Welcome to the Matinas BioPharma third quarter 2022 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. I would now like to turn the conference over to Dr. Ankit Bhargava, investor relations representative for Matinas BioPharma. You may begin. Thank you, Dagmar. Good afternoon, everyone, and thank you for joining the Matinas BioPharma third quarter 2022 results conference call. Earlier this afternoon, we issued a press release with our financial results along with business updates. The release is available on the Matinas BioPharma website under the investor section. There are slides accompanying today's presentation, which are available by joining the webcast through the investor section of the company website. Speaking on today's call will be Jerry Jabbour, Chief Executive Officer, Dr. Terry Matkovits, Chief Development Officer, Dr. Terry Ferguson, Chief Medical Officer, and Keith Kucinski, Chief Financial Officer. We also have Mr. Thomas Hoover, Chief Business Officer, available to answer questions during the Q&A section. At this time, I would like to remind our listeners that the 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 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 any 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 investor section of the company's website and on the SEC's website. An archive of this call will be posted to the company website also in the investor section. Following the company's prepared remarks, we will open the call for a question and answer session. Now I will turn the call over to Jerry. Thank you, Ankit. Good afternoon, everyone, and thank you for taking the time to join us today. This afternoon, we will review our 2022 third quarter financial results and provide some highlights of our recent progress. We have departed from our normal filing schedule and call timing for this quarter, so I thought I would begin by providing some quick color to explain this change. First, we have seen that there is a lot of competition for analyst and investor attention with the early morning calls. We wanted to provide an opportunity at a more convenient time for our analysts and valued investors to be able to participate in a meaningful way. Second, Dr. Matkovits and I had been planning to travel to Uganda tomorrow in preparation for our phase III trial and not returning until our annual meeting of stockholders set for Monday, November 14th. Despite that trip being postponed temporarily, we thought it best to stay on the schedule we had laid out for our analysts earlier this fall. Now let's get into it. During the third quarter and through today, we have achieved significant milestones for our company. We are a company which prides itself on being able to set and accomplish goals, and we are very proud of the list of boxes we have been able to check during 2022. At the very top of that list was the announcement of the interim results from cohort 4 of our phase I ENACT trial of MAT2203 and cryptococcal meningitis. Overall, ENACT was a highly successful phase II trial with patient survival results that are simply unprecedented for an oral therapy in this vulnerable patient population. Dr. Matkovits and her team, working closely with Dr. David Boulware from the University of Minnesota delivered something many never thought would be possible. A clinical trial showing that oral MAT2203 could deliver effective doses of amphotericin B directly to the brain, achieve survival rates in excess of 90%, and virtually eliminate the kidney toxicity historically associated with IV formulations of amphotericin, allowing for the safe use of MAT2203 for up to six weeks. We want to thank all of the ENACT patients, our dedicated investigators, and the entire clinical study staff in Uganda for their commitment to this important clinical trial. The feedback from KOLs and infectious disease doctors at IDWeek two weeks ago in Washington was fantastic, and we're aggressively preparing to commence our phase III trial in cryptococcal meningitis in the first quarter of next year. Dr. Matkovits will go into more detail on our ENACT results and how we are well-positioned for phase III a bit later in the call. In addition to these impressive data in crypto, Dr. Ashraf Ibrahim of The Lundquist Institute at Harbor-UCLA Medical Center presented data at IDWeek with MAT2203 and its impact on another deadly fungal infection, mucormycosis. Dr. Ferguson will briefly review some of the highlights from this promising preclinical study in vivo. During the quarter, we also received important feedback from the European Medicines Agency in the form of scientific advice and the granting of orphan drug designation by the EMA for the treatment of cryptococcosis. The EMA feedback was overall aligned with our FDA-supported plan for phase III, which positions this product for global development and registration. Positioning MAT2203 for global development and continuing to generate compelling data across invasive fungal infections could not come at a more opportune time. As you may be aware, in October, the World Health Organization released its first fungal priority pathogens list to guide research and development. In its report, the WHO highlighted that invasive fungal diseases are rising at an alarming rate, particularly among immunocompromised populations. The underrecognized and emerging global health threat of invasive fungal disease is compounded by