Q2 2025 INmune Bio Inc Earnings Call
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At this time it is my pleasure to introduce Mr. Daniel Carlson head of Investor Relations at immune bio Daniel.
Thank you operator, and good afternoon, everyone.
Thank you for joining us for the call for immune <unk> second quarter 2025 financial results.
Presenting on today's call are David Moss co founder and CEO.
Dr. CJ Barnum head of neuroscience and Dr. Mark Labelle, Chief Scientific scientific officer, and co founder of <unk>.
Before we begin however, I remind everyone that except for statements of historical fact, 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.
Speaker #5: Trainings and welcome to the Inmune Bio Second Quarter 2025 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 and answer session.
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Those such as forward looking statements. Please see the forward looking statements disclaimer on the Companys earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC.
Speaker #5: As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations at Inmune Bio.
There is no assurance of any specific outcome 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 #5: Daniel?
Speaker #6: Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for Inmune Bio's second quarter 2025 financial results. Presenting on today's call are David Moss, co-founder and CEO; Dr. C.J.
Sept as required by law immune bio disclaims any obligation to update these forward looking statements to reflect future information events or circumstances now.
Speaker #6: Barnum, Head of Neuroscience; and Dr. Mark Lowdell, Chief Scientific Scientific Officer and co-founder of Inmune Bio. Before we begin, however, I remind everyone that except for statements of historical fact, the statements made by management in response questions on this conference call are forward-looking statements, under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.
Now, it's my pleasure to turn the call over to our CEO David.
Good afternoon, everyone and thank you for joining us for this investor update I'm, David Moss and I'm honored to address you today as the new Chief Executive Officer of <unk>.
I've had the pleasure to meet many of our shareholders over the years and as many of you know I'm very excited with the opportunity within <unk> three therapeutic platforms and the opportunity they present to patients and shareholders before we dive into our progress I want to take a moment to acknowledge RJ Tessie, who has retired resigned as president and CEO of <unk>.
Speaker #6: These statements involve risks and uncertainties that can cause actual results to differ material 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 filings with the SEC.
Chief Medical Officer, Chairman of the Board and co founder of the mobile.
Along with Mark myself and the team at <unk> Bio we acknowledged that RJ has been a driving force behind the new bio and his leadership has positioned us for the opportunities we are discussing today as.
Speaker #6: There is no assurance of any specific outcome. 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.
As argued transitions to retirement, we wish him all the best and extend our deepest gratitude for his contributions I'm excited to step into this role and build on the strong foundation he has laid.
Speaker #6: Except as required by law, Inmune Bio disclaims any obligation to update these forward-looking statements to reflect future information events or circumstances. Now it's pleasure to turn the call over to our CEO, David.
So, let's start with EXPAREL and the results from our phase two mindful trial.
Speaker #7: Good afternoon, everyone, and thank you for joining us for this Investor Update. I'm David Moss, and 'm honored to address you today as the new Chief Executive Officer of Inmune Bio.
The trial was designed to define the patient population for registration trial and I'm pleased to report that the data confirms that patients with Alzheimer's disease.
Speaker #7: I've had the pleasure meet many of our shareholders over the years, and as many as you know, I'm very excited with the opportunity with Inmune Bio's three therapeutic platforms and the opportunity they present to patients and shareholders.
Exhibit two or more biomarkers of inflammation.
The optimal candidates for EXPAREL.
The trial confirms our original hypothesis and fully aligns with our novel approach to Alzheimers that extra would benefit patients with the most inflammation, especially in a short trial.
Speaker #7: Before we dive into our progress, I want to take moment to acknowledge RJ Tesi, who has retired and resigned as President and CEO, Chief Medical Officer, Chairman of the Board, and co-founder of Inmune Bio.
As T J will speak about in more detail shortly I want to emphasize something that I think is really important about phase. Two studies is that the purpose of phase III trial is to is which is to inform the design of our phase III program of which clear identification of the target population is critical.
Speaker #7: Along with Mark, myself, and the team at Inmune io, we acknowledge that RJ has been a driving force behind Inmune Bio and his leadership has positioned us for the opportunities we're discussing today.
Speaker #7: As RJ transitions to retirement, we wish him all the best and extend our deepest gratitude for his contributions. I'm excited to step into this role and build on the strong foundation he has laid.
These findings reinforce our hypothesis that Xtra is uniquely suited to address alzheimers disease patients with elevated inflammation levels. A group, we estimate that compromise is somewhere between 40% to 60% of all Alzheimers cases.
Speaker #7: So let's start with Expro and the results from our Phase Two mindful trial. The trial was designed to define the patient population for the registration trial, and I'm pleased to report that the data confirms that patients with Alzheimer's disease who exhibit two or more biomarkers of inflammation are the optimal candidates for Expro.
We believe strongly that we have a potential first in class drug to treat Alzheimer's that is unique and differentiated from current treatments.
We believe the export program represents a significant offers significant opportunity for a strategic partner.
Advancing to the next phase will require substantial investment in manufacturing and clinical trials, but we believe the potential is massive.
Speaker #7: The trial confirms our original hypothesis and fully aligns with our novel approach to Alzheimer's, that Expro would benefit patients with the most inflammation, especially in the short trial.
Big pharma routinely take on programs at this stage and we believe exco could be transformative. In addition, and in a transformative addition to their pipelines addressing a critical unmet need in Alzheimer's disease.
Speaker #7: As C.J. will speak about in more detail shortly, I want to emphasize something that I think is really important about phase two studies. It that the purpose of phase two trial is to, which is to inform, design of a phase three program of which clear identification of the target population is critical.
While we have not yet entered into any strategic partnerships, we have begun exploring potential opportunities and have held preliminary conversations with a limited number of parties.
Speaker #7: These findings reinforce our hypothesis that Expro is uniquely suited to address Alzheimer's disease patients with elevated inflammation levels, a group we estimate that compromises somewhere between 40 to 60 percent of all Alzheimer's cases.
<unk> is a unique drug that has potential multi targeted therapeutic applications that could be very meaningful to the right partner and our shareholders and we intend to prudently pursue these avenues, while also being creative to advance them on our own with limited resources.
Speaker #7: We believe strongly that we have a ential first-in-class drug to treat Alzheimer's that is unique and differentiated from current treatments. We believe the Expro program represents a significant opportunity for a strategic partner.
Beyond Alzheimer's X pro as a multi targeted drug with broad potential.
We are actively exploring the shorter faster pathways to marty market, including opportunities potentially in rare disease to maximize its impact and accelerate patient access.
Speaker #7: Advancing to the next phase will require a substantial investment in manufacturing and clinical trials. But we believe the potential is massive. Big pharma routinely take on programs at this stage, and we believe Expro could be transformative in addition and a transformative addition to their pipelines addressing a critical unmet need in Alzheimer's disease.
