INmune Bio Inc.

Greetings and welcome to the In MUN Bio first quarter 2022 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 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, co-founder and CFO of ImmuneBio. David, the floor is yours.

Thank you, Paul, and good afternoon, everybody. We thank you for joining us for the call for ImmuneBio's first quarter 2022 financial results. With me on the call is Dr. RJ Tesse, CEO and co-founder of ImmuneBio, who will provide a business update on our DN-TNF platform and Dr. C.J. Barnum, head of neuroscience, who will speak about both of our Phase II programs in Alzheimer's disease and our Phase II program in treatment-resistant depression. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provision of the Private Securities Litigation Act reform 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 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 of the date they are made, as of the facts and circumstances underlying these forward-looking statements may change. Except as required by law, ImmuneBio disclaims any obligations to update these forward-looking statements to reflect future information events or circumstances. Now, to start, I'd like to state that we're very optimistic about the developments on our two platforms, IncMune for NK cells and ExPro for CNS indications. Both platforms have significant potential, and we like to say that what we're pursuing today is just the tip of the iceberg. To update you on our progress, I'd like to turn the call over to Dr. RJ Tessie, co-founder and CEO of Immune Bio. RJ.

Thank you, David, and thank you, everyone, for joining the call. As usual, I will arrange my remarks to highlight the key takeaways for the first quarter and subsequent period and provide updates on our platform programs. I will start by reviewing our developments in the EXPRO programs, and I will then hand it over to Dr. C.J. Barnum, the VP of CNS Development, to speak about those programs in detail. And obviously, David will finish with the financial results and upcoming news milestones before we move to Q&A. We recently announced the dosing of the first patient in the Phase II EXPRO trial for the treatment of neuroinflammation as a cause of cognitive decline in Alzheimer's disease. Immune Bio believes that restoration of synaptic connections and prevention of nerve cell death with ex-pro therapy will have a pro-cognitive effect on patients with ADI. ADI, that's capital A, capital D, small i, is the term we use to define the AD patients with neuroinflammation that are the target of our clinical programs in Alzheimer's disease. The design of the Phase II ADI trials are based on what we learned from the successful phase one trial. The use of biomarkers help select dose, duration, and endpoints of the trials to de-risk the programs. These biomarkers are relevant beyond ADI and provides new opportunities for the staging and treatment of CNS diseases. The opportunities to expo beyond ADI are real. Alzheimer's disease is the first of the neurodegenerative diseases we will be treating with EXPRO, we have announced a phase two program in treatment-resistant depression, or TRD, in depressed patients with neuroinflammation, something we call TRDI, and are performing IND-enabling preclinical studies in ALS. Each of these programs began with extramural, non-diluted funding from the Alzheimer's Association, the NIH, and the ALS Foundation, respectively. Neuroinflammation is the common denominator of these CNS indications. More than 70 publications covering more than a dozen diseases gives a hint of the opportunities before us. These publications can be found on our website. We will be enrolling additional patients in the coming months in the Phase II mild ADI trial. We will be initiating our Phase II MCI trial soon. But first, during the first quarter, we presented additional data from the successful Phase I trial at the ADPD 2022 conference in Barcelona. Our imaging partner, IMICA, demonstrated that measures of white matter pathology are different in MCI versus Alzheimer's disease patients and may provide a means of predicting progression from MCI to Alzheimer's. These data have implications for our clinical development programs and drove our decision to separate trials in MCI and mild ADI. In the future, the ability to identify patients at risk of conversion from MCI to AD to Alzheimer's disease may prove to be a key step in preventing the development of dementia related to Alzheimer's disease. Why start an MCI trial now? The answer is quite simple. There are two elements necessary for drug approval, clinically relevant efficacy data and an ample safety database. By adding the MCI trial, not only do we get insight into a clinically and commercially relevant market beyond mild AD, but we also expand the safety database. Both of these trials will help us achieve our goal of moving EXPRO closer to registration trials. C.J. Barnum, the VP of CNS Development at Immune Bio and the architect of our AD trials, will provide more detailed information on our Alzheimer's Disease Clinical Program.