INmune Bio Inc. (INMB) has announced a public offering of 2,341,260 shares of its common stock, combined with warrants to purchase an equivalent number of shares. Priced at $5.50 per share and accompanying warrant for Third-party investors and $6.50 for Insiders, the offering aims to generate approximately $12 million in net proceeds after deducting placement agent fees and estimated expenses. The offering closed on September 16, 2024.
Use of Proceeds
The company intends to allocate the net proceeds to several key initiatives:
- Phase 2 Alzheimer's Disease (AD) Trial of XPro: Funding to complete the ongoing clinical trial.
- Phase 2 Trial of Treatment-Resistant Depression (TRD): Initiation of a new clinical trial targeting TRD.
- INKmune Programs: Continued development of the INKmune platform.
- General Corporate Purposes: Allocation for working capital, research and development, and manufacturing activities.
Warrant Details
The warrants included in the offering are exercisable starting March 16, 2025, at an exercise price of $6.40 per share. They will expire on March 16, 2030, unless accelerated based on specific conditions. Acceleration can occur if INmune Bio publicly announces positive top-line data (EMACC p-value ≤ 0.05) from the Phase 2 Alzheimer's program of XPro1595, and the common stock price equals or exceeds 200% of the exercise price for fifteen consecutive trading days within one and a half years from the announcement, with a daily trading volume of at least $5.0 million for seven consecutive trading days.
Insider Participation
Certain officers, directors, and employees of INmune Bio have committed to purchasing approximately $800,000 worth of shares and warrants in this offering. These insiders will acquire the securities under the same terms as other investors, except for a slightly higher combined offering price of $6.50 per share and accompanying warrant. Additionally, insiders will have an extended exercise period for their warrants if the termination date falls during a trading blackout period.
Clinical Programs Overview
INmune Bio is a clinical-stage company focused on developing immunotherapies by targeting the innate immune system. Their two primary platforms are:
- DN-TNF Platform (XPro): This platform neutralizes soluble TNF (sTNF) without affecting trans-membrane TNF (tmTNF) or TNF receptors. The lead candidate, XPro, is currently in a Phase 2 trial for Alzheimer's disease and is also being developed for treatment-resistant depression (TRD) and cancer.
- NK Platform (INKmune): This platform aims to enhance the cancer-killing ability of natural killer (NK) cells. INKmune is being developed for NK-resistant hematologic malignancies and solid tumors.
The Phase II trial in early ADi has six important elements. Two hundred and one patients are being enrolled in a 2:1 ratio (XPro vs placebo). The patients will receive 1mg/kg/week as a subcutaneous injection for six months. An enrichment strategy identical to the successful strategy used in the Phase I trial will be used to ensure patients have neuroinflammation. Patients will need to have one or more enrichment criteria: elevated blood level of at least one of C-reactive protein, hemoglobin A1c, erythrocyte sedimentation or at least one allele of ApoE4. The primary endpoint will be Early/mild Alzheimer’s Cognitive Composite (“EMACC”), a validated cognitive measure that is more sensitive than traditional endpoints used in many studies of patients with early AD. Although EMACC is a primary endpoint, CDR-SB, a well recognized cognitive test is being used as a secondary endpoint as well.
The Company expects to receive authorization to initiate a clinical trial in TRD in the 2H24. The TRD trial is expected to start enrollment after the AD Phase II trial finishes patient enrollment.
The Phase I/II trial using INKmune™ to treat patients with metastatic castrate resistant prostate cancer (mCPRC) is an open label trial. Biomarker data from the patients will be visible as patients are treated. The Company will report data from each cohort as it becomes available. In addition to clinical data, the Company will communicate when the Phase I portion of the trial has completed follow-up. This is expected in September 2024. Because of the modified Bayesian design, the Company estimates the trial will be completely enrolled 1H25 with top-line data available 6 months later. Topline data are divided into immunologic and tumor response variables.
Financial Position
As of September 11, 2024, INmune Bio had 19,755,494 shares of common stock outstanding. The company's stock is listed on The Nasdaq Capital Market under the symbol "INMB."
Placement Agent
A.G.P./Alliance Global Partners acted as the sole placement agent for this offering.