In the rare disease pathway would enable us to bring extra to market faster with more efficient use of resources will put I will provide updates on these efforts in the future.
Our immediate next steps for X grown 80 include publishing the trial results in a peer reviewed journal and preparing a briefing book for end of Phase two meeting with the FDA, which we expect to occur before year's end.
Speaker #7: While we have not yet entered into any strategic partnerships, we have begun exploring potential opportunities and have held preliminary conversations with a limited number of parties.
Well 80 trials are inherently challenging the data from this study underscores ex broke 10 X growth potential as a best in class treatment for all farmers patients with inflammation.
Speaker #7: Expro is a unique drug that has potential multi-targeted therapeutic applications that could be very meaningful to the right partner and our shareholders, and we intend to prudently pursue these avenues while also being creative to advance them on our own with limited resources.
This is a significant development for patients families and our shareholders and we're committed to charging the best path forward with EXPAREL.
Before I move to courts for them I want to highlight that the company has made the decision to not pursue treatment resistant depression at this time.
Speaker #7: Beyond Alzheimer's, Expro, as a multi-targeted drug with broad potential, we are actively exploring the shorter, faster pathways to market, including opportunities potentially in rare disease to maximize its impact and accelerate patient access.
We are reevaluating the best opportunity for EXPAREL beyond a D that combines efficiencies with cost and shortest timeline to approval for targeted diseases, where TNF plays a vital role.
Speaker #7: Targeting the rare disease pathway would enable us to bring Expro to market faster, with more efficient use of resources. We'll provide updates on these efforts in the future.
These likely include rare diseases as I mentioned earlier.
Now turning to courtroom we.
We believe there is tremendous underappreciated value to this program and our focus is clear.
Speaker #7: Our mediate next steps for Expro AD include publishing the trial results in a peer-reviewed journal and preparing a briefing book for our end-of-phase two meeting with the FDA which we expect to occur before year's end.
Securing approval in the U K and U S for recessive dystrophic epidermolysis below so or are Deb.
We anticipate filing for approval in both jurisdictions by.
Speaker #7: While AD trials are inherently challenging, the data from this study underscores Expro's potential as a best-in-class treatment for Alzheimer's patients with inflammation. This is a significant development for patients, families, and ur shareholders, and we're committed charting the best path forward with Expro.
By mid year 2026.
Partly for US we believe that Congress is likely to pass that give kids that give the kids a chance act that would extend the P. R V voucher or the priority review voucher program through 2029.
We believe that courts from will qualify for a P. R V. If approved in the U S.
Speaker #7: Before I move to Cordstrom, I want to highlight that the company has made the decision not to pursue treatment-resistant depression at this time. We are reevaluating the best opportunity for Expro beyond AD that combines efficiencies with cost and the shortest timeline to approval for targeted diseases where TNF plays a vital role.
Critically our clinically.
We believe courtrooms have shown tremendous promise and its potential extends beyond our deb to other forms of E D.
We also see additional opportunities for of course for them to expand to other indications depending on available capital will aim to develop these opportunities internally with non dilutive funding or partnerships to ensure we fully realized courtrooms value.
Speaker #7: These likely include rare diseases, as I mentioned earlier. Now, turning to Cordstrom, we believe there is tremendous underappreciated value to this program and our focus is clear.
Finally, I'd like to touch on the interview.
Speaker #7: Securing approval in the UK and US for recessive dystrophic epidermolysis bellosa or RDEB. We anticipate filing for approval in both jurisdictions by mid-year 2026.
Our phase one two program is near completion and as Mark will detail. Shortly the data has demonstrated that it can be in a safe and deliberate immunologic benefits like many immunotherapies checkpoint inhibitors, except in et cetera, and it's most effective when administered earlier in the disease course.
Speaker #7: Importantly for us, we believe Congress is likely to pass the Give the Kids a Chance Act that would extend the PRV voucher or the priority review voucher program through 2029.
Targeting residual disease, rather than late stage metastatic disease with heavy tumor burden.
In new therapies require time and multiple doses to achieve their full effect with this in mind, we plan to explore a trial focused on earlier stage disease to optimize to optimize it means potential.
Speaker #7: We believe that Cordstrom will qualify for a PRV if approved in the US. Critically, our linically, we believe Cordstrom has shown tremendous promise, and its potential extends beyond RDEB to forms of EB.
Before I turn this call over to the rest of the team I'd like to thank all of our investors for our continued to support its an honor to take over the role of CEO and I'm confident in our path forward and excited about the opportunities ahead, we have a tremendous team of people and the exciting clinical programs and the opportunities in front of us I'll now hand and.
Speaker #7: We also see additional opportunities for Cordstrom to expand to other indications. Depending on available capital, we'll aim to develop these opportunities internally with non-delude funding or partnerships to ensure we fully realize Cordstrom's value.
Speaker #7: Finally, I'd like to touch on Incmune. Our phase one two program is near completion, and as Mark will detail shortly, the data is demonstrated that Incmune is safe and delivers immunologic benefits.
To describe the opportunities in front of us I'll now hand, it over to C. J to dive deeper into the extra data T.
T J.
Thank you David and good afternoon, everyone.
I am pleased to share the latest updates on our <unk> program. A novel approach that continues to show promise as a potential treatment for Alzheimer's disease.
Speaker #7: Like many immunotherapies, checkpoint inhibitors, Herceptin, etc., Incmune is most effective when administered earlier in the disease course targeting residual disease rather than late-stage metastatic disease with heavy tumor burden.
Our phase II clinical trial is marked an important milestone in extra Oz development.
Providing both encouraging data and valuable insights.
Speaker #7: Immunotherapies require time and multiple doses to achieve their full effect. With this in mind, we plan to explore a trial focused on earlier-stage disease to optimize Incmune's potential.
While the trial did not meet its primary endpoint in the overall population and reveal notable benefits and a key subgroup alzheimers patients with a high burden of information.
These patients are identified by the presence of at least two inflammatory biomarkers at baseline.
Speaker #7: Before I turn this call over to rest of the team, I'd like to thank all of our estors for their continued support. It's an honor to take over the role of CEO, and I'm confident in our path forward and excited about the opportunities ahead.
In this subgroup, we observed an effect size of 0.27 on the primary endpoint E Mac and 0.23 on a key secondary behavioral end point.
Speaker #7: We have a tremendous team of people and exciting clinical programs and the opportunities in front of us all now. And to describe the opportunities in front of us, I'll now hand it over to C.J.
Euro psychiatric inventory.
Although modest these effect sizes are comparable to or even exceed those achieved by currently approved Alzheimer's disease therapies.
Speaker #7: to dive deeper into the Expro data. C.J.
Indicating that extra could provide a meaningful real world benefits for patients with high inflammation.
Speaker #8: Thank you, David. And good afternoon, everyone. I am pleased to share the latest updates on our Expro program. A novel approach that continues to show promise is a potential treatment for Alzheimer's disease.
