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INmune Bio Inc.
10/30/2025
Your program is about to begin. Greetings and welcome to the ImmuneBio third quarter 2025 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 questions by pressing the star and 1 on your telephone keypad. You may withdraw yourself from the queue by pressing star 2. 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. Daniel Carlson, Head of Investor Relations of Immune Bio. Daniel?
Thank you, Operator, and good afternoon, everyone. We thank you for joining us for the call for ImmuneBio's third quarter 2025 financial results. Presenting on today's call are David Moss, CEO and co-founder of ImmuneBio, Dr. Mark Lodell, chief scientific officer and co-founder of ImmuneBio, Dr. CJ Barnum, head of neuroscience, and Corey Elsperman, ImmuneBio's CFO. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to question 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 material 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 filings 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 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. It's now my pleasure to turn the call over to ImmuneBio's CEO, David Moss. David?
Thank you, Dan, and good afternoon, everyone. For our third quarter 2025 call, today I will review key takeaways and provide an update on our platform programs. Following my review of the recent developments at ImmuneBio, I will pass the microphone to Dr. Lodell, ImmuneBio's Chief Scientific Officer and inventor of Cordstrom, who will provide an update on our Cordstrom MSC platform, and particularly our RDEB program, along with Incbune. Next, Dr. C.J. Barnum, who leads our CNS drug development efforts, will provide an update on the Alzheimer's program, and then Corey Elsperman, our CFO, will present our financial results, after which I'll conclude our prepared remarks with a review of our upcoming catalyst, and then we'll be happy to take your questions. Since taking over the role of CEO at Immune Bio in July, it's been a time of transition for the company. Having spent the last two years with our main focus on Alzheimer's trial, which ended in late June, we're now able to direct our attention to the next stage of development for our platform drug programs. And we're highly optimistic that the next couple of years will demonstrate the success of our efforts as we take our programs through key development milestones, which we expect could lead to benefits not only for investors, but for patients suffering from diseases with limited therapeutic options available at this time. Cordstrom is our most advanced program as we are now in the process of preparing for submission for marketing approval to the regulatory bodies in both the UK and the US. We believe Cordstrom has demonstrated a clear and safe benefit to patients suffering from recessive dystrophic epidemolosis bullosa, also referred to as RDEB, a very debilitating disease. Patients on the drug had a significantly reduced itch, which not only affects wound healing in these young sufferers, but also reduces the itch, scratch, wound cycle. While R-deb primarily manifests as a genetic condition causing skin fragility, blistering, and scarring due to mutations of the collagen 7 gene, it also involves mucous membrane and internal organs leading to multi-system complications. While R-deb has traditionally been treated topically, R-deb is a systemic disease that has blisters and scarring in the mouth, esophagus, eyes, urethra, and anal area, causing nutritional deficiencies, emotional stress, and other problems. We believe Cordstrom is potentially one of the first systemic treatments for RDEB and made an improvement in the quality of life of the patients treated in our trial. Looking beyond our initial indications are Deb, we believe Cordstrom is a platform opportunity for immune bio, as it has the potential to accomplish all sorts of things in many different diseases. For example, we can genetically modify it to treat cancer cells, which is what it was originally developed for. And there are many other modifications you will hear about in the near future. So there's a lot of things that we can do with Cordstrom to improve its targeting and a variety of rare diseases and indeed less rare or more common diseases. We'll be excited to share these modifications in the future as well as expansions towards other indications. Turning to the EXPRO platform, we remain confident in its potential to treat neuroinflammation in Alzheimer's disease. In September, we submitted a manuscript detailing the results of the Phase 2 MINDFUL trial for peer review publication. As we analyzed the complete data set, we're gaining deeper insight into the drug's activity. Dr. Barnum will elaborate, but our findings indicate positive results in patients with higher baseline inflammation. We're actively pursuing an accelerated regulatory pathway and preparing for end of phase two meeting with the FDA. Defining a clear path forward for EXPRO is a primary objective and may be crucial for strategic funding and partnership discussions. 2025 also saw us complete the phase two trial of Incubune in prostate cancer ahead of schedule. With the primary endpoint and two of the three secondary endpoints met, I'm excited to have Mark share more on Incubune later. To conclude my remarks before I turn the call over to the team to discuss the individual programs, I'd like to thank the patients that participated in our trials, the clinical trial sites, and our dedicated team for helping us execute these very complex trials. I also want to thank our investors for their continued belief in our novel platforms and support. Our decision to develop three very different drug platforms in parallel to provide strength and opportunity has borne fruit. IMU now has two later stage platform therapeutics that have demonstrated success in clinical trials and are ready to advance to the next stage of development, and a third which completed a phase two trial successfully. Our value proposition to shareholders and patients is clear. First is to get Cordstrom to MAA in the UK, followed by a BLA in the US. Meanwhile, for X-Pro, we await regulatory alignment with the end of phase two study to determine next steps. We anticipate all of this will happen in 26, an exciting year for the company. Now, I'll turn the call over to Mark Liddell for more color on Cordstrom and Inc.
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