Q4 2022 Matinas BioPharma Holdings Inc Earnings Call

Thank you for standing by the conference will begin shortly please remain on the line. Thank you.

[music].

Greetings and welcome to the Mattina, Biopharma 20, twenty-two fourth quarter and full year conference call. At this time all participants are in a 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 zero on your telephone keypad as a reminder, this conference is.

Being recorded it is now my pleasure to introduce your host Jody Cain. Thank you Jody you may begin.

This is Jody Cain with L. A J. Thank you for participating in today's call speaking on today's call from machine. This biopharma won't be Jerry Jabbour, Chief Executive Officer, Keith Kucinski, Chief Financial Officer.

We'll have Dr. Terry back to.

Do you get there wasn't an officer and Dr. Terry Ferguson, Chief Medical officer available to answer questions during our Q&A session.

I'd like to remind listeners that remarks made during this call may state management's future intentions hopes beliefs expectations or projections. These forward looking statements and involve risks and uncertainties that these statements are.

Are made pursuant to the safe Harbor provisions of the federal Securities laws.

These forward looking statements are based on the Chinas biopharma current expectations and actual results could differ materially.

You should not place undue reliance on forward looking statements.

Some of the factors that could cause actual results to differ materially from those contemplated by such forward looking statements are discussed in the periodic reports that Chinas Biopharma files with the Securities and Exchange Commission.

Documents are available in the investors section of the company's website and on the SEC website.

Furthermore, the content of this conference call contains information that is accurate only as of the data. The live broadcast March 15, 2023, but chinas Biopharma undertakes no obligation to revise or update any statements to reflect events or circumstances, except as required by law.

And now I'd like to turn the call over to Jerry Jabbour Jerry.

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

During our 2023 strategic outlook call in late January we detailed our strategy of focusing on the non toxic extra hepatic delivery of nucleic acids and small molecules through our proprietary lipid nano crystal platform technology or LNC.

This strategy capitalizes on the increasingly sophisticated approaches to targeting the body's genetic machinery to develop highly effective therapeutics as we believed genetically targeted therapy is the future of medicine. We continue to believe that our LNC technology and our business strategy are putting us on a path to becoming a leader in the.

Ever evolving world of delivering genetic material.

Currently available options for the intracellular delivery of therapeutics include life as arms lipid nanoparticles and viral vectors. While these technologies have been widely adopted each has well recognize limitations such as challenges with extra hepatic delivery undesirable and dangerous toxicity and adverse immunogenicity.

D and unstable formulations that can necessitate challenging storage conditions, we believe our LNC delivery platform overcomes many of these limitations.

Our competence is significantly bolstered by the success of about 20 203 results from the phase II clinical trial of <unk> 22, or three in a deadly brain fungal infection.

Constraints that our LNC platform is able to deliver amphotericin, b and a safe well tolerated oral for our cross the blood brain barrier with dramatic survival outcomes. In contrast to the currently available formulations of this potent yet highly toxic antifungal, which are only available with shorter term intravenous.

Australia.

We are actively working to further validate and advanced development of our LNC platform with several notable milestones expected during the second quarter.

These are anticipated data readout on key differentiating and value, creating aspects of the platform from our internal program with smaller oligonucleotides like SA RNA N. A S o's and for larger oligonucleotides like messenger, and our messenger RNA and DNA being explored in collaborations with bio attack.

National resilience two of the world's leading companies working in the rapidly emerging nucleic acid space.

You may recall that we announced our exclusive research collaboration with biotech last April involving a combination of our LNC platform technology, and bio and Tech messenger RNA formats in.

In addition to meaningful financial support. This collaboration has also provided an opportunity to evaluate the capabilities of our technology for large all to go delivery and even potentially the oral delivery of messenger RNA widely considered to be the Holy Grail of RNA delivery.

We are extremely pleased with the progress of our in vitro work over the past year and expect to gain additional insights from upcoming in vivo testing.

