On March 30, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported financial results for the year ended December 31, 2022 (Press release, Can-Fite BioPharma, MAR 30, 2023, View Source [SID1234629582]).
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2022 & Recent Corporate and Clinical Development Highlights Include:
PICLIDENOSON
Phase III COMFORT Psoriasis Trial Met Primary Endpoint – Patients receiving Piclidenoson 3mg demonstrated a statistically significant improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index (PASI) 75 response at week 16 of treatment. An excellent safety profile was recorded.
Pivotal Phase III Psoriasis Registration Plan for Piclidenoson Submitted to EMA – Can-Fite submitted a market registration plan to the European Medicines Agency (EMA) for Piclidenoson in the treatment of moderate to severe psoriasis. A submission to the U.S. Food and Drug Administration (FDA) will follow.
Developing Piclidenoson as a Topical Psoriasis Treatment – In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured by PASI calculated based on observation of erythema, thickness, scaling, and a score of skin lesions. The topical treatment may serve as a complementary product to oral Piclidenoson.
Piclidenoson Advances as a Treatment for Osteoarthritis in Dogs – Vetbiolix, Can-Fite’s veterinary commercialization partner, achieved progress in the development of Piclidenoson for the canine osteoarthritis market projected to reach $3 billion by 2028. Vetbiolix is covering all costs associated with veterinary clinical development.
NAMODENOSON
Namodenoson Found to Significantly Inhibit Pancreatic Cancer in Preclinical Studies – Namodenoson was found to have a significant anti-cancer effect in pancreatic carcinoma as a monotherapy, as well as an additive effect when combined with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer. Namodenoson’s excellent safety profile and its ability to directly inhibit the growth of pancreatic tumors present its potential as an effective drug for the treatment of this disease which has a 5-year survival rate of only 11% in the U.S. Can-Fite has filed a patent application that covers the use of Namodenoson for the treatment of pancreatic cancer.
The U.S. Patent and Trademark Office Granted Can-Fite a Patent for the Treatment of Liver Fibrosis – The invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA" is a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications. The patent opens an opportunity for much broader market needs which entail all clinical conditions with advanced liver fibrosis.
Ongoing Advanced Clinical Studies with Namodenoson:
● Pivotal Phase III Liver Cancer Study for Namodenoson – Can-Fite’s pivotal Phase III liver cancer study for Namodenoson will enroll ~450 patients diagnosed with advanced hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to 1 or 2 other lines of therapy. The primary end point is overall survival. An interim analysis will be performed.
● Phase IIb Namodenoson NASH Study – 140 subjects with biopsy-confirmed NASH will be enrolled in the Phase IIb multicenter, randomized, double-blind, placebo-controlled study. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo as determined by a histological endpoint. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect.
Following Complete Response in a Patient with Advanced Liver Cancer Treated with Namodenoson:
● Namodenoson Approved for Compassionate Use in Romania – Romania became the second country, following Israel, to approve Namodenoson for compassionate use in patients with advanced liver cancer. Namodenoson induced a complete response with disappearance of all metastases in a patient who was enrolled in Can-Fite’s prior Phase IIb liver cancer study. The patient is continuing treatment under the compassionate use program.
● Patients with Decompensated Liver Cirrhosis Will Be Treated with Namodenoson Under Compassionate Use in Israel – Patients with decompensated cirrhosis, an advanced form of cirrhosis associated with liver failure for which there are no therapeutic options other than liver transplantation, will be treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use. Decompensated cirrhosis is an advanced form of cirrhosis associated with liver that impacts an estimated 10.6 million people globally.
"With two Phase III indications advancing through our pipeline, we look ahead to the potential commercialization of our small molecule drugs, Piclidenoson and Namodenoson," stated Can-Fite CEO Dr. Pnina Fishman. "Namodenoson in particular is showing the potential for efficacy across several indications from liver disease to pancreatic cancer. We remain focused and committed to bringing our safe, oral drugs to patients with unmet needs."
Financial Results
Revenues for the year ended December 31, 2022 were $0.81 million, a decrease of $0.04 million, or 4.7%, compared to revenues of $0.85 million during the twelve months ended December 31, 2021. The decrease is considered to be not material.
