Raphael Pharma Issues Shareholder Letter

Raphael Pharmaceutical Inc., a clinical-stage biotechnology firm, has issued a letter to its shareholders from CEO and Chairman, Shlomo Pilo. The company, which has been publicly traded since May 2021, focuses on developing cannabinoid-based treatments for inflammatory diseases. Pilo highlighted the company's exclusive relationship with Rambam Health Care Campus, a leading medical research institution in Israel, as a cornerstone of their innovative approach.

The origins of Raphael Pharmaceutical's research trace back to 2019, when Dr. Igal Louria-Hayon established the Medical Cannabis Research and Innovation Center (MCRIC) at Rambam. This exclusive partnership has provided Raphael with access to cutting-edge facilities and extensive resources, facilitating advanced cannabinoid research. The collaboration has been instrumental in the development of Raphael's unique technology platform and product pipeline.

Raphael’s research platform is characterized by an in-depth understanding of the interaction between the human endocannabinoid system, external cannabinoids from specific cannabis strains, intercellular communication, and immune response. This scientific approach aims to uncover the molecular mechanisms by which cannabis impacts the body, moving beyond anecdotal evidence. Their proprietary methods have identified 12 cannabinoid receptors in human and mouse models, enabling the development of formulations that potentially modulate inflammation.

The company's lead product candidate, HPC1, targets rheumatoid arthritis, a prevalent autoimmune disease affecting millions globally. Preclinical studies conducted in collaboration with Rambam showed that HPC1 could reduce pro-inflammatory cytokines, indicating its potential to slow disease progression. Raphael aims to offer a novel, cost-effective treatment alternative to current therapies, which often have significant side effects or high costs.

In May 2024, Raphael commenced an in-human proof of concept clinical study for HPC1 in the United States. This study, managed by Citruslabs, seeks to assess the effectiveness of HPC1 in rheumatoid arthritis patients. The first patient was enrolled in May, with the study expected to conclude by the end of 2024. Positive results could pave the way for partnerships or further clinical trials, marking a significant milestone for Raphael.

Beyond rheumatoid arthritis, Raphael is exploring broader applications of its cannabinoid-based platform. Preclinical research has indicated potential treatments for chronic lung inflammation. Studies using human donor cells and mouse models revealed that a high-cannabidiol, non-psychoactive cannabis strain (CBX) could prevent cytokine storms and reduce immune cell migration to the lungs. These findings, published in Frontiers in Immunology, support the development of a formula targeting autoimmune diseases and chronic lung inflammation, with FDA Phase I trials anticipated in 2025.

Raphael's mission emphasizes accessible medical solutions, aiming to provide affordable, effective treatments for inflammatory diseases. The company envisions an asset-light business model, leveraging royalty-based agreements and outsourcing manufacturing and distribution. Following U.S. FDA approval, Raphael plans to expand to Europe and other regions, ensuring global accessibility.

Raphael's leadership is committed to maintaining transparency and integrity in communications with shareholders and the financial community. The company believes its innovative medical solutions have the potential to address significant market needs, offering a promising investment opportunity.

Raphael Pharmaceutical Inc. continues to advance its cannabinoid-based research platform, with a strong focus on developing treatments that enhance patient quality of life while managing inflammation-related conditions.