rapid emergence of resistance to many available therapies, resistance that generally leads to prolonged therapy and recurrent hospital stays. Despite this continually growing threat to human health, fungal infections receive very little attention and resources globally. The WHO classified the identified fungal priority pathogens into three groups, critical, high, and medium. Both cryptococcal meningitis and aspergillosis were on the critical list, followed closely by mucormycosis on the high priority list. With our phase II success in ENACT, MAT2203 is well-positioned to become an important weapon in the battle against cryptococcal meningitis. We have also generated consistent and compelling preclinical data in both aspergillosis and mucormycosis, which could position MAT2203 to become an important part of effective treatment for many of these critical and high-priority fungal pathogens. We believe MAT2203 has many of the attributes of an ideal fungal agent. It's fungicidal. It's not prone to resistance. It's well-tolerated and safe with no observed kidney toxicity, despite use for extended periods up to 6 weeks. It has minimal to no drug-to-drug interactions. It's oral, and it's delivered directly to infected tissues without exposing the body to toxic levels of drug in the blood. The profile for MAT2203 was one of the reasons we felt so comfortable in first studying its impact in cryptococcal meningitis, a severe invasive fungal infection with among the highest rates of mortality. Complicating treatment, this infection houses itself in the brain, making it very difficult to reach. However, for Matinas, this infection presented the opportunity to not only demonstrate that MAT2203 could safely and effectively treat this deadly fungus, but we could also show that our LNC platform could eliminate the historic toxicity of amphotericin B and carry this molecule across the blood-brain barrier and directly to infected tissues. With ENACT successful and in our rear view mirror, our confidence is extremely high that, one, MAT2203 is positioned for success in phase III in cryptococcal meningitis. 2, MAT2203 can also be used to treat other high-priority fungal pathogens like mucormycosis and aspergillosis safely and effectively, which informs the balance of our planned phase III program. I'd like to turn the call over now to Dr. Matkovits to walk us through the MAT2203 ENACT data in more detail. Thanks, Jerry, and good afternoon, everyone. I won't go into detail on the design of ENACT, since by now everyone is familiar with our phase II randomized open label sequential 4-cohort study evaluating MAT2203 in the treatment of cryptococcal meningitis. We announced data from cohort 2 in September of 2021, and just recently at IDWeek, where interim data from the all-oral cohort 4 were presented by one of the principal investigators of this study. ENACT received the Outstanding Abstract and IDSA Award from the Infectious Diseases Society of America, an honor we believe is reflective of the impressive nature of the data and the unprecedented survival rates achieved with our oral therapy. Turning now to data from cohort 4, slide 9 depicts the survival scene with MAT2203 treatment in both cohorts 2 and 4, versus the survival scene with standard of care IV amphotericin throughout the entire 18-week trial. Ultimately, survival is what infectious disease doctors and FDA care about in this patient population. At each time point in ENACT, MAT2203 outperforms standard of care on survival. Importantly, ENACT was not powered or designed for non-inferiority, but these data provide a great deal of confidence heading into our phase III trial, where the primary endpoint will be 2-week all-cause mortality or survival, with a key secondary endpoint of 10-week survival. As Jerry mentioned earlier, these are unprecedented survival rates with an all-oral therapy. The primary endpoint in ENACT was early fungicidal activity or EFA, which is the rate of yeast clearance in cerebrospinal fluid. This is a direct measurement of the quantitative rate of antifungal activity at the site of infection and has become a well-recognized surrogate marker for survival. The pre-specified target EFA threshold in ENACT was 0.2, which is clinically meaningful and represents a robust degree of fungal clearance that is associated with enhanced survival. Importantly, and as pointed out on this slide, treatment EFAs beyond the 0.2 threshold have not historically resulted in any incremental benefit. Overall, MAT2203 achieved the primary endpoint and demonstrated robust early fungicidal activity in both cohorts 2 and 4, which is why we believe MAT2203 was able to reach such remarkable survival rates in this study. Several patients with high baseline fungal burdens had noteworthy antifungal activity within the MAT2203 treatment arm, including one patient with quantitative cryptococcal culture as high as 915,000 CFU/mL at the time of screening. Each of these noteworthy cases highlighted effective clearance during the induction period, a key demonstration of potent antifungal activity even in the most challenging of cases. This shows that our drug is having an immediate and high impact on the disease, a key observation for infectious disease doctors. These next two slides highlight the data from cohort two and the design of our phase III trial, which is predicated upon the design of cohort two of ENACT. As a reminder, cohort two was designed to evaluate MAT2203 as step-down therapy after only two loading doses of IV amphotericin. In cohort two, our two-week survival was 98%. 