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INMB

INmune BioF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-02
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2026-05-15
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Earnings documents stored for INMB.

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Investor releaseQuarter not tagged2026-05-15

INmune Bio Publishes Phase 2 MINDFuL Trial Results in NPJ Dementia, Advancing the XPro™ Platform

GlobeNewswire

Boca Raton, FL, May 15, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing therapies that target innate immune dysfunction, today announced that results from its Phase 2 MINDFuL trial in Alzheimer’s disease have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro™ (XPro1595, pegipanermin) in patients with mild Alzheimer’s disease characterized by biomarkers of inflammation. In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro™ showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no amyloid-related imaging abnormalities (ARIA) observed. The publication, titled “XPro1595 in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” discusses how XPro™ demonstrated consistent positive trends in a pre-specified enriched subpopulation (n=100) with amyloid-beta positivity and two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele). The paper further highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive (EMACC, International Shopping List Test), Patient-Reported Outcomes (Goal Attainment), behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro™ treatment effect. These findings support prioritization of the enriched population in future studies to optimize detection of treatment effects. CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio, said, “MINDFuL is the first peer-reviewed trial to prospectively identify Alzheimer’s patients by both amyloid pathology and a biomarker-defined inflammatory signature. In this pre-specified subgroup, we observed directional improvements across cognitive, global, functional, behavioral, and biomarker endpoints, with no ARIA. The cross-domain consistency tracks with the underlying biology and represents the type of signal a Phase 2 trial is designed to identify, forming the foundation of a Phase 3 program.” David Moss, CEO of INmune Bio, said, “The publication of the Phase 2 results from MINDFuL in NPJ Dementia, together with the FDA Fast Track designation, strengthens the value of the XPro platform. The trial also su...

Investor releaseQuarter not tagged2026-05-08

INmune Bio (INMB) Q1 2026 Earnings Transcript

Motley Fool

Image source: The Motley Fool. Thursday, May 7, 2026 at 4:30 p.m. ET Chief Executive Officer — David Moss Chief Scientific Officer — Mark Lowdell Chief Financial Officer — Cory Ellspermann Need a quote from a Motley Fool analyst? Email [email protected] 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 tha...

Investor releaseQuarter not tagged2026-05-08

INmune Bio Inc. Announces First Quarter 2026 Results and Provides Business Update

GlobeNewswire

Company to Host Conference Call Today, May 7th, at 4:30pm ET BOCA RATON, Fla., May 07, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended March 31, 2026 and provides a business update. Q1 2026 Recent Highlights: CORDStrom™ Platform: Completed a pre-submission package with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). The CORDStrom™ program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions. Signed an amended and restated Material Transfer and License Agreement with Anthony Nolan. This expanded strategic collaboration secures the long-term, reliable supply of high-quality umbilical cord tissue from their world-class cord blood bank to fuel our CORDStrom™ platform. Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom™ in patients with RDEB. Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy. DN-TNF Platform: XPro™: Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future. Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro™ in early Alzheimer's Disease. Hosted expert-led webinar on XPro™ registrational study strategy for early Alzheimer's Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting. INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond. INB03: Announced New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Mo...

Investor releaseQuarter not tagged2026-05-08

INmune Bio, Inc. Q1 2026 Earnings Call Summary

Moby

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is prioritizing the regulatory filing for CORDStrom as a potential first-in-class systemic therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB). The company secured a long-term strategic collaboration with the Anthony Nolan Cord Blood Bank to ensure a consistent supply of high-quality umbilical cord tissues for commercial manufacturing. A new agreement with Anthony Nolan allows for U.S. laboratory testing to satisfy specific FDA requirements established during previous Type B meetings. The CORDStrom active ingredient has been formally named pobistrocel by the WHO, with the commercial name Ebstracel selected for the RDEB formulation. For the XPro platform, management is shifting focus toward disease-modifying imaging data, specifically MRI analysis of myelin preservation and structural integrity. Strategic positioning for XPro now includes exploring rare disease trials and seeking external partnerships to define late-stage development and regulatory alignment. Management expects to submit the Marketing Authorization Application (MAA) to the U.K. MHRA in early Q3 2026 following minor regulatory delays. The company aims to complete EMA and FDA submissions by the end of 2026, utilizing TMC Pharma to manage these parallel rare disease filings. Commercial manufacturing and supply for Ebstracel are currently targeted for a 2027 launch. The company is currently undergoing three process validation manufacturing runs to meet upcoming regulatory submission deadlines. Cash runway is projected to be sufficient to fund operations through the first quarter of 2027 based on current operating plans. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The Pediatric Investigation Plan (PIP) received rapid assessment approval from U.K. regulators in April with no substantial issues raised. Research and development expenses decreased significantly to $3.6 million from $7.6 million year-over-year, reflecting shifting program stages. Management noted minor regulatory delays have pushed the initial MHRA submission into early Q3, though year-end goals for other regions remain intact.

