Matinas BioPharma Holdings, Inc.
Q2 2020 Earnings Call Transcript

Published: 11 Aug 2020

[Operator:]

Welcome to the Matinas BioPharma Second Quarter 2020 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 from Matinas BioPharma. You may begin.

[Peter Vozzo:]

Thank you, Jessie. Good afternoon, everyone and thank you for joining the Matinas BioPharma second quarter 2020 results conference call. Just after the market close today, we issued a press release with our second quarter 2020 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. We also have Dr. Terri Matkovits, Chief Development 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, 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 the Matinas BioPharma's current expectations and actual results may 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 on the company's website also in the Investor Relations Section. Following the companies prepared remarks we'll open up the call for a question and answer session. I'll now turn the call over to Jerry.

[Jerry Jabbour:]

Thank you, Peter. Good afternoon and thank you for taking the time to join us today as we provide a business update and discuss our 2020 second quarter results. We hope that you and your families have been well during these uncertain and challenging times. The second quarter of 2020 was unprecedented in all respects. Fortunately, as a company and as a team, we have been able to remain focused on execution, and on getting our clinical programs back on track as a key priority during the second quarter. I would first like to commend our employees for their extraordinary commitment to our mission, as we implemented a variety of processes, which successfully allowed us to advance both of our internal development programs while continuing to emphasize the safety of patients, our research and development partners, and our internal team. From a clinical perspective, we are pleased to announce that both the ENHANCE-IT study of MAT9001 and the EnACT study of MAT2203 have actively resumed enrollment after a temporary pause due to the pandemic in the second quarter. Beginning with MAT9001, we are rapidly approaching completion of our enrollment in our ENHANCE-IT trial, our head-to-head crossover comparative study of MAT9001 versus Vascepa. This clinical trial remains an important and compelling study for our next generation prescription Omega-3 therapy. With more than 90 out of 100 patients randomized and dose to-date in ENHANCE-IT, we expect to complete enrollment in August and remain on track to have top line data available early in the first quarter of 2021. We continue to believe that MAT9001 has best-in-class potential in the prescription Omega-3 class with clear differentiation in pharmacokinetics and impact on lipid markers such as triglycerides and PCSK9. We look forward to the ENHANCE-IT data to provide important information on the potential for MAT9001versus placebo across these markers. We also remain on track to meet with the FDA for an End-of-Phase 2 meeting evaluating MAT9001. The meeting will focus on the results from our recently completed comparative clinical bridging bioavailability study and the 90-day comparative toxicology study, both to support a potential 505(b)(2) registration pathway. During this meeting, we will also review the protocol for a plan Phase 3 registration trial of MAT9001 in patients with severe hypertriglyceridemia. Assuming we can reach agreement with FDA on the above issues, we would expect to begin our Phase 3 program in 2021. MAT9001 has understandably been the focus of investors' intention over the past 18 months. And unintended result of this attention on MAT9001 however has been the lack of focus and understanding for the enormous potential of our lipid nano-crystal or LNC platform delivery technology. To put it simply, Matinas is much more than a single asset Omega-3 biotech company. With our LNC platform delivery technology, Matinas has the opportunity to develop a multitude of therapies both internally and in collaboration with biotech and pharmaceutical partners. The safe and targeted delivery of therapies continues to be one of the most challenging areas of drug development. Unfortunately, this is nowhere more prevalent than in the battle against infectious disease, which has come roaring back to the forefront in terms of clinician and investor focus due to the COVID-19 pandemic. We have spent the last two years since the reemergence of MAT9001 advancing this technology with the financial and scientific support of the National Institute of Allergy and Infectious Disease at NIH, led by Dr. Tony Fauci. In addition, we have forged relationships with some of the most respected names in the pharmaceutical industry to advance the breadth of application for our LNC platform delivery technology. We have recently emphasized that MAT2203, our oral LNC formulation of the broad spectrum antifungal drug amphotericin B represents a gateway opportunity, both in terms of advancing the critical care of patients suffering from deadly fungal diseases and as a demonstration of the capabilities of our platform. Given our progress in this area and the resumption of enrollment in our EnACT trial of MAT2203 in cryptococcal meningitis, we are very close to data which could represent a transformational opportunity for Matinas. We believe that cohort progression in the EnACT trial, combined with ongoing and potential new collaborations for our LNC technology with big pharma molecules could change the perception of Matinas in the eyes of the market and in the eyes of clinicians and patients. We are excited by this potential and remain committed to capitalizing on the opportunities to be created through the safe and targeted delivery of a variety of medicines. With that backdrop, I would like to go into more detail on MAT2203, our lead drug candidate applying the LNC platform delivery technology. In MAT2203, we believe we have the