Earnings Call Transcript - MTNB Q4 2021

Operator, Operator

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. I would now like to turn the conference over to Peter Vozzo, Investor Relations representative for Matinas BioPharma. Please go ahead, Peter.

Peter Vozzo, Investor Relations

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. 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. 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. I'll now turn the call over to Jerry.

Jerome Jabbour, CEO

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. 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 three 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 four additional weeks of oral consolidation therapy with MAT2203. Cohort 4 is comprised of 40 patients on MAT2203 and a control group of 16 patients receiving IV amphotericin B. This is an especially informative cohort of patients. Since the patients in the MAT2203 group do not receive any dose of IV amphotericin, it presents a great opportunity to demonstrate that clinically meaningful impact that oral MAT2203 can have in these highly vulnerable patients. We have enrolled 15 patients as of today and all patients receiving MAT2203 are reported to be doing well. In fact, to date, all of the Cohort 4 patients who received MAT2203 have achieved sterility, meaning the absence of infection by the end of the 14-day induction period. It appears that Cohort 4 is off to a very good start, and we remain very optimistic that the positive patient experience and compelling clinical data will continue through the completion of this all oral open label cohort. Enrollment in Cohort 4 is expected to complete in the second quarter of 2022 with availability of topline interim data anticipated in the third quarter of 2022. This past December we met with FDA to discuss the data from EnACT and the pathway to a new drug application or NDA filing for MAT2203, focused initially on an indication for step down therapy from IV amphotericin for induction treatment in patients with cryptic meningitis. Based on those discussions, and documented in the official minutes of the meeting, we plan to expand the current EnACT trial to include an additional cohort of patients, Cohort 5, which would include patients receiving MAT2203 as step-down therapy for induction following two days of IV amphotericin, using a treatment protocol similar to the previously successfully completed Cohort 2. New features of Cohort 5 will include the primary endpoint and the non-inferiority margin, each of which will be discussed with FDA at our upcoming meeting. We believe that Cohort 5 will generate the confirmatory evidence FDA is seeking to facilitate an NDA submission in late 2023 or early 2024. We have completed protocol design for Cohort 5 in close collaboration with Dr. David Bower from the University of Minnesota and are scheduled to meet with the FDA early in the second quarter of 2022 to discuss specifics of the protocol. Our discussions will focus on the primary endpoint of 30-day survival, agreement on a non-inferiority margin, and the size of the safety database necessary to support an NDA filing. Following feedback from FDA, we expect that Cohort 5 will commence in the second half of 2022 and based on current projections take approximately one year to complete enrollment. Of course this remains subject to FDA agreement on the above-mentioned key points. Furthermore, our plans for MAT2203 as a safe oral formulation of amphotericin B go well beyond the treatment of Cryptococcal Meningitis and well beyond a purely domestic regulatory strategy. Given the increasing interest from third parties in licensing MAT2203, to support our partnering efforts as well as expand the global footprint for MAT2203, we are undertaking a number of important initiatives in 2022. First, we are preparing to submit a formal request for scientific advice to the European Medicines Agency during the second quarter of 2022. This is a key step in gaining regulatory advice outside the US and the key strategic input for partners seeking to develop and eventually commercialize MAT2203 outside the US. We expect to receive feedback from EMA later in 2022. In addition, preclinical studies of MAT2203 in Candida auris and mucormycosis or black fungus are scheduled to begin in the second quarter of 2022 to support potential label expansion into other dangerous invasive fungal infections. We know that amphotericin B has significant activity against these infections, and these studies are designed to show that our oral MAT2203 then has the same or perhaps even better efficacy along with the picture of enhanced safety that seems to be emerging from EnACT. These studies in turn will support a potential registration trial in the treatment of a variety of invasive fungal infections, with the ultimate goal being to position MAT2203 as the therapeutic of choice in the treatment of invasive fungal infections, which is projected to grow to an $8 billion market in the coming years. Finally, in anticipation of a potential NDA submission for MAT2203, we recently selected and reached agreement with a leading global contract manufacturing organization to support the scale-up and commercial manufacturing for MAT2203. We believe this key relationship will support MAT2203 domestically and potentially globally and be another important consideration for our partners seeking to develop and commercialize MAT2203 on a global scale. Regarding MAT2501, our LNC oral formulation of the broad-spectrum aminoglycoside antibiotic drug amikacin, our single ascending dose study in healthy volunteers is ongoing with data expected later in the second quarter of 2022. Turning now to our current research collaborations, our programs with Genentech, the NIH, and Gilead continue to highlight the breadth and capabilities of our LNC platform. We expect to begin work on Genentech's third chosen compound in the coming months. Our second in vivo trial of oral LNC remdesivir is