INmune Bio (NASDAQ:INMB) management highlighted progress toward regulatory submissions for its CORDStrom cell therapy platform during the company’s 2026 first-quarter earnings call, while also outlining continued work to expand the clinical case for its XPro program through additional imaging analyses and partnership discussions.
CORDStrom remains the top near-term priority
Chief Executive Officer and Co-Founder David Moss said the company entered 2026 with “clear priorities and strong momentum,” with the CORDStrom platform as the central focus. Moss told listeners the program is “approaching a key milestone with our regulatory filings,” adding that, based on progress in analyses, manufacturing readiness, and regulatory preparation, the company expects to begin filing “in the near term.”
Regulatory and manufacturing updates for CORDStrom in RDEB
Chief Scientific Officer and Co-Founder Dr. Mark Lowdell provided additional detail on regulatory steps and manufacturing work tied to CORDStrom.
Lowdell said INmune Bio submitted its Pediatric Investigation Plan (PIP) to the U.K. medicines regulator in February and was approved for rapid assessment, with a response received on April 9. “No substantial issues were raised,” he said, and the company anticipated submitting its final response “in the next few days.” Lowdell noted that PIP approval is an essential step before submission of a Marketing Authorisation Application (MAA) in the U.K. and then to the European Medicines Agency (EMA) for Europe.
On manufacturing, Lowdell said the company started “the first of the three process validation manufacturing runs on time,” with the remaining two scheduled to meet the MAA submission deadline.
Lowdell also said INmune Bio concluded negotiations with the Anthony Nolan U.K. Cord Blood Bank to secure supply of umbilical cords and allow testing by U.S. laboratories to meet FDA requirements discussed in a prior Type B meeting. He said the agreement was signed “yesterday” and called it “the final step in getting the hucMSC isolation part of the manufacturing process validated, ready for commercial manufacture.”
As part of product definition for the RDEB formulation, Lowdell said the active ingredient was named by the World Health Organization as pobistrocel, and the company chose the commercial drug name Ebstracel for the recessive dystrophic epidermolysis bullosa (RDEB) indication.
Timing and next steps for filings
Lowdell said a meeting with the MHRA is planned “in 2 weeks time” for further advice on the marketing authorization filing, after which the company expects to finalize documents. He added that “some minor regulatory delays” now mean INmune Bio expects to submit to the MHRA in early Q3.
To support parallel submissions, Lowdell said the company contracted TMC Pharma, a U.K. company with rare disease submission expertise, to run the EMA and FDA submissions in parallel “to meet the end of year deadline that we described before to you.”
Lowdell also referenced outreach to the patient community, noting he spoke at the Cure EB Annual General Meeting in London and presented company data. He said the company’s plan “was overwhelmed by the response from patients and carers,” and added that patients are eager for the therapy to reach market and for the next phase of clinical trials in the U.K. to open. Lowdell said the company is working toward “commercial manufacture and supply in 2027.”
XPro program: imaging work and potential partnering
Turning to the company’s XPro program, Moss said the company continues to make “meaningful progress,” including additional imaging analysis from the MINDFuL study. He specifically cited MRI data focused on “myelin preservation and structural integrity,” which he said are important for further characterizing XPro’s potential as a disease-modifying therapy.
Moss also said INmune Bio is exploring potential rare disease trials for XPro and potential partners as it defines the path forward, including “regulatory alignment and late-stage development strategies.”
First-quarter financial results and runway
On the financial results, the company reported a net loss attributable to common stockholders of approximately $5.4 million for the quarter ended March 31, 2026, compared with approximately $9.7 million for the comparable period in 2025. Research and development expenses totaled approximately $3.6 million, down from approximately $7.6 million in the prior-year period. General and administrative expenses were approximately $2.2 million, compared with approximately $2.3 million in the comparable 2025 period.
As of March 31, 2026, INmune Bio had approximately $21.4 million in cash and cash equivalents. Based on its current operating plan, the company said it believes its cash is sufficient to fund operations through Q1 of 2027. The company also reported approximately 26.6 million shares of common stock outstanding as of May 7, 2026.
Management did not take questions due to travel schedules. Moss said the company’s focus remains on executing toward CORDStrom regulatory filings while continuing to build the case for XPro through imaging data, potential rare disease trials, and partnership discussions.
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.