potential gold standard and drug of choice for the treatment, and potentially the prevention of deadly invasive fungal infections. Building on extensive and impressive preclinical data in the treatment of invasive fungal infections, and two separate Phase 2 studies conducted in the treatment of mucosal fungal infections, MAT2203 is currently being investigated for the treatment of cryptococcal meningitis, a deadly invasive fungal infection of the central nervous system. The EnACT study, which is financially supported by the NIH is a study to treat HIV infected patients with cryptococcal meningitis in Uganda. This Phase 2 study is designed to explore the use of MAT2203 for both induction and maintenance therapy in these very sick patients. As we previously communicated, all clinical studies being conducted in Uganda, including EnACT were suspended in March of this year by mandate of the Uganda National Drug Authority due to the threat posed by the COVID-19 pandemic. Due to the hard work of our internal team in collaboration with the clinical staff on-site in Uganda, we are pleased to confirm that enrollment resumed in EnACT in July. To-date several patients have been randomized and dosed in the first cohort of 10 patients. As a reminder, patients in cohort 1 begin treatment with five days of IV amphotericin, followed by nine days of oral MAT2203 for the balance of the 14-day induction period. Thereafter, patients are transitioned on to four weeks of maintenance therapy with MAT2203 in combination with flucytosine. The primary endpoint for EnACT is measured at the end of the induction period, and includes a measure of reduction and fumble count in the cerebral spinal fluid, an independent Drug Safety Monitoring Board or DSMB will review all data for both safety and efficacy and make a recommendation as to whether to proceed to the next cohort of patients. Because we were able to resume enrollment in EnACT in July, we currently remain on track to make an announcement as to potential progression from the first cohort of patients to the second cohort of patients early during the fourth quarter of this year. We believe cohort progression is significant with this drug in this patient population, and an important potential value inflection point for this therapy. As we look to evaluate data from EnACT and the implications on the development of MAT2203, as well as our LNC platform technology, we do believe it is important to provide a bit more information and context on the challenges that cryptococcal meningitis infection represents for patients on the one hand, and in the treatment of these patients on the other. Cryptococcal meningitis has emerged as one of the most frequent and deadly opportunistic fungal infections in human immunodeficiency virus or HIV patients. Although these infections are common in patients with HIV, they can also occur in other immunocompromised individuals such as organ transplant recipients, cancer patients, diabetics, non-HIV infected and non-transplant hosts and other unique risk populations. Early mortality from HIV associated cryptococcal meningitis remains unacceptably high at more than 40%, enlarge due to the high cost, toxicity and relatively limited repertoire of effective anti-fungals. To make matters worse, IV amphotericin B, which is the current standard of care is limited in use by its crippling side effects including nephrotoxicity, anemia and infusion related reactions, or is otherwise unavailable to many patients due to the cost or inconvenience of infusion. Complicating treatment of cryptococcal meningitis is the location of this infection in the brain, which requires drug to be able to be transported across the blood brain barrier. This additional hurdle makes this infection a particularly challenging model for an oral treatment, which traditionally has not been able to effectively cross the blood brain barrier. As a result, the EnACT study represents a great challenge for MAT2203 both because of the seriousness of the underlying infection, but also because of the need to cross the blood brain barrier. Accordingly, the likelihood of success in a study like EnACT for any oral therapy is realistically small. However, MAT2203 unlike other oral therapies has shown the ability pre-clinically to cross the blood brain barrier to target an infection, which is very encouraging. We continue to view cryptococcal meningitis as an important and potentially valuable gateway indication for MAT2203. Following a possible approval to treat cryptococcal meningitis, we believe that MAT2203 would be well suited for streamlined 505(b)(2) approvals and other indications. As we have guided previously, this could position MAT2203 to become the antifungal drug of choice for the treatment of many invasive fungal infections. I would like to turn briefly to MAT2501, which is an application of our LNC platform delivery technology to the broad spectrum aminoglycoside drug amikacin, commonly used to treat chronic and acute bacterial infections. During the second quarter of 2020, we submitted an additional application to the Cystic Fibrosis Foundation for funding to develop this promising drug through Phase 2. We have previously received generous support from the Cystic Fibrosis Foundation to perform a variety of preclinical studies to evaluate the oral delivery of MAT2501, which would become the first ever orally bioavailable amino glycosides. Because of the impressive results of this pre-clinical work, the Cystic Fibrosis Foundation invited us to submit this application for funding, which was developed in consultation with the leading experts in the treatment of non-tuberculosis mycobacteria, a chronic bacterial infection of the lungs, which often impacts cystic fibrosis patients. We are awaiting a decision from the foundation, which has been delayed slightly due to complications from COVID-19. We expect to hear from them in the current quarter, and we'll provide an update