INmune Bio (NASDAQ: INMB) gains FDA, UK alignment on key drugs
Rhea-AI Filing Summary
INmune Bio Inc. reports two major regulatory milestones for its pipeline. The company has submitted a pre-submission package to the UK Medicines and Healthcare Products Regulatory Agency for CORDStrom™, a cell therapy being developed as a potential first systemic treatment for recessive dystrophic epidermolysis bullosa. This step is intended to streamline a future Marketing Authorization Application targeted for mid-summer 2026, with potential EU and U.S. submissions in Q4 2026. CORDStrom already holds U.S. Orphan Drug and Rare Pediatric Disease designations and may benefit from the recently reauthorized FDA Rare Pediatric Disease Priority Review Voucher program, which runs through September 30, 2029.
Separately, INmune Bio received official minutes from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration confirming regulatory alignment on an integrated Phase 2b/3 registration-intent strategy for XPro1595 in early Alzheimer’s disease. The design uses a nine‑month Phase 2b segment informed by cognitive and biomarker endpoints (EMACC and plasma p‑tau‑217), followed by a Phase 3 segment that will use CDR-SB as the sole primary efficacy endpoint. The company is incorporating FDA feedback into the final protocol for this precision-medicine, enrichment-led program.
Positive
- Regulatory clarity for XPro1595 in Alzheimer’s: FDA End-of-Phase 2 minutes confirm alignment on an integrated Phase 2b/3, registration-intent strategy with CDR-SB as the sole primary efficacy endpoint for Phase 3.
- Defined UK pathway for CORDStrom in RDEB: MHRA pre-submission accepted, with a full Marketing Authorization Application targeted for mid-summer 2026 and follow-on EU and U.S. submissions planned for Q4 2026.
- Enhanced rare-disease incentive profile: CORDStrom holds U.S. Orphan Drug and Rare Pediatric Disease designations and may benefit from the reauthorized FDA Rare Pediatric Disease Priority Review Voucher program through September 30, 2029.
Negative
- None.
Insights
INmune Bio reports UK and U.S. regulatory alignment on two late-stage programs, potentially accelerating paths to approval.
INmune Bio highlights coordinated progress on two key assets. For CORDStrom™, formal submission of a pre-submission package to the UK MHRA initiates structured dialogue ahead of a full Marketing Authorization Application targeted for mid-summer
In parallel, the company received End-of-Phase 2 meeting minutes from the U.S. FDA confirming alignment on an integrated Phase 2b/3 registration-intent trial for XPro1595 in early Alzheimer’s disease. The plan includes a nine‑month Phase 2b segment using EMACC and plasma p‑tau‑217, and a Phase 3 segment with CDR-SB as the sole primary endpoint.
The filing underscores additional regulatory leverage: CORDStrom carries Orphan Drug and Rare Pediatric Disease designations and stands to benefit from reauthorization of the Priority Review Voucher program through
UNITED STATES
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Item 7.01. Regulation FD Disclosure.
On February 10, 2026, INmune Bio Inc. (the “Company”) issued a press release announcing that the Company formally submitted its pre-submission package for CORDStrom with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency. A copy of the press release is furnished herewith as Exhibit 99.1.
On February 12, 2026, the Company issued a press release announcing that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration. A copy of the press release is furnished herewith as Exhibit 99.2.
The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Such information shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release, dated February 10, 2026 | |
| 99.2 | Press Release, dated February 12, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INMUNE BIO INC. | ||
| Date: February 13, 2026 | By: | /s/ David Moss |
| David Moss | ||
| Chief Executive Officer | ||
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Exhibit 99.1
INmune Bio Advances CORDStrom™ Towards UK Marketing Authorization in RDEB
Pre-submission package is a process that facilitates early feedback from the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA), designed to streamline the final approval process and reduce time to market
Boca Raton, FL, Feb. 10, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a clinical-stage inflammation and immunology company, today announced a critical step toward the commercialization of CORDStrom™ for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The Company has formally submitted its pre-submission package for CORDStrom with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). This early engagement step is designed to solicit targeted scientific, regulatory, and procedural feedback, streamlining the full Marketing Authorization Application (MAA) process and potentially shortening time to market for what could become the first systemic therapy for this devastating “butterfly skin” disease.
CORDStrom is being developed as a disease-modifying treatment for recessive dystrophic epidermolysis bullosa (RDEB), a rare, debilitating genetic disorder affecting approximately 1 in 1 million births worldwide. Characterized by extreme skin fragility, chronic wounds, severe itch and pain, gastrointestinal/esophageal complications, and elevated skin cancer risk, RDEB has no approved systemic therapies. Current options are limited to topical wound treatments.
