Angel Oak Mortgage REIT Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
March 27, 2025

There are 10 speakers on the call.

Operator

As a reminder, this conference is being recorded and a transcript will follow within twenty four hours of this conference call. At this time, it is now my pleasure to introduce Mr. David Moss, CFO of ImmuneBio. David?

Speaker 1

Thank you, Margo, and good afternoon, everyone. We thank you for joining us for the call for ImmuneBio's twenty twenty four fourth quarter and full year financial results. With me on the call today is Doctor. R. J.

Speaker 1

Tessie, CEO and Co Founder of InduBio, who will provide an update on our clinical programs. Also on the call is Doctor. C. J. Barnum and Doctor.

Speaker 1

Mark Liddell, who will be available for Q and A. 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 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward looking statements. 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 filing with the SEC. There is no assurance of any specific outcome.

Speaker 1

Undue reliance should not be placed on forward looking statements, which speak only as to the date they are made as the facts and circumstances underlying these forward looking statements may change. Except as required by law, ImmuneBio disclaims any obligations to update these forward looking statements to reflect future information, events or circumstances. With that behind us, at this time, I'd like to turn the call over to Doctor. R. J.

Speaker 1

Tessie, who will provide an overview of our clinical programs before I discuss the financials and we conclude with Q and A. Over to you, R. J.

Speaker 2

Thank you, David, and thank you to everyone joining our call. These are exciting times at ImmuneBio. Twenty twenty four was a transitional year for our company. We believe this year will be a transformational year. In less than one hundred days, we expect to announce top line data for our randomized blinded placebo controlled Phase two trial using EXPARO to treat patients with early AD with inflammation.

Speaker 2

We call the trial ADO2 or MINDFUL. We have worked tirelessly to get to this point and I must say hats off to the entire team at ImmuneBio for reaching this major milestone. We can't wait to learn the results. ImmuneBio's ADO2 Alzheimer's trial stands out from conventional approaches of treating Alzheimer's disease due to a focus on treating neuroinflammation as the primary driver of the disease. Rather than targeting plaques and tangles, the dominant traditional targets of Alzheimer's drug development, we have targeted inflammation as the main driver.

Speaker 2

Because of the frustrating history of failed trials to treat Alzheimer's disease, we adopted a precision medicine approach for our Phase two program. That precision is first seen in patient selection. The ADO2 trial uses clinical biomarkers to match the patient's pathophysiology with EXPAROS mechanism of action. That is EXPAROS targets neuroinflammation. Therefore, we enriched the trial with eighty patients who have neuroinflammation driving their Alzheimer's disease.

Speaker 2

To our knowledge, ADO2 remains the only Alzheimer's trial using biomarkers other than amyloid or tau to guide patient selection. Next, we embraced EMAC as the primary endpoint of the trial. EMAC is designed to accurately test cognitive function in patients with early Alzheimer's disease. We don't understand why others embrace the use of cognitive tests designed for staging patients with Alzheimer's disease or develop for use in patients with moderate to severe Alzheimer's disease as the primary endpoints for studies in patients with early Alzheimer's disease. Those measures of cognition are not designed to measure the clinical effectiveness of a therapy.

Speaker 2

EMAC is purpose built objective test of cognitive function designed to be used in patients with early Alzheimer's disease with a dynamic range that allows the measure of worsening and improving cognitive function. Although the term precision medicine is most often used to define patient selection criteria in clinical trials, we believe EMAC provides a precision medicine measure to efficacy in Alzheimer's trials. The embrace of these novel approaches is based on solid preclinical data, compelling Phase one data and a belief that addressing the structural and pharmacological aspects of protocol design derisk the trial and improve the probability of success. By integrating inflammatory biomarkers to identify response to patients and utilizing a precise measure of cognitive response, ImmuneBios hopes to do more than just slow cognitive decline. Our goal is to stop cognitive decline.

Speaker 2

If successful, we will challenge the longstanding amyloid centric paradigm of Alzheimer's disease while supporting the perspective that Alzheimer's is an immunologic disease. Today, we are less than one hundred days away from reporting the results of ADO2. The trial enrolled two zero eight patients in eight countries. We work to enroll the right patients into the trial, which resulted in a screening nearly 800 patients. This is seem the seemingly simple process of patient screening is time was time consuming, complicated and expensive, but one of the four important drivers of success in ADO2.

