Q4 2024 INmune Bio Inc Earnings Call
Speaker Change: Please stand by. Your program is about to begin. If you need audio assistance during today's program, please press star zero.
Speaker Change: Greetings and welcome to the INmune Bio's 2024 fourth quarter and full year earnings call. At this time all participants are in a listen only mode. Later you will have the opportunity to ask questions during the question answer session. You may register to ask a question at any time by pressing the star than the one key on your telephone keypad. You may withdraw yourself from the queue by pressing the star to key. I will be standing by should you need any assistance as a reminder this conference is being recorded and a transcript will follow within 24 hours of this conference call. Thank you very much. Thank you very much.
Speaker Change: Simon is now my pleasure to introduce Mr. David Moss, CFO of INmune Bio, David.
David Moss: Thank you, Margo, and good afternoon everyone. We thank you for joining us for the call for INmune Bio's 2024 fourth quarter and full your financial results.
Speaker Change: With me on the call today is Dr. RJ Tesi, CEO and co-founder of INmune Bio, who will provide an update on our clinical programs. Also on the call is Dr. CJ Barnum and Dr. Mark Lowdell, who will be available for Q&A.
Speaker Change: Before we begin, I remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are for looking statements.
Speaker Change: Under the Safe Harbor provisions of the Private Security's litigation reform act of 1995, these statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements.
Speaker Change: Please see the forward-looking statements disclaimer on the company's earnings press release, as well as risk factors in the company's SEC following including our most recent quarterly following of the SEC.
Speaker Change: There is no assurance of any specific outcome. Undo reliance should not be placed on forward looking statements would speak only as to the date they're made as the facts and circumstances underlying these forward looking statements may change.
Speaker Change: Accept is required by law in Mune Bio Disclamps, any obligations to update these horror-looking statements to reflect future information events or circumstances.
Speaker Change: With that behind us at this time, I'd like to turn the call over to Dr. RJ Tesi who will provide an overview of our clinical programs before I discuss the financials and we conclude with Q&A. Over to you, RJ.
Speaker Change: In less than 100 days, we expect to announce topline data for a randomized blinded placebo controlled phase II trial using X pro to treat patients with early a D with information we call the trial a D O two or mindful. We have worked tirelessly to get to this point and I must say hats off to the entire.
Speaker Change: Your opinion medimmune bile for reaching this major milestone we can't wait to learn the results.
Speaker Change: <unk> D O two Alzheimer's trial stands out from conventional approaches of treating Alzheimer's disease due to our focus on treating neuro inflammation is the primary driver of that.
Speaker Change: Disease, rather than targeting plaques and tangles that dominant traditional targets of Alzheimer's drug development.
Speaker Change: Yeah.
Speaker Change: We have targeted inflammation as the main driver because of the frustrating history of failed trials to treat Alzheimer's disease, we adopted a persistent precision medicine approach for our phase II program that precision is first seen in patient selection.
Speaker Change: Oh, two trial uses clinical biomarkers to match the patient pathophysiology with extra this mechanism of action that is ex pro targets neuro inflammation. Therefore, we enriched the trial with.
Speaker Change: With 80 patients who have neuro inflammation driving there.
Speaker Change: <unk> disease.
Speaker Change: To our knowledge a D O two remains the only Alzheimer's trial, using biomarkers other than amyloid or Tau to guide patient selection.
Speaker Change: Next we embraced E Mac as the primary endpoint of the trial <unk> is designed to accurately test cognitive function in patients with early Alzheimer's disease.
Speaker Change: We don't understand why others embrace the use of cognitive tests designed for staging patients with Alzheimer's disease or developed for use in patients with moderate to severe Alzheimer's disease as the primary endpoint for studies in patients with early Alzheimer's disease, those measures of cognition or not.
Speaker Change: Time to measure the clinical effectiveness of its therapy.
<unk> is purpose built objective.
Speaker Change: Tests of cognitive function designed to be used in patients with early.
