INmune Bio Inc. Reports Third Quarter 2025 Financial Results
Today, INmune Bio Inc. (NASDAQ: INMB), a pioneering clinical-stage company focused on harnessing the innate immune system to combat diseases, shared its financial results for the quarter ending September 30, 2025. The company is excited to highlight significant advancements in its product platforms designed to address inflammatory and immune-related diseases.
Key Highlights from Q3 2025
CORDStrom™ Platform:
- Successful completion of the first two commercial pilot-scale manufacturing runs of CORDStrom™ at CGT Catapult, paving the way for future regulatory submissions.
- Anticipated filing of the Marketing Authorization Application (MAA) in mid-2026, followed by a Biologics License Application (BLA) submission shortly thereafter.
- CORDStrom™ aims to provide viable treatment options for recessive dystrophic epidermolysis bullosa (RDEB), a debilitating genetic skin condition.
Additionally, a recent BBC news article shared insights from a patient within the recently completed CORDStrom™ trial, emphasizing the real-world impacts of the treatment.
Upcoming Events and Milestones for CORDStrom™
Data presentations related to CORDStrom™ are planned for Q4 2025, including insights that may influence further development and adoption of the treatment.
DN-TNF Platform Updates (XPro™)
In recent developments, INmune Bio has submitted a manuscript titled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial” for peer review. This study showcases promising results indicating enhanced clinical benefits in patients with Alzheimer’s who adhered closely to the treatment protocol.
- The data suggest a clear correlation between increased drug exposure and improved cognitive outcomes across clinical endpoints.
- Involving 100 amyloid-positive early Alzheimer’s patients, XPro™ demonstrated the potential to slow cognitive decline and positively impact neuropsychiatric symptoms.
Moreover, the safety profile of XPro1595 remains robust, with no reported instances of amyloid-related imaging abnormalities (ARIA), setting it apart from traditional anti-amyloid therapies.
Plans for Future Trials
INmune Bio is preparing for an End of Phase 2 meeting with the FDA, expected in the first quarter of 2026, as part of its strategic approach to advancing this promising therapy.
INKmune® Platform Progress
In terms of immunotherapy, the INKmune® platform demonstrated promising results as the CARE-PC trial successfully met its primary endpoint and two of its three secondary endpoints.
- Results revealed significant NK cell proliferation and evidence of functional memory-like NK cells in the majority of trial participants, indicating strong therapeutic potential.
- Final data analysis is currently in progress, with findings expected to be shared in Q4 2026.
Corporate Changes and Updates
Recent leadership changes include the appointment of David Moss as the new President and CEO, alongside the appointment of Cory Ellspermann as CFO. The board of directors has also seen the addition of Kelly Ganjei as Chairman, indicating a strong commitment to strategic direction moving forward.
Financial Overview for Q3 2025
The financial results for the third quarter revealed some interesting metrics:
- Net loss attributable to common stockholders stood at approximately $6.5 million, a notable decrease from the previous year’s $12.1 million loss.
- Research and development expenses for this quarter were around $4.9 million, also significantly reduced from $10.1 million year-over-year.
- The company maintained a solid cash position, reporting approximately $27.7 million in cash and cash equivalents.
- As of this reporting, INmune Bio has approximately 26.6 million shares outstanding.
These financial results reflect the company’s ability to streamline operations while still investing in the research and development necessary for future growth.
Participate in the Earnings Call
Investors and interested parties are encouraged to participate in the upcoming earnings call for further insights into INmune Bio's current strategies and future plans. The call takes place at 4:30 PM Eastern Time on the same day as this report, with dial-in details provided for accessibility.
Frequently Asked Questions
What are CORDStrom™ and its significance?
CORDStrom™ is a groundbreaking treatment product developed for recessive dystrophic epidermolysis bullosa (RDEB), aimed at addressing critical gaps in current therapies for this rare condition.
How does XPro™ differ from traditional Alzheimer’s treatments?
XPro™ selectively neutralizes soluble TNF without affecting other components, potentially offering a safer and more effective alternative for Alzheimer's disease treatment.
What safety measures are in place during clinical trials?
INmune Bio prioritizes patient safety through rigorous reporting and monitoring processes to ensure any adverse effects are quickly addressed.
Who has been appointed to the leadership team recently?
The company has welcomed David Moss as CEO and Cory Ellspermann as CFO, reinforcing its commitment to strategic growth and financial oversight.
How can I learn more about INmune Bio’s research programs?
Visit INmune Bio’s official website for detailed updates on their clinical trials and product pipelines, highlighting their innovative approaches to immunotherapy.