Speaker 2

The second and third drivers are the previously mentioned enrichment criteria used to select patients with neuroinflammation and the use of EMAC to precisely assess cognitive response. The final driver is EXPAREL the drug. Success of this drug in patients with dementia caused by neuroinflammation may open a world of possibility for patients with neurologic disease because neuroinflammation is a common denominator in many difficult to treat CNS diseases. Also in 2024, we completed the pivot to solid tumors with INKMUNE, our NK cell targeting platform. Although INKMUNE had interesting data in the treatment of hematologic diseases, we believe the future opportunities for INKMUNE were greater by targeting and treating solid tumors.

Speaker 2

The CARE PC trial using INKMUNE 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 onetwo trial and continue to dose patients in the Phase two part of the trial at the medium and high dose cohorts. As currently designed, we expect to complete dosing of patients with Xyngthen 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. Koresham is a 2025 event, but in fact, Koresham has been a quiet part of a new vial since 2018.

Speaker 2

Doctor. Mark Liddell invented and perfected Kordstrom to support an NIHR funded trial in The UK treating kids with intermediate to severe recessive dystrophic epidermolysis bullosis or Rdub. Rdub is a rare genetic disease caused by the mutation of the COL7A1 gene. The NIHR is the research arm of The United Kingdom's National Health Service. The ImmuneBio team saw the clinical data on the use of Korfstrom in kids with RDEB for the first time in November of twenty twenty four.

Speaker 2

The data are compelling and provides ImmuneBio with a unique in licensing opportunity that is ImmuneBio owns and invented and owns, gorges from the drug and GOSH, which is the Great Ormond Street Hospital for Children, which is the largest pediatric hospital in The UK was the sponsor of the clinical trial and owned the Mission EB clinical data. Mission EB is the name of the clinical trial that was performed at GOSH. Combining the two assets was necessary to generate value to the patients, caregivers and investors. Immune Bio in license, the Mission EB clinical data resulting in what we believe is a BLA ready program that has already been awarded orphan drug status and rare pediatric disease designation. Cortram differentiates itself from other approved therapies for RDEB by providing a systemic disease modifying approach rather than focusing on local wound management.

Speaker 2

Many of you know that the difficult the wounds that don't heal are one of the major problems of this debilitating disease. We are not discounting the importance of those therapies, but RDEB affects every organ system in the body except the brain. Topical wound therapies while providing important local benefits do not address problems in the eyes, problems eating and elsewhere in the body. These many problems require systemic disease modifying therapy. KORSTORM is an allogeneic pooled umbilical cord derived mesenchymal stromal cell platform delivered intravenously.

Speaker 2

KORSTORM is a systemic therapy that aims to modulate inflammation, promote wound healing, reduce the debilitating itch pain and scarring that exacerbate RDEB in the skin, the esophagus, the eyes and beyond. The patient caregiver interviews provide some of the most interesting information or data from the blinded randomized MISSION EB trial. Those are best heard by listening to the webinar that in which Professor Anna Martinez reports the responses from the trial that's available on our website. The impact of Corksham 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 2

While we love our cell therapy programs, we understand that ADO2 top line data is the catalyst everyone including ourselves are looking forward in the near term. At our core, ImmuneBio is a CNS company focused on Alzheimer's disease. We have built this company around our EXPAREL platform and now less than one hundred days away from the results of the trial in the Phase two trial in Alzheimer's patients with biomarkers of inflammation. I reiterate, we will provide top line results for the trial in June. I don't know exactly what date in June the top line data will release.

Speaker 2

There are too many moving parts, but it will be June. Also, there is no industry wide definition of what top line data means. Our definition is simple. The data will provide unequivocal evidence of the impact of EXPAREL on the treatment and the response of those clinical symptoms of patients with early Alzheimer's disease with biomarkers of inflammation. This means we will provide a robust package of cognitive, clinical and functional data from patients treated with EXPAREL in the trial.

Speaker 2

From these data, we will provide an answer to the question, does treating early Alzheimer's disease in patients with biomarkers of inflammation with EXPAREL safely alter the trajectory of their cognitive decline? There are four important aspects in the statement I just made. The trial is in early AD. We are not studying patients with moderate or severe disease. Early AD patients are the same group that virtually everyone studies including the approved anti amyloid drugs.

