INmune Bio (NASDAQ:INMB) management used its fourth quarter and full-year 2025 earnings call to outline progress across its three development platforms and to reiterate a 2026 focus on regulatory execution, late-stage trial planning, and capital efficiency.
CORDStrom advances toward regulatory filings in RDEB
Chief Executive Officer and Co-Founder David Moss said 2025 marked a “pivotal year” as the company advanced CORDStrom toward registration in recessive dystrophic epidermolysis bullosa (RDEB) and prepared for regulatory submissions. Moss highlighted “clinically meaningful wound healing, reductions in itch, and improvements in quality of life,” along with a “favorable safety profile,” based on additional patient data presented by the company.
Chief Scientific Officer and Co-Founder Mark Lowdell expanded on the platform, describing CORDStrom as distinct among mesenchymal stromal cell (MSC) products because it is created from cell banks pooled from “four or more pooled donors,” which he said contributes to “unrivaled stability and reproducibility.” Lowdell said pooling also enables the company to select donor seed stocks with “the appropriate potency characteristic for each disease indication,” allowing CORDStrom to be tailored for different indications.
Lowdell said the company has spent the past six months dissecting the mechanism of action in RDEB. He described RDEB as “predominantly a disease of inflammation,” driven by type one macrophages (M1 cells). According to Lowdell, cytokines secreted by CORDStrom help drive M1 cells to mature into “M2 non-inflammatory wound-healing cells,” which secrete IL-10 and other signals that can dampen itch-inducing cytokines and enhance wound repair.
Lowdell also referenced analyses of serum samples from the U.K. trial, stating that CORDStrom recipients showed cytokine patterns consistent with the proposed mechanism, and that patients with higher concentrations reported “much less pain, less itch, and had better skin scores,” as well as improved measures of well-being and “increased ability to eat.” He added that patients, caregivers, and doctors “all want to continue to have access to CORDStrom.”
On timing, Lowdell said the company is working to submit marketing authorization applications in the U.K., then the European Union, and then the U.S. by the end of 2026, and “hope to be supplying CORDStrom to RDEB patients in 2027.”
Regulatory differences: FDA focus on donor testing and new seed stock
During Q&A, Lowdell addressed anticipated differences between a U.K./EU marketing authorization application and an FDA submission. He said the company last spoke with the FDA about 13 months ago and asked whether it could use U.K. donor umbilical cord material for a U.S. submission. Lowdell said the FDA response was “Absolutely, yes,” but required that U.K. donors be screened for standard infectious disease markers “tested in U.S. labs, in CLIA-accredited labs.”
As a result, Lowdell said INmune Bio is “creating new master seed stock from donors that we can ethically test in the U.S.” He said the next master seed stocks currently being made for an FDA filing are intended to support commercialization globally. Lowdell added that, aside from donor testing requirements, “the rest of the questions…were identical to those from the MHRA,” and that the company would present “exactly the same data set.”
Moss said the company recently submitted a “pre-MAA package” to the U.K.’s MHRA, likening it to a “Type D meeting” intended to smooth and speed the marketing authorization process. He said that after receiving MHRA feedback, the company intends to submit a similar Type D meeting package to the FDA “in preparation…like a pre-BLA.”
XPro: MINDFuL insights, FDA alignment, and phase III preparation
Head of Neuroscience CJ Barnum discussed XPro and the company’s completed MINDFuL phase II Alzheimer’s disease trial. Barnum said the trial was designed to test whether selecting patients with both Alzheimer’s pathology and signs of systemic inflammation—and treating the inflammation—could lead to better outcomes. He said results “consistently favored XPro” across clinical and behavioral measures, patient-reported outcomes, and blood and imaging biomarkers.
Barnum said MINDFuL helped identify “what works, who it works for,” and addressed open questions to support phase III planning. He described a planned 18-month phase III program, arguing this duration is intended to allow cognitive effects observed at six months to translate into functional measures required for approval.
He outlined an adaptive design with two stages, where a “Phase II-B” component would provide a go/no-go decision point at nine months before committing to the full phase III investment. If data support continuation, Barnum said the trial would roll seamlessly into a registrational stage using CDR-SB at 18 months as the primary endpoint—an endpoint he noted was used to approve lecanemab and donanemab.