TranscriptFY2026 Q12026-05-07

FY2026 Q1 earnings call transcript

Earnings source - 15 paragraphs
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

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

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

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. Mark 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

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

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. 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 3 process validation manufacturing runs on time. The remaining 2 are scheduled to meet our MAA submission deadline.

Mark Lowdell

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 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

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

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

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 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

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

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.

Investor releaseQuarter not tagged2026-04-30

INmune Bio Inc. to Report First Quarter 2026 Financial Results and Provide Corporate Update on Thursday, May 7th

GlobeNewswire

Management to host conference call and webcast at 4:30 pm ET on that day Boca Raton, Florida, April 30, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), today announced that it will host a conference call on Thursday, May 7th, 2026 at 4:30pm EDT to discuss results for its quarter ended March 31, 2026 and to provide a corporate update. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching the operator. Date: May 7th, 2026 Time: 4:30 PM Eastern Time Participant Dial-in: 1-800-267-6316 Participant Dial-in (international): +1-203-518-9783 Conference ID: INMUNE A live audio webcast of the call can be accessed by clicking here or using this link: https://viavid.webcasts.com/ A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin no. 11158539. About INmune Bio Inc. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: (1) CORDStrom™, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa; (2) XPro™, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit www.inmunebio.com. Forward Looking Statements Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities...

Investor releaseQuarter not tagged2026-03-31

INmune Bio Inc. Announces 2025 Results and Provides Business Update

GlobeNewswire

Company to Host Conference Call Today, March 30, at 4:30pm ET BOCA RATON, Fla., March 30, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announces its financial results for the year ended December 31, 2025 and provides a business update. Recent Corporate Highlights CORDStrom™ Platform: The CORDStrom™ program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions. Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom™ in patients with RDEB. Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy. XPro™ Platform: Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer's Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future. Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro™ in early Alzheimer's Disease. Hosted expert-led webinar on XPro™ registrational study strategy for early Alzheimer's Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting. INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond. INKmune® Platform: Met primary and two of three secondary endpoints in CARE-PC trial Continued evaluation of clinical data from the INKmune® CARE-PC trial in metastatic castration-resistant prostate cancer. Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy. Corporate: Received Australian R&D rebate of $5.2m AUD ($3.6 million USD) during January 2026. Company estimates that cash on hand provides runway through Q1 of 2027. During 2025, the Company sold 4,304,707 shares of common stock in exchange for net cash proceeds of $27.5 million. Continued alignment of capi...