97% of patients achieved sterility, including all patients completing the induction course of treatment with MAT2203, and there were no breakthrough infections. MAT2203 was additionally safe and well-tolerated, with no kidney toxicity or electrolyte abnormalities observed, even with six weeks of treatment with MAT2203. Our phase III study replicates this cohort design, and we believe there should be a high degree of confidence in its success. We've chosen this design for a few key reasons. First, it's a de-risk design predicated on 98% survival at our key primary endpoint, with a 10% non-inferiority margin against standard of care, which is a very comfortable goal. Secondly, in practice, most physicians treating patients presenting with cryptococcal meningitis or other deadly invasive fungal infections are most likely going to start patients on an IV therapy. Third, enrollment is likely to proceed faster with the IV loading doses available. Fourth, treatment guidelines will likely look more favorably upon this design, and MAT2203 could be included much faster than is customary, an important element for both physician adoption and payer acceptance. We're excited to initiate this phase III study early in the first quarter of next year. We will expand our clinical sites up to five, and another important aspect of our de-risked FDA-reviewed adaptive design is the potential to add additional patients once enrollment has reached 75% to offset unforeseen patient deaths unrelated to study drugs. Enrollment is expected to take approximately 18 months, with top-line data expected in the second half of 2024. Before I turn the call over to Dr. Ferguson. Ferguson, I would like to mention some of the progress we've been able to make on the CMC readiness for MAT 2203. I am pleased to report that due to both internal and external efforts, our transition to Thermo Fisher is proceeding on schedule, and we are in a good position as we enter phase III. We are intent on doing everything within our control to ensure the successful development, registration, and commercialization of this important product for ourselves and prospective partners around the world. I will now turn the call over to Dr. Ferguson for some additional color on our MAT 2203 program. Thanks, Terry. Building off of Jerry and Terry's comments, we are positioning MAT 2203 as an ideal antifungal agent with key value propositions of longer-term oral administration and avoidance of significant kidney toxicity. The capability of our LNC platform to both preserve the efficacy and fungal killing power of amphotericin B, while at the same time making it convenient and safe for patients, is incredibly important. While we are beginning our phase III program with an indication for the treatment of cryptococcal meningitis, we have also developed a protocol outline for a phase III study for the broader treatment of invasive fungal infections and plan to meet with the FDA to discuss this in the first half of 2023. Our ultimate goal is securing multiple orphan indications for MAT2203, maximizing the available regulatory exclusivities while also positioning this drug to be used as broadly as possible in the treatment of those WHO-identified priority fungal pathogens. Additionally, we believe MAT2203 has important potential applications for the prevention of invasive fungal infections, especially in immunocompromised patients such as leukemia patients and transplant patients. Underscoring these plans are data we continue to generate in support of potential broader use of MAT2203. As Jerry mentioned earlier, Dr. Ashraf Ibrahim of the Lundquist Institute at Harbor-UCLA Medical Center presented MAT2203 data for the treatment of invasive mucormycosis at IDWeek. This late-breaking study demonstrated impressive in vivo efficacy of MAT2203 in treating two different strains of Mucorales in immunosuppressed mice, with a prolonged median survival time, enhanced overall survival, and significantly reduced tissue fungal burden of target organs, including lung and brain, comparable to that of AmBisome, conventional IV amphotericin B, thus positioning MAT2203 as a potentially important clinical option for the treatment of these deadly invasive fungal infections. Overall, MAT2203 is being positioned for global success, with significant projected U.S. and global revenues. We've seen more partnership interest in MAT2203 lately, and recent deal activity in this space bodes well for the value we believe we have created in our MAT2203 program. I will now turn this call over to Keith Kucinski, our Chief Financial Officer, who will discuss our financial results. Thanks, Terry, and good afternoon, everyone. Today, the company reported its financial results for the third quarter of 2022, which reflected a net loss attributable to common shareholders of approximately $5.5 million or $0.03 per basic and diluted share, compared to a net loss attributable to common shareholders of $6.8 million or a net loss of $0.03 per share, basic and diluted, for the same period of 2021. The reduced loss resulted from the company recording $1.1 million in revenue during the current year period from its research collaboration with BioNTech SE, along with a slight decrease in operating expenses