INmune Bio Inc.

Greetings and welcome to the ImmuneBio third quarter 2022 earnings call. At this time, all participants have been placed on a listen-only mode. A question and answer session will follow the formal presentation. If you would like to have an opportunity to ask questions during today's event, please press star 1 on your telephone keypad. If anyone should require operator assistance, please press star 0 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, thank you. The floor is now yours.

Thank you, Donna, and good afternoon, everybody. We thank you for joining us for the call for ImmuneBio's third quarter 2022 financial results. With me on the call is Dr. RJ Tessie, CEO of ImmuneBio, and Dr. CJ Barnum, head of neuroscience. who together will provide a business update on our dominant negative TNF platform, or DNTNF for short. Also on the call is Dr. Mark Liddell, Chief Scientific Officer of Immune Bio, who will provide an update on IncMune, our memory-like natural killer 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 Harbors Provision 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 in such 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's 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. Except as required by law, ImmuneBio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. With the forward-looking statements behind us, now I'd like to turn the call over to Dr. RJ Tessie, CEO of ImmuneBio. RJ.

Yes, thank you, David. And today's call is organized a little bit differently. We have both Mark Liddell and CJ Barnum on the call, and I believe going forward, you will see this larger cast on the calls because, you know, we are a complicated company with a lot of programs going on. And we believe that investors learn the most when they hear directly from the people that are responsible for those programs. So I will begin with ExPro with some just top line comments. And obviously the most important issue is the clinical hold. that we are under from the FDA. As we have stated previously, the clinical hold was placed on Expo 1595 due to manufacturing issues. These issues are technical in nature, and they are related to the fact that manufacturing batches were separated by many years and by geography, i.e., different manufacturing plants, and this has caused some problems related to the manufacturing controls and release testing. We have been working very closely with the FDA and our manufacturing teams to resolve these problems, and we continue to look forward to clearing these hurdles. Despite this delay, we continue to make progress with the ADO2 trial in mild Alzheimer's disease patients in Australia. and we are exploring other regulatory venues that we will hopefully be able to open the trial and continue to enroll patients or begin to enroll patients. The EXPRO program is like a coiled spring. Once the clinical hold is lifted, we will work to have both ADO2 in mild AD and ADO3 in MCI, or mild cognitive impairment, enrolling in all regulatory jurisdictions. Soon after those two programs are enrolling, we plan to launch the treatment resistant depression program in the U.S. Importantly, we will update guidance on the timing of top line readouts in the Alzheimer's trials at the end of the year. Obviously, the timing of those readouts depends on our discussions with the FDA. I will now pass it back to Dr. C.J. Barnum, the VP of Neurosciences, to speak about the Alzheimer Phase II programs.