to the market at that time. We remain particularly enthusiastic about MAT2501 given its profile, the unmet medical need, and the clinical and commercial success of Insmed's ARIKAYCE, which is an inhaled version of amikacin, recently approved under FDA's new LPAD pathway, albeit with significant limitations for its indicated use, due to a significant black box warning associated with inhaled administration. We believe that MAT2501 if approved would represent a significant improvement over ARIKAYCE and give patients and physicians the opportunity to utilize an oral therapy and the fight against this chronic infection, which often can require treatment up to 18 months. Further, unlike ARIKAYCE, MAT2501 could also potentially be utilized to treat acute bacterial infections such as gram negative bacterial infections, given the broad spectrum nature of amikacin. We look forward to providing an update on MAT2501 in the coming months. Finally, before moving to a discussion of our financials, we would like to provide brief commentary on our LNC platform collaborations. We continue to make progress across all of our collaborations. Although in certain instances, some of our partners attention has been adjusted to focus on COVID-19. However, Genentech, a Roche company has been particularly active and we have made significant headway with two of their molecules. We would expect additional progress over the balance of 2020 and potentially additional molecule formulation work extending into 2021. We are pleased with the nature of Genentech's interest and the pace at which that collaboration is moving. On the COVID-19 front, obviously, a lot has been made in terms of progress on the vaccine for the prevention of COVID-19. The nature of any vaccine program or our potential involvement is first to demonstrate safety and efficacy of the vaccine itself before moving on to formulation development and the potential to deliver that vaccine orally. We do believe that our LNC platform could potentially become a valuable tool for mass formulation and efficient and cost-effective delivery of a vaccine. However, in any endeavor of this nature, there would need to be an analysis of the chemical composition of the molecule and the mechanism of action of a target vaccine to determine whether it would be a good candidate for LMC delivery. It is not an automatic that our LNC platform delivery technology can be applied to a vaccine to make it orally bioavailable and effective. We remain in contact with the NIH for this type of effort but the reality is that we need to see one or more of these vaccines achieved the necessary demonstrations of safety and efficacy before we can have meaningful involvement. The development and approval for COVID-19 vaccine, however, is in stark contrast to the potential for applying our LNC platform to therapies currently used in the treatment of this infection, as well as in treating the subsequent and often overwhelming immune response. This is where our current attention is focused in collaboration with the NIH, and in discussion with potential large pharmaceutical partners. These discussions are progressing and we are moving as quickly as possible to consummate these relationships and programs, although nothing can be assured. Turning now to our financial results, for the second quarter of 2020, the company reported a net loss attributable to common shareholders of approximately $5.8 million or $0.03 per basic and diluted share, compared to a net loss attributable to the common shareholders of approximately $3.6 million or $0.03 per basic and diluted share for the same quarter the previous year. Research and Development expenses were approximately $3.4 million in the second quarter of 2020, compared to approximately $2.8 million in the same quarter last year. The increase was due primarily to higher clinical development expenses related to the development of MAT9001 and MAT2203. General and administrative expenses were approximately $2.4 million in the second quarter of 2020, compared to the previous year second quarter G&A expenses of approximately $1.8 million. The increase was due primarily to higher compensation expense associated with planned increased headcount. Turning to our balance sheet, we ended the second quarter of 2020 with approximately $68 million of cash, cash equivalents and marketable securities, compared to approximately $27.8 million at year-end 2019. This increase includes net proceeds of approximately $46.7 million from the company's public offering completed in January. Based on current projections, we continue to believe that cash on hand is sufficient to fund operations into the first half of 2023. This long cash runway is important, as we advance our products towards potentially significant data readouts and inflection points. In summary, we continued meaningful progress across our business in the first half of 2020. I thank my teammates for this and commend them for their continued dedication and drive as we all work together to get through these uncertain times. We also remain grateful for the patients enrolled in our clinical trials, whose participation provides important and meaningful data as we look to advance our product candidates. As we look ahead into the second half of 2020 and into 2021, we remain fully on track as we approach several important catalysts and milestones for Matinas. For our internal products candidates, we expect cohort progression from MAT2203 and EnACT during the fourth quarter of this year and topline data from MAT9001 and ENHANCE-IT early in the first quarter of 2021. In support of our business, we are maintaining a strong financial position, which will enable us to stay the course with several meaningful inflection points anticipated over the coming quarters. With that, we have reached the conclusion of our prepared remarks. And I will turn the call over to the operator to begin the question-and-answer session.