year-over-year. Cash, cash equivalents and marketable securities at September 30th, 2022 were approximately $33.1 million compared to $49.6 million at December 31st, 2021. Based on current projections, we continue to believe that cash on hand is sufficient to fund planned operations through 2023. I will now turn the call back over to Jerry to provide some pipeline updates and concluding thoughts. Jerry? Thanks, Keith. I did wanna provide an update on our pipeline programs, as I know many of our investors are following these closely. First, and most importantly, our licensing discussions with BioNTech remain ongoing. The potential for the oral delivery of nucleic acids is extremely large, and we wanna make sure we are putting our company and our shareholders in the best position, both near and long term. Happily, our research collaboration is progressing well, and we have learned a lot about our technology and its application to nucleic acids over these past few months. We are diligently working together with BioNTech to commence in vitro and in vivo studies as soon as possible. Ultimately, we are both looking to increase the overall probability of success for these studies, and for each of us, there are a lot of steps along the way. On the license side, I have stated numerous times publicly that we are looking for the right deal and are prepared to make a fair deal for access to our LNC platform. We look very favorably at the precedents in this space, and we are also gratified to see a lot of interest from other third parties. We continue to believe that a deal with BioNTech makes sense for both companies and are optimistically working toward that goal. We hope to have an update on this prior to year's end. The other thing I want to highlight is that we have consciously chosen to slow down development of MAT 2501 to allocate resources judiciously in these uncertain market times. While we continue to believe in the opportunity for the first oral aminoglycoside, we wanna prioritize allowing some of our potential non-dilutive and inexpensive financing options to materialize and/or mature prior to moving into a phase II/phase II-A study with that drug. In the short term, we believe advancing MAT2203 into phase III and focusing our other efforts on platform expansion provide the greatest return for shareholders. In looking at our overall financial picture, we continue to push forward from a relative position of strength. Unlike many small cap biotech companies, our enterprise value is far in excess of our cash, which we believe represents the market's belief in our LNC platform and its considerable potential. While we do believe we continue to be undervalued, a cash runway into 2024 and multiple short-term opportunities for non-dilutive cash influxes position us to be able to capitalize intelligently as we advance our products and technology. We have always been good stewards of our resources, and we will continue to protect our shareholder interests. We will continue to be thoughtful with how we extend our cash runway, and we believe that there are several ways this could happen in the short term, which would be viewed beneficially by our shareholders and the market. Overall, we are pleased with the progress we have made year to date, and there are several boxes remaining to be checked between now and the end of the year, and then into 2023. Each of these could and should be viewed as potential value inflection points, and we are intently focused on executing to achieve one or more of these key objectives. Importantly, we have also used 2022 to expand our IP portfolio surrounding the LNC platform with multiple key new provisional patent filings, which we believe can further protect this technology and position us well internally and with partners globally. We have also taken the opportunity to increase awareness of our platform and its capabilities at multiple scientific and business development conferences throughout this year. Events such as the Next Generation Lipid-Based Nanoparticles Delivery Summit, Partnerships in Drug Delivery, BIO-Europe Spring, the Mycosis Study Group Biennial Meeting, the mRNA-Based Therapeutics Summit, the International mRNA Health Conference, and the American Society of Gene & Cell Therapy have given our team the opportunity to both present and to engage with others to help them better understand our platform and how it potentially could solve some of the most challenging issues with drug delivery today. We wanna increase our exposure and awareness. At the same time, we are doing whatever is within our control to advance our platform. This will conclude our prepared remarks for today. I will now turn the call over to the operator to facilitate a question and answer session. Thank you. The floor is now open for questions. If you would like to ask a question, please press star one on your telephone keypad at this time. Again, ladies and gentlemen, if you would like to ask a question, please press star one on your telephone keypad at this time. Please hold while we poll for questions. Our first question comes from Greg Fraser with Truist. Please state your question. Good afternoon, and thanks for taking the questions, and congrats on the progress. The first question on MAT2203, can you expand on the feedback that you heard from the docs at IDWeek? Was the feedback universally positive? Was there any data that the docs were