Speaker Change: Alzheimer's disease with a dynamic range that allows the measure of worsening and improving cognitive function.
Speaker Change: Although the term precision medicine is most often used to define patient selection criteria and clinical trials. We believe <unk> provides a precision medicine measure to efficacy in Alzheimer's trials.
Speaker Change: The embrace of these novel approaches based on solid preclinical data compelling phase one data and then belief that addressing the structural and pharmacological aspects of protocol design de risks the trial and improves the probability of success.
Speaker Change: By integrating inflammatory biomarkers to identify responsive patients and utilizing a precise measure of cognitive response.
Speaker Change: Immune buyers hopes to do more than just slow cognitive decline.
Speaker Change: Our goal is to stop cognitive decline if successful we will challenge the longstanding amyloid centric paradigm of Alzheimer's disease work supporting the perspective.
Speaker Change: Alzheimer's is an immunological disease.
Speaker Change: Today, we are less than 100 days away from reporting the results of radio to the trial enrolled 208 patients in eight countries. We work to enroll the right patients into the trial, which resulted in that screening nearly 800 patients.
Speaker Change: This has seen this seemingly simple process of patient screening is tied was time consuming complicated and expensive, but one of the four important drivers of success in Asia.
Speaker Change: To.
Speaker Change: The second and third drivers are the previously mentioned enrichment criteria used to select patients with neuro inflammation and the use of the Mac to precisely assess cognitive response. The final driver is X product driving success of this drug in patients with dementia caused by neuro inflammation may open a world of possible.
Speaker Change: Patients with neurologic disease, because neuro inflammation is a common denominator and many difficult to treat CNS diseases.
Speaker Change: Also in 2024, we completed the pivot to solid tumors with <unk>, our NK cell targeting platform, although <unk> had interesting data in the treatment of hematologic diseases. We believe the future opportunities for Inc were greater by targeting and treating solid tumors the care.
Speaker Change: C trial, using <unk> to treat men with castrate resistant metastatic prostate cancers has made steady progress, we recently announced completion of dosing in the phase one dose escalation part of the phase one two trial.
Speaker Change: Continue to dose patients in the phase II part of the trial at the medium and high dose cohorts. As currently designed we expect to complete dosing of patients with <unk>.
Speaker Change: During 2025, and we have promised that as data become available in those cohorts because it is an open label trial, we will report it.
Speaker Change: Courtroom is a 2025 of that but in fact <unk> has been a quiet part of immune buyouts since 2018.
Speaker Change: Dr. Mark Lidell invented and perfected courtroom to support an NIH funded trial in the UK treating kids with intermediate to severe recessive dystrophic, epidermolysis <unk> or R. R.
Speaker Change: Our debt is a rare genetic disease caused by the mutation of the coal <unk> gene.
Speaker Change: NIH or is the research arm of the United Kingdom's National Health service.
Speaker Change: You mean buyout team saw the clinical day data on the use of cord stem in kids with Ardeb for the first time in November of 2024. The data are compelling and provides <unk> with a unique and licensing opportunity that is immune buyout owns and invented and homes cord from the drug.
Speaker Change: And gosh, which is the great Ormond Street hospital for children, which is the largest largest pediatric hospital in the U K was the sponsor of the clinical trial and own the mission he'd be clinical data <unk> is the name of the clinical trial.
Speaker Change: Perform that gosh.
Speaker Change: Combining the two assets was necessary to generate value to the patients caregivers and investors.
Speaker Change: While in licensed the <unk> clinical data, resulting in what we believe is a BLA ready program.
Speaker Change: That has already been awarded orphan drug status and rare pediatric disease designation.
Speaker Change: Corsham differentiates itself from other approved therapies for our debt by providing a systemic disease modifying approach rather than focusing on local wound management.
Speaker Change: Many of you know that the default.
Speaker Change: Once the wounds that don't heal.
Speaker Change: One of the major problems of this debilitating disease.
