Acasti Pharma Inc. (ACST) on Q1 2023 Results - Earnings Call Transcript
Operator: Good day, and welcome to the Acasti Pharma's First Quarter Fiscal Year 2023 Financial Results Conference Call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Robert Blum with Lytham Partners. Please go ahead.
Robert Blum: Thank you very much, Rocco. Welcome to Acasti Pharma's first quarter fiscal 2023 conference call. On the call with us this afternoon is Jan D'Alvise, President and CEO; Brian Ford, Chief Financial Officer; Pierre Lemieux, Chief Operating and Scientific Officer; and Prashant Kohli, VP of Commercial Operations. Following management's prepared remarks there will be a Q&A session. Should any questions remain after the call, please feel free to contact me at 602-889-9700. 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 the US Private Securities Litigation Reform Act of 1995 and the Securities and Exchange Act of 1934. Such forward-looking statements involve known and unknown risks and uncertainties that could cause the actual results to be materially different from those expressed or implied by such forward-looking statements. In addition to statements, which explicitly describe such risks and uncertainties, listeners are urged to consider statement labeled with terms belief, expects, intends, anticipates, potential, should, may, will plans, continue, targeted 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 during this conference call may include but are not limited to the success and timing of regulatory submissions of the planned Phase 3 study for GTX-104 and Acasti's other preclinical and clinical trials, regulatory requirements or developments in the outcome of meetings with the FDA, changes to clinical trial designs and regulatory pathways, legislative, regulatory, political, and economic developments and costs associated with Acasti's clinical trials. The forward-looking statements made during this conference call are expressly qualified in their entirety by this cautionary statement. The cautionary note regarding the forward-looking information section and the risk factors contained in Acasti's documents that have been filed and are filed by Acasti from time to time with the Securities and Exchange Commission and Canadian securities regulators, which are available on EDGAR at www.sec.gov on SEDAR at www.sedar.com and on the Investors section of Acasti's website at www.acastipharma.com. In addition any forward-looking statements represent Acasti's views as of today and should not be relied upon as representing our views of any subsequent date. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date in which they were made except as required by applicable securities law. With that said, I'd like to turn the call over to Jan D'Alvise, President and CEO of Acasti Pharma. Jan, please proceed.
Jan D'Alvise: Thank you Robert and I want to thank everyone for joining the call today. We're really excited to update you today on the strong progress we're making on our three clinical programs, each of which have key clinical trials either underway or planned to be initiated in this new fiscal year. As a reminder our strategy is to leverage the company's novel drug delivery and formulation technologies to improve marketed drugs for orphan indications where a significant unmet need exists. The well-understood efficacy and safety profiles of these marketed compounds provides the opportunity for us to utilize the FDA's Section 505b2 regulatory pathway for the development of our drug candidates and therefore may potentially provide a shorter, less risky, and less costly path to regulatory approval. For those not familiar under Section 505b2, if sufficient evidence of a product's safety and efficacy exists either through previous FDA experience or sufficiently within the scientific literature and may eliminate the need to conduct some of the preclinical and clinical studies that new drug candidates might otherwise require. All three of our drug candidates have already received orphan drug designation from the FDA and each one has the potential to be considered for fast track review and approval. Orphan drug designation provides for seven years of marketing exclusivity in the United States post-launch provided certain conditions are met and 10 years of exclusivity in Europe. These rare diseases also typically involve clinical trials with fewer patients and they often require a much smaller, more targeted commercial infrastructure to realize the market potential. It's important to point out that the specific diseases targeted for drug development by Acasti are well-understood, although these patient populations may remain poorly served by current available therapies or for example in the case of our GTX102 for children with ataxia-telangiectasia approved drug therapies do not yet exist. Our aim is to effectively treat the debilitating symptoms that result from these underlying diseases with the ultimate goal of improving