asking for, like the sterility or the relapse data to better understand the clinical profile? Yeah. Greg, thanks for your question. I'll turn that right over to Dr. Matkovits, and then if he wants to weigh in, Dr. Ferguson. Terry, go ahead. Sure. Thank you for the question, Greg. Two of the key elements of our clinical data for our crypto study that really resonated with the physicians was survival and safety. The ability to, with an all-oral regimen, have survival rates that exceeded, far exceeded what has been seen with other of the available therapies was really resounding and really supported where they saw the benefit of our drug in the clinical setting. Secondly, the safety profile of our drug. Being able to treat patients for the first time with a longer treatment course of an amphotericin B product was really fitting into a high area of unmet need with patients suffering from invasive fungal infections. Those really were key attributes of our drug that really has highlighted the clinical interest and the opportunities to expand the use of our drug for the treatment of other deadly invasive fungal infections such as Mucor and aspergillosis, endemic mycoses and the Candida infections really is the expanded potential to for the first time be able to use an amphotericin product clinically for longer-term use in these other deadly infections. Got it. Terry Ferguson, anything else to add there? Terry Ferguson? [crosstalk] Yeah, just to add to that, I think that they were very happy with the data that they saw. There were not additional questions or holes that they found in the data, so they were very excited about it. You saw a lot of people taking pictures of the slides during the presentation, and I think that the general air that I sensed was one of excitement around an opportunity to do things with amphotericin that hitherto were not really possible, to be able to give it orally, to be able to give it without worrying about the nephrotoxicity. I think that the sense that I saw was a lot of excitement and very happy with the data that they saw. Just to add to that too, I mean, Greg, the one thing that jumped out at me the most is that the questions, instead of talking about the data themselves, jumped to the how, and it was all about mechanism of action and how our platform works and trying to understand PK. That gave us the opportunity to talk about how this LNC platform, you know, encapsulates drugs in a solid crystal. It keeps drug out of the blood. We access activated cells who go right to the site of infection. They were so impressed with the ability to achieve these survival data with an oral therapy that it jumped right to the how and then it became a platform moment. I think that's the other thing that happened at IDWeek that had people really interested. That's really helpful. Thanks for all the color. I'm curious about the phase III study for invasive fungal infections. Will you be enrolling patients with different infections like Mucor and aspergillosis? How are you thinking about size and duration, and also costs? Yeah. It's a good question. I would say, you know, we've developed the protocol outline for that, and our plan is to enroll patients who are suffering from a variety of invasive fungal infections. There's precedent in this category for these so-called, you know, all-comer or basket studies. I think you'll see us focus on the big ones of Mucor, aspergillosis, and maybe some of the more endemic mycoses. We're working on patient numbers now. We don't think it needs to be a huge study based upon precedent in the space and the fact that we have demonstrated success in cryptococcal meningitis. We'll obviously prepare well and submit a package to FDA to have those discussions. That will be something that happens in the first quarter. Theresa Matkovits, anything to add to that? Yeah. I think, Jerry, you hit it on the head. We intend to leverage what we've already demonstrated vis-à-vis efficacy in treating cryptococcal meningitis to then allow us to do a more streamlined basket study for treating invasive fungal infections, where we hope FDA would be amenable to a more streamlined design that perhaps would allow us to do a smaller open label study with external comparators that would not require us to do a significantly sized study. Can you use the same formulation in the study that you used in ENACT? Correct. Yes. Would you initiate that study on your own or possibly wait for a partner to help fund it or? Yeah, it's a great question. I mean, you know, given the interest in this asset and the fact that we're in an active process, you know, our hope and expectation would be, you know, that we have a partner on board, particularly given the global nature of that sort of trial, not from a cost perspective, but just from setting this asset up the right way from the beginning to be able to check a lot of the regulatory boxes around the world. So, you know, that is. We anticipate that that would be part of the discussions we're having with third parties. I'll add one more quick one and get back in the queue. Can you just remind us how long? What's the standard treatment protocol with ampho for Mucor and aspergillosis? Yeah, it's different, and I'll let Theresa Matkovits field that one. Because of the toxicities associated with IV amphotericin use, it's typically restricted to one to two weeks of treatment, followed by step down to