Furthermore, favorable trends were noted across multiple end points with effect sizes nearing point to and other cognitive measures patient reported outcomes and biomarker data.
Speaker #8: Our phase two clinical trial has marked an important milestone in Expro's development. Providing both encouraging data and valuable insights. While the trial did not meet its primary endpoint in the overall population, it revealed notable benefits in a key subgroup.
Notably biomarker trends, including P. Tau to one seven and G. Fast suggests that Xtra is effectively targeting underlying neurodegenerative processes and alignment with its anti inflammatory mechanism.
Speaker #8: Alzheimer's patients with a high burden of information. These patients are identified by the presence of at least two inflammatory biomarkers at baseline. In this subgroup, we observed an effect size of 0.27 on the primary endpoint, EMAC, and 0.23 on a key secondary behavioral endpoint, the neuropsychiatric inventory.
These findings underscore the potential of Expo is a promising therapeutic option for alzheimers patients.
For potential partners. The key question is whether there's a clear signal and a viable path to phase III. We believe the answer is a resounding yes early feedback from the Alzheimer's Association International Conference indicate strong interest from industry partners, who recognize the promising results as appropriate for this stage of development.
Speaker #8: Although modest, these effect sizes are comparable to or even exceed those achieved by currently approved Alzheimer's disease therapies. Indicating that Expro could provide a meaningful real-world benefit for patients with high inflammation.
And emphasise to clear actionable path forward.
Feedback we received highlights that partner see Expos, a unique and compelling opportunity in Alzheimer's treatment extended beyond cognitive benefits to address critical areas of behavior and safety.
Speaker #8: Furthermore, favorable trends were noted across multiple endpoints, with effect sizes nearing 0.2 in other cognitive measures patient-reported outcomes and biomarker data. Notably, biomarker trends, including P-tau217 and GFAP, suggest that Expro is effectively targeting underlying neurodegenerative processes and alignment with its anti-inflammatory mechanism.
It's targeted effectiveness in patients with inflammation reinforces the hypothesis that EXPAREL delivers the greatest impact within this subgroup, providing meaningful benefits to those who need it most.
Furthermore, improvements and the neuropsychiatric inventory scores demonstrate its ability to reduce behavioral symptoms issues that often weigh more heavily on caregivers and cognitive decline.
Speaker #8: These findings underscore the potential of Expro as a promising therapeutic option for Alzheimer's patients. For potential partners, the key question is whether there's a clear signal and a viable path to phase three.
It's positioned extra as a comprehensive solution for Alzheimers care.
Perhaps most importantly, the complete absence of amyloid related imaging abnormalities or ARIA even in high risk patients underscores its exceptional safety profile.
Speaker #8: We believe the answer is a resounding yes. Early feedback from the Alzheimer's Association International Conference indicates strong interest from industry partners who recognize the promising results as appropriate for this stage of development and emphasize the lear actionable path forward.
Stinker wishing Expo is a safer and potentially complementary option for combination therapies.
With its unique blend of targeted efficacy behavioral benefits and unmatched safety extra stands out as an innovative and broadly appealing option and alzheimers treatment. We're excited to further explore these opportunities.
Speaker #8: The feedback we received highlights that partners see Expro as a unique and compelling opportunity in Alzheimer's treatment. Extending beyond cognitive benefits to address critical areas of behavior and safety.
Speaker #8: Its targeted effectiveness in patients with high inflammation reinforces the hypothesis that Expro delivers the greatest impact within this subgroup, providing meaningful benefits to those who need it most.
Some investors have raised questions about why we missed the primary endpoint in the overall population your.
The explanation is straightforward the placebo group did not decline.
It's impossible to test a drug's ability to slow stop or reverse disease progression. It's a comparison group remained stable.
Speaker #8: Furthermore, improvements in the uropsychometric inventory scores demonstrate its ability to reduce behavioral symptoms—issues that often weigh more heavily on caregivers than cognitive decline.
We initially expected at one inflammatory biomarker would be sufficient to show decline over six months. This was not the case and this cohort a higher inflammatory burden was necessary just as part of the learning process.
Speaker #8: This positions Expro as a comprehensive solution for Alzheimer's care. Perhaps most importantly, the complete absence of amyloid-related imaging abnormalities, or ARIA, even in high-risk patients, underscores its exceptional safety profile.
Our data reveals that six months is not enough time to observe protection all functional benefits of Expro in this cohort.
This is unfortunate it's not entirely unexpected as functional improvement often lags behind cognitive improvements and can require longer trials to demonstrate meaningful differences.
Speaker #8: Distinguishing Expro as a safer and potentially complementary option for combination therapies. With its unique blend of targeted efficacy, behavioral benefits, and unmatched safety, Expro stands out as an innovative and broadly appealing option in Alzheimer's treatment.
Two as part of the learning process and underscores why clinical development progresses through multiple phases. Each phase builds on the previous one providing the critical information needed to advance our phase III trial mindful has successfully achieved that objective.
Speaker #8: We're excited to further explore these opportunities. Some investors have raised questions about why we missed the primary endpoint in the overall population. The explanation is straightforward.
Looking ahead, we are preparing to apply for breakthrough therapy designation with the FDA, which could expedite express path forward.
Speaker #8: The placebo group did not decline. It is impossible to test a drug's ability to slow, stop, or reverse disease progression if a comparison group remains stable.
We are also planning an end of phase two meeting with the FDA to align on the design of our phase III trial. Additionally, we are actively exploring strategic partnerships to support the programs continue to advance.
Speaker #8: We initially expected that one inflammatory biomarker would be sufficient to show decline over six months. This was not the case. And this cohort, a higher inflammatory burden was necessary.
These steps are essential to maintaining our momentum and bringing extra to patients as quickly as possible.
Speaker #8: This is part of the learning process. Additionally, our data revealed six months is not enough time to observe potential functional benefits of Expro in this cohort.
We are deeply encouraged by these results and remain steadfast in our commitment to advancing EXPAREL as a novel safe and effective therapy for Alzheimer's disease, I look forward to sharing further updates as we progress towards phase III and worked to make a meaningful difference for patients and their families now I'll hand, the call over to Mark to discuss our other platforms.
Speaker #8: While this is unfortunate, it's not entirely unexpected, as functional improvement often lags behind cognitive rovements and can require longer trials to demonstrate meaningful differences.
Speaker #8: This, too, is part of the learning process and underscores why clinical development progresses through multiple phases. Each phase builds on the ious one, providing the critical information needed to advance.
Thanks C J C J and good afternoon, everyone. Thanks for joining the cool.
So as David said called Stroma, showing great promise in the randomized controlled trial and all that but it's potentially extends way beyond that to other film. This extra most places and indeed other conditions and indications as David alluded.
Speaker #8: Our phase two trial mindful has successfully achieved that objective. Looking ahead, we're preparing to apply for breakthrough therapy designation with the FDA. Which could expedite Expro's path forward.
First we have to remember that the orphan drug designation. We received last year was awarded for all forms of Epsilon as Melissa just started in the accident and safety data and ease of administration in the real world clinical setting that we saw in the adapt trial I mean, it will well place to treat a much wider group of adult and indeed pediatric Avi suffers.
Speaker #8: We are also planning an end-of-phase two meeting with the FDA to align on the design of our phase three trial. Additionally, we are actively exploring strategic partnerships to support the program's continued advancement.
Speaker #8: These steps are essential to maintaining our momentum and inging Expro to patients as quickly as possible. We are deeply encouraged by these results and remain steadfast in our commitment to advancing Expro as a novel, safe, and effective therapy for Alzheimer's disease.
And we're developing plans for this.
However, the umbilical cord derived MSC product, we've developed is truly revolutionary in the MSC field since it's manufactured from four individuals.
Speaker #8: I look forward to sharing further updates as we progress towards phase three and work to make a meaningful difference for patients and their families.
I'm black record MSC products.
It gives you excellent stability, unlike conventional MSC drugs and crucially allows us to tailor the final product to target different disease indications.
Speaker #8: Now, I'll hand the call over to Mark to discuss our other platforms.
Speaker #9: Thanks, C.J. And good afternoon, yone. Thanks for joining the call. So, as David said, Cordstrom is showing great promise in the randomized controlled trial in RDEB.
Because we can test the potency of the individual's 'single-quote M. S. C seats Stokes, but different functional characteristics. We can then combine a specific number for with the Oxford potencies for different indications to create a different type of cold stone.
Speaker #9: But its potential extends way beyond RDEB to other forms of epidermolysis bellosa. And indeed, other conditions and indications as David alluded. First, we have to remember that the orphan drug designation we received last year was awarded for all forms of epidermolysis bellosa, not just RDEB.
For example, the cold stone product for all that can be made from full M. S. E. T stocks with the best wound healing capacity and then they switched to create the right cytokines to enhance win repair and suppress H.
Speaker #9: And the excellent safety data and ease of administration in the real-world clinical setting that we saw in the RDEB trial mean that we're well placed to treat a much wider group of adults and indeed pediatric EB sufferers.
For in indications such as osteoarthritis. However, we would select msas feedstocks with the greatest accretion of anti inflammatory factors.
At the moment, we're investigating many other potential indications.
Speaker #9: And we're developing plans for this. However, the umbilical cord-derived MSC product we've developed is truly revolutionary in the MSC field. Since its manufactured from four individual umbilical cord MSC products, it gives excellent stability unlike conventional MSC drugs.
We'll consider genetic modification of course from products to deliver specific proteins, such as the collagen seven protein and gene which is missing in patients without it.
Depending on available capital, we aim to develop these opportunities internally or through strategic partnerships to ensure we fully realized cost Trump's funny.
Speaker #9: And crucially, it allows us to tailor the final product to target different disease indications. Because we can test the potency of the individual single cord MSC seed stocks for different functional characteristics, we can then combine a specific number of four with the optimal potencies for different indications to create a different type of Cordstrom.
As a company, we're keenly focused on preparing the market authorization application to the U K and the biologics license application for the U S. By mid 2026, as David said now we understand the aggressiveness of these timelines are not fully with all of the details required to meet these goals, but I would like to thank our team in the U K.
Speaker #9: For example, the Cordstrom product for RDEB can be made from four MSC seed stocks with the best wound healing capacity and those which secrete the right cytokines to enhance wound repair and suppress itch.
Working so hard to keep these timelines and remain confident that the external third parties, who would have to work with and a critical space will also remain on track to allow us to meet this timeline.
Speaker #9: For an indication such as osteoarthritis, however, we would select MSC seed stocks with the greatest secretion of anti-inflammatory factors. At the moment, we're estigating many other potential indications.
On the other side with regards to ink clean we've continued to develop the manufacturing data to support commercial development and make it the least expensive cellular truck in the field of oncology.
Speaker #9: And we'll consider genetic modification of Cordstrom products to deliver specific proteins such as the collagen 7 protein in gene, which is missing in patients with RDEB.
In Q1 this year, we close the phase one aspect of our phase one phase two cat P. C trial in metastatic prostate cancer, having met the primary safety endpoint.
Speaker #9: Depending on available capital, we aim to develop these opportunities internally or through strategic partnerships to ensure we fully realize Cordstrom's value. As a company, we're enly focused on preparing the market authorization application for the UK and the biologic license application for the US by mid-2026 as David said.
Importantly, this didn't do any confirm safety of inconvenient three dose levels, but it also demonstrated the ease with which it could be delivered to patients through the day clinic setting without hospitalization overnight.
Is unique in the field of cellular oncology drug.
We listen to the phase two trial stage of the trial in February and started to receive the blinded patient blood monitoring samples from the phase one patients.
Speaker #9: Now, we understand the aggressiveness of these timelines. And I'll not bore you with all of the details required to meet these goals. But I would like to thank our team in the UK for working so hard to keep these timelines and remain confident that the external third parties who we have to work with and who are critical to this will also remain on track to allow us to meet this timeline.
It became apparent very rapidly some patients who are responding tweak that's predicted with increased number of NK cells in the circulation and in vivo stimulation of memory like function.
Independent analysis is the past somebody's pet scans, which isn't the assay, we've chosen to measure disease burden.
Speaker #9: On the other side, with regards to Incmune, we've continued to develop the manufacturing data to support commercial development and make it the least expensive cellular drug in the field of oncology.
Sure that despite worsening disease and all of these heavily pre treated advanced stage patients some individual lesions that reduced in size and others a pitch resolved completely.
Speaker #9: In Q1 this year, we closed the phase one aspect of our phase one, phase two care PC trial in metastatic prostate cancer, having met the primary safety endpoint.
I was fortunate to present these data at the innate killer summit in San Diego in March and got a lot of very interesting feedback and interest from the field.
Speaker #9: Importantly, this didn't only confirm safety of Incmune at three dose levels, but it also demonstrated the ease with which it could be delivered to patients in a day clinic setting without hospitalization overnight.
The phase II trials in real patients through Q2.
Its intermediate and high doses.
Jane analysis of blood cells was confirmed the effect.
An increasing NK cell numbers and activation and crucially it became apparent that these facts. The facts are limited to patients who started within pet NK function at the tons enrollment.
Speaker #9: This is unique in field of a cellular oncology drug. We moved into the phase two trial stage of the trial in February, and started to receive the blinded patient blood monitoring samples from the phase one patients.
In other words this patient group and can only improve dysfunctional NK immunity and did not supercharge NK cells in patients with preexisting adequate TNK function. This country to what we saw in the hematology patients, which was the favorite leukemia.
