Inmune Bio, Inc. Q3 FY2024 earnings call

• Closed enrollment on September 27 to the ADO2 global, blinded and randomized Phase II trial of XPro in patients with Alzheimer's disease and biomarkers of inflammation. This was a major achievement with the team navigating complex regulatory landscapes outside the U.S.
• INKmune, a novel MK focused cancer program, is enrolling patients in a Phase I/II trial for metastatic castrate-resistant prostate cancer (CaRe PC), with first patient in high-dose cohort enrolled and Phase II extension of intermediate dose cohort ongoing. Results from low-dose cohort showed consistent immunologic effects and excellent safety profile.
• ADO2 Phase II trial in Alzheimer's has primary objective of demonstrating improved cognitive function; enrollment completed, with clinical team focused on data collection. Operations team making progress in launching Phase II trial for treatment-resistant depression, anticipating first site open by end of 2024.
• INmune Bio raised $13 million in gross proceeds from a registered direct equity offering, with management and employees purchasing about $800,000 worth of stock, showing financial commitment.

No specific product segments with detailed financial performance and revenue contribution % provided in the transcript.

• Expect top line cognitive data from Phase II trial in Alzheimer's disease in Q2 of 2025.
• Initiate Phase II trial of XPro in patients with treatment-resistant depression by end of 2024.
• Complete enrollment in third cohort of metastatic castration-resistant prostate cancer program around January 2025 and complete Phase II portion expected in Q2/Q3 2025.
• Cash on hand sufficient to fund operations into Q3 2025.
• Expect to have secured additional funding and focus on achieving primary clinical objectives while being cost prudent.

Forward-looking statements involve risks and uncertainties such as actual results differing from forward-looking statements, which are subject to risks and uncertainties in clinical trials, regulatory approvals, and market acceptance. See company's SEC filings for detailed risk factors.

Q: In the XPro Phase II in Alzheimer's, talk about patient enrollment process and potential challenges in moving to Phase III or commercially.

A: RJ Tesi mentioned targeting patients with inflammation driving Alzheimer's disease, like those with ApoE4, about 50% of patients. CJ Barnum added that biomarker is not major issue for Phase III, but enrollment in early phase is more about similar pathology.

Q: Regarding the depression study, what biomarkers are used?

A: CJ Barnum said they use blood C-reactive protein and behavioral biomarker of anhedonia, with 45%-55% of patients expected to meet criteria.

Q: On INKmune, what needs to be seen to continue investment?

A: Unidentified representative said looking for clinical outcome convincing chief investigator of clinical response, with safety profile also important as median age of patients is 76.

Q: Changes in Alzheimer's trial since interim analysis?

A: CJ Barnum said no changes to criteria, and more on webinar about interim data.

Q: Delivery of INKmune?

A: Mark Lowdell explained it's delivered like regular medicine, at -80°C, using familiar infusion methods, suitable for outpatient setting and any infusion site.

Q: R&D rebate from Australia?

A: David Moss said rebate is from doing R&D in Australia, related to ADO2 program, no restrictions, and expected to reduce burn by ~$4 million next year.