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spk04: Good day and welcome to the Ecosti Pharma first quarter fiscal year 2023 financial results conference call. All participants will be in listen-only mode. So if you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Robert Bloom with Lithum Partners. Please go ahead.
spk01: Thank you very much, Rocco. Welcome to Akasi Pharma's first quarter fiscal 2023 conference call. On the call with us this afternoon is Jan Delvis, 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 U.S. Private Securities Litigation Reform Act of 1995 and the Securities in 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 statements labeled with terms, beliefs, 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 III study for GTX104 and ACASI'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 CDAR at www.cdar.com, and on the Investors section of Acosti's website at www.acostifarma.com. In addition, any forward-looking statements represent Acosti's views as of today and should not be relied upon as representing our views of any subsequent date. Kosti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities law. With that said, I'd like to turn the call over to Jen DelVise, President and CEO of Kosti Pharma. Jen, please proceed.
spk08: 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, it 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 ACOSTI are well understood, although these patient populations may remain poorly served by current available therapies Or, for example, in the case of our GTX-102 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 505b2 regulatory pathway for the development of our novel and 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, GTX-104, and then I'll provide an update on the status of our ongoing clinical efforts. As a reminder, GTX-104 is a novel formulation of nemotipine to be administered via a continuous intravenous infusion designed specifically for patients with subarachnoid hemorrhage, or SAH, which is a condition caused by bleeding on 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 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 GTX 104 represents a total addressable market in the U.S., of more than $300 million. The current standard of care is an orally administered drug called nemotipine, which was approved by the FDA way back in 1988. Nemotipine 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 healing. Nemotipine is typically given throughout the entire time that the patient remains in the hospital which can be up to three to four weeks. Nimodipine is available in the U.S. 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 nemotipine 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 GTX-104 delivered intravenously could be a game changer for patients with SAH as a more convenient, efficient, and precise way to deliver nemotipine 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 18th that our GTX104 pharmacokinetic bridging study had successfully met all of its endpoints. The primary objective of the study was to evaluate the relative bioavailability of GTX104 administered intravenously compared to oral nemotipine in healthy adult male and female subjects, while the secondary objective was to assess its safety and tolerability. The results showed statistically no difference in the maximum and total exposure between GTX104 and the oral formulation of nemotipine. and no serious adverse events were observed. This meant that GTX104, delivered intravenously, can be considered essentially bioequivalent to oral numedipine. Importantly, the inter- and intra-subject PK variability was also much lower for GTX104 as compared with oral numedipine. We believe that because of its better absorption profile and more consistent blood levels, GTX-104 may provide physicians with a more reliable and more effective treatment for patients with SAH. This could be a key advantage, as GTX-104 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're now recommending for our Phase III safety study based on our excellent PK results. We also want to review our proposed design for the Phase III safety study with the FDA and to obtain their feedback and guidance before initiating this 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 three study in the first half of calendar 2023. I'll remind everyone that while the major objective of our phase three safety study is to show that the safety profile of our GTX104 and SAH patients is similar to or no worse than oral nimetipine, 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 GTX104 compared to oral nematopine. 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 III Safety Study is expected to be the final clinical step required. to seek regulatory approval under the 505 regulatory pathway before submitting a new drug application to the FDA for GTX104 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 GTX102, and I'll start with a brief program overview. Again, as a reminder, GTX-102 is a novel concentrated oral mucosal spray of beta-methazone intended to improve the neurological symptoms of ataxia telangiectasia, or AT, for which there are currently no FDA-approved therapies. AT 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 and cancer. Patients typically die in their mid-20s from complications of lung disease or cancer. A market research study commissioned by ACOSTI found that AT 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 glucocorticosteroid beta-methazone that can be sprayed conveniently over the tongue of the AT 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 GTX102 administered as an oral spray. We plan to compare GTX102 in this study to an intramuscular injection of beta-methazone, which is the reference product for U.S. filing purposes. and we'll also compare it to an oral solution of beta-methazone, 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 this single center study, comparing five different treatments, including the oral and IM forms of beta-methazone, and three different treatment doses of GTX-102. in a crossover study design. Blood levels and safety measures will be compared to beta-methazone IM injectable and to the beta-methazone 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 report out top-line results before the end of 2022. Assuming the PK bridging study meets its primary endpoint, we plan to conduct a Phase III safety and efficacy trial for GTX102 in AT patients, and like GTX104, 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 GTX102 under Section 505B2 would follow. Okay, and finally, let me discuss the nice progress that's being made on GTX 101, our novel, non-narcotic, thin-film, bioadhesive, 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, experience 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, 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 bupivacaine, we believe that GTX 101 may only need to be applied once or twice a day for 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 pigskin 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 a non-objection letter from Health Canada. The PK study is a Phase I 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 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 II 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 III study for GTX104 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 III 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 III 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 GTX102 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 three safety and efficacy trial in AT 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'll 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 two 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 III and 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?