scheduled to commence very shortly, with data expected in mid-2022. Before we move into a discussion of our full-year 2021 financial results, I would like to comment briefly on where we see the future of our LNC platform beyond the reformulation of small molecules. As we transitioned away from LYPDISO in early 2021, we focused on execution of the EnACT trial, which we believed would yield critical clinical data validating our LNC platform technology, highlighting the impressive efficacy and safety of an oral amphotericin formulation, while at the same time serving as a very important demonstration of how our LNC technology was able to carry drugs across the blood-brain barrier and target tissues that have been very challenging to reach with oral therapies. Encouraged by these compelling clinical data and supported by a vast amount of preclinical data in the formulation and delivery of siRNA, DNA, and antisense oligonucleotides, we have continued to significantly expand our internal capabilities, focused specifically on platform efforts to move aggressively into the intracellular delivery of nucleic acid. Since the middle of last year, we have added more than 15 new scientists and professionals, mostly PhD level with people coming from companies like BMS and Merck, and attracted by the potential of our LNC technology as a major step forward in advancing the capabilities for intracellular delivery. We have established internal cell culture and nucleic acid formulation labs and initiated discovery programs based on the delivery of messenger RNA, DNA, and antisense oligonucleotides. We are intent on further expansion of our LNC platform and establishing both an internal and external pipeline of drug candidates in the nucleic acid space. The unique properties of our LNC platform, including oral bioavailability, extrahepatic targeting, large payload capacity, and improved stability and safety are supported by key preclinical data that differentiates our technology from both lipid nanoparticles or LNPs and viral vectors. Despite advances and treatments comprising nucleic acids, including the COVID-19 vaccines, safe and efficient intracellular delivery remains perhaps the greatest challenge to the effectiveness of these therapies as both LNPs and viral vectors have significant limitations. LNPs are limited in that they can typically only access the cell via clathrin-mediated endocytosis, followed by disruption of the endosomes membrane within the cell to gain access to the cytoplasm. LNPs are typically very inefficient, and patients can also experience injection site adverse events and other toxicity, thereby limiting chronic or repeated use. LNPs cannot be delivered orally and are very unstable requiring extreme cold chain storage temperatures to maintain their integrity. Viral vectors, including adeno-associated virus, attempt to harness viral intracellular delivery mechanisms to facilitate fusion with the cell membrane and delivery of molecules into a cell. Unfortunately, viral vectors have historically been associated with severe negative immune responses and, like LNPs, cannot be delivered orally. We believe LNCs provide a differentiated alternative to LNP and vector delivery. LNCs can effectively deliver molecules through both endocytosis and membrane fusion, in addition to having great flexibility with the desired route of administration. Because of their unique structure and delivery mechanisms, LNC formulations are not immunogenic and allow for safe, repeated administration, without the significant drawbacks that have been observed with vectors and LNPs. The structure of an LNC is also highly stable, protecting the payload both prior to and following administration into the body. This stability obviates the need for the extreme cold chain storage temperatures otherwise required for maintaining the integrity of LNPs. Furthermore, since LNC payloads are protected outside of cells and within the digestive tract, LNC formulations enable oral and even intranasal delivery in addition to the more standard IV administration. Because of their unique and proprietary composition, LNC enters cells in unique ways, and once they get inside of a cell, they release their cargo, thanks to the much lower calcium concentrations. Clinical and preclinical studies have demonstrated successful delivery of LNC and a therapeutic cargo to professional phagocytes, including macrophages and directly to sites of infection, inflammation, and tumors. Each of these sorts of target cells has either exposed phosphatidylserine which enables cellular fusion or specific phosphatidylserine receptors which facilitate receptor-mediated cellular uptake. This specific cellular targeting, coupled with the potential to deliver a broad range of therapeutic agents, including small molecules, vaccines, peptides, and proteins, as well as nucleic acid polymers, provides a broader array of potential targets and modalities from which to create a broad pipeline of internal product candidates and partnerships. Alongside our internal discovery work focused on messenger RNA, DNA, and antisense oligonucleotides, we remain in advanced discussions with leading biopharmaceutical companies in the nucleic acid space. We believe that a true partnership in this area will further validate our LNC platform while increasing third-party interest in additional applications of our technology. Unlike numerous other companies in the LNP area, Matinas is the only company working with LNCs and we have built a significant intellectual property portfolio combined with decades of know-how to protect what we believe can become the next generation platform in intracellular delivery. We remain very excited about our work with small molecules and we are intense on taking our technology more broadly into nucleic acids and look forward to important and potentially significant updates on these efforts during 2022. I will now turn the call over to our CFO, Keith Kucinski, who will discuss our financial results.