Speaker Change: We are not discounting the importance of those therapies, but our debt affects every organ system in the body accept the brain topical wound therapies, while providing important local benefits did not address problems in the eyes problems eating.
Speaker Change: Elsewhere in the body.
Speaker Change: These men.
Speaker Change: Problems require systemic disease modifying therapy.
Speaker Change: <unk> is an allogeneic pool of umbilical cord derived message gambles Mesenchymoma stromal cell platform delivered intravenously.
Speaker Change: Excuse me.
Speaker Change: <unk> is a systemic therapy that aims to modulate inflammation promote wound healing reduce the debilitating itch pain, scaring that exacerbate our debt and skin the esophagus the eyes and beyond.
Speaker Change: The patient caregiver interviews provide some of the most interesting.
Speaker Change: Information or data from the blinded randomized <unk> trial.
Speaker Change: Those are best heard by listening to the web webinar that and which professor Ana Martinez reports the responses from the trial that's available on our website.
Speaker Change: The impact of course from therapy on patients quality of life seems clear. We believe this program is on a rapid path to the market, where it will fulfill an unmet clinical need in kids with this desperately debilitating and ultimately lethal disease.
Speaker Change: Well, we love our cell therapy programs, we understand that Ato to topline data as the catalysts, everyone, including ourselves are looking forward in the near term.
Speaker Change: At our core immune biology, CNS company focused on Alzheimer's disease.
Speaker Change: We have built this company around our <unk> platform and analysis in 100 days away from the results of the trial.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: In the phase II trial in Alzheimer's patients with Biomarkers of inflammation.
Speaker Change: I reiterate we will provide top line results for the trial.
Speaker Change: <unk>.
Speaker Change: June I don't know exactly what date in June the topline data will the lease there are too many moving parts, but it will be June.
Speaker Change: Also there is no industry wide definition of what topline data make meets our definition is simple the data will provide unequivocal evidence of the impact of EXPAREL on the treatment and the clinical and the response of those clinical symptoms of patients with early Alzheimer's disease with Biomarkers.
Speaker Change: Information.
Speaker Change: This means we will provide a robust package of cognitive clinical and functional data.
Speaker Change: From patients treated with <unk> in the trial.
Speaker Change: From these data we will provide an answer to the question.
Speaker Change: Does treating early Alzheimer's disease, and patients with Biomarkers of inflammation with Expro safely alter the trajectory of their cognitive decline.
Speaker Change: There are four important aspects in the statement I just made.
Speaker Change: The trial is in early <unk>, we are not studying patients with moderate or severe disease. Early patients are the same group that.
Speaker Change: Virtually everyone studies, including the approved anti amyloid trucks.
Speaker Change: We are enrolling patients with biomarkers of inflammation that is this is not an all comers trial, but a precision medicine trial enriched with early Alzheimer's patients that have neuro inflammation.
Speaker Change: Three of the foreign Richmond criteria are more biomarkers of peripheral inflammation central information. This first makes them easy to obtain a peripheral club blood, but importantly experts agree that peripheral inflammation caused a central inflammation that drives the Alzheimer's disease, because ex pro treats both peripheral and central.
Speaker Change: Information it should stop disease in the brain and eliminate the fuel that feeds progression of the disease.
Speaker Change: Safety is paramount and treating elderly patients with Alzheimer's as of today, there have been no unscheduled neuro imaging studies no emergency Mris there've been no deaths in the number of infections can be treated on one hand.
Speaker Change: This is a remarkable history and a group of patients that averages 73 years old.
Speaker Change: Thus far X pro has shown to be safe in that target population.
Finally, I chose the word trajectory of their cognitive decline carefully currently approved therapy slow the rate of cognitive decline.
Speaker Change: And realistically, we need to be as good as the currently approved therapies.
Speaker Change: <unk> claimed success, but we have higher aspirations. Our goal is to halt disease progression or halt cognitive decline rather than the slow the progressive decline. We believe the results of this chart trial will challenge the longstanding plaques entangled disease paradigm with Alzheimer's disease.