The transition from in vitro demonstration of protein expression to achieving similar results in vivo is a complex one with many physiologic factors that can impact both the success of intracellular delivery in tissues and subsequent protein expression and biological activity in vivo.

Importantly, we believe our internal in vivo bio distribution data arising from this collaboration will ultimately set the stage for us to quickly move into therapeutic applications of both smaller and larger oligonucleotides and becomes a key decision point considered for the potential expansion of our biotech collaborations.

<unk> to a licensing agreement.

One of the unique aspects of our delivery technology is its flexibility with route of administration.

In addition to pursuing the highly challenging oral delivery of messenger RNA. We are also evaluating the use of our technology to deliver messenger RNA intramuscularly as well as other routes for systemic administration.

While the successful oral delivery of messenger RNA would represent a scientific burst.

Our demonstrated ability to also deliver large oligos systemically with the technology that is more stable less toxic and can deliver nucleic acids extra hepatic Lee or beyond the liver would also represent a significant advancement in the field of nucleic acid delivery and position our company to become a leader in this space.

Yes.

We view, our technologies versatility and cargo dependent characteristics as potential advantages both from design and intellectual property perspective, we believe we are building a solid foundation underlying our goal of creating a pipeline of internal and external product candidates and the nucleic acid space.

The exclusivity constraints of our current agreement with bio and Tech expire next month, allowing us to pursue interest from the many other firms working with messenger RNA.

Things that we have learned during our in vitro and in vivo work over the past year, both internal and as part of our biotech collaboration.

<unk> us to approach potential partners with a compelling data package.

We remain in discussions with bio attack and interested in expanding our collaboration through a license agreement, but flexibility in this area should only benefit those discussions while also allowing us the opportunity to broaden the application of our technology and engage with other leaders in this space, who have expressed interest in differentiated delivery.

Moving onto our material transfer an evaluation agreement with national resilience.

Since announcing disagreement in January we and resilience have been working closely on a comprehensive research program that includes design formulation optimization and delivery of certain nucleic acids applying the LNC platform.

We anticipate in vitro testing data during the second quarter with our collaborative work than advancing to in vivo testing with data potentially available in the second half of 'twenty to 'twenty three.

We envision that national resilience could be a true platform partner for our technologies, bringing CMC expertise manufacturing scale and unparalleled industry relationships and the nucleic acid space.

In the coming months, we also anticipate results from our internal program for the delivery of smaller oligonucleotides, such as antisense Oligos are ASO and short interfering RNA R. S. I aren't as we've chosen to focus our internal efforts on these smaller Ali goes because of the greater ease with which they can be encapsulated theyre documented.

Successful delivery in prior in vitro and in vivo studies with our technology and the overall success of the LNC platform in oral delivery of smaller molecules.

Following initial in vitro testing with cargoes, including newer therapeutic agents, we intend to move forward with multiple in vivo bio distribution and animal efficacy studies in the second half of 2023. These.

These data are expected to be highly useful in identifying the companys next internal product candidate later this year and in positioning matina for developing a broader pipeline of ASO in SA RNA therapies.

I'd like to turn now to key next steps in the <unk> 20, 203 clinical development program.

With all of our enthusiasm for potential applications for our technology in the nucleic acid space, we have not lost sight of the fact that we have a clinically validated asset in Matt 20, 203, a drug that saves lives and has the potential to become the ideal antifungal agent for the treatment of serious and potentially deadly invasive fungal infection.

<unk>.

Preparations are underway for a type b meeting with the FDA that is scheduled to take place in the second quarter, we will be seeking the agency's guidance an agreement on the design of a phase III clinical trial to assess the efficacy safety and Tolerability of oral Mat 20, 203 in patients with life threatening invasive fungal infections for which.

There are few treatment options.

The meeting will include a discussion of our proposed pivotal study design and overall strategy for achieving Matt 22, or three marketing approval for a multitude of invasive fungal infection treatment indications.

As previously announced we made the prudent decision to gain important feedback from the FDA on our plans for a phase III study.

