Matinas BioPharma Holdings, Inc. (MTNB) on Q1 2022 Results - Earnings Call Transcript
Operator: Welcome to the Matinas BioPharma first 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 Peter Vozzo, Investor Relations representative for Matinas BioPharma. You may begin.
Peter Vozzo: Thank you. Good morning everyone and thank you for joining the Matinas BioPharma first quarter 2022 results conference call. Early 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; 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 who will be available to answer questions during our Q&A session. At this time, I would like to remind our listeners 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 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 in the 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 will now turn the call over to Jerry.
Jerome Jabbour: Thank you Peter. Good morning everyone and thank you for taking the time to join us today. This morning, we will review our 2022 first quarter financial results and provide a business update. Despite an incredibly challenging market for biotech stocks, we have managed to make substantial progress across our business during 2022. We continue to validate our disruptive LNC platform delivery technology by delivering consistent and compelling clinical and pre-clinical data in the advancement of our internal pipeline. At the same time, our external collaborations focused on expanding the reach of our LNC platform also continued to yield new data and exciting new molecules to encapsulate. Our recently announced partners with messenger RNA pioneer, BioNTech, provides clear external validation for our LNC platform from a global pharmaceutical leader and creates the opportunity for the oral administration of messenger RNA vaccines and other cutting edge therapeutics which could potentially benefit hundreds of millions of patients. Our own internal discovery programs built around pre-clinical data further validating the LNC delivering of nucleic acids and other biological materials, combined with our ongoing projects with Genentech and Gilead, provide momentum as we seek to capitalize upon the significant potential for our proprietary next-generation drug delivery technology. Joining me today to speak to all of the progress we have been able to make so far this year are Dr. Matkovits and Dr. Ferguson, and it’s my pleasure to turn the call over to Terry Matkovits to guide us through the updates on our clinical stage LNC assets.
Theresa Matkovits: Thanks Jerry and good morning everyone. I’d like to begin by discussing some very exciting developments with the MAT2203 program, which is our oral LNC formulation of the broad spectrum fungicidal drug, amphotericin B. Our ongoing EnACT trial is a Phase II evaluation of MAT2203 in HIV patients suffering from cryptococcal meningitis, a deadly fungal disease. With compelling data already demonstrated in the first three cohorts of this trial, we are currently enrolling patients in cohort four, which began in late January of 2022. Cohort four is studying an all-oral regimen of MAT 2203 during the 14-day induction period followed by four additional weeks of oral consolidation therapy with MAT 2203. Cohort four is comprised of 40 patients on MAT2203 administered with 5-FC and a control group of 16 patients receiving IV amphotericin B, also administered with 5-FC. As discussed previously, this is an especially informative cohort of patients since patients in the MAT2203 group do not receive any dose of IV amphotericin and therefore represents a great opportunity to demonstrate the clinically meaningful impact that oral MAT2203 can have in treating these highly vulnerable patients. We are very pleased to report that 50% of the patients for cohort four have been enrolled and that enrollment continues to meet our expectations. Further, all patients currently on active treatment are reported to be doing quite well, which is a very good sign at this point in the trial. The DSMB review of 50% enrolled patients is scheduled for the end of this month and, as with past reviews, will include a review of the overall safety as well as efficacy data from the cohort. We do not anticipate making any announcement following the DSMB review, but enrollment in this open label cohort is anticipated to complete early in the third quarter of 2022 with reporting of top line data also anticipated in the third quarter of 2022. Turning now to the regulatory strategy for our MAT2203 development program, we recently held a productive follow-up clinical type C meeting with the FDA and have received written feedback concerning the confirmatory data required to support the submission of a new drug application - NDA for MAT2203. As reflected in the official minutes of the meeting, the FDA is now considering the potential registration of MAT2203 for both a step-down induction indication as well as a consolidation treatment indication based upon a single Phase III confirmatory trial. This pivotal registration trial will feature a non-inferiority design comparing MAT2203 administered with 5-FC with a control arm of IV amphotericin also administered with 5-FC, randomized two to one in favor of MAT2203 as induction followed by consolidation therapy in HIV patients with cryptococcal meningitis. Critical elements of EnACT III will include a primary end point of two week all cause mortality for an induction indication, a non-inferiority margin of 10% translating into a total trial size of approximately 250 patients with 