quality of life and patient outcomes. We believe by leveraging the Section 505(b)(2) regulatory pathway for the development of our novel reformulated versions of these drugs provides us with highly attractive opportunities in orphan disease indications with little or no competition. So with that as a background, let me give you a quick overview of our lead drug candidate GTX104 and then I'll provide an update on the status of our ongoing clinical efforts. As a reminder, GTX104 is a novel formulation of nimodipine to be administered via a continuous intravenous infusion designed specifically for patients with subarachnoid hemorrhage or SAH, which is a condition caused by bleeding in the brain due to a ruptured aneurysm. SAH presents a life-threatening emergency for the patient and our new proprietary IV drug formulation addresses a vital need in the critical care market that's seen little innovation in over the last 30 years. The condition of SAH patients is so critical that 10% to 15% of them die before ever reaching the hospital and about one-third ultimately do not survive. Another one-third of these patients require dependent care for the rest of their lives. SAH is estimated to affect about 50,000 patients per year in the United States alone. And based on our market research, we believe that GTX104 represents a total addressable market in the US of more than $300 million. The current standard of care is an orally administered drug called nimodipine which was approved by the FDA way back in 1988. Nimodipine is a potent calcium channel blocker that relaxes the blood vessels in the brain and lowers blood pressure to allow more oxygenated blood flow into the brain to enhance feelings. Nimodipine is typically given throughout the entire time that the patient remains in the hospital which can be up to three weeks to four weeks. Nimodipine is available in the US only as an orally administered capsule or liquid solution, which is problematic as many of these SAH patients are not conscious or if they're awake they have a hard time swallowing oral drugs. Consequently, nimodipine must often be delivered via a nasogastric tube, which leads to a lot of variability in dosing as the drug can stick to the inside of the tube making it difficult to control the resulting blood pressure of the patient. Furthermore, oral nimodipine is subject to a large variation in blood levels due to a food effect as well as diurnal variations caused by changes in blood flow, renal function and hepatic metabolism over the course of a 24-hour day all which can affect absorption of an oral drug. So we believe that GTX104 delivered intravenously could be a game changer for patients with SAH as a more convenient efficient and precise way to deliver nimodipine directly into the patient's bloodstream. With that brief overview, let me share the latest updates on the rapidly advancing clinical program for GTX104. As we discussed on our last conference call, we announced on May 18 that our GTX104 pharmacokinetic bridging study had successfully met all of its end points. The primary objective of the study was to evaluate the relative bioavailability of GTX104 administered intravenously compared to oral nimodipine in healthy adult male and female subjects, while the secondary objective was to assess itâs safety and tolerability. The results showed statistically no difference in the maximum and total exposure between GTX104 and the oral formulation of nimodipine and no serious adverse events were observed. This meant that GTX104 delivered intravenously can be considered essentially bioequivalent to oral nimodipine. Importantly, the inter and intra subject PK variability was also much lower for GTX104 as compared with oral nimodipine. We believe that because of its better absorption profile and more consistent blood levels, GTX104 may provide physicians with a more reliable and more effective treatment for patients with SAH. This could be a key advantage as GTX104 could help to reduce the incidence of hypotensive events and vasospasm which require immediate and costly intervention and can lead to worse outcomes for the patient. We plan to submit our recent PK bridging study results to the FDA in calendar Q3. And we plan to request a Type C meeting to get the FDA's guidance on the final dosing regimen that we are now recommending for our Phase 3 safety study based on our excellent PK results. We also want to review our proposed design for the Phase 3 safety study with the FDA and to obtain their feedback and guidance before initiating the study. There's a 75-day response time following our meeting request for the FDA for them to provide their comments. So we would expect to have the FDA's feedback by the end of this calendar year or at the very latest early in 2023. As a result, we expect to start our Phase 3 study in the first half of calendar 2023. I'll remind everyone that while the major objective of our Phase 3 safety study is to show that the safety profile