INmune Bio Inc. Reports Q3 2024 Results and Business Update

INmune Bio Inc., a clinical-stage biotechnology company focused on using the patient's innate immune system to combat disease, recently reported financial results for the quarter ending September 30, 2024, and provided a business update.

**Key Developments in Q3 2024**

**DN-TNF Platform (XPro™)**:
The company completed enrollment for its Phase 2 Alzheimer's Disease (AD) trial, known as the AD02 trial, aimed at early AD patients with elevated neuroinflammation biomarkers. Enrollment concluded with sufficient participants in screening to meet the goal of 201 patients. Current screening participants remain eligible, allowing for slight over-enrollment.

Interim analysis of the trial's blinded data revealed significant findings:
- **Statistical Correlation**: Independent review confirmed a strong correlation (p<0.001) between baseline scores on the EMACC cognitive measure and the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a secondary endpoint.
- **Reliability**: EMACC showed a consistent correlation of 0.93 when measured at screening and first study visit.
- **Differentiation Capability**: EMACC effectively differentiated between prodromal AD (CDR global rating 0.5) and mild dementia (CDR rating 1.0), with a significant effect size (Cohen’s d of 0.87, p<.0001).

Noteworthy, INmune Bio published data in Cell Reports highlighting the role of microglia in cortical remyelination and the impact of soluble TNF in neurodegenerative diseases, suggesting that blocking soluble TNF could be a viable treatment strategy.

A webinar on cognitive testing using EMACC and CDR-SB is scheduled for November 7, 2024.

**INKmune™ Platform**:
In the Phase I/II CaRe PC trial for metastatic castration-resistant prostate cancer (mCRPC), INKmune™ displayed excellent safety and increased NK-cell activity. The first dose cohort showed notable changes in NK cell phenotype and function, with an increase in activated NK cells and sustained function for over 40 days post-infusion. One participant experienced a 21% reduction in PSA levels correlated with enhanced NK cell activity.

So far, 21 INKmune™ administrations in the mCRPC study reported no significant adverse events, including zero instances of cytokine release syndrome (CRS). Combining results from MDS/AML and mCRPC trials, over 30 safe infusions of INKmune™ have been administered without conditioning therapy, pre-medication, or cytokine support.

The CaRe PC trial recently began dosing in the highest cohort and opened phase II enrollment for the intermediate dose group. Higher dose cohorts will be monitored, with results expected as they become available.

Additionally, a landmark paper published in the Journal Immunotherapy of Cancer demonstrated that memory-like NK cells, primed by cytokines or INKmune™, show increased cytotoxicity against various tumors. This research supports INKmune™'s potential in cancer immunotherapy, highlighting its efficacy in converting patients' NK cells into potent tumor-killing cells.

INmune Bio also announced a new INKmune™ formulation that supports higher doses with a single bag administration and expanded bioreactor capacity, enhancing scalable manufacturing. An IND amendment with the improved formulation has been submitted to the FDA.

**Corporate Developments**:
- INmune Bio executed securities purchase agreements, raising approximately $13.0 million.
- The Company was added to the Russell 3000® Index on July 1, 2024.
- Received a $2.5 million research and development rebate from Australia in July.

**Upcoming Milestones**:
- Top-line data from the Phase 2 Alzheimer’s trial expected in Q2 2025.
- Phase II trial of XPro™ in Treatment-Resistant Depression to begin 2H 2024.
- Completion of Phase I enrollment of INKmune™ trial in mCRPC by year-end, with Phase II expected to complete in Q2 2025.

**Financial Summary for Q3 2024**:
- Net loss for Q3 2024 was approximately $12.1 million, up from $8.6 million in Q3 2023.
- Research and development expenses increased to approximately $10.1 million, compared to $6.0 million in Q3 2023.
- General and administrative expenses were approximately $2.2 million, down from $2.6 million in Q3 2023.
- The Company had cash and cash equivalents totaling approximately $33.6 million as of September 30, 2024.
- As of October 31, 2024, INmune Bio had around 22.2 million common shares outstanding.

INmune Bio continues to advance its clinical trials and research, aiming to harness the innate immune system to address neurologic diseases and cancer effectively.