Business Overview and Company History
INmune Bio Inc. is a clinical-stage biotechnology company that has developed an innovative approach to treating diseases by targeting the innate immune system. Founded in 2015 and headquartered in Boca Raton, Florida, the company has made significant strides in advancing its pipeline of therapies focused on Alzheimer's disease, treatment-resistant depression, and cancer.
INmune Bio was established in 2015 with the goal of developing novel treatments that leverage the power of the innate immune system to combat disease. The company's co-founders, Dr. RJ Tesi and Dr. Mark Lowdell, have extensive experience in the fields of immunology and inflammation, and they have assembled a talented team of scientists and clinicians to drive the company's research and development efforts.
In 2017, INmune Bio made significant strides in expanding its technological capabilities. The company licensed intellectual property for its DN-TNF platform from Xencor, Inc., which became a cornerstone of its research efforts. This platform utilizes technology to selectively neutralize soluble TNF, which the company believes plays a key role in diseases involving inflammation and immune dysfunction. In the same year, INmune Bio entered into an exclusive license agreement with Immune Ventures, LLC for its NK cell priming platform, called INKmune.
The company's early focus on Alzheimer's disease led to the advancement of its lead DN-TNF product candidate, XPro1595, into a Phase 1 clinical trial. This trial yielded positive results, demonstrating that XPro1595 could safely decrease neuroinflammation in patients. These encouraging findings informed the design of the company's subsequent Phase 2 trial in early Alzheimer's disease.
To support its growing research and development activities, INmune Bio secured a $15 million term loan agreement with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P. in 2021. However, the company faced financial challenges in 2022 and 2023, necessitating the renegotiation of certain terms with its lenders and the raising of additional capital through equity offerings.
Despite these financial hurdles, INmune Bio has continued to make progress in its clinical programs. In 2023, the company initiated a Phase 1/2 trial of its INKmune product candidate in metastatic castration-resistant prostate cancer, reporting positive early data. Additionally, INmune Bio has expanded its manufacturing capabilities and formed partnerships with academic institutions to further develop its mesenchymal stromal cell platform, CORDStrom.
Therapeutic Platforms and Pipeline
INmune Bio's approach is centered around two therapeutic platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform and the Natural Killer (NK) cell priming platform. The DN-TNF platform, which includes the lead drug candidates XPro, XPro1595, and INB03, focuses on selectively neutralizing soluble tumor necrosis factor (sTNF) without affecting the beneficial effects of transmembrane TNF (tmTNF) or TNF receptors. This unique mechanism of action differentiates INmune Bio's therapies from current non-selective TNF inhibitors, which can lead to adverse effects such as immunosuppression and demyelination.
The company's NK cell priming platform, led by the INKmune drug candidate, aims to convert a patient's resting NK cells into memory-like NK cells with enhanced ability to recognize and kill cancer cells. This approach is being evaluated in clinical trials for various hematologic malignancies and solid tumors.
INmune Bio has made significant progress in advancing its pipeline over the past several years. For Alzheimer's disease, the company completed a Phase 1 trial with XPro that demonstrated the ability to decrease neuroinflammation and biomarkers of neurodegeneration in patients with early AD and biomarkers of inflammation. Based on these results, INmune Bio initiated a Phase 2 blinded, randomized, placebo-controlled trial in 201 patients with early AD and biomarkers of inflammation. This trial, known as the "AD02" study, completed enrollment in September 2024 and is expected to report top-line data in the second quarter of 2025. The primary endpoint of this study is the Early-mild Alzheimer's Cognitive Composite (EMACC) score.
For treatment-resistant depression (TRD), INmune Bio received a $2.9 million grant from the National Institute of Mental Health (NIMH) to conduct a Phase 2 trial of XPro in TRD patients with peripheral biomarkers of inflammation. The company plans to initiate this trial in the second half of 2024, after completing enrollment in the Alzheimer's disease Phase 2 study.
In the oncology space, INmune Bio had a Phase 1 trial using INKmune to treat patients with high-risk myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), which demonstrated the safety and ability of INKmune to induce the development of cancer-killing memory-like NK cells. The company has also initiated a Phase 1/2 trial of INKmune in metastatic castration-resistant prostate cancer, known as the CaRe PC trial, with the goal of improving NK cell function and persistence to eliminate residual disease. INmune Bio expects to complete enrollment in the third cohort of this trial around January 2025 and complete the Phase 2 portion in Q2 or Q3 of 2025, with results to be released as they become available.
Financials
As of September 30, 2024, INmune Bio reported cash and cash equivalents of $33.6 million, which the company believes will be sufficient to fund its operations into the third quarter of 2025. The company's net loss for the nine months ended September 30, 2024, was $32.9 million, with research and development expenses totaling $25.8 million and general and administrative expenses of $7.4 million.
For the most recent fiscal year ended December 31, 2023, INmune Bio reported annual revenue of $155,000, an annual net loss of $30 million, and annual operating and free cash flow of negative $12 million. In the most recent quarter ended September 30, 2024, the company reported no revenue and a net loss of $12.1 million. Year-over-year, revenue decreased from $43,000 in Q3 2023 to $0 in Q3 2024, primarily due to the company not generating any product sales in Q3 2024. The net loss increased from $8.6 million in Q3 2023 to $12.1 million in Q3 2024, mainly due to increased research and development expenses related to the advancement of the company's Alzheimer's disease clinical program.
It's worth noting that INmune Bio has been able to leverage government and non-profit funding to support its research and development efforts. For example, the company's Phase 2 trial in treatment-resistant depression is being funded by a grant from the National Institute of Mental Health.
Liquidity
INmune Bio's current cash position of $33.6 million provides the company with a runway into the third quarter of 2025. This liquidity allows the company to continue advancing its clinical programs and pursuing its research and development objectives. However, as with many clinical-stage biotech companies, INmune Bio may need to secure additional funding in the future to support its ongoing operations and clinical trials.
As of December 31, 2023, the company reported a debt-to-equity ratio of 0.055, a current ratio of 2.59, and a quick ratio of 2.59. INmune Bio has a $15 million term loan facility with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P., of which $2.5 million was outstanding as of September 30, 2024.
The company's recurring net losses and negative cash flows from operations have raised substantial doubt about its ability to continue as a going concern. INmune Bio plans to seek additional financing through the public or private sale of equity, debt financing, or other capital sources to fund its ongoing operations and product development.
Competitive Landscape and Risks
INmune Bio operates in a highly competitive biotech industry, with numerous companies developing therapies for Alzheimer's disease, depression, and cancer. The company faces competition from both large pharmaceutical companies and other innovative biotechnology firms.
One of the key risks facing INmune Bio is the inherent uncertainty of clinical development. The success of the company's drug candidates is dependent on positive results from its ongoing and future clinical trials. Delays or failures in these trials could significantly impact the company's ability to bring its therapies to market.
Additionally, INmune Bio's reliance on government and non-profit funding, while beneficial, also introduces a degree of uncertainty. The company's ability to secure additional grants or collaborations could have a significant impact on its financial position and ability to advance its pipeline.
Outlook and Catalysts
As INmune Bio looks ahead, the company has several important milestones on the horizon. The expected readout of top-line data from the AD02 Phase 2 Alzheimer's trial in the second quarter of 2025 will be a crucial catalyst for the company, as positive results could pave the way for further development and potential partnerships.
The initiation of the Phase 2 trial in treatment-resistant depression, expected in the second half of 2024, will also be an important milestone as the company seeks to expand the application of its DN-TNF platform.
Additionally, the continued advancement of the INKmune program in metastatic castration-resistant prostate cancer, with the completion of the Phase 1/2 CaRe PC trial expected in Q2 or Q3 of 2025, will be closely watched by investors and the broader oncology community.
INmune Bio's innovative approach to targeting the innate immune system, its diversified pipeline, and its current financial position position the company as a potentially compelling investment opportunity in the dynamic and rapidly evolving biotech sector. However, investors should carefully consider the risks associated with clinical-stage biotechnology companies, including the need for additional financing and the uncertainties inherent in drug development.