an azole, typically, or an echinocandin. Those classes of antifungals have significant liabilities associated with their use, such as resistance and significant complications with drug-drug interactions. Just to remind us that these are immunocompromised patients that have significant underlying comorbidities, and they're on polypharmacy. The ability to treat with a safe alternative to a class that has significant drug-drug interaction and limitations of use due to those drug-drug interactions really positions our drug to really expand the opportunity with any amphotericin product. Got it. Thanks so much. Okay, our next question comes from Robert Hazlett with BTIG. Please state your question. Thanks. I've got one or two. Congrats on the progress as well from me. Just, with regard to the harmonization of the EU phase III, can you just go into a little bit more detail there? Are there any particular wrinkles in the either additional work or work you're doing to make it amenable to an EU filing and acceptance? Yeah, I mean, one of the benefits, you kno w, Bert, of us going early to EMA was that we were able to get their feedback in time to incorporate it into our overall protocol planning for the phase III for cryptococcal meningitis. Even though I would say the majority of their comments were aligned, there are some things that they wanna see, which we will be able to incorporate pretty easily. We think that this is a study that we will be able to use to meet the criteria of both regulatory agencies, which is obviously a huge advantage. I think that's the benefit of Dr. Matkovits, you know, being proactive there and going and getting that feedback 'cause then we can align everything at the start of phase III and not find ourselves in the position of having to do smaller studies or other things to appease regulatory agencies. Okay, thank you. Talked about being in an active process with regard to MAT2203. I'd love to just get your sense of maybe where you are and what a good deal might look like there. I know there's 1,000 different ways to slice this, but is this something where you might consider a geographic carve out, or is this something, you know, given this alignment that seems to be in place, you'd like to license the whole thing? Just a little bit more of the status and a little bit more of the types of deals that you might be considering. Thanks. Yeah. Bert, it's a good question. You know, in this business, timing is everything, and I think the fact, you know, there have been parties who have actively been following the development of this drug for some time. Obviously, their interest was piqued by Cohort 2, which is the first time you really saw the ability of this therapy to effectively treat, you know, immunocompromised Cryptococcus patients. But that's only increased with the data at IDWeek and now the attention brought by the World Health Organization's call for additional development. We've also seen over the last year and a half, particularly during the pandemic, the increase in the prevalence of these, you know, fungal infections, particularly in immunocompromised patients. It's a perfect storm. There's a lot of precedent in this space for deals that are done on a regional basis. I mean, you can look pretty recently, at least in the last couple of years, at things like Cidara or F2G, you know, in that space. I think we have a better product. I think we have a product that has a broader spectrum and has the ability to more effectively treat these pathogens. We wanna be smart about it. What we know is we're not gonna slow down this train because we have a drug that works really well in these patient populations and has the opportunity to stack indications. That interest is increasing. We would and are open to regional sort of licensing deals, but we have not discounted the possibility that there's a global deal here giving. Given the emergence and the attention. We're focused on execution. We're being smart about how we fund. The NIH's support of the phase III in cryptococcal meningitis is a big reason why we can be patient. You know, that again, they're gonna stand firmly behind supporting a lot of the patient costs in that study, so that's a big variable for us. I know Tom Hoover and Theresa Matkovits and others are working hard to inform partners. We have an active data room that's open. We will be opportunistic. We want to be comprehensive in terms of canvassing all interested parties. But finding that right partner is a key part of our business objective, I would say, over the next two quarters. That's terrific. Just following on that exact topic with regard to BioNTech, certainly don't wanna negotiate on a quarterly conference call, but at the same time, I'm interested if there's any particular ask or any particular hurdle that's being considered in order to be able to effect the broader transaction there. Bert, in which transaction? I'm sorry. A potential broader deal for BioNTech. With BioNTech. Yeah, I don't think it's an obstacle. I think for them, there's a number of things that they need to consider. I think they're quite happy with how the research collaboration is going, and we all know that their intention has been pulled in a number of different directions. You know, the parties are talking about value. I think anytime you're trying to wrap your head around valuations and things like exclusivity and things like the