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Date

Thursday, May 7, 2026 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — David Moss
  • Chief Scientific Officer — Mark Lowdell
  • Chief Financial Officer — Cory Ellspermann

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Takeaways

  • Cash and cash equivalents -- $21.4 million at March 31, 2026, with management stating this is sufficient to fund operations through Q1 2027.
  • Net loss -- $5.4 million, a reduction from $9.7 million in the comparable period in 2025.
  • Research and development expenses -- $3.6 million, down from $7.6 million for the prior year period.
  • General and administrative expenses -- $2.2 million, slightly lower than $2.3 million in the previous year.
  • Shares outstanding -- Approximately 26.6 million shares of common stock as of May 7, 2026.
  • CORDStrom regulatory progress -- All key steps for U.K. Pediatric Investigation Plan approval are on track, with final response submission imminent and no substantial issues raised.
  • CORDStrom manufacturing -- The first of three validation runs has begun, with the remaining two scheduled to align with the Marketing Authorization Application timeline.
  • CORDStrom supply chain -- A new expanded material transfer agreement with Anthony Nolan U.K. Cord Blood Bank secures long-term umbilical cord supply for commercial manufacturing.
  • XPro development -- Additional imaging analysis from the MINDFuL study is advancing, focused on MRI data related to myelin preservation and structural integrity.
  • Partnership and development strategy -- CEO Moss said, "we're exploring potential rare disease trials for XPro and potential partners as we define the path forward, including regulatory alignment late-stage development strategies."

Summary

INmune Bio (INMB +2.10%) delivered an update signaling concrete progress across its CORDStrom and XPro platforms, as well as disciplined financial management. Regulatory preparations for CORDStrom's marketing submission in the U.K. and Europe have reached advanced stages, with milestone filings and supply chain agreements completed to support near-term manufacturing. Imaging analyses are being expanded to inform XPro’s positioning as a disease-modifying therapy, with rare disease indications and partnerships under consideration. Management highlighted that current cash reserves position the company to achieve these execution milestones into early 2027.

  • The active ingredient of CORDStrom for RDEB is formally named pobistrocel, with the commercial drug name Ebstracel chosen for this formulation.
  • Submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is now expected in early Q3, slightly later than previously planned due to minor regulatory delays.
  • Parallel submissions to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are scheduled to proceed alongside the U.K. filing to meet an end-of-year deadline.
  • XPro’s development pathway includes ongoing regulatory alignment efforts and consideration of late-stage trial strategies, as stated by management.

Industry glossary

  • RDEB (Recessive Dystrophic Epidermolysis Bullosa): A rare, inherited skin disorder causing fragile skin and blistering.
  • PIP (Pediatric Investigation Plan): A development plan mandated by European and U.K. regulators to ensure new medicines are studied appropriately in children.
  • MINDFuL study: The clinical trial evaluating XPro in neurologic conditions, referenced for ongoing MRI-based imaging analyses.
  • UCMSC (Umbilical Cord Mesenchymal Stem Cell): The cellular component isolated from umbilical cord tissue for use in cell therapy platforms such as CORDStrom.
  • MAA (Marketing Authorization Application): The regulatory application required to commercialize pharmaceuticals in Europe and the U.K.
  • Ebstracel: The commercial name for the CORDStrom formulation targeted at RDEB.
  • Pobistrocel: The World Health Organization–assigned nonproprietary name for the active ingredient of CORDStrom.

Full Conference Call Transcript

David Moss: Thank you, Daniel, and good afternoon, everyone. For our first quarter 2026 earnings call, today, I'll review key takeaways and provide an update on our platform programs. Following my review of recent developments at INmune Bio, I will pass the microphone to Dr. Lowdell, INmune Bio's CSO and inventor of CORDStrom, who will provide an update on our CORDStrom MSC platform and particularly our RDEB program. Next, Cory Ellspermann will provide our financial results, after which I'll conclude our prepared remarks. We entered 2026 with clear priorities and strong momentum across our platforms. Most importantly, our CORDStrom platform remains on track, and we are now approaching a key milestone with our regulatory filings.

Based on the progress of our analyses, manufacturing readiness and regulatory preparation, we expect to file for approval beginning in the near term, and we remain confident in the time line that we previously outlined. CORDStrom represents a potential first systemic therapy for RDEB, and we believe the data continue to support both its clinical benefits and its broader platform potential. Execution against this filing is our top priority. Turning to XPro. While CJ is not speaking today, I want to emphasize that we continue to make meaningful progress. We are advancing additional imaging analysis from the MINDFuL study, including MRI data focused on myelin preservation and structural integrity.

