INmune Bio (NASDAQ:INMB) plans to submit a U.K. marketing application for its experimental recessive dystrophic epidermolysis bullosa treatment Ebstrocel in early February 2027, with potential approval by midyear, executives said on the company’s third-quarter earnings call.
CEO and co-founder David Moss said the company is also targeting a U.S. biologics license application around mid-2027, subject to feedback from a planned Food and Drug Administration meeting. INmune is prioritizing the U.S. application ahead of a European Medicines Agency submission.
The company reported a narrower third-quarter loss and said its cash should fund operations through the third quarter of 2027 under its current operating plan. Moss said INmune intends to defer significant company-funded investment in a new development program for its XPro drug candidate until after Ebstrocel approval.
U.K. submission strategy changes
Ebstrocel is a cell therapy being developed as a systemic treatment for recessive dystrophic epidermolysis bullosa, or RDEB. Moss said the treatment is intended to address concerns including itch, pain, inflammation and wounds.
Chief Scientific Officer and co-founder Mark Lowdell said INmune submitted a final pre-marketing application package to the U.K. Medicines and Healthcare products Regulatory Agency on Oct. 20. The company plans to use the agency’s feedback to finalize its full application.
Lowdell said progress in manufacturing and quality work allowed INmune to plan a complete submission rather than the piecemeal rolling review it had previously considered. He said the revised approach could advance potential U.K. approval by six to 12 weeks compared with prior expectations.
The company anticipates an MHRA response three to six months after submission, subject to validation, review and any requests for additional information. Lowdell described that timeframe as a planning assumption, not a guaranteed decision date. He also said the agency’s written alignment on elements of the planned application and approval of a pediatric investigation plan do not constitute marketing approval.
INmune expects its company-funded confirmatory Phase III trial to open in the first quarter of 2027 at Great Ormond Street Hospital and Birmingham Children’s Hospital. Lowdell said roughly 40 children are expected to be treated in the trial, which runs until mid-2028.
Patient access and manufacturing plans
Lowdell said discussions with U.K. clinical experts identified approximately 100 patients who would be eligible for Ebstrocel upon approval. Reimbursement discussions with the U.K. government are expected to begin in early 2027, he said.
INmune’s agreement with Uniphar provides a framework for pursuing named-patient access in selected European, Middle Eastern and North African markets. Where local rules permit, physicians could request the treatment for eligible patients before local marketing approval or broad commercial availability.
Moss said such supplies could provide an earlier source of revenue, but the company did not give a sales forecast or date for first sales. Timing and scale depend on factors including country-specific arrangements, physician requests, lawful supply agreements and funding or reimbursement.
Lowdell said INmune has begun transitioning to manufacturing scale for commercial supply, with initial batches for the confirmatory trial intended to validate that scale. He also said the company’s CORDStrom patent application remains under examination; it is not an issued patent.
Alex Hersham, founder of ABE and the father of a child with severe RDEB, described the burden of itch, inflammation and daily care. He said VYJUVEK had improved his son’s wounds, but itch can cause wounds, including previously closed ones, to reopen.
Loss narrows as company sets XPro priorities
Chief Financial Officer Cory Ellspermann said the net loss attributable to common stockholders was approximately $4.7 million for the quarter ended Sept. 30, compared with $6.5 million a year earlier. Research and development expenses fell to about $3.2 million from $4.9 million, while general and administrative expenses declined to about $1.8 million from $2.5 million.
INmune held approximately $16.3 million in cash and cash equivalents at quarter-end. In October, it raised $4.5 million in gross proceeds through a stock and warrant transaction with an investor, Ellspermann said.
For XPro, Moss said INmune is looking for a rare disease indication that could support a smaller and more capital-efficient program than a large Alzheimer’s trial. A collaboration with Quantum Computing will use optimization, artificial intelligence and conventional analytics to assess company and public data, he said.
Moss said INmune has not selected an indication or established a clinical or regulatory timeline. The company can conduct selection work and partnership discussions while focusing its resources on Ebstrocel, he said.
About INmune Bio (NASDAQ:INMB)
INmune Bio, Inc is a clinical-stage biotechnology company focused on developing treatments that harness and modulate the innate immune system. The company’s research is aimed at addressing diseases in which chronic inflammation or impaired immune function plays a significant role, including cancer, neurodegenerative disorders and certain psychiatric conditions.
Its lead product candidate is XPro, a next-generation tumor necrosis factor inhibitor designed to selectively neutralize soluble TNF while preserving transmembrane TNF signaling.