Speaker #9: It became apparent very rapidly that some patients were responding to Incmune as predicted with increased number of NK cells in their circulation and in vivo stimulation of memory-like function.
Speaker #9: Independence analysis of the PSMA PET scans, which is the assay we've chosen to measure disease burden, showed that despite worsening disease in all of these heavily pretreated and advanced stage patients, some individual lesions had reduced in size and others appeared to resolve completely.
Data allowed us to confirm that two of the most important secondary biomarker endpoints have been met first the increase NK cell count following treatment and secondly increased NK cell function.
There was no significant impact on disease burden as measured by P estimate that so.
Speaker #9: I was fortunate to present these data at the Innate Killer Summit in San Diego in March and got a lot of very interesting feedback and intrigue from the field.
So we decided last months to close the tranche recruitment with three patients treated with low dose six intermediate dose and five at the highest dose level and to close the trial after follow up of the current patient who is on treatment.
Speaker #9: The Phase Two trials enrolled patients through Q2 at both intermediate and high doses. Again, analysis of blood samples confirmed the effect of Inmune on increasing NK cell numbers and activation. Crucially, it became apparent that these effects are limited to patients who started with impaired NK function at the time of enrollment.
In general Immunotherapies are best to target the minimal residual disease, that's been well known for over 30 years and that has been our intention and since its conception. These.
These data showing safety and in vivo NK cell priming potency allows us to move forward and planning a trial in a less advanced patient group either alone or with suitable partners.
Speaker #9: In other words, in this patient group, Incmune only improved dysfunctional NK immunity and did not supercharge NK cells in patients with pre-existing adequate NK function.
So that ends my update on the coasts from new platforms and I'd like to turn the call back over to David David.
Speaker #9: This is contrary to what we saw in the hematology patients with lymphoma and leukemia. These data allowed us to confirm that two of the important secondary biomarker endpoints have been met.
Yeah, Thank you Mark and C J.
You May now have Corey <unk>, who has been with the company for many years now he's been a key person in finance and accounting has recently been appointed interim CFO for immune.
Speaker #9: First, the increased NK cell count following treatment and second, the increased NK cell function. There was no significant impact on disease burden as measured by PSMA PET.
Corey and I have worked together almost since the start of immune when he was a consultant and I can tell you not only do we worked incredibly well together, but he is more than capable to take a strong leadership role as interim CEO I have full confidence and support and Corey disability help take immune forward.
Speaker #9: So we decided last month to close the trial to recruitment with three patients treated at the low dose, six at the intermediate dose, and five at the highest dose level.
Speaker #9: And to close the trial after follow-up of the current patient who is on treatment. In general, immunotherapies are best to target minimal residual disease.
Now, let me move on to the financials.
Net loss attributable to common stockholders for the quarter ended June 32025 was approximately $24 5 million compared with approximately $9 7 million for the comparable period and 24.
Speaker #9: That's been well known for over 30 years. And that has been our intention with Incmune since its conception. These data showing safety and in vivo NK cell priming potency allow us to move forward in planning a trial in a less advanced patient group, either alone or with suitable partners.
Research and development expense totaled approximately 5.8 million for the quarter ended June 30th twenty-five compared with approximately $7 1 million for the comparable period and 24.
Speaker #9: So that ends my update on the Cordstrom and the Incmune platforms. And I'd like to turn the call back over to David. David?
General and administrative expenses were approximately $2 3 million for the quarter ended June 30th 2025, compared with approximately $2 8 million for the comparable period in 2024.
Speaker #6: Yeah. Thank you, Mark and C.J. Some you may know Corey Allsperman, who has been with the company for many years now. He's been a key person of finance and accounting and has recently been appointed interim CFO for Inmune.
Impairment of acquired in process research and development intangible assets was $16 5 million compared with zero during the comparable period in 2024 bond.
Speaker #6: Corey and I have worked together almost since the start of Inmune when he was a consultant, and I can tell you not only do we work incredibly well together, but he is more than capable to take a strong leadership role as interim CEO.
Following the release of these two are mindful data. The company has decided to take a very conservative approach and to halt the immediate plans to further develop extra E. D. At this time given the cost of a phase III program as it seeks partnerships.
Speaker #6: I have full confidence and support in Corey and his ability to help take Inmune forward. Now, me move on to the financials. Net loss attributable to common stockholders for the quarter ended June 30th, 2025, was approximately $24.5 million, compared with approximately $9.7 million for the comparable period in '24.
Since we can't guarantee a partnership with US took the conservative approach and wrote off the value of <unk> intangible asset value.
As of June 32025, the company had cash and cash equivalents of approximately $33.4 million.
Speaker #6: Research and development expense totaled approximately $5.8 million for the quarter ended June 30th, 25, compared with approximately $7.1 million for the comparable period in '24.
Based on our current operating plan, we believe our cash is sufficient to fund operations into Q3 of 2026.
As of August seven 2025, the company had approximately 26 6 million shares of common stock outstanding.
Speaker #6: General and administrative expenses were approximately $2.3 million for the quarter ended June 30th, 2025, compared with approximately $2.8 million for the comparable period in 2024.
Now, let me move and talk about some key upcoming milestones.
Speaker #6: Impairment of acquired in-process research and development in tangible assets was $16.5 million, compared with zero during the comparable period in 2024. Following the release of phase two mindful data, the company has decided to take a very conservative approach and to halt immediate plans to further develop Expro and AD at this time given the cost of a phase three program as it seeks partnerships.
We expect to have the manuscript and the public in the peer reviewed publication filed on the mindful trial sometime this month.
And it should be available to the public as well.
We expect to have the end of phase two meeting with the FDA to take place sometime in Q4 of this year.
As Mark had mentioned the company is working vigorously on the cord from marketing authorization application in the biologics licensing application to file by mid year or earlier 2026.
Speaker #6: Since we can't guarantee a partnership, we thus took the conservative approach and wrote off the value of Expro's intangible asset value. As of June 30th, 2025, the company had cash and cash equivalents of approximately $33.4 million.
In addition, the company expects to have additional courts from data to hopefully share in Q4 as Mark had mentioned earlier.
Speaker #6: Based on our current operating plan, we believe our cash is sufficient to fund operations into Q3 of 2026. As of August 7th, 2025, the company had approximately $26.6 million shares of common stock outstanding.
Okay.
In closing I want to emphasize it a new miles at a pivotal moment.
With corn from X pro and it's been we have a robust pipeline with clear path to potential value creation. The recent progress in our programs combined with the opportunities like the potential extension of the rare pediatric disease priority review voucher program through bills like create the create hope authorization Act of 2000.
Speaker #6: Now, let me move and talk about some key upcoming milestones. We expect to have the manuscript and the public in the peer-reviewed publication filed on the mindful trial sometime this month.
Four position us to capitalize on significant market opportunities.