“Meeting the deadline for our pre-submission for CORDStrom marks a critical milestone, building upon the positive safety and efficacy data demonstrated in the MissionEB clinical trial and the successful transition into our commercial manufacturing facility in Stevenage, UK,” said Professor Mark Lowdell, PhD, FRCPath FRSB, Co-Founder & CSO of INmune Bio. “The Mission EB trial demonstrated improvement in itch, pain, skin integrity and quality of life, with excellent tolerability and no treatment-related serious adverse events. We are committed to delivering the first systemic therapy for RDEB patients and families, starting in the UK, and look forward to feedback from the MHRA in the hope of accelerating the regulatory and commercial pathway to approval.”
INmune Bio has completed three commercial pilot-scale manufacturing runs at the state-of-the-art CGT Catapult facility, each demonstrating consistent product characteristics that met predefined release criteria. These manufacturing results confirm readiness for commercial supply. The Company anticipates filing a full Marketing Authorization Application (MAA) with MHRA following receipt of pre-submission feedback, currently targeted for mid-summer 2026, with subsequent EU and U.S. regulatory submissions to follow in Q4, 2026, subject to regulatory alignment and manufacturing readiness.
While advancing the regulatory pathway in the UK, INmune Bio also stands to benefit from recent U.S. legislative progress regarding rare pediatric diseases. CORDStrom has already been granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease (RPD) designation for the treatment of EB in the United States. These designations take on added significance following the February 3, 2026, passed legislation that reauthorizes the FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program through September 30, 2029 (incorporated into the Consolidated Appropriations Act, 2026, via the Mikaela Naylon Give Kids a Chance Act). The program incentivizes development of therapies for rare pediatric diseases like RDEB by awarding a transferable priority review voucher upon approval.
“We welcome Congress’s bipartisan action to extend the Rare Pediatric Disease PRV program,” said CEO David Moss. “This reauthorization removes a major uncertainty and strengthens the incentive landscape for advancing innovative treatments for children with devastating rare conditions. With our planned BLA submission targeted for later this year, we are well-positioned to potentially benefit from this important incentive as we work to bring CORDStrom™ to RDEB patients who urgently need new options.”
CORDStrom is potentially the first systemic treatment designed to address the severe unmet symptoms of RDEB patients. RDEB not only manifests as extreme fragility of the skin but also inflammation of internal linings of the mouth, gut and behind the eyes, leading to widespread pain, failure to thrive and multi-organ complications and even increasing the risk of skin cancer. RDEB affects nearly every organ system. Limited options are available for treatment, none of which address the systemic tissue damage.
About CORDStrom™
CORDStrom™ is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom™ platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification, independent of donor characteristics. While the first generation CORDStrom™ product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.
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 expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595™ (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
Exhibit 99.2
INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer’s Disease
Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development
Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune Bio” or the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it received the official minutes from its End-of-Phase 2 (Type B) meeting with the U.S. Food and Drug Administration (FDA). The minutes confirm regulatory alignment on the Company’s proposed integrated Phase 2b/3 clinical development strategy for XPro1595 in early Alzheimer’s Disease (AD).
“The outcome of the End-of-Phase 2 interaction is an important inflection point for XPro1595,” said CJ Barnum, PhD, Vice President of Neuroscience at INmune Bio. “The FDA’s feedback on our enrichment-led design, primary endpoint, and integrated Phase 2b/3 structure validates our scientific and clinical strategy and provides a clearly defined regulatory path to advancing XPro1595 into a registration-intent program in early Alzheimer’s disease.”
The FDA’s feedback was consistent with the Company’s precision medicine approach, which utilizes an enrichment-led trial design to identify patients whose inflammatory biomarker profiles are mechanistically linked to soluble TNF signaling, the biological target of XPro1595. The Agency’s review was informed by the Company’s Phase 2 clinical data package, including cognitive and biomarker analyses in the enriched population.
