Q1 2025 INmune Bio Inc Earnings Call
Yes.
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Speaker Change: Please standby your program is about to begin if you need assistance during your conference today. Please press Star zero.
Speaker Change: Greetings and welcome to the immune bio first quarter 2025 earnings call.
Speaker Change: At this time all participants are in a listen only mode. Later, you will have the opportunity to ask questions. During the question and answer session.
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Speaker Change: As a reminder, this conference is being recorded a transcript will follow within 24 hours that this conference call.
Speaker Change: At this time it is my pleasure to introduce Jeff excuse me, Mr. David Miller, CFO of Ami and bio David.
Speaker Change: Thank you Jessie and good afternoon, everyone. We thank you for joining us for the call for a new Bio's first quarter 2025 financial results.
Speaker Change: With me on the call today are Doctor R. J T E C E O of immune biology, and Dr. Mark Lidell, Chief Scientific Officer, IV, Nubile, who will provide an update on our courts for mini programs.
Speaker Change: Also on the call is doctors CJ Barnum head of neuroscience, who will be here to answer questions.
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 forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 1095. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as whole.
Speaker Change: 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 filings, including our most recent quarterly filings with the SEC.
Speaker Change: There's no assurance of any specific outcome.
Speaker Change: Undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as the facts and circumstances underlying these forward looking statements may change.
Speaker Change: Is that just required by law in new bio disclaims any obligation to update these forward looking statements to reflect future information events or circumstances with that behind US now it's my pleasure to turn the call over to RJ taxi RJ.
RJ Taxi: Thank you David for our first quarter 2025 call I will review key takeaways and provide an update on our platform programs. Following my comments on recent developments Dr. Mark modality mean bio CSL, an inventor of both fortunate underneath me and we'll provide an update on those programs David Moss.
Speaker Change: And by our CFO will then conclude with a review of first quarter financial results and update future catalysts, then we'll be happy to take your questions I'm sure everyone. On this call knows we will soon be reporting top line results from mindful that as our phase two trial in patients with early Alzheimer's disease.
The results are expected mid to late June.
Speaker Change: That is and give or take 50 days, we will know the answer to the question what happens in Alzheimer's disease, when you properly target inflammation.
RJ Taxi: Our last Investor update call with just a short six weeks ago, but there have been important.
RJ Taxi: And I believe positive changes in the market.
RJ Taxi: Market Alzheimer's disease marketplace during that short period of time, we believe these changes will be beneficial to.
RJ Taxi: X crows market opportunity in early Alzheimer's disease.
RJ Taxi: Last month at ADP D, which is the largest Alzheimer's.
RJ Taxi: Disease meeting in Europe.
RJ Taxi: In Europe, I mean by a reported the biomarker profile of patients enrolled in the mindful study.
RJ Taxi: The data confirmed that we have been under estimating.
RJ Taxi: The market opportunity for EXPAREL in patients with early <unk>.
RJ Taxi: Historically, we stated that up to half a day early Alzheimer's patients will qualify for EXPAREL based on the Biomarkers, we use as our enrollment criteria.
RJ Taxi: Based on the data and your bio and other companies presented ADP D. We now believe more than two thirds early Alzheimer's disease patients will be eligible for X pro based on April four status alone.
RJ Taxi: I remind you that April esports positivity was one of the four enrichment or enrollment criteria, we used in the mine.
RJ Taxi: Right.
RJ Taxi: The April before status in patients and mindful was almost identical to what is reported in recent major trials.
RJ Taxi: Alzheimer's patients with at least one a bowie for Liam make up more than two thirds of the patients in these trials. This means the market opportunity for X Portland early a D has increased to nearly 70% of early a D patients not the 40% we have previously.
RJ Taxi: But you're talking about.
RJ Taxi: On the call six weeks ago I also mentioned the safety profile of EXPAREL.
RJ Taxi: Mindful trial nothing has changed there are no reports of area no patients have had unscheduled mris due to CNS symptoms there.
RJ Taxi: Et cetera, and there have been no deaths, so far extra was safe and well tolerated in this patient population that has an average age of 73 years old and many of them have a long list of Comorbidities.
RJ Taxi: The excellent safety profile of EXPAREL in these patients provides a unique April E four related market opportunity.