80% power, and a key secondary end point which may include meningitis relapse-free survival time through 18 weeks to evaluate consolidation treatment in support of a single NDA filing for both induction and consolidation treatment with MAT2203 in patients with cryptococcal meningitis. This streamlined development pathway represents a meaningful improvement from customary requirements for an NDA filing which traditionally requires two adequate and well controlled Phase III trials for registration. We plan to meet with FDA early in the third quarter of 2022 to finalize the trial design and we anticipate that the pivotal Phase III registration trial will commence later in 2022, assuming the continued financial support of the National Institutes of Health. Looking outside of the United States, we are pleased to report that we recently submitted a formal request for scientific advice to the European Medicine Agency, or EMA to facilitate the a development and registration program in support of expanding the regulatory footprint for MAT2203 globally. We anticipate receiving feedback on our package later this year. Concurrent with the EMA process, the company remains in discussions with key third parties interested in obtaining rights to MAT2203 on a global and regional basis. As part of our life cycle management program for MAT2203 focused on unlocking the full clinical potential of MAT2203 as an oral and safe version of the most fungicidal anti-fungal drug available, the previously planned pre-clinical studies of MAT2203 in Candida auris and mucormycosis have been initiated to support potential label expansion for MAT2203 into the treatment of other invasive fungal infections. We are excited to report today that preliminary data generated to date demonstrate that MAT2203 is as effective as liposomal amphotericin B in protecting against mucormycosis, a deadly invasive fungal infection. Additional confirmatory studies in different strains of mucormycosis are ongoing. Further pre-clinical evaluation of MAT2203 against Candida auris was initiated in April of this year and preliminary data is expected early in the third quarter of 2022. Finally, in anticipation of filing an NDA for MAT2203 following conclusion of our planned Phase II registration trial in cryptococcal meningitis, during the first quarter of 2022 the company selected and reached agreement with Thermo Fisher Scientific to support scale-up and manufacturing for MAT2203. Thermo Fisher Scientific, with more than 65 locations around the world, provides integrated end-to-end capabilities across all phases of development, including APIs, biologics, viral vectors, CGMP plasmids, formulation, clinical trial solutions, logistics services, and commercial manufacturing and packaging. This is a significant step forward for MAT2203 and for our platform technology, and we look forward to working alongside such a well-respected and experienced partner to achieve our CMC objective. I’d like to turn now to MAT2501, our oral LNC delivered amikacin product under development initially for the treatment of non-tuberculous mycobacterial, or NTM infections. This program is focused on delivering the first and only oral aminoglycoside with the potential to treat both acute and chronic bacterial infections, pulmonary and disseminated. Our team has made significant progress to advance the program with several critical pre-clinical tox studies that should enable the longer term dosing required for our planned Phase II safety and efficacy trials. In the meantime, we recently completed our clinical single ascending dose trial with our optimized MAT2501 LNC formulation in healthy volunteers and we are pleased to able to share our top line results with you this morning. Overall, the results from the trial confirmed earlier findings with the legacy formulation of MAT2501 at the same doses tested - 200, 400 and 800 milligrams, along with an additional higher dose of 1000 milligrams evaluated only in this study. Overall, there were no serious adverse events or study discontinuations in the completed study. No significant increases in adverse events were seen with MAT2501 generally or any associated with an increase in the MAT2501 dose administered, with the exception of diarrhea which was mild to moderate in severity and not inconsistent with what we have seen at very high doses of other LNC formulated small molecule drugs. There was no evidence of any renal or ototoxicity observed in the trial, which are the two most common toxicities seen with IV administered amikacin. From a pharmacokinetic perspective, there was a relatively rapid absorption of MAT2501 with oral administration with the time to maximal concentration of approximately two hours. There were dose proportional increases in amikacin levels observed with increased dose, demonstrating good absorption of drug via oral delivery. Importantly, circulating plasma levels of amikacin with our LNC platform were significantly lower than IV administered amikacin, which is expected to translate to a more favorable safety profile. We look forward to submitting and discussing these data with FDA and the Cystic Fibrosis Foundation as we plan next steps for our MAT2501 development program and anticipate being in a position to potentially commence a Phase II program in 2023 following completion of the ongoing and planned long term tox studies with MAT2501. I’d like to now turn the call over to Dr. Terry Ferguson who will discuss exciting developments with some of our external collaborations.
