INmune Bio outlines 2026 regulatory path in shareholder letter

The latest announcement is out from Inmune Bio ( (INMB) ).

In a shareholder letter dated January 27, 2026, INmune Bio reviewed 2025 as a pivotal year marked by progress in two lead programs and solidified financial footing. The company reported substantial advances in CORDStrom™ for RDEB, including successful commercial pilot-scale manufacturing runs in the UK during 2025 and preparations for a Marketing Authorization Application to the UK MHRA targeted for mid-summer 2026, with a subsequent U.S. FDA Biologics License Application anticipated toward the end of 2026, underscoring its push toward regulatory approval of a systemic therapy for this multi-organ disease. INmune also highlighted 2025 Phase 2 MINDFuL trial data for XPro™ in Alzheimer’s disease, noting that while the overall modified intent-to-treat population showed no treatment effect, a predefined biomarker-defined subpopulation of amyloid-positive early patients with elevated inflammation markers demonstrated biologically consistent cognitive, neuropsychiatric and biomarker signals supportive of a precision-medicine strategy. Imaging data presented in December 2025 at CTAD, along with reductions in blood pTau217 and grey-matter MRI changes, were cited as backing XPro’s mechanism of selectively inhibiting soluble TNF, and the company is engaging with regulators on a registrational development path. Financially, INmune exited September 30, 2025 with approximately $27.7 million in cash and cash equivalents, supplemented by a June private placement and an expected Australian R&D rebate, which management believes will fund operations through the end of 2026 as it pursues these key milestones.

The most recent analyst rating on (INMB) stock is a Hold with a $1.50 price target. To see the full list of analyst forecasts on Inmune Bio stock, see the INMB Stock Forecast page.

Spark’s Take on INMB Stock

According to Spark, TipRanks’ AI Analyst, INMB is a Neutral.

Overall score is held down primarily by weak financial performance (minimal revenue, large losses, and ongoing cash burn) and bearish technical trend (trading below major moving averages). The earnings call provided some support via improved quarterly loss, stated runway into Q4 2026, and pipeline/regulatory progress, but clinical/regulatory uncertainties (XPro topline miss and timing delays) and a negative P/E limit the score.

To see Spark’s full report on INMB stock, click here.

More about Inmune Bio

INmune Bio Inc. is a Nasdaq-listed, clinical-stage biotechnology company focused on targeting the innate immune system to treat serious neuroinflammatory, immunologic and oncologic diseases. Its pipeline includes the DN-TNF platform drug XPro™ for neuroinflammatory conditions such as Alzheimer’s disease, CORDStrom™, an allogeneic umbilical cord-derived mesenchymal stromal cell therapy initially aimed at recessive dystrophic epidermolysis bullosa (RDEB), and INKmune®, designed to prime natural killer cells to eliminate minimal residual disease in cancers such as metastatic castration-resistant prostate cancer.

Average Trading Volume: 413,262

Technical Sentiment Signal: Sell

Current Market Cap: $44.4M

For a thorough assessment of INMB stock, go to TipRanks’ Stock Analysis page.