INmune Bio is a clinical-stage biotechnology company that develops immunotherapies designed to reprogram a patient’s innate immune system to fight cancer, Alzheimer’s disease, and other chronic inflammatory conditions. Pulse 2.0 interviewed INmune Bio co-founder and CEO David Moss to learn more.
David Moss’ Background
Could you tell me more about your background? Moss said:
“I’ve been with INmune Bio since its founding in 2015, initially serving as CFO, Director and Secretary and stepping into the role of CEO in August 2025. I have over 25 years of experience founding, funding, and running companies, mainly in biotech. Prior to INmune Bio, I was Managing Director of Corporate Finance at a New York–based securities firm, and Managing Partner of a Seattle venture capital firm. I also co-founded Reliant Service Group, which was acquired by a leading private equity firm in 2015. I hold an MBA from Rice University and a BA in Economics from the University of California, San Diego.”
Formation Of The Company
How did the idea for the company come together? Moss shared:
“The company was founded to develop therapies that target the innate immune system to treat chronic inflammation and immune dysfunction. Our goal was to create disease-modifying therapies for conditions such as Alzheimer’s disease and cancer, rather than simply managing symptoms. As CEO, I focus on guiding the company’s strategy, ensuring our clinical programs advance efficiently, and maintaining alignment between management, investors, and all stakeholders.”
“A recent update in our strategy was the focus on rare disease drug development with our lead candidate CORDStrom, targeting Recessive Dystrophic Epidermolysis Bullosa, or RDEB. RDEB is a rare and severe genetic skin disorder characterized by extreme skin fragility, leading to chronic pain, itching, blisters, scarring, and internal complications. CORDStrom is really unique as the first potential product to address the systemic nature of the disease as existing approved products only address the topical nature of RDEB.”
Favorite Memory
What has been your favorite memory working for the company so far? Moss reflected:
“One particularly rewarding moment was dosing the first patient in our Phase 2 XPro trial for Alzheimer’s disease in April 2022, followed by the trial’s successful completion in Australia in early 2023. It was inspiring to see our science translate into real progress for patients facing devastating diseases.”
“Another standout moment came recently when INmune Bio was highlighted during a Senate HELP Committee hearing on “The Future of Biotech: Maintaining U.S. Competitiveness and Delivering Lifesaving Cures to Patients.” Florida Senator Ashley Moody recognized us publicly as a leading biotech company, underscoring the state’s growing role in U.S. biotech innovation. These moments reflect both our scientific progress and the broader impact we’re having in the biotech community.”
Core Products
What are the company’s core products and features? Moss explained:
“INmune Bio’s main product is CORDStrom, an off-the-shelf, umbilical cord-derived mesenchymal stromal cell (hucMSC) therapy designed to treat RDEB, which we noted is a very devastating and life-shortening genetic skin disorder. CORDStrom addresses the underlying inflammation and tissue damage that cause chronic pain, blistering, and scarring, making it the first potential systemic treatment for this ultra-rare pediatric disease. Unlike therapies that only address localized symptoms, CORDStrom modulates inflammation and promotes healing throughout the body. In Phase 2 Mission EB trials, patients experienced meaningful improvements in pain, itch, wound healing, and quality of life. The product has received both Orphan Drug and Rare Pediatric Disease designations and is on track for Marketing Authorization in the UK and Biologics License submission in the US in 2026.”
“INmune Bio’s XPro platform, meanwhile, is a next-generation therapy targeting neuroinflammation in Alzheimer’s disease and mild cognitive impairment. It selectively reduces harmful inflammation in the brain without broadly suppressing the immune system, offering a precision approach to slowing or halting cognitive decline.”
Challenges Faced
Have you faced any challenges in your sector of work recently? Moss acknowledged:
“Developing innovative therapies for rare and complex diseases is inherently challenging, from clinical trial design to regulatory alignment. For example, XPro required biomarker-driven patient identification to maximize efficacy. We learned in the Phase 2 trial, that XPro did not fail the trial, but the trial design failed XPro. In other words, what we now know, being a first of the kind trial in an enriched Alzheimer’s trial treating neuroinflammation, is that the Phase 2 trial defines the appropriate patient population and trial design to run a Phase 3 trial with a high degree of certainty. This is something you discover being the first to run a novel trial in AD with neuroinflammation.”
Evolution Of The Company’s Technology
How has the company’s technology evolved since launching? Moss noted:
“Since its inception, INmune Bio’s CORDStrom platform has advanced significantly. It progressed from a conceptual off-the-shelf, umbilical cord–derived Mesenchymal Stromal Cell therapy to a fully developed systemic treatment for RDEB. The platform has demonstrated meaningful clinical improvements in pain, itch, wound healing, and quality of life in Phase 2 Mission EB trials, showing its potential to transform the standard of care for this ultra-rare pediatric disease.