spk05: Thank you, Jan, and welcome everybody to the call. Please note that unless otherwise indicated, all financial numbers that we discuss are denominated in U.S. dollars, and the financials are reported as conforming to U.S. GAAP guidelines. 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 half a 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-month end of June 30th, 2021, related to the completion of our Trilogy Phase III clinical program for our former drug candidate, Capri. General and administrative expenses for the quarter ended June 30th, 2022, were $1.9 million compared to $2.7 million for the quarter ended June 30th, 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 30th, 2021. Cash equivalents and short-term investments totaled $38.4 million as of June 31st, compared to $43.7 million in cash as of March 31st, 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 31st, 2024, which would include the ability to fund our lead asset, GTX 104, through to NDA submission, and GTX 102 and 101, through additional important milestones. With that, I'll now turn the call back over to Jan.
spk07: Thanks, Brian.
spk08: Before I turn it over to the operator for questions, I wanted to let everyone know that we'll be participating in the HC Wainwright Investor Conference from September 12th through the 16th, as well as the LIFM Partners Fall 2022 Investor Conference on September 28th and 29th. So if you'd like to arrange a meeting with us at either conference, please reach out to Robert Bloom at LIFM. With that, I'd like to now turn the call over to the operator. Rocco, can you open it up for questions, please?
spk04: Absolutely, ma'am. And as a reminder, everyone, if you'd like to ask a question, please press star then 1 on your touch-tone phone. Today's first question comes from Leland Gershow with Oppenheimer. Please go ahead.
spk03: 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 102 opportunity in AT, 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 can it be developed initially and perhaps find its initial use for in terms of that evolving and progressive disorder as patients get older. Sure. And, you know, also if you could, you know, maybe let us know if there's any additional work you may need to do to show that beyond up to the 505B2 requirements. And I guess this may hark 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.
spk08: Sure. Maybe, Prashant, if I could turn the first question over to you. I think you've had, you know, 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, Leland?
spk06: Sure, Jan. Yes. So, you know, in terms of the primary market research that we conducted with the GTX 102 with 80 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 Zanoli 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 where patients are treated for a number of years, and our understanding is that is how physicians would anticipate treating pediatric patients with GTX-102. However, this is a key area that we intend to tease out and flesh out in our ongoing discussions with with KOLs as well as when we get closer to designing the pivotal phase three study, the clinical study with AT patients. Jen?
spk08: Yeah, 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.
spk06: So currently, obviously this drug is not approved in the market nor is any such product used in AP patients. The original Zanoli trial did include the crossover design with the tapering strategy that you were alluding to.
spk03: And this is something that I wouldn't defer to Pierre.
spk08: Leland, we can hear you. Maybe you could go on mute.
spk03: Oh, sorry about that.
spk08: Yeah, sorry. Go ahead, Prashant.
spk06: Yeah, I was just going to comment if, Pierre, you want to jump in about specifically the Zanoli trial design, which did include the tapering concept that Jan was alluding to.