Speaker #6: And it should be available to the public as well. We expect to have the end of phase two meeting with the FDA to take place sometime in Q4 of this year.
We are committed to executing our strategy with discipline exploring strategic partnerships to help fuel our growth and complete trials and deliver therapies that have the potential to transform lives.
Speaker #6: As Mark had mentioned, the company is working vigorously the Cordstrom marketing authorization application and the biologics licensing application to file by mid-year or earlier 2026.
Support of shareholders is critical to our success and I'm confident that together, we can achieve great things.
Stephanie at this point I'd like to turn it over to you to poll for questions.
Thank you at this time, we will open the floor for questions if you'd like to ask a question you May press star one on your Touchtone phone now.
Speaker #6: In addition, the company expects to have additional Cordstrom data to hopefully share in Q4 as Mark had mentioned earlier. In closing, I want to emphasize that Immune Bio is at a pivotal moment.
He would like to remove yourself from the queue you May press star two.
Again that is star one if you'd like to ask a question, we'll pause for just a moment to allow questions to queue.
Speaker #6: With Cordstrom, Expro, and Incmune, we have a robust pipeline with clear paths to potential value creation. The recent progress in our programs combined with the opportunities like the potential extension of the rare pediatric disease prior to review voucher program through bills like CREATE, the CREATE HOPE authorization act of 2024, position us to capitalize on significant market opportunities.
We will take our first question from Gary Nachman with Raymond James.
Hey, guys. This is Dennis resonate on for Gary Nachman, Congrats on the new role David and thanks for taking my questions.
Speaker #6: We are committed to executing ur strategy with discipline, exploring strategic partnerships to help fuel our growth and complete trials, and deliver therapies that have the potential to transform lives.
So first you had mentioned that you plan to conduct the end of phase two meeting with the FDA in the fourth quarter <unk> Pro we tried to confirm has a specific meeting date been set yet and hasn't been any changes to anyone who has been previously communicating with the agency and then can you talk a little bit more about the atmosphere and I see and what the takeaways were from various thought leaders and Kols to your plan.
Speaker #6: Your support as shareholders is critical to our success, and I'm confident that together we can achieve great things. Stephanie, at this point, I'd like to turn it over to you to poll for questions.
Location, there and Ive got one follow up.
No I appreciate that I'll answer the first question and then I'll, let T. J talk about any I see we have not yet filed the briefing book with the F. D. A we're preparing that along with the manuscript.
Speaker #10: Thank you. At this time, we will open the loor for questions. If ou'd like to ask a estion, you may press star one on your touchstone phone now.
Speaker #10: If you would like to remove yourself from the queue, you may press star two. Again, that is star one if you'd like to ask a estion.
And we expect to have that in soon and as you know I think there's a 60 day window before you hear about the date.
Speaker #10: We'll pause for just a moment to allow questioners to queue. We'll take ur first question from Gary Nakman with Raymond James.
It should fall sometime in November December if we get it in on our target date.
So that's with regards to your end of phase two meeting to the F. D. A C. J you want to discuss the mood at AAC.
Speaker #11: Hey, guys. This is Dennis Resnick on for Gary Nakman. Congrats on the new role, David. And thanks for taking our questions. So first, you had mentioned that you plan to conduct the end-of-phase two meeting with the FDA in the fourth quarter for Expro.
And so something that I addressed in.
In the script.
But you know to add a little more color to it I have to say it was.
Even more.
Promising the feedback then than I expected and I think one of the interesting things about it is as.
Speaker #11: We just want to confirm, has the specific meeting date been set yet? And has there been any changes to anyone you've been previously communicating with at the agency?
As we walked through the data.
Speaker #11: And then can you talk a little bit more about the atmosphere at AAIC and what the takeaways were from various thought leaders and KOLs to your presentation there?
You can see you know the clinicians and the experts in the field sort of nodding. Their heads. Yes. This is a logical step yes that makes sense. That's how you would proceed and you know we really didn't get too many questions about the science per se.
Speaker #11: And 've got one follow-up.
Speaker #6: No, I appreciate that. I'll answer the first question, and then I'll let C.J. talk about AAIC. We have not yet filed the briefing book with the FDA.
It was you know at least based on the feedback it was pretty obvious that this is the appropriate sard grew up in our lives near hypothesis.
Speaker #6: We're preparing that along with the manuscript and we expect to have that in soon. And as you know, I think there's a 60-day window before you hear about the date.
The endpoints that are expected to change. So I think that was really good I think one of the things I was perhaps maybe a little surprised about was the real interest in the neuropsychiatric inventory in the chain and the potential there. So for those of you that aren't familiar with the behavioral changes that occur in Alzheimer's patients are really quite debilitating and as the disease.
Speaker #6: It should fall sometime November, December if we get it in on our target date. So that's with regards to the end-of-phase two meeting to the FDA.
Speaker #6: C.J., you want to discuss the mood at AAIC?
Speaker #12: Absolutely. So some of that I addressed in the script but, you know, to add a ittle more color to it, I have to say it was even more promising the feedback than I expected.
<unk>, it's one of those things that really brings patients through the physicians often certainly not the cognitive decline after a certain period of time and it's quite distressing to both patients and caregivers are not interactions.
Speaker #12: And I think one of the interesting things about it is as we walked through the data, you could see, you ow, the clinicians and the experts in the field sort of, you ow, nodding their head as well, eah, this is the logical step.
So to have a another auction with a differentiated mechanism that can treat the <unk>.
Neuropsychiatric symptoms really provides.
In some ways a separate avenue.
Speaker #12: Yes, that makes sense. That's how you would proceed." And, you ow, we really didn't get too many questions about the science per se. Because it was, you ow, at least based on the feedback, it was pretty obvious that this is appropriate subgroup.
But prefer to be also promising is.
Disease modifying therapy, I think you know.
People are really responding to and then of course as it relates to the lack of ARIA.
Despite the fact that most of our patients had a higher risk factors associated for developing ARIA I think that's something that the field is really looking for especially because combination therapies are where we're going and when you start thinking about putting two therapies together.
Speaker #12: It aligns with your hypothesis. These are the endpoints that are expected to change. And so I think that was really good. I think one of the things I was perhaps maybe a little surprised about was the real interest in the uropsychiatric inventory and the potential there.
Speaker #12: So for those of you that aren't familiar, the behavioral changes that occur in Alzheimer's patients are really quite debilitating. And as the disease progresses, it's one of those things that really brings patients to physician's office.
Especially those that potentially a safety signals associated with ARIA really.
He makes a.
It stifles that quite a bit so I think that was those three things were really well received.
Speaker #12: 's really not the cognitive decline after a certain period of time. And it's quite distressing to both patients and caregivers. Not to mention the physicians.
By by the community and you know they understand that.