opportunity for an oral messenger RNA, I think things get complicated. These are, I think, mature, pleasant discussions. We always have a sense of urgency in everything that we do, but we are comfortable proceeding on a timeline which puts us and our shareholders in the position for the right deal. If we would've had the right deal two months ago, we would've done it. I think we're moving closer every day. Both parties, I think, believe it makes sense. It's just a question of being able to cross those T's and dot the I's. Thank you. Appreciate the answers and look forward to more progress. Okay. Okay, our next question comes from Mayank Mamtani from B. Riley Securities. Please state your question. Hi, good afternoon, team. This is Sahil Kazmi on for. Congrats on all the progress, and thanks for this really comprehensive update and some of the interesting data we're seeing from ENACT. Maybe just starting there, as you think about the phase III study, could you talk about some of your expectations for the different treatment arms in terms of the induction consolidation versus standard of care, and maybe put in context how significant that, you know, 1-week loading dose of amphotericin is? Yeah. A couple things, you know, that we need to sort of walk back there. There's not gonna be a 1-week loading dose for the phase III, at least as far as the MAT2203 arms. We're talking about 2 loading doses. Over the first 2 days, patients will receive a loading dose, and then it will transition on day 2, actually, to oral MAT2203 for the balance of the 14-day induction period. It's only in the standard of care arm where they will be getting 7 days of IV amphotericin, you know, followed by fluconazole. We don't expect, and what we saw both in cohort 2 and was validated in cohort 4, is that the loading dose was not responsible for the antifungal effect of our drug. I think that's one of the benefits of having not stopped at cohort 2 and gone all the way to an all-oral regimen in cohort 4. It takes away the very question that you asked about what is the benefit of the loading dose. I think it's just peace of mind for physicians at the beginning. I think there's big enrollment benefit to doing it that way, and I do think that there is going to be some guideline impact there. I'll let Theresa Matkovits talk specifically about the two treatment arms. I mean, this is approximately a 270-patient study. It'll be randomized 2 to 1 to the MAT 2203 treatment arms. Theresa, maybe you wanna talk about that and what the difference is and the opportunity that FDA gave us, essentially, to look at the data and file on what we believe is the strongest indication, either treatment of crypto for 2 weeks or treatment of crypto for 6 weeks. Yeah. Thanks, Jerry. As Jerry mentioned, and as we discussed during the call, our design for phase three is really replicating identically to what we did in cohort two, so the 2 days of IV amphotericin stepping down to our MAT 2203 arm. In the final design of the study, which was collaboratively worked with the FDA, the design will allow us, for the first time, to potentially get a treatment indication that expands the use of any amphotericin product, ours specifically, for a 6-week treatment period. The way that the primary endpoint is positioned, it's focused on 2-week all-cause mortality, which we saw in our cohort two data, we performed better than standard of care, which will be the same comparison that will be tested in our phase three registration trial. We believe that we are very much positioned for success given that we have now, in 2 independent cohorts of ENACT, been able to demonstrate numerically better survival relative to standard of care. Recall that the overall statistical analysis will be one of non-inferiority, so we need to demonstrate that we are non-inferior to standard of care. It's not a superiority endpoint, which is also a much lower bar from a regulatory perspective. Secondly, the 10-week all-cause mortality endpoint will be the key endpoint that will support this longer-term treatment indication that will be a first-ever indication for any amphotericin product. There again, based on our cohort 2 data, we saw numerical benefit of our drug versus the standard of care, where we had 90% survival relative to 85% survival in the standard of care arm. This was also replicated in cohort 4, the all-oral regimen. We believe we really are very well positioned to be able to meet the criteria that will be pre-specified as the success of the study for both induction as well as that 6-week treatment, throughout for the label final label. Thanks, Theresa. Just to follow up on that too, I mean, that's one of the benefits of our having multiple interactions with FDA this past year is getting them to agree to be open to that longer indication, you know, of up to 6 weeks. That's primarily because of the safety data that we were able to generate and that they saw in addition to the efficacy. Because that's also what sets you up for the treatment of mucormycosis and the treatment of aspergillosis, whose treatment periods, you know, are longer than 2 weeks. The FDA will be able to see the data from crypto, and that should factor in very favorably to how we're thinking about the possibility of longer indications with a streamlined, less challenging trial for the invasive fungal infections as well. Excellent. That's really helpful. Thanks for