Terry Ferguson: Thanks Terry. I’d like to take a few minutes to update everyone on some of our external research collaborations and the substantial progress we’ve already made this year. First, we very recently received data from the second in vivo study of oral LNC remdesivir in mice infected with SARS-CoV-2. The study performed in collaboration with the National Institute of Allergy and Infectious Diseases - NIAID, and the Department of Epidemiology at the University of North Carolina at Chapel Hill demonstrated that an oral LNC formulation of remdesivir significantly reduced viral lung titres as early as day two, significantly improved lung congestion scores, and significantly improved COVID-associated weight loss in a well established model of SARS-CoV-2. We are still waiting final histological analyses and will shortly be discussing next steps with the NIAID and Gilead. These data are important for two reasons: first, the therapeutic efficacy against SARS-CoV-2 of an oral formulation of remdesivir itself, and second, the very encouraging early knockdown of lung viral titres, something that might not otherwise be expected with conventional IV remdesivir. Next, Matinas has also expanded its ongoing collaboration with Genentech to include a third compound, a specialized antibody fragment for which Matinas will be creating an optimized oral LNC formulation. For Matinas, this is a particularly exciting project because it represents an opportunity to take advantage of the protection that LNCs provide and apply it to fragile biologics that would otherwise not be able to withstand the hostile environment of the GI tract. We anticipate that oral formulations of this compound will enter pre-clinical testing in the next few months with potential results anticipated later in 2022. Finally, I’d also like to provide some of my own perspectives on the BioNTech collaboration. For me, one of the most exciting aspects of this program is how it builds on a very strong foundation of prior in-house vaccine work with LNCs which to date has not gotten a lot of external attention. Our work with oral LNC amphotericin and amikacin, the ongoing collaborations with NIH and Gilead on oral remdesivir and Genentech in developing oral formulations of difficult to deliver molecules have all taken advantage of the unique capabilities of LNCs for intracellular delivery. The collaboration with BioNTech takes this a step further into the realm of delivering vaccines into the complex biological world of cellular and humeral interactions in the immune system, areas where the LNCs have already shown a large body of in vivo vaccine work with proteins, peptides, DNA plasmids, and even DNA protein complexes, successful oral immunization, robust antibody and cellular responses to LNC vaccines, both of which persist over time, can be boosted with repeat administration, and can be even further enhanced with adjuvants, systemic and mucosal responses following oral administration of LNC vaccines, in some instances the cellular responses were substantially stronger than with native infections, a high degree of inhibition of viral replication, and demonstrated enhancement of the antibody response to an LNC formulation of a commercial flu vaccine. LNC vaccine delivery can thus be differentiated by flexible routes of administration - subcu, IM, by inhalation and oral, enhanced mucosal and systemic responses with humeral and cellular immunity, a breadth of effective vaccine payloads - proteins, peptides, DNA plasmids and DNA protein complexes with potentially more to follow, a delivery mechanism that is itself not immunogenic and not associated with resulting potential adverse reactions, and the opportunity to create much more stable formulations. When you combine this strong foundation of prior work with BioNTech’s vast experience with mRNA vaccines and add to this mix the strengths of the LNC platform itself and our own internal expertise in creating LNC formulations that can potentially take intracellular delivery in whole new directions, you can begin to understand why this is such an exciting collaboration for us. Throughout the course of this collaboration, we will be learning a great deal about both the subtle nuances of creating LNC formulations for a variety of nucleic acids as well as refining techniques for successfully delivering them to different target tissues. This additional knowledge will in turn establish a deeper and broader foundation for the LNC delivery of additional payloads to other targets, allowing us to both forge additional potential partnerships and to establish our own robust internal pipeline of nucleic acid or other therapies that take full advantage of the unique capabilities of our LNC platform to package and deliver highly sensitive biologics. We’re really looking forward to sharing additional updates on our progress during 2022 and beyond. I will now turn the call over to our CFO, Keith Kucinski who will discuss our financial results. Keith?