of our GTX-104 in SAH patients is similar to or no worse than oral nimodipine, we also want to collect additional pharmacoeconomic data compared to the oral for future publication and marketing purposes. So based on the discussions we're having with our key opinion leaders, we plan to collect important data such as the amount and intensity of nursing time associated with drug administration, and patient follow-up for GTX-104 compared to oral nimodipine. Also, the number of hypotensive events and the length of stay in the ICU for each drug and so on. Therefore, we believe that getting the FDA's guidance in the form of a Type C meeting before starting the study will be really important. And the net effect of obtaining their input in advance will ultimately reduce regulatory risk and increase the program's likelihood for success. As a reminder to everyone, the Phase 3 safety study is expected to be the final clinical step required to seek regulatory approval under the 505(b)(2) regulatory pathway, before submitting a new drug application to the FDA for GTX-104 to treat SAH patients. We're extremely excited about the opportunity to bring this new treatment option to patients with SAH. So now let me transition to GTX-102, and I'll start with a brief program overview. Again, as a reminder GTX-102 is a novel concentrated oral mucosal spray of betamethasone, intended to improve the neurological symptoms of ataxia-telangiectasia or A-T, for which there are currently no FDA-approved therapies. A-T is a progressive genetic neurodegenerative disorder that primarily affects young children causing severe disability, impairment of the immune system, and an increasing susceptibility to infections in cancer. Patients typically die in their mid-20s from complications of lung disease or cancer. A market research study commissioned by Acasti found that A-T affects approximately 4,300 patients per year in the United States, and has a potential total addressable market of about $150 million, based on the estimated number of treatable patients. GTX-102 is comprised of a novel concentrated formulation of the gluco-corticosteroid betamethasone that can be sprayed conveniently over the tongue of the A-T patient, who often have difficulty swallowing. So I'm pleased to report that, we remain on schedule to initiate the PK bridging study of GTX-102 in the third quarter of 2022. This study will be a randomized open-label crossover study in healthy male and female subjects, to evaluate the comparative bioavailability, pharmacokinetics, and safety of GTX-102 administered as an oral spray. We plan to compare GTX-102 in this study to an intramuscular injection of betamethasone, which is the reference product for US filing purposes. And we'll also compare it to an oral solution of betamethasone, which would be the reference product for filing purposes in Europe. This study will be conducted in Canada. And a total of 48 healthy adult male and female subjects will be enrolled in the single-center study, comparing five different treatments including the oral and IM forms of betamethasone and three different treatment doses of GTX-102 in a crossover study design. Blood levels and safety measures will be compared to betamethasone IM injectable, and to the betamethasone oral solution. As I mentioned earlier, we plan to initiate this PK bridging study in the third calendar quarter of 2022 and we expect to record our top line results before the end of 2022. Assuming the PK bridging study meets its primary endpoint, we plan to conduct a Phase 3 safety and efficacy trial for GTX-102 in A-T patients. And like, GTX-104, we plan to request a Type B or end of Phase 1 meeting with the FDA, following the completion of the PK study to confirm the Phase 3 study design. The Phase 3 study is expected to be initiated in the second half of calendar 2023. If both studies meet their primary endpoints an NDA filing for GTX-102 under Section 505(b)(2) would follow. Okay. And finally let me discuss the nice progress that's being made on GTX-101 our novel, nonnarcotics thin film, bio-adhesive, topical bupivacaine spray, designed to treat PHN the severe and often debilitating nerve pain that can persist following a shingles infection. It's important to point out that market studies suggest a significant unmet need exists for treating patients with PHN. Approximately 40% of the patients that are prescribed the standard of care, which includes oral gabapentin and lidocaine patches experienced insufficient pain relief. And gabapentin has unpleasant side effects, and also has abuse potential. The benefits of GTX-101 could include faster onset of action, which is an inherent characteristic of our active ingredient bupivacaine versus lidocaine, as well as a longer and more sustained duration of pain relief. GTX-101 can be conveniently sprayed on the skin, wherever the pain is located. And based on the PK profile of the bupivacaine, we believe that GTX-101 may need -- may only need to be