[Operator:]

[Operator Instructions] Our first question is coming from the line of Jason McCarthy from Maxim Group. Please proceed with your question.

[Michael Okunewitch:]

This is Michael Okunewitch on for Jason. Thanks for taking the question, congrats on the progress. As you mentioned on the call, the COVID pandemic has brought a lot of attention to the infectious disease space, and particularly surrounding how under average are and given that drug development antifungals kind of lag behind other forms of infectious disease, I'd like to see if you could discuss in a bit more detail some of the challenges that have made antifungal development so difficult and the need for a safer alternative like MAT2203 or even gold standard drugs like amphotericin?

[Jerry Jabbour:]

Michael, thanks very much for the question. So a lot of the challenges that we face in the development of antifungal drugs. I think first and foremost, there is just been a lack of focus on it. If you look at over the last 15 to 20 years, there has been a lack of investment in development of medicines in that space, because there were available therapies because they were cost effective, but the bugs have started to fight back. So you've had a lack of big pharma investment in that space. That's where the development of new therapies becomes so important, but then you start to talk about development hurdles, and the reality of developing an antifungal medicine means a demonstration as an initial matter in a non-life threatening infection, and that in and of itself takes time, it costs additional resources, and then you have the challenge of conducting studies in deadliest infections where patient recruitment can take a long time, and that becomes a challenge from a resource perspective, from an endpoint perspective, and certainly from an ethical perspective in the recruitment of patients. Oftentimes where FDA wants to look at these studies versus placebo, you can't really do that in those contexts. And so that's why we think our opportunity here at least as an initial matter is how do we take our technology, apply it to existing medicines, where we know that the drug is effective at killing the bug. So where the fungicidal therapies that could benefit from being made number one oral, but also a removal of toxicity when you talk about amphotericin B, doctors know this drug is ampho terrible. It actually can end kidney therapy after about 14 days of use, and so doctors are forced to make tough decisions between killing an infection or putting the patient's kidneys at risk. What we think we've been able to do, and we certainly have demonstrated this in collaboration with the NIH, is we really think we have an opportunity to take one of the most broad spectrum drugs and actually make it more available for patients and physicians to use. And that's ideal especially when you're dealing with fungal infections where you may not readily be able to identify the type of infection. So the sooner you can take a broad spectrum drug off the shelf and use it safely, that's going to become a first choice for physicians. There will always need to be other antifungal drugs in development and there are currently a number of them, but none of the profile of those drugs in development look like amphotericin B if it can be delivered safely and orally. And so - that's why I think our focus is in the right space and FDA when we met with them in the back half of last year, you saw our renewed interest even pre-COVID-19 in accelerating the development of these sorts of drugs and whether it's LPAD, or whether it's looking at a study, like EnACT with some positive demonstrations of efficacy and safety and the opportunity to turn studies like EnACT into a registration trial potentially, we do think there is going to be opportunities to take advantage of the current climate, which has a greater focus on infectious disease and the need to accelerate these through development and make them available for patients. Does that help?

[Michael Okunewitch:]

Yes, very much. So thank you for answering the question. And then I also have another one relating to today's news regarding the approval of a second generic Vascepa, but to see if you could comment on how the Vascepa generics could impact the space and more specifically, what does this mean for a second-generation Omega-3 like MAT9001. Would you anticipate the availability of generics have an impact on pricing or could it actually have a positive impact creating a greater access and familiarity in the market for when a potentially superior product enters the field?

