INMB 8-K
Inmune Bio, Inc. (INMB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 8, 2026, the Board of Directors (the “Board”) of INmune Bio, Inc. (the “Company”) approved to increase the number of directors and to set the number of directors serving on the Board at seven, and, pursuant to the Company’s by-Laws, appointed R. Duane Clark II and James Sapirstein to serve as directors of the Company until the next annual election and until their successors are duly elected and qualified. The Board also appointed Mr. Clark and Mr. Sapirstein to serve as members of the Nominating and Corporate Governance Committee of the Board.
Mr. Clark, age 63, brings more than 40 years of global pharmaceutical and biotechnology leadership, with particular depth in rare diseases, immunology and specialty-product commercialization. He currently serves as General Manager, U.S. Rare Diseases at Sanofi, where he leads a multi-billion-dollar business spanning seven rare-disease brands with full profit-and-loss responsibility. His experience includes multiple product launches, market-access strategy, M&A integration, and leadership across sales, marketing, medical and commercial operations. Earlier in his career, he led Sanofi’s U.K. and Ireland multiple sclerosis business and held commercial and business-development roles at CTI Clinical Trial & Consulting Services, Encysive Pharmaceuticals, Astellas Pharma, Ortho Biotech and Marion Laboratories. Mr. Clark received a B.A. in Business and Marketing from University of Kentucky.
Mr. Sapirstein, age 65, brings more than 40 years of biopharmaceutical leadership spanning business development, licensing, commercialization, capital formation and public-company operating experience. He has led six global commercial product launches and participated in more than 20 additional launches. Mr. Sapirstein is currently the Chief Executive Officer of Cocrystal Pharma, Inc. (Nasdaq: COCP) and the Chief Executive Officer and Chairman of 8 Prime Biosciences, a private company. Prior to that, from October 2019 to February 2025, Mr. Sapirstein as Chief Executive Officer and Chairman of Entero Therapeutics, Inc. (Nasdaq: ENTO) (now known as GridAI Technologies Corp., Nasdaq:GRDX) and as a consultant from February 2025 to March 2026. His career includes senior roles at Gilead Sciences, Bristol Myers Squibb, Hoffmann-La Roche, Eli Lilly and Serono Laboratories. Mr. Sapirstein currently also serves as the Executive Chairman of Onconetix, Inc. (Nasdaq: ONCO) and as a director of ZyVersa Therapeutics, Inc (OTC Pink: ZVSA). He also founded and led Tobira Therapeutics which was later acquired by Allergan and has extensive experience structuring strategic transactions and guiding biotechnology companies through growth, restructuring and value-creating exits. Mr. Sapirstein received a B.S. in Pharmacy from Rutgers University and his MBA from Fairleigh Dickinson University.
The Board has determined that Mr. Clark and Mr. Sapirstein are both independent directors within the meaning of Nasdaq Listing Rule 5605. Mr. Clark qualifies to serve on the Board because of his extensive experience and leadership in the global pharmaceutical and biotechnology industries, with particular depth in rare diseases, immunology and specialty-product commercialization. Mr. Sapirstein qualifies to serve on the Board because of his extensive experience and leadership in the biopharmaceutical industry, which includes business development, licensing, commercialization, capital formation and public-company operating experience.
Mr. Clark and Mr. Sapirstein do not have a family relationship with any of the executive officers or directors of the Company. There are no arrangements or understandings between Mr. Clark and Mr. Sapirstein and any other persons pursuant to which they were selected as directors, and there are no transactions in which they have an interest requiring disclosure under Item 404(a) of Regulation S-K.
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In consideration for their service as members of the Board, Mr. Clark and Mr. Sapirstein shall each receive, upon approval by the Compensation Committee of the Company, an option to purchase 100,000 shares of the Company’s common stock under the Third Amended and Restated INmune Bio Inc. 2021 Stock Incentive Plan. The initial grant will vest in 36 equal monthly installments beginning one month after the grant date, so that the initial grant is fully vested on the third anniversary of the grant date, in each case subject to their continued service on the Board on each applicable vesting date. In addition to the initial grant, Mr. Clark and Mr. Sapirstein shall each receive: (i) an annual cash retainer of $50,000 for their service as directors, payable quarterly in arrears and pro-rated for any partial quarter of service, and (ii) reimbursement for reasonable and documented out-of-pocket expenses related to their service as members of the Board. In connection with their appointment, the Company will enter into its standard form of indemnification agreement with Mr. Clark and Mr. Sapirstein.