applied once or twice a day, for a 24/7 pain relief although this dosing schedule will need to be confirmed in our clinical trials. We believe GTX-101 has the potential to be a disruptive therapy, as a non-opioid, analgesic for PHN patients who suffer from this debilitating pain. We completed a mini pig skin sensitivity study in the second quarter of 2022. And on July 26th, we initiated our planned single-dose pharmacokinetic bridging study, to evaluate the relative bioavailability of our topical spray form of bupivacaine, GTX-101 compared to the reference listed intramuscular injectable form of the drug in 48 healthy subjects. The initiation of the study in Canada, followed feedback from the FDA, on the study protocol and the non-objection letter from Health Canada. The PK study is a Phase 1 randomized single dose, four cohort parallel study, designed to evaluate the pharmacokinetics dose proportionality, safety and tolerability of GTX-101 compared to the subcutaneous injectable form of bupivacaine in healthy subjects. The primary objective is to assess the pharmacokinetics and pharmacodynamics, of three dose levels of GTX-101, given as a single dose topical application via a metered spray. As mentioned, the study will enroll up to 48 subjects, with 12 subjects per cohort. Subjects in cohorts one, two and three will receive GTX-101 at three different dosage levels respectively and subjects in cohort four will receive a single subcutaneous injection, of the active control. In addition, a pharmacodynamic assessment measuring skin sensation and sensitivity, will be performed to collect early information on efficacy and to guide important further decisions for advancing GTX-101 clinical development. The initiation of this single dose PK study for GTX-101 is yet another accomplishment achieved so far in 2022, by the Acasti team. This study is the next step in our proposed 505(b)(2) regulatory pathway for GTX-101, and it's expected to be completed on schedule by the end of calendar 2022. The results will provide important information on the dose and dosing frequency for GTX-101, which will guide the design of our multiple ascending dose study to be conducted in healthy human volunteers next year, followed quickly by our planned Phase 2 study in PHN patients. So let me recap quickly, before I turn the call over to Brian, for a quick review of our Q1 numbers. First, we're planning to initiate a Phase 3 study for GTX-104 in the first half of 2023 and all of the planning is underway now. As mentioned, we'll be requesting a Type C meeting with the FDA, before initiating the Phase 3 study to confirm the study design and final dosing regimen, based on our excellent PK results and also to obtain the agency's feedback on the additional pharmacoeconomic data that we would like to collect, which could help to support our marketing and commercialization efforts once the product is approved. While this means that our Phase 3 trial will now start a month or two later than originally planned, we believe the net effect of obtaining this clarification and guidance from the FDA reduces regulatory risk and will ultimately benefit the program's opportunity, for clinical and commercial success. We remain on schedule to initiate the PK bridging study of GTX-102, in the third calendar quarter of 2022, and we continue to expect to report out our top line results as planned before the end of calendar 2022. Assuming the PK bridging study meets its primary endpoint and based on the FDA's guidance, we plan to conduct a Phase 3 safety and efficacy trial in 80 patients in the second half of calendar 2023. In July, we initiated on schedule our single-dose PK bridging study, to evaluate the relative bioavailability of GTX-101, compared to the reference listed drug bupivacaine in 48 healthy subjects. This study is expected to be completed as planned, by the end of calendar 2022 and it will provide important information on the dose and dosing frequency in humans that will guide the design of our multiple ascending dose study, in healthy human volunteers, as well as our Phase 2 study in PHN patients. And while Brian will expand on this in a moment, I think it's important to also point out that given our continued focus on tightly managing cash, we've identified and implemented additional operating efficiencies across the organization. And we now believe that we have sufficient capital to fund, at least 21 months of operations through March of 2024. This capital will continue to support the advancement of GTX-104 through Phase 3 and GTX-102 and 101 to important additional key value inflection points. So bottom line, we're very excited about the prospects ahead for the company and I look forward to keeping you apprised of our progress towards our many milestones in this new fiscal year. Now, I'd like to turn the call over to Brian Ford, our CFO, to review our financial results. At the conclusion of Brian's remarks, we'll open the call for your questions. Brian?
