INmune Bio, Inc. is making strides in its clinical programs, particularly with XPro in Alzheimer's disease (AD), while navigating significant financial challenges. The biotechnology firm, focused on developing treatments for neurodegenerative diseases and cancer, recently released its Form 10-Q report for the quarter ended September 30, 2024, outlining both progress and financial concerns.
Clinical Trial Advancements
The company's Phase II trial for Alzheimer's disease is ongoing, showing significant enrollment progress. Data from the Phase I trial of XPro in Alzheimer's indicated a notable decrease in biomarkers of neurodegeneration and improvements in synaptic function. These findings support the continued development of XPro and its potential as a disease-modifying therapy. INmune Bio is also progressing with its Phase I/II trial for INKmune in metastatic castrate-resistant prostate cancer (mCRPC), which has moved to the second cohort.
Regulatory Strategy
INmune Bio plans to pursue accelerated approval pathways and Fast Track status for XPro in Alzheimer's disease. The company anticipates potential eligibility for Breakthrough Therapy designation after the completion of the Phase II trial in 2025. These regulatory strategies aim to expedite the development and approval process, addressing the urgent unmet need in Alzheimer's treatment.
Financial Challenges and Outlook
Despite clinical advancements, INmune Bio faces substantial financial hurdles. The company reported $0 revenue for the three months ended September 30, 2024, and operating expenses of $12.3 million for the same period, resulting in a net loss of $12.1 million. For the nine months ended September 30, 2024, the net loss totaled $32.9 million. The company anticipates continued significant expenses and operating losses as it advances its clinical trials and research programs.
In the SEC filing, INmune Bio acknowledges that its current cash and cash equivalents may be insufficient to sustain operations through one year following the issuance of the financial statements, raising concerns about its ability to continue as a going concern. The company is exploring various strategies to secure additional funding, including public or private sales of equity, debt financings, government funding, collaborations, and licensing arrangements.
Treatment-Resistant Depression Program
Beyond Alzheimer's disease, INmune Bio is preparing for a Phase II trial of XPro in treatment-resistant depression (TRD), supported by a $2.9 million award from the National Institute of Mental Health (NIMH). Enrollment for this trial is expected to begin after the AD Phase II trial completes patient enrollment. This expansion into TRD highlights the potential of the DN-TNF platform to address multiple neurological disorders.
Strategic Focus and Risks
INmune Bio is actively advancing its clinical trials and research programs, focusing on its DN-TNF platform for Alzheimer's disease and treatment-resistant depression, as well as its INKmune platform for cancer treatment. However, the company acknowledges substantial risks and uncertainties, including clinical and regulatory risks, financial risks, and product development and commercialization risks. The success of clinical trials is uncertain, and there is no guarantee of regulatory approval.
