoneally. And we are encouraged by their ability to maintain both structural stability and undiminished biological...
Speaker 3: resilience, which has expanded to include studies with messenger RNA following the April expiration of exclusivity with biantech, and our own internal misdeeds discovery programs in the SIRNA space. Dr. Ferguson will have more on this shortly.
Speaker 4: With those comments, I'd now like to turn the call over to Dr. Terry. Thanks, Jerry, and good afternoon, everyone. As Jerry mentioned, we recently received official minutes from a very productive meeting with the FDA held in April .
Speaker 4: We believe that the written feedback reflects the clinical benefit the agency sees in developing a safe, targeted, orally administered form of amphitheateris and B for the treatment of patients with life-threatening IFIs.
Speaker 4: FDA also expressed its desire to continue to work collaboratively with us to advance development of MAT20203, while also acknowledging the impressive novelty of our LNC platform technology and its unique pharmacokinetic profile for the delivery of amphoteric and B without the Texas City associated with IV administration.
Speaker 4: Importantly, the FDA provided us with the valuable guidance for pursuing MAT-2203 registration in a broader IFI indication.
Speaker 4: The agency was encouraged by the impressive results from our NAACC phase 2 trial in Cryptococlomanian Gytus, which demonstrated that our LNC platform was able to deliver amphithearest and bee in a safe, well-tolerated oral form across the blood brain barrier with unprecedented survival outcome for oral antipongal therapy.
Speaker 4: in broader IFI indications, since MAT-222 or 3 would be administered as combination treatment with flu cytosine or fluconazole.
Speaker 4: While surprising, following robust discussion with FDA, we now believe that the revised Phase III SBGILIS-IFI study design, assessing the efficacy and safety of MA-20203 as early step down monotherapy in a comparative non-inferiority Phase III trial in SBGILIS.
Speaker 4: should establish the desired pharmacodynamic bridge to unlock a 505B2 pathway to indications for the treatment of other invasive formal infections. We expect this strategy to result in the broadest possible label for MAT-20203 utilizing the most efficient clinical development pathway.
Speaker 4: Now let's take a look at our Phase 3 strategy.
Speaker 4: We are designing this trial to include a comparative study targeting a single IFI, the deadly fungal infection aspergillosis, and will include both first and second line treatment indications.
Speaker 4: The main estbergelosis cohort in this new trial design will include a non-inferiority comparison with standard of care IV Azale or IV Ampeterasin B with a step down to oral Azale or oral Mad 20203 as monotherapy treatments beginning as early as two days after treatment with IV Ampeterasin B.
Speaker 4: in this cohort will likely include invasive mucleurmicosis and other rare mold infections, invasive candidysis, candidocystitis, endendemic mycosis, including caxidiumicoses, hystoplasmosis, and blastomycosis. Our strategy of including a cohort with a broader group of eye
Speaker 4: and to 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.
Speaker 4: We are in the process of finalizing this revised Phase III protocol for submission to FDA later this month, and FDA has agreed to review the protocol and provide comments on an off-cycle basis.
Speaker 4: This benefits us from a timing perspective and is another example of the FDA working collaboratively with us.
Speaker 4: We also expect this collaborative spirit to impact agreement on the acceptable non-inferiority margin for the main Aspergerless cohort in this trial, which will directly impact the size of this cohort and the overall timing for study completion.
Speaker 4: During our meeting, FDA also recognized the clinically meaningful outcomes from compassionate use patients receiving MAT-202-03 as part of our expanded access program.
Speaker 4: While the case numbers are limited, the data demonstrate the ability of MAD-20303 to safely target and effectively eradicate several invasive bungalow infections, even in the most clinically challenging cases.
Speaker 4: Since beginning this program in August of last year, we have received inbound requests from physicians at the National Institutes of Health, University of Michigan, nationwide children's hospital, and Johns Hopkins, among others, on behalf of patients who have experienced significant renal toxicity while receiving IV amphitheateris and B.
