00:02 Hello, and welcome to the Matinas BioPharma Fourth Quarter and Full-Year 2021 Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. 00:18 I would now like to turn the conference over to Peter Vozzo, Investor Relations representative for Matinas BioPharma. Please go ahead Peter.

00:27 Thank you, Kevin. Good morning everyone and thank you for joining the Matinas BioPharma fourth quarter and full-year 2021 results conference call. Earlier this morning we issued a press release with our financial results along with business updates. The release is available on the Matinas BioPharma website under the Investors section. 00:45 Speaking on today's call will be Jerry Jabbour, Chief Executive Officer; and Keith Kucinski, Chief Financial Officer. We also have Dr. Terry Ferguson, Chief Medical Officer; Dr Terry Matkovits, Chief Development Officer; Mr. Thomas Hoover, Chief Business Officer; and Dr. Raphael Mannino, Chief Scientific Officer, who will be available to answer questions during our Q&A session. 01:07 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 projections of the future. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of 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 SEC's website. An archive of this call will be posted to the company's website, also in the Investors section. Following the company's prepared remarks, we will open the call for a question-and-answer session. 02:03 I'll now turn the call over to Jerry.

02:06 Thank you, Peter. Good morning, everyone, and thank you for taking the time to join us. Today, we will review our 2021 fourth quarter and full-year financial results and provide a brief business update following the more comprehensive business update that we provided in late January. I would also like to take a few moments to expand on our stated strategic intentions of moving aggressively with our LNC platform technology into the delivery of nucleic acids, including messenger RNA, DNA and antisense oligonucleotides. We believe that the unique attributes of our delivery platform could position Matinas’s LNC technology to become the next generation drug delivery platform for the intracellular delivery of nucleic acid. 02:53 When looking back on 2021, we are extremely proud of the significant progress that we've made over the course of the year to advance our LNC platform technology, highlighted by compelling clinical data from the first 3 Cohorts of our EnACT trial of MAT2203. As you know, this trial is evaluating our oral LNC formulation of amphotericin B in the treatment of Cryptococcal Meningitis, a deadly fungal infection of the brain which is especially problematic in immunocompromised patients, such as the HIV patients enrolled in EnACT. We are extremely pleased to report that Cohort 4 is actively recruiting and continues to meet our enrollment expectations. As has been previously discussed, Cohort 4 is studying an all oral regimen of MAT2203 during the 14 day induction period, followed by 4 additional weeks of oral consolidation therapy with MAT2203. 03:51 Cohort 4 is comprised of 40 patients on MAT2203 and a control group of 16 patients receiving IV amphotericin B. This isn't especially informative cohort of patients. Since the patients in the MAT2203 group do not receive any dose of IV amphotericin and so it's a great…

17:04 Thanks, Jerry and good morning everyone. Today, the company reported a net loss attributable to common shareholders of approximately $6.7 million or $0.03 per basic and diluted share for the fourth quarter of 2021, compared to a net loss attributable to common shareholders of $6.6 million or net loss of $0.03 per share basic and diluted for the same period in 2020. 17:34 For full year 2021, the company reported a net loss attributable to common shareholders of approximately $23.7 million or $0.11 per basic and diluted share, compared to a net loss attributable to common shareholders of $23.2 million or a net loss of $0.12 per share, basic and diluted, for full year 2020. 18:00 Research and development expenses were approximately $4.2 million in the fourth quarter of 2021, compared to approximately $3.5 million in the same quarter of 2020. For full year 2021, R&D expenses were approximately $14.6 million, compared to approximately $14.3 million for full year 2020. 18:24 General and administrative expenses were approximately $2.5 million in the fourth quarter of 2021, compared to $3 million in the same period of 2020. For full year 2021, SG&A expenses were approximately $10.2 million, compared to $10 million for full year 2020. 18:47 Cash, cash equivalents and marketable securities at December 31, 2021 were approximately $49.6 million, compared to $58.7 million at December 31, 2020. Based on current projections, we continue to believe that cash on hand is sufficient to fund planned operations through 2023. 19:14 I will now turn the call back over to Jerry.

19:18 Thanks, Keith. In summary, we are on a strong trajectory for a highly successful year ahead. We continue to deliver a highly compelling clinical data with the EnACT trial. Cohort 4 data expected early in the third quarter of 2022 and recently partnering with a global CMO to drive toward NDA readiness for MAT2203, positioning it to hopefully potentially become the leading therapy in the treatment of invasive fungal infections. We continue to invest and expand our discovery team with active programs now in a variety of areas in the nucleic acid space. We'll have data from Genentech and from Gilead coming up in the middle of 2022 and the potential for early data from our Discovery programs in messenger RNA, DNA and antisense oligonucleotides. We are intent on driving these programs forward and addressing some of the major challenge in the delivery of these therapeutics. We have real momentum going forward, near term milestones and we look forward to keeping everyone updated on our progress through 2022. 20:29 With that, I will turn the call over to the operator for a question-and-answer session.

