INmune Bio (INMB 1.09%), a clinical-stage biotechnology company focused on developing immunotherapies for neurodegenerative and inflammatory diseases, released its earnings for the second quarter on August 7, 2025. The primary news was a major net loss, stemming from a $16.5 million impairment charge, and clinical data from its lead XPro program in Alzheimer’s failing primary endpoints in the main patient group. The loss widened from $(0.50) (GAAP) in the prior year. There was no revenue, in line with expectations for a pre-commercial biotech. Overall, the quarter brought major clinical and financial setbacks, with ongoing questions around regulatory timelines and financial sustainability. Cash reserves increased thanks to a new equity raise, giving some operational cushion but keeping capital needs in sharp focus for potential investors.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | $(1.05) | $(0.38) | $(0.50) | (-110.0%) |
| Revenue (GAAP) | $0.0 | $0.0 | $0.0 | — |
| Research and Development Expenses | $5.9 million | $7.1 million | (16.9%) | |
| General and Administrative Expenses | $2.3 million | $2.8 million | (17.9%) | |
| Cash and Cash Equivalents (end of period) | $33.4 million |
Source: Analyst estimates for the quarter provided by FactSet.
Business Overview and Strategic Drivers
INmune Bio (INMB 1.09%) is developing therapies that leverage the innate immune system—a branch of immunity that forms the body's first line of defense—to address diseases like Alzheimer's, various cancers, and rare skin disorders. Its approach targets immune functions not exploited by most rivals, focusing on drugs that neutralize specific inflammation drivers or enhance the activity of “natural killer” (NK) cells in attacking tumors.
The company’s commercial success hinges on four main factors: successful advancement of its clinical pipeline, execution of regulatory approval paths (including orphan drug and accelerated pathways), and robust intellectual property protection. Pipeline progress and regulatory discussions will be critical, particularly as its programs approach late-stage trials in highly competitive markets for Alzheimer’s, oncology, and rare dermatological disorders.
Quarterly Highlights: Financials, Pipeline, and Key Developments
The net loss (GAAP) ballooned to $24.5 million, compared to approximately $9.7 million during the quarter ended June 30, 2024, mainly due to a one-time, $16.5 million impairment charge for acquired research assets. This reflects a downward reassessment of pipeline value, after lackluster clinical data from its lead program.
Research and development expenses (GAAP) fell to $5.9 million, compared to approximately $7.1 million during the quarter ended June 30, 2024, and General and administrative spending (GAAP) decreased to $2.3 million, compared to approximately $2.8 million during the quarter ended June 30, 2024. The company continues to report no meaningful revenue, in line with its ongoing clinical-stage status. Cash and cash equivalents reached $33.4 million by June 30, 2025, up from $20.922 million at December 31, 2024. This increase was mainly driven by a $19 million equity raise. The company’s pace of cash burn remains high, with net cash used in operations (GAAP) totaled $14.2 million for 6M 2025.
On the clinical front, the most notable event was the release of top-line results from the MINDFuL Phase 2 trial for XPro, designed to target neuroinflammation in early Alzheimer’s disease. The study failed to meet its main (primary) cognitive endpoints in the broader, intended trial population of 200 patients. There were “positive trends” in a pre-specified biomarker-enriched subgroup—those with two or more inflammatory markers—covering about half the trial participants. In this group, XPro demonstrated an effect size approaching 0.2 on cognitive endpoints in patients with MCI and early Alzheimer’s in the MINDFuL Phase 2 trial, but was underpowered and did not reach statistical significance. The ambiguity clouded the regulatory and commercial prospects for XPro in Alzheimer’s.
The company continued to push ahead in other parts of the pipeline. The CORDStrom program, which uses mesenchymal stromal cell (MSC) therapy aimed first at treating the rare disease recessive dystrophic epidermolysis bullosa (RDEB), made progress in manufacturing and intellectual property protection. The company secured a favorable patent opinion from the U.S. Patent Office and expanded commercial manufacturing capabilities through a partnership with Cell and Gene Therapy Catapult. Further, it advanced work toward submitting both U.S. and U.K. regulatory filings in 2026, and key trial data are expected later in the year. The company says BLA and MAA filings for CORDStrom in RDEB remain on track for mid-2026, contingent on pending clinical results and effective manufacturing scale-up.
INKmune, the company’s solid-tumor immunotherapy platform aimed at treating metastatic castration-resistant prostate cancer, also advanced. Phase II enrollment for this cancer therapy opened in early 2025, drawing in the first group of patients, with biomarker analysis showing successful natural killer cell activation. Manufacturing was completed for all necessary doses through the current stage. Early clinical findings indicate some disease control or reduction at the lesion level, and imaging updates are expected later in the year. The company is positioning INKmune for future randomized trials, using phase II data to shape the overall program design.
Leadership transition marked another key change. Dr. RJ Tesi retired as CEO, with David Moss, the former CFO, stepping in. An interim CFO and a new board chair were also appointed, reflecting a strategic shift toward more capital markets and operational expertise during a volatile period for the company.
Looking Ahead: Guidance and Watch List
No quantitative or financial guidance was provided for upcoming quarters or for the remainder of fiscal 2025. Company management highlighted anticipated milestones: an end-of-phase-2 FDA meeting for XPro in Alzheimer’s, the publication of full trial data, regulatory engagement on CORDStrom, a read-out for additional indications, and progress toward pivotal trials for INKmune in cancer indications.
The company does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