the additional color there. Then maybe just a brief question on the BioNTech collaboration. Are you able to discuss in a little more detail kinda some of the ongoing research and diligence that might have been informative of the preclinical models you're thinking as you look to deploy some of the attractive features of the platform here? Yeah, we can't. I mean, we're not really at liberty to go into the exact nucleic acids or the targets or things like that. This is really two parties coming together who have strengths and expertise in two unique areas. You know, us with our ability, you know, to formulate and create novel formulations and them with their unique messenger RNA format. There was a lot of learning that had to go on between the two groups in terms of understanding what they had used before to deliver, what challenges that they ran into. Then we also did a lot of work with them on cell identification, cell uptake, basic stuff, to position us then to be able to identify what are gonna be the best, you know, in vitro and in vivo studies. It was really building it from the foundation for the long term. Other than that, I can't go into many details, but but it has been collaborative, and back and forth. I think both parties have learned a great deal about why it makes sense, for the two of us to work together for the long term. Understood. Thanks so much for taking our questions, and congrats on all the progress throughout the quarter. Thank you. Our next question comes from Matthew Kausal. Please state your question. Hi. Thanks, and congrats guys on the continued LNC progress. Based on the cohort 4 success and pivotal developments in CM focused on step-down therapy, what are your thoughts on future usage of MAT2203 as a frontline therapy, and how relevant do you see that ultimately being in terms of treatment benefit and the focus on platform expansion? Thanks. Yeah, Matt, thank you for the question. Thank you for your patience too for being in the queue this long. Yeah, of course. It's a really good question because we get this question a lot from investors. You know, why are we talking about step-down versus just starting with oral therapy? You know, you're giving up prescription days and things like that. We've looked at all of those issues. We obviously have been able to look at the cohort 4 data, as an open label trial. We obviously have gone over the cohort 2 data pretty significantly. We've had the opportunity to talk to physicians and payers about how they view all of this and gain a good understanding of what the treatment landscape is like. We come back. We keep coming back to the same place, where using MAT2203 as step-down therapy just checks a lot of boxes. It allows us to sort of de-risk our studies. It allows us to align ourselves with what physician practice may be. It allows us to get through these studies faster. It eliminates questions in some physicians or patients' minds about enrolling in the study. We think this is how it will work in practice, and we think that it's not necessarily. It's obviously after cohort four, there's no fear that we couldn't do it, but it's taking every factor into account and positioning the drug for big success. The reality of starting with IV and transitioning to oral MAT2203, and the beauty of our phase III study design, is if we can show that there's a survival benefit in taking therapy out, you know, to 10-week survival, you know, the reward you get there in not only showing that you can enhance survival at 10 weeks, but you're also going to be able to show that you can use MAT2203 safely for longer, you get a much longer prescription time. So the length of time that a patient is going to be comfortably on your drug, you know, more than makes up for the 2 days. From a health economic perspective, the ability to show in both, more likely in the invasive fungal infection study than in the crypto study just because of the nature of the design and the location in Uganda, there's gonna be a health economic aspect that we're gonna be able to measure and show that we're getting patients out of the hospital faster. They are not going to be prone to the resistance you see with azoles and the echinocandins today, which may, you know, cause relapse or hospital readmission. We think that on balance, the economics are gonna be better for us, and we're gonna be able to get the study done faster and get it in patients' hands much quicker. Very helpful. Thank you for that. Congrats again on the progress. Thank you. Now I will turn it back over to Jerry for closing remarks. Great. Thank you, Dagmar. We appreciate everyone taking the opportunity to join today. We look forward to your feedback. If this afternoon slot works better for our investors and the analysts, I think judging by our analyst queue today and the participation I'm able to see online and calling in, I think this is a good thing. We look forward to keeping you apprised as to our progress for the balance of 2022. We're gonna close strong. We thank you for your support. One of the benefits we have as a small biotech company is the strength of our investor base. We have a very passionate, informed investor base who follows us closely. We're gonna continue to work hard on your behalf and check those boxes for the rest of the year and in 2023. Thanks, everybody. Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time, and have a great day.