Speaker 4: and or have not responded to or are unable to tolerate Azals or other classes of anti-fungals.
Speaker 4: To date, seven patients with various life threatening fungal diseases, including Canada, Espergelosis, Mucormycosis, Caxidiumicosis, Fusarium, Rotatoriala, and Protophico infections have been treated with May 22, 2003 as part of our program.
Speaker 4: These infections have presented across various tissues in the body, including bone, skin, lungs, sinus, bladder, and the brain or central nervous system.
Speaker 4: Treatment courses with MAT-2203 administered as monotherapy have ranged from two weeks to six months or longer with no evidence of any renal toxicity. Of the seven patients, five have successfully completed treatment with resolution of the infection with one patient discontinuing treatment for reasons unrelated to MAT-2203.
Speaker 4: Renal function for the patients returned to normal after switching to MAT202.03 with no further need for any electrolyte supplementation. Additionally, all were discharged from the hospital soon after switching to MAT202.03 and received treatment on an outpatient basis. Of note, the pace of inbound request for our expanded access program has been...
Speaker 4: data outside of the clinical trial setting.
Speaker 4: I'd now like to turn the call over to Dr. Terry Ferguson to discuss our nucleic acid programs. Terry?
Speaker 1: Thanks, Terry, and good afternoon, everyone. We very recently received results of an initial in vivo study of an oral mRNA delivery formulation that was conducted in collaboration with BioNTech.
Speaker 3: The results did not demonstrate oral preclinical activity. By way of background, this study was conducted in Healthy Mice and involved oral administration of a unique proprietary non-LNC formulation of BioNTech Supplied Reporter Firefly Luciferase mRNA
Speaker 3: This new proprietary phosphatidal serine containing nanofonmulation is distinct from our conventional LNCs.
Speaker 3: and was developed by scientists at Metenus to handle the physical complexity and biological fragility of mRNA and other large oligonucleotides.
Speaker 3: We had been quite optimistic about moving into the oral study as this new delivery technology had successfully delivered mRNA in vitro in multiple cell lines.
Speaker 1: Because of the timelines required under the BioNTech collaboration, we opted to bring it forward for oral in vivo evaluation. Unfortunately, we were not successful in this initial study, and our collaboration agreement with BioNTech has been concluded. In parallel to our work with BioNTech, we decided to take a look at the results of the BioNTech collaboration.
Speaker 1: We conducted additional internal in vivo studies with similar non-LNC mRNA formulations. And these have shown significant activity with systemic administration, both intramuscularly and intrepairtnelly.
Speaker 1: Our new mRNA formulations have also demonstrated impressive structural stability and continued biological activity out to at least 17 weeks at 4 degrees Celsius, which compares favorably to lipid nanoparticles or LNP's. Matinas has filed numerous provisional patent applications based on the
Speaker 1: on these novel, unique, phosphatidal serine-based formulations.
Speaker 1: With the exclusivity constraints of the BioNTech agreement expiring last month, we were able to pursue interest from others working with mRNA. We have taken this opportunity to shift our work under our agreement with national resilience.
Speaker 1: to focus more on mRNA, including in vitro delivery of reporter oligonucleotides with LNP reference comparators.
Speaker 1: Delivery of even larger reporter oligonucleotides.
Speaker 1: and ultimately extending this work to include delivery of therapeutic oligonucleotides, such as Cas9, mRNA, both in vitro and in vivo.
Speaker 1: Current plans involve a move into initial in vivo studies in the third quarter of this year.
Speaker 1: We envision that national resilience could be a true platform partner for our technologies by bringing to the table their considerable CMC expertise, their substantial manufacturing scale, and their unparalleled industry relationships in the nucleic acid space. We're also continuing our internal discovery work.
Speaker 1: with smaller oligos, such as short interfering
Speaker 1: RNA or SIRNA with specific inflammatory and oncology targets.