Item 8.01 Other Events
On September 14, 2026, the Company issued a press release (the “Release”) announcing Mr. Clark’s and Mr. Sapirstein’s appointment to the Board. A copy of the Release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. Exhibits 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01 Financial statements and Exhibits
(d) Exhibits.
| 99.1 | Press Release dated September 14, 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: September 14, 2026 | By: | /s/ David Moss |
| Name: | David Moss | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
INmune Bio Appoints Sanofi Rare-Disease Executive and Biopharma Business Development Leader to Board
Appointments
strengthen rare-disease commercialization planning and strategic partnering capabilities as
Ebstrocel™ advances toward potential
commercialization
BOCA RATON, Fla., Sept. 14, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced the appointments of R. Duane Clark II and James Sapirstein, R.Ph., MBA, to its Board of Directors. The appointments add commercial and strategic operating expertise as INmune Bio prepares Ebstrocel™ for potential rare-disease commercialization and pursues business-development and partnering opportunities across its pipeline.
Mr. Clark brings more than 40 years of global pharmaceutical and biotechnology leadership, with particular depth in rare diseases, immunology and specialty-product commercialization. He currently serves as General Manager, U.S. Rare Diseases at Sanofi, where he leads a multi-billion-dollar business spanning seven rare-disease brands with full profit-and-loss responsibility. His experience includes multiple product launches, market-access strategy, M&A integration, and leadership across sales, marketing, medical and commercial operations. Earlier in his career, he led Sanofi’s U.K. and Ireland multiple sclerosis business and held commercial and business-development roles at CTI Clinical Trial & Consulting Services, Encysive Pharmaceuticals, Astellas Pharma, Ortho Biotech and Marion Laboratories.
Mr. Sapirstein brings more than 40 years of biopharmaceutical leadership spanning business development, licensing, commercialization, capital formation and public-company leadership experience. He has led six global commercial product launches and participated in more than 20 additional launches. His career includes senior roles at Gilead Sciences, Bristol Myers Squibb, Hoffmann-La Roche, Eli Lilly and Serono Laboratories. He also founded and led Tobira Therapeutics, which was later acquired by Allergan in a transaction with total potential consideration of up to approximately $1.7 billion, including contingent milestone payments. Mr. Sapirstein also brings extensive experience structuring strategic transactions and guiding biotechnology companies through growth, restructuring, and value-creating exits.
“These appointments bring capabilities directly aligned with INmune Bio’s next stage of growth,” said David Moss, Chief Executive Officer of INmune Bio. “Duane’s rare-disease leadership leading a major rare-disease business will strengthen our planning for market access and potential commercialization of Ebstrocel. James’s business development, licensing, and financing experience will support our evaluation of strategic opportunities for our broader pipeline. Together, they add practical experience to help us translate development progress into potential patient and shareholder value.”
The new directors strengthen the Board in:
| ● | Rare-disease commercialization: Guide market access and pricing, patient identification, commercial infrastructure and launch execution for Ebstrocel™ in recessive dystrophic epidermolysis bullosa (RDEB) and potential additional rare-disease indications. |
| ● | Business development and strategic transactions: Strengthen the evaluation and negotiation of licensing, distribution, co-development and other strategic relationships intended to accelerate development and broaden commercial reach. |
| ● | Commercial scale and execution: Help align clinical, regulatory, manufacturing and commercial functions as INmune Bio advances from late-stage development toward potential product launches. |
“Ebstrocel has the potential to address important unmet needs in rare disease, and INmune Bio is approaching the stage at which disciplined launch and market-access planning can become a meaningful competitive advantage,” said Mr. Clark. “I look forward to helping the Company build a patient-focused commercialization strategy and the capabilities required to execute it.”
“INmune Bio has multiple opportunities to create value through focused internal development and well-structured strategic partnerships,” said Mr. Sapirstein. “I look forward to contributing my business-development, transaction and commercialization experience as the Company evaluates the best path to advance its differentiated platforms.”
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. 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:
| ● | CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission. |
| ● | XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform designed to selectively neutralize soluble TNF (sTNF) and reduce neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. |
To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.
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Forward Looking Statements
The Company’s product candidates remain in clinical development stage 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 Ebstrocel™, XPro™ and INKmune™ 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
Daniel Carlson
Head of Investor Relations
(415) 509-4590
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