Speaker Change: Professor excuse me a fresh perspective on the treatment of Alzheimer's disease as an immunologic disease.
Speaker Change: We hope the first day of X pro therapies, the last day of cognitive decline in patients with early AP, We will know soon if this.
Speaker Change: Lofty aspiration is realized.
Speaker Change: We are confident.
Speaker Change: Okay.
Speaker Change: While we remain very optimistic about the upcoming results for <unk>. Two we believe bigger changes are positive results will create a paradigm shift for the treatment of Alzheimer's disease and other CNS diseases.
Speaker Change: Neuro inflammation often ignored in untreated is finally recognized as an element of many of these diseases.
And we now have a tool for them to add to that.
Speaker Change: <unk> armamentarium.
Speaker Change: For instance, neuro inflammation plays important roles of dementia associated with STD Parkinson disease traumatic brain injury stroke depression and beyond.
Speaker Change: Chronic inflammation is to driver of many diseases of aging and if we achieve our expected results targeting the immune dysfunction until <unk> becomes a reality.
Speaker Change: 2024 was a major a year a major accomplishment accomplishments in all our programs great progress was made in the clinic with our legacy programs.
Speaker Change: The addition of <unk> has added a third therapeutic platform to the company that should accelerate our timeline to becoming a commercial entity.
Speaker Change: Ill turn it back to David to go over the financials.
David Moss: Thank you RJ as usual I'll provide a brief overview of our financial results and upcoming milestones before we head to Q&A.
David Moss: During 2024, we raised $29 $9 million from the sale of common stock and warrants for cash in total the company issued an aggregate $4 million 145978 shares of common stock and warrants to purchase an aggregated 3 million 898852 shares of common.
David Moss: Stop.
David Moss: The term of the warrants issued in 2024 may be accelerated with positive <unk> data as defined in the warrant agreements, which if exercised for cash we raise additional capital to the company.
David Moss: I know that with close to 4 million warrants issued and the ability to accelerate as stated in the filings this could potentially raise approximately $30 million.
David Moss: In the financing management employees and members of the board of directors demonstrated strong participation cannot underscore had financially committed and align the entire India team is to the success of the company.
David Moss: We also greatly appreciate the support we saw in the offering for both new and existing investors along with our team here at <unk> bio we thank our shareholders, who have stuck with us during a very volatile time in drug development.
David Moss: Net loss attributable to common stockholders for the year ended December 31, 2024 was approximately $42 1 million compared to approximately $30 million for 2023 research and development expenses totaled approximately 33 million $33 2 million for the year ended December 31, 2024 compared with approximately.
David Moss: $23 million for 2023.
David Moss: General and administrative expenses was approximately $9 5 million for the year ended December 31, 2024, compared with approximately $9 6 million for 2023.
David Moss: At December 31, 2024, the company had cash and cash equivalents of approximately $20 9 billion since year end, we raised an additional $5 4 million through the use of the ATM.
David Moss: Based on our current operating plan, we believe our cash is sufficient under operations through Q3, not including any R&D rebates exercise of warrants or any financings.
David Moss: As of March 27, 2025, the company had approximately $22 9 million shares of common stock outstanding we continue to focus on achieving our primary clinical objectives, while remaining cost prudently with the potential to recover a portion of R&D expenses in Australia and the UK.
David Moss: Now I'd like to move on enlist our upcoming important milestones as RJ said, we expect topline and secondary cognitive endpoints with supporting data from our phase II <unk> trial for the treatment of neuro inflammation that causes Alzheimer's disease in June.
David Moss: We're very excited this key milestone for <unk> bio is now less than 100 days away from clinical readout.
David Moss: We have completed all three cohorts of metastatic castration resistant prostate cancer program.
David Moss: We have now moved on to phase two of the trial, which will enroll six additional patients in each of the middle and high dose cohorts, we expect to complete enrollment of the trial as it is currently designed by the end of 'twenty five data and the trial will be released as it becomes available later this year.
David Moss: Finally, we expect to file a BLA for <unk> in our debt sometime.
David Moss: In the first quarter of next year. This is a seminal event for the company if approved it would be our first Marshall therapeutic and transition us to a revenue generating company a major milestone for any biotech.
David Moss: I'd like to reiterate reiterate that we're incredibly proud of our team for navigating a difficult environment to get to this point of less than 100 days to readout, which we believe could be a major milestone for patients and their families with all timers disease. When I say team is not only includes our incredible co workers, but also our shareholder.
Or is that taking the time to properly understand our scientific approach.
David Moss: Great companies as we like to say, our bill when management thinks like shareholders and investors and investors shareholders things like management.
At this time I'd like to turn the call back to the operator for Q&A Margo and then we will conclude a argue will have some concluding comments Margo can you. Please poll for questions. Thank you. So much as a reminder, ladies and gentlemen, if you would like to ask a question. Please press star one on your telephone keypad.
Speaker Change: Remove yourself from the queue at any time by pressing star two and again that is star one for a question, while we build that queue. We will take our first question from George Farmer with Scotiabank. Please go ahead.
Hi, good afternoon. Thanks for taking my questions a couple from me.
Speaker Change: Regarding.
Speaker Change: Dr. Deb program. It says in the press release Youre doing this 12 month open label.
Speaker Change: Trial is that.
Speaker Change: Required for filing.
Speaker Change: And.
Speaker Change: And as Ed neither different requirements do you think for FDA approval and U K approval.
Speaker Change: Mark you want to.
Speaker Change: And all that.
Speaker Change: Yes.
Speaker Change: We're gathering the.
Speaker Change: I think we said in February we now have access to all of the clinical data from the current trial mission EP.
Speaker Change: <unk>.
Speaker Change: Those are the data that the FDA have seen.
Speaker Change: Spoke to the FDA in that discussion about this being adequate for our BLA and we still believe that it will be obviously, that's a decision that the FDA will take satellite coke.
Speaker Change: Could you tell me what the FDA will say.
Speaker Change: They did not.
Speaker Change: So we would not be eligible for BLA, so they're working towards that and we are doing the.
Speaker Change: A considerable amount of work not just on the data analysis.
Speaker Change: The data more available to us, but also in developing the.
Speaker Change: The rest of the day space that will be needed to submit the BLA with respect to the understanding of the product manufacturing at all.
Speaker Change: The rest of that those data in terms of the MH rate.
Speaker Change: Proved the trial initially as well.
Speaker Change: They didn't approve it but.
Speaker Change: To them initially as a registration trial.
Speaker Change: We expect to be able to see other tasted with EMEA tree and get a full opinion on that.
Speaker Change: Next year, they will say, we want to see the CMC data that we have to put together with it.
Speaker Change: The answer is we are waiting to hear we wait to hear from regulators when we're able to show them. The data that we have we still intend to go ahead with the the.
Speaker Change: The open label because it tells US a lot more about the persistence of the effects and the best way to deliver the drug.
Speaker Change: In terms of the number of repeat treatments on the timing if they repeat treatments.
Speaker Change: We plan to do that dropped both in the U S and in the UK.
Speaker Change: Okay. Thanks, and then on X pro.
Speaker Change: Uh huh.
Speaker Change: You know we've talked about how you intend to release the data in June thanks for the clarity RJ.
Speaker Change: There is the Mac endpoint, but theres also the C D. Our endpoint and I and I believe you said that those those results would be staggered is that correct and is that still how you're thinking about communicating that C. J.
Speaker Change: Yes, thanks for the question so.
Speaker Change: What we're going to be able to do is we're going to provide cognitive and functional event. So all of the assessments that SaaS false cognition and function will be available.
Speaker Change: At the time for lease.
Speaker Change: We have got so that before we wanted to make sure that we could do all those things and we've worked really hard with our vendors to make sure that we have the data clean we have the data analyzed so that you're getting the most accurate data at the time. So we will have all of those clinical endpoints available.