These data sets are important as they further characterize XPro's potential as a disease-modifying therapy. At the same time, we're exploring potential rare disease trials for XPro and potential partners as we define the path forward, including regulatory alignment late-stage development strategies. Naturally, we'll update the markets as these milestones develop. Overall, we believe we're well positioned across both platforms as we move through a catalyst-rich period for the company and a marked change potentially for the company as we get closer to commercialization. With that, I'll turn the call over to Mark Lowdell to provide more details on CORDStrom. Mark?

Mark Lowdell: Thank you, David, and thank you to everyone that's joined the call. As David said, since our last earnings call, we've moved forward significantly in bringing CORDStrom to market, and it is our central aim. First, we submitted the pediatric investigation plan known as a PIP to the U.K. medicines regulator in February, and we were approved for rapid assessment and receiving their response on the 9th of April. No substantial issues were raised, and we anticipate submitting our final response in the next few days. The approval of the PIP is an essential step to complete prior to submission of the marketing authorization application in the U.K. and then to the EMA for Europe.

We've started the first of the 3 process validation manufacturing runs on time and the remaining 2 are scheduled to meet our MAA submission deadline. Most significantly, we've concluded negotiations with the Anthony Nolan U.K. Cord Blood Bank this month to ensure secure supply of umbilical cords and allow testing by U.S. laboratories to meet the requirements laid down by the FDA in our Type B meeting last year. This agreement was signed yesterday and is the final step in getting the UCMSC isolation part of manufacturing process validated, ready for commercial manufacture. Facilitating our ability to manufacture consistent batches of CORDStrom, we're pleased to announce that we recently signed an amended material transfer agreement with Anthony Nolan.

This expanded strategic collaboration secures the long-term reliable supply of these high-quality umbilical cord tissues from their world-class cord blood bank to further our CORDStrom platform. Having a consistent supply is essential for us, not only for regulatory authorities, but also to enhance our ability to take the CORDStrom platform forward into other disease indications. The marketing authorization application submission requires completion of a very significant body of documents in 5 sections. These are now well underway. And as part of the product definition section, we've had to determine the formal names for CORDStrom as applied to RDEB to show it's different to other formulations targeting other diseases in the future.

The active ingredient was named by the World Health Organization as pobistrocel, and we've chosen a commercial drug name of Ebstracel for the formulation to be used in recessive dystrophic EB. In 2 weeks' time, we will meet with the MHRA for further advice about the marketing authorization submission filing in the U.K. and then start to finalize those documents. Some minor regulatory delays have meant that we expect to submit to the MHRA in early Q3, and we've contracted a U.K. company, TMC Pharma, with expertise in rare disease submissions to run the EMA and the FDA submissions in parallel to meet the end of the year deadline that we described before to you.

Finally, I had the great privilege to speak at the Cure EB Annual General Meeting in London last month, which is one of the largest EB charities in the U.K. I presented our data and our plan was overwhelmed by the response from patients and carers who attended. They're desperate for us to get Ebstracel to the market and to open the next phase of the clinical trial in the U.K. We're doing our utmost to deliver on our promises to them and to you to get into commercial manufacturing and supply in 2027. I'll hand over to Cory now for an update of the current financials. Cory?

Cory Ellspermann: Thank you, Mark. At this time, I'll provide a brief overview of our financial results. Net loss attributable to common stockholders for the quarter ended March 31, 2026, was approximately $5.4 million compared with approximately $9.7 million for the comparable period in 2025. Research and development expenses totaled approximately $3.6 million for the quarter ended March 31, 2026, compared with approximately $7.6 million for the comparable period in 2025. General and administrative expenses were approximately $2.2 million for the quarter ended March 31, 2026, compared with approximately $2.3 million for the comparable period in 2025. And at March 31, 2026, the company had cash and cash equivalents of approximately $21.4 million.

Based on our current operating plan, we believe our cash is sufficient to fund our operations through Q1 of 2027. And as of May 7, 2026, the company had approximately 26.6 million shares of common stock outstanding. And now I'll hand the call back to David.

David Moss: Thank you, Cory. To close, our focus is straightforward. We're executing towards regulatory filings for CORDStrom, which we believe represents a major inflection point for the company. At the same time, we're continuing to build the case for XPro through additional imaging data, exploring the future rare disease trials and ongoing partnership discussions aimed at advancing the program efficiently. We believe these efforts position INmune Bio for a significant year ahead with multiple opportunities to create value for both patients and shareholders. Due to travel schedules, we'll not be taking questions, and this concludes our prepared remarks.

If you have further questions, please reach out to the contacts at the end of our press releases, Dan Carlson or myself via those phone numbers or e-mails. Thank you for joining us today.

Operator: And thank you, ladies and gentlemen. This concludes today's conference call. We thank you for your participation, and you may now disconnect.