Brian Ford: Thank you, Jan and welcome everybody to the call. Please note that unless otherwise indicated, all financial numbers that we discuss are denominated in US dollars and the financials are reported as conforming to US GAAP guidelines. We should -- we also should note that we are a clinical stage company thus we do not yet generate revenues or have any cost of goods expenses. Research and development expenses net of government assistance for the three months ended June 30, 2022 totaled $2.6 million compared to $0.5 million or $0.5 million for the three months ended June 30, 2021. Our research and development during the quarter ended June 30, 2022 focused primarily on advancing our clinical development programs for GTX-104, GTX-102 and GTX-101 drug candidates. Research and development expenses during the three months ended June 30, 2021 related to the completion of our TRILOGY Phase III clinical program for our former drug candidate CaPre. General and administrative expenses for the quarter ended June 30, 2022 were $1.9 million compared to $2.7 million for the quarter ended June 30, 2021. This decrease was a result of decreased legal tax accounting and other professional fees that we incurred in connection with the Grace merger and the renewal of our at-the-market program during the three months ended June 30, 2021. The decrease in professional fees was partially offset by an increase in salaries and benefits due to the renewed accrual of our employee incentive bonus program. Loss from operating activities for the quarter ended June 30, 2022 was $4.7 million compared to $3.1 million loss for the quarter ended June 30, 2021. Net loss and total comprehensive loss for the quarter ended June 30, 2022 was $4.5 million or $0.10 loss per share compared to a net loss of $3.1 million or $0.12 loss per share for the quarter ended June 30, 2021. Cash, cash equivalents and short-term investments totaled $38.4 million as of June 30 compared to $43.7 million in cash as at March 31, 2022. As Jan mentioned we have identified numerous cost savings and overall efficiencies across the organization and we now believe that we have sufficient capital to fund operations through at least March 2024 which would include the ability to fund our lead assets GTX-104 through to NDA submission and GTX-102 and 101 to additional important milestones. With that I'll now turn the call back over to Jan.
Jan D'Alvise: Thanks Brian. Before I turn it over to the operator for questions, I wanted to let everyone know that we'll be participating in the H.C. Wainwright Investor Conference from September 12 through the 16th, as well as the Lytham Partners Fall 2022 Investor Conference on September 28 and 29. So if you'd like to arrange a meeting with us at either conference, please reach out to Robert Blum at Lytham. With that I'd like to now turn the call over to the operator. Rocco can you open it up for questions please?
Operator: Today's first question comes from Leland Gershell with Oppenheimer. Please go ahead.
Leland Gershell: Good afternoon and thanks for taking my question and glad to hear on all the progress. Just a question from me Jan with respect to the one or two opportunity in A-T. I wanted to ask this is a condition obviously that begins at early age genetically driven, a lot of variability in terms of both the neurological signs and symptoms as well as others. If you could just kind of put into context where you would see the candidate be developed initially and perhaps find its initial use for in terms of that evolving and progressive disorder as patients get older? And also, if you could maybe let us know if there's any additional work you may need to do to show that beyond obviously the 505(b)(2) requirements and I guess this may hard back to the data shown by Zanolli in the patients that were reviewed in that study. If you could just remind us kind of what the picture of those patients had looked like from Zanolli? Thank you.
Jan D'Alvise: Sure. Maybe Prashant, if I could turn the first question over to you. I think you've had long deep discussions with the KOLs on how they would anticipate using this. My sense is that they would use this in children once they're diagnosed and use it chronically. But could you expand on that for me?