Speaker 2

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 patients that have neuroinflammation. Three of the four enrichment criteria are biomarkers of peripheral inflammation, not central inflammation. This first makes them easy to obtain in peripheral blood, but importantly experts agree that peripheral inflammation causes central inflammation that drives the Alzheimer's disease. Because Expro treats both peripheral and central inflammation, it should stop disease in the brain and eliminate the fuel that feeds progression of the disease.

Speaker 2

Safety is paramount when treating elderly patients with Alzheimer's. As of today, there have been no unscheduled neuroimaging studies, no emergency MRIs. There have been no deaths and the number of infections can be treated on one hand. This is a remarkable history in a group of patients that averages 73 years old. Thus far, EXPAREL has shown to be safe in that target population.

Speaker 2

Finally, I chose the word trajectory of their cognitive decline carefully. Currently approved therapy slow the rate of cognitive decline And realistically, we need to be as good as the currently approved therapies to claim 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 trial will challenge the longstanding plaques and tangle disease paradigm of Alzheimer's disease providing a fresh perspective on the treatment of the Alzheimer's disease as an immunologic disease. We hope the first day of EXPAREL therapy is the last day of cognitive decline in patients with early AD.

Speaker 2

We will know soon if this lofty aspiration is realized. We are confident. While we remain not very optimistic about the upcoming results from ADO2, we believe bigger changes are afoot. Positive results will create a paradigm shift for the treatment of Alzheimer's disease and other CNS diseases where neuro inflammation often ignored and untreated is finally recognized as an element of many of these diseases. And we now have a tool for to add to the physician's

Speaker 1

armamentarium.

Speaker 2

For instance, neuro inflammation plays important roles of dementia associated with FTD, Parkinson's disease, traumatic brain injury, stroke, depression and beyond. Chronic inflammation is the driver of many diseases of aging and if we achieve our expected results targeting the immune dysfunction of lymphoma aging becomes a reality. 2024 was a major a year of major accomplishments in all our programs. Great progress was made in the clinic with our legacy programs. The addition of Korfstrom has added a third therapeutic platform to the company that should accelerate our timeline to becoming a commercial entity.

Speaker 2

I turn it back to David to go over the financials.

Speaker 1

Thank you, RJ. As usual, I'll provide a brief overview of our financial results and upcoming milestones before we head to Q and A. During 2024, we raised 29,900,000 from the sale of common stock and warrants for cash. In total, the company issued in aggregate 4,145,978 shares of common stock and warrants to purchase and aggregated 3,898,852 shares of common stock. Term of the warrants issued in 2024 may be accelerated with positive ADO2 data as defined in the warrant agreements, which if exercised for cash will raise additional capital to the company.

Speaker 1

I note that with close to 4,000,000 warrants issued and the ability to accelerate as stated in the filings, this could potentially raise approximately $30,000,000 In the financings, management, employees and members of the Board of Directors demonstrated strong participation. I cannot underscore how financially committed and aligned the entire Immune team is to the success of the company. We also greatly appreciate the support we saw in the offering from both new and existing investors along with our team here at ImmuneBio. We thank our shareholders who have stuck with us during a very volatile time in drug development. Net loss attributable to common stockholders for the year ended 12/31/2024 was approximately $42,100,000 compared to approximately $30,000,000 for 2023.

Speaker 1

Research and development expenses totaled approximately $33,200,000 for the year ended 12/31/2024 compared with approximately $20,300,000 for 2023. General and administrative expenses was approximately $9,500,000 for the year ended 12/31/2024, compared with approximately $9,600,000 for 2023. At 12/31/2024, the company had cash and cash equivalents of approximately $20,900,000 Since year end, we've raised an additional $5,400,000 through the use of the ATM. Based on our current operating plan, we believe our cash is sufficient to fund our operations through Q3, not including any R and D rebates, exercise of warrants or any financings. As of 03/27/2025, the company had approximately 22,900,000.0 shares of common stock outstanding.

Speaker 1

We continue to focus on achieving our primary clinical objectives, while remaining cost prudent with the potential to recover a portion of our R and D expenses in Australia and UK. Now I'd like to move on and list our upcoming important milestones. As R. J. Said, we expect top line and secondary cognitive endpoints with supporting data from our Phase II EXPAREL trial for the treatment of neuroinflammation that caused Alzheimer's disease in June.