Keith Kucinski: Thanks Terry and good morning everyone. Today, the company reported a net loss attributable to common shareholders of approximately $6 million or $0.03 per basic and diluted share for the first quarter of 2022 compared to a net loss attributable to common shareholders of $5.2 million, also a net loss of $0.03 per share basic and diluted for the same period in 2021. Research and development expenses were approximately $5 million in the first quarter of 2022 compared to approximately $3.2 million in the same quarter of 2021. The increase is due primarily to higher development expenses associated with advancing our internal product candidates and higher people costs as organizational headcount has grown year over year. General and administrative expenses were approximately $2.7 million in the first quarter of 2022, down from $3.1 million in the same period of 2021. Cash, cash equivalents, and marketable securities at March 31, 2022 were approximately $43.9 million compared to $49.6 million at December 31, 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.
Jerome Jabbour: Thank you Keith. In summary, efficient, effective and safe delivery of molecules and therapeutics is mission critical to the future of all medicines but especially so for nucleic acids and other biological materials. Embodied in our LNC technology, we have a unique and differentiated true platform which provides solutions to some of the significant challenges faced by other delivery modalities, including lipid nanoparticles and viral vectors. We continue to generate impressive data across all our programs, further validating our technology. Our team has managed to keep its collective eye on the ball in adroitly executing our strategic plan under challenging conditions. We are extremely pleased with the positive impact our MAT2203 has had on saving patients’ lives, and we look forward to reporting additional confirmatory data from cohort four of EnACT in the coming months. In also aligning ourselves with pharma giants hungry for an effective delivery platform and a resultant competitive advantage, we are building a strong foundation across the board. With a cash runway through 2023, we believe we are well positioned to take advantage of some of the numerous catalysts and milestones lining our path ahead over the next several months and quarters. We’re grateful to our investors for joining us on this exciting journey and we look forward to keeping everyone apprised as to our progress moving forward. This concludes the end of our prepared remarks, and I will now turn the call back over to our Operator, Peter to facilitate a question and answer session.
Operator: Our first question is from Bert Hazlett with BTIG. Please go ahead.
Bert Hazlett: Thank you. Congratulations on all the progress - very impressive. I have a number of questions, but in fairness to my colleagues on the phone, I’ll ask only one or two and come back to them. Jerry, with the BioNTech and the movement toward a formal license agreement, without getting too far ahead of yourself or anybody, could you just outline the general terms which you would like to see in such an agreement, and then I have a couple on 2203, but would love to hear that.
Jerome Jabbour: Sure, thanks for the question, Bert. Obviously there’s a lot of attention on a relationship like this, specifically because of the visibility BioNTech brings not only to the messenger RNA space but now to our technology. The foundation of this relationship began with science, and so it was very, very important for us with BioNTech that they truly wanted to collaborate with us, so right now we’re intently focused on that collaboration, essentially letting them into our kitchen, the appropriate protections are in place there, so that they can fundamentally understand what we’re doing, and that’s going to be central to then arriving at what we believe can be a deep and extensive relationship in the form of a license agreement, whether it begins with an option to license agreement with appropriate trigger points. There’s plenty of precedent in this area both with delivery vehicles, also in the vaccine space about what these relationships look like, but our discussions have centered around both trying to get a fundamental understanding of just how broad the relationship is, are we talking about the entire field of messenger RNA, are we talking about particular products. Those are very thoughtful, complex discussions, but beginning from a shared interest in optimizing the value of our collective technologies for the benefit of patients. We believe that it’s going to look very much like an option to license or a license agreement. The biggest questions now are breadth of exclusivity, how closely we’re going to work together, and what is then our ability to take things that we learn as a result of this collaboration and apply them into other areas of nucleic acids, that’s especially important for Matinas, and so in looking at some of the delivery deals that have been done just in the last six months, without naming them specifically, they’re pretty easy to find if you Google them, it would consist of sort of the normal upfront payments, a variety of triggers, development milestones, and then royalties associated with sales of the product. The real wildcard here is just how much does BioNTech want to control the field of messenger RNA, and I think there’s obviously a great deal of value associated with something like that and a truly exclusive relationships, giving a multitude of areas that you can take messenger RNA vaccines, so that remains to be seen. Very encouraged by the spirit of discussions which really began at the highest levels between Ugur and myself quite a while ago. That spirit has continued and we’re working to sort of finalize that, no update on timing, and we won’t be commenting on it more broadly other than on today’s call. Hopefully that gives you a sense of how it could be framed.