RJ Taxi: Extra let me explain.
RJ Taxi: Both the EU and the U K have a crew Mccanna man the assai bias in drug for patients with early Alzheimer's disease, who have none or one copy of the April E for Qi <unk>.
RJ Taxi: The market authorization, specifically exclude patients who carry two April E for leos.
RJ Taxi: In the early <unk> trials that report April week, four status April E. Four homozygote, that's the patients that had two April week four deals.
RJ Taxi: Our 15% of the patients.
RJ Taxi: That means because of labeling restrictions on mechanic and the U K E.
RJ Taxi: Early April early Alzheimer's patients who are <unk>.
RJ Taxi: POI for homozygotes will not be eligible for therapy with the anti amyloid drugs.
RJ Taxi: This group now is an important unmet need ideally suited for extra therapy in.
RJ Taxi: In the U S. Recent surveys of practice patterns indicate this patient population is not treated in many centers is the risk bearer, yes, so even in the U S where the labeling is different than you see in the UK and Europe, we believe that after approval extra will be the.
RJ Taxi: That's the only treatment option available for this subgroup important subgroup of early Alzheimer's patients, we should have an exclusive biologically based market.
RJ Taxi: Finally, the biomarker landscape of Alzheimer's disease is really evolving quite quickly and it's evolving in a way that highly that really benefits our focus in these patients.
RJ Taxi: Now once the diagnosis of Alzheimer's is may teach out to 17 and blood has become the biomarker of most important interests by clinical teams treating these early Alzheimer's patients.
RJ Taxi: C 17 levels to find the severity of the Alzheimer's teach out to 2017 levels in the blood have prognostic value and correlate with stage of disease.
RJ Taxi: In the near future, we predict the changes in <unk> 17 blood levels will be used as a pharmacodynamic blood marker of therapeutic response in these patients.
RJ Taxi: As a reminder, X pro significantly decreased <unk> 17 during the three month phase one study in this biomarker is included in the package of Biomarkers that we are studying.
RJ Taxi: In the mindfulness.
RJ Taxi: Phase two program.
RJ Taxi: Having a great drug as NES is a necessary element for successful clinical program, but it is only part of the story since the last patient was enrolled in November we've been highlighting the hard work needed to report the top line data from <unk>. These are the busiest times for example, after the last patient as their final safety visit but.
RJ Taxi: For the database lock a complex series of critical data management and quality assurance SASSA undertaken to ensure the data are complete accurate and ready for analysis. The process begins with data cleaning where it would be a case report forms and entries into the electronic data capture system.
RJ Taxi: And to resolve discrepancies fill in missing data and look for out.
RJ Taxi: This is a patient by patient process. It is labor intensive.
Queries that ratio to trial sites to clarify any consistency and they are a source data verification to confirm that the recorded data matches. The source documents for instance, the medical records.
RJ Taxi: This phase also involves ensuring compliance with regular regulatory standards.
Speaker Change: P S.
RJ Taxi: That's true.
RJ Taxi: Kinross trail documenting all changes after data cleaning now complete the focus shifts to the final quality checks and preparation for database lock.
RJ Taxi: A comprehensive review of the data is for them to confirm that all queries resolved deviation documented and validation checks satisfied the statistical plan Ross check to ensure that all data points are present and correctly format and the data monitoring committee's conduct final safety and <unk>.
RJ Taxi: <unk> reviews, we don't.
RJ Taxi: The database until we're sure the database is clean and accurate I would also say that this is all done with wanted to state that no one knows who got what during this process. We don't run the statistical programs until the database lock and it's only when that statistical.
RJ Taxi: Package comes out that's a real unblinded curves we remain on track with this process to be completed in mid to late June and I can tell you we can hardly wait to see the fruits of our labor. This is the moment we've been anticipating for several years. We are confident we will report results change the care of patients with early Alzheimer's.
RJ Taxi: And this confidence is highlighted by men in Madison substantial show share ownership like you we are investors and immune by our interests are aligned with yours.
RJ Taxi: As important as mindful, our Alzheimer's trial is to the company and our investors, it's not our only Copa <unk>.
RJ Taxi: <unk> for the treatment of children with recessive dystrophic effort and the license allows us our debt is expected to file a BLA in 2026 and <unk> can take program continues to move forward in men with metastatic castrate resistant prostate cancer.