Speaker 1

We're very excited this key milestone for immune bio is now less than one hundred days away from clinical readout. We've completed all three cohorts of the metastatic castration resistant prostate cancer program. We have now moved on to Phase two of the trial in which we'll enroll six additional middle and high dose cohorts. We expect to complete enrollment of the trial as it's currently designed by the end of twenty twenty five and data in the trial will be released as it becomes available later this year. Finally, we expect to file a BLA for cord strum in RDEB sometime in the first quarter of next year.

Speaker 1

This is a seminal event for the company. If approved, it would be our first Markel therapeutic and transition us to revenue generating company, a major milestone for any biotech. I'd like to reiterate that we're incredibly proud of our team for navigating a difficult environment to get to this point of less than one hundred days to readout, which we believe could be a major milestone for patients and their families with Alzheimer's disease. When I say team, this not only includes our incredible coworkers, but also our shareholders that have taken the time to properly understand our scientific approach. Great companies, as we like to say, are built when management thinks like shareholders and investors and investors shareholders think like management.

Speaker 1

At this time, I'd like to turn the call back to the operator for Q and A, Margo, and then we'll conclude, RJ will have some concluding comments. Margo, can you please poll for questions?

Operator

Thank you so much. And again, that is Star one for a question. While we build that queue, we'll take our first question from George Farmer with Scotiabank. Please go ahead.

Speaker 3

Hi, good afternoon. Thanks for taking my questions. A couple from me regarding the RDEB program. It says in the press release you're doing this twelve month open label trial. Is that required for filing?

Speaker 3

And is another different requirements do you think for FDA approval and UK approval?

Speaker 2

Mark, you want to handle that?

Speaker 4

Yes. We're gathering the as I think we said in February, we now have access to all of the clinical data from the current trial MISSION EB Part one. And we are those are the data that the FDA have seen. We spoke to the FDA in that discussion about this being adequate for a BLA and we still believe that it will be. Obviously, that's a decision the FDA will take, so I can't predetermine what the FDA will say.

Speaker 4

But they did not tell us that we would not be eligible for a BLA. So we're working towards that and we are doing the considerable amount of work, not just on the data analysis as the data are made more available to us, but also in developing the rest of the database that will be needed to submitted BLA with respect to the understanding of the product, manufacturing and all of the rest of those data. In terms of the MHRA, they approved the trial initially as a well, they didn't approve it, but it went to them initially as a registration trial. And we expect to be able to share the data with the MHRA and get a formal opinion on that early next year. They will also want to see the CMC data that we have to put together with it.

Speaker 4

So at the moment, the answer is we are waiting to hear from regulators when we're able to show them the data that we have. We still intend to go ahead with the open label because it tells us an awful lot more about the persistence of the effects and the best way to deliver the drug in terms of the number of repeat treatments and the timing of those repeat treatments. And we will plan to do that trial both in The U. S. And in The UK.

Speaker 3

Okay, thanks. And then on EXPAREL, I think we've talked about how you intend to release the data in June. Thanks for the clarity, RJ. There is the EMAC endpoint, but there's also the CDR endpoint. And I believe you said that those results would be staggered.

Speaker 3

Is that correct? And is that still how you're thinking about communicating the top line results?

Speaker 2

CJ?

Speaker 5

Yes. Thanks for the question. So

Speaker 6

what we're going to be able

Speaker 5

to do is we're going to provide cognitive and functional evidence. So all of the assessments that assess both cognition and function will be available at the time of release. We have not said that before we wanted to make sure that we could do all those things and we worked really hard with our vendors to make sure that we have the data cleaned, we have the data analyzed, so that you're getting the most accurate data at the time. So we will have all those clinical endpoints available.

Speaker 3

In June.

Speaker 2

So George, that means both EMAC and CDR will be released when the data becomes public.

Speaker 7

Okay.

Speaker 3

Thanks, RJ.

Operator

And we'll next go to Paul Raider with BTIG. Please go ahead.

Speaker 5

Is that me, Paul Raider?

Speaker 2

I think that's Tom. It's Tom. It's Tom Raider. We just who it was

Speaker 1

by the last name. Go ahead, Tom.

Speaker 6

I've been fired. Anyways, good luck. It's going to be the longest hungry one hundred days of your lives, but I don't know. It is. Just remind us where the FDA is on EMAX.

Speaker 6

Is lot of the acceptance going to come from this trial if it aligns closely with CDR? Do you think the FDA is already there? And then just a clarification, you said you'd screened eight hundred. That was eight hundred after they were already neuro or inflamed or is that eight hundred total? And then one quick follow-up on TRD.

