INmune Bio to Present at the H.C. Wainwright Global Investment Conference

INmune Bio uses the conference to spotlight two late-stage platforms moving toward regulatory milestones and registrational programs.

Rhea-AI Summary

INmune Bio (INMB) will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York, with an on-demand presentation available starting September 11, 2026, at 7:00 a.m. ET.

Chief Executive Officer David Moss will host one-on-one meetings with institutional investors and deliver a live presentation on Monday, September 14 at 10:30 a.m. ET. The company highlights two late-stage platforms: CORDStrom™, which is moving to regulatory filing phases with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027 plus a planned U.S. BLA; and XPro1595™, which has FDA Fast Track designation and is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease.

Positive

• CORDStrom™ advancing to MAA filings with UK MHRA in 2026 and EU EMA in 2027, plus a planned U.S. BLA submission
• XPro1595™ granted FDA Fast Track designation following End-of-Phase 2 regulatory alignment
• XPro1595™ positioned for an integrated Phase 2b/3 seamless adaptive registrational program in early Alzheimer’s disease

Negative

• None.

Key Terms

fast track designation, marketing authorization application, biologics license application, phase 2b/3

4 terms

fast track designation regulatory

"Backed by recently granted FDA Fast Track designation"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

marketing authorization application regulatory

"with an MAA planned for the UK MHRA in 2026"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

biologics license application regulatory

"alongside a planned U.S. Biologics License Application (BLA)"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

phase 2b/3 medical

"an integrated Phase 2b/3 seamless adaptive registrational program"

A phase 2b/3 trial is a combined late-stage clinical study that first refines the best dose and measures how well a treatment works (phase 2b) then expands to a larger, definitive test of safety and effectiveness needed for regulatory approval (phase 3). For investors, results from a phase 2b/3 act like a dress rehearsal that turns into opening night: positive, well-controlled outcomes substantially raise the chance of approval and future sales, while failures can sharply reduce a drug’s value.

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The on-demand presentation will be available on September 11, 2026, at 7:00 A.M. (ET)

BOCA RATON, Fla, Sept. 09, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced their attendance at the H.C. Wainwright 28^th Annual Global Investment Conference, taking place September 14-16 at the Lotte New York Palace Hotel in New York City.

David Moss, Founder and Chief Executive Officer, will be hosting one-on-one meetings with institutional investors on September 14 - 16 and will be presenting on Monday, September 14 at 10:30am ET. To watch the live presentation, click here, or follow this link:

https://journey.ct.events/view/59675c97-a699-4f75-a6ed-ce228a36c940

Investors interested in scheduling one-on-ones should contact H.C. Wainwright at meetings@hcwco.com.

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:

• 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 that selectively neutralizes soluble TNF (sTNF) to eliminate 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.

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

FAQ

How can investors watch INmune Bio’s presentation at the H.C. Wainwright Global Investment Conference?

The live presentation on Monday, September 14 at 10:30 a.m. ET can be viewed by clicking the provided conference link: https://journey.ct.events/view/59675c97-a699-4f75-a6ed-ce228a36c940. An on-demand version will be available starting September 11, 2026, at 7:00 a.m. ET.

How can institutional investors schedule one-on-one meetings with INmune Bio at the conference?

Institutional investors interested in one-on-one meetings with Chief Executive Officer David Moss during September 14–16 should contact H.C. Wainwright by email at meetings@hcwco.com.

What is INmune Bio’s focus as a biotechnology company?

INmune Bio is described as a late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease, using a precision-medicine strategy that matches drug mechanisms to patient biology to optimize clinical outcomes.