Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) announced today that it has secured $3 million in financing through a registered direct offering of American Depositary Shares (ADSs). The Israel-based biotechnology company, which specializes in developing small-molecule drugs for oncological and inflammatory diseases, has entered into definitive agreements to sell 2.5 million ADSs at a purchase price of $1.20 per share.
The transaction is expected to close on or about April 15, 2025, pending satisfaction of customary closing conditions. H.C. Wainwright & Co. is serving as the exclusive placement agent for the offering.
Funding Allocation for Clinical Development
According to company officials, the net proceeds from this offering will be directed toward funding ongoing research and development activities, advancing clinical trials, and supporting general working capital requirements. This financial boost comes at a critical time for Can-Fite as it progresses several key drug candidates through late-stage clinical development.
"This funding will help support our robust pipeline of therapeutic candidates that address significant unmet needs in oncology and inflammatory diseases," said a company representative. The financing was structured as a registered direct offering under a "shelf" registration statement previously filed with the U.S. Securities and Exchange Commission.
Advanced Clinical Pipeline
Can-Fite's drug development platform targets multi-billion dollar markets across several therapeutic areas. The company's lead drug candidate, Piclidenoson, recently reported topline results from a Phase III trial for psoriasis and has commenced another pivotal Phase III study. Psoriasis affects approximately 125 million people worldwide, representing a substantial market opportunity.
Namodenoson, the company's liver-focused drug candidate, is currently being evaluated in multiple clinical trials:
- A Phase III trial for hepatocellular carcinoma (HCC), the most common type of primary liver cancer
- A Phase IIb trial for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- A Phase IIa study in pancreatic cancer
The drug has received significant regulatory support, having been granted Orphan Drug Designation by both U.S. and European regulatory authorities. Additionally, the U.S. Food and Drug Administration has awarded Namodenoson Fast Track Designation as a second-line treatment for HCC, potentially expediting its development and review process.
Preclinical studies have also indicated that Namodenoson may have therapeutic potential in other cancer indications, including colon, prostate, and melanoma, further expanding its possible applications.
Safety Profile and Additional Pipeline Assets
A notable strength of Can-Fite's drug candidates is their established safety profile. The company reports that its drugs have been administered to over 1,600 patients in clinical studies to date, demonstrating excellent safety characteristics—a critical factor in drug development and regulatory approval.
Beyond Piclidenoson and Namodenoson, Can-Fite is advancing CF602, its third drug candidate, which has shown efficacy in the treatment of erectile dysfunction, representing yet another substantial market opportunity.
Market Position and Forward Outlook
Can-Fite BioPharma positions itself as an advanced clinical-stage drug development company with a technology platform designed to address substantial market opportunities. The global market for psoriasis treatments alone is projected to reach approximately $24 billion by 2027, while the hepatocellular carcinoma treatment market is expected to exceed $5 billion by 2025.
While the company has made significant progress with its clinical programs, it faces the typical challenges of clinical-stage biotechnology companies, including the need for ongoing capital to fund operations and clinical trials. This latest financing represents an important step in addressing these capital requirements.
The offering is being conducted pursuant to a "shelf" registration statement on Form F-3 that was filed with the SEC on September 1, 2023, and declared effective on September 12, 2023. Investors can access the final prospectus supplement and accompanying prospectus related to this offering through the SEC's website or by contacting H.C. Wainwright & Co.