Investor releaseQuarter not tagged2026-03-31

INmune Bio, Inc. Q4 2025 Earnings Call Summary

Moby

Transitioned from a clinical-stage developer to a regulatory-focused organization following the completion of the MINDFuL Alzheimer's trial and CORDStrom data readouts. Attributed CORDStrom's therapeutic success in RDEB to its unique pooled-donor manufacturing process, which ensures batch-to-batch consistency and commercial-grade uniformity. Defined the CORDStrom mechanism of action as a cytokine-driven shift from inflammatory M1 macrophages to wound-healing M2 cells, addressing the systemic 'itch-scratch' cycle. Positioned XPro for Alzheimer's as a 'preapproved blueprint' for partners, leveraging FDA alignment on an adaptive Phase III design to mitigate execution risk. Reported that the INKmune Phase II trial in metastatic castration-resistant prostate cancer met its primary endpoint ahead of schedule and under budget. Maintained a lean, capital-efficient operating model, focusing resources on high-probability regulatory milestones rather than broad-based internal expansion. Targeting mid-summer 2026 for the CORDStrom MAA filing in the U.K., followed by EMA and U.S. BLA submissions by year-end. Anticipating potential commercial supply of CORDStrom to RDEB patients by 2027, contingent on feedback from all three major regulatory geographies. Planning a two-stage adaptive Phase III trial for XPro, featuring a 9-month Phase IIb 'go/no-go' decision point before committing to full registrational investment. Projecting that a successful BLA for CORDStrom could yield a high-value Priority Review Voucher due to existing Rare Pediatric Disease designations. Actively pursuing business development partnerships to fund the late-stage development of XPro and expand the CORDStrom platform into broader inflammatory indications. Recorded a $16.5 million full impairment of intangible assets in 2025 after the Alzheimer's trial missed its clinical primary endpoint. Reported a cash runway extending through Q1 2027, supported by $24.8 million in cash and recent equity offerings totaling approximately $27.5 million. Identified a specific regulatory requirement to create new master seedstocks for the U.S. market using donors screened in CLIA-accredited U.S. laboratories. Acknowledged that while the MINDFuL trial missed its top-line endpoint, management believes the failure was due to patient population powering rather than drug efficacy. Our analysts just identified a stock with t...

Investor releaseQuarter not tagged2026-03-31

INmune Bio Inc (INMB) Q4 2025 Earnings Call Highlights: Strategic Advances Amid Financial Challenges

GuruFocus.com

This article first appeared on GuruFocus. Net Loss: Approximately $45.9 million for the year-ended December 31, 2025, compared to $42.1 million for 2024. Research and Development Expenses: Approximately $20.7 million for 2025, down from $33.2 million in 2024. General and Administrative Expenses: Approximately $10.3 million for 2025, compared to $9.5 million for 2024. Intangible Asset Impairment: Full impairment of $16.5 million in 2025 following Phase 2 Alzheimer's trial results. Cash and Cash Equivalents: Approximately $24.8 million as of December 31, 2025. Shares Outstanding: Approximately 26.6 million shares as of March 30, 2026. Capital Raised: $17.4 million from a registered direct offering and $10.1 million from at-the-market offerings in 2025. Warning! GuruFocus has detected 3 Warning Signs with INMB. Is INMB fairly valued? Test your thesis with our free DCF calculator. Release Date: March 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. INmune Bio Inc (NASDAQ:INMB) completed the MINDFuL Alzheimer's trial and advanced CORDStrom towards registration, positioning their platform programs for the next stage of development. The CORDStrom program showed promising results in Recessive Dystrophic Epidermolysis Bullosa (RDEB) with clinical meaningful wound healing, reductions in itch, and improvements in quality of life. INmune Bio Inc (NASDAQ:INMB) is preparing regulatory submissions for CORDStrom in the UK and the United States, with plans to file the MAA in the UK by the end of summer 2026. The company completed its Phase 2 trial in metastatic castration-resistant prostate cancer ahead of schedule and under budget, meeting its primary endpoint and two of its three secondary endpoints. INmune Bio Inc (NASDAQ:INMB) has a clear strategy for advancing multiple differentiated platforms in parallel, creating meaningful opportunities for value creation. The net loss attributable to common stockholders for the year-ended December 31, 2025, was approximately $45.9 million, an increase from the previous year. The company recorded a full impairment of its intangible asset of $16.5 million in 2025 following the release of the Phase 2 results of the Alzheimer's trial, which did not meet the clinical endpoint. Research and development expenses decreased due to lower expenses in connection with the Alzheimer's t...

TranscriptFY2025 Q42026-03-30

FY2025 Q4 earnings call transcript

Earnings source - 57 paragraphs
Operator

Greetings, and welcome to the INmune Bio's 2025 fourth quarter and year-end 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 now my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations of INmune Bio. Daniel.

Daniel Carlson

Thank you, Chloe, and good afternoon, everyone. We thank you for joining us on the call for INmune Bio's 2025 fourth quarter and year-end 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, Dr. CJ Barnum, Head of Neuroscience, INmune Bio, and Cory Ellspermann, Interim Chief Financial Officer, INmune Bio. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management in 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 expressed in such forward-looking statements.