20:34 Thank you. We will now be conducting a question-and-answer session. Our first question today is coming from Bert Hazlett from BTIG. Your line is now live.

21:04 Yes, thanks. Thank you for taking the questions and congratulations on all the progress. Material efforts underway and obviously, have been accomplished during 2021. With regard to 2022, Jerry, you made a couple of very intriguing points with regard to interest by third parties. I'm interested in the strategy in general there. Interest, I guess, is growing in 2203, is that a candidate for licensing or partnering? Or is it more with regard to other opportunities in the platform like an antisense oligos or RNA or DNA or other different types of molecules. Just interested in the strategy more broadly with regard to Matinas.

21:51 Yeah. Bert, great question, and thanks for joining this morning. I think 2203 has always been for us a foundational drug. It's clearly demonstrating the key attributes of the platform. We are getting oral bioavailability, we're keeping patients safe and we're having success in targeting infections in hard to reach places in the body. The data from EnACT, those first 3 Cohorts and what we're seeing in Cohort 4 do set this up to be a very successful drug and that's attracted a lot of interest from third parties. So our strategy is to capitalize on that we've seen deals in the anti-infective space during and just after Phase II from global partners where the increasing incidents of infections globally and the lack of investment in this space has made companies very hungry for differentiated assets. And when you're talking about 2203 with its broad spectrum nature of amphotericin B and now the opportunity to make that oral and essentially safe, you're talking about a drug that has an opportunity to treat 10s of millions of patients. 23:00 So we are preparing this drug because of the interest that's been expressed already. We have an idea of what these companies are looking for. And for us, it's a question of timing and checking boxes. So as we think about where Matinas is today with roughly 34 employees and a focus on discovery and formulating drugs and creating drug candidates, we do believe that 2203 is a great candidate for a partnership. That doesn't mean that we would not continue to develop that drug through NDA filing and perhaps through global development as well, but the interest is real and we think they care about things like Cohort 4 data, the Cohort 5 validation from FDA, certainly now that we…

25:28 That's terrific. Makes a lot of sense. I have about 7 or 8 more, but I'm only going to ask one. And I love to ask about 2 questions -- 2 programs, excuse me. Could you describe a little bit more about the data that is upcoming, we can expect with regard to 2501 during the year? And then, with regard to the -- remind us of the Gilead and Genentech data that we might see during the year as well? Thanks so much.

25:59 Sure. Thanks, Bert. So 2501 first. Look, it's a little bit in the shadows of 2203, just because it's a little earlier, but when you have the potential for the first oral aminoglycoside, the big drug with a lot of interest. We actually had another great update meeting with the Cystic Fibrosis Foundation yesterday who continues to be very motivated in helping to drive the development of that drug. We're right now in a single ascending dose PK study, so we're gathering data about the safety of our drug in healthy volunteers. Enrollment is going well and we expect to have data right in the middle of 2022, but we expect this drug to be safe. So what we're really doing now, in the background we're also doing some longer term tox studies which are going to set us up for a Phase II trial. We need to begin and have begun to plan what that may look like with the Cystic Fibrosis Foundation and others, but the data from the SAD is really validating that we continue to have a safe drug. 27:01 I mean, amikacin is one of the most highly toxic aminoglycosides, in addition to sort of nephrotoxicity you get ototoxicity, it can take away your hearing. And so we need to continue to demonstrate that our LNCs can eliminate that toxicity. In addition to facilitating intra cellular delivery, which can target the therapy right to the lung, a lot of therapies targeting NTM and other pulmonary infections fail because they can't get any drug or they can get limited amount of drug to the lungs. Well, we've shown the ability to get drug right to the lungs, and that's because of our mechanism of action being taken up by monocytes maturing into macrophages going right…

30:04 Thank you. I really appreciate and look forward to the data.

30:10 Thank you. Our next question today is coming from Mayank Mamtani from B. Riley. Your line is now live.

30:21 Hi, team. This is Juan on for Mayank. Thank you for taking our questions. So can you share more details of the design for Cohort 5? And we want to know will this new cohort have impact on the timeline? Also can you clarify why this cohort might be required in terms of regulatory requirements? Because on one side it’s requested by FDA, but on the other side, it seems that you still need FDA input on the design? Thank you.

30:51 It's a good question. And I'll ask Dr. Matkovits to go into some detail. So our discussions in December focused specifically on this and the opportunity and the pathway for -- to filing an NDA for step-down treatment. So there's always already been a good deal of FDA input into this idea of Cohort 5. It being satisfactory to them in qualifying for essentially a pivotal stage cohort and generating the data necessary to file an NDA. So now, taking that feedback from December our discussions in early April are really just refining the design that FDA has already comfortable with. So it's really going to be narrowly focused on the endpoint, which we've said we believe can be 30 day survival where our data is very compelling versus IV amphotericin, the non-inferiority margin and then the size of the safety database. 31:49 So overall, it doesn't change our timeline. CMC was always our gating item to filing an NDA and with the expansion of the number of clinical sites from 2 to 5 in Uganda, we think we can enroll it reasonably quickly, keeping in mind that this is still a deadly invasive fungal infection. So it doesn't necessarily change our timelines too much in terms of being able to file an NDA. But we do expect that our discussion with the FDA in April will be pretty narrow and -- gaining their agreement is important, but we feel that they already have a lot of information and have already provided a lot of input. But Terry, maybe you can expand on that a little bit.