Speaker 1: We have chosen to focus these internal efforts on smaller oligos because of the greater ease which with which they can be encapsulated into traditional LNCs, the previously documented success of traditional LNC of small oligos in prior in vitro and in vivo studies.
Speaker 1: and the overall success of the LNC platform in the oral delivery of small molecules.
Speaker 1: Following initial in vitro testing with cargos that include new therapeutic agents, we intend to move forward with multiple in vivo biodistribution and animal efficacy studies in the second half of 2023.
Speaker 1: Data from these studies are expected to be highly useful in positioning Martinez for developing a broader potential pipeline of ASO and SIRNA therapeutics.
Speaker 1: Now, I'd like to turn the call over to Keith Kaczynski to review our first quarter financial performance. Keith?
Speaker 1: Thank you, Terry. Today we reported revenue for the first quarter of 2023 of $1.1 million, which was generated from our research collaborations with BioNTech and Genentech. We had no revenue for the first quarter of 2022.
Speaker 1: Total cost and expenses for the first quarter of 2023 were $6 million, compared with $7 million for the first quarter of 2022. The decrease was primarily attributable to lower manufacturing costs of clinical trial materials.
Speaker 1: partially offset by higher headcount. Our net loss for the first quarter of 2023 was $5.5 million or $3 cents per share.
Speaker 5: This compares with the net loss for the first quarter of 2022 of $6 million also $3 cents per share.
Speaker 5: Our cash, cash equivalents and marketable securities as of March 31, 2023 were $24.9 million.
Speaker 5: Based on current projections, we believe our cash is sufficient to fund planned operations into the second half of 2024.
Speaker 3: With that, I'll turn the call back to Jerry. Thanks, Keith. In summary, MAT-202-03 has been established as a highly promising treatment for serious and often deadly fungal infections.
Speaker 3: Survival data from our Phase II in ACX study in Cryptococcal meningitis. Combined with the growing evidence of clinical impact and the treatment of invasive fungal infections through compassionate use in our expanded access program, I provided a solid basis upon which to engage FDA in the thoughtful and productive discussion on a Phase III program.
Speaker 3: designed to have the broadest clinical impact resulting in a significant commercial opportunity for potential partners.
Speaker 3: FDA's feedback, guidance, and willingness to engage collaboratively have placed us in a stronger position to advance development of this life-saving drug.
Speaker 3: We're excited to finalize and submit our plan protocol to FDA for final review and obtain a big piece of the puzzle in unlocking partner value and government funding support. We remain on track with a later stage, impactful clinical asset and one we continue to build a company around.
Speaker 3: While the recent in vivo study result with a novel oral messenger RNA delivery formulation we conducted with BioNTech may represent a short term setback, we are reminded that our goal of oral delivery of messenger RNA is ambitious and has today not been accomplished by anyone else.
Through our collaboration with BioNTech, we generated promising in vitro data, followed by in vivo data demonstrating that our delivery technology could successfully deliver larger nucleic acids like messenger RNA systemically.
even if the holy grail of world delivery remains elusive at this point in time.
We remain committed to expanding our understanding of the capabilities of our platform technologies and continue to believe they have the potential to provide differentiated delivery of nucleic assets.
through programs with National Resilience with Messing R&A, and internal programs focused on LNC delivery of SIRNA and small molecules, the second half of this year should yield multiple opportunities for additional data and expansion of our platform. We're grateful for your continued support.
and will continue to diligently advance our promising technologies and resulting therapies for the benefits of patients globally. With that, we have finished our prepared remarks, and I will now turn the call back over to our operator, Paul, to facilitate a question-and-answer session. Paul?
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions.
While we're waiting for that first question, I'd like to mention that we have been invited to present at the JMP Healthcare Conference next Monday, May 15th in New York. The presentation will be webcast and will be available on the IR Calendar page of the company website. Okay, Paul, if we have that first question, we're ready.