Key Highlights of FDA Alignment:
| ● | Integrated Phase 2b/3 Framework: The FDA indicated no objection to the Company’s proposed integrated Phase 2b/3 design under a single master protocol. The Phase 2b portion will enroll approximately 300 participants over a nine-month evaluation period designed to validate key efficacy and biomarker assumptions before expansion into the Phase 3 registration segment. The full program is expected to enroll approximately 1,000 participants, with the Phase 3 portion evaluating XPro1595 over 18 months. |
| ● | CDR-SB as Sole Primary Endpoint: The FDA raised no objection to the use of Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) as the sole primary efficacy endpoint for the Phase 3 portion of the study. CDR-SB is the primary endpoint used in recently approved Alzheimer’s disease therapies. |
| ● | Biomarker-Driven Enrichment Strategy Supported: The FDA raised no objection to the Company’s inflammation-based enrichment strategy, which will enroll patients defined by two or more biomarkers associated with peripheral inflammation and immune-mediated disease risk (hsCRP, ESR, HbA1c, APOE4), which are mechanistically linked to soluble TNF signaling. This approach is designed to align patient biology with XPro1595’s selective soluble TNF mechanism of action and supports a precision medicine development strategy. |
| ● | Exploratory Cohort: At the FDA’s recommendation, the trial will include an exploratory cohort (approximately 20% of enrollment) of non-enriched early Alzheimer’s Disease patients to assess the broader effect of XPro1595. This cohort is not required to be independently powered, and in the absence of a treatment signal at month 9, it would not be required to continue into the Phase 3 segment. |
The Phase 2b portion of the study includes a nine-month evaluation period designed to establish the clinical evidence base for Phase 3. The Phase 2b assessment will be informed by the Early Mild Alzheimer’s Cognitive Composite (EMACC), a cognitive measure, and plasma p-tau-217, a marker of neurodegeneration. These endpoints were selected for their demonstrated sensitivity to early changes over shorter treatment periods. CDR-SB is the sole primary efficacy endpoint for Phase 3, consistent with its established role as a global functional outcome measure in registrational Alzheimer’s programs. Final powering assumptions and statistical analyses will be specified in the study protocol, which will be submitted for FDA review.
“Our Phase 2 MINDFuL trial provided important insights into cognitive and biomarker measures in the enriched population,” said Dr. Barnum. “These findings informed the statistical assumptions and powering strategy for the Phase 3 portion of the program. We are encouraged that the FDA raised no objections to the use of CDR-SB as the sole primary endpoint for the Phase 3 segment of the proposed study, which is intended to support a registrational-directed program.”
“Our End-of-Phase 2 interaction with the FDA reflects alignment between our proposed development strategy and the Agency’s expectations for late-stage Alzheimer’s programs,” said David Moss, Chief Executive Officer of INmune Bio. “XPro1595 represents a differentiated approach to Alzheimer’s disease, based on precision patient selection and selective immune modulation, with a favorable safety profile that included zero cases of ARIA in our Phase 2 study. We appreciate and thank the FDA for its constructive engagement and look forward to advancing XPro1595 in a registration-directed program.”
INmune Bio is incorporating the FDA’s feedback into the final Phase 2b/3 protocol and anticipates submitting the protocol to the Agency for review. The Company will provide additional updates on timelines as the protocol is finalized.
About XPro™
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of INmune Bio’s website.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage clinical 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.
2
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 expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, including statements regarding FDA feedback or the design of future clinical trials, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. FDA feedback, including statements that the Agency has no objection to aspects of a proposed trial design, does not constitute approval or an agreement that such design will be sufficient to support regulatory approval. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595™ (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David
Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel
Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
3
FAQ
What did INmune Bio (INMB) announce about CORDStrom in the UK?
INmune Bio submitted a pre-submission package for CORDStrom to the UK MHRA for recessive dystrophic epidermolysis bullosa. This early engagement is meant to streamline a future Marketing Authorization Application targeted for mid-summer 2026 and support subsequent EU and U.S. filings later in 2026.
How does the FDA End-of-Phase 2 meeting affect INmune Bio’s XPro1595 program?
The FDA’s End-of-Phase 2 meeting minutes confirm alignment on an integrated Phase 2b/3 strategy for XPro1595 in early Alzheimer’s disease. Phase 3 will use CDR-SB as the sole primary endpoint, supporting a registration-intent development path consistent with late-stage Alzheimer’s standards.
What is the planned design of INmune Bio’s Phase 2b/3 trial for XPro1595?
The XPro1595 program features a nine‑month Phase 2b segment using EMACC and plasma p‑tau‑217 to build evidence for Phase 3. The Phase 3 portion will use CDR-SB as the single primary efficacy endpoint in an enrichment-led, precision-medicine design for early Alzheimer’s disease.
Which regulatory designations does CORDStrom have in the United States?
CORDStrom holds both Orphan Drug Designation and Rare Pediatric Disease designation in the U.S. for epidermolysis bullosa. These statuses can provide development incentives and, upon approval, may enable eligibility for a transferrable Priority Review Voucher under the reauthorized rare pediatric disease program.
How does the Rare Pediatric Disease Priority Review Voucher program impact INmune Bio?
The reauthorized FDA Rare Pediatric Disease Priority Review Voucher program, extended through September 30, 2029, enhances incentives for therapies like CORDStrom. If approved, INmune Bio could receive a transferrable voucher, potentially adding strategic and financial value to its rare pediatric disease portfolio.
What are INmune Bio’s next regulatory steps for CORDStrom and XPro1595?
For CORDStrom, INmune Bio plans a full UK MAA in mid-summer 2026 and EU/U.S. submissions in Q4 2026. For XPro1595, the company is finalizing the integrated Phase 2b/3 protocol incorporating FDA feedback before submitting it for regulatory review.
Filing Exhibits & Attachments
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