Prashant Kohli: Sure Jan. Yes, so in terms of the primary market research that we conducted with the GTX-102 with A-T patients the handful of center of excellence that treat for this particular condition, such as Johns Hopkins in our interaction with the physicians based on Zanolli data they anticipate using the drug chronically once the patient is diagnosed. There are precedents with a glucocorticoid that is dosed chronically for Duchenne muscular dystrophy, for example. So there are some analogs in the market and where patients are treated for a number of years. And our understanding is that is how physicians would anticipate treating pediatric patients with GTX102. However, this is a key area that we intend to tease out and flesh out in our ongoing discussions with KOLs as well as when we get closer to designing the pivotal Phase 3 study, the clinical study with A-T patients. Jan?
Jan D'Alvise: Yes. Thanks Prashant. And maybe you or Pierre could also comment. I know that these patients aren't typically kept on the drug constantly, right? They are -- when symptoms flare, they tend to ramp up on the drug and then stay on it and then, potentially taper down.
Prashant Kohli: So currently obviously, this drug is not approved in the market nor is any such product used in A-T patients. The original Zanolli trial did include the crossover design with the tapering strategy that you were alluding to and -- this is something that we do...
Jan D'Alvise: Leland, we can hear you. Maybe you could go on mute.
Leland Gershell: Sorry about that.
Jan D'Alvise: Yes, sorry, go ahead Prashant.
Prashant Kohli: Yes. I was just going to comment if Pierre you want to jump in about, specifically the Zanolli trial design, which did include the tapering concept that Jan was alluding to.
Pierre Lemieux: Yes. No definitely this trial by the way that was published, I think the data that came out of this on 13 patients, not a big sample, but still there was some significant improvement of the ICAR scores. And so, depending on the physicians, we're extremely cautious about how to give this formulation of betamethasone. And -- but overall, I think what was monitored very closely and what was very positive from that study was the posture and gate disturbances that were really improved such as there was also some kinetic functions and speech disorders, I would say, scored attached to these conditions that were improved significantly. So there was only one particular disorder, which is the ocular motor, these kids tend to have an issue with their eyes. And that was about the only factor, I would say that was not necessarily corrected with betamethasone but the rest is very promising. And that's why the physicians would certainly won't have to -- would like to have this formulation, probably develop like we're doing it right now developing it right now making it more easily to swallow, keep that in mind. So, these kids are young at their age and the formulation that is available has large volumes. So it's not very user-friendly, I would say. So in our case, I think we can certainly -- probably be in a better position to control the dosage because of our spray that we've developed and that is applied to the tongue.
Jan D'Alvise: Yes. Thanks Pierre. And to that point, I think what's important also is that our novel formulation really concentrates the betamethasone but we're delivering 170 of the dose, so significantly less of this corticosteroid and getting the same -- reaching the same blood levels. We hope it will translate into efficacy as well. So we're hopeful that this will be more conducive to long-term chronic use and have less of a risk of side effects as a result. So Leland, I don't know if that answered your question.
Leland Gershell: Yes. Thank you very much, Jan and team. Thank you.
Jan D'Alvise: Did you have any other questions for us?
Leland Gershell: No, that's all for me. Thank you very much.
Jan D'Alvise: Okay. Thank you. Appreciate it. Robert?
Operator:
Robert Blum: Jan, maybe I've got a couple here that have come in. I just wanted to maybe run these by to see, if there's any other questions while we wait. The first one here is that, we're hearing some rumors that federal many agencies are understaffed, obviously that includes the FDA. Are you or your regulatory attorneys experiencing any issues or delays in dealing with them right now?
Jan D'Alvise: It's interesting. We have experienced a little bit of a delay. We've had to file updated INDs for these PK studies that are underway or about to start. And we've seen a delay of just a few days, so nothing significant. So we're really hopeful that, particularly, as we move forward and request our Type C meeting for GTX-104 here shortly, that will go forward and we'll get our meeting in time. I mean it's a 75-day clock. So, we're hopeful that we can get our meeting within that window. But I would say, a little bit of delay not bad.