Thank you. Our first question is from Greg Alexander with Truist. Please proceed with your question.
Hey, Jerry. Thanks for the presentation and really appreciate it. Just had a question about the BioNTech collaboration. Over the past year, you had mentioned that the deal was almost over the finish line or near the finish line. Can you just talk a little bit about what happened and where we are right now with BioNTech?
Greg, I'm an individual investor. Alexander.
Oh, okay. So, Greg, thanks for the question. I know that the BioNTech relationship has been on the minds of investors since we first announced it last April . And, you know, it's a relationship we're really excited about and scientifically being able to collaborate with a group like BioNTech represented a great opportunity for us.
And BioNTech came to the table, you know, with money on the table and ready to support us. But I think everyone recognizes that, and certainly BioNTech did too, that we went into that relationship having not yet demonstrated our ability to encapsulate and deliver messenger RNA. But the opportunity...
that the oral bioavailability could present for that particular nucleic acid was worth the work. The parties collaborated together over a year, certain aspects of that agreement put bio attack in position to want to potentially discuss a license agreement which the parties did over the course of the last 12 months.
As the year advanced and the work proceeded, we developed a series of encouraging in vitro data where we showed the ability to encapsulate and get penetration essentially in a lab. And the decision was made at that time by BioNTech that they would like to wait for the in vivo data. Please visitanna.org
And so we were full steam ahead towards an in vivo study. One single study that BioNTech planned, we worked with their reporter, Luciferase Messenger RNA, encapsulated it, gave that product to them for the conduct of that study in April . And very recently, they shared the results of that study.
Due to constraints of that agreement, I can't go into a lot of the details around what was discussed with BioInTech, but they made it clear, and we parted ways in a very cordial manner, but that they were going to focus on other projects. So after we reviewed that data with their scientific teams, we also made them aware.
of our in vivo studies highlighting our ability to deliver systemically. It's clear that they were focused on oral and based upon certainly what we've seen with BioNTech over the last few months, I think they've got a lot on their plate. For us, it was an opportunity worth taking, no question. We do it again all day long. But that's also one of the reasons why at the first opportunity.
effective but not perfect and there's a great need across the board for us to advance effective delivery. And so we're going to continue to work on it. It may not be with BioNTech but we're excited about what we're doing with National Resilience, we're excited about what we're doing in the SIR and A space with targets in inflammation and oncology and we wish BioNTech the best.
We're disappointed it didn't work, but when no one's been able to do it for 30 years, shame on us for believing we'd be able to do it the first time. But we had good reason for optimism. We're going to drive forward. We're not done in nucleic acids. And, you know, by the way, we don't want anybody to lose sight of the fact that when we sat down with FDA for MAT 2203...
We now have a lot of momentum, a plan for phase three there, and a clinical stage asset that saves lives. So one of the unique things about Metenus is that it's not a single-shot-on-goal company. We have a technology that we believe can be broadly applicable. We took a shot with BioNTech. We do it again.
and discussed over the past couple of months, this drug saves lives. So, Greg, congratulations to you for being the first individual investor to ever circumvent the lineup of analysts we have, but your question's a worthy one and a good one, so we welcome it. Hopefully, that gave you some color. Thank you. Our next question is from Julian Harrison.
with BTIG. Please proceed with your question. Hi, I can grads on the progress and thank you for taking my questions. First on Matt, I was wondering if you could just remind us of the opportunity in post-transplant prophylaxis patients and what the development strategy might be there going forward.
Then, on the L&C technology, you noted that you plan to continue with in vivo biodistribution and efficacy studies in the back half of this year. I'm curious if this will include oral dosing or are you going to focus on other routes of administration there and also when might we expect data from these additional studies? Thanks.
Sure. Julian, thanks very much and welcome to the story. We're thrilled to have you working with us with BTIG.
