Q1 2026 INmune Bio Inc Earnings Call

May 7, 2026

Greetings, and welcome to the immune bios. 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.

Thank you, operator. And good afternoon everyone. We thank you for joining us for the call for immune bios 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 my 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 material 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 Finance was the SEC.

There's no Assurance of any specific outcome. I'm due 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. Immune bio. Disclaims, any obligation to update these board? Looking statements to reflect future information. Events are circumstances.

Now my pleasure to turn the call over to immune bio CEO David Moss.

Thank you, Danielle, 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 in a new bio, I will pass the microphone to Dr. Ludell in my bio CSO and inventor of corn. Who provide an update on our course from MFC platform and particularly our, our Dev program

Next, Corey alsman will provide our financial results after which I'll conclude a prepared marks.

We enter 2026 with clear priorities and strong momentum across our platforms. Most importantly, our cards from platform remains on track, and we now approaching a key Milestone with our regulatory filings.

Based in the progress of our analyses manufacturing Readiness and Regulatory preparation.

We expect a file for approval beginning in the near term, and we remain confident in the timeline that we previously outlined.

Courts and represents a potential first, systemic therapy for ardeb. And we believe the data continues to support both its clinical benefits and its broader platform potential execution. Against this filing is our top priority.

Turn the 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 data sets are important as they further. Characterize expose 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.

The markets as these Milestones develop.

overall, we believe we're well positioned across both platforms so we move through a Talus Rich period for the company and a marketable change potentially for the company as we get closer to commercialization,

With that, I'll turn the call over to Marc Liddell to provide more details on Quorum mark.

Uh, thank you, David, and thank you to everyone, that's joined the call. Um, as David said, since our last earnings call, we've moved forward significantly in bringing code strong to Market and it is our Central aim. First, we submitted the Pediatric investigation plan known as a pip to the UK 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 to 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 UK and then to the EMA for Europe,

We started the first of the 3 process validation manufacturing runs on time and the remaining 2 are scheduled to meet our mmaa submission deadline.

Most significantly, we concluded negotiations with the anti knowing UK Cord, Blood Bank, this month, to ensure secure supply of underlying chords and allow testing by us. 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 ucmc Isolation. Part of the manufacturing process validated ready for commercial manufacturer.

This expanded strategic collaboration secures the long-term, reliable supply of these high-quality umbilical cord tissues from their world-class Core Blood Bank to further acorns from platform.

Having a consistent Supply is essential for us, not only for regulatory authorities, but also to enhance our ability to take records from platform forward into other disease, indications.

The marketing authorization application submission requires compilation of a very significant body of documents in 5 seconds.

These are now well underway. And as part of the product definition section, we've had to determine the formal names for cords from as applied to our Deb 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 peristrophe.

In 2 weeks time, we will meet with the mhra, for further advice about the marketing, authorization submission, filing in the UK 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 UK company. TMC farmer 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.

Operator: Greetings, welcome to the INmune Bio's 2026 Q1 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.

Finally, I had the great privilege to speak at the Cure EB annual general meeting in London last month, which is 1 of the largest ev charities in the UK.

I presented our data and our plan was overwhelmed by the response from patients and carers, who attended

Daniel Carlson: Thank you, operator. Good afternoon, everyone. We thank you for joining us for the call for INmune Bio's 2026 Q1 financial results. Presenting on today's call are David J. Moss, CEO and Co-Founder of INmune Bio; 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 material 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: Thank you, operator. Good afternoon, everyone. We thank you for joining us for the call for INmune Bio's 2026 Q1 financial results. Presenting on today's call are David Moss, CEO and Co-Founder of INmune Bio, 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 material 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.

They're desperate for us to get extra, sell to the market and to open the next phase of the clinical trial in the UK.

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 Corey now for an update of the current financials.

Quarry.

Thank you Mark. At this time, I'll provide a brief overview of our financial results.

Net, Mass 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.

Daniel Carlson: 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.

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.

And that March 31st 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.

David J. Moss: Thank you, Daniel, good afternoon, everyone. For our Q1 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 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 timeline that we had previously outlined.

David Moss: Thank you, Daniel, good afternoon, everyone. For our Q1 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 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 timeline that we had previously outlined.

And as of May 7th 2026, the company has a approximately 26.6 million shares of common stock outstanding

And now, I'll hand the call back to David.

Thank you, Corey.

To close. Our focus is straight forward. We're executing towards regulatory filings for corn, which we believe represents a major inflection point for the company.

At the same time, we're continue to build the case for Expo through additional Imaging data. Exploring the future rare disease, trials and ongoing partnership discussions aimed at advancing the program efficiently.

Leave these efforts position in new bile for a significant year ahead with multiple opportunities, to create value for both patients.

And shareholders.

Due to travel schedules will not be taking questions and this concludes our prepared remarks. If you have further questions,

David J. Moss: 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 TJ 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 and late-stage development strategies. Naturally, we'll update the markets as these milestones develop.

David Moss: 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 TJ 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 and late-stage development strategies. Naturally, we'll update the markets as these milestones develop.

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.

And thank you. Ladies and gentlemen, this concludes today's conference call. We thank you for

your participation and you may now disconnect

David J. Moss: 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.

David Moss: 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: 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 UK medicines regulator in February, and we were approved for rapid assessment, receiving their response on 9 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 authorization application in the UK and then to the EMA for Europe.

Mark Lowdell: We've started the first of the three process validation manufacturing runs on time, and the remaining two are scheduled to meet our MAA submission deadline. Most significantly, we've concluded negotiations with the Anthony Nolan Cord Blood Bank this month to ensure secure supply of umbilical cords and allow testing by US 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 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.

Mark Lowdell: 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 compilation of a very significant body of documents in five sections. These are now well underway, as part of the product definition section, we've had to determine the formal name this records from 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 two weeks' time, we will meet with the MHRA for further advice about the marketing authorization submission filing in the UK then start to finalize those documents.

Mark Lowdell: Some minor regulatory delays have meant that we expect to submit to the MHRA in early Q3. We've contracted a UK 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 UK. 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 UK. 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: 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 31 March 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 31 March 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 31 March 2026, compared with approximately $2.3 million for the comparable period in 2025. At 31 March 2026, the company had cash and cash equivalents of approximately $21.4 million.

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

David J. 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, Daniel Carlson or myself, via those phone numbers or emails. Thank you for joining us today.

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, Daniel 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.