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

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  • INmune Bio submitted its final pre-Marketing Authorization Application for Ebstrocel to the UK MHRA on October 20, 2026, targeting a complete submission in early February 2027.
  • The company anticipates a potential UK approval for Ebstrocel in mid-2027, following an expected MHRA review period of three to six months after submission.
  • An international access framework with Uniphar has been established to enable named-patient treatment for Ebstrocel in select European, Middle Eastern, North African markets prior to full commercial approval.
  • Preparations for a U.S. Biologics License Application are advancing, with a planned Type B meeting with the FDA and a targeted BLA submission for mid-2027.
  • INmune Bio is evaluating the XPro platform for rare diseases using quantum computing collaboration, but will not commit capital to new clinical programs until Ebstrocel receives approval.
  • The company raised approximately $4.5 million through a registered direct offering of stock 1 warrants on October 28, 2026, to support ongoing operations.
  • Net loss for the quarter ended September 30, 2026, was approximately $4.7 million, a decrease from $6.5 million in the same period of 2025, driven by lower research 1 administrative expenses.
  • Cash 1 cash equivalents totaled $16.3 million as of September 30, 2026, with the company projecting sufficient funds to operate through the third quarter of 2027.
  • R&D tax rebates of $4.2 million from Australia 1 $0.4 million from the UK were received in mid-2026 to provide non-dilutive funding.
  • Two new directors, R. Duane Clark II 1 James Sapirstein, joined the board in September to enhance rare-disease 1 business development expertise.
  • A patent application for the CORDStrom platform advanced to the U.S. national phase, potentially extending intellectual property protection until at least 2045.
  • INmune Bio hosted a conference call on November 5, 2026, at 4:30pm ET to discuss financial results 1 regulatory updates regarding Ebstrocel.