Keith Kucinski, CFO

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 a net loss of $0.03 per share basic and diluted for the same period in 2020. For the 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 the full year 2020. 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 the full year 2021, R&D expenses were approximately $14.6 million, compared to approximately $14.3 million for the full year 2020. 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 the full year 2021, SG&A expenses were approximately $10.2 million, compared to $10 million for the full year 2020. 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. I will now turn the call back over to Jerry.

Jerome Jabbour, CEO

Thanks, Keith. In summary, we are on a strong trajectory for a highly successful year ahead. We continue to deliver 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 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 challenges 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. With that, I will turn the call over to the operator for a question-and-answer session.

Operator, Operator

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

Robert Hazlett, Analyst

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 regarding interest from 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 regarding other opportunities in the platform like antisense oligos or RNA or DNA or other different types of molecules? Just interested in the strategy more broadly with regard to Matinas.

Jerome Jabbour, CEO

Thank you for your question and for joining us this morning. I consider 2203 to be a foundational drug for us, clearly showcasing the key features of our platform. It demonstrates oral bioavailability, ensures patient safety, and successfully targets infections in challenging areas of the body. The data from the EnACT study, particularly from the first three cohorts and what we're observing in Cohort 4, positions this drug for significant success, attracting considerable interest from third parties. Our strategy is to leverage that interest. We've observed deals in the anti-infective market during and shortly after Phase II, driven by a global surge in infections and a lack of investment in this area, making companies eager for differentiated assets. With 2203's broad-spectrum capabilities and the potential for oral administration, we have a drug that can treat millions of patients. We are preparing this drug due to the interest already expressed. We understand what these companies are looking for, and for us, it comes down to timing and meeting specific criteria. Currently, Matinas has around 34 employees focused on drug discovery, formulation, and candidate development. We believe 2203 is an excellent candidate for partnership; however, we may continue developing it through NDA filing and possibly global development. The interest is tangible, especially concerning the data from Cohort 4 and the validation from the FDA for Cohort 5. With our new global CMO in place, we are achieving critical milestones. Planning for CMC and scale-up and receiving guidance from the EMA are also significant steps. We anticipate that as we move into the second half of the year, particularly with the advancements from Cohort 4, interest will grow even stronger. Meeting some of these short-term milestones will enhance the drug's value, making it more appealing for potential partnerships. For 2501, we see similar potential. As we look forward, our strategy focuses on being a platform company with a unique approach to intracellular delivery. The increasing focus on delivery is evident in the market, as shown by recent deals like the one with Novartis. This highlights the growing investment in delivery solutions, particularly in gene therapy and nucleic acid spaces. This is one reason we have heavily invested in nucleic acids since the latter half of 2021 and are continuing this focus into 2022. We see real partnership interest here as well. Ultimately, we aim to prepare our clinical assets for commercial partnerships while expanding our platform's use, allowing for more meaningful collaborations with third parties in the oligonucleotide space.

