Grace Therapeutics, Inc. (GRCE) Q2 2020 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Acasti Pharma Second Quarter 2020 Business Update Conference Call. After the presentation, there will be a question-and-answer session. [Operator Instructions]. At this time, it’s my pleasure to turn the floor over to Mr. David Waldman, Investor Relations. Sir, the floor is yours.

Thank You. Good afternoon, everyone, and welcome to Acasti Pharma's second quarter fiscal 2020 conference call. On the call with us this afternoon are Jan D’Alvise, President and CEO; Pierre Lemieux, Chief Operating Officer, Chief Scientific Officer and Co-Founder; Brian Groch, Chief Commercial Officer; and Jean-François Boily, Vice President of Finance. If you have any questions after the call or would like any additional information about the company, please contact Crescendo Communications at 212-671-1020. I'd also like to remind everyone that statements on this conference call that are not statements of historical or current facts constitute forward-looking information within the meaning of the Canadian Securities Laws and forward-looking statements within the meaning of U.S. Federal Security Laws. Such forward-looking statements involve known and unknown risks, uncertainties and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms believes, belief, excepts, intend, anticipates, potential, should, may, will, plans, continue, or other similar expressions to be uncertain and forward-looking. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Forward-looking statements in this conference call include but are not limited to information or statements about Acasti's strategy, future operations, prospects and the plans of management. Acasti's ability to conduct all required clinical and non-clinical trials for CaPre, including timing and results of those trials; the timing and the outcome of licensing negotiations; CaPre’s potential to become the best-in-class cardiovascular drug for treating severe hypertriglyceridemia; CaPre’s potential to meet or exceed the target primary endpoint; Acasti's ability to commercially launch CaPre; and Acasti's ability to fund its continued operations. The forward-looking statements contained in this conference call are expressly qualified in their entirety by this cautionary statement. The Cautionary Note Regarding Forward-Looking Information section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis, which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov and on the Investor Relations section of Acasti's Web site at www.acastipharma.com. All forward-looking statements in this conference call are made as of the date of this conference call. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti's public securities filings with the Securities and Exchange Commission and the Canadian Securities Commission, including Acasti's latest annual report on Form 20-F and most recent MD&A. I'd now like to turn the call over to Jan D’Alvise. Please go ahead, Jan. Jan D’Alvise: Thank you, David, and I’d like to welcome everyone who’s joined us on the call today. This has truly been another busy and productive quarter for the Acasti team. Anticipation is growing now as we’re only about a month away from reporting our first top line results from our TRILOGY Phase 3 program. And as we discussed and disclosed last quarter, both TRILOGY trials have reached 100% randomization and I’m very pleased to report that now more than 90% of the patients in both studies have completed their six months treatment plan. As a result, the last patient, last visit in TRILOGY 1 remains on track to take place later this month, with database lock and top line results still expected in December. We’re confident in this timeline as we already have about 95% of our data cleaned for TRILOGY 1. The last patient, last visit in TRILOGY 2 also remains on track to take place in early January with top line results still expected before the end of January 2020. And as a reminder, each of the TRILOGY trials are designed to provide at least a 90% statistical power to detect the difference of at least 20% reduction in triglycerides from baseline between CaPre and placebo in patients with severe hypertriglyceridemia. This is the key target endpoint that we need to achieve in order to proceed with the submission of our NDA to the FDA and to hopefully obtain regulatory approval for CaPre in the United States. We currently intend to report our top line TRILOGY results independently for each study shortly after we receive those results. The top line results will include a readout of the primary endpoint which is intended to show CaPre’s overall impact on lowering triglycerides after 12 weeks as compared to placebo. And as previously disclosed, the placebo we’re using in the TRILOGY studies is simple cornstarch, which is inert, and consequently is expected to have a neutral effect on key biomarkers of patients in the placebo group, and furthermore unlike mineral oil, cornstarch has no known effect on statin absorption or on statin efficacy. Now we currently do not expect top line results to include any secondary or exploratory endpoints. Those results are expected to follow the release of the top line results of TRILOGY 2, which again is anticipated in late January 2020. According to the statistical analysis plan, which has been submitted to the FDA, the primary endpoint of triglyceride reduction must first be positive having achieved statistical significance prior to proceeding with analyzes of the most important secondary and exploratory endpoints. We currently expect that these additional key endpoints will be analyzed in the following order. So first, we’ll analyze and report additional important triglyceride secondary endpoints which will include triglyceride reduction at week 26, which is measured at the end of the study and is intended to show CaPre’s persistence of effect. Secondly, we will also analyze triglyceride reduction in various subgroups to show consistency of effect, such as patients stratified with baseline qualifying triglyceride levels of between 500 and 750 milligrams per deciliter as compared to those with baseline triglyceride levels which are greater than 750 milligrams per deciliter. And finally, a comparison of