Bert Hazlett: That’s very helpful. Good luck with all of that. Then a couple on 2203. Cohort four is pretty meaningful, as you mentioned in the opening remarks, a number of you did, with an all-oral induction and consolidation regimen. Could you just benchmark safety and efficacy readouts that would be upcoming for that? Then with regard to the registrational process - thank you for the additional color, congratulations on all that. Is there a way to win, and I’m air quoting there, on the safety side of things, and is there an ability to harmonize the process with the EMA during your discussions? A lot there in those questions, so I’ll shift it back over to you after those.
Jerome Jabbour: Great, thanks Bert. All right, so let’s take them one at a time. Cohort four, as you point out, really is a big cohort. I mean, obviously we’re thrilled with the results from cohort two, where there was an IV lead-in, but when you’re talking about an all-oral regimen of MAT2203, you’re removing any doubt about the impact of IV amphotericin on efficacy during the induction period, so cohort four is a big one, very pleased with what we’ve seen so far. Dr. Boulware is reporting that all patients are doing well, so the next readout for that really will be the announcement update of the full data set from cohort four, which we continue to anticipate will occur in Q3 of this year, so right around the corner going to get a look at really what was now the fully envisioned complete EnACT study, where you’re getting that look at both transition from IV to oral therapy and then what is the patient experience with an all-oral regimen of MAT2203, so figure right smack in Q3 there. Exactly when in Q3, it’s hard to predict based upon enrollment, but that continues to move along well, but that’s a big data point certainly for our program, certainly will help continue to encourage FDA to work with us in a way that makes this drug available to patients as soon as is reasonable under the circumstances, but that’s a big data point for us in Q3. When we look--and then you asked a question on safety and can we differentiate, that’s a big deal, so safety and convenience of administration are two big wins, and that’s just within the induction period, but you’re also--with the way that we can encapsulate and deliver amphotericin, you’re also positioning it to be--for the potential to be used in a way that it could never in the past, so you’re also optimizing and extending the potential use of the most broad spectrum anti-fungal drug beyond induction, so yes, we want to win on safety, we want to win on convenience, we want to win on health economics, getting people out of the hospital sooner - we know that that’s a valuable sort of point for payors, and then certainly we want to broaden the opportunity for physicians and patients to have the benefit of being able to use the broadest spectrum drug, which in and of itself chemically is not as susceptible to the development of resistance, which means it really can be used for a long period of time because of the way it really attacks the fungus. Then to go to the third point, I’ll ask Dr. Matkovits to chime in here on our strategy with FDA and EMA. She’s spent an incredible amount of time putting together even a more comprehensive package for EMA than is required for FDA, and she and her team did that in just under two months, so she’s in best position to sort of talk about synergies and how you harmonize that and how we’re approaching expanding the global footprint of this drug.
Theresa Matkovits: Thanks Jerry, and thanks for your question, Bert. Just to follow on, it is exactly our strategy, as you’ve indicated in your question, to harmonize the regulatory and global footprint of our development program, so with the timing of the start of Phase III later this year, we are able to get that very important feedback from the European regulatory authority to gain alignment on what a registration trial would need to be in order to support global registration, and we believe that the timing lines up very well across both FDA and EMA that will allow us to really optimize the design of this Phase III trial to meet both regions’ regulatory requirements.
Jerome Jabbour: And to just add onto that, Bert, at the end of the day there is really a dual purpose to everything we’re doing here. Fundamentally, we understand that in a safe and oral version of amphotericin, you have the potential for a broad reach not just with cryptococcal meningitis but for all invasive fungal infections, so everything here is about positioning this drug to optimize its potential in being the key agent in the treatment of all invasive fungal infections. We know, based upon the data, that the prevalence of these invasive fungal infections, including cryptococcal meningitis, are higher outside of the U.S., so it was a necessary approach for us whether we were going to completely hold onto this asset ourselves and build a global franchise or respond to the interests, comments and questions of parties who are interested in taking this drug and commercializing and developing it outside the U.S., that we had those necessary inputs to be able to inform strategic discussions, so harmony is key. FDA has been a great foundation. The EMA now has the full data package. We’ll engage in those discussions in the third and fourth quarter of this year with the idea that we do want total alignment here because it will help us and our partner to optimize the value of this drug.
