• Net Loss: Approximately $42.1 million for the year ended December 31, 2024, compared to approximately $30 million for 2023.
• Research and Development Expenses: Approximately $33.2 million for the year ended December 31, 2024, compared with approximately $20.3 million for 2023.
• General and Administrative Expenses: Approximately $9.5 million for the year ended December 31, 2024, compared with approximately $9.6 million for 2023.
• Cash and Cash Equivalents: Approximately $20.9 million as of December 31, 2024.
• Additional Capital Raised: $5.4 million through the use of the ATM since year-end.
• Shares Outstanding: Approximately 22.9 million shares of common stock as of March 27, 2025.
• Capital Raised from Common Stock and Warrants: $29.9 million during 2024.

• Warning! GuruFocus has detected 2 Warning Signs with INMB.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• INmune Bio Inc (NASDAQ:INMB) is less than 100 days away from announcing topline data for their phase 2 trial targeting neuroinflammation in early Alzheimer's disease, which could potentially transform treatment paradigms.
• The ADO2 trial is unique in its use of biomarkers other than amyloid or tau for patient selection, focusing on neuroinflammation as a primary driver of Alzheimer's disease.
• INmune Bio Inc (NASDAQ:INMB) has completed the pivot to solid tumors with their NK cell targeting platform, showing progress in treating castrate-resistant metastatic prostate cancer.
• The company has raised $29.9 million from the sale of common stock and warrants, with potential to raise an additional $30 million through warrant exercises.
• INmune Bio Inc (NASDAQ:INMB) has a promising pipeline with the addition of Chordstrom, a systemic therapy for a rare genetic disease, which has already been awarded orphan drug status and rare pediatric disease designation.

Negative Points

• The company reported a net loss of approximately $42.1 million for the year ended December 31, 2024, compared to $30 million in 2023, indicating increased financial strain.
• Research and development expenses increased significantly to approximately $33.2 million in 2024 from $20.3 million in 2023, reflecting higher costs associated with their clinical programs.
• The company's cash and cash equivalents stood at approximately $20.9 million at the end of 2024, which may only be sufficient to fund operations through Q3 2025 without additional financing.
• The success of the ADO2 trial is critical, as it is the catalyst for future developments, and any negative results could significantly impact the company's prospects.
• There is uncertainty regarding the FDA's acceptance of the novel endpoints used in the ADO2 trial, which could affect the trial's regulatory approval process.

Q & A Highlights

Q: Is the 12-month open-label trial for the RD program required for filing, and are there different requirements for FDA and UK approval? A: Mark Lowdell, Chief Scientific Officer & Chief Manufacturing Officer, explained that the data from the current Mission EB trial is believed to be adequate for a BLA, although the final decision rests with the FDA. The open-label trial will provide additional insights into the drug's effects and optimal delivery, and it will be conducted in both the US and UK.

Q: Will the results of the XPro trial be staggered, and how will they be communicated? A: Christopher Barnum, Vice President, Neuroscience, confirmed that both cognitive and functional evidence will be available at the time of release. The company has worked to ensure data accuracy, and both EMAC and CDR endpoints will be released when the data becomes public.

Q: What is the FDA's stance on EMAC, and how does it relate to the trial's acceptance? A: Christopher Barnum stated that the FDA will review the data before commenting. The company has followed the FDA's guidelines and believes they have a strong case for acceptance, although the FDA's response can be unpredictable.

Q: Are there any concerns about patient dropouts in the XPro phase 2 trial, and what are the plans for a phase 3 trial? A: Christopher Barnum noted that dropout rates are within expected ranges and are mostly due to typical issues with elderly patients. The design and timing of a phase 3 trial will depend on the phase 2 data and discussions with the FDA.

Q: What are the plans for the potential commercial launch of Courtstrom? A: David Moss, CFO, indicated that while the company aims to move towards commercialization, they expect to partner for distribution and marketing, as they are not experts in those areas. The focus is on regulatory approval, and partnerships will be considered as they approach commercialization.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.