triglyceride reduction in patients stratified according to the use of statins at baseline. Our Phase 2 data and many other previous omega-3 studies have shown that statins can have a positive and synergistic effect with omega-3s. And when taken together, they tend to increase the amount of triglyceride lowering seen in these patients. Now secondly, after triglyceride lowering, we'll report out results on non-HDL-cholesterol; followed by VLDL and then HDL; and then finally, LDL and hemoglobin A1c. And again, I’m remind everybody on the call that the TRILOGY protocol required that our investigators determine if patients who presented at screening with high LDL and/or high hemoglobin A1c levels, they needed to be put on standard therapies such as statins or short-acting diabetes meds. If so, those patients had to show that their LDL and hemoglobin A1c levels had stabilized prior to being randomized into one of the TRILOGY studies. Therefore, any change in LDL or hemoglobin A1c in the CaPre treated group versus the placebo group would represent an incremental benefit of CaPre above and beyond the standard of care by itself. Furthermore, the results for both LDL and hemoglobin A1c will require subgroup analyses. This will require combining results from both studies, from diabetic patients and separately from patients with high LDL at baseline, in order to reach adequate statistical power to detect the difference from the respective placebo groups, if one exists. Now Acasti expects that the numerous secondary and exploratory endpoints, along with various additional subgroup analyses, should be completed well before the end of March 2020. In addition to our preliminary top line data, we will seek to present the full dataset, including results for all of our key secondary and exploratory endpoints of interest and we’ll present these at important scientific meetings throughout the first half of 2020, potentially including the American College of Cardiology in March, the National Lipid Association in May, the American Diabetes Association in June. We’ll continue to communicate more information in the weeks ahead on how and when all of the TRILOGY results will be reported. Now assuming TRILOGY results are positive, we believe that CaPre has the potential to address an important market need for an effective, safe and well-absorbing omega-3 therapeutic that could have a positive impact on major blood lipids and hemoglobin A1c and therefore potentially improve the lives of millions of patients with cardiometabolic disease. Additionally, based on recent third party outcome data, we believe the potential exists to expand CaPre’s initial indication to the roughly 70 million patients in the United States with elevated triglyceride levels above 150 milligrams per deciliter, although this may require that we do at least one additional study in the future. Now let me also take a moment to recap some of the key highlights from our Phase 2 trials and why we believe our Phase 3 studies are well designed to potentially achieve our primary endpoint. First, we demonstrated a significant reduction in triglycerides in our Phase 2 trials while also indicating that CaPre may have a positive effect on other major lipid markers as well as hemoglobin A1c in patients with diabetes. Second, the patients enrolled in the TRILOGY trials have a much higher baseline triglyceride level. All are above 500 milligrams per deciliter as compared to our Phase 2 studies where most of the patients enrolled actually had baseline triglyceride levels significantly below 500. And based on the large body of clinical data in patients with elevated triglycerides, we know that the higher the starting baseline level, typically the greater the magnitude of triglyceride reduction that is realized when given a therapeutic omega-3. And third, a greater number of patients randomized in our TRILOGY studies are also taking a statin. We believe based on the prevalence in the initial screen population, probably close to 50% of our patients were on a statin at baseline. We know from our previous Phase 2 studies as well as studies published by others that there’s a synergistic effect between statins and omega-3s and as I mentioned earlier we tend to see a greater reduction in triglycerides in those patients taking a statin along with their omega-3. Lastly, patients randomized in CaPre in the TRILOGY trials all received 4 grams per day and will remain on drug for a full six months compared to our Phase 2 studies that included a range of doses from 1 gram to 2 grams and 4 grams per day for a duration of only 8 to 12 weeks. This is important due to the favorable dose response that was seen in our Phase 2 studies. Okay. So what makes CaPre different from other prescription omega-3 products and why do we believe CaPre has the potential to become the best-in-class omega-3 assuming our TRILOGY results replicate our Phase 2 data? Well, CaPre is uniquely sourced from krill. And it contains a highly purified and concentrated composition of phospholipids, EPA and DHA. The important differentiator for CaPre is the phospholipids, which allow for efficient and rapid absorption of the omega-3s in the gut. In fact, almost two-thirds of CaPre’s composition is phospholipids and we believe the phospholipids are all for the reason we see a positive effect on other major blood lipid markers such as VLDL, LDL, cholesterol and HDL, which is what we refer to as CaPre’s Trifecta Effect. The phospholipids may also be the reason we saw a positive effect in hemoglobin A1c in patients with diabetes in our Phase 2 study at 4 grams per day. Now by comparison, the current prescription omega-3s on the market such as LOVAZA and VASCEPA do not contain phospholipids but rather are bound to ethyl esters which require that patients must take their omega-3s with a high fat meal in order to get ideal absorption. We have demonstrated through our pharmacokinetic studies in subjects in the fasting state that CaPre showed significantly better bioavailability in absorption than LOVAZA as measured by blood levels of EPA and DHA. This is an important distinction as patients with high triglycerides are advised by physicians to follow a restricted low fat diet. And last week, Acasti announced the publication of a