spk02: Yeah. No, definitely, you know, this trial, by the way, that was published, you know, I think the data that came out of this on 13 patients, not a big sample, but still, you know, there was some significant improvement of the ICAR scores. And so, depending on... The physicians were extremely cautious about how to give this, you know, this formulation of... of beta-metazones. But overall, I think what was monitored very closely, and that was very positive from that study, was the moisture and gait 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 oculomotor. These kids tend to have an issue with their eyes. That was about the only factor I would say that was not necessarily corrected with betamidazole, but the rest is very promising. And that's why the physician certainly would like to have this formulation probably developed 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, you know, we can certainly probably be in a better position to control the dosage, you know, because of our spray that we've developed and that is applied to the tongue.
spk08: Yeah, thanks, Pierre. And, you know, to that point, I think what's important also is that, you know, our novel formulation really concentrates the beta-methazone, but we're delivering one-seventieth of the dose, so significantly less of this corticosteroid, and getting the same, reaching the same blood levels. We hope it'll translate into efficacy as well. So, you know, 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.
spk07: So, Leland, I don't know if that answered your question.
spk03: Yes, thank you very much, Jan and team. Thank you.
spk07: Did you have any other questions, Leland?
spk03: No, that's all for me. Thank you very much.
spk07: Okay, thank you. Appreciate it.
spk04: Ladies and gentlemen, as a reminder, to ask a question, please press star then 1.
spk01: You know, Jan, maybe I've got a couple here that have come in. I just wanted to maybe run these by you to see if there's any other questions while we wait. You know, the first one here is that we're hearing some rumors that many federal 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?
spk08: You know, 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, you know, we're really hopeful that, particularly as we move forward and request our Type C meeting for GTX 104 here shortly, that, you know, that will go forward and we'll get our meeting, you know, in time. I mean, it's a 75-day clock, so we're hopeful that, you know, we can, you know, get our meeting within that window. But, you know, I would say a little bit of delay, not bad.
spk01: Okay. On that topic you just mentioned here, and I just have maybe two more, you know, maybe talk about why the change to conduct the Type C meeting. I know you mentioned some of it in your prepared remarks, but maybe you could expand upon that just a bit more.
spk08: Yeah, and just to say, I don't think it's a change. You know, just as good practice, we typically request a Type C meeting, particularly prior to starting a Phase III study. So, in this case, you know, we feel it's very important to, you know, confirm with the FDA the design of the study, The dosing, remember that we did these PK studies to really, you know, confirm, you know, 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, you know, get their support for that dosing regimen going forward in Phase III. But, you know, we also want to get their input on collecting additional important pharmacoeconomic data. As I mentioned earlier, you know, 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 a 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 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, you know, rescue therapies. And hopefully that will translate into shorter length of stay. So that's the kind of data that, you know, we really want to collect and we want to get the FDA's guidance on that as well.
spk01: Okay, great. And then last one for either maybe yourself or Brian here. Maybe talk about the changes to, you know, in some more detail to the extent you can on the cash flow runway being extended and and what sort of the current cash burn rate looks like.
spk07: Yeah, sure. Brian, do you want to take that one?
spk04: Yeah, sure.
spk05: 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 one 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. So we've been able to negotiate contracts and other efficiencies that have extended our runway by about six months through at least March of 2024. And this gives us enough breathing space cash-wise to complete the GTX 104 through its Phase III and NDA submission.
spk08: And I might add, thank you, Brian, I might also add that, you know, when we put our budget together at the beginning of the fiscal year, we, you know, had planned these studies, but we didn't have actual proposals from CROs, and so we were careful to make sure that we you know, plan 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, you know, save relative to budget on the actual costs of these studies as well. So it was really a combination of those things and just really, you know, kind of really rigorous, careful review of our cash on a daily, weekly, monthly basis.
spk01: 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.
spk04: Absolutely. I'm actually not showing any further questions at this time, so I'd like to turn it back to Jen for closing remarks.
spk08: 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 Acosti. We've got multiple drugs in the clinic that leverage Acosti'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 is 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.
spk04: Thank you. This concludes today's conference call, and we thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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