Daniel Carlson

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. 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. It's now my pleasure to turn the call over to INmune Bio CEO, David Moss.

David Moss

Thank you, Dan, and good afternoon, everyone. Thank you for joining us for INmune Bio's fourth quarter and full-year 2025 earnings call. Today, I'll begin with an overview of our progress and strategic priorities across the business. Mark will then provide an update on our CORDStrom platform with a focus on our RDEB program. CJ will follow with an update on XPro and our Alzheimer's disease development efforts. Cory will then review our financial results. After that, I'll return to highlight our key upcoming milestones before we open the call to questions. 2025 was a pivotal year for INmune Bio. We completed our MINDFuL Alzheimer's trial, advanced CORDStrom towards registration, and continued to position each of our platform programs for the next stage of development.

David Moss

As we move into 2026, our focus is very clear. Execute against the most important regulatory, clinical, and strategic milestones across the portfolio. Starting with CORDStrom, this remains our most advanced program and a major value driver for the company. We recently presented additional patient data that further reinforces the therapeutic profile of CORDStrom in recessive dystrophic epidermolysis bullosa or RDEB. These data showed clinically meaningful wound healing, reductions in itch, and improvements in quality of life, all with a favorable safety profile. Based on this progress, we're in the final stages of preparing our regulatory submissions in both the U.K. and the United States, and we remain on track to file the MAA in the U.K. by the end of summer of 2026. As Mark will tell you shortly, CORDStrom has a clear batch-to-batch manufacturing consistency which makes the product reproducible, ensuring commercial grade uniformity.

David Moss

Further, the clinical mechanism of action of CORDStrom for RDEB has been worked out along with the potency assays, which is an important step for regulators. The repeatable manufacturing reliability with the worked out MOA along with CMC readiness, safety, and clinical results is what gives us confidence in CORDStrom for RDEB. Importantly, we want to highlight that CORDStrom is not simply a single asset opportunity, but as a platform with broader potential. Beyond RDEB, we believe the biology underlying the program may support development in additional inflammatory and degenerative conditions, and over time, may also enable genetically modified applications in oncology and rare disease settings. Our immediate priority is to bring this therapy to patients with RDEB while also building the foundation for long-term platform expansion.

David Moss

Personally, there is no greater mission in my career than delivering CORDStrom to the children and families living with RDEB. Behind every trial result is a story that I've read and a face that I've seen in the video shared by these incredibly brave families. These images serve as a constant reminder of why we do what we do. Our team is deeply motivated by the human element of this condition, and we are working with an absolute urgency to bring this therapy to patients who need it most. Furthering our mission to develop medicines to unmet needs, I now turn to XPro for Alzheimer's disease. We believe this program is in the strongest position it has ever been. We completed MINDFuL, we've aligned with the FDA on the development path, and we're now preparing for a phase III.

David Moss

This alignment effectively creates a pre-approved blueprint for a partner to execute. CJ will give you the full picture shortly. On INKmune, we completed our phase II trial in metastatic castration-resistant prostate cancer ahead of schedule and under budget. The study met its primary endpoint and two of its three secondary endpoints. Mark will explain more on this later. Before I hand the call over, I want to thank patients and family who participated in the clinical studies, the investigators and trial sites who supported this work, and our employees for their continued commitment and execution throughout the years. I also want to thank our shareholders for their continued support. Our strategy of advancing multiple differentiated platforms in parallel continues to create meaningful opportunities for value creation.

David Moss

We now have one platform approaching the regulatory stage, another with a completed phase II study and important translational data, and a third that has also generated encouraging clinical results. We believe 2026 will be an important year for INmune Bio as we work to advance CORDStrom towards approval, further clarifying the next steps for the phase II-B trial for XPro, and continue to build the partnerships and resources we need to move our programs forward. With that, I'll turn the call over to Mark Lowdell for an update on CORDStrom. Mark.

Mark Lowdell

Thank you, David, and thank you to everyone who's joined the call today. Welcome. As David said, CORDStrom showed great promise in the randomized placebo-controlled trial in RDEB, but its potential extends way beyond RDEB to other forms of epidermolysis bullosa and indeed to other conditions and indications. CORDStrom remains truly revolutionary in the MSC field. Last year we reported on the fact that since it's created from mesenchymal stromal cell banks from four or more pooled donors, it really has unrivaled stability and reproducibility as compared to all of the other mesenchymal stromal or stem cell products that are being developed or are on the market.