second pharmacokinetic study in a leading peer review journal called Clinical Therapeutics. The study showed again that the bioavailability of CaPre did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration. A link to this publication can be found in our Q2 press release, which is available on our Web site. Furthermore, it’s important to remind you that in all of our studies to date, CaPre has shown no negative side effects or a safety concern. Now in Acasti market research, prescribing physicians have said that the currently marketed fish oil prescription omega-3s on the market can be difficult to swallow as the large soft gel capsules tend to stick in the throat, can cause gastrointestinal upset and have a strong fishy taste. CaPre is not a fish oil and it has no reported fishy taste and it is packaged in a hard gel cap, which may be easier to swallow. In preparation for building inventory of CaPre for our planned commercial launch, we recently announced the signing of a supply agreement with Aker BioMarine for raw krill oil or what we refer to as RKO. Based on current projections, this agreement should ensure an adequate supply of raw materials to meet our anticipated needs through at least 2021. This inventory supports the anticipated ramp up of our commercial production of CaPre and since it is a two-year fixed price agreement, it should also ensure that we achieve our targeted product cost at launch. We’re very excited to work with Aker on this project and we look forward to building and expanding on this relationship and in the future with other validated RKO suppliers. Now before I close my prepared remarks, I’d like to take a brief moment to comment on our balance sheet. As of September 30, we had 25.8 million of cash, cash equivalents and marketable securities including approximately 8.7 million in proceeds received from the exercise of warrants since July 1. Also, we recently announced receiving an award for 750,000 in non-dilutive and non-repayable funding from the National Research Council of Canada Industrial Research Assistance Program, which we intend to apply towards eligible R&D disbursements for our exclusive commercial manufacturing platform for CaPre. And as we near completion of our Phase 3 clinical activities, our monthly cash burn continues to decline. We believe that we are currently capitalized well beyond completion of the Phase 3 trial through June of 2020. This capital will support continued work to prepare our NDA for CaPre which we plan to submit to the FDA in calendar Q3 of next year, assuming our Phase 3 study successfully achieved our primary endpoint. We also believe our current cash position is sufficient to support the planned expansion of business development and U.S. commercial prelaunch activities well into next year. We’re currently actively exploring a variety of strategic and non-dilutive funding options which could further extend our cash runway beyond mid next year. We will provide further updates on this at an appropriate time in the future. Finally, we’re in active discussions with a number of major pharma companies regarding potential commercialization partnerships in key countries around the world. These discussions are gaining momentum now as we near our data release and assuming positive results, management expects one or more of these partnership deals could be signed sometime next year. We believe that having the data in hand from our Phase 3 trials puts us in a much stronger position to negotiate any potential partnership deal. That said, I will remind you that our strategy in the U.S. is not dependent on partnership. We are planning our U.S. commercial launch with the assumption it will bring CaPre to market ourselves through a very focused and targeted go-to-market strategy. We will only enter into commercial distribution agreements with the right strategic partners and only if we believe those deals are in the best long-term interest of our shareholders. So on that note, I’ll now turn the call over to Jean-François who will discuss the Q2 financials in more detail. Jean-François Boily: Thank you, Jan. Turning to our results for the quarter, R&D expenses before depreciation, amortization and stock-based compensation expenses were 4.3 million for the quarter ended September 30, 2019, down from 8.4 million in the quarter ended September 30, 2018. The 4.1 million decrease was primarily attributable to a 4.6 million decrease in research contracts. The lower research contract expense is primarily attributed to the advancement of the Phase 3 clinical program as it is getting closer to completion. General and administrative expenses before stock-based compensation expenses were $1.5 million for the quarter ended September 30, 2019 compared to $890,000 for the quarter ended September 2018. Our loss from operating activities for the second quarter ended September 30, 2019 was 8.7 million compared to a loss from operating activities of 10.4 million for the quarter ended September 2018. The approximately 1.7 million decrease was due in part to a reduction in research contract expenses again as the Phase 3 clinical program is approaching completion. Net loss for the quarter ended September 30, 2019 was 28.3 million or $0.34 per share compared to a net loss of $22.7 million or $0.62 per share for the quarter ended September 30, 2018. This higher net loss was primarily due to the non-cash financial loss of 19.7 million for the three months ended September 30, 2019, again due mostly to the change in fair value of the warrant derivative liability partially offset by a decrease in the number of warrants. As Jan mentioned, cash, cash equivalents and marketable securities totaled 25.8 million as of September 30, 2019 compared to 6 million for the quarter ended September 2018. This increase was mainly generated by the net proceeds from the public offerings and the recent exercise of warrants, which again generated approximately 8.7 million in additional proceeds since July 1, 2019. Furthermore, we recently announced receiving up to 750,000 from the government of Canada. With that government funding, recent exercise of warrants and cash on hand, the company is sufficiently funded to at least June of 2020. Operator, we’ll now open the call to questions.

