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INMUNE BIO INC. (NASDAQ:INMB) - Pioneering Immunotherapies for Alzheimer's and Cancer
Published on September 24, 2024 | Ticker: INMB

INmune Bio Inc. (NASDAQ:INMB) is a clinical-stage biotechnology company focused on developing innovative therapies that reprogram the patient's innate immune system to treat disease. The company has two therapeutic platforms - a dominant-negative TNF platform (DN-TNF) and a Natural Killer (NK) cell priming platform (INKmune).

The DN-TNF platform, which includes lead candidate XPro1595, selectively neutralizes soluble tumor necrosis factor (sTNF) without affecting the beneficial trans-membrane TNF (tmTNF) or TNF receptors. This unique mechanism differentiates INmune's drugs from currently approved non-selective TNF inhibitors, which can cause immunosuppression and other safety issues. The company believes XPro1595 has potential applications in Alzheimer's disease, treatment-resistant depression, Duchenne muscular dystrophy, and cancer.

The INKmune platform aims to prime a patient's own natural killer (NK) cells to eliminate minimal residual disease in cancer. Unlike adoptive cell therapies, INKmune does not require pre-conditioning chemotherapy or NK cell stimulating cytokines. INmune is currently evaluating INKmune in a Phase I/II trial for metastatic castration-resistant prostate cancer.

Business Overview

INmune Bio was founded in 2015 and is headquartered in Boca Raton, Florida. The company has two wholly-owned subsidiaries - one in Australia and one in the United Kingdom - which allow it to participate in research and development tax credit programs in those countries.

The company's lead program, XPro1595 for Alzheimer's disease, is currently in a Phase II clinical trial called AD02. This 201-patient, 2:1 randomized, placebo-controlled study is evaluating the efficacy of XPro1595 in patients with early Alzheimer's disease and biomarkers of neuroinflammation. The primary endpoint is the Early/Mild Alzheimer's Cognitive Composite (EMACC), a more sensitive measure of cognitive function compared to traditional endpoints. Enrollment is expected to complete by mid-2024, with top-line data approximately 6 months later.

INmune is also preparing to initiate a Phase II trial of XPro1595 in patients with treatment-resistant depression (TRD) in the second half of 2024. This study will be supported by a $2.9 million grant from the National Institutes of Health.

On the oncology side, the company's INKmune program is being evaluated in a Phase I/II trial for metastatic castration-resistant prostate cancer (mCRPC). This open-label study is assessing the safety and efficacy of INKmune in priming patients' own NK cells to target their cancer. Enrollment in the Phase I portion is expected to complete by the end of Q3 2024, with the Phase II portion completing enrollment in Q2 2025.

Financials

For the full year 2023, INmune Bio reported revenue of $155,000 and a net loss of $30.0 million. The company's annual operating cash flow and free cash flow were both -$11.98 million.

In the first quarter of 2024, the company reported revenue of $14,000 and a net loss of $11.0 million. Research and development expenses were $8.7 million, up from $4.1 million in the prior year period, reflecting increased activity in the Alzheimer's and INKmune programs. General and administrative expenses were $2.3 million, flat year-over-year.

As of March 31, 2024, INmune Bio had $26.0 million in cash and cash equivalents. Subsequent to the quarter, the company raised an additional $14.5 million in gross proceeds from two equity offerings, providing runway into 2025. Management believes the current cash position is sufficient to fund operations through the key upcoming milestones, including completion of enrollment in the Alzheimer's Phase II trial and initial data readouts from the prostate cancer program.

Risks and Outlook

INmune Bio's success is dependent on the clinical and regulatory progress of its two therapeutic platforms. Failure or delays in the development of XPro1595 or INKmune could significantly impact the company's future prospects. Additionally, the company's recurring losses and negative cash flows raise substantial doubt about its ability to continue as a going concern.

However, the company's recent equity raises have strengthened its balance sheet, and management remains focused on executing on its key clinical programs. Upcoming milestones include:

- Completion of enrollment in the Alzheimer's Phase II trial (AD02) by mid-2024, with top-line data approximately 6 months later - Initiation of the Phase II trial of XPro1595 in treatment-resistant depression in the second half of 2024 - Completion of enrollment in the Phase I portion of the prostate cancer INKmune trial by the end of Q3 2024, with the Phase II portion expected to complete enrollment in Q2 2025

If the company can successfully advance its pipeline and achieve positive clinical results, it could unlock significant value for shareholders. However, the inherent risks of drug development, the company's history of losses, and its going concern uncertainty warrant a cautious approach. Investors should closely monitor INmune Bio's progress in the coming quarters and years.

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