Form 10-Q for the Three Months Ended March 31, 2025

Press release · 05/08 21:14
Form 10-Q for the Three Months Ended March 31, 2025

Form 10-Q for the Three Months Ended March 31, 2025

Inmune Bio Inc. filed its Form 10-Q for the quarter ended March 31, 2025, reporting a net loss of $4.3 million, or $0.19 per share, compared to a net loss of $3.4 million, or $0.15 per share, for the same period in the prior year. The company’s total assets decreased to $23.4 million from $27.3 million at the end of the prior year, primarily due to a decrease in cash and cash equivalents. Research and development expenses increased to $2.5 million from $1.9 million, while general and administrative expenses decreased to $1.3 million from $1.6 million. The company had $10.3 million in cash and cash equivalents as of March 31, 2025, and anticipates that its current cash resources will be sufficient to fund its operations for at least the next 12 months.

Summary and Analysis of Key Points

Overview of the Company’s Financial Performance:

  • INmune Bio reported a net loss of $9.7 million for the three months ended March 31, 2025. As of March 31, 2025, the company had $19.3 million in cash and cash equivalents.
  • The company continues to incur significant development and other expenses related to its ongoing operations, resulting in substantial doubt about its ability to continue as a going concern within one year.
  • INmune Bio expects to continue incurring significant losses for the foreseeable future as it advances its product candidates through clinical development and seeks regulatory approvals.

Revenue and Profit Trends:

  • Revenues were $50,000 in Q1 2025 compared to $14,000 in Q1 2024, an increase of $36,000.
  • Research and development expenses decreased from $8.7 million in Q1 2024 to $7.6 million in Q1 2025, a decrease of $1.1 million.
  • General and administrative expenses were relatively flat at $2.3 million in both Q1 2025 and Q1 2024.
  • The company reported a net loss of $9.7 million in Q1 2025 compared to a net loss of $11.0 million in Q1 2024, an improvement of $1.3 million.

Strengths and Weaknesses: Strengths:

  • The company has made progress in advancing its key product candidates, including XPro1595 for Alzheimer’s disease and CORDStrom for recessive dystrophic epidermolysis bullosa (RDEB).
  • CORDStrom has received Rare Pediatric Disease and Orphan Drug Designations from the FDA, which provide certain benefits.
  • The company has secured funding, including a $2 million award from the National Institute of Mental Health to support the development of XPro1595 for treatment-resistant depression.

Weaknesses:

  • The company continues to incur significant losses and has substantial doubt about its ability to continue as a going concern within one year.
  • The company will need to secure additional funding, either through public or private equity, debt financing, or other sources, to continue its operations and advance its product candidates.
  • The company’s research and development expenses are expected to increase significantly as it advances its product candidates, which could further strain its financial resources.

Outlook for the Future:

  • The company plans to continue advancing its key product candidates, including XPro1595 for Alzheimer’s disease and CORDStrom for RDEB.
  • The company expects to report data from the Phase II trial of XPro1595 for Alzheimer’s disease in June 2025 and plans to hold an end-of-Phase II meeting with the FDA to finalize plans for a pivotal Phase III trial.
  • The company plans to submit a Biologics License Application (BLA) for CORDStrom for the treatment of RDEB in the first half of 2026 and also plans to submit Marketing Authorization Applications in the EU and UK.
  • The company’s ability to continue its operations and advance its product candidates will depend on its ability to secure additional funding, either through public or private equity, debt financing, or other sources.