RJ Taxi: The light is shining more on more brightly on quartz in the states. It is an orphan disease program and after a recent comments from the FDA. We are increasingly excited by its prospects. The FDA has stated their intention to move rare disease treatments through the approval process faster with more imports from patients and caregivers.
RJ Taxi: And our job Carson provides a systemic therapy for systemic genetic disease that has the support of patients and caregivers.
Speaker Change: But enough for me I'll turn the microphone over to Marc Madelle, CSO and inventor of both courts for a minute to give you more in depth.
Speaker Change: State on those programs smart.
Speaker Change: Thanks, Alex and good afternoon, everyone and thank you for joining us.
Speaker Change: So with regard to the latest developments with you in the car T. C trial in prostate cancer completed the phase one dose escalation cohorts in December which allowed us to open the phase two extensions of both the high days and intermediate dose cohorts in parallel and we reported net loss cool.
Speaker Change: We saw no adverse events and any of the patients treated during phase one at least that's met the primary endpoint of the entire trial.
Speaker Change: None of the patients face to face to today to show any adverse event.
He remains extremely well tolerated in this challenging and elderly patients have had lots of previous treatment and a lot of time morbidities.
Speaker Change: At the end of March we reported eight infusions had led to increased NK cell potency and the patients treated at the lowest stays in the blood samples from patients at intermediate and high dose cohorts of phase one of the phase two are being received and do you mean by Atlanta in London, and not being prepared for testing with <unk>.
Speaker Change: Further results as soon as that are available.
Speaker Change: But in parallel we're receiving the independent reports the P. SMA pet screening of the phase one patients had completed follow up.
Speaker Change: This is a very precise assay that's of size as an individual accumulations in each patient before treatment and then three months after completion.
Speaker Change: Treatment.
Speaker Change: This is very complex dataset is being reviewed by the lease commission with the Cat P C.
Speaker Change: We can already see from subjects in the lowest dose cohort, but some of the issues have resolved completely following treatment.
Speaker Change: We eagerly await the date for the intermediate and high risk patients because share as soon as they become available.
Speaker Change: The Cat P. C trial continues to recruit phase III subjects remains on track to complete enrollment this year.
Speaker Change: Do you mean by a team is manufactured doses I think instead the completion of the trial and we successfully transitioned the U S drug supply logistics from our previous contracted into a U S company called chronicled say, we're set up for the successful completion of the trial.
Speaker Change: In line with our ambition sprinkling in prostate cancer and other solid tumors. We are transitioning manufacturing until you take government incubated facility well. We can then if Manny if I could kick off batteries for clinical trial, and if successful commercial manufacturing and global supply.
Speaker Change: Okay.
Speaker Change: <unk> P C as I'm getting in fact Korea. So okay. As you said, we announced the development of our quartz from asset towards a BLA filing next year 2026 for the treatment of the extremely debilitating disease, where especially if just terrific applicable assist Melissa.
Speaker Change: Ted.
Speaker Change: That's the most below sort of what Charles said estimates to therefore is an inherited disease, which manifest in the first two years of life.
Speaker Change: Absolutely I have the skin the epidermis doesn't anchor properly to the underlying Dennis and children yourself I have a thick skin blisters over that whole study.
Speaker Change: Well, it's still is at EEP as a systemic disease as Andre said say children stuff with lesions behind that is kind of Suffolk is some throw out that gastro intestinal track.
Speaker Change: No systemic treatment for that.
Speaker Change: Cold stone, it's an off the shelf allogeneic leasing came on stream will sell drug from pool Steadiness Mckamie Patton at least since 2019.
Speaker Change: It was developed by me and some colleagues with academic funding in the U K.
Speaker Change: That's something that can be used to treat in multiple clinical indications by specific selection of the individual tenant products used to formulate the final pool drug.
Speaker Change: We've been selling one formulation of course from into the U K multi center trial, they buy pediatricians from grandchildren Street Children's Hospital in London.
Speaker Change: To treat children with it with all debt.
Speaker Change: This was a double blind placebo controlled crossover trial, which treated all of the eligible children in England, we don't want that.
The results when they were unblinded led to the conditions in the U K National Health research asking immune biology to develop towards from a license medicine for this disease and we presented the trial data to the U S. S. T. A N December as Al said.
Speaker Change: The F D. A data review led to the award of Brad pediatric disease, and orphan drug status for the treatment most epic most places unfilled.
Speaker Change: Unfolding a type C meeting with the FDA in February we have a clear route to submission of that'd be like in 2026.
Speaker Change: Parallel submissions to the U K to make sure I kind of the European Medicines agency.
Speaker Change: Okay.
Speaker Change: On our last call, we said that clinical trials all of the poster children of drug development.
Speaker Change: I think from trials to market requires much more not at least a full development of the drug manufacturing talk like which meets regulatory climates.
Speaker Change: Cost effective at scale and meet some likely global demand.
Speaker Change: We've taken at some point with respect to the courts from in the same way. We have we think and in fact have developed parallel processes for both drugs, which can share the same manufacturing platforms at all stages of manufacturing.
Speaker Change: Still tiny simplifies manufacturing facility set up and designed but it allows us to maximize the use of manufacturing space, we rent by being able to switch between production and codes from manufacturer.
Speaker Change: Controlling our production costs as we move towards commercial supply.
Speaker Change: Having used the income for selling codes from into the U K trial and ebay to subsidize the supply of inks into Cat P. C. The equipment, we've been using to manufacturing is now subsidizing the development of codes from which is a nice secular situation.
Speaker Change: I think completely all money factoring in for Cat D. C. U K team is dedicated to providing all of the data needed for the BLA submission next year, so call it strong and transitioning into the new production space to allow of course from as a commercial product.
Speaker Change: And as an investigational product for our next clinical trials.
Speaker Change: So that ends my update on the coasts from platform was just to say we are as excited about these as we are about.
Speaker Change: Of the two trials.
Speaker Change: Like to turn the call over to tell you that most our CFO to discuss financials David.
David: Thank you Mark as usual I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q&A session.
David: Net loss attributable to common stockholders for the quarter ended March 31, 2025 was approximately $9 7 million compared with the proxy 11 million for the comparable period in 2004.
David: Research and development expenses totaled approximately seven 6 million for the quarter ended March 2025, compared with approximately $8 7 million for the comparable period in 2024.
David: General and administrative expenses were approximately $2 3 million for the quarter ended March 31, 2025, compared with approximately $2 3 million for the comparable period in 2024.
David: At March 31, 2025, the company had cash and cash equivalents of approximately $19 3 million based on our current operating plan. We believe our cash is sufficient to fund our operations through Q3 of 2025.
David: As of May eight 2025, the company had approximately $23 2 million shares of common stock outstanding subsequent to the end of the quarter. The company raised gross proceeds of approximately 2.1 million from the sale of common stock on the ATM.
David: Now I'd like to focus on some key upcoming milestones.
David: As everybody is well aware, we expect to have top line cognitive data from our phase two trial in all timers disease in the second half of June.
David: As already stated everyone at the company is looking forward to this event.
David: We anticipate an end.
David: A phase two meeting with the FDA in the fourth quarter of 2026 to agree on the design of our phase III trial.
David: We expect to complete enrollment in the phase two portion of the trial. This year as Mark mentioned earlier with periodic updates on immunologic and therapeutic responses to it even as data becomes available.
David: We anticipate filing a BLA for cord strong in our dead in the first half of 2026.
David: Finally, we will initiate a phase two trial of EXPAREL in patients with treatment resistant depression, once and NIH funding is made available.
Jesse: At this point Jesse I'd like to now poll for questions and open it up to Q&A Jesse.
David: Yeah.
Speaker Change: Thank you at this time, if you would like to ask a question. Please press star one on your telephone keypad, you may remove yourself from the queue at any time by pressing star to once again that is star one to ask a question.
Speaker Change: Well go first to Gary Nachman with Raymond James.
Speaker Change: Hey, guys. This is Dennis Rasnake on for Gary and Thank you for taking our questions and congrats on all the progress.
Speaker Change: So just assuming a positive readout in June can you just continue walking us through the exact next steps for the program. You mentioned you can meet with the FDA at the end of this year, but what's a realistic timeline as to when you can initiate the phase III and then could you provide maybe some metrics as to whats reasonable as to how many sites you can get online and how many patients can be enrolled.