32:32 Sure. Thanks, Jerry. And you covered it very well. So we're really very well positioned now to have a very focused discussion with the FDA. We've already crossed the major hurdles with getting their alignment that we don't need to expand the program into US patients, we can focus on where we know that patients exist and where there is a high unmet need, in Uganda, where we know we can enroll the trial very quickly at the same sites, at the same centers that are already treating patients with our oral MAT2203. So the operational execution should be very seamless as we're really just replicating what was already demonstrated in Cohort 2. It will continue to be, we expect an open label design for an endpoint that we know we will win based upon, of course, the data that we've generated to-date. 33:26 So we are optimistic that FDA will agree with the endpoint and the statistical analysis plan that we will be submitting for their review. And really this is just a final step in getting FDA alignment on the study that will be critical for NDA submission.

33:47 That's very helpful. And just one follow here. After the April discussion, when we will really hear any feedback or update on this program?

33:57 Sure. So --

33:58 Great, great. Yeah, go ahead Terry.

33:58 Sorry. It takes about 30 days. Within 30 days we should receive the final minutes, but we will have an idea around the time of the meeting as we get their written feedback, their initial thoughts on the design. But final feedback is typically 30 days after the meeting is concluded.

34:19 And just given the way the calendar is setting up, it does look like we will be in position to provide that substantive input during our first quarter conference call in May. So the calendar is sort of working in our favor, whereas the update comes in, it's sort of right in line with when we expect to inform the market about Q1 results. So it's going to line up pretty nicely. And by then, we should also be much further along with Cohort 4. And so during that May call, those would be 2 key updates from the company, both with respect to FDA and then the continued successful intervention with MAT2203 and then all oral regimen.

35:01 Yeah. That's great. Thank you for the update.

35:07 Thank you. Next question today is coming from Greg Fraser from Truist. Your line is now live.

35:12 Good morning and thanks for taking the questions. I got on a bit late, so I apologize if this was asked already. But on 2203 for a theoretical upside scenario in terms of filing timing in which you're able to submit NDA prior to completing Cohort 5. What do you envision potentially supporting an early submission, interim results to hit a certain threshold? I realize this will depend on your discussions with FDA, but I'm curious how you're thinking about an upside scenario for timing? 35:39 And then just a quick one on R&D and SG&A spend. How do we think about spend in 2022? And then specifically for Cohort 5, how should we think about the cost for that cohort? And how much of that cost would you expect the NIH to cover? Thank you.

35:55 Sure. So, Greg, I'll take those and thanks for the questions. So in terms of upside timing, there is 2 different variables to that, right? Because some of the upside in timing will also be FDA's willingness to allow us to file an NDA with shorter stability on registration batches, so that's already assuming that FDA is comfortable with a 6-month stability which is, there's precedent for that, but that would be sort of the first opportunity for an earlier filing. And then in terms of -- because it's open label and because we can have more frequent interactions with FDA because of our regulatory status and some of the other designations that MAT2203 has, there is that opportunity to go in there if we're seeing consistent results through, let's say, the first half to 75% and may be an opportunity to go in, that will be one of the things that we talk about with FDA, not only in April, but probably more as Cohort 5 starts to get drawn off. 36:56 I still think it's optimistic to think that we'd be able to file an NDA in late 2023, primarily because of the CMC side, but if the data continue to be as compelling as they have been in Cohort 2 and now what we're seeing with Cohort 4. Remember, when FDA was evaluating this drug or we were discussing the data in December, we didn't have the benefit of any of the data from Cohort 4, which is important because it eliminates that question of what impact does IV amphotericin have for example. And in Cohort 4, you get to answer that question. And so far, it's none that all of the results we're seeing during the induction phase with MAT2203 or MAT2203s alone and the…

39:24 Just how to think about R&D and G&A –

39:29 Yeah. I mean, obviously, we're continuing to invest in the platform, but we're doing so in a disciplined way, adding head count has increased sort of the R&D spend modestly over the period. We don't expect huge increases and any increases or any additional investment we're also we believe is going to have the opportunity to offset those with some non-dilutive capital. So we're not evaluating any sort of capital raise at the moment, we're generally comfortable with our cash position taking into account some of the catalysts and milestones we have ahead. But for 2022 it's going to look consistent with what we've spent, I would say, over the last 6 months internally here as we've shifted away for from LYPDISO and that would continue sort of on a straight line through 2023 as well.

40:25 Great. Thank you so much.

40:28 Thank you.

40:30 Thank you. We reached end of our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

40:37 Great. Thanks, Kevin, and thank you all for joining us today. We appreciate your continued interest in Matinas and the team here really looks forward to providing with updates on our future progress. Have a great day.

40:49 Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.