Barnum said the company presented the program at an end-of-phase II meeting with the FDA earlier in 2026, and that the agency aligned with the data package, enrichment strategy, and trial design. He said INmune Bio is continuing analysis of the MINDFuL dataset while preparing for phase III initiation, including finalizing the protocol based on FDA feedback and pursuing partnerships and funding to execute.
Moss acknowledged that MINDFuL “did not achieve its top-line primary endpoint,” attributing that to “powering the patient population properly,” but said the “totality” of the dataset supports the company’s conviction in XPro’s potential in Alzheimer’s and other neuroinflammatory disorders. He also said the company has received minutes from the FDA meeting and obtained “positive initial feedback on the accelerated approval pathways” it is preparing for next steps.
In response to an analyst question about partnering interest, Moss said the company has “ongoing discussions with some groups” and intends to engage business development support to broaden outreach. He argued the program could appeal to mid-sized and large pharmaceutical companies given what he described as a relatively small investment needed to evaluate the Phase II-B portion versus the potential market opportunity.
INKmune: phase II prostate cancer trial results
Moss briefly addressed INKmune, stating the company completed its phase II trial in metastatic castration-resistant prostate cancer ahead of schedule and under budget. He said the study met its primary endpoint and two of three secondary endpoints, noting Lowdell would provide more detail later; no additional specifics were discussed on the call.
Financial results, cash runway, and 2026 milestones
Interim Chief Financial Officer Cory Ellspermann reported a net loss attributable to common stockholders of approximately $45.9 million for the year ended December 31, 2025, compared to approximately $42.1 million in 2024. Research and development expenses were approximately $20.7 million in 2025 versus approximately $33.2 million in 2024, which Ellspermann attributed to “lower expenses in connection with the Alzheimer’s trial in 2025.” General and administrative expenses were approximately $10.3 million in 2025, compared with approximately $9.5 million in 2024.
Ellspermann said the company recorded a full impairment of an intangible asset of $16.5 million in 2025 following the release of phase II Alzheimer’s results “in which the trial did not meet the clinical endpoint.”
On financing, Ellspermann said INmune Bio sold 3.0 million shares for net proceeds of approximately $17.4 million in a registered direct offering and sold approximately 1.3 million shares for net proceeds of approximately $10.1 million through at-the-market offerings during 2025. The company ended 2025 with approximately $24.8 million in cash and cash equivalents. As of March 30, 2026, the company had approximately 26.6 million shares outstanding. Ellspermann said that based on the current operating plan, management believes cash is sufficient to fund operations through Q1 2027.
Moss reiterated a commitment to capital efficiency, saying the company is focused on “clear data-driven milestones” and maintaining a “lean, execution-oriented culture.” Looking ahead, he outlined expected CORDStrom filing timing: a U.K. MAA by mid-summer 2026, followed by an EMA submission a few months later and a BLA submission to the FDA “towards the end of the year.” Moss said the company expects feedback from all three geographies in 2027, “if not approvals by then.”
- CORDStrom: U.K. MAA targeted for mid-summer 2026; EMA filing expected a few months after; U.S. BLA targeted toward the end of 2026.
- XPro: Continue MINDFuL analyses; finalize phase III protocol based on FDA feedback; pursue partnerships and funding for late-stage development.
In closing remarks, Moss said the company’s priorities moving into 2026 are to advance CORDStrom toward market approval in the U.K., EU, and U.S., secure regulatory clarity for XPro’s path forward, and build partnerships and financial support needed to move the programs toward patients.
About INmune Bio (NASDAQ:INMB)
INmune Bio, Inc is a clinical-stage immunology company based in San Diego, California, focused on harnessing the innate immune system to combat a range of serious diseases. The company’s research and development efforts concentrate on modulating cellular pathways to restore and enhance the body’s natural defenses, particularly in oncology and neurodegenerative conditions.
The company’s lead therapeutic candidate, XPro1595 (also referred to as INB03), is a proprietary selective inhibitor of soluble tumor necrosis factor (TNF) designed to reduce chronic inflammation without impairing membrane-bound TNF functions.
