INmune Bio Inc.

Greetings and welcome to the InMuneBio first 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. You may register to ask a question at any time by pressing star 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. 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, excuse me, Mr. David Moss, CFO of ImmuneBio. David?

Thank you, Jessie, and good afternoon, everyone. We thank you for joining us for the call for ImmuneBio's first quarter 2025 financial results. With me on the call today are Dr. RJ Tessie, CEO of ImmuneBio, and Dr. Mark Lodell, Chief Scientific Officer of ImmuneBio. We'll provide an update on our cords for many immune programs. Also on the call is Dr. C.J. Barnum, head of neuroscience, who will be here to answer questions. 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 Harbors 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 filings with the SEC. There's no assurance of any specific outcome. 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, ImmuBio disclaims any obligation to update these forward-looking statements to reflect future information events or circumstances. With that behind us, now it's my pleasure to turn the call over to R.J. Tessie. R.J. Thank you, David.

For our first quarter 2025 call, I will review key takeaways and provide an update on our platform programs. Following my comments on recent developments, Dr. Mark Liddell, ImmuneBio CSO and inventor of both quaternum and inkimmune, will provide an update on those programs. David Moss, ImmuneBio CFO, will then conclude with a review of first quarter financial results and update future catalysts. Then we will be happy to take your questions. I'm sure everyone on this call knows we will soon be reporting top line results from MINDFUL. That is our phase two trial in patients with early Alzheimer's disease. The results are expected mid to late June. That is in give or take 50 days, we will know the answer to the question, what happens in Alzheimer's disease? when you properly target neuroinflammation. Our last investor update call was just a short six weeks ago, but there have been important and, I believe, positive changes in the Alzheimer's disease marketplace during that short period of time. We believe these changes will be beneficial to ExPRO's market opportunity in early Alzheimer's disease. Last month at ADPD, which is the largest Alzheimer's disease meeting in Europe, ImmunBio reported the biomarker profile of patients enrolled in the mindful study. The data confirmed that we have been underestimating the market opportunity for Expro in patients with early AD. Historically, we stated that up to half of the early Alzheimer's patients will qualify for Expro. based on the biomarkers we used as our enrollment criteria. Based on the data in the bio and other companies presented at ADPD, we now believe more than two-thirds of early Alzheimer's disease patients will be eligible for EXPRO based on APOE4 status alone. I remind you that APOE4 positivity was one of the four enrichment or enrollment criteria we used in the mindful study. The APOE4 status of patients in the mindful is almost identical to what is reported in recent major trials in Alzheimer's. Patients with at least one APOE4 allele make up more than two-thirds of the patients in these trials. This means the market opportunity for expo in early AD has increased to nearly 70% of early AD patients, not the 40% we have previously been talking about. On the call six weeks ago, I also mentioned the safety profile of Expro in a mindful trial. Nothing has changed. There are no reports of area. No patients have had unscheduled MRIs due to CNS symptoms or headache, et cetera, and there have been no deaths. So far, Expro is safe and well-tolerated in this patient population that has an average age of 73 years old, and many of them have a long list of comorbidities. The excellent safety profile of Expro in these patients provides a unique ApoE4-related market opportunity for Expro. Let me explain. Both the EU and the UK have approved leucanumab, the aside biasing drug, for patients with early Alzheimer's disease who have none or one copy of the ApoE4 gene. The market authorizations specifically exclude patients who carry two ApoE4 alleles. In the early AD trials that report ApoE4 status, ApoE4 homozygotes, that's the patients that have two ApoE4 alleles, are 15% of the patients. That means because of labeling restrictions on lucanumab in the UK and EU, Early Alzheimer's patients who are APOE4 homozygous will not be eligible for therapy with the anti-amyloid drugs. This group now is an important unmet need, ideally suited for expo therapy. In the U.S., recent surveys of practice patterns indicate that this population is not treated in many centers due to the risk of area. So even in the U.S., where the labeling is different than you see in the UK and Europe. We believe that after approval, Expro will be the best and only treatment option available for this subgroup, important subgroup of early Alzheimer's patients. We should have an exclusive biologically based market. Finally, the biomarker landscape of Alzheimer's disease is really evolving quite quickly. And it's evolving in a way that really benefits our focus in these patients. Now, once the diagnosis of Alzheimer's is made, PTAL217 in blood has become the biomarker of most important interest by clinical teams treating these early Alzheimer's patients. PTAL217 levels define the severity of Alzheimer's. PTAL217 levels in the blood have prognostic value and correlate with stage of disease. In the near future, we predict that changes in PTAL217 blood levels will be used as a pharmacodynamic blood marker of therapeutic response in these patients. As a reminder, EXPRO significantly decreased PTAL217 during the three-month Phase I study, and this biomarker is included in the package of biomarkers that we are studying in the MINDFULS Phase II program. Having a great drug is a necessary element for a successful clinical program, but it is only part of the story. Since the last patient was enrolled in November, we have been highlighting the hard work needed to report the top line data in June. These are the busiest of times. For example, after the last patient has their final safety visit, but before the database is locked, a complex series of critical data management and quality assurance tasks are undertaken to ensure the data are complete, accurate, and ready for analysis. The process begins with data cleaning, where we review case report forms and entries into the electronic data capture system to resolve discrepancies, fill in missing data, and look for outliers. This is a patient-by-patient process. It is labor intensive. Queries are issued to trial sites to clarify inconsistencies, and there is source data verification to confirm that the recorded data matches the source documents, for instance, the medical records. This phase also involves ensuring compliance with regulatory standards, such as GCP, by documenting all changes. After data cleaning are complete, the focus shifts to the final quality checks and preparation for database lock. A comprehensive review of the data is performed to confirm that all queries are resolved deviations documented and validation checks satisfied the statistical plan cross check to ensure that all data points are present and correctly formatted and the data monitoring committees conduct final safety and efficacy reviews we don't lock the database until we are sure the database is clean and accurate i will also say that This is all done with blinded data. No one knows who got what during this process. We don't run the statistical programs until the database are locked. And it's only when that statistical package comes out that the real unblinding occurs. We remain on track for this process to be completed in mid to late June. And I can tell you, we can hardly wait to see the fruits of our labors. This is the moment we've been anticipating for several years. We are confident we will report results that will change the care of patients with early Alzheimer's disease. And this confidence is highlighted by management's substantial share ownership. Like you, we are investors in ImmuneBio. Our interests are aligned with yours. As important as mindful our Alzheimer's trial is to the company and our investors, it's not our only program. the treatment of children with recessive dystrophic epidermolysis bullosa, or RGUD, is expected to file a BLA in 2026. The in-community program continues to move forward in men with metastatic castrate-resistant prostate cancer. The light is shining more brightly on Cortstrom these days. It is an Orson disease program, and after recent comments from the FDA, we are increasingly excited by its prospects. The FDA has stated their intention to move rare disease treatments through the approval process faster with more input from patients and caregivers. In our job, Cordstrom provides a systemic therapy for systemic genetic disease that has the support of patients and caregivers. But enough from me. I will turn the microphone over to Mark Liddell, the CSO and inventor of both Cordstrom and IncMUDE, to give you a more in-depth update on those programs. Mark?