[Jerry Jabbour:]

Yes, thanks, Michael. It's a good question. And I think it remains to be seen exactly how this impacts, whether it be from a pricing perspective or an access perspective. What is reality is that no one should be surprised that a second generic was approved, because the initial win by the generics and the district court opened up the ability for FDA to approve these products, pending an appeal and you're likely not to see any of these generic products launch in the phase of an appeal, which is set to be argued on September 2, and then potentially have a decision for the Vascepa later this year. It remains a constantly evolving and challenging market, but what is clear is that if the profile of MAT9001 continues to demonstrate that it is a superior drug to placebo, it has an opportunity to not only be a successful drug, but a drug that most physicians will write even over a generic. Pricing will always come into play but the way we've thought about our drugs and the way we can price it gives us a lot of flexibility as that market evolves. What we're really looking to see and this is why the enhanced study is so important. How do we once again stack up to Vascepa because if we demonstrate and ENHANCE-IT once again, that were superior on triglycerides, on reduction of PCSK9, on reduction of non-HDL cholesterol, on VLDL cholesterol if we do not raise LDL cholesterol, and we are achieving as high or higher blood levels of EPA that bodes well for the profile of our drugs in the eyes of both payers and physicians, especially when you're talking about an initial indication of severe hypertriglyceridemia, where the potency and reducing triglycerides matters. The reality of generic competition here is it's likely to make the entire market competitive, which underscores our need to have a better drug. The profile of our drug and the data to date suggests that that's true and ENHANCE-IT gives us another opportunity to demonstrate that. We keep a close eye on what's going on with Amarin, we do note that they continue to increase both new RXs, and total RXs, the numbers are going in the right direction. At the end of the day, generic entry Vascepa will most effect Vascepa and our job will continue to demonstrate with the data that we have a better job to Vascepa and any copy thereof. So it remains to be seen, but ENHANCE-IT will tell us a lot about the future of MAT9001.

[Michael Okunewitch:]

Next, I'd like to follow-up on something you mentioned there regarding the EnACT study. I'd like to see if you could just quantify a little bit how much of a change from baseline versus Vascepa you'd need to see to consider it, clinically meaningful and takes this to doctors and say we have, significantly better product?

[Jerry Jabbour:]

Yes Michael, thanks for the question. As we previously communicated this study, the ENHANCE-IT study has been powered on a primary endpoint for reduction of triglycerides to show a 10% delta. And we believe that that is clinically meaningful versus Vascepa in this space. And so, we're looking for that 10% delta on triglycerides. In our first head-to-head study in a patient population with triglycerides 200 to 400, we saw a reduction with MAT9001 of approximately 33% and a reduction with Vascepa at approximately 11%. Amarin and others were quick to point out that that Vascepa underperformed relative towards performance in both [Anchor] and in REDUCE-IT, where its triglyceride reduction in a similar patient population was around 18% to 19%. The reality of the way ENHANCE-IT is set up from a design perspective is that both drugs are going to be given twice a day with food, which is the way Vascepa is currently indicated. Our expectation and I think it's a reasonable one would be that Vascepa should be expected to perform in line with where it has previously in these sorts of patients, which is around an 18% to 20% reduction in triglycerides. For MAT9001 in the profile of its drug, a change from a low fat diet to simply giving the drug twice a day with food is not likely to penalize MAT9001, while the entry criteria in ENHANCE-IT is slightly broader than it was in the first study, we would expect our triglyceride reduction to be in the neighborhood of where it was in the first study. And so, based upon the way we've looked at the numbers, we felt comfortable that 10% was correct, both based upon that data. And then what we think physicians, based upon the KOL feedback would view as a clinically meaningful difference in triglyceride reduction. So we've tried to set up a study to answer some of the questions that came out of the first study without putting MAT9001 at a disadvantage. Because the reality is a meal higher and fat is also going to improve the absorption of a free fatty acid, maybe not to the same degree as an ethyl-ester, but it's not likely to prejudice MAT9001.

[Operator:]

[Operator Instructions] Our next question comes from the line of Gregg Gilbert from Truist. Please proceed with your question.

[Gregg Gilbert:]

Sorry, I got in a little late so I'm hoping I don't repeat make you repeat yourself. But did you say when the End-of-Phase 2 meeting will actually occur?