Bert Hazlett: Thanks for all that. I’ll hop back in the queue. Thanks.
Operator: Thank you. Ladies and gentlemen, if you would like to ask a question, please press star, one on your telephone keypad. We have a question from Bert Hazlett with BTIG. Please go ahead.
Bert Hazlett: The next steps for 2501, then, the Phase II for NTM infection can start when? Maybe I missed that in your comments. Then I think you’ve mentioned previously, Jerry, about planning for other indications. Do you have any evolution with regard to 2501 with regard to indications beyond NTM? Thanks.
Jerome Jabbour: Sure. I’ll let Dr. Matkovits handle the first part of that question, and it really has to do, Bert, with putting in place sort of the long term tox studies. Terry, why don’t you shed some light on what’s necessary to put us in position to start Phase II?
Theresa Matkovits: Sure. We are currently in the middle of a very important tox study that will allow us to treat patients through 90 days, which really would cover the treatment duration based on our preliminary thoughts for our Phase II development program. Based on the current timelines, we anticipate meeting with the FDA at the end of this year or early next year to share with them our Phase II development program, get alignment on study design, and be in a position to initiate a Phase II trial in probably quarter two, quarter three of next year.
Jerome Jabbour: And then Bert, just to talk about planning for other indications, the reality of amikacin from a profile perspective, it’s not dissimilar in its broad spectrum nature from the way amphotericin is viewed in the anti-fungal space. Amikacin is a very broad spectrum aminoglycoside which has impact and efficacy against, for example, both gram negative and gram positive infections. NTM was a natural place for us to start because of the pre-clinical data that was generated in NTM by Dr. Mannino and his colleagues and working with Eugene Bermudes and others, and so it made sense to stay on that path particularly with the support of the Cystic Fibrosis Foundation, who is eagerly looking for a solution that a drug like can’t fill, so there is first sort of the unique profile of our ability to encapsulate amikacin and get it directly to the lung, it’s going to broaden the potential uses in the NTM market, but then you don’t have to look far to see the graveyard of drugs that have been attempted to be developed for the treatment, for example of gram negatives, of UTIs and things like that, we’re trying to be careful with how we resource these programs and how we advance them, sensitive to utilizing as much as possible non-dilutive funds. The team continues to evaluate how we brought in indications outside NTM - that’s actually something that’s planned for the second half of this year, but if you historically look at aminoglycosides and their potential for the treatment of other disseminated bacterial infections, the data are there, you just haven’t been able to really use amikacin for those before because of the toxicity profile. The pathway is there, the logic is there, the indications are there, and that’s something that we’ll be focused on as we move this program forward closer towards Phase II in NTM. It’s also something that we’re talking to third parties about who recognize the potential for the first oral aminoglycoside, so at Matinas we’re in a little bit of a unique position. We’re certainly not resource starved but we’re resource conscious. I think we’ve done a good job of utilizing non-dilutive funds to advance both our clinical stage assets. We want to continue to do that, and then as much as possible expand those indications at the right time, with the right resources. That’s all part of our plan.
Bert Hazlett: Okay, thank you for that. That’s an intriguing program as well. You’re making material progress broadly on the LNC collaborations. Want to make sure we don’t give short shrift to the LNC remdesivir. I want to ask this - the COVID pandemic has gone--has evolved in a number of different ways, as we all know, but with what urgency should we be thinking about the advancement of LNC remdesivir? Just one last one, how should we think about your plans on evolving the antibody fragment program and other efforts with Genentech? Is that data going to be published, press released? Just would love to get a sense of how we should understand the potential evolution of that research agreement. Thank you.
