INmune Bio Inc.

Ladies and gentlemen, greetings and welcome to the Immune Bio fourth quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero 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 is my pleasure to introduce Mr. David Moss, CFO of ImmuneBio. David, the floor is yours.

Thank you, Ryan, and good afternoon, everybody. We thank you for joining us for the call for ImmuneBio's year-end 2023 financial results. With me on the call is Dr. RJ Tessie, CEO and co-founder of ImmuneBio, and Dr. Mark Lodell, Chief Scientific Officer and co-founder of ImmuneBio, who will provide an update on IncBio, our memory-like natural color cell oncology platform. 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's no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements which speak only as 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 obligation to update these forward-looking statements to reflect future information, events, or circumstances. Now I'd like to turn the call over to Dr. R.J. Tessie, CEO of Immune Bio. R.J.? ?

Yeah, thank you, David, and thank everyone for joining the call. As usual, I will arrange my remarks to highlight the key takeaways for the fourth quarter and the subsequent period and provide updates on our platform programs. I will start by reviewing developments on our EXPRO platform and then pass it over to Mark Liddell, who will provide an update on Incmeon. David will conclude with a discussion of our final results. and providing an update on upcoming and new milestones. During the fourth quarter in early 2024, there were several positive developments in our phase two trial in patients with early Alzheimer's disease. First, we received acceptance of our clinical trial application by several EU countries to allow us to initiate the phase two trial in those countries. Clinical trial sites in Poland, Spain, France, Czech Republic, and Slovakia will soon be enrolling patients. The UK continues to be very active in recruiting patients for the phase two trial. And the UK is ideal, an ideal jurisdiction to expand or to develop our program because it possesses one of the highest rates of Alzheimer's disease in the rest of the world, coupled with a robust for-profit medical research infrastructure. Patient enrollment tends to be faster in the private for-profit sites compared to academic or government-run hospitals. The FDA lifted the clinical hold for the AD program in January of this year. We have previously announced we will not be enrolling patients or adding trial locations in the U.S. This is a simple issue of timing. The time and cost to open U.S. sites is such that we probably would not be successful getting any patients enrolled before the phase one and phase two, excuse me, enrollment is completed. That cost just can't be justified. We expect no U.S. patients to be enrolled in this trial period. We are often asked if this strategy will compromise the expo development program in Alzheimer's disease. The answer is a loud no. There is no requirement that U.S. patients be included in any drug trial. The FDA's preference for including U.S. patients in clinical trials is due to demographic considerations, not due to doubts about the validity of non-US clinical trial results. Although the FDA has issued guidance recommending that clinical trials reflect demographic diversity of the US population, this goal has not been achieved in the recent pivotal trials for the anti-amyloid treatments. We expect the US will be a key jurisdiction for clinical trials and patient enrollment in the pivotal AD trial that will follow this trial. One of the realities of a six month clinical trial is that phase three planning must begin well before patient enrollment in the phase two trial is complete. Our goal is to complete end of phase two meetings with the FDA and other regulatory authorities in mid 2025 to get a clear outline of what would be required for an approvable phase three trial. Discussions of patient diversity in the U.S. cohort will be had at that time. This does not mean we are not in communication with the FDA on ex pro for Alzheimer's disease. We plan to submit for accelerated approval pathways for ex pro in Alzheimer's disease. The first submission will be a fast track pathway. Then once we have compelling phase two human data, we will submit for breakthrough status. Recently, in fact, a month ago or less, the FDA released draft guidance on the development of drugs for the treatment of patients with early and prodromal Alzheimer's disease. The guidance supports many of the strategies we have been including in our trials, including enrichment and novel endpoints. The guidance also provides direction on how to think about prevention of Alzheimer's in patients with prodromal disease. This is something we think EXPRO will be very good at and we will be talking about more in the future. I want to take a moment to address two unique elements of our Phase II clinical trial, the endpoint and the six-month duration of the trial. We are often reminded that we do not look like, excuse me, that we look different than the gold standard set by a big pharma in their anti-amyloid trials, but looks can be deceiving. A look below the surface shows many similarities between those large and long trials and our trial. Despite all of the talk about EMAC as our primary endpoint for ADO2, the trial is powered on CDR. CDR is a well-accepted cognitive endpoint used in all of the anti-amyloid trials. In fact, let's compare our trial with Expo for the treatment of early AD with the positive phase three trials that use the anti-amyloid drug for the treatment of early AD. The three trials have two things in common, the use of CDR and a six-month trial time point. Both the Canumab and Donamimab phase three trials showed statistically significant advantages of the anti-amyloid treated patients compared to placebo at six months. Put another way, both those trials could have been stopped at six months with positive results. The difference seen between the placebo and treatment groups in the anti-amyloid trials is exactly the same difference we expect to see between expro-treated and placebo-treated patients. In summary, we are very confident that the expro trial is well-designed, statistically sound and substantially de-risked. The ex-pro trial looks almost exactly what has been successful with leucanumab and donaminab. In early March, INCME issued a joint press release with Kinos Bioscience, highlighting advanced AD patients who received weekly ex-pro treatment for four weeks had a statistically significant increase in alpha wave frequency and power. Reduced alpha-weight power has been linked to cognitive decline and progression in MCI and Alzheimer's disease. The EEG long considered a gold standard in objectively measuring brain activity provides valuable insight into brain function and neural connectivity. Studies have consistently highlighted a progressive decline in alpha-band power in patients like ours. To our knowledge, we are unaware of reports of drugs in AD development that show consistent decreases in alpha wave power. We believe this is an easily measured biomarker of improved brain function in patients without Alzheimer's disease. But without a roadmap, that is other results, we need to wait for the results of our trial to determine if an increase in alpha wave power correlates with cognitive improvements. Just to be clear, the seven patients in this pilot study are patients with moderate to severe Alzheimer's disease. And so they're very different than those in the early Alzheimer's trial. We sought to evaluate the utility of EEG as a functional biomarker in this group. We believe this is just the beginning, or as we like to say, the tip of the iceberg, of what we can expect to be positive news on Alzheimer's, not only in halting the progression of cognitive decline in Alzheimer's disease, but hopefully in restoring cognitive functionality. This last point is why we're using EMAC. EMAC has the ability to demonstrate improved cognitive function after expert treatment. Standard cognitive measures in Alzheimer's disease can only measure stable or decreasing cognitive function. We like to boast that targeting neuroinflammation with Expro provides many market expansion opportunities into other neurodegenerative and behavioral diseases. Go no further than our website to see 87 publications and more than 12 different diseases where Expro has been effective in clinical models, preclinical models. Treatment-resistant depression, or TRD, will be the first disease beyond Alzheimer's that we've developed. We will be making further announcements on the TRD Phase II trial using EXPRO in the near future. Our goal is to enroll the first patient in this NIH-supported Phase II trial in the second half of 2024. I now pass the mic to Mark Liddell, the co-founder and CSO of ImmuneBio, to update progress on the InCommune program. Before I do so, I and the entire ImmuneBio team want to recognize congratulate Mark for a recent significant achievement. Two weeks ago, we received notice that Mark was awarded a career achievement award in cell and gene therapy by the International Society of Cell and Gene Therapy. The ISCT is the society in cell and gene therapy, and the organization considers this award its highest honors. The award was announced as part of the annual ISCT major awards announcement. And Professor Liddell received the award during the organization's annual meeting in Vancouver on May 29th. We couldn't be happier for Mark and believe this recognition is well-deserved. Congratulations, Mark.