Thank you, sir. [Operator Instructions]. We’ll take our first question from Nathan Weinstein with Aegis Capital.

Hi, guys. Thanks for taking my questions. Jan D’Alvise: Hi, Nathan.

So obviously, with the AdCom for VASCEPA tomorrow and the briefing document was released earlier this week, just wanted to see if you had any comments to make on that and anything surprised you there? Jan D’Alvise: Yes. No, it was a very complete briefing document and I can only say at this point that we look forward to the AdCom meeting tomorrow as we see it as truly an opportunity for the FDA to provide further constructive guidance not just to the industry but also to physicians on the utilization of omega-3s. And I could only add that our program continues on track. We remain very confident in the overall important role that therapeutic omega-3s can play in treating heart disease. And really beyond that, we’re not in a position to comment further on the AdCom or on anything related to that at this point.

Thank you. And then if we look ahead a year or two, and there is conceivably multiple omega-3s on the market at that time, can you just talk about interactions you’ve had with doctors or key opinion leaders and how you think CaPre could function within a marketplace with several alternatives? Jan D’Alvise: Yes, sure. So just briefly again I think that what’s important is to remember the key points of difference between us and the other omega-3s on the market and those coming into the market. Again, we’re the only product derived from krill oil and consequently uniquely contain phospholipids, which not only help to improve absorption and distribution in metabolism of omega-3s but also appear to play a role in acting on the synthesis of cholesterol, actually decreasing LDL, impeding cholesterol absorption and stimulating lipid secretion from the bile. It also appears that these phospholipids may play a role in improving the metabolism of glucose which would be truly unique in the category. So, again, based on our pending Phase 3 results, if we can replicate what we saw in Phase 2, we believe that CaPre would represent a better, more broadly cardiometabolic solution than the other products on the market. But again, we have to wait for our Phase 3 data and the good news is it’s only a month away now. Brian, I don’t know if you want to add anything about the market?

Jan, I think you touched on it. The only thing that I would add in general if you look at historically, physicians really like to have options and I think what’s really nice about our product is, as Jan mentioned, for the cardiometabolic patient, it really – hopefully at the end of the day when we see our Phase 3 data, it’s going to support a product that really indicated for that cardiometabolic patient and works at multiple endpoints across the lipid spectrum. So we’re excited about our Phase 3 data and how we will fit into the hierarchy of treatment.

Thanks so much. It’s very helpful. Jan D’Alvise: Thanks, Nathan.