Jerome Jabbour: Thanks Bert. Appreciate the questions, and glad you brought both of these up because these relationships are important, but they also share a certain similarity. When you work with the 800-pound gorillas, you’re not always in control of how data is discussed and disseminated, so in terms of when things will be announced and published, we obviously as much as we can practically within the confines of what we believe we need to disclose legally, we’re sort of bound by what they want to do in terms of data announcements. But let’s take each of those in turn. With Gilead, you just heard on their call the other day that they believe in the future of oral remdesivir, so we do and are cognizant of the fact that they are approaching that in a number of different ways. They do have and have developed a pro-drug of remdesivir - it’s not remdesivir, to be clear, that they have also studied in pre-clinical models at UNC. Ours actually is an oral version of remdesivir, which obviously has regulatory advantages as you think about streamlined development pathways, so the enthusiasm is there. For us, we need the full data set from UNC and NIH. We’re still waiting on the histo. We will reengage with Gilead at that time, although they’ve already seen the data generated to date. It goes beyond just how we think about remdesivir and the fight against COVID-19. The oral delivery, efficient delivery of an anti-viral has broad implications, so for us it’s sort of a dual path. We certainly are interested in continuing to engage with Gilead and really optimizing the potential remdesivir has as an oral--actual remdesivir has an oral drug, and so we’ll do that, but for a platform company, this sort of proof of concept demonstration of an anti-viral, intracellular delivery of an oral anti-viral is big, so it checks a number of boxes. We would expect at some point that this data will be published, and that’s something that remains under discussion with Gilead. Genentech is not dissimilar in the sense that we’ve already got a small molecule in an ASO, which we’ve successfully encapsulated and delivered. Genentech is really looking at this holistically, so they really want to see the data across all of these programs. On one hand, that requires a little bit of patience; on the other hand, I like the fact that at least to our mind, they’re looking at this as a true platform and how it could solve a lot of their delivery challenges. Just having now the opportunity to move from small molecules to an ASO, and now to an antibody is progress as well - it’s expanding the breadth. We already have received these materials from Genentech. The team, alongside everything else we’re doing, is slotting these in for formulation activities in the next few months. Our plan is to prepare those, get those back to Genentech to run through their in vitro models, and then we do expect that there would be data available later this year. How and when that’s presented, obviously, is subject to Genentech and our obligations of confidentiality, but in our experience good data finds a way to be made public, so that’s the confidence that we have. That’s the way our team is approaching this, and just this collection, whether it’s Genentech, whether it’s Gilead, whether it’s BioNTech, whether it’s our own clinical stage assets, everything we’ve announced so far over the last year has demonstrated our ability to do this successfully. That’s not a guarantee that everything we’ll ever do will work, but we have to like how things are lining up, and with each step we take with each of these relationships and with our own programs, we’re showing that this LNC platform, we think can be a real difference maker in the delivery field.
Bert Hazlett: Thanks for all that. Just one quick follow-up, do you expect this collaboration with Genentech to evolve maybe in a way that you’re seeing things move more rapidly with the BioNTech collaboration? Is that the goal here, or will this at some point?
Jerome Jabbour: It’s absolutely a goal, Bert. You have different goals when you start different collaborations. It was a great proof of concept. I think the BioNTech has brought sort of a stamp of approval from a big pharma. We’d love to get to that point with Genentech, and anything else is about does it maximize the value that our technology brings. The relationship with Genentech is broad, it’s across a number of different molecules, so yes, one key for us is generating the data necessary to, I would say, better formalize especially from a financial perspective our relationships with Genentech. For the present time, we’re sort of content with continuing to generate great data, and in our experience and the experience of our board of directors, ultimately that leads to somebody becoming very interested in controlling that. We’ll continue to do our part under these collaborations. We do think that that has great potential for us to become a more cemented relationship. How and when is what remains to be seen.
Bert Hazlett: Terrific, thanks for all that.
Operator: Thank you. Ladies and gentlemen, we have reached the end of the question and answer session, and now I would like to turn the call back to Jerry Jabbour for closing remarks.
Jerome Jabbour: Peter, thanks very much, and thanks to all our valued and loyal investors who have been following us. We’re thrilled with the progress we’ve been able to make during 2022, very cognizant of the market we’re operating in, but intent on continuing to check boxes, deliver on our corporate strategy and line up milestones and catalysts over the balance of this year and early next year, which we think will put us in position for people to better recognize the value of having a differentiated drug delivery platform. We hope you have a great day and look forward to keeping you apprised of our progress. Take care.
Operator: Thank you. This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.
