INmune Bio Q1 2026 Earnings Report

INmune Bio EPS Results

• Actual EPS: -$0.20
• Consensus EPS: -$0.25
• Beat/Miss: Beat by +$0.05
• One Year Ago EPS: N/A

INmune Bio Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $1.11 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

INmune Bio Announcement Details

• Quarter: Q1 2026
• Date: 5/7/2026
• Time: After Market Closes
• Conference Call Date: Thursday, May 7, 2026
• Conference Call Time: 4:30PM ET

INmune Bio (NASDAQ:INMB) is a clinical-stage biotechnology company developing treatments that target the innate immune system. The company focuses on therapies designed to address chronic inflammation and immune dysfunction associated with cancer, neurodegenerative diseases and other serious medical conditions.

Its lead technology, XPro, is an engineered form of tumor necrosis factor (TNF) designed to selectively neutralize soluble TNF while preserving transmembrane TNF activity. INmune Bio is studying XPro in conditions involving neuroinflammation, including Alzheimer’s disease and treatment-resistant depression. The company’s second platform, INKmune, is designed to activate a patient’s natural killer cells and is being developed as an oncology immunotherapy.

INmune Bio was founded in 2015 and is headquartered in Boca Raton, Florida. Its clinical development activities have included studies in the United States and other regions. The company is led by Chief Executive Officer and co-founder R. J. Tesi, M.D., who has a background in medicine, oncology and biotechnology.

INmune Bio Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: CORDStrom is moving toward regulatory filing — the company completed a rapid-assessed PIP, started process‑validation manufacturing runs, signed a supply agreement with Anthony Nolan for umbilical cords, and expects to submit the U.K. MAA in early Q3 as it aims for commercial manufacture in 2027.
• Positive Sentiment: XPro development continues with additional MINDFuL imaging analyses (MRI myelin preservation and structural integrity) and the company is exploring rare‑disease trials and partner options to define late‑stage/regulatory paths.
• Positive Sentiment: Operational spending fell this quarter, with net loss narrowing to approximately $5.4 million (from $9.7M) and R&D down to ~$3.6M (from $7.6M), reflecting lower burn compared with the prior year period.
• Negative Sentiment: Cash and equivalents were approximately $21.4 million at March 31, 2026, which management says funds operations only through Q1 2027, indicating a near‑term need for additional financing or partnerships to support commercialization and late‑stage programs.

Presentation

[Operator]

Welcome to the INmune Bio's 2026 first quarter earnings call. As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations of INmune Bio.

[Daniel Carlson, Head of Investor Relations at INmune Bio]

Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio's 2026 first quarter financial results. Presenting on today's call are David Moss, CEO and Co-Founder of INmune Bio, Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder of INmune Bio, and Cory Ellspermann, INmune Bio CFO. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements. Please see the forward-looking statements disclaimer on the company's earnings press release, as well as risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC.

[Daniel Carlson, Head of Investor Relations at INmune Bio]

There is no assurance of any specific outcome. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made, as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, INmune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. Now my pleasure to turn the call over to INmune Bio CEO, David Moss.

[David Moss, CEO and Co-Founder at INmune Bio]

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 enter 2026 with clear priorities and strong momentum across our platforms. Most importantly, our CORDStrom platform remains on track, and we're 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 timeline that we had previously outlined.

[David Moss, CEO and Co-Founder at INmune Bio]

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's 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 datasets 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 and late-stage development strategies. Naturally, we'll update the markets as these milestones develop.

[David Moss, CEO and Co-Founder at INmune Bio]

Overall, we believe we're well-positioned across both platforms as we move through a catalyst-rich period for the company and a market will 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, Chief Scientific Officer and Co-Founder at INmune Bio]

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. 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. 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 Authorisation Application in the U.K. and then to the EMA for Europe. We've started the first of the three process validation manufacturing runs on time. The remaining two are scheduled to meet our MAA submission deadline.

[Mark Lowdell, Chief Scientific Officer and Co-Founder at INmune Bio]

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 hucMSC isolation part of the 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 the Anthony Nolan. This expanded strategic collaboration secures 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.

[Mark Lowdell, Chief Scientific Officer and Co-Founder at INmune Bio]

The Marketing Authorisation Application submission requires compilation 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 name 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. 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.

[Mark Lowdell, Chief Scientific Officer and Co-Founder at INmune Bio]

Some minor regulatory delays have meant that we expect to submit to the MHRA in early Q3. 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 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. 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 manufacture and supply in 2027.

[Mark Lowdell, Chief Scientific Officer and Co-Founder at INmune Bio]

I'll hand over to Cory now for an update of the current financials. Cory.

[Cory Ellspermann, CFO at INmune Bio]

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 31st, 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 31st, 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 31st, 2026, compared with approximately $2.3 million for the comparable period in 2025. At March 31st, 2026, the company had cash and cash equivalents of approximately $21.4 million.

[Cory Ellspermann, CFO at INmune Bio]

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

[David Moss, CEO and Co-Founder at INmune Bio]

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 emails. Thank you for joining us today.

[Operator]

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

Participants

Executives

• Cory Ellspermann, CFO
• Daniel Carlson, Head of Investor Relations
• David Moss, CEO and Co-Founder
• Mark Lowdell, Chief Scientific Officer and Co-Founder