Mark Lowdell

Moreover, what we found is that the pooling allows us to select the individual mesenchymal stromal cell donor seed stocks, and we can choose those that have the appropriate potency characteristic for each disease indication, which allows us to tailor the final product to target different disease indications and thus have different drugs. As you know, RDEB is our first disease indication, and over the past six months, we've been able to dissect the precise mechanisms of action of CORDStrom in RDEB. That's pretty unique for a mesenchymal stromal cell product, where the diversity of the product means that working out quite how it delivers its effect is actually very challenging. But we now know that CORDStrom works by secreting an array of chemical messengers called cytokines, which are used by the body to control inflammation.

Mark Lowdell

We know that RDEB is predominantly a disease of inflammation, and it's driven by cells in the skin which are called type one macrophages or M1 cells. These M1 cells secrete inflammatory cytokines which drive the itch and lead to the scratching, which causes the skin wounds so prevalent in RDEB patients and which you'll be familiar with. M1 cells in normal skin also induce itch when provoked, but in RDEB patients, the absence of the protein which binds the skin layers together means that the itch-scratch cycle causes those very severe lesions that are so famous. One of the cytokines secreted by CORDStrom drives the M1 cells in the skin to mature into an M2 non-inflammatory wound-healing cells. We all have these, and these M2 cells secrete a cytokine called IL-10, which switches off other immune cells driving the itch-inducing cytokines.

Mark Lowdell

In parallel, the M2 cells also secrete other chemical messengers, cytokines, which enhance wound repair. When we looked at the serum samples from the patients who were treated with CORDStrom on the U.K. trial and compared those to those treated with placebo, the CORDStrom recipients all had in their blood cytokines that our mechanisms of action predicted. Those patients that had the highest concentration reported much less pain, less itch, and had better skin scores. They scored better in all measures of well-being and increased ability to eat. This is the first RDEB treatment to have such diverse whole body clinical benefits over and above those which we see from the skin treatments that are already licensed. The patients, their caregivers, and their doctors all want to continue to have access to CORDStrom.

Mark Lowdell

As David said, we're working tirelessly at present to submit the applications for marketing authorizations in the U.K., and then the European Union and finally the U.S. before the end of the year. We're driving forward, so they're all completed by the end of this year, and we hope to be supplying CORDStrom to RDEB patients in 2027. As I said earlier, the fact that CORDStrom is manufactured from a pool of four or more donor cell banks means that we can select the best donor cells for specific clinical indications. While we're progressing with CORDStrom for RDEB and the marketing authorizations, my group of R&D scientists here in the U.K. are working on other broader indications, and we're seeking business partnerships to develop those through clinical trials and bring those to market accordingly.

Mark Lowdell

As a company, we're laser-focused on preparing the marketing authorization application for the U.K. and then the EU and the Biologics License Application or BLA for the U.S. by the end of 2026. These are highly aggressive timelines, but so far we've met all of the deadlines that have been set, and I'm incredibly proud of our team in the U.K. for working so diligently to keep to these timelines, to remain on track, and to use all the resources that we have in the U.S. office to support them. I'm happy to take questions that you have, but meanwhile, I'll hand over to CJ for the latest update on XPro. CJ, the floor is yours.

CJ Barnum

Thank you, Mark. I'll give you an update on XPro and where we're headed. MINDFuL was our phase II trial on Alzheimer's disease. We designed it around a simple question.

CJ Barnum

If we pick patients who have both Alzheimer's pathology and signs of inflammation in their body and we treat the inflammation, do they do better? What we saw was very encouraging. The results consistently favored XPro across clinical, behavioral, patient-reported, and blood and imaging biomarkers. The phase II identified what works, who it works for, and resolved the open questions so that phase III can be successful. These results directly informed how we designed the phase III program. We identified the patient population, those with both Alzheimer's pathology and biomarkers of inflammation. Decades of Alzheimer's research show that cognitive changes come first and functional changes follow with time. That's why the phase III trial runs 18 months, long enough for the cognitive effects we saw at six months to show up on the functional measures the FDA requires for approval.