Robert Blum: Okay. On that topic you just mentioned here and I just had maybe two more. Maybe talk about why the change to conduct the Type C meeting? I know you mentioned some of it in your prepared remarks so maybe you could expand upon that just a bit more.
Jan D'Alvise: Yes. And just to say, I don't think it's a change. We â just as a good practice we typically request a Type C meeting, particularly to starting a Phase III study. So in this case we feel it's very important to confirm with the FDA, the design of the study, the dosing. Remember that we did these PK studies to really confirm the dosing regimen. So it will be an initial loading dose followed by continuous infusion. So we want to take the FDA through that data and get their support for that dosing regimen going forward in Phase III. But we also want to get their input on collecting additional important pharmacoeconomic data. As I mentioned earlier, this is going to be really important. We believe because of the more consistent blood levels that we're seeing with GTX-104 that this should improve safety, right? It will translate into better control of blood pressure, hopefully a reduction in hypotensive events. And we would hope to see improved safety over the oral. We also expect to see that this is going to be a lot easier for the nursing staff to handle. Today they have to take apart of capsule, deliver it through a nasogastric tube. And because dosing is so inconsistent oftentimes they back off on the dose maybe deliver half a dose every two hours. So it's really a very burdensome from a nursing perspective and it's prone to mistakes. That's the other thing. So we really think that GTX-104 is going to be much easier less of a burden for the nursing staff and we hope that we see a reduced need for rescue therapies. And hopefully, that will translate into shorter length of stay. So that's the kind of data that we really want to collect and we want to get the FDA's guidance on that as well.
Robert Blum: Okay. Great. And then last one for either maybe yourself or Brian here. Maybe talk about the changes in some more detail to the extent you can on the cash flow runway being extended? And what sort of the current cash burn rate looks like?
Jan D'Alvise: Yes. So Brian do you want to take that one?
Brian Ford: Yes sure. Like a lot of other companies, the current economy is people are concerned about interest rates and cash and markets. So we've always been looking at ways to preserve our cash and extend our operating run way. Over the last quarter, we identified and implemented a lot of internal efficiencies. This is really a fairly detailed look at all of our overheads and making sure that we're managing them appropriately. And so we've been able to negotiate certain contracts and other efficiencies. But we have extended our runway by about six months through at least March of 2024. So â and this gives us enough breathing space cash-wise to complete the GTX-104 through a Phase III and NDA submission.
Jan D'Alvise: And I might add â thank you Brian. I might also add that when we put our budget together at the beginning of the fiscal year, we had planned these studies but we didn't have actual proposals from CROs. And so we were careful to make sure that we planned for enough cash for those studies. But I want to acknowledge Pierre and the team have done a terrific job, not only selecting really good CROs but negotiating really good contracts with them and we were able to save relative to budget on the actual cost of these studies as well. So it was really a combination of those things and just really kind of really rigorous careful review of our cash on daily, weekly, monthly basis.
Robert Blum: Okay. Great. Thank you for addressing those. Rocco, I guess I'll turn it back over to you, if there's any other questions there.
Operator: Absolutely. I'm actually not showing any further questions at this time. So I'd like to turn it back to Jan for closing remarks.
Jan D'Alvise: Okay. Great. Thank you, Rocco. And again, I want to thank you all for taking the time to be with us today on this call. I hope you can hear from us that it's a really exciting time at Acasti. We've got multiple drugs in the clinic that leverage Acasti's novel drug delivery technologies and they're now rapidly progressing towards, what we believe to be important value-enhancing milestones in this fiscal year. We believe our strategy to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects and more convenient drug delivery provides us with significant upside potential while minimizing our downside risk. Our enthusiasm is high and we look forward to reporting back to all of you in the quarters to come. So thank you again and have a great rest of your day. Rocco, I'll turn the call back to you for closing.
Operator: Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