Speaker Change: Each month.
Speaker Change: And then I've got a couple of follow ups.
RJ Taxi: Yeah, well this is RJ. So thank you, Gary but I think.
RJ Taxi: Expecting us to really design the trial before we have the results before we talked to the FDA as we would.
RJ Taxi: I'd like to defer that opportunity our goal as as David mentioned in his milestones.
RJ Taxi: So as quickly as possible get to the FDA for a end of phase two meeting it is classified as a type b meeting by the USDA.
RJ Taxi: Yes, so there's a 70 70 day clock. So hopefully as we said it will be completed in the fourth quarter.
RJ Taxi: And then we will move as quickly as possible to getting sites open and those first patients enrolled we are lucky that we've got a lot of sites ready to go in Europe, So and we Oh, there's considerable enthusiasm for this program in the U S. So we anticipate you know.
RJ Taxi: Now being able to get the sites, but I don't want to put a date on it we don't want to put a size on it and because we can't put a size on it we don't want to really predict what the capital needs will be at this point, but suffice it to say that you know we believe that it will look very much like the phase II trial.
RJ Taxi: Bill.
RJ Taxi: Although we expect it will be larger.
RJ Taxi: And you know there may be.
RJ Taxi: Fewer set of Biomarkers, but we won't know until we talk to the FDA.
Speaker Change: So did I understand that and that's helpful color I'm just a couple of quick follow ups, just because theres been a lot of turnover uncertainty at the FDA recently can you comment on if the people who will be reviewing your program are all still there everyone who has previously signed off on that your math is all still there.
Speaker Change: And then what the poster presentation you guys had at ADP V. Last month, maybe you can just talk a little bit more about the rest of the activity you've received at the conference and then overall the level of interest in companies that are Steven recently as we approach June Readouts.
Speaker Change: Yeah, I'll, let TJ answer the ADP D.
Speaker Change: Call, but we've obviously like any biotech has been watching what's going on at the F. D a quite closely.
Speaker Change: Our intelligence, which is pretty good we believe suggests that when it comes to drug development. The FCA has remained on track or delays appear to not be a you know be developing that everyone here.
Speaker Change: You know, we can't predict the future, but everything we hear so far is okay.
Speaker Change: Let me remind you that the FDA has not yet completely signed off on the back our goal is and C. J can add more color to this our goal is to present them EMACS data side by side with the CVR data and one of the major questions will be asking them at the end of phase II.
Speaker Change: Meaning is can we use the Mac is the primary endpoint for the registration trial remember and we've been saying this forever that you know, we believe that our superior metric of cognitive.
Speaker Change: Function in these patients, but it's the F D. A sandbox than if they say no. We will look what happened will not happy, but we will move ahead with a C. D R.
Speaker Change: And in fact, you know the trial that we are currently doing will allow us to perfectly designed the study to get.
C.J.: That's the kind of result, we meet C. J you want to add any color to that and also comment on this.
Speaker Change: ADP D question, yes.
Speaker Change: Yeah, sure just sort of give you clarify a little bit about what what we've communicated with the FDA is weak.
Speaker Change: Even in the plants.
Speaker Change: And to do it with <unk> and what they've done is they've responded to that in a way that really says that outlines their guidelines on how are you.
Speaker Change: Validate a measure really.
Speaker Change: Think about it more like a checklist, which is what we've done in this trial. So you know, they're not going to comment on that until they see the data. That's just a standard response, but we think we've done everything we've hit all of those bullets knows checklist I think we're in a good position.
Speaker Change: Peter was pretty interesting I think theres two two things that I think really came out of it as it relates to feedback we got from the poster. One is I think people are excited for an anti amyloid or a therapy, that's not targeting anti amyloid and I would say.
Speaker Change: Even more so if we got a lot of traffic and interest in <unk> and one of the comments that we especially from neuroscience that work with big companies or worked in this space and then measuring cognition are really excited that there is a company that's driving the appropriate measures moving forward. So there's a lot of excitement and interest around <unk>.
Speaker Change: There.
Speaker Change: Great. Thanks, so much we're looking forward to the readout.
George Farmer: We'll move next to George Farmer with Scotiabank.
