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Matinas BioPharma Holdings, Inc. (MTNB)

Q4 2016 Earnings Call· Mon, Apr 3, 2017

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Transcript

Operator

Operator

Greetings and welcome to Matinas BioPharma Quarterly Update Conference Call and Webcast. At this time, all participants are in a listen-only mode. A brief questions-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Jenine Thomas with Investor Relations. Please go ahead, Ms. Thomas.

Jenene Thomas

Analyst

Good morning, everyone, and thank you for joining Matinas BioPharma's quarterly business update conference call and webcast. I would like to remind you that today's webcast will be accompanied by a slide presentation that can be found under the investors section of the Company's website matinasbiopharma.com under events and presentations. At this time, I would like to remind our listeners that remarks made during this call may state management's intentions, hopes, beliefs, expectations or predictions of the future. These are forward-looking statements that involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws. These forward-looking statements are based on Matinas BioPharma's 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 from those contemplated by such forward-looking statements are discussed in the periodic reports Matinas BioPharma files with the Securities and Exchange Commission. These documents are available in the investors section of the Company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Following the Company's prepared remarks, the call will be opened up for a question-and-answer session. Joining me on the call today are Jerry Jabour, the Company's Co-Founder and President; and Roelof Rongen, Co-Founder and CEO. It is now my pleasure to turn the call over to Jerry Jabbour.

Jerry Jabbour

Analyst

Thank you, Jenene. Good morning to everyone and thank you for joining us today. This morning's call is an appropriate time for us to briefly look back at our progress over the last 12 months and highlight certain notable accomplishments during the period and then discuss upcoming milestones and how Matinas is positioned for 2017 and beyond. There is no question that 2016 was a year of tremendous growth for Matinas as our focus on operational excellence and building a foundation for our disruptive and proprietary technology has placed us in a strong position to make 2017 a potential transformational year for our Company. 2016 was filled with notable achievements such as QIDP and Orphan designations for our product candidates, establishing a relationship with and receiving grant support from the Cystic Fibrosis Foundation for a portion of our MAT2501 development program as well as our Chief Scientific Officer, Dr. Raphael Mannino, receiving the 2016 Edison Patent Award in the drug delivery category as the inventor of our cochleate technology. Most importantly, however, in 2016 we successfully advanced our lead anti-infective product candidate MAT2203 into two separate Phase 2 clinical studies and launched our Phase 1 development program for our second anti-infective product candidate MAT2501. In fact just last week, we announced positive data from our first Phase 1 study of MAT2501 and as discussed in our press release this morning, we expect to announce interim and top line results from our two ongoing Phase 2 studies of MAT2203 in June of this year. Our CEO Roelof Rongen will go into more detail on both the results of Phase 1 study of MAT2501 and our expectations for our Phase 2 date announcements for MAT2203 in a few minutes. It is also worth mentioning that on top of our clinical progress, we…

Roelof Rongen

Analyst

Thanks for that update Jerry. I will spend the next few minutes addressing our two key development programs, our lead antifungal program MAT2203, the oral formulation of amphotericin B, and our amikacin antibiotic program MAT2501 which is targeted at non-tuberculous mycobacterium, unexplored for other difficult-to-treat gram-negative infections. So beside of making very significant progress on our corporate finance side, we are also very encouraged by the progress that we've made on the clinical development side and we believe we are on the way to address several key company value drivers. First, proof-of-concept with efficacy data for our lead program 2203, and with that proof-of-concept for the entire lipid crystal nano-particle cochleate program and also put a first stake in the ground for that and show the value of our technology platform with the advancement of MAT2501. So I'd like to first go to our most recent announcement which were the positive results for our Phase 1 study of MAT2501, which is our cochleate formulation of the currently IV-only aminoglycoside amikacin. I'd like to share with you a vision, a vision that we are actively exploring with preclinical research at this point, of how this product potentially can take the most potent agent of a mostly hospital-based intravenous antimicrobial category called the aminoglycosides and take this in oral delivery form to the community for the treatment of drug-resistant gram-negative bacterial infections and with that add to the armamentarium of infectious disease specialist treating these drug-resistant patients at home instead of an expensive hospital environments and thus saving very dear healthcare system dollars. The need in this vision is widely recognized and unfortunately the field is marked with several failures to develop approvable forms of novel medications in the field. And we believe that this provides a unique opportunity for MAT2501. MAT2501…

Operator

Operator

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question is from the line of Jason MCcarthy with Maxim Group. Please proceed with your question.

Jason McCarthy

Analyst

Good morning guys. Thanks for taking the questions. For 2203, I'm really forward towards a pivotal program in prophylaxis. Can you discuss your thoughts on how many patients you would expect to enroll? How many centers given the variability in IFI high rates at different centers and really what the endpoint of the study would be? Would it be prevention of infection over the period of neutropenia or would it be time in the hospital? Can you walk us through what you are thinking?

Roelof Rongen

Analyst

Yes, good morning, Jason. Thank you. That's a very good question. And we have thought carefully about that. There are a number of precedents out in the field. So, there has been some regulatory action, successful regulatory action in this field. And if we look carefully at the palette of studies that is out there and the risk profile we see in these patients, there are slightly north of 15% infection rate, we probably need a patient, a trial that is in the range of 400 to 500 patients. And we will look at the key endpoint of prevention of proven or probable IFI infection during that neutropenic period. And that can range from 6 to 14 weeks, depending the type of patients whether it's ALL or AML.

Jason McCarthy

Analyst

Okay, great. And for 2501 I know that there are FDA limitations for standard IV. Do you think that docs would use IV amikacin and transition patients to oral or would you just go straight to an oral? Thank you.

Roelof Rongen

Analyst

I think that probably depends on the situation. Physicians are at liberty to treat the patients in the best mode. I also know that there's a lot of pressure on physicians nowadays to minimize the use of healthcare resources. So, in between those tensions, we believe it would be great to have the MAT2501 option available. I think for our lead indication, oral treatment is probably going to be the standard. NTM is not an acute infection and, therefore, warrants that oral use from day one on. That may be different in other indications, but as I said those type of gram-negative drug-resistant infections we're still exploring how we best enter that and how we best design our studies.

Operator

Operator

Our next question is from the line of Robert LeBoyer of Aegis Capital. Please proceed with your questions.

Robert LeBoyer

Analyst

I was hoping that you could elaborate a little bit on the data presentations coming out in June in terms of where they will be and anything that you can disclose at this point without jeopardizing the presentation?

Roelof Rongen

Analyst

Yes, thank you, Robert. That's a good question. So, the NIH team of physicians involved in the mucocutaneous candidiasis study, they submitted an abstract for the ASM Microbe Medical Conference, which is one of the leading infectious disease conferences. This will be in the period of June 1 through 5 in New Orleans and this particular study poster is going to be presented on June 3rd on the Saturday. We believe that there will be at least one more other poster presented at that meeting, which is to be announced in the future.

Robert LeBoyer

Analyst

Okay, and is there any information in abstract or anything else that is publicly available or disclosable?

Roelof Rongen

Analyst

At this point not yet. I think the ASM Microbe Conference has a policy of disclosing that at midnight just before June 1.

Robert LeBoyer

Analyst

Okay. And can you remind us on what the design and endpoints of the NIH study were that will be presented?

Roelof Rongen

Analyst

Yes, the NIH study was focusing on both safety, tolerability and efficacy endpoints in patients with mucocutaneous candidiasis that were refractory to azole therapy or standard oral therapy which at this point essentially is limited to azoles. It means most of those patients have a resistant strain of Candida on their mucous membranes, and with that they have a chronic infection. Many of these patients already had infections for more than a decade, and so this is a very detrimental condition and people have a very poor lifestyle, quality of life with these infections. So, it was our goal to demonstrate that we could alleviate that quality-of-life burden in these patients and they have many other issues, but just focused on this issue to really improve their quality-of-life. And with that for taking it back to the Company side, show the benefit of the product and the ability to dose not just for the typical two weeks in which you can use the amphotericin B IV formulations, but extend this to multiple weeks, up to eight weeks in this protocol and with the extension a potential additional six months. We think that is revolutionary because physicians have never dreamt of using amphotericin longer than a few weeks. So, if you can take this out to months we think that will be monumental.

Operator

Operator

Your next question is from the line of Jason Napodano of BioNap. Please proceed with your question.

Jason Napodano

Analyst

Can you give us a sense of the number of patients that we will see data on in June?

Roelof Rongen

Analyst

We have not disclosed anything on the number of patients that's in any trial at this point in time. The NIH trial is in essence out of our control. But we were very encouraged that they took the initiative to say this is something we want to present at a major medical conference. So, I think that is very good. I think it's good for everybody to be able to see the data in this very hard-to-treat patient population firsthand from the NIH in a way that they prefer to disclose key data like this.

Jason Napodano

Analyst

Okay. I'm just trying to recall, you guys were looking for a certain type of response rate and I'm curious if we'll see maybe in June the number of patients that have essentially progressed to the point where the NIH has put them in this open label extension study and that would signify certainly a response and if we're already essentially meeting that target with the data that we'll see in June?

Roelof Rongen

Analyst

We cannot be 100% certain how many patients there will be in June. We still have a few months to go. But, again, I think the fact that, one, they requested the extension and, two, that they now moved to file the abstract which got accepted it is very positive and we are encouraged by that.

Jason Napodano

Analyst

Okay, just one more question. In terms of you guys have now demonstrated safety with the 2501. We will see initial data in June on 2203. And I'm curious in terms of platform validation and whether or not that brings forth the opportunity for some sort of business development activities, whether it's either with new molecules and potential partners or opportunities outside the US, obviously the more you can validate the platform the more valuable it gets. And I'm wondering if you're seeing interest from other parties now that you are starting to present this type of data?

Jerry Jabbour

Analyst

Hi, Jason, this is Jerry. Thanks for the question. Obviously, we continue to tout this technology as having that broad applicability and certainly as the months have passed, those discussions have increased. Certainly the opportunity for data in patients demonstrating the platform technology and its delivery capabilities is a very important component of advancing those sorts of discussions. The way BD works in these large organizations, it usually revolves around them being able to analyze that sort of data. So it adds another element of importance to being able to disclose this data in June, two months away. And we expect and are really looking forward to not only discussions on our own products but more importantly advancing those discussions, which are already ongoing, and putting other sorts of compounds into our delivery technology and improving the therapeutic profile of those drugs. So it's an active part of our strategy. It's something that we will in certainly intensify post-June. But we will be very strategic with what we explore next because it really is important that we identify the right sort of not only compounds but partners to responsibly advance the science. So good question, and something certainly in the back half of this year that we expect to move the ball forward on.

Operator

Operator

I will now turn the call back to Jerry Jabbour for closing remarks.

Jerry Jabbour

Analyst

Great, in summary just thanks everyone for joining this morning. Obviously, the next two months are an exciting time for the Company as we anticipate data and we look forward to continuing to update you on our progress. Thanks for joining today.

Operator

Operator

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