INmune Bio Sets Mid-2026 Timeline for BLA and MAA Filings Amid CEO Transition

INmune Bio has outlined its plans to submit a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for its lead asset, CORDStrom, in mid-2026. The company has also announced the appointment of David J. Moss as Chief Executive Officer, following the retirement of co-founder RJ Tesi. Moss highlighted the strategic shift towards developing CORDStrom for the treatment of autoimmune diseases.

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage immunology company, has outlined its strategic plans for the coming year, including the submission of a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for its lead asset, CORDStrom™, in mid-2026. The company also announced significant leadership changes and financial results for the second quarter ended June 30, 2025.

David J. Moss has been appointed as the new Chief Executive Officer, succeeding co-founder RJ Tesi, who retired after a long tenure. Moss emphasized the strategic shift towards developing CORDStrom™ for the treatment of autoimmune diseases. The company aims to submit the BLA and MAA for CORDStrom™ in the UK and the US, respectively, by mid-2026.

Financial results for the second quarter ended June 30, 2025, showed a net loss of approximately $24.5 million, compared to approximately $9.7 million during the same period in 2024. Research and development expenses totaled approximately $5.8 million for the quarter, down from $7.1 million in the previous year. General and administrative expenses were approximately $2.3 million, a decrease from $2.8 million in the same period last year. The company reported an impairment of acquired in-process research and development intangible assets of $16.5 million during the quarter, compared to none recorded in the previous year. As of June 30, 2025, INmune Bio had cash and cash equivalents of approximately $33.4 million and approximately 26.6 million common shares outstanding [1].

INmune Bio continues to make progress in its clinical trials. The MINDFuL phase 2 trial in patients with mild cognitive impairment (MCI) and early Alzheimer’s disease showed promising results, with XPro™, a next-generation inhibitor of tumor necrosis factor (TNF), demonstrating a positive impact on the primary cognitive endpoint EMACC in a pre-defined subset of patients. The company also presented data from the MINDFuL trial at the Alzheimer’s Association International Conference (AAIC) on July 29th. Additionally, the company received a favorable written opinion from the USPTO on all claims in its international patent application for CORDStrom™ and partnered with the Cell and Gene Therapy Catapult (CGT Catapult) to establish large-scale, commercial-ready manufacturing for CORDStrom™ and other cell therapy platforms.

The company's interim CFO, Cory Ellspermann, and new Chairman of the Board, Kelly Ganjei, were also appointed during the quarter. INmune Bio closed a $19 million registered direct offering during the quarter. The company remains on track to file a publication on the MINDFuL trial results expected to be available this month.

INmune Bio's strategic focus on developing CORDStrom™ for autoimmune diseases, along with its progress in clinical trials and leadership changes, positions the company for significant growth in the coming years. Investors and financial professionals should closely monitor the company's progress and upcoming events to stay informed about its strategic initiatives and financial performance.

References:
[1] https://www.inmunebio.com/index.php/newsroom/2025-news/muneioncnnounceseconduarter2025esultsrovi20250807131005