Hi, good afternoon. Thanks for taking my questions a couple for me on.
George Farmer: That's probably so.
George Farmer: Uh huh.
George Farmer: With the trial coming up in the data coming up what.
George Farmer: How do you think.
George Farmer: Our investors will with that to a scenario whereby you hit on E Mac, but C D or the bid equivocal.
George Farmer: And then.
Speaker Change: Jay you were talking about.
Speaker Change: The potential benefit of X pro in patients, who would be eligible for anti amyloid therapy, including <unk>.
Speaker Change: Equally homozygotes do you have a feel for how many a bogie homozygous certain your trial.
CJ Barnum: Yeah. So C J why don't you.
Speaker Change: The specific question about hitting on the Mac and what.
Speaker Change: CVR will look like because it will be more correlated than not.
Speaker Change: So.
Speaker Change: Yes.
Speaker Change: Sure or what are you doing that RJ, but let me just to ask the question about.
You know how investors.
Speaker Change: I actually would ask you that question.
Speaker Change: From a scientific standpoint.
Speaker Change: What I can tell you is is that the E. Mac is.
Speaker Change: Is the tool thats actually capturing cognitive changes that occur in early <unk>.
Speaker Change: It's it's identifying those patients the ability to measure cognitive decline, it's the right tool. The CVR is a more blunt instrument.
Speaker Change: RJ I think what RGA is saying is one of the things that we're seeing as it correlates very well. So we're seeing correlations between he and I can see here, which is a good sign but the CVR is inherently more notice noisy because it's because it's a blunt tool. So I would say well I can't answer how the investors would think and I'm hopeful that we've talked to.
Speaker Change: With enough of us so that you understand how we think and the scientific validity and rationale for using the <unk> for us.
Speaker Change: The <unk> is really the primary driver and we'll understand what <unk> for example, as far as the well I have a clear understanding the most likely scenario is just it's a it's a power issue due to noise.
Speaker Change: We won't know until we see the data.
Speaker Change: Yeah, and just to add a little bit more color. We believe the professionals in the field I E. The academics and potential Biopharma partners will be able to understand.
Speaker Change: And if there is you know.
Speaker Change: They don't both arent, both perfect and as T. J said, it's not going to be that C. D ours going in a different direction. It's just gonna be a power and a size of study issue, which is easily solved in the phase III trial.
Speaker Change: Yeah, So let's talk about the April four homozygote.
Owens [inaudible]
Yeah, so let's talk about the April 4th home of Zygote.
Speaker Change: In both the LeCanemap and the Denanemab trial, they were 15% of the patients. In our trial it is 9%
Speaker Change: They're smaller trials. I don't see 15 and 9% that difference. I expect, you know, it will, it will be in the 15% range. Interesting, out of canemap did not break out. The home was eye goats in number. At least I don't remember it. [inaudible]
Speaker Change: So I think it's a it's a pretty and when you go into the literature and you look at clinical
Speaker Change: Data. That's about where it stands. So that's a pretty, you know, in Europe it's a big population. And as you know in Europe in the UK they don't do off label.
prescribing. So that group is ready and waiting for ex-pronged mites.
Thank you. Thank you.
Speaker Change: All right, great, and then one more for me. You know, the impact of X-Pro on FOSSA TOW-217 looks pretty compelling, went back and looked at your presentation. How do you think that magnitude compares to other?
Alzheimer's disease, chemo approaches that have been published.
C.J., I'm going to leave film to you.
Speaker Change: I think that's tough to answer. The only thing that I can say is you don't rarely, I can't think of another study where you saw changes in the CSF at early, quite robustly. I think this is one of those things that holds a lot of promise, but...
Speaker Change: We'll see what it looks like when we have the full data set.
Speaker Change: Yeah, we're the only we're the only company with data in a drug that treats no inflammation. You know, the anti-amola drugs do decrease towel. I mean, I think when you when neuron stop dying, you see what you know you get some decrease in towel, but we like
Speaker Change: P-Tao 2-17, the clinical teams like P-Tao 2-17, and I suspect most of the regulatory agencies are going to be very receptive to that biomarker as part of our data package.
Thank you.
Okay, thanks very much.
Thank you.
We'll go next to Tom Shrader with BTIG.