So I want Dr. McEvitz to weigh in here, but prophylaxis has long been on our sites for those investors that have been around for a number of years. Prophylaxis is actually where this drug was targeted and heading based upon its unique profile. Anytime you can take a broad spectrum drug that's going to be effective against a lot of different bugs.
works in immunocompromised patients and has the ability to be given orally, given the increased incidence of immunocompromised patients developing fungal infections. Prophylaxis is a natural place you would take a drug like Matt 20203. When Dr. McEvitz joined, we smartly sort of pivoted that to, let's prove we can treat and fungal infections first.
But we never lost sight of the opportunity that Provolaxis brings, and certainly it is there and very much a large part of the value proposition. But Terry, why don't you shed a little light on that? Sure. Thanks, Jerry, and thanks for the question, Julian.
So we believe that through the clinical program that we have generated data from in patients with invasive fungal infections, we've really highlighted the three critical attributes of our oral MAT 2203 that we believe ideally positions this drug for the prophylaxis setting in patients post-transplant. And that includes the ability to administer orally, the favorable long-term safety profile of our drug.
and the significant safety profile that allows the drug to be administered without any risk for any drug-drug interactions. So those three pivotal components of our drug we believe ideally and uniquely positions our drug to really replace oral azole therapy in the prophylaxis setting.
significant inbound interest from clinicians who are treating patients who are immunocompromised and have expressed interest in being part of our clinical program as we expand into the the prophylaxis indication.
On the second part of your question, nucleic acids, one of the best things to come out of the last year specifically are work with BioNTech is we showed we have some pretty impressive scientists internally. And I'd say that because we started utilizing lipid nanocrystals.
But when we recognized that there was going to have to be optimization there that was going to change the timelines of our relationship with bio-intect, in less than six months, the internal team here essentially came up with a novel fossil-title serine-based lipidantal particle.
that didn't have cytotoxicity in vivo, that was able to target cells, that was able to demonstrate activity, and that continued in an in vivo environment. So when you think about the historical legacy of lipid nanoparticles in the 20 plus years it took to get a therapy approved using lipid nanoparticles, the fact that...
the team here was able to do that in such a short period of time is frankly remarkable. And it gives us a couple of different opportunities. We do think that there is a size issue with the larger oligos, which represent a challenge for lipid nanocrystals, getting things to embed themselves in the bilayer.
And so it gives us an opportunity to do two things. So with the national resilience, we're going to be focused more on systemic delivery, a huge need for IV, particularly in the vaccine area. So we're going to work with them utilizing this next generation phosphatidylserine nanoparticle technology.
But our internal work, smaller oligos are different. So, siRNA for us still represents an important oral opportunity. We are targeting inflammation and oncology there. But it will be, you know, at least, you know, at present, our belief is that we can successfully encapsulate siRNA.
and deliver it with our LNCs. We've done that with other smaller oligos, but maybe, Terry Ferguson, you want to shed some light on that. But our expectation, Julian, the second half of this year is that we'll have data with both. Yeah, Jerry, to build on what you were saying, I think that it's important to recognize that with the, you know, as a result of the work that we've been doing with mRNA and the...
our first opportunity with mRNA, we learned a lot. And, you know, it's a different kind of cargo to be able to deliver. And we developed a specialized system for delivery of large oligos. It just didn't work orally. Our LNC technology, the traditional LNC technology, the nanocrystal...
and the strengths of what we've been able to prove and prior work that has shown delivery in vitro and in vivo of small oligos. So that work will probably be more focused in the oral direction. Okay, great. Thanks very much.
Thank you. We're going for joining us today and for your interest in Metinus. We're very excited about our company's future. We're very excited about our ability to save lives with Matt 20203. And we're very excited about the potential we have.
with a number of different delivery technologies going forward in nucleic acid. We look forward to reporting our progress during our Q2 investor call in August , and should we have developments before then, we certainly will be informing the market as soon as we can. Thanks and have a great evening.