Speaker Change: And Joe Oh, George George that means both both E Mac and CVR will be released when Samsung win.
Speaker Change: When the data becomes public.
RJ: Okay. Thanks RJ.
Paul: And we will next go to Paul <unk> with BTG. Please go ahead.
Paul: Does that mean all greater.
Paul: No.
Paul: Tom if you stopped schrader.
Paul: Go ahead Tom.
Paul: But I've been fired anyway, it's good luck.
Speaker Change: August longest hungry the 100 days in your lives, but I don't know it is.
Paul: Yes.
Paul: Just remind us where the FDA is on EMACS as lot of the acceptance going to come from this trial if it aligns closely with CD or do you think the FDA is already there and then just a clarification you said you'd screened 800 that was 800. After they were already neuro we are inflamed.
Paul: Or is that 800 total and then one quick follow up on <unk>, if I could ask a quick follow up on <unk>. All the same cuts in patients. There makes sense will it be peripheral inflammation, that's going to be basically the same enriched population. Thanks.
P J: P J I'll take the last yeah, let me take the last one first so the.
Speaker Change: They are in rich, we're using CRP and we're using a behavioral mark urban enrichment of Ana Danya that is tied really closely to not only.
Speaker Change: Personal information, but the biological response to inflammation, which is there.
Speaker Change: It's sort of functional desk disconnecting witty within the CNS and we can talk more about that so similar but a little bit different and it's really based more on specifics regarding E. Mac.
Speaker Change: The FDA doesn't comment.
Speaker Change: On on it until they see the data their comment as always let us see the data, but what we've done is we've made sure that we follow there.
Speaker Change: And I think we said this before they have a playbook, we followed it and Dx.
Speaker Change: And we think we've got as good a chances I need to get them to agree to it we don't see too many holes, but I also don't know what they're thinking.
Speaker Change: And as you know.
Speaker Change: I'm always surprised I want to ask you so I think that.
Speaker Change: That's something to be aware of and I forgot the third question.
Speaker Change: The screening screen failure question yeah.
Speaker Change: We're gonna have a poster that describes that next week, so I won't give too much detail because that information is embargoed.
Speaker Change: I will say that.
Speaker Change: No.
The screening is not a function of the inflammatory biomarker in fact, the screen failure due to the inflammatory biomarkers very low on the list, it's actually less than 10% of patients that didn't make it most of them didn't make it because of more typical things.
Speaker Change: Diagnosis and that sort of thing and the screen failure rate, which is about 72% is really spot on compared to what you see with all the other 80 trials somewhere around 70 mid 70% and that was obviously a concern of ours is what would happen when we sort of superimpose inflammation that would would we see more screen failures in the accident the answer.
Speaker Change: No I think that's a testament to the fact that most of these patients that have Alzheimer's disease actually have underlying inflammation. So I think that's a good thing.
Speaker Change: Yes, if I can just add too.
Speaker Change: Two if I can just add a reinforced with CJ said that next week as ADP D, which is the largest Alzheimer's meeting in Europe, and we have a poster that was accepted that discusses.
Speaker Change: Shall we say the profile of the patients that were enrolled and Youll see a pressure on that and then a link to the poster I think on Wednesday or Thursday. So.
Speaker Change: I encourage you to look at it because it's kind of fun reading because you've been hearing about it for a couple of years and you'll see what the actual data art and Tom One last thing is I encourage you to go back and look at the <unk> webinar, because there is actually up.
Speaker Change: Sarah Barnum actually goes over the variables that the FDA requires for approval with the Mac and in sheet highlights all of the key criteria and what we've done to meet them it's actually.
Speaker Change: Worth your time.
Speaker Change: Great. Thank you.
Speaker Change: Next we'll go to Kerry Nachman with Gary Nachman with Raymond James. Please go ahead.
Speaker Change: Hey, guys. Good afternoon. This is Dennis Resnick on for Gary Nachman, Thanks for taking the questions and congrats on all the progress. So first on the extra a phase two trial are you aware of any dropouts occurring and if they are occurring as it in the range that you were expecting and what might be some of the main reasons behind those dropouts and then if you think a little bit further down the <unk>.