Robert Hazlett, Analyst

That's great to hear. It makes a lot of sense. I have several more questions, but I will only ask one. Could you provide more details about the upcoming data we can expect regarding 2501 this year? Additionally, can you remind us of the Gilead and Genentech data we might see this year as well? Thank you.

Jerome Jabbour, CEO

Thank you, Bert. Regarding 2501, it's somewhat overshadowed by 2203 as it is earlier in development, but there's significant interest in the potential for the first oral aminoglycoside. We had a very positive meeting with the Cystic Fibrosis Foundation yesterday, and they are eager to support the drug's development. Currently, we are conducting a single ascending dose pharmacokinetic study to assess safety in healthy volunteers. Enrollment is progressing well, and we anticipate data in mid-2022, with expectations for the drug's safety. In the meantime, we are also performing long-term toxicology studies to prepare for a Phase II trial. We are collaborating with the Cystic Fibrosis Foundation and others to plan that trial, and the data from the SAD is reassuring regarding the drug's safety profile. Amikacin, a highly toxic aminoglycoside, has nephrotoxicity and ototoxicity, impacting hearing. It’s crucial for us to demonstrate that our lipid nanoparticles can remove that toxicity. Additionally, our approach facilitates drug delivery directly to the lungs, addressing the challenges many therapies face in targeting NTM and other pulmonary infections. We have established our ability to deliver drugs effectively to the lungs, validated through multiple preclinical studies and the EnACT trial. We are enthusiastic about 2501, expecting the SAD data to align with our safety expectations for the platform. Regarding the Genentech collaboration, we are working on a third compound that differs from our previous small molecule and antisense oligonucleotide work. We cannot disclose details yet, but it is in a fascinating area. This will be a chance to expand our platform, and we are awaiting the final protocol from Genentech. We believe this compound will attract substantial interest from investors more than our previous approaches. On the Gilead front, the second in vivo study is set to start soon, likely within the next week, as formulations were sent a few weeks ago. This study will focus on another COVID-19 model, allowing us to demonstrate our ability to reduce the inoculum. Delivering a pro-drug orally is quite challenging; Remdesivir, for instance, is difficult to handle. Our ongoing collaboration with Gilead and the NIH continues to validate our platform across various areas. Regardless of opinions on Remdesivir's prospects, this additional data on pro-drug delivery and antiviral efficacy is important. With the evolving landscape, oral antiviral medications are becoming increasingly critical, and our ability to deliver them inside cells without triggering an immune response is a significant advantage. This data is also expected around mid-2022. Thank you for your questions.

Operator, Operator

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

Unidentified Participant, Analyst

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 an impact on the timeline? Also, can you clarify why this cohort might be required in terms of regulatory requirements? Because on one side it is requested by FDA, but on the other side, it seems that you still need FDA input on the design? Thank you.

Jerome Jabbour, CEO

It's a good question. I'll ask Dr. Matkovits to go into some detail. Our discussions in December focused specifically on this opportunity and the pathway for filing an NDA for step-down treatment. There has already been substantial FDA input regarding Cohort 5, confirming its suitability for qualifying as a pivotal stage cohort and generating the necessary data for an NDA filing. Taking that feedback from December, our discussions in early April are centered on refining the design that the FDA is already comfortable with. This will be narrowly focused on the endpoint, which we believe can be 30-day survival, where our data is very compelling compared to IV amphotericin, as well as the non-inferiority margin and the size of the safety database. Overall, this does not affect our timeline. CMC has always been the critical factor for filing an NDA, and with the expansion of clinical sites from two to five in Uganda, we think we can enroll participants fairly quickly, considering this is still a serious invasive fungal infection. Thus, it does not significantly alter our timelines for filing an NDA. We anticipate our discussion with the FDA in April will be quite focused, and while obtaining their agreement is important, we believe they have already received a lot of information and provided extensive input. Terry, would you like to elaborate on that?