Tom Schrader: Good afternoon. Thanks for taking the questions. You said something that I hadn't really thought of and I'm wondering if it's correct, if it's if I'm hearing, but are APOE for patients inherently inflammatory?
Tom Schrader: How much does CDR have to decline? How big does the reduction in decline of CDR have to be?
Tom Schrader: To hit in a trial of 300 patients that's only run for six months. Is it reasonable or is it a pipe dream? Do you have a sense of what the reduction in decline would have to be for a trial of this size to hit?
Thanks. Thank you.
Tom Schrader: Yeah, I can take that. I can keep the first one. Keep it on the second one.
So Tom, what's interesting is-
Tom Schrader: When we powered the study, which was powered on CDR by the way, the assumptions that we had in terms of our expectation for decline.
Tom Schrader: over six months, and the effect size of that decline was…
Tom Schrader: somewhat conservative based on the the admi group that was used to power the study. What's interesting is, you know, a few years later when we can't amend.
And to Nanomath came out, what we saw was...
Tom Schrader: about the exact same number that we used to decline for six months.
Tom Schrader: And I think that's important. And the effect size of that decline was almost exactly what we use to calculate our power. So I think that gives us a lot of
Tom Schrader: A lot of confidence that, you know, our assumptions were right out. I think the other thing that I want to point out is, is this is for a cohort of patients that weren't in rich for inflammation, and of course, we expect that we're going to get a little bit faster to climb with inflammation, so I think that gives us even a little more confidence.
Speaker Change: It is considered that with your APOE4 forest, you are hot, so to speak.
CJ Barnum: and as CJ just said, if you look at APOE for either heterozygos or homozygos,
Thank you very much.
CJ Barnum: They actually get, they're age of onset is earlier, but the hetero is being later than the
CJ Barnum: Their progression of the disease, IAE going from MCI to earlier, mild A.D. is faster. And actually, when you look at the ApoE
CJ Barnum: Apoe and Forehomozygos, they actually have a higher mortality rate. They have about a five to seven year worst survival compared to the other groups. So Apoe is a is a bad
Speaker Change: Jean Tahab, and any of you that have done 23 and me, you know, and they asked that question, do you want to know what your Alzheimer's risk is? The main thing they're going to tell you was there was whether or not you were able to eat for a positive, and I don't know how many said yes, but I never wanted to know quick.
Thank you.
Speaker Change: If I can follow up with CJ, how much of the other two trials hitting their bigger trials, right? There's something like
Speaker Change: I don't know, there's a few fold more patients. Is that the reason they separated in six months or do you still think you're powered correctly to see it if you have a similar type of effect?
Well, I think, um...
Speaker Change: So, I mean, there's some variables we don't know. I think we're close.
I don't think we're going to be wise off.
Speaker Change: So it's hard to answer that question, but I would say that the data that we see, despite the fact that they've got...
Speaker Change: More patients, you know, we're looking at standard deviation, the standard deviation was around one for those
Speaker Change: for those trials, which is very similar to what we've used in our projections. And the decline was quite similar. So I think we're going to be OK. I think we're going to be close.
Speaker Change: And Tom, remember, we have racked about the quality control that we've had in this trial, the procedure of the type of situation we involve. I think that is really an unharrowed advantage.
Thank you very much.
Speaker Change: You know, when you're run rolling 1,600 patients, and I think it was like in 42 countries or something as a big trial, the quality control, you just get a messier patient population. Not because people aren't trying. It's just a big animal pain.
Speaker Change: You know, and I can tell you we've spent a huge amount of time and resources on our quality control and our crowd was much smaller It was like 208 patients in eight or nine countries so the quality in will be reflected in the in the output I believe
All right, great. Thanks for all the color.
Speaker Change: Our final question will come from James Molloy with Alliance Global Partners.
Speaker Change: Hello, this is Laura Serial on Frigian Molloy. Thank you for taking the questions.
James Malloy: So, for a court's drama, he's still on track to initiate the 12-month open label trial mid this year, and I obviously that US patients are expected to be enrolled later on, so what's the enrollment aim here, and how many sites do you expect to have open in the US?
Mark.
Thank you very much.