Speaker Change: The line assuming positive results suggest progressing without that forward. How soon could you start a phase III trial, and then any additional color as to what a phase III could look like in terms of the amount of patients being enrolled duration and the endpoint to consider and then I've got one follow up.
Jackson: Alright, Yes Jackson.
Speaker Change: C J.
Jackson: Yeah.
Jackson: Yeah. So I think the spirit of your question if I'm wrong. Please correct me as you know are we are we concerned that there's too many patients dropped out there we're not going to have enough power and the answer is no. We account for for that and and I would say that I don't know the exact number off top my head, but but it's less than what we expected.
Jackson: The most common reason for dropouts quite honestly.
Jackson: Yes.
Jackson: What you get with elderly patients. So we're not seeing anything that indicates patients dropping out.
Jackson: At a high rate due to a potential drug efficacy or safety impact.
Jackson: Mostly just elderly related issues. So I think that's a good thing.
Jackson: And the second thing regarding our phase three trial.
Jackson: We don't know how to answer that I think a lot of it.
Jackson: It just depends on.
Jackson: The discussion with the FDA I mean, we may see.
Jackson: Incredible results that suggest we could power a study with 150 patients. The FDA may come back and say no you need a larger safety database, we want a thousand patients. So I think there's so much that's up in the air I think it also depends on whether or not they.
Jackson: They may say, yes, great do the Mac than we can do for your patients are they may say no. We want you to do the Ctr and we may have to power it definitely so I.
Jackson: I think what the trial is going to look like what it's going to cost them. When we can start is really going to be dependent on that conversation with the FDA, but the expectation is we'll we're going to move as fast as we tend to get it going very quickly.
Jackson: That's very helpful. Thank you.
Jackson: And then just I know, it's still early but on the potential commercial launch on <unk>. What's your current thinking about how you plan to commercialize that would that be by yourself or would you look for a partner for that thanks, So much guys and congrats on all the progress go ahead, David or.
Jackson: Jonathan Great question, you know and I think that's actually probably all surprised with EXPAREL. We always say you never build a company for acquisition you build to be Standalone or our goal is to really move it forward to get it to commercialization I do fully expect we will probably get a partner when it gets that close just because we are not distribution experts or marketing experts. So we don't necessarily want to recruit.
Jackson: Right that wheel.
Jackson: But at this point, we're really heads down and focusing on getting that regulatory document in so that we can get to that point. Once we get close I think there'll be a lot more interest in what we're doing same thing goes for EXPAREL right. I mean, we're working to get to a phase III program.
Jackson: I do believe that if we.
Jackson: If we have the accomplishments that we all believe we're going to have.
Jackson: There'll be a lot of interested parties and again, we don't want to recreate the wheel on in drug distribution and so on.
Jackson: But we're prepared to go it alone if we have to.
Jackson: I doubt that'll be the case I'll also say that when it comes to partnerships and when it comes to M&A or whatever it may be we have pretty lofty goals. If we're successful and we want to make sure. If it's done it's done right.
Jackson: Thanks, so much.
Speaker Change: Perfect next we'll go to Omar <unk> with Rodman. Please go ahead.
Speaker Change: I think all of my <unk> related questions around said so thank you.
Speaker Change: But I just wanted to clarify on the odd that program.
Speaker Change: Did I understand correctly that you would need the balance of the year to complete the CMC and actually consider filing broker in the U K I mean, the U S.
Speaker Change: Probably in the early part of 2026.
Speaker Change: Yeah.
Speaker Change: Yes that yes, so yes, that's true.
Speaker Change: We are in.
Speaker Change: The team in the U K manufacturers and does all the process development regulatory filing for but I think and caused from and so now there at all.
Speaker Change: The drug is made to complete the phase II trial that team is swinging entirely into call. It strong and we are appointing additional stuff. So it will take us until the end of the year to get the.
