INmune Bio Reports Q2 2024 Results and Business Update

INmune Bio Inc. (NASDAQ: INMB), a clinical-stage company focused on the development of therapies targeting the innate immune system, has disclosed its financial outcomes for Q2 2024, ending June 30, 2024. Furthermore, it provided an update on its ongoing business activities and progress in clinical trials.

DN-TNF Platform (XPro™) Highlights

INmune Bio's DN-TNF platform, primarily focused on XPro™, is advancing well. The Phase 2 clinical trial for Early Alzheimer's Disease is nearing full enrollment, anticipated by the end of the third quarter, with top-line data expected approximately six months after the last patient is enrolled. A blinded interim analysis of this trial confirmed that it is sufficiently powered to evaluate its primary and secondary cognitive endpoints, the Early Mild Alzheimer’s Cognitive Composite (EMACC) and CDR.

Additionally, new findings from a Phase 1b analysis of proteomic data, presented at the Alzheimer's Association International Conference (AAIC), highlighted XPro's significant impact on synaptic proteins and pathways after 12 weeks of treatment. This is critical as synaptic proteins are essential for neuronal communication, and their degradation leads to cognitive impairment in Alzheimer's Disease. The company also reported successful stability validation for XPro™, confirming a 24-month shelf life under specific storage conditions.

Two patients in the Phase 1b Alzheimer's Disease trial in Australia continue to receive XPro™ under an open-label program, showcasing potentially halting cognitive decline, contrasting current treatments that only decelerate the progression.

INKmune™ Platform Developments

INmune Bio has introduced a new formulation of INKmune™, which supports single-bag administration and expanded bioreactor capacity for scalable manufacturing. An IND amendment with this improved formulation has been submitted to the FDA, incorporating additional validation data to fortify supply chain redundancy.

The company completed the first cohort in the Phase I/II open-label trial of INKmune™ in metastatic castration-resistant prostate cancer (mCRPC). Following approval from the Safety Review Committee, the trial is progressing to the second dose level. Early data from this trial will be shared as it becomes available, with patient enrollment proceeding as scheduled.

Recent pre-clinical data and early clinical outcomes of INKmune™ have been published in the Journal for ImmunoTherapy of Cancer. The study indicates that memory-like natural killer (mlNK) cells, which are primed by INKmune™, are effective against multiple tumor types. This finding supports INKmune™'s methodology and suggests potent cancer immunotherapy potential.

Corporate Achievements

INmune Bio will present at BTIG’s Virtual Biotechnology Conference 2024 on August 6, 2024, with one-on-one meetings scheduled for August 5 and 6. The company also joined the Russell 3000® Index as of July 1, 2024.

Financially, the company raised $14.5 million in equity capital from two separate transactions in late April. Management and Board members participated in the first $4.8 million offering. INmune Bio also received approximately $2.5 million in research and development rebates from Australia.

Upcoming Milestones

- XPro™ Phase II Trial: Complete enrollment by the end of Q3 2024 and release top-line data six months post-enrollment.
- Treatment-Resistant Depression: Initiate Phase II trial in the second half of 2024.
- INKmune™ Phase I/II Trial: Finish Phase I enrollment by Q4 2024, with Phase II expected to complete in Q2 2025. Periodic updates on immunologic and therapeutic responses will be provided.

Financial Summary

For the quarter ending June 30, 2024, INmune Bio reported a net loss of approximately $9.7 million, compared to $6.5 million in the same period in 2023. Research and development expenses increased to $7.1 million from $4.1 million, and general and administrative expenses rose to $2.8 million from $2.3 million. The company had $31.1 million in cash and cash equivalents as of June 30, 2024, with approximately 19.8 million common shares outstanding as of August 1, 2024.

INmune Bio continues to advance its clinical programs while maintaining a robust financial position to support ongoing and future trials.

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