Speaker #12: So to have another option with a differentiated mechanism that can treat the neuropsychiatric symptoms really provides in some ways a separate avenue but for to be also promising as, you know, a ase-modifying therapy, I think, you know, people were really responding .
The results are appropriate for our phase II study.
And it's sort of what you would expect and it provides a clear path forward and that's really what we're looking for at this stage of development at least that's what the so the.
The scientific community is looking for and so.
Yeah really great feedback all around.
That was great color. Thank you so much and then.
If I can ask about how the strategic partnerships to accelerate EXPAREL are going can you just provide some more color about how those conversations are going well, you're specifically looking for in a partner and wasn't ideal partnership from a financial perspective, it looks like to you and is it likely that you'll have to meet with the FDA for end of phase two meeting before signing the partnership or could we see a partner.
Speaker #12: And then, of course, as it relates to the lack of ARIA, despite the fact that most of our patients had high-risk factors associated for developing ARIA, I think, you know, that's something that the field is really looking for.
Shipping out before that thanks, so much guys.
No I mean, that's a very detailed question and smart of you to ask I don't expect the partnership to occur until after we've had and if there is going to be one that occurs until after we've had the end of phase two meeting with the FDA I think that's a critical component I think the partners are going to want to see the publication theyre going to want to dig into the data and they're going to want to see what the F. D. A.
Now keep in mind that depending on who you partner with most partners are going to have their own regulatory view and how they.
Want to push this through the regulatory process.
And that could have geographic input as well.
But I don't I don't suspect that a partnership for X Pro is anytime in the short period of time, it's going to be more of a long term type of approach most likely leading into next year or the first half of next year. If it occurs at all.
What do we want out of a partnership.
We believe that ex Bro can address a major population in Alzheimer's disease with a therapy, that's never been addressed before which is neuro inflammation. You know if you think about the trial that we ran it really wasn't incredibly novel trial, it's something that no one has ever done before and it's really among.
The first to truly address neuro inflammation I mean, if you think about it we've always said that the higher levels of neuro inflammation, you have the faster decline and that showed with whether you had one or two biomarkers right. We kind of confirmed that in this trial.
So my belief is is that I think everybody knows that there's more and more research coming out about neuro inflammation in neurodegenerative disease, and specifically all timers.
I think that we've got a tremendous amount of data from this phase two program.
And the partner, we're going to look for is the one that's going to help us get to be able to help finance a registration trial to get this to.
<unk> approval.
How that structure financially Ah I couldn't tell you at this point, that's that's in negotiation to be had.
Thanks for the color guys.
Thank you we'll take our next question from Tom Shrader with P. P. I G.
Hi. This is Jenny came on for Tom Shrader. Thank you for taking my question I wanted to ask about the biomarker of your trial, particularly like and the Mac. Knowing what you do know there'd be any refinements you made you would make to I'm not sure if theres marker and the behavioral marker MTI for registration.
Point of view hasn't been used before in trials or in conversations with the FDA. Thank you.
So I think you cut out a little bit yeah, you cut out a little bit so I think I understand that.
Just to clarify if I if I don't have this right so you're asking about the.
In Iraq as a biomarker or are you referring to the <unk>.
The true blood biomarkers in relation to Iraq.
Yeah cause a marker in general.
Yeah, Okay. So it's a good question.
A question regarding how we see that as it relates to the FDA or how do we win in our phase III based on the back and so I have that right.
Yeah.
Okay.
Yeah, Okay sorry.
I haven't got to clarify so I think.
From a.
Our fragrance perspective, the impact and what it was supposed to do.
In the sense that it captured change that is sensitive to capture change in these patients.
C N.
The placebo group that you know that also means that you don't get as much time with them.
Perform is it <unk>.
Expected.
The right patient population the patients that are high enough information with no decline.
So from a pure performance perspective, we were very happy with the performance of the game back we think that the psychometric properties more broadly so how the test performs as it relates to being able to measure.
Cognate a change in earlier patients.
Really aligns well with what the F D a.
Putting our guidance to what a new.
We are a new I'm, sorry, a new a scale should should look like so I actually I'm pretty confident that the FDA yes.
And have a favorable opinion.
On the back but they do have some things in the guidance from one of them is.
That I think is less clear somewhat Vegas is there has to be scientific.
Consensus around that.
And in fact later and what that really means but what I can tell you is that there are at least.
There are companies that.
I have used or are using E Mac.
<unk> ourselves there are additional companies that are now going to be looking to put it into the clinical trial and the neuro side groups that we're developing your back R. F.
That's the point of publishing a couple of papers on it but I think to me.
It's going to be well received.
You know it remains.
Thanks, we've seen lots of discretion will peak.
I feel pretty confident does that address the question.
Okay.
Yeah.
Okay.
No.
Okay.
I'm, sorry, I did not at all yeah that question that question cut out quite a bit of T. J I think she was talking about N P. I.
Uh huh.
Yeah exactly.
Yeah.
Okay.
Okay.
I didn't get that I'm, sorry did you yeah, no I actually was cutting out.
I'm, sorry, I think we're gonna have to go to the next question, but I think she was asking something about NPI.
Thank you we'll take our next question from James Molloy with Alliance Global partners.
Speaker #1: Are using including ourselves . There are additional companies that are now going to be looking to put it into the clinical trial . And the neuropsych groups that were developing eMac are at the point of publishing a couple papers on it .
Hey, guys. Thank you for taking my question I couldn't hear that question on this one either.
On the other part I guess, it's probably safe to assume that perpetual partnership there isn't no one's in the data room, yet that would be.
A post phase two.
Speaker #1: So I think the the eMac is going to be well received . But , you know , it remains you know , it remains to be seen what the decision will be .
At the meeting.
Great.
627.
Such a partnership again, assuming things go well at the end of phase two with the email endpoint and all that.
Speaker #1: But I feel pretty confident . Does that address the question ?
Yeah, I think that's fair to assume Gary.
Speaker #2: Yes . And also about the . Was there ever been used in the FDA ?
Speaker #1: I'm sorry I didn't get that at all .
Thank you we'll go okay great.
Speaker #3: Yeah . That question , that question cut out quite a bit . I think she was talking about NPI .
Alright, Alright, and e-commerce, the experts on the Mac endpoints as well and Thats what are their thoughts.
Speaker #2: Yeah , exactly . Want to know more about the NPI and whether use it with FDA ?
So I don't think we've had any detailed discussions about E Mac as an endpoint.
Speaker #1: I didn't get that . I'm sorry . David . Did you ?
Speaker #3: Yeah . No , she's cutting out . I'm sorry . I think we're going to have to go to the next question . I think she was asking something about NPI .
In a way that would sort of satisfy your question. What I can tell you is that we've had some of the early interest are quick interest.
Speaker #4: Thank you . We'll take our next question from James Malloy with Alliance Global Partners .
See around E Mac.
