INmune Bio Inc.

all sites on hold we appreciate your patience and ask that you please continue to stand by your program will begin momentarily © transcript Emily Beynon Please stand by, your program is about to begin. Greetings and welcome to the Immune Bio second quarter 2024 earnings call. At this time, all participants are in a listen-only mode. Later, you'll have the opportunity to ask questions during the question and answer sessions. You may register to ask a question over the phone at any time by pressing the star and 1 on your telephone keypad. As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it's my pleasure to introduce Mr. David Moss, CFO of ImmuneBio. David?

Thank you, Operator, and good afternoon, everyone. We thank you for joining us for the call for ImmuneBio's second quarter 2024 financial results. With me on the call today are Dr. RJ Tessie, CEO and co-founder of ImmuneBio, and Dr. Mark Liddell, Chief Scientific Officer and co-founder of ImmuneBio, who will provide an update on IncMune, our memory-like natural killer cell oncology platform. Also on the call is Dr. CJ Barnum, Head of Neuroscience, who will provide some details on our ongoing Phase II Alzheimer's study. 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 disclaimers 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, ImmuneBio 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 Dr. RJ Tessie. RJ.

Thank you, David. Good afternoon to everyone. We will keep our prepared remarks brief. I will review the key takeaways from the second quarter, relevant news from recent weeks, and provide updates on our platform programs. I will then pass it to CJ Barnum, VP of CNS Drug Development, for more details on the ongoing Phase II trial in Alzheimer's disease. Dr. Mark Lodell will follow. with an update on our increment program in prostate cancer, and David Moss will conclude with a review of our financial results for the second quarter before we take your questions. Since our first quarter conference call in May, we continue to make steady progress in both clinical programs. Before I comment on our AD, on our ex-pro program in AD, or in Alzheimer's disease, I want to make a couple comments about the rapidly changing landscape of Alzheimer's disease diagnosis and treatment. Just in the last month, the second drug, Donanumab, was approved for the treatment of Alzheimer's disease. It is an anti-amyloid drug. And it does have a black box warning for highlighting the increased risk of AREA, which is edema in the brain, in patients with two copies of APOE4 gene. Last week, the EU regulatory authorities did not approve the aside Biogen's drug lucanumab for the treatment of Alzheimer's disease. We don't know if the EU's decision is going to be unique to lucanumab or affect other drugs in the anti-amyloid class. Today, the last day of AIC in Philadelphia, AIC is the Alzheimer's Disease International Congress, which is the largest meeting in AD that occurs every year. But at this meeting, there is cautious hope for the future of therapeutic options for patients with Alzheimer's disease and a lot of discussion about alternatives to amyloid therapy. People understand the risk and efficacy profile of this class of drugs, and they look forward to other options in the future. Much excitement was focused on the anti-inflammatory treatment strategies, and obviously we like to think we are leaders in this particular area. All in all, it was a very bullish meeting for EXPRO and Alzheimer's disease. In June, we completed a planned blinded interim analysis of ADO2, our phase two trial of EXPRO, in patients with early Alzheimer's disease with biomarkers of inflammation. The purpose of the analysis was to evaluate the power and performance characteristics of the primary endpoint. The primary endpoint is EMAC, which is Early Mild Alzheimer's Cognitive Composite Score. Independent third-party statisticians and neuropsychologists determined the ADO2 trial is appropriately powered and concluded the trial design, operational execution, data collection, and management are of the highest quality. As of today, we have many patients in the screening process and pipeline and are on track to reach full enrollment of this trial by the end of September. We eagerly await top line data readout on the primary endpoint approximately six months later, or excuse me, approximately six months after the last patient is enrolled. At AAIC this week, we presented additional data on the effects of EXPRO on the brain of patients with Alzheimer's disease. The data demonstrate EXPRO's direct impact on synaptic proteins and provide biologic support for the improvement in synaptic function that we recently demonstrated with EEG. I remind you that synapses are the things that allow nerve cells to talk to each other, and they are a critical part of neurologic disease in general and Alzheimer's disease specifically. These data are another example of how EXPRO normalizes the brain's immune system to improve the biology of the aging brain. That includes less neurodegeneration, that's nerve cell death, increased remyelination, and improved synaptic function. We predict the ongoing phase two trial will demonstrate these biologic benefits correlate with cognitive benefits. The importance of controlling neuroinflammation extends well beyond Alzheimer's disease, and we continue to move forward with our plans to initiate a treatment-resistant depression phase two study. The trial is sponsored by the NIH, and we expect to enroll patients later this year. InCommune, our novel NK-focused cancer program, also continues to make progress. We announced the publication of a paper in the prestigious high-impact Journal of Immunotherapy of Cancer. The data showed the unique ability of InCommune to create cancer-killing memory like NK cells in situ in situ, meaning within the patient's blood system, using NK cells of their own. Dr. Liddell will provide more detail on this in a moment. We're excited by these data and their implications for treating multiple types of solid tumors with INCMUME in the future. We plan to provide patient-level data from the ongoing Phase I-II trial and cache-resistant metastatic prostate cancer later this year. For now, I'll turn it over to C.J. Barnum, VP of CNH Drug Development, to provide a more in-depth discussion of our ongoing Phase II trial in patients with Alzheimer's disease. C.J.?