Speaker 6

Do all the same cuts in patients there make sense? Will it be peripheral inflammation? Is that going to be basically the same enriched population? Thanks.

Speaker 5

CJ, do you Let me take the last one first. So they are enriched. We're using CRP and we're using a behavioral marker of enrichment of anhedonia that is tied really closely to not only peripheral inflammation, but the biological response to inflammation, which is this sort of functional disconnectivity within the CNS and we can talk more about that. So similar, but a little bit different and it's really based more on the disease specifics. Regarding EMAC, the FDA doesn't comment on it until they see the data.

Speaker 5

Their comment has always let us see the data. But what we've done is we've made sure that we follow their and I think we've said this before, they have a playbook, we've followed it and we think we've got as good a chance as any to get them to agree to it. We don't see too many holes, but I also don't know what they're thinking. And as you know, I'm always surprised by what the FDA says. So I think that's something to be aware of.

Speaker 5

And I forgot the third question.

Speaker 2

The screening failure question.

Speaker 5

We're going to have a poster that describes that next week. So I won't give too much detail because that information is embargoed. But I will say that, no, the screening is not a function of the inflammatory biomarker. In fact, the screen failure due to the inflammatory biomarker is very low on the list. It's actually less than ten percent of patients that didn't make it.

Speaker 5

Most of them didn't make it because of more typical things, like diagnosis and that sort of thing. And the screen failure rate, which is about seventy two percent is really spot on compared to what you see with all the other 80 trials, somewhere around seventy percent, mid seventy percent. And that was obviously a concern of ours is what would happen when we sort of superimposed inflammation on that? Would we see more screen failures? And the answer is no.

Speaker 5

And 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 2

Yes. If I can just add, to reinforce what CJ said that next week is ADPD, which is the largest Alzheimer's meeting in Europe. And we have a poster that was accepted that discusses the, shall we say, the profile of the patients that were enrolled. And you'll see a presser on that and then a link to the poster, I think, on Wednesday or Thursday. So, I encourage you to look at it because it's kind of

Speaker 1

fun reading because you've been hearing about it for a couple of years and you'll see what the actual data are. And, Tom, one last thing is I encourage you to go back and look at the EMAC webinar because there's actually a, Sarah Barnum actually goes over the variables that the FDA requires for approval with EMAC and she highlights all of the key criteria and what we've done to meet them. It's actually, worth your time.

Speaker 5

Great. Thank you.

Operator

Next, we'll go to Gary Nachman with Raymond James. Please go ahead.

Speaker 8

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 EXPAREL Phase two trial, are you aware of any dropouts occurring? And if they are occurring, is it in the range that you were expecting?

Speaker 8

And what might be some of the main reasons behind those dropouts? And then if you think a little bit further down the line, assuming positive results that suggest progressing this asset forward, how soon could you start a Phase three trial? And then any additional color as to what a Phase three could look like in terms of the amount of patients being enrolled, duration and the endpoints you consider? And then I've got one follow-up.

Speaker 2

All right. C. J, start with the dropout.

Speaker 5

Yes. So I think the spirit of your question, if I'm wrong, please correct me is, are we concerned that there's too many patients dropout that we're not going to have power? And the answer is no. We account for that. And I would say that, I don't know the exact number off the top of my head, but it's less than what we expected.

Speaker 5

The most common reason for dropouts quite honestly is just what you get with elderly patients. So we're not seeing anything that indicates patients are dropping out at a high rate due to a potential drug efficacy or safety impact. It's mostly just elderly related issues. So I think that's a good thing. And the second thing regarding a Phase II trial, I don't know how to answer that.

Speaker 5

I think a lot of it depends on the data, it depends on the discussion with the FDA. I mean, we may see 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 go like the EMAC.

Speaker 5

They may say, yes, great, do the EMAC, then we can do fewer patients or they may say, no, we want you to do the CDR and we may have to power it differently. So I think what the trial is going to look like, what it's going to cost and when we can start is really going to be dependent on that conversation with the FDA. But the expectation is we're going to move as fast as we can to get it going very quickly.

Speaker 8

That's very helpful. Thank you. And then just I know it's still early, but on the potential commercial launch of KORSTRAVUM, 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.

Speaker 8

Thanks for asking all the progress.

Speaker 2

Go ahead, David. Yes. I'll jump in.