We’ll take our next question from Leland Gershell with Oppenheimer. Jan D’Alvise: Hi, Leland.

Thanks for taking my questions. Hi, Jan. Thanks. Just one question from me and just to continue on a point you had raised in the formal remarks about seeking label expansion for the much broader population with lower triglycerides. So what you said is, is you may need one additional trial. I guess one question is, do you have a specific meeting with the FDA set to discuss those requirements? And in relation to this, we have REDUCE-IT data on VASCEPA. We will have the STRENGTH data from EPANOVA late next year, which would be shortly after your NDA filing for the initial severe indication. Just curious what you may be hearing from your thought leaders and advisors about the requirement that a third outcomes trial would be required versus perhaps a biomarker study? Thanks. Jan D’Alvise: Yes. Thanks, Leland. So let me respond and then Pierre you’re welcome to join in here if I miss anything. But I think that clearly we may ultimately need to conduct an outcome trial but we believe that if our Phase 3 results can replicate our Trifecta Effect as we saw in Phase 2, we believe based on our discussions with key opinion leaders and high volume prescribers that CaPre could gain significant market traction without a cardiovascular trial and really become a preferred omega-3 for patients with severe hypertriglyceridemia or patients with broader cardiometabolic disease, again, even without outcome data. So we do not believe and in fact we’re going after a label in severe hypertriglyceridemia, it’s the same – I will remind everybody same label that Amarin has had over the last many years, so only now seeking to expand that label. So that is the label that we are hoping to get approved based on the basis of our Phase 3 data. So we don’t believe we need a cardiovascular outcome trial to get that label in severe hypertriglyceridemia proved. Now we’re going to definitely have a better idea after STRENGTH and our Phase 3 results are reported whether or not we may need to do an additional outcome trial. And if so, how we would want to design it? And if and when we decide to conduct our own outcome trial, we would expect to enroll clinical patients from around the world and potentially in collaboration with one or more strategic partners. So, Pierre, I don’t know if you want to add anything.

Thank you. You said it right, Jan. So I think Leland it’s all depending on our Phase 3 data. It will indicate to us where to go next. I think it’s very premature to have a discussion with the FDA with regards to an additional trial with the mid-to-moderate population over any other outcome trial. So it would be foolish on our part to speculate on the type of an outcome trial. And I’m going to give you an example. So if we do have interesting data in diabetes and show clearly a better glucose management, for instance, then it’s going to have a different design. That outcome trial might be totally different than what you’ve seen so far. So I think it’s cautious [ph] on our part to wait for Phase 3 data and we’ll have more information to deal with and be smarter about the design – the future design. That’s what I can add. Jan D’Alvise: Yes. Thanks, Pierre. That’s great.

Thank you. That’s helpful. Thanks for the added color.

[Operator Instructions]. There appear to be no further questions at this time. I’d like to turn the call back over to – I’m sorry. We did just have a question come through from Mayank Mamtani with B. Riley.

Hi, Jan. This is Wayne [ph] on for Mayank. Congrats on all the progress. And I do have a quick question. So what’s your expectation for the – all the Trifecta Effect especially the LDL lowering effects in the readout for the TRILOGY? Jan D’Alvise: Sorry, Wayne. You’re breaking up a little bit. You said what is our expectation?

Just for the LDL lowering because it seems like everything is on track and I’m fairly confident you guys will get approved. So I’m just wondering with that lowering effect, were you looking to other space in the future like in – for the NASH, that kind of space? Jan D’Alvise: Yes. So let me comment first on the LDL expectations. So I just would remind everybody that currently, a neutral effect with LDL is perceived as being a very positive thing in omega-3s. The fact that we actually saw some reduction in LDL in our Phase 2 is very exciting. And again, we think it’s attributable to the phospholipids in our composition. So our expectation is that we would see at least a neutral effect which would be I think perceived by physicians as a very positive thing. And then with regards to your second question, yes, it’s really interesting this mechanism of the phospholipids. They remove that from the liver. And so for that reason we’re actually conducting right now very interesting animal study. It’s a mechanistic study that will give us more insight into how CaPre is actually acting on lipids and specifically its role in clearing lipids from the liver. So that study is actually winding down right now and together with another study that we’re running in parallel in the diabetes model, we’re hoping to compile those results within the next month or two and the plan would be to put out a publication. But it’s just so interesting the mechanism of action that these phospholipids have and again the objective here is to better understand it. And as a result, we hope to be able to see that CaPre could have a broader effect not just in cardiometabolic disease but potentially in other diseases such as fatty liver disease as well. But again, we’re a long way from proving that, so very early days.

Okay. Thank you.

And we’ll take our next question from Robert Hazlett with BTIG.

Thank you for taking the question and congratulations on all the progress ahead of again what looks to be meaningful events not only for you but for the omega-3 sector as well. Just a little bit more clarity in terms of the – assuming success in your Phase 3 studies, the pace of the NDA filing and then could you give us a little bit more clarity on the manufacturing capacity that you expect to have at launch? Thank you very much. Jan D’Alvise: Yes. Hi, Bert. Thank you very much for being on the call today and for your question. So the plan is to – we’re actually well along now in preparation of our NDA. We fully expect to be able to file on schedule which is targeted for Q3 of next year. So that would basically have us getting hopefully approval by mid-2021. And regarding the manufacturing capacity, I’ll turn that over to Pierre because he’s done tremendous amount of work here and actually was instrumental in getting the Aker partnership collaboration signed. So, Pierre, do you want to comment on manufacturing capacity.

Yes, sure. So thank you, Bert, for the question. So as we reported before, our current capacity is 20 tons. So it’s large enough already to do a lot of good work, but we’ve been working hard to scale it up to 60 tons and this is what we’re doing with our partner in France and with whose channel that we’ve chosen. And that’s going to be what we’re targeting for the launch. So it’s giving us a year, year and a half to get it up – to get it scaled up and that’s what we’re going to be – this is what we’re targeting to be ready for launch. And so far, so good. I think we’ve been able to show that we can easily take it up to some 20 to 40 and now it’s a matter of adding an additional 20 tons. But everything is under control and we also have – we will in the NDA have some exchange about the manufacturing and as you might imagine on the CMC side, so everything is well under control. And I think with the Aker deal, Aker BioMarine deal, it’s also providing some security about the long-term supply of krill oil – raw krill oil. So we wanted to put this behind us and it have that secure. So, as I said, I think we’re ahead of the curve here and we’re being proactive with the NDA with regards to the scale up of this process. But remind you that we haven’t changed anything. It’s the same product. No worries there. And we’ve been I think getting some good feedback from the FDA. So this is where we are, Bret.

Thank you for the color. Again, congratulations on the progress. We look forward to readouts and events upcoming. Thanks. Jan D’Alvise: Thanks, Bert.

[Operator Instructions]. We’ll go next to Richard Ehrlich with JH Darbie.

Hi, guys. On the financial side, although you have enough cash for the trials, can you tell me how many warrants you have left outstanding? Jean-François Boily: Yes. I’ll take that one. So as we’ve disclosed in the MD&A and in fact this is the ultimate last page of the MD&A, we’ve got approximately I would say 16 million warrants still pending. And the warrants are exercisable, the bulk of them until 2023 and their price range between CA$1.05 and CA$1.30. Jan D’Alvise: Richard, did that answer your question?

That’s great. I just wanted to have an idea on how much cash we can see coming in as they’re in the money right now. So if you’re on the same kind of path that you have been for the last few months with people selling the warrants, you could have additional 10 million or so come in the next quarter or two. Jan D’Alvise: Yes, exactly. Thanks.

I’m good. Jan D’Alvise: Thanks, Richard.

And there are no further questions at this time. Ms. D’Alvise, I’ll turn the call back to you for closing comments. Jan D’Alvise: Okay, great. Thanks, Tom. So to wrap up in summary, our TRILOGY program remains on schedule and we eagerly await our first top line data which we anticipate is now only about a month away. We continue progressing the plan on all operational fronts as we advance preparations for our NDA submission in calendar Q3 of next year. We remain on schedule for a planned commercial launch in the U.S. in the second half of '21 and assuming our Phase 3 studies successfully achieve their endpoint. Additionally, as mentioned, our cash runway has been extended now due to recent warrant exercises and government funding, which has also helped to improve our balance sheet. And as always, I want to thank you again for joining us today and we look forward to providing further updates in the very near future, including top line results from our TRILOGY 1 and 2 studies. Thank you and have a good day.