Speaker Change: The answers to some of the questions that the FDA raised.
Speaker Change: Finding.
Speaker Change: But yes, we expect to have all of those questions outs at all of the data ready for us filing as David said in Q in the first half.
Speaker Change: First quarter of 2025.
Speaker Change: They stuff peso being filled.
Speaker Change: At the very moment. So yes, those data are ongoing and we will have those data ready. We're also looking at a third party to do it in an external review of the data that we have.
Speaker Change: GAAP analysis on a new for us.
Speaker Change: After the regulatory expertise that we will be ready by the end of Q1 next year.
Speaker Change: Thank you and maybe just a little follow up there, but you are able to start the open label extension trial early next.
Speaker Change: Next year.
Speaker Change: So the open label trial in the U K is ready to go we already have the first doses manufactured.
Speaker Change: Subject to this to great Ormond Street being ready to open.
Speaker Change: We are currently putting together the paperwork for the IMD to open parallel trial in the U S.
Speaker Change: Subject to.
Speaker Change: The funding environment, which related but yes, we have an R&D plan for the U S.
Speaker Change: The Cta is already approved in the U K.
Speaker Change: Thank you. Thank you very much.
Speaker Change: And our last question.
James Molloy: Our last question comes from James Molloy with Alliance Global partners.
James Molloy: Hey, guys. Thanks, very much for taking my questions I had a question on the on the courts from platform with the BLA coming into first quarter 2016 run up and Anthony.
James Molloy: Issues with getting under the wire of the PIV program are being granted.
James Molloy: Any thoughts on what's going on with the PRA, that's going to be renewed.
Jim: Yes, Hey, Jim I'll, just leave that to David.
Speaker Change: Yeah, No Jim I appreciate it look if we get it in you know it's about a six month process since we have O D D designation already.
Speaker Change: We're going to we're working as quickly and diligently scan to make that the deadline is really the end of September for approval.
Speaker Change: My guess is as that program gets extended and the reason I think it gets extended just because truly there is no cost at all to the U S. Government. They are very obviously focused on cutting costs.
Speaker Change: This program actually provides no cost it provides benefit in fact I think it is very clear to them.
Speaker Change: Because of the PRP program. It's one of the reasons why there is so much ultra rare and rare disease drug development I cannot see the rare disease programs necessarily going forward that are.
Speaker Change: Small unless they have a program like this in place. So I really see no reason why it doesn't get extended but we're planning just in case. It doesn't my guess is we probably know by the way before the end of this year, if it gets extended or not and we will plan.
Speaker Change: Accordingly, but our goal as we did with the <unk> submission to Eni Indy is to do one submission and try and get it through in one pass. So we're really going to spend a lot of time on the quality of these applications.
Speaker Change: Hi, great. Thank you for taking my questions.
Speaker Change: Okay.
Jay: I would like to now turn the call back over to Dr. Jay <unk> for closing remarks.
Jay: So we are busy its head down the heads down at immune but as we get ever closer to our important readout and any oh too, but as of three platform company, we have not taken our eye off our cell therapy programs, which are pretty exciting and.
Jay: Quite novel.
Jay: We are confident in these programs because we have compelling science excellent drugs.
Jay: When we do clinical trials, they're well designed and we execute them with care.
Jay: But as far as <unk> goes in Alzheimer's the idea that inflammation immune dysfunction or drivers of this awful disease is no longer considered novel by the scientific and Biopharma community.
Jay: We believe immune bio is the leader in this neuro inflammation space and look forward to presenting our.
Jay: Our data to the World in June these are exciting times and we greatly appreciate our committed shareholder base and.
Jay: And we thank them for investing alongside us as we work to achieve our goals. Thank you very much.
Jay: Thank you and ladies and gentlemen that does conclude today's conference. We appreciate your participation and you may disconnect at anytime.
Jay: Mhm.
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Jay: Mhm.
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Jay: Mhm.
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Jay: Hello.
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