“On the manufacturing side, CORDStrom successfully completed its first commercial pilot-scale production at the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in the UK, illustrating readiness for broader commercialization. The platform has also received Orphan Drug and Rare Pediatric Disease designations and is on track for Marketing Authorization applications in the UK, US, and EU in 2026. These milestones reflect both the scientific and operational evolution of CORDStrom as a leading systemic therapy for RDEB.”
Significant Milestones
What have been some of the company’s most significant milestones? Moss cited:
“Some of our most pivotal milestones for CORDStrom include:
- i) The topline results from the Phase 2 “Mission EB” trial in pediatric patients with RDEB showing meaningful reductions in itch, pain, and improved skin integrity.
- ii) Completing the Phase 2 trial with XPro in Alzheimer’s Disease, showing a signal with XPro in patients with elevated neuroinflammation and AD, something very novel and much needed for Alzheimer’s.
iii) Receipt of Orphan Drug and Rare Pediatric Disease Designations for CORDStrom, positioning the product for regulatory incentives.
- iv) Successful completion of the first commercial pilot‑scale manufacturing run of CORDStrom at the Cell & Gene Therapy Catapult in the UK, demonstrating our readiness for scale and commercialization.
- v) Advancing regulatory‑filing plans: Targeting submission of Marketing Authorization Applications (MAA) in the UK mid‑2026, followed by a Biologics License Application (BLA) in the U.S. in the second half of 2026.
These milestones underscore both the scientific progress and the operational readiness of CORDStrom, bringing us closer to delivering a systemic therapy for a life‑shortening rare disease.”
Customer Success Stories
Can you share any specific customer success stories? Moss highlighted:
“One compelling example comes from the Mission EB trial of CORDStrom in children with RDEB. Patients treated with CORDStrom experienced a sustained reduction in itch severity, with some children showing more than a 27% improvement at six months. Across the study cohorts, no serious adverse events related to the treatment were reported, highlighting a favorable safety profile. Feedback from patients and caregivers also indicated meaningful improvements in wound healing, skin integrity, and overall quality of life, with many expressing a desire to continue therapy. These outcomes are particularly significant given the very limited treatment options currently available for RDEB, and the systemic nature of CORDStrom offers hope for a broader impact beyond topical therapies.”
Total Addressable Market (TAM)
What total addressable market (TAM) size is the company pursuing? Moss assessed:
“INmune Bio is targeting both rare and more widespread diseases driven by inflammation. For CORDStrom, the primary focus is Recessive Dystrophic Epidermolysis Bullosa (RDEB), which affects approximately 12,500 patients in the U.S. and 16,290 in Europe. CORDStrom represents the first potential systemic treatment for RDEB, addressing the underlying inflammation and tissue damage rather than just topical symptoms. In parallel, the company is advancing XPro for Alzheimer’s disease, which currently impacts roughly 7.2 million Americans aged 65 and older. The prevalence of Alzheimer’s rises sharply with age, and no therapies reliably halt disease progression, making XPro’s biomarker-driven, neuroinflammation-targeted approach highly significant, especially with an aging population. By pursuing these complementary rare and large markets, INmune Bio is positioned to deliver transformative therapies across multiple disease areas.”
Differentiation From The Competition
What differentiates the company from its competition? Moss affirmed:
“INmune Bio is distinguished by its focus on disease-modifying therapies that harness the innate immune system rather than broadly suppressing it. CORDStrom is the first therapy addressing the root causes of chronic inflammation and tissue damage for RDEB, rather than providing just topical symptom relief. On the other hand, XPro targets neuroinflammation in Alzheimer’s patients with a precision, biomarker-driven approach that maximizes efficacy while avoiding immunosuppression. Across both platforms, we emphasize targeting the underlying drivers of disease rather than simply managing symptoms, which sets us apart from other therapies in rare pediatric and age-related inflammatory diseases.”
Future Company Goals
What are some of the company’s future goals? Moss emphasized:
“Looking ahead, INmune Bio’s priorities include submitting Marketing Authorization Applications for CORDStrom in the UK and Biologics License Applications in the U.S. in 2026. For XPro, the company is preparing for pivotal Phase 3 trials in Alzheimer’s disease, guided by biomarker-driven patient selection and regulatory alignment with the FDA. Beyond these immediate milestones, INmune Bio aims to advance its immunotherapy platforms into additional diseases driven by inflammation and immune dysregulation. Throughout all programs, the company remains committed to a patient-centric approach, ensuring that therapies address meaningful clinical outcomes and improve quality of life.”
Additional Thoughts
Any other topics you would like to discuss? Moss concluded:
“At INmune, we like to solve large complex diseases, particularly if they are a large burden on patients, families and society. Everyone at the company is dedicated to this mission.”