In these invasive fungal infections prior to going into phase III in Cryptococcal meningitis, we believe a broader focus on invasive fungal infections positions Latinos to potentially receive non dilutive funds from BARDA and or the NIH and makes this asset much more attractive to potential partners such.

Abundant could be sufficient to complete development of them at 20 203 through market approval for the targeted IFA indications as well as to support supply chain and commercial readiness.

We believe Matt 20, 203 is a strong candidate for BARDA funding based upon its oral well tolerated and broad spectrum profile. Its recent clinical success in the phase II enact trial in Cryptococcal meningitis and the criteria set forth by BARDA for grants for promising antifungal treatments.

We also believe pursuing <unk> provides the best means to maximize Matt 22, all threes commercial potential domestically.

Domestically with the potential for 12 years of exclusivity in the U S and will also favorably position. This important drug for global expansion, where there is additional and significant need and commercial opportunity.

Now I'd like to turn the call over to Keith Kucinski to review, our 2022 financial performance Keith.

Yeah.

Thank you Jerry and good afternoon everybody.

Today, we reported revenue for 2022 of $3 $2 million, which was generated from our research collaboration with bio intact that we announced in April 2022.

This compares with revenue for 2021 of $33000 from our feasibility study agreement with Genentech.

Total costs and expenses for 2022 were $27 $8 million compared with $24 $8 million for 2021.

The increase was due mainly to higher research and development expenses related to the later stage of our mat 2000 to two or three clinical development program.

Net loss attributable to common shareholders for 2022 was $21 million or 10 cents per share.

This compares with a net loss attributable to common shareholders for 2021 of $23 $7 million or <unk> 11 per share.

Yeah.

As of December 31, 2022, cash cash equivalents and marketable securities were $28.8 million.

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

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

Thanks, Keith we believe that the <unk> investment thesis has never been stronger and we could not be more excited about our prospects going forward, we are well positioned with the phase III ready asset that has produced compelling and unprecedented survival data in the treatment of a deadly fungal infection about 'twenty two or three has established a solid foundation for our <unk>.

Company, and we are taking prudent steps to position that asset for long term success.

With our LNC platform, we have the potential to disrupt the delivery of nucleic acids by providing safe extra hepatic intracellular delivery with enhanced stability with multiple potential routes of delivery, including world. We are gaining confidence in our technology through internal programs with ISO isn't S. A rnas and through collaborations with.

Industry leaders like biotech Genentech and has shown resilience.

All of this supports our goal of building robust internal programs and external pipelines with leading pharmaceutical companies.

We see tremendous value for our company and our shareholders and establishing a leadership position for mid teen is an intracellular delivery, we have many high value milestones in the near term and throughout this year and we look forward to reporting on our progress and execution.

With that I will now turn the call over to the operator for a question and answer session.

Thank you well now be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two 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.

We poll for questions.

Thank you. Our first question is from Greg Fraser with Truth Securities. Please proceed with your question.

Hey, good afternoon folks thanks for taking the question.

On 'twenty, two or three will there be any new or incremental data from the data presented at that meeting.

Sure Terry Mcevoy do you want to handle that one.

Sure. Thanks for the question, Greg So as we've completed enrollment in all patients have completed the entire treatment phase and follow up.

We'll be releasing the overall final dataset.

So, but I can say is that the data that we're seeing in the final dataset supports and is very much in line with what we saw with the interim data readout. So very favorable results both from an efficacy as well as a safety perspective.

Alright.

I'm not sure if I missed this.

We have been meeting with BARDA.

So it's a good question. So Greg we have had an initial meeting with BARDA.

And then through the ASIC meeting, where we reviewed sort of their criteria our program and how it aligns with their mission.

To identify promising antifungal therapies.

Theyre as interested in we are in Fda's feedback on the phase III program in <unk>. Their primary focus is on <unk> like aspergillosis, Mucormycosis and things like husks toxicity of my closest valley fever.

So they very much want to see what fda's feedback the areas on program size lanes, because it's at that point that we have been invited to submit a white paper seeking it's essentially a form of proposal we've skipped a couple of steps with BARDA.

