Can-Fite Announces H1 2024 Financials & Phase III Clinical Progress

RAMAT GAN, Israel, Aug. 29, 2024 -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology firm focusing on oncological and inflammatory diseases, has released its financial results and clinical progress for the first half of 2024.

Key Highlights from H1 2024:

Warrant Exercises
In August, Can-Fite reported that certain outstanding warrants were exercised, generating approximately $5.0 million in gross proceeds. Specifically, these warrants allowed the purchase of up to 2,857,143 American Depositary Shares (ADSs) at an exercise price of $1.75 per ADS. As an incentive for immediate exercise, new unregistered warrants for up to 5,714,286 ADSs were issued.

Piclidenoson Developments
Vetbiolix, Can-Fite’s partner, reported positive interim results from a clinical study on osteoarthritis in dogs using Piclidenoson. Vetbiolix can now opt to enter a full licensing agreement, requiring upfront and milestone payments to Can-Fite, along with sales royalties post-regulatory approval.

Namodenoson Advancements 
For liver cancer, Can-Fite’s Phase 3 pivotal study now spans 31 recruiting medical centers across Europe, Israel, and the US. Namodenoson has received Orphan Drug status from both the FDA and European Medicines Agency and has Fast Track Status with the FDA. Compassionate use programs in Israel and Romania continue, and two scientific articles have been published highlighting Namodenoson's potential in treating advanced liver cancer and MASH.

For pancreatic cancer, Can-Fite secured approval from the Institutional Review Board (IRB) of Rabin Medical Center for a Phase IIa study and awaits further approval from the Israeli Ministry of Health (MOH). An application for Orphan Drug Designation for pancreatic carcinoma treatment is also under review by the FDA.

In treating MASH, the FDA granted IND clearance for a Phase IIb study. Can-Fite is enrolling patients in both Europe and Israel, with US recruitment authorized by the FDA.

Motti Farbstein, Can-Fite’s CEO & CFO, emphasized the company's ongoing commitment to advancing its clinical programs: “With two drugs in advanced clinical stages, we continue to enroll patients and push toward positive outcomes, targeting unmet needs in multi-billion-dollar markets.”

Financial Performance
For the six months ending June 30, 2024, Can-Fite reported revenues of $0.32 million, down from $0.39 million during the same period in 2023. This revenue mainly reflects advance payment recognitions from distribution agreements with entities like Gebro, CKD, Cipher, and Ewopharma.

Research and development expenses decreased to $2.89 million from $3.42 million in the previous year, primarily due to reduced costs associated with Piclidenoson. General and administrative expenses slightly increased to $1.53 million, attributed to a cut in D&O insurance and bonus expenses.

The net financial income for the period was $0.14 million, a drop from $0.28 million in 2023, mainly due to decreased income from short-term deposits. The net loss for the first half of 2024 was $3.95 million, compared to $4.22 million in 2023, largely due to lower operating expenses.

As of June 30, 2024, the company held cash and cash equivalents and short-term deposits totaling $4.72 million, down from $8.90 million on December 31, 2023. This reduction is attributed to ongoing operational activities.

In addition to the warrant exercises, on August 8, 2024, Can-Fite entered an inducement offer agreement with a warrant holder for the cash exercise of warrants to purchase 2,857,143 ADSs, receiving total gross proceeds of $5 million. New warrants for 5,714,286 ADSs at $2.25 per ADS were also issued, along with warrants for 200,000 ADSs at $2.1875 per ADS to the placement agent.

The company’s financial statements for the six months ending June 30, 2024, are prepared in accordance with US GAAP Reporting Standards.

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