Inmune Bio ((INMB)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Inmune Bio’s recent earnings call conveyed a generally positive sentiment, underscored by significant advancements in their CORDStrom and INKmune platforms. The company demonstrated improved operating efficiency, despite facing challenges with XPro trial results and regulatory delays.
CORDStrom Advances Towards Regulatory Approval
CORDStrom is making strides towards regulatory approval in both the U.K. and the U.S. The platform has shown significant improvements in patients with recessive dystrophic epidermolysis bullosa (RDEB), particularly in reducing itch and enhancing quality of life. This progress marks a crucial step forward in the company’s mission to address unmet medical needs.
XPro Potential in Alzheimer’s Disease
The XPro platform is showing promise in Alzheimer’s disease, particularly in patients with higher baseline inflammation. Inmune Bio is pursuing an accelerated regulatory pathway and is preparing for an end of Phase II meeting with the FDA, highlighting the platform’s potential impact on Alzheimer’s treatment.
INKmune Phase II Success in Prostate Cancer
INKmune has successfully completed its Phase II trial in prostate cancer ahead of schedule, achieving the primary endpoint and two of the three secondary endpoints. This success underscores the platform’s potential in oncology and strengthens Inmune Bio’s position in the cancer treatment landscape.
Financial Position and Reduced Loss
Inmune Bio reported a net loss of approximately $6.5 million for the quarter, a significant improvement from the $12.1 million loss in the same period last year. The company maintains a robust financial position with cash reserves of approximately $27.7 million, expected to fund operations into Q4 2026.
Challenges with XPro Trial Results
Despite the positive momentum, Inmune Bio faced challenges with the XPro platform, missing the top line on the MINDFuL trial. However, the company remains optimistic about the platform’s potential and is committed to overcoming these hurdles.
Delay in FDA Meeting for XPro
The anticipated end of Phase II meeting with the FDA for XPro has been postponed to Q1 2026, instead of occurring before the end of 2025. This delay represents a setback in the regulatory process, but the company is focused on aligning with regulatory expectations.
Forward-Looking Guidance
Inmune Bio provided key guidance metrics during the call, highlighting a net loss reduction and a strategic focus on advancing their platform programs. They plan to file a marketing authorization application for CORDStrom in the UK by mid-2026 and a biologics licensing application in the US thereafter. The company is also pursuing an accelerated regulatory pathway for XPro in Alzheimer’s treatment, with expectations for regulatory alignment with the FDA by Q1 2026.
In conclusion, Inmune Bio’s earnings call reflected a positive outlook, driven by advancements in their platform programs and improved financial performance. Despite facing challenges with XPro, the company remains committed to its strategic goals and regulatory milestones, promising a dynamic future for stakeholders.