CJ Barnum

The program is built as an adaptive trial with two stages. Phase II-B gives us a decision point at nine months, a clear go or no-go before we commit to the full phase III investment. If the data hold, the trial continues seamlessly into the registrational stage with the CDR-SB, the same primary endpoint used to approve lecanemab and donanemab at 18 months. We presented this program to the FDA at the end-of-phase II meeting earlier this year. The agency reviewed our data, our enrichment strategy, and our trial design and aligned with our approach. We are now moving forward on several fronts. On the development side, we continue to analyze the MINDFuL dataset to fully understand the impact of XPro treatment.

CJ Barnum

At the same time, we are preparing the phase III program for initiation, which includes finalizing the protocol based on the FDA's feedback and pursuing the partnerships and funding needed to execute it. There's a lot of work ahead, but the foundation is solid. I'll hand it back to David. I look forward to your questions. David.

David Moss

Thanks, CJ. Before I hand the call to Cory to go through our financial results, I want to emphasize from a capital perspective, we remain committed to capital efficiency. Our strategy is built on hitting clear data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We're focused on maintaining the lean, execution-oriented culture that has brought us to this stage. With that, let me pass the call to Cory to go through our financial results. Cory.

Cory Ellspermann

Thank you, David. Net loss attributable to common stockholders for the year ended December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million for 2024. Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared with approximately $33.2 million for 2024, with the decrease due to incurring lower expenses in connection with the Alzheimer's trial in 2025. G&A expenses was approximately $10.3 million for the year ended December 31, 2025, compared with approximately $9.5 million for 2024. We also recorded a full impairment of our intangible asset of $16.5 million in 2025 following the release of the phase II results of the Alzheimer's trial, in which the trial did not meet the clinical endpoint.

Cory Ellspermann

During 2025, the company sold three million shares of common stock for net proceeds of approximately $17.4 million in a registered direct offering. In addition, the company sold approximately 1.3 million shares of common stock for net proceeds of approximately $10.1 million under at-the-market offerings. At December 31, 2025, the company had cash and cash equivalents of approximately $24.8 million. As of March 30, 2026, the company had approximately 26.6 million shares of common stock outstanding. Based on the current operating plan, we believe our cash is sufficient to fund our operations through Q1 2027. Now I'll hand the call back to David.

David Moss

Thanks, Cory. Now I'd like to present upcoming milestones for the company, and then we can start with the Q&A. For our CORDStrom program, we have several significant milestones ahead, which will really set our track for 2027. As Mark mentioned, we're on track to file the MAA in the U.K. by mid-summer 2026. A few months after the MAA filing, we expect to submit the MAA to the EMA and then the BLA to the FDA towards the end of the year. We should have feedback from all three geographies in 2027, if not approvals by then. I remind investors that it's our belief that a successful BLA application would likely result in the company obtaining a priority review voucher from the FDA, given that the program already has orphan drug designation and rare pediatric disease designation.

David Moss

For XPro, we continue to make strong progress. We've now received the minutes from our end-of-phase II meeting with the FDA, as CJ had mentioned, and we obtained positive initial feedback on the accelerated approval pathways we're actively preparing for next steps. We're advancing partnership and funding discussions to support late-stage development of XPro. Stepping back, we enter 2026 with a focused set of objectives and multiple meaningful opportunities to create value. While MINDFuL trial did not achieve its top-line primary endpoint due to powering the patient population properly, the totality of XPro dataset continues to support our conviction in the program's potential in Alzheimer's disease and other neuroinflammatory disorders. At the same time, we believe CORDStrom is advancing towards a potentially transformative regulatory and commercial inflection point, with the broader platform still not fully reflected in the market.

David Moss

We appreciate the continued support of our shareholders and the commitment of our team as we work towards these goals. At this point, Chloe, I'd like you to tell people how they can ask questions and poll for questions.

Operator

We'll take a question from Elemer Piros with Lucid Capital Markets. Your line is open.

Elemer Piros

Yes. Good afternoon. David, what I'd like to ask, and maybe Mark can help us out here, if there is any anticipated differences between an MAA and an FDA submission. Have you had interactions with the FDA, what might be their requirements different from the European or from the U.K. agency?

Mark Lowdell

Yeah, I'll take that.

David Moss

Yeah.

Mark Lowdell

Um, that's a very-

David Moss

Yeah, go ahead, Mark.

Mark Lowdell

That's a very good question. Yeah. The last time we spoke to the FDA specifically was a little bit about 13 months ago, and what they came back with were some. One of the things that has been at the top of my mindset is all of the work we've done so far in our RDEB, the product's been made from umbilical cord donors from the U.K.. There is a sensitivity about using U.K. donor materials in the U.S.. We asked the FDA specifically whether we would be allowed to use U.K. donor cords for the U.S. submission.

Mark Lowdell

They came back and said, "Absolutely, yes, but we would have to screen the U.K. donors for the standard globally agreed infectious disease markers, but they'd have to be tested in U.S. labs, in CLIA-accredited labs." What we're doing at the moment is creating new master seed stock from donors that we can ethically test in the U.S.. That's the biggest difference. We have to create a new master seed stock, which is ongoing at the moment. Because, as I said earlier on, we've worked out the mechanism of action, we now have potency assays. We've been able to demonstrate that we've made four different master seed stocks experimentally from U.K. donors, and they've all been consistent.

Mark Lowdell

The next ones that we make for the FDA filing, which are going through at the moment, will be those that we take through for commercialization globally. That was the principal question that we had, and it was the principal answer they came back with. The rest of the questions they came back with were identical to those from the MHRA. We will present exactly the same data set.

Elemer Piros

Thank you. Thank you very much, Mark.

David Moss

Elemer, let me-

Elemer Piros

Yeah.

David Moss

Elemer, if you don't mind, let me just add to that.

Elemer Piros

Sure.

David Moss

The plan is, a few weeks ago, we submitted essentially a pre-MAA package to the MHRA, which really effectively is like a Type D meeting, and it kinda smooths the process of the MA, the full MAA application, speeds the process up, that we would tend to file midsummer. Once we get the feedback from the MHRA, and as Mark will tell you, they've already set a face-to-face meeting with us. Once we get that, we'll put that together with the answers to whatever questions they have or whatever feedback they give us, and then we'll submit that as a Type D meeting to the FDA, in preparation, really like a pre-BLA, in preparation the BLA with the FDA.

Elemer Piros

Yeah.

David Moss

That'll be the next steps that'll take place. I think that might have been a little bit of what you were asking if I'm correct.

Elemer Piros

Yeah.

David Moss

Yeah.

Elemer Piros

Just maybe one more detail around this. So would you have to have the samples tested in U.S. labs before you submit, or you can have that during the submission or during the evaluation and submit it when you have the results?

Mark Lowdell

What they will ask is for a confirmation that we will only supply drug into the U.S. from U.S.-tested donors. In point of fact, we're making the master cell batch now. We will have products that have been made from U.S.-tested donors before we submit the BLA.

Elemer Piros

Yes. Thank you. Maybe one question about the XPro program. David, have you had any interest, any interactions with potential pharma partners at AD/PD?

David Moss

So the-

Elemer Piros

What sort of feedback you get?

David Moss

No, good question, Elemer. We have ongoing discussions with some groups, and one of the things that now, you know, we—you have to realize we just got the end of phase II meeting a few weeks ago, three, four weeks ago now. Everything's being packaged up.

David Moss

One of the things we intend on doing is finding a group to help us on the BD perspective, because there's just a lot of, not just large pharma, but mid-sized companies that we think the program is very appropriate for because, if you think about it's a relatively small investment to see the phase II-B portion for obviously a very large market, potentially one of the largest markets, and if the phase II-B portion reads out as we expect with the right patient population from what we've learned from the MINDFuL trial, then it's a very clear path to the registration program, as CJ had talked about, linking the cognitive aspects of EMACC to the cognitive aspects of CDR and then getting the functional scale of CDR, which comes after cognitive changes over time. The link is very logical.

David Moss

The correlation between EMACC and CDR is very logical. We think that this package, if explained appropriately to the mid-size, you know, EBITDA, biotech companies that have an interest in neurology all the way up to the large pharma, I think it's going to be a very attractive program.

Elemer Piros

Okay. Thank you. Thank you very much, both.

David Moss

I appreciate it, Elemer. Thank you.

