• Net Loss: Approximately $9.7 million for Q2 2024, compared to $6.5 million in Q2 2023.
• Research and Development Expense: $7.1 million for Q2 2024, compared to $4.1 million in Q2 2023.
• General and Administrative Expenses: $2.8 million for Q2 2024, compared to $2.3 million in Q2 2023.
• Cash and Cash Equivalents: Approximately $31.1 million as of June 30, 2024.
• Equity Offerings: Raised approximately $14.5 million in gross proceeds from two equity offerings.
• Shares Outstanding: Approximately 19.8 million shares of common stock as of August 1, 2024.

• Warning! GuruFocus has detected 3 Warning Signs with INMB.

Release Date: August 01, 2024

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

Positive Points

• INmune Bio Inc (NASDAQ:INMB) has made steady progress in both its Alzheimer's and cancer programs, with promising interim data from the Phase 2 Alzheimer's trial.
• The company's Alzheimer's drug, XPro, is showing potential in improving synaptic function, which is crucial for cognitive health.
• INKmune, the company's cancer treatment, has demonstrated the ability to create cancer-killing memory-like NK cells, showing promise for treating solid tumors.
• The company successfully raised approximately $14.5 million in gross proceeds from equity offerings, strengthening its financial position.
• INmune Bio Inc (NASDAQ:INMB) joined the Russell 3000 Index, which is expected to increase its visibility within the investment community.

Negative Points

• Enrollment for the Phase 2 Alzheimer's trial has taken longer than expected due to stringent patient selection criteria.
• The company's net loss increased to approximately $9.7 million for the quarter ended June 30, 2024, compared to $6.5 million for the same period in 2023.
• Research and development expenses rose significantly, totaling $7.1 million for the quarter, up from $4.1 million in the previous year.
• There is uncertainty regarding the EU's stance on anti-amyloid drugs, which could impact the Alzheimer's treatment landscape.
• The company faces challenges in manufacturing and scaling up its INKmune product, although steps are being taken to address these issues.

Q & A Highlights

Q: Can you explain the role of synaptic markers in Alzheimer's treatment and their relevance compared to other biomarkers like Phospho-tau? A: Christopher Barnum, Head of Neuroscience, explained that while synaptic markers are not a long-term biomarker solution, they are useful in reinforcing the biology of XPro. They align well with EEG changes, which are likely subserved by changes at the synapse level. Although not a permanent solution, they help support decision-making and align with the expected biology of XPro.

Q: What is the current understanding of what drives the biology of INKmune, and is there potential for it to be additive with cytokines? A: Mark Lowdell, Chief Scientific Officer, stated that INKmune is a complex cell with millions of molecules on its surface. While three critical molecules have been identified, replicating them artificially has been challenging. INKmune's unique mechanism involves trogocytosis, where NK cells incorporate INKmune's membrane, allowing them to prime other NK cells. This complexity makes it difficult to create an artificial version, but INKmune's safety and cost profile are advantageous.

Q: How is INmune Bio enriching for patients likely to complete the Phase 2 Alzheimer's trial, and what are the challenges? A: Christopher Barnum explained that the trial requires frequent monitoring, with patients needing to visit at least once a week. This high commitment level is communicated to patients upfront to ensure they can complete the trial. Additionally, the company is more rigid with clinical diagnosis criteria to ensure consistency, which slows enrollment but improves data quality.

Q: How do patients with biomarkers of inflammation fare compared to the general population in terms of baseline characteristics? A: Christopher Barnum noted that patients with biomarkers of inflammation generally have more severe and faster-progressing disease. However, the variance in progression among these patients is smaller, allowing for shorter trials with fewer patients.

Q: Why is the blinded interim data from the Alzheimer's trial exciting, and what insights does it provide? A: Christopher Barnum highlighted that the interim data confirmed the study's power and sample size assumptions, showing that the trial is accurately powered. The high quality of data collection and the independent consultant's praise for the data quality are encouraging, indicating that the trial is being conducted effectively.

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