Inmune Bio ((INMB)) has held its Q4 earnings call. Read on for the main highlights of the call.
INmune Bio’s recent earnings call presented a mixed sentiment, highlighting both significant milestones and notable challenges. The anticipation of Phase 2 trial results for Alzheimer’s and the BLA filing for the CORDStrom program were key positive highlights. However, the increased net loss and high patient screening failure rate posed challenges. Despite these hurdles, the company’s successful fundraising efforts have ensured financial stability, allowing it to continue operations smoothly.
Upcoming Phase 2 Trial Results for Alzheimer’s
INmune Bio is on the cusp of announcing top-line data for its Phase 2 trial using XPro to treat early Alzheimer’s disease, focusing on neuroinflammation. This announcement, expected in less than 100 days, is significant due to the trial’s innovative use of biomarkers for patient selection and the novel endpoint EMACC to assess cognitive function. The trial enrolled 208 patients across eight countries, employing a precision medicine approach.
CORDStrom Program for RDEB
The CORDStrom program is poised for a BLA filing and has been recognized with orphan drug status and rare pediatric disease designation. This program offers a systemic, disease-modifying approach for treating RDEB, with preparations for the BLA submission already underway. These developments mark a significant step forward in addressing this rare condition.
Financial Stability and Fundraising
INmune Bio has bolstered its financial position by raising $29.9 million through the sale of common stock and warrants, with the potential to secure an additional $30 million. The company currently holds cash and cash equivalents of approximately $20.9 million, ensuring it can fund operations through the third quarter of 2025. This financial stability is crucial for the company’s ongoing research and development efforts.
Increased Net Loss
The company reported a net loss of approximately $42.1 million for the year ended December 31, 2024, up from $30 million in 2023. This increase in net loss is primarily attributed to higher research and development expenses, reflecting the company’s commitment to advancing its pipeline.
High Patient Screening Failure Rate
The ADO2 trial for Alzheimer’s experienced a screening failure rate of about 72%, which is consistent with other Alzheimer’s trials. This high failure rate was mainly due to typical issues like diagnosis rather than the inflammatory biomarker criteria, highlighting the challenges of patient selection in Alzheimer’s research.
Forward-Looking Guidance
Looking ahead, INmune Bio is on track to announce top-line data for its Phase 2 trial of XPro in treating early Alzheimer’s disease with inflammation. The company is also preparing for significant milestones, including the completion of the metastatic castration-resistant prostate cancer program and the BLA filing for CORDStrom in the first quarter of 2025. These developments underscore the company’s strategic focus on advancing its clinical programs.
In conclusion, INmune Bio’s earnings call reflected a balanced sentiment, with promising developments in its Alzheimer’s and RDEB programs countered by financial and operational challenges. The company’s robust fundraising efforts have provided a solid foundation for continued progress, setting the stage for key upcoming milestones.