Speaker 1

That's a great question. And I think that's actually probably also a prize with EXPAREL. We always say you never build a company for acquisition, you build to be standalone. 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.

Speaker 1

We don't necessarily want to recreate that wheel. But at this point, we're really heads down on 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 three program.

Speaker 1

I do believe that if we have the accomplishments that we all believe we're going to have, there'll be a lot of interested parties. And again, we don't want to recreate the wheel in drug distribution and so on. But we're prepared to go in alone if we have to. I doubt that'll be the case. I'll also say that when it comes to partnerships and when it comes to M and 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.

Speaker 8

Thanks so much.

Operator

Perfect. Next we'll go to Omar Pajares with Rodman. Please go ahead.

Speaker 7

I think all of my AD related questions were answered, so thank you. But I just wanted to clarify on the ORDEB program. Did I understand correctly that you would need the balance of the year complete the CMC and actually consider filing both in The UK and in The U. S. And probably in the early part of twenty twenty six.

Speaker 6

Mark?

Speaker 4

Yes. So yes, that's true. We are in the team in The UK manufacturers and does all the process development and regulatory filing for both Incmune and Kordstrom. And so now that INKMUNE all of the drug is made to complete the Phase two trial that team is swinging entirely into Kordstrom and we're appointing additional staff. So it will take us until the end of the year to get the answers to some of the questions that the FDA raised in our last filing.

Speaker 4

But yes, we expect to have all of those questions answered, all of the data ready for us filing, as David said, in the first half and the first quarter of twenty twenty five. And those staff posts are being filled

Speaker 2

at

Speaker 4

the very moment. So yes, those data are ongoing and we will have those data ready. We are also looking at a third party to do an external review of the data that we have and to do a GAAP analysis and inform us from their regulatory expertise that we will be ready by the end of Q1 next year.

Speaker 7

Thank you. Maybe just a little follow-up there. But you are able to start the open label extension trial earlier than next year?

Speaker 4

Yes. So the open label trial in The UK is ready to go. We already have the first doses manufactured and that's subject to Great Ormond Street being ready to open. We are currently putting together the paperwork for an IND to open a parallel trial in The US and that's subject to the funding environment which we live. But yes, we have an IND planned for The U.

Speaker 4

S. And the CTA is already approved in The UK.

Speaker 7

Thank you. Thank you very much.

Operator

And our last question comes from James Malloy with Alliance Global Partners.

Speaker 9

Hey guys, thanks very much for taking my question. I had a question on the cord stream platform with the BLA coming in the first quarter twenty sixteen run up into any issues with getting under the wire of the PRV program being granted. And any thoughts on what's going on with the PRV that's going to be renewed in

Speaker 5

there? Hey, Jim, I'll just leave that to David.

Speaker 1

Yes, no, Jim, I appreciate it. Look, if we get it in, it's about a six month process since we have ODD designation already. We're going to we're working as quickly and diligently as we can to make that. The deadline is really the September for approval. My guess is that program gets extended.

Speaker 1

And the reason I think it gets extended is because truly there's no cost at all to the U. S. Government. They're very obviously focused on cutting costs. And this program actually provides no cost.

Speaker 1

It provides benefit. In fact, I think it's very clear to them that because of the PRV 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 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, as we probably know by the way before the end of this year if it gets extended or not and we'll plan accordingly.

Speaker 1

But our goal as we did with the INKBN submission, the INKBN IND 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 9

All right, great. Thank you for taking my questions.

Operator

I'd like to now turn the call back over to Doctor. R. J. Tessie for closing remarks.

Speaker 2

So we are busy. It's heads down at ImmuneBio as we get ever closer to our important readout in NDO2. But as a three platform company, we have not taken our eye off our cell therapy programs, which are pretty exciting and quite novel. We are confident in these programs because we have compelling science, excellent drugs. When we do clinical trials, they're well designed and we execute them with care.

Speaker 2

But as far as ADO2 goes and Alzheimer's, the idea that inflammation, immune dysfunction are drivers of this awful disease is no longer considered novel by the scientific and biopharma community. We believe ImmuneBio is the leader in this neuroinflammation space and look forward to presenting our data to the world in June. These are exciting times and we greatly appreciate our committed shareholder base and we thank them for investing alongside us as we work to achieve our goals. Thank you very much.

Operator

Thank you. Ladies and gentlemen, that does conclude today's conference. We appreciate your participation and you may disconnect at any time.

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