[Jerry Jabbour:]

We expected in this quarter so imminently. So that's on track for that. We've always said the third quarter of 2020.

[Gregg Gilbert:]

And can you educate me on whether you would actually get an answer during the meeting or by when would you get an answer on A) 505(b)(2) pathway being appropriate and B) the actual protocol?

[Jerry Jabbour:]

Yes, so typically, the way these things work, Gregg is in advance of the meeting, you submit a number of questions which you would like the FDA's input on and then within a certain period of time of requesting that meeting, you put together a briefing package for FDA. FDA then reviews those materials, and a few days - in some instances, it could be the day before the meeting you get FDA responses to those questions. And then the company provides some additional kind of clarity to FDA on the exact issues it would like to discuss during the meeting, the meeting occurs and then the FDA typically prepares minutes of those meetings, which follow, a period of time after the meeting. So it's not always a definite, but it's usually around 30 days. With respect to the issues that are going to be disgusted at a meeting like this obviously, you'd like to get some clarity on your regulatory pathway, but the reality is that the 505(b)(2) issue in and of itself as a review issue. So at the end of the day, the FDA does like to, keep its cards close to the chest and not necessarily give you a green light that you were going to be in position to satisfy the requirements for 505(b)(2). That being said, the topics that are going to be likely discussed during this meeting, which is the data from the comparative PK and the comparative tox will go a long way to giving, the company comforts that then can communicate to the market about the intended pathway. With respect to the Phase 3 protocol, there would be some back and forth with the FDA on that protocol. It's possible that you received, a green light to proceed following that meeting, but there may also be some additional information they require. And what you would be looking at then is, us planning for Phase 3 and then putting ourselves in position to just not have a clinical hold on the start of that study. So unclear exactly what will come out in the minutes, but nonetheless, it will give us invaluable information on being able to start Phase 3 and what our data looks like relative to the reference listed drug and does that give the FDA comfort from a safety and efficacy perspective, that you can refer to data generated by that in support of your application.

[Gregg Gilbert:]

And then one more might be a little bit farfetched, but in a world where generic versus Vascepa could be launched later this year. If they are and there's no injunction, and it looks like it's clearly a genericized product, is there a scenario where you would actually change the design of your pivotals or would you try to - either way, you're trying to seek the maximum amount of differentiation in your pivotals as opposed to needing to do other types of studies later?

[Jerry Jabbour:]

I think that's a very fair question, Gregg, and something that we've been talking about frankly, since we met last year, for the first time with our Scientific Advisory Board. You're always looking at the ability to discern whether staying true to the past, the pathways that have been blazed and how quickly you can get approval, versus how do you identify a potential patient population, which could distinguish you certainly from an indication and from a competitive standpoint for other available therapies. We're always kind of noodling on those, currently, there has - nothing has risen to the level of us being aggressive in pursuit of that. But that doesn't mean that those sorts of designs and thoughts about different patient populations, which may or may not rely on an impact on triglycerides, aren't kind of in the wings. So we'll wait to see how that goes. Certainly our discussions with FDA could impact our thinking on that. Other things that could impact our thinking on that, of course, are the outcome of the Vascepa trial and also a desire to see the data from strength at some point, which could inform our understanding of how populations may matter. So a lot of additional information required. We feel comfortable with the path that we've set forth. But we also have the potential to make some adjustments. Should the science and should the commercial opportunity dictate that makes sense.

[Operator:]

[Operator Instructions] Thank you. We have reached the end of our question-and-answer session. So I'd like to pass the floor over to Mr. Jabbour for any additional closing comments.

[Jerry Jabbour:]

Jessie, thanks very much. Thank you again to everyone who joined us today as we reviewed our second quarter of 2020 and gave you an outlook. Just a reminder that really within the next six months we have several opportunities for transformational data both with cohort progression and EnACT and data from ENHANCE-IT early in Q1, but also taking into account feedback from the Cystic Fibrosis Foundation in terms of being able to drive MAT2501 forward, plus opportunities with large pharma collaborators on our LNC platform. We look forward to keeping you updated on our progress. We wish all of you good health as we continue to chart these, you know unnavigated waters, and wish you the best for the rest of 2020. Thank you.

[Operator:]

Ladies and gentlemen, this does conclude today's teleconference and webcast. We thank you for your participation and you may disconnect your lines at this time.