Operator

It does appear that there are no further questions at this time. I would like to hand it back to David Moss for any additional or closing remarks.

David Moss

Thank you, Chloe. 2025 was a year of significant progress for INmune Bio. We completed and analyzed the MINDFuL Alzheimer's trial, advanced CORDStrom towards registration in RDEB, and positioning INKmune for its next stage of development in prostate cancer. As we move towards 2026, our priorities are very clear. Advance CORDStrom towards market approval in the U.K., EU, and the U.S.. Secure regulatory clarity on the path forward for XPro, and build the partnerships and financial support necessary to bring these programs to patients. On behalf of the entire INmune Bio team, thank you for your continued support and confidence in our mission. We look forward to updating you on our progress in the months ahead. Have a great evening, everybody.

Operator

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Investor releaseQuarter not tagged2026-03-24

INmune Bio Inc. to Report Year End 2025 Financial Results and Provide Corporate Update on Monday, March 30th.

GlobeNewswire

Management to host conference call and webcast at 4:30 pm ET on that day Boca Raton, Florida, March 24, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it will host a conference call on Monday, March 30th, 2026 at 4:30pm EDT to discuss results for its year ended December 31, 2025, and to provide a corporate update. Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio First Quarter Conference Call when reaching the operator. Date: March 30th, 2026 Time: 4:30 PM Eastern Time Participant Dial-in: 1-800-343-4136 Participant Dial-in (international): +1-203-518-9843 Conference ID: INMUNE A live audio webcast of the call can be accessed using this link or clicking here: https://viavid.webcasts.com/starthere.jsp?ei=1748958&tp_key=96ca7c85d7 A replay will be available approximately 3 hours after the call through April 13, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11160807. About INmune Bio Inc. INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: (1) CORDStrom™, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa; (2) XPro™, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit www.inmunebio.com. Forward Looking Statements Clinical trials are in early stages, and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including trial results, timing of key milestones, future plans or expecta...

Investor releaseQuarter not tagged2025-10-31

INmune Bio Inc (INMB) Q3 2025 Earnings Call Highlights: Regulatory Progress and Financial ...

GuruFocus.com

This article first appeared on GuruFocus. Release Date: October 30, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. INmune Bio Inc (NASDAQ:INMB) is preparing for marketing approval submissions for its Chordstrom MSC platform in both the UK and the US, indicating progress in regulatory pathways. The company has completed a phase 2 trial for its Alzheimer's drug, XPro, and is pursuing an accelerated regulatory pathway with the FDA. INmune Bio Inc (NASDAQ:INMB) has successfully completed a phase 2 trial of Incommune in prostate cancer, meeting primary and two secondary endpoints. The company has reduced its net loss significantly from $12.1 million in Q3 2024 to $6.5 million in Q3 2025, indicating improved financial management. INmune Bio Inc (NASDAQ:INMB) has a strong cash position with $27.7 million in cash and cash equivalents, sufficient to fund operations into Q4 2026. The company is facing delays in its end of phase 2 meeting with the FDA for XPro, which was initially expected by the end of 2025 but is now anticipated in Q1 2026. There is uncertainty regarding the regulatory approval timeline for Chordstrom in the US, with expectations to hear back from the FDA by mid-2027 or later. INmune Bio Inc (NASDAQ:INMB) is still in the process of gathering comprehensive data for potential partnerships, indicating that significant work remains before serious discussions can occur. The company faces competition from existing gene therapies for RDEB, which are already approved in the US, potentially impacting market positioning. Despite progress, the company acknowledges the challenges inherent in Alzheimer's drug development, which could affect the future success of XPro. Warning! GuruFocus has detected 3 Warning Signs with INMB. Is INMB fairly valued? Test your thesis with our free DCF calculator. Q: Can you walk us through the biggest questions or discussion topics for the end of phase two meeting with the FDA regarding XPro? Also, why was there a delay in the meeting timeline? A: (David Moss, CEO) We weren't able to gather enough data in time for the meeting initially planned for Q4. We're close to having everything ready, and the meeting could still happen soon. The delay is due to the time needed to compile the data and receive feedback from the FDA. (Dr. CJ Barnum, Head of Neuroscience) Key questions in...

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook