Q3 2023 Acasti Pharma Inc Earnings Call

Speaker 1: All participants will be in listen only mode. Should you need assistance, please signal conference specialist by pressing star key followed by zero. 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 Bloom with Lith and Partners. Please go ahead.

Speaker 2: All right, thank you very much Jason. Welcome to Acosta Pharma's third quarter fiscal 2023 conference call. On the call with us this afternoon is Jen Delvis, president and CEO , Brian Ford, chief financial officer.

Speaker 2: Pierre Lemieux, Chief Operating and Scientific Officer and a Acosta Co-Founder and Prashant Kohli, Chief Commercial Officer. Following management's prepared remarks there will be a Q&A session. Should any questions remain after the call, please contact me at 602...

Speaker 2: 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 Canadian securities laws and forward looking statements.

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Speaker 2: For looking statements during this conference called MANCLUDE, but are not limited to the success and timing of regulatory submissions of a costee's planned pre-clinical and clinical trials, regulatory requirements or developments and the outcome of meetings with the FDA.

Speaker 2: changes to clinical trial designs and regulatory pathways.

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Speaker 2: The forward-looking statements made during this conference call are expressly qualified in their entirety by this cautionary statement, the cautionary note regarding forward-looking information section, and the risk factors contained in documents that have been filed and are filed by COSD from time to time with the

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Speaker 2: at www.acosti.com. In addition, any forward-looking statements representing Acosti's views as of today and should not be relied upon as representing our views of any subsequent date.

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Speaker 2: I'd now like to turn the call over to Jan Delvies, President and CEO of Acosti. Jan, please proceed.

Speaker 3: Hey, thank you, Robert, and thank you to everyone joining the call today. We're very excited to update you on the significant progress made to advance our three clinical programs over the last few months. Let me start with a high-level overview, and then I'll provide more details.

Speaker 3: First, in late December 2022, we announced successful results following the completion of two pharmacokinetic or PK trials and human volunteers for both GTX 101 and 102. In both cases, the top-line results met all primary outcome measures, allowing us to advance both programs.

Speaker 3: to the next stage of clinical development in 2023. I'll expand more on each of these programs in a moment. Further with GTX 104, we submitted a letter to the FDA to request a type-c meeting to review and discuss the results of the PK Bridging Study that was reported out last May.

Speaker 3: as well as our proposed design for the Phase 3 Safety Study.

Speaker 3: We anticipate receiving the FDA's clarifying guidance before the end of calendar Q1. We expect that favorable guidance will confirm our 505B2 regulatory strategy and will allow us to finalize the study protocol paving the way for the initiation of our phase 3 safety study.

Speaker 3: in patients with subarachnid hemorrhage caused by a ruptured aneurysm or A-S-A-H.

Speaker 3: And very importantly, we finished the third fiscal quarter with 31.3 million in cash, cash equivalents, and short-term investments. We continue to believe that based on current projections, we have sufficient capital to fund operations into calendar Q2 of 2024.

Speaker 3: allowing for the advancement of GTX 104 well into Phase 3 and advancing GTX 102 and 101 to key value inflection points.

Speaker 3: So at a high level, we ended the quarter in a very strong fashion, and we expect calendar 2023 to be even more exciting with two of our drug candidates ready to enter Phase 3.

Speaker 3: With that brief summary of the quarter, let me expand on the positive results that we received on our two PK studies as announced in December , and I'll also provide a brief reminder of the market opportunity that each of these drug candidates represent.

Speaker 3: I'll start with GTX 101, our topical spray form of bouquetticane, that we're developing to treat patients with post-herpetic neuralgia or PhN.

Speaker 3: On December 22nd, we announced that the top line results for our single-dose PK study for GTX 101, that all its primary outcome measures for the study. This study was designed to evaluate the relative bioavailability of GTX 101 compared to a subcutaneous injection of the pivotcane.

Speaker 3: which is the reference listed drug in the United States for regulatory purposes.

Speaker 3: This TK study was the next step in the proposed 505B2 regulatory pathways for GTX 101, and the results provide us with important information on the dose and dosing frequency in humans for future plan clinical studies.

Speaker 3: As a reminder, GTX 101 is a unique and patented formulation of bupivocane hydrochloride that incorporates a novel, bioadhesive, film-forming polymer and is administered via a topical spray. As I mentioned, GTX 101 is being developed to relieve the severe pain associated with PHN.

Speaker 3: The persistent and often debilitating neuropathic pain caused by nerve damage from the varicela of those survivors. The virus that causes shingles and chickenpox.

Speaker 3: PHN pain may persist for months or even years, and based on our primary market research, there are still significant unmet medical needs for this indication.

Speaker 3: The single dose PK study enrolled 48 healthy adult subjects with 24 males and 24 females having a mean age of 36 years and they were randomized into four separate cohorts with 12 subjects in each cohort. Subjects in cohorts 1, 2, and 3 received 50, 100, and 100.

Speaker 3: or 200 milligrams of GTX 101 respectively, in adjacent and overlapping sprays on the lower back. Subjects in cohort four received a single 10 milligrams subcutaneous injection of the active but pivot came comparator.

Speaker 3: The primary objective of this PK study was to assess the pharmacokinetics of three different dose levels of GTX 101 at 5100 and 200 milligrams. Each dose of GTX 101 was administered to a separate cohort of 12 subjects as a single dose topical application in a metered spray.

Speaker 3: For clarity, 50 milligrams was delivered as five sprays, 100 milligrams is 10 sprays, and 200 milligrams is 20 sprays. These sprays were not administered one on top of the other, but rather adjacently to cover the entire targeted area. An additional 12 subjects in cohort 4 received a single 10 milligrams.

Speaker 3: to further characterize the PK parameters and the safety and tolerability of GTX 101, and will support additional future clinical development.

Speaker 3: We expect that the full clinical study report will be received from the ZERO in the first half of calendar 2023, and we intend to publish this data. We plan to follow this successful PK study with a multiple ascending dose study. Results from both of these days, one clinical study, once completed, will be...

Speaker 3: And when that fails, that it often does, due to poor efficacy and unpleasant side effects, lidocaine patches are typically prescribed as a second-line therapy. According to our recent research with more than 250 physicians who regularly treat these patients,

Speaker 3: Up to 40% of patients do not experience satisfactory pain relief from the patch. And these refractory patients may end up being prescribed opioids to address their persistent pain.

Speaker 3: Gabatent and opioid abuse have continued to proliferate, and lidocaine patches are sub-optimal for many reasons.

Speaker 3: The lidocaine patch can only be worn for 12 hours at a time. They're difficult to use if they fall off and can cause skin sensitivity and irritation, especially in older individuals, and depending on their placement they can be inconvenient, uncomfortable, and unattractive. Prescription lidocaine patches are currently only approved for PHN.

Speaker 3: and the market is made up of both branded and generic offerings. You can certainly see the many issues with the current treatment options that we hope GTX 101 will address.

Speaker 3: It's important to note that the potential benefits of GTX 101 could include faster onset of action and a longer duration of pain relief as compared to the light of pain patch.

Speaker 3: GTX 101 can be conveniently sprayed on the skin wherever the pain is located. And based on the PK ProFala Dupevican, we believe that GTX 101 may only need to be applied to the affected area once a day or possibly even less frequently to get 24-7 pain relief.

Speaker 3: Although, this dosing schedule will be confirmed in additional clinical studies.

Speaker 3: Based on this product profile and assuming a successful development program, we believe GTX 101 has the potential to be a game changer as a non-opioid alternative to the light of Kane Patch for pediatric patients who suffer from this debilitating pain.

Speaker 3: In terms of market size, it's estimated that PHN affects approximately 130,000 patients per year in the United States. And according to the third-party market research report commissioned by Acosti, the total addressable market for GTX 101 could be as large as 2.5 billion.

Speaker 3: consisting of approximately $200 million for PHN pain and $2.3 billion for non-PHN pain. So this certainly represents a large addressable market opportunity for Acosta.

Speaker 3: Now I'd like to transition to GTX 102 and on December 28th and only a week after we reported our positive clinical study results for GTX 101, we announced that the top line results of our GTX 102-001 PK bridging study met all primary outcome measures.

Speaker 3: and represented an important milestone in the advancement of this program.

Speaker 3: The PK Bridging Study was a phase one randomized open label crossover study and healthy adult subjects designed to evaluate the comparative bioavailability from a co-kinetics and safety of GTX 102 administered as an oral spray compared to intramuscular beta metasome.

Speaker 3: which is expected to be the reference product for regulatory bridging purposes.

Speaker 3: as well as to an oral solution of beta-methasone, which is available in Europe , but not in the United States.

Speaker 3: A total of 48 healthy adult subjects comprised of 27 males and 21 females were enrolled in a single-center, five-treatment, eight-sequence two-period crossover study. Our new and patented formulation of data metasone is intended to improve the neurological symptoms of a taxiotel and jactasia or AT.

Speaker 3: in a pediatric population for which there are currently no FDA-approved therapies. GTX-102 can be sprayed conveniently over the tongue of AT patients who often have difficulty swallowing. As a reminder, the Beta Methasone Oral solution that we're comparing to GTX-102

Speaker 3: was shown to reduce neurological symptoms in children with AT and a multi-center double-blind, randomized, placebo-controlled cross-over-trial conducted in Italy by doctors and only, and this study was published in 2012. As I mentioned, our PK bridging study met all primary outcome measures.

Speaker 3: Providing us with confidence that the expected final development step for GTX 102 will now be to conduct a Phase 3 Safety and Epochacy Trial in AT patients using a treatment regimen in a dosing range comparable to the one already shown to be effective in doctors' and only study.

Speaker 3: A background I'll remind you that 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 cancers. The home-ark symptoms of AT are still a beller ataxia.

Speaker 3: and other motor dysfunction as well as dilated blood vessels or telangetasia that occur in the sclera of the eyes and on the skin.

Speaker 3: Children begin to experience balance and coordination problems when they begin to walk at a toddler age and ultimately, they become wheelchair bound in their second decade of life. In pre-adolescence, around five to eight years of age, patients experience ocular motor apraxia. This is difficulty moving their eyes in a desired direction.

Speaker 3: And they also experience a weakness in the muscles of the face used for speech, causing slowed or slurred speech.

Speaker 3: As well as dysphagia, or difficulty swallowing, they often develop compromised immune systems and are at an increased risk of developing respiratory tract infections and cancers, typically lymphomas and leukemia.

Speaker 3: Tasons typically die in their second decade of life from complications of lung disease or cancer. Unfortunately, there's no known treatment to slow the disease progression of AT, and treatments that are used are strictly aimed at symptoms or conditions secondary to the disease.

Speaker 3: A third-party market research study that we commissioned found ATFX approximately 4,300 patients per year in the United States and has a potential and dressable market of about $150 million based on the number of treatable patients.

Speaker 3: Dushane muscular dystrophy or DMD is another rare inherited and progressive muscular disorder that typically affects boys. And like AT, it is often diagnosed at a young age. And Flaza is the first and only FDA approved corticosteroid for treating boys with DMD over the age of two.

Speaker 3: Like GTX 102, the dosing of M-Plaza is determined for this pediatric population based on their weight.

Speaker 3: And Flasso, which is sold by PPC Pharmaceuticals, was launched back in 2017, and it's reached more than $200 million in sales last year. Given the many similarities with GTX 102, we believe that in Flasso could serve as an excellent analog for successful commercialization of our drug.

Speaker 3: In terms of next steps following the receipt of the full PK data study data set from our CRO, which is expected sometime in the first half of calendar 2023, we plan to request a type B meeting with the FDA to confirm our proposed phase three study design and the 5-0-5-B2 bridging strategy with the listed intramuscular

Speaker 3: as expected to follow.

Speaker 3: Transitioning now to GTX 104, our lead development program, as previously discussed, we submitted a Type C meeting package to the FDA back in November . That package included the data from our PK bridging study, as well as our proposed design for our Phase 3 safety study.

Speaker 3: We anticipate receiving the FDA's clarifying guidance before the end of calendar Q1. This should allow us to benefit from the FDA's buy-in and should allow us to begin recruiting clinical sites and initiate the Phase 3 Safety Study as planned. We've already selected our CRO.

Speaker 3: and clinical trial site selection is currently underway. For those of you who may not already be familiar with our lead drug candidate, GTX 104 is a novel patented formulation of nemotropine for IV infusion designed specifically for patients with aneurysmal.

Speaker 3: subarachnoid hemorrhage or ASAH, which is a condition caused by bleeding on the brain due to a ruptured aneurysm. ASAH presents a life-threatening emergency for the patient and our new proprietary IV drug formulation addresses a vital need in the critical care market.

Speaker 3: that seen little innovation over the last 30 years. The condition of ASAH 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.

Speaker 3: As a reminder, we completed a Phase I PK bridging study in May of 2022, which successfully met all of its endpoints. The primary objective of the study was to evaluate the relative bioavailability of our GTX 104 administered as a continuous IV infusion compared to oral pneumodopine capsules.

Speaker 3: and healthy adult nail and female subjects. While the secondary objective was to assess its safety and tolerability, importantly, the interim interest subject variability was much lower for GTX 104 as compared with oral nematopeins. We believe that because of its better absorption profile and more consistent and predictable blood levels,

Speaker 3: GTX 104 may provide physicians with a more reliable and effective treatment for patients with ASAH. This could be a major advantage as GTX 104 could help to reduce the incidence of hypotensive events and vasospasms which require immediate and costly intervention.

Speaker 3: such as balloon angioplasty or the use of intra arterial vasopressors, which can lead to worse outcomes for the patient.

Speaker 3: As I mentioned, while we wait for the guidance from the FDA on our proposed Phase III study design, we continue to plan and prepare for the initiation of the study. We have engaged a CRO to manage the study for us, and we are qualifying and recruiting sites now to enroll patients. We expect the study to take about 18 months to complete once the first...

Speaker 3: Before I turn it over to Brian to review our Q3 financial, I think it's important to mention that the strategy that we're undertaking to leverage a cost these unique drug delivery capabilities by reformulating and repurposing marketed drugs for new orphan indications, where significant unmet medical needs exist.

Speaker 3: is advancing nicely according to our plans. So well understood efficacy and safety profiles of the currently marketed forms of these drugs, provide the opportunity for us to utilize the FDA Section 505B2 regulatory pathway for the expedited development of our reformulated drug candidates. And therefore may provide

Speaker 3: potentially provide a shorter, less risky, and less costly path to regulatory approval.

Speaker 3: And as I've mentioned before, all three of our drug candidates have already received orphan drug designation from the FDA and have 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.

Speaker 3: and 10 years in Europe . These rare diseases also typically involve clinical trials with fewer patients and provide market opportunities that often require a much smaller, more targeted commercial infrastructure.

Speaker 3: It's important to point out that the orphaned diseases that a costee has targeted for drug development are well understood, although these patient populations may remain poorly served by available therapies, or for example, in the case of our GTX 102 for children with AT, approved drug therapies do not yet exist.

Speaker 3: Our aim is to effectively treat the debilitating symptoms to resolve from these underlying diseases with the ultimate goal of improving quality of life and outcomes for these patients and their families. We believe that leveraging the Section 505B2 regulatory pathways for the development of our reformulated versions of these drugs

Speaker 3: I'll then quickly wrap things up and we can then open the call up for questions.

Speaker 4: Brian ? Thanks, Jan. Please note that unless otherwise indicated all financial numbers that we discussed are just nominated in US dollars and the financials are reported conforming to US cap guidelines.

Speaker 4: We should also note that we are a clinical stage company.

Speaker 4: Thus, we do not yet generate revenues or have any costs of good expense.

Speaker 4: research and development expenses, net of government assistance for the three-month on September 31st, 2022, total 2.5 million.

Speaker 4: compared to $2.2 million for the three months ended December 31st, 2021.

Speaker 4: Our research and development during the quarter-ended December 31, 2022.

Speaker 4: was focused primarily on a dancing hour clinical development program, Sir GTX 104, 102, and 101, the drug candidates.

Speaker 4: General and administrative expenses for the three months ended December 31, 2022 were 1.6 million compared to 1.8 million for the three months ended December 31, 2021.

Speaker 4: This decrease was the result of decreased legal, tax, accounting, and other professional fees that had been incurred in connection with the GRACE acquisition.

Speaker 4: The decrease in professional fees was partly offset by an increase in...

Speaker 4: salaries and benefits due to the reinstated accruals for our employee incentive bonus programs.

Speaker 4: Last from operating activities for the three months ended December 31st, 2022.

Speaker 4: It was 4.2 million compared to a loss of 4.5 million for the three months and a December 31, 2021.

Speaker 4: For the three months ended September 30th, 2021, the financial gain of $0.7 million resulted mostly from...

Speaker 4: the decrease in the fair value of the derivative warmth liabilities.

Speaker 4: Net loss and total comprehensive loss for the three months ended to SEMP-31, 2022, was 3.9 million or a loss of 0.9 cents per share, which was pretty much identical to the net loss.

Speaker 4: of $3.8 million or a loss of $0.09 per share for the three months ended December 31st, 2021.

Speaker 4: Cash equivalents and short-term investments.

Speaker 4: Total 31.3 million as of December 31st, 2022, compared to 34.9 million in cash, cash equivalents.

Speaker 4: short-term investments as of September 30, 2022.

Speaker 4: As Jan mentioned, we continue to believe that we have sufficient capital to fund operations in the calendar Q2 of 2022 or 2024, which would include the ability to fund our lead asset GTX 104. Well in Phase 3.

