INmune Bio Inc.

Greetings and welcome to the ImmuneBio's 2024 fourth quarter and full year earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. You may register to ask a question anytime by pressing the star, then the one key on your telephone keypad. You may withdraw yourself from the queue by pressing the star two key. I will be standing by should you need any assistance. As a reminder, this conference is being recorded and a transcript will follow within 24 hours of this conference call. At this time, it is now my pleasure to introduce Mr. David Moss, CFO of ImmuneBio. David?

Thank you, Margo, and good afternoon, everyone. We thank you for joining us for the call for ImmuneBio's 2024 fourth quarter and full year financial results. With me on the call today is Dr. RJ Tessie, CEO and co-founder of ImmuneBio, who will provide an update on our clinical programs. Also on the call is Dr. CJ Barnum and Dr. Mark Liddell, who will be available for Q&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. 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, Immune Bio 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 Dr. RJ Tessie, who will provide an overview of our clinical programs before I discuss the financials, and we conclude with Q&A. Over to you, RJ.

Thank you, David, and thank you to everyone joining our call. These are exciting times at ImmuneBio. 2024 was a transitional year for our company. We believe this year will be a transformational year. In less than 100 days, we expect to announce top-line data for our randomized, blinded, placebo-controlled Phase II trial using expo-to-treat patients with early AD with inflammation. 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 Immune Bio 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. 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 EXPRO's mechanism of action. That is, EXPRO targets neuroinflammation, therefore we enrich the trial with AD patients who have neuroinflammation driving their Alzheimer's disease. 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 developed 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. 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 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 de-risk the trial and improve the probability of success. By integrating inflammatory biomarkers to identify responsive 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. 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 100 days away from reporting the results of ADO2. The trial enrolled 208 patients in eight countries. We worked to enroll the right patients into the trial, which resulted in us screening nearly 800 patients. This seemingly simple process of patient screening was time-consuming, complicated, and expensive, but one of the four important drivers of success in ADO2. 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 EXPRO, 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 INCMUNE, our NK cell targeting platform. Although INCMUNE had interesting data in the treatment of hematologic diseases, We believe the future opportunities for IncMUNE were greater by targeting and treating solid tumors. The CARE-PC trial using IncMUNE to treat men with castrate-resistant metastatic prostate cancers has made steady progress. We recently announced completion of dosing in the Phase 1 dose escalation part of the Phase 1-2 trial and continue to dose patients in the Phase 2 part of the trial. at the medium and high-dose cohorts. As currently designed, we expect to complete dosing of patients with Empan 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. Cortrum is a 2025 event. But in fact, Cortrum has been a quiet part of ImmuneBio since 2018. Dr. Mark Liddell invented and perfected Cordstrom to support an NIHR-funded trial in the UK treating kids with intermediate to severe recessive dystrophic epidermolysis pilosus, 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 Immune Bio team saw the clinical data on the use of Cordstrom in kids with R-DEP for the first time in November of 2024. The data are compelling and provides Immune Bio with a unique in-licensing opportunity. That is, Immune Bio owns and invented and owns Cordstrom 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. ImmuneBio enlicensed 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. Cortrum differentiates itself from other approved therapies for R-Dub by providing a systemic disease-modifying approach rather than focusing on local wound management. Many of you know that the wounds that don't heal are one of the major problems of this debilitating We are not discounting the importance of those therapies, but Ardeb 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. Cordstrom is an allogeneic pooled umbilical cord-derived mesenchymal stromal cell platform delivered intravenously. Kordstrom is a systemic therapy that aims to modulate inflammation, promote wound healing, reduce the debilitating itch, pain, and scarring that exacerbate R-DEP 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 in which Professor Ana Martinez reports the responses from the trial that's available on our website. The impact of courtship 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. 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 ExPro platform and are now less than 100 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. 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 EXPRO 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 EXPRO in the trial. From these data, we will provide an answer to the question, Does treating early Alzheimer's disease in patients with biomarkers of inflammation with Expro 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 drug. 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. 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. 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, EXPRO has shown to be safe in that target population. Finally, I chose the word trajectory of their cognitive decline carefully. Currently, approved therapies 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 flaxen-tangled disease paradigm of Alzheimer's disease, providing a fresh perspective on the treatment of Alzheimer's disease as an immunologic disease. We hope the first day of expo therapy is the last day of cognitive decline in patients. with early AD. We will know soon if this lofty aspiration is realized. We are confident. While we remain 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 neuroinflammation, often ignored and untreated, is finally recognized as an element of many of these diseases, and we now have a tool to add to the physician's armamentarium. For instance, neuroinflammation 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 inflammation 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 Cordstrom has added a third therapeutic platform to the company that should accelerate our timeline to becoming a commercial entity. I turn it back to David. to go over the financials.