Terry Matkovits, Chief Development Officer

Sure. Thanks, Jerry. You covered it very well. 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. 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. So we are optimistic that FDA will agree with the endpoint and the statistical analysis plan that we will be submitting for their review. Really, this is just a final step in getting FDA alignment on the study that will be critical for NDA submission.

Unidentified Participant, Analyst

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

Terry Matkovits, Chief Development Officer

Sure. It takes about 30 days. Within 30 days, we should receive the final minutes. 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.

Jerome Jabbour, CEO

And just given the way the calendar is setting up, it does look like we will be in a position to provide that substantive input during our first quarter conference call in May. 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. By then, we should also be much further along with Cohort 4. During that May call, those would be two key updates from the company, both with respect to FDA and then the continued successful intervention with MAT2203 and then the all oral regimen.

Greg Fraser, Analyst

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? And then just a quick one on R&D and SG&A spend. How do we think about spend in 2022? 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.

Jerome Jabbour, CEO

Sure, Greg, I appreciate your questions. Regarding the timing for potential upside, there are two main factors involved. Some of the upside hinges on the FDA's willingness to let us file a new drug application with shorter stability requirements for registration batches. This is based on the assumption that the FDA would accept a six-month stability, which has been done before. That would present an opportunity for an earlier filing. Additionally, since it's an open-label study and we can interact more frequently with the FDA due to our regulatory status and specific designations for MAT2203, there might be a chance to engage with them if we observe consistent results, particularly through the first half to 75% of the data. This will be a topic of discussion not just in April, but also as we start gathering data from Cohort 5. It may be optimistic to expect to file an NDA in late 2023, primarily due to the chemistry, manufacturing, and controls (CMC) aspects. If the data continues to be as promising as it has been in Cohort 2, and if the results from Cohort 4 hold significance, that could change things. When we discussed the drug with the FDA back in December, we lacked the data from Cohort 4, which is crucial to assessing the impact of IV amphotericin. So far, it seems to have no impact, and all patients on MAT2203 are progressing well, with nearly all achieving sterility; only those who haven’t completed the induction phase remain uncertain. These factors will be vital in our discussions with the FDA. While there may be a chance to accelerate the NDA filing slightly in 2023, we'll need to evaluate how those key factors unfold throughout the year. As for the costs associated with Cohort 5, we anticipate that the NIH will cover them, and that process is already underway. Dr. Bower is collaborating with the NIH on this, and they have been an excellent partner for Matinas and our platform. We expect that support to continue. Historically, Matinas has primarily contributed to the manufacturing and supply costs of the drug, along with some study monitoring, but we are confident that regardless of the size of Cohort 5, the NIH will be willing to assist, which is significant for us. Our cash flow projections reflect this expectation, and we would not proceed without strong confidence. David Bower maintains a robust relationship with the NIH as well. That covers our perspective on MAT2203. I think I missed one of your questions, so please remind me what the third point was.

Greg Fraser, Analyst

Just how to think about R&D and G&A spend.

Jerome Jabbour, CEO

Yeah. I mean, obviously, we're continuing to invest in the platform, but we're doing so in a disciplined way. Adding headcount has increased 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. 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 six months internally here as we've shifted away from LYPDISO, and that would continue sort of on a straight line through 2023 as well.

Greg Fraser, Analyst

Great. Thank you so much.

Jerome Jabbour, CEO

Thank you.

Operator, Operator

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

Jerome Jabbour, CEO

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 updates on our future progress. Have a great day.

Operator, Operator

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.