Speaker Change: Yeah, great. Thanks very much for that question. What we're doing at the moment is following the guidance from the FDA about how to make the UK manufactured cords usable in the US and we're starting manufacturing program later this week, actually, on a new batch of products using US approved cord donors.
Speaker Change: So that allows us what we have this data to draft the IND.
Speaker Change: We're expecting to submit an I&D later this year. We've been delayed by various factors, including the the the funding situation, but we're so on track to all sort of planning and I&D in the US for what goes from, but it's not the BLA is not dependent upon the US I&D or indeed that the open label in the UK. We're going to submit for the BLA with the data we already have from the double blind placebo controlled cross over trial. And then we will run the
Speaker Change: a follow-on trial in the US, opening next year in parallel with trials in the UK in which we further explore the dosing of the drug and the periodicity of dosing. Does that answer your question?
Speaker Change: Yes, it does. Thank you. And um, just as a follow up with the BLA filing coming up, how would you describe like the overall regulatory space for our debt treatments, um, like ABO enough for instance, just got approval for their gene therapy for our debt. So do you consider this a positive for where you're at with courtship?
Speaker Change: So there are two things about that. That's a very good question. So the synthetic skin, a gene modified product which has just been licensed. It's a great product. The challenge is that it's applicable to.
Speaker Change: Open rooms on the skin, and that's its only indication and it requires a surgical intervention to apply it.
Speaker Change: One of the side effects is known side effects is H and obviously one of our principal clinical outcomes from the first trial has been reduction in H.
Speaker Change: Even in the presence of the Modified Product, we have a window to treat the same patients.
with courts from...
Speaker Change: But more importantly, it's a systemic therapy. And as I said in the presentation just a few minutes ago, our death and indeed all we be is actually a systemic disease and these kids and indeed when they get through adulthood, they suffer the condition throughout their suffocating attract and then
I'm more widespread than just the dermis.
Speaker Change: and so we see a role for cord strong in treating those patients with systemic disease as well as skin lesions. Indeed that, you know, a tribe, a similar MSC product that's not going through the license in South Korea showed improvement in skin.
Speaker Change: scores after treatment as well when the children were followed up long enough. So we do see a really good opportunity for courts from even in the presence of the current licence to alternatives.
I miss that. Thank you for taking the questions.
Speaker Change: And now that will conclude the Q&A portion, I will turn the program back over to Dr. Tessi for an additional closing remarks
Dr. Tesi: Yes, thank you all for attending today's call and I just make a moment of closing comments because we are excited, we are approaching the most significant milestone in the company history when we started Immune Bio
Dr. Tesi: and God Expo in 2017 and became a company focused on Alzheimer's disease. No one viewed it as an immunologic disease or few did.
Dr. Tesi: But that time the focus was exclusively on Anne Wooden's house. Since then, with two hands, I am like drugs on the market We have seen a sea change in the way
Dr. Tesi: Alzheimer's is considered by many a CNS disease driven by immune dysfunction. No inflammation is no longer viewed as a side effect of Alzheimer's disease, pathology, but a significant driver of that pathology.
Dr. Tesi: Immune Bio has positioned itself as a leader in targeting the immune dysfunction that drives destructive
Dr. Tesi: We are very careful and precise with our terminology here. Stopping their information by immunosuppression.
Dr. Tesi: Cleal Suppression is very different than stopping destructive neuroinflammation by repolarizing
to support.
the CNS.
Dr. Tesi: Cellular Units, and Improving Remodeling and Repair. The goal of effective therapy.
for the Alzheimer's disease is to reestablish normal, pale homostasis, homeostasis.
Dr. Tesi: The idea of the brains of the LDL with the mention of can undergo remodeling and repair as novel.
Dr. Tesi: We believe data from the mindful trial will change the direction of scientific research and discovery in the neuro neurology and CNS drug development arena.
Dr. Tesi: I've said before that this is the dawn of the Golden Age of CNS development.
Dr. Tesi: We believe it is, and we look forward to leading the charge.
Dr. Tesi: So with that, I thank you and we will be talking to you all.
Dr. Tesi: Sue, when the data are released. So thank you very much.
Speaker Change: Thank you, ladies and gentlemen, this does conclude today's program. Thank you for your participation. You may disconnect at any time.
Speaker Change: Uh-huh.