Speaker 4: and GTX 102 and 101, two additional important milestones. With that, I'll now turn the call back over to Chan.

Speaker 3: Thank you, Brian . So to quickly wrap things up, we ended calendar 2022 in a very strong fashion with the completion of three successful clinical trials, two that reported that in December alone. We look forward to receiving clarifying guidance from the FDA before the end of Q1 on the Phase 3 study design for the...

Speaker 3: If you are most exciting year yet, and we look forward to keeping you all apprised of our progress towards our mini milestones this year.

Speaker 3: So with that, I'll turn the call back over to the operator. Jason, can you open it up for questions for us?

Speaker 1: Yes, we will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you're using a speaker phone, please pick up your headset before pressing the keys. And to withdraw your question, please press star then two.

Speaker 1: Our first question comes from Leland Gerschel from Oppenheimer. Please go ahead.

Speaker 5: Thanks, Jan, for the update. Just a question from me as you get 102 into its next trial this year. I wonder if you could share with us any of you on enrollment timelines and potential timing for the top-line data. Thank you.

Speaker 3: Yeah, thanks, Leyland. Well, you know, as I mentioned, we are really now waiting on the final clinical trial report. We need to submit that to the FDA before we can start to phase three. And we have always felt that it's a good idea to make sure that...

Speaker 3: with our proposed study design and we really want the FDA's feedback on that. And so what we're doing now is we're working with our key opinion leaders and our regulatory experts to really, you know, draft the design of the study.

Speaker 3: We're well into that. We're really looking to get a lot of really good input here over the next couple of months from our opinion leaders. And then we'll plan to submit all of that. And I would expect, given the kind of time clock on this, that the type B meeting would be sometime this summer.

Speaker 3: And once we get their feedback, of course, we'll be planning the study in parallel. So we're, again, hoping that we can initiate startup activities, certainly in the second half of this year.

Speaker 5: Great, thanks very much for the update.

Speaker 6: Thanks, Leilin.

Speaker 1: Again, if you have a question, please press star then one.

Speaker 1: Our next question comes from Orrin Lidmat from HC Wainwright. Please go ahead.

Speaker 7: Thanks for taking my question and congrats on the progress. I actually have a few. On 104, are you able to clarify if you already did have that type of meeting with FGA? And if so, I know we're waiting on the minutes of course, but are you able or allowed to?

Speaker 7: You know give us any sort of color there if there's any surprises or As far as you can tell things going according to plan for just a strictly safety phase three study and I have a few follow-ups. Thanks

Speaker 3: Yeah, sure thanks, thanks, Lauren. And so, no, we are waiting on guidance from the FDA. We're asking them to clarify a number of things. So, you know, based on our positive results from our PK study, we've asked them to confirm...

Speaker 3: you know, whether we are eligible to use the 505B to regulatory pathway. You know, we showed bioequivalence with the oral, so we believe that's straightforward, but we want to get that confirmation from them. We also want them to confirm our proposed dosing regimen.

Speaker 3: We are recommending a 3.6 milligram bolus delivered over 30 minutes and that's followed by a continuous infusion. Again, we're proposing a rate of 1.2 milligrams per hour.

Speaker 3: This was the dosing regimen that matched the C-max on day one and the AUC at day three of the oral. So, again, it's really important that we get the FDA's confirmation on that, and we do not have that yet.

Speaker 3: We're also asking them to give us guidance on the number of patients. And again, based on previous discussions with the FDA, we are, you know, guesstimating or estimating that it'd be somewhere between 100 and 200 patients. But we want, you know, we need to get that confirmation.

Speaker 3: between the oral and the GTX 104 IV. So, you know, we've asked for their guidance on, you know, should it be based on, you know, what threshold should it be based on systolic only, diastolic orcist end, you know, systolic.

Speaker 3: I shouldn't call them endpoints, the various exploratory data that we want to collect. We want to do SPARC PK sampling of the patient population to build on our PK PD modeling.

Speaker 3: We're going to collect some efficacy in pharmacalachinomic data that, you know, really for publication purposes. So really, you know, this is a long way of answering your question, but it's really important that we get that clarification before we, you know, really finalize the protocol design and start the study.

Speaker 7: And I might have missed it, but did you already have that meeting?

Speaker 8: No.

Speaker 7: Okay. Is that expected or is things dragging just at the FG agency in general or is there been some back and forth?

Speaker 3: You know, things are dragging, you know, absolutely. And, you know, the FDA has indicated that they're short-staffed. You know, and again, you know, we've had good communication with them. So, you know, I just think, you know, we expected, you know, to get this.

Speaker 3: Soon. And as soon as we get it, obviously we'll be putting out the information that we get.

Speaker 7: Okay.

Speaker 7: Big picture commercially on 104 as the stuff is going on separately. It's obviously a pretty concentrated market. Has there been further progress?

Speaker 7: In your relationship with a big center of the excellence and the associated KOL there that theoretically are helping you continue to prime the palm for lay the groundwork for excitement and rapid adoption if and when this thing works into the proof.

Speaker 3: Yeah, you know, I'll just make a quick comment and then I'll hand it over to Prashant to expand. But you know, as we begin to identify and qualify sites...

Speaker 3: You know, we're building on relationships we have and expanding those relationships. But let me pass it over to Prasant. Prasant, do you want to add anything there?

Speaker 9: Hi, Shorjan. Hi, Orn. Thank you. As Jan mentioned, our strategy is multi-pronged to prime the market. Obviously, having a prime keeping in leaders, very credible, helping us in that process is very important.

Speaker 9: And we believe we have a really robust scientific advisory board.

Speaker 9: prominent neurointensiveists from University of Texas and Houston, the largest neurocritical care site in the country with 75 neurocritical care beds, barren neuroscience, again, very prestigious, very prominent site as well, center as well.

Speaker 9: And really helping, you know, using their, you know, systems to help, you know, recruit sites, high volume sites, you know, really excite the local PIs at those sites. It is a big part of our strategy of priming the market. The second part of it is.

Speaker 9: as part of conducting the actual study, having these high volume side both comprehensive, you know, an advanced stroke centers, a combination of them, you know, having them to gain experience, of course, can experience with GTX 104 versus oral, see the benefits of that.

Speaker 9: We strongly believe that will provide a great impetus when our product hopefully does get approved and launched, that they would become the early adopters. And in this market, as we have gotten closer to understanding the

Speaker 9: The buying center, if you will, with the PNT committee of a hospital clinical champion. And it's a multi-stakeholder decision process. We believe that having wins behind our sale with having the early adopters, the key opinion leaders, the talk leaders.

Speaker 9: helping present at medical congresses. We've identified a handful of those where in the intensiveest the neurosurgeons, even the neuroscience nurses come together and having those talk leaders talk about our program, you know, are all things that would really help drive.

Speaker 9: product uptick. And the last piece and the least is, last but not the least, I mean is medical communication. Jan mentioned publication strategy, collecting pharmacoeconomic data, and then being able to publish those in peer review journal.

Speaker 9: journals is also, you know, primed to getting the market geared for the product and hopefully a solid uptick once it's on the market.

Speaker 7: All right, and lastly, if I may apologize for taking so much time, but I'm 101. Are you still expecting with this full clinical report in first half the, I guess you called it an exploratory pharmacodynamic, quote unquote efficacy look, and will you share that with us?

Speaker 3: Yeah, I'm going to turn that over to Pierre. Pierre, can you respond on that? Because I'm not sure what the data is. For 101.

Speaker 9: Yes, can you hear me? Yep. Yeah. Hi, Aaron. Thank you for the question. Yeah, regarding GDX 101.

Speaker 9: We're still finding together the final clinical study report in May. But as you know, we've announced a data, but now it's a question of finalizing the report with all the bells and whistles that are increasing the report. So in terms of the, I think the PK data were reported and were, were comfortable.

to provide this update before Christmas. Regarding the PD, the pharmacodynamic, it's a bit more complicated. Honestly, it was not a primary endpoint of this study. We've looked into some, I would say attempt to get pharmacodynamics, so using some bond free assessment.

So we'll be able to report a bit of that piece of data, but I want, again, I can say this, we've done this to really find the multiple ascending dose study, which will be the next step. So I mean, we'll be sharing once we have the final report what we believe is really...

and we see relevant in the preparation of the multiple ascending though but it's so part of the plan to communicate that in the formation in due time.

All right, well thanks for answering all the questions. Appreciate it.

Thank you, Warren. Appreciate it.

There are no more questions in the queue. This concludes our question and answer session. I'd like to turn the conference back over to management for any closing remarks.

Okay, thank you, Jason. Again, I just want to thank you all for taking the time to be with us on this call today. We're really excited about the progress we're making to deliver innovative new treatments to thousands of patients who currently lack effective therapies. And we look forward to updating you on our progress towards several key milestones in the coming months.

Thank you again and have a great rest of the day. Back to you, Jason. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

And mar.