INmune Bio Inc. Announces Second Quarter 2026 Results and Highlights Regulatory, Manufacturing and Clinical Progress
BOCA RATON, Fla., Aug. 06, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced its financial results for the quarter ended June 30, 2026 and provided a business update.
“The second quarter and subsequent weeks were defined by execution across both of our late-stage platforms,” said David Moss, Chief Executive Officer of INmune Bio. “For Ebstrocel™, we secured MHRA alignment, PIP approval and commercial-ready manufacturing, materially reducing regulatory and operational risk ahead of our planned UK MAA submission. For XPro™, FDA Fast Track designation and statistically significant MRI findings strengthened the clinical and regulatory foundation for a registrational Phase 2b/3 program in early Alzheimer’s disease that we believe establishes XPro™ as a first-in-class, late-stage neuroimmunology program in CNS disease. Looking ahead, our core priority is clear: driving Ebstrocel efficiently through regulatory filing and approval to bring this critical therapy to patients in need while delivering long-term value for our shareholders.”
Second Quarter and Recent Corporate Highlights
CORDStrom™ Platform (Ebstrocel for RDEB):
Completed a key commercial manufacturing milestone by successfully processing the first commercial-ready umbilical cord tissues at the Cell and Gene Therapy Catapult Manufacturing Innovation Centre in Stevenage, UK. The transferred process is designed to meet MHRA, EMA and FDA standards and supports planned Phase 3 confirmatory development, global regulatory submissions and future commercial supply.
Received formal MHRA written alignment across the CMC, non-clinical and clinical elements of the planned UK MAA, providing a clear regulatory path toward a Conditional Marketing Authorization application for Ebstrocel™ in RDEB.
Obtained MHRA approval of the Ebstrocel™ Pediatric Investigation Plan in less than three months, preserving the Company’s planned 2026 UK MAA timetable and incorporating the agency’s feedback into the planned open-label Phase 3 confirmatory trial.
Completed preparations for the Phase 3 trial of Ebstrocel in RDEB remaining on track for first patient treatment in Q4 2026.
Advanced the CORDStrom™ platform patent application into the U.S. national phase following a favorable international Written Opinion. If granted, the patent family is expected to provide broad platform protection, including composition-of-matter and method-of-treatment claims, extending into at least 2045.
Expanded the Company’s agreement with Anthony Nolan Cord Blood Bank, securing long-term access to high-quality umbilical cord tissue to support scalable global development and commercialization of the CORDStrom™ platform.
Established a Scientific Advisory Board comprising internationally recognized leaders in MSC biology, clinical translation, manufacturing, potency assessment and rare pediatric skin disease. Chaired by Professor Mark Lowdell, the working SAB will support Ebstrocel’s late-stage regulatory and clinical development, including Phase 3 design, biomarkers, manufacturing consistency and product-release criteria, while helping prioritize additional indications for the CORDStrom platform. The SAB adds substantial independent expertise as the Company advances Ebstrocel toward regulatory submissions and expands CORDStrom into additional disease-specific cell therapies.
XPro1595 Platform Highlights (XPro™):
Reported a statistically significant treatment effect on a white matter myelin MRI biomarker in the Phase 2 MINDFuL trial. XPro™ demonstrated an effect in the full modified intent-to-treat population (p=0.0028; Cohen’s d=0.46; n=200), with a larger effect in the biomarker-enriched population (p=0.0098; d=0.59; n=100), supporting the precision-medicine strategy for the planned registrational program.
Published the Phase 2 MINDFuL results in NPJ Dementia. In the pre-specified, 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 zero ARIA-E and zero ARIA-H observed.
Presented expanded Phase 2 imaging analyses at the Alzheimer’s Association International Conference showing concordant treatment-related effects across independent white matter and cortical gray matter measures at Week 24, strengthening evidence of early biologic activity and tissue-level target engagement.
Received FDA Fast Track designation for XPro™ (pegipanermin) for early Alzheimer’s disease, encompassing mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia, enabling more frequent FDA interactions and potential eligibility for expedited review mechanisms.
Published a Department of Defense-funded, peer-reviewed Journal of Neurotrauma study showing that XPro1595 prevented the injury-induced rise in amyloid pathology and improved early cognitive and pain-related outcomes in a preclinical model linking traumatic brain injury to Alzheimer’s disease.
Presented AACR 2026 preclinical data showing that INB03 (XPro1595 for oncology) enhanced the activity of HER2-targeted tyrosine kinase inhibitors and reduced metastatic spread to the brain, lungs and liver in HER2-positive breast cancer models.
Corporate:
Received an approximately US$4.2 million research and development tax rebate from Australia during July 2026, providing non-dilutive capital to support ongoing development activities.
Announced it has been named a founding member of the American Biotech Innovation Alliance (ABIA). The newly launched national coalition brings together biotechnology leaders with the shared objective of defining a national strategy to sustain and extend U.S. leadership in biotech innovation.
Upcoming Events and Milestones:
Financial Results for the Second Quarter Ended June 30, 2026:
Earnings 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 Second Quarter Conference Call when reaching the operator.
Date: August 6 th, 2026
Time: 4:30 PM Eastern Time
Participant Dial-in: 1-800-717-1738 Participant Dial-in (international): +1-646-307-1865
Conference ID: INMUNE
A live audio webcast of the call can be accessed by clicking here or using this link:
https://viavid.webcasts.com/starthere.jsp?ei=1769234&tp_key=7c277bcdb8
A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through September 21st, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN 1166817.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.
INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:
To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.
Forward Looking Statements
The Company’s product candidates are in clinical development 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 the 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 U.S. 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
The following tables summarize our results of operations for the periods indicated: