INmune Bio Inc. Reports Q1 2024 Results and Business Update

INmune Bio Inc., a clinical-stage immunology company, has released its financial results for Q1 2024 and provided updates on its ongoing projects. The company, which focuses on leveraging the innate immune system to combat diseases, highlighted several progress points in its various platforms.

For the DN-TNF Platform (XPro™), significant strides were made with the AD02 trial for Early Alzheimer’s Disease. This trial is on track to achieve its final enrollment target by mid-2024, with top-line data expected around six months after the last patient is enrolled. The trial is operational across North America, the UK, the EU, and the Pacific Rim. Following this, the company plans to hold a Phase II FDA meeting in early 2025 before transitioning to a global Phase III trial later that year.

Additionally, the company has completed extended stability validation for XPro™, demonstrating 24-month stability in solution at 2C-8C, which supports the dosing requirements anticipated in the Phase III trial. On April 30th, a press release showcased the progress of two patients from the Phase 1b AD trial in Australia, who continue to receive XPro™ treatment under an open-label program, underscoring the potential of XPro™ to prevent the progression of cognitive impairment.

In the INB03 cancer platform, two posters were presented at the American Association of Cancer Research in April 2024, highlighting research on MUC4 expression in high-risk breast cancer subtypes. The findings indicated that tumors expressing MUC4 exhibit unfavorable immunobiology and increased metastatic potential, driven by soluble TNF. Neutralizing soluble TNF with INB03 was shown to down-regulate immune checkpoint proteins on T cells and macrophages, suggesting that testing for MUC4 could predict resistance to first-line therapy and help improve treatment choices and patient outcomes.

The INKmune™ platform also saw advancements, with the first cohort in the Phase I/II trial for metastatic castration-resistant prostate cancer (mCRPC) successfully completing the initial dosing. The Safety Review Committee approved proceeding to the second dose level, and two patients have been enrolled. The first patient from the middle dose cohort is expected to be treated this month. Safety remains on track, with no significant adverse events reported from nine administrations in the mCRPC study. Combining experiences from the MDS/AML and mCRPC trials, over 20 INKmune infusions have been administered safely, without the need for conditioning therapy, pre-medication, or cytokine support. The trial features three dosing levels in a modified Bayesian Phase I/II trial.

On the corporate front, INmune Bio raised $14.5 million in equity capital through two transactions in late April. Management, employees, and board members purchased over 20% of the $4.8 million offering, demonstrating internal confidence in the company’s future. Both offerings were priced at the market, excluding shares and warrants acquired by insiders. The warrants terminate either two years from the initial exercise date or 30 trading days following the reporting of top-line data from the Phase 2 Alzheimer's program of XPro1595, whichever comes first. If the warrants are exercised for cash, the company would receive additional funding.

The company also outlined upcoming events and milestones, including full enrollment in the Phase II XPro™ trial for Alzheimer’s Disease expected by mid-2024, with top-line data six months thereafter. A Phase II trial for XPro™ in Treatment-Resistant Depression is slated to begin in the second half of 2024. For the mCRPC trial, Phase I enrollment is expected to complete by Q3 2024, with Phase II enrollment finishing by Q2 2025, allowing for periodic updates on immunologic and therapeutic responses to INKmune in trial participants.

Financially, INmune Bio reported a net loss of approximately $11.0 million for Q1 2024, a significant increase from the $6.5 million loss in Q1 2023. Research and development expenses more than doubled to $8.7 million. General and administrative expenses remained steady at $2.3 million. As of March 31, 2024, the company held cash and cash equivalents amounting to $26.0 million. Following the quarter’s end, the company raised an additional $16.6 million from common stock and warrant sales. As of May 9, 2024, INmune Bio had 19.8 million common shares outstanding.