What endpoint, what's really happened with the neuro sites and consultants in the industry that are really interested in that sort of thing and I can tell you that those conversations where we're extremely supportive and I think to me. That's a good sign because that's where you develop that scientific consensus so.
Speaker #5: Hey , guys . Thank you for taking my question . I couldn't hear that question on this end either . On the on the part , I guess it's safe to assume that potential partnership .
Speaker #5: There isn't no one's in the data room yet . It'll be a post end of phase two meeting . And then , should we anticipate 2627 potential partnership again , assuming things go well at the end of phase two with the eMac endpoint and all that ?
Not a whole lot of I.
I would say conversation and that's a conversation.
With partners, but I will say, we didn't get pushed back. So I think that itself is a good song.
Speaker #3: Yeah , I think that's fair to assume , Gary .
Okay, great. Thanks for taking the questions and best to R. J in his retirement.
Thank you so much.
Thank you we'll take our next question from Boris Welcome Camp with Freedom broker.
Speaker #4: Thank you . We'll go next .
Speaker #3: Sorry , sorry .
Speaker #5: On the iMac endpoint as well . And sort of their thoughts .
Good afternoon, and thanks for taking my questions I'd like to switch gears a bit to courts for them.
Speaker #1: So so I don't think we've had any detailed discussions about iMac as an endpoint in a way that would sort of satisfy your question .
First regarding the ongoing preparations for the BLA submission.
As I understood from the press release, the clinical data are currently undergoing independent statistical analysis. So are you expecting any new insights from that process or just more of a final quality checks to make sure everything's ready for submission.
Speaker #1: What I can tell you is that we've had some of the early interest, the quick interest that I see around iMac as a valid endpoint was really had with the neuropsych and consultants in the industry that are really interested in that sort of thing.
And Additionally, could you elaborate a bit on the details of planned open label post to be elite trial of quotes to them.
Speaker #1: And I can tell you that those conversations were were extremely supportive . And I think to me that's a good sign because that's where you develop that scientific consensus .
Hum.
Is there any intention to eventually include these the results of this trial in the BLA package.
Speaker #1: So not a whole lot of of , I would say conversation in depth conversation with , with partners . But I will say we didn't get pushback .
Okay.
Good question Boris Mark.
Yes, thanks very much so.
Speaker #1: So I think that in and of itself is a is a good sign .
First off the statistical analysis plan that was designed by the sponsor of the crossover trial.
Speaker #5: Okay , great . Thank you for taking the questions . And best to RJ and his retirement .
Speaker #3: Thank you so much .
Isn't really adequate for true detailed analysis of the patient populations. We've looked at that statistical analysis plan and identified great improvements and I do believe that the.
Speaker #4: Thank you . We'll take our next question from Boris Tolkachev with Freedom Broker .
Speaker #6: Good afternoon and thanks for taking my questions . I'd like to switch gears a bit to Nordstrom . First , regarding the ongoing preparations for the Bla submission .
The plan, we put together with Meramec the independent consultants.
Is likely to identify significantly improved data that will help our submission both the MAA and BLA I can't be certain of that so I haven't seen the data that they're blinded to us but.
Speaker #6: As I understood from the press release , the clinical data currently undergoing independent statistical analysis . So are you expecting any new insights from that process or just more of a final quality check to make sure everything's ready for submission ?
I think we have the analysis plan, we put together is certainly likely to come up with them.
Speaker #6: And additionally , could you elaborate a bit on the details of planned open label , possibly trial of Nordstrom ? So is there any intention to eventually include the the results of this trial in the Bla package ?
With a more intuitive.
Analysis of data online.
Stronger days to present to the regulators in terms of the open label.
Our plan is from discussions with both feet.
The formal discussions with the FDA and informal discussions with the MH rate. We believe that we have data that are adequate from the the crossover trial bear in mind that this is the first ever fully randomized controlled crossover placebo controlled trial, a multicenter site done in this patient group of anywhere in the world.
Speaker #6: Thank you .
Speaker #3: Good question Boris . Mark .
Speaker #7: Yes , thanks very much Boris . So first off , the statistical analysis plan that was designed by the sponsor of the the crossover trial wasn't really adequate for true detailed analysis of the patient populations .
Are they still in the two largest centers in Europe.
For pediatric Ardeb. So the data really can be improved upon in terms of patient number.
Speaker #7: We've looked at that statistical analysis plan and identified great improvements . And I do believe that the the plan we've put together with the independent consultants is likely to identify significantly improved data that will help our submission , both for Ma and Bla .
Okay.
What we expect to do after we had submitted our MAA and BLA applications.
Is to go to look at the open label.
Trial protocol is still under negotiation in fact, I was discussing it with the clinical needs today.
At that open label and.
Speaker #7: can't be I certain of that because I haven't seen the data . They're blinded to us , but I think the analysis plan that we've put together is certainly likely to come up with with a more intuitive analysis of the data and stronger data to present to the regulators .
And we will move forward, probably early 2027 to make certain that those data start to be a quad. After we've submitted the BLA submissions.
Does that answer your question.
Yes. Thank you so much I appreciate it bounces okay no. Thank you David.
Speaker #7: In terms of the open label , our plan is from our discussions with both the with the formal discussions with the FDA and informal discussions with the MHRA .
Yeah.
Thank you. This does conclude our question and answer session I would like to now turn it back to our presenters for any additional or closing remarks.
Speaker #7: We believe that we have data that are adequate from the the crossover trial . Bear in mind that this is the first ever fully randomized , controlled , crossover , placebo controlled trial on multicenter site done in this patient group anywhere in the world .
Thank you Stephanie and thank you everyone for joining us in new bio has come a long way over the last few years and we have a very exciting future ahead of US. We thank you greatly for your support and look forward to sharing more accomplishments with you in the near future.
Speaker #7: And it's done in the two largest centers in in Europe for pediatric R Dept . So the data really can't be improved upon in terms of patient number .
Yeah.
Thank you ladies and gentlemen, this does conclude today's presentation you may now disconnect.
Speaker #7: What we expect to do after we've submitted our Ma and Bla applications is to go to look at the open label . The trial protocol is still under negotiation .
Speaker #7: In fact , I was discussing it with the clinical leads today looking at that open label . And we will move forward probably early 2027 , to make certain that those data start to be acquired after we've submitted the the Bla submissions .
Speaker #7: Does that answer your question ?
Speaker #6: Yes . Thank you so much . I appreciate the answers . Thank you .
Speaker #7: Thank you David .
Speaker #4: Thank you . This does conclude our question and answer session . I'd like to now turn it back to our presenters for any additional or closing remarks .
Speaker #3: Thank you Stephanie , and thank you everyone for joining us . EMU bio has come a long way over the last few years , and we have a very exciting future ahead of us .
Speaker #3: We thank you greatly for your support and look forward to sharing more accomplishments with you in the near future . Thank you .