INmune Bio (INMB) Q3 2024 earnings summary

Executive summary

• Completed enrollment in the global, blinded, randomized phase II trial of XPro (AD02) for Alzheimer's disease with inflammatory biomarkers, targeting 201 patients and supporting a potential phase III study in more countries and sites.

• INKmune, a novel NK-focused cancer program, is enrolling metastatic castration-resistant prostate cancer patients in a phase I/II trial, with the first patient in the highest dose cohort recently enrolled and positive safety data from the low-dose cohort.

• Interim blinded data from AD02 showed strong correlation between the novel EMACC cognitive measure and CDR-SB, supporting EMACC's sensitivity and precision.

• The company raised $13 million in gross proceeds from a registered direct equity offering, with management and board members participating, and has $33.6 million in cash and equivalents as of September 30, 2024.

• Substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and projected insufficient liquidity within one year.

Financial highlights

• Net loss attributable to common stockholders for Q3 2024 was $12.1 million, up from $8.6 million in Q3 2023; for the nine months ended September 30, 2024, net loss was $32.9 million, up from $21.6 million in the prior year period.

• Research and development expenses were $10.1 million for Q3 2024, compared to $6 million in the prior year quarter; for the nine months, R&D expenses rose to $25.8 million from $14.3 million.

• General and administrative expenses were $2.2 million for Q3 2024, down from $2.6 million in Q3 2023; for the nine months, G&A expenses were $7.4 million, up from $7.2 million.

• Cash and cash equivalents stood at $33.6 million at September 30, 2024, down from $35.8 million at December 31, 2023.

• Revenue for the nine months ended September 30, 2024, was $14,000, down from $127,000 in the prior year period, primarily from stem cell sales.

Outlook and guidance

• Cash is expected to fund operations into Q3 2025, but management projects insufficient liquidity to sustain operations for the next year.

• Top-line cognitive data from the phase II Alzheimer's trial is expected in Q2 2025, with additional regulatory meetings to follow.

• Phase II trial for treatment-resistant depression to initiate by year-end 2024.

• Completion of enrollment in the third cohort of the prostate cancer program expected by January 2025, with phase II extension results anticipated in Q2/Q3 2025.

• Management is evaluating financing strategies, including equity, debt, government funding, collaborations, and licensing, but there is no assurance of success.