Research and development expenses for the year ended December 31, 2022 were $7.76 million, a decrease of $2.09 million, or 21.2%, compared to $9.85 million for the year ended December 31, 2021. Research and development expenses for the year ended December 31, 2022 comprised primarily of expenses associated with the completion of the Phase III study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase III study in the treatment of advanced liver cancer and a Phase IIb study for NASH. The decrease is primarily due to the wrap up of the Phase III study of Piclidenoson for the treatment of psoriasis in 2022.
General and administrative expenses were $3.14 million for the year ended December 31, 2022, a decrease of $0.70 million, or 18.2%, compared to $3.84 million for the same period in 2021. The decrease is primarily due to the decrease in professional services and public and investor relations expenses. We expect general and administrative expenses will remain at the same level for 2023 and beyond.
Financial expense, net for the year ended December 31, 2022 was $0.07 million compared to financial income, net of $0.22 million for the same period in 2021. The decrease in financial income, net was mainly due to an increase in revaluation of our short-term investments which was offset by an increase in interest from short term deposits.
Can-Fite’s net loss for the year ended December 31, 2022 was $10.17 million compared with a net loss of $12.61 million for the same period in 2021. The decrease in net loss was primarily attributable to a decrease in research and development expenses and a decrease in general and administrative expenses.
As of December 31, 2022, Can-Fite had cash, cash equivalents, and short-term deposits of $7.97 million as compared to $18.90 million at December 31, 2021. The decrease in cash during the year ended December 31, 2022 is due to Company’s operating activity. During January 2023, the Company raised approximately $6.80 million net.
The Company’s consolidated financial results for the twelve months ended December 31, 2022 are presented in accordance with US GAAP Reporting Standards.
More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2022, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at View Source as well as via the Company’s investor relations website at View Source The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778, Israel or by phone at +972-3-9241114.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
December 31,
2022 2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 2,978 $ 4,390
Short-term deposits 5,001 14,512
Prepaid expenses, and other current assets 1,170 929
Short-term investment 8 237
Total current assets 9,157 20,068
NON-CURRENT ASSETS:
Operating lease right of use assets 84 138
Property, plant and equipment, net 42 47
Total non-current assets 126 185
Total assets $ 9,283 $ 20,253
CONSOLIDATED BAL
U.S dollars in thousands (except for share and per share data)
December 31,
2022 2021
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables $ 896 $ 954
Current maturity of operating lease liability 48 53
Deferred revenues 783 818
Other accounts payable 775 905
Total current liabilities 2,502 2,730
NON-CURRENT LIABILITIES:
Long-term operating lease liability 14 71
Deferred revenues 2,295 3,070
Total non-current liabilities 2,309 3,141
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no par value – Authorized: 5,000,000,000 shares at December 31, 2022 and 2021; Issued and outstanding: 815,746,293 shares as of December 31, 2022 and 2021 - -
Additional paid-in capital 154,192 153,929
Accumulated other comprehensive income 1,127 1,127
Accumulated deficit (150,847 ) (140,674 )
Total shareholders’ equity 4,472 14,382
Total liabilities and shareholders’ equity $ 9,283 $ 20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Year ended December 31,
2022 2021 2020
Revenues $ 810 $ 853 $ 763
Research and development expenses (7,763 ) (9,850 ) (11,951 )
General and administrative expenses (3,143 ) (3,845 ) (2,951 )
Operating loss (10,096 ) (12,842 ) (14,139 )
Total financial income (expense), net (77 ) 227 (304 )
Loss before taxes on income (10,173 ) (12,615 ) (14,443 )
Taxes on income - - -
Net loss $ (10,173 ) $ (12,615 ) $ (14,443 )
Deemed dividend - (2,590 ) (715 )
Total comprehensive loss $ (10,173 ) $ (15,205 ) $ (15,158 )
Basic and diluted net loss per share $ (0.01 ) $ (0.03 ) $ (0.04 )
Weighted average number of ordinary shares used in computing basic and diluted net loss per share 815,746,293 553,079,638 358,411,297