Can-Fite Reports First Quarter 2021 Financial Results & Provides Clinical Update

Rhea-AI Summary

Can-Fite BioPharma Ltd (NYSE American: CANF) reported its financial results for Q1 2021, revealing revenues of $0.15 million, down 25.2% from $0.20 million in Q1 2020. The company secured a $42.7 million out-licensing deal with Ewopharma, including $2.25 million upfront and up to $40.45 million contingent on milestones. The Phase III Comfort™ psoriasis study reached 75% enrollment, with topline results anticipated in Q4 2021. Can-Fite’s R&D expenses declined by 65.5% to $1.30 million, while general and administrative expenses rose to $1.01 million. Future trials for liver cancer and NASH are set for late 2021.

Positive

• Secured $42.7 million out-licensing deal with Ewopharma, potentially worth $130 million in future payments.
• 75% enrollment achieved in Phase III Comfort™ psoriasis study, with topline results expected by Q4 2021.
• R&D expenses decreased by 65.5% to $1.30 million, indicating cost management.
• Plans to commence pivotal Phase III liver cancer trial in Q4 2021.

Negative

• Revenues decreased by 25.2% to $0.15 million from $0.20 million year-over-year.
• General and administrative expenses increased by $0.3 million, potentially indicating rising operational costs.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended March 31, 2021.

Clinical Developments and Corporate Highlights Include:

Signed Large Out-licensing Deal Worth $42.7 Million with Ewopharma –During the first quarter, Can-Fite signed a large out-licensing agreement with Swiss-based Ewopharma for distribution of its drug candidates in Central Eastern Europe and Switzerland, receiving $2.25 million upfront with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Together with Ewopharma, Can-Fite’s existing out-licensing deals are worth a potential $130 million in future milestone payments plus double-digit royalties on net sales upon regulatory approvals. Can-Fite has received over $20 million in non-dilutive funding to date.

Phase III Psoriasis Study Achieves 75% Enrollment – The Phase III Comfort™ study completed enrollment of 75% of planned patients for the study which is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla®) in patients with moderate to severe plaque psoriasis. The majority of costs associated with the Phase III Comfort™ study have been previously paid. The Company expects to complete enrollment in Q3 2021 and report topline results in Q4 2021.

Phase II COVID-19 Study Expands to Europe – Can-Fite is enrolling 40 patients hospitalized with moderate to severe COVID-19 in its Phase II study, under a U.S. Food and Drug Administration (FDA) approved protocol, in Israel and Europe.

Phase IIb NASH Study Expected to Commence Q4 2021 – Based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson which met its primary endpoint, Can-Fite completed the design of a Phase IIb study with the help of top NASH Key Opinion Leaders, Dr. Friedman and Dr. Harrison, and the Company plans to commence the Phase IIb study before the end of 2021.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 - Can-Fite is preparing to commence its pivotal Phase III trial for the treatment of hepatocellular carcinoma (HCC) based on a protocol agreed upon with the U.S. FDA and the European Medicines Agency. Should the study meet its efficacy endpoint and be approved by the FDA and EMA, Namodenoson would become one of only a few drugs available to treat advanced liver cancer patients. Recently announced data from Can-Fite’s Phase II advanced liver cancer study included overall survival of 4 years in two patients. Additional findings show disappearance of ascites, normal liver function and good quality of life. A scientific paper titled, “Namodenoson in Advanced Hepatocellular Carcinoma and Child–Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial” published in the peer reviewed journal Cancers provided more in-depth data from the Phase II study including a significant 12-month overall survival benefit in the CPB7 population, the target population for the pivotal Phase III study.

Cannabis Compounds May Have Role in Treatment of Liver Diseases - Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis. Liver fibrosis is associated with increased liver disease including NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Topical CF602 Shows Preclinical Efficacy in Erectile Dysfunction (ED) – A new preclinical study of Can-Fite’s drug candidate CF602 in the treatment of ED in a diabetes experimental rat model showed that topically applied CF602 resulted in a statistically significant improvement in ED compared to controls. CF602 may be an ideal candidate for development due to topical efficacy, as ED is a common complication of diabetes and is difficult to treat with systemic drugs due to the high risk profile of these patients.

“Our robust advanced stage clinical pipeline, including a pivotal trial in liver cancer expected to commence in the fourth quarter, is supported by our growing number of global distribution agreements and accompanying non-dilutive funding,” stated Can-Fite CEO Dr. Pnina Fishman. “Recent efficacy findings in cannabis and ED create additional co-development and funding opportunities for Can-Fite with pharma partners.”

Financial Results

Revenues for the three months ended March 31, 2021 were $0.15 million, a decrease of $0.05 million, or 25.2%, compared to $0.20 million for the three months ended March 31, 2020. The decrease in revenues was mainly due to the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals which were offset by the recognition of an advance payment portion received under a distribution agreement with Ewopharma.

Research and development expenses for the three months ended March 31, 2021 were $1.30 million, a decrease of $2.47 million, or 65.5%, compared to $3.77 million for the three months ended March 31, 2020. Research and development expenses for the first quarter of 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first quarter of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis partially offset by the two ongoing studies of Piclidenoson in the first quarter of 2021. We expect that the research and development expenses will increase through 2021 and beyond.

General and administrative expenses for the three months ended March 31, 2021 were $1.01 million an increase of $0.3

FAQ

What were Can-Fite BioPharma's revenues for Q1 2021?

Can-Fite reported revenues of $0.15 million for Q1 2021, a 25.2% decrease from $0.20 million in Q1 2020.

When will Can-Fite's Phase III Comfort™ psoriasis study report results?

Topline results from the Phase III Comfort™ study are expected to be reported in Q4 2021.

What is the significance of the $42.7 million deal with Ewopharma for CANF?

The deal provides Can-Fite with $2.25 million upfront and up to $40.45 million based on regulatory and sales milestones, enhancing its financial position.

What are Can-Fite's plans for future clinical trials?

Can-Fite plans to commence pivotal Phase III trials for liver cancer and the Phase IIb trial for NASH in Q4 2021.