But that key piece there for that White paper will come as a result of the FDA meeting.

In the second quarter.

Got it and how quickly after that meeting would you expect to have visibility on the study design and FDA.

Yeah, I mean, having been through a number. This is now I think our our fifth or sixth meeting with this division with this product. So we've developed a very good rapport with this group you usually get a pretty good sense during our meetings with F. D. A.

How they're leaning theyre very collaborative with Mochida in fact, it was during one meeting last year, where they.

Suggested a tweak to the design of.

The phase III for Cryptococcal, meningitis, which which.

Very much it was in our favor. So we expect to have a pretty detailed discussion with them at this meeting.

Have to wait typically 30 days for the formal minutes of those of that of those meetings, but we will have a good sense before that we obviously prepare our own minutes of those meetings.

But we will want to wait for the official minutes before you make any comment on that.

Got it Okay, and then I just had a question on an emergency use.

Treatment I'm curious, how many patients have been treated with 22 or three.

Is there a limit to the number that can be treated and what are your plans to present or publish data.

Related to those patients.

Yeah.

Terry Mcmahon has handled this I just want to say that I think this has been one of the most exciting things that has happened over the last six months is the amount of interest we've seen.

From patients interested in compassionate use I think there's some confusion between the use emergency use spacious and compassionate use and I want to be clear that this is an emergency use basis like you see for a global pandemic. This is compassionate use consistent with the intended use of your drug.

Certainly other routes of administration, our ability to provide amphotericin in oral form that can be used for longer as a big attraction for disposition, but Terry why don't you comment on.

And the number on what we're seeing and then some of the exciting things that will be.

Feel that estimate, but with some of these other invasive fungal infections outside crypto.

Sure I'd be happy to so we have agreed and supported the compassionate use of Mad 'twenty two three for the treatment of five patients.

Four of whom has had a very favorable responses both from a safety and efficacy perspective, all of the patients who has been put forward as compassionate use patients have had significant renal toxicity associated with their IV administered IV amphotericin.

And these were patients for whom there were no other treatment options. So they were clinically responding to the IV administered amphotericin, but had significantly no toxicity, which is why they were coming to us for our support and very happy to be able to share with you that two of the patients have.

Completed treatment and have successfully responded to treatment. This first patient, which will be presented as an oral presentation at akhmed had an osteomyelitis or bone infection in her left but and what's at risk for amputation. She had a rhodotorula infection.

That was not she was not able to continue IV amphotericin, because she had significant renal failure upon.

Transitioning to our oral med 22 O suites. She had continued clinical response, such that we were able to save her foot she was able to meet.

Zone normal weight bearing activity and very importantly, the renal dysfunction and toxicity was completely reversed once she transitioned to our oral mat 22, or three and now after three to four months of treatment she's completely clinically.

Her infection is completely clinically resolved the second patient had a candida infection in his bladder after only two weeks of transitioning on to oral Med 23. He also had complete clinical resolution of his symptoms.

The other two patients continue to improve unmet 20 tool suite one of the patients who is severely presented with severe aspergillosis and mucormycosis is continuing to improve on treatment. This is a chemotherapy patients who was again significantly.

Had a safety risk with the IV amphotericin that she was receiving after transitioning to address he has been clinically improving and has had very favorable response, both for her aspergillosis as well as her new client section.

In the fourth patient who is continuing to receive them at 22 or three has a musical cutaneous infection who's also responding very well to treatment.

Great. Thanks for all that color.

Yeah.

As a reminder, if you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue.

Thank you there are no further questions at this time I'd like to turn the floor back over to Jerry Jabbour for any closing comments.

Thanks, Paul Thank you once again for joining us today and for your interest in <unk> Biopharma, we're very excited about our company's future and look forward to reporting progress to work during our Q1 investor call. A short time from now in May Thanks, and have a great evening.

This concludes today's conference you may disconnect your lines at this time. Thank you for your participation.