Full Press Release Details
Can-Fite Reports 2023 Financial Results
Ewopharma acquired marketing rights for namodenoson
in the treatment of pancreatic carcinoma
RAMAT GAN, Israel, March 28, 2024 -- Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that
address oncological and inflammatory diseases, today announced financial results and clinical updates for the twelve months ended December
Recent Clinical & Development Milestones
Namodenoson Drug Candidate:
Can-Fite received a Notice of Allowance
from the Canadian Intellectual Property Office for its patent application titled "An A3 Adenosine Receptor Ligand For Use In Treating
Ectopic Fat Accumulation". This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH
a clinical indication that is being developed by Can-Fite. In a successfully concluded Phase IIa study, Namodenoson, one of the Company's
two drugs in advanced clinical development, reduced liver fat content, showed anti-inflammatory effects manifested by a significant decrease
in the liver enzymes ALT & AST, and decreased body weight in patients with NASH. A Company-sponsored study for Namodenoson for this
indication is currently enrolling patients for a Phase IIb study which will include 140 patients, in whom liver pathology is the primary
endpoint. Patent has already been issued in other major markets including the U.S., EU, Japan and China.
Piclidenoson Drug Candidate:
Positive Data from the COMFORT-1 Phase III
Psoriasis Study Published in a Top Scientific Journal The Journal of the European Academy of Dermatology and Venereology (EADV) published
an article titled "Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1)".
EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology.
The article's first author, Dr. K.A Papp, is an internationally renowned key opinion leader in the psoriasis field and was the engine
for some registered drugs on the market for this devastating skin disease. The EADV article presents the safety and efficacy of Piclidenoson
in the randomized, placebo- and active-controlled, double-blind Phase III COMFORT-1 trial. As previously reported, the study met its primary
endpoint which was the proportion of patients achieving 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline
(PASI-75) at Week 16 (3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for Piclidenoson vs. placebo, p=0.037). Piclidenoson's efficacy
continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile. Currently, Piclidenoson
is being evaluated in COMFORT-2 a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA).
"Our advanced-stage pipeline continues to
achieve milestones, with Piclidenoson and Namodenoson both positioned as potentially safe and effective treatments for the oncological
diseases liver cancer & pancreatic carcinoma and the inflammatory and metabolic diseases psoriasis and NASH. We anticipate additional
clinical progress and new out licensing deals in this year," stated Can-Fite CEO Motti Farbstein.
Revenues for the year ended December 31, 2023
were $0.74 million, a decrease of $0.07 million, or 8.6%, compared to $0.81 million for the year ended December 31, 2022. The decrease
in revenues was mainly due to the recognition a lower portion of advance payments received under the Ewopharma distribution agreement
entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals,
and Cipher Pharmaceuticals.
Research and development expenses for the year
ended December 31, 2023 were $5.98 million, a decrease of $1.78 million, or 22.9%, compared to $7.76 million for the year ended December
31, 2022. Research and development expenses for the year ended December 31, 2023 comprised primarily of expenses associated with the completion
of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment
of advanced liver cancer and a Phase 2b study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenosnon.
General and administrative expenses were $2.95
million for the year ended December 31, 2023 a decrease of $0.19 million, or 6.05%, compared to $3.14 million for the year ended December
31, 2022. The decrease is primarily due to the decrease in directors and officer's insurance policy premium. We expect that general
and administrative expenses will remain at the same level through 2024.
Financial income (expense), net for the year ended
December 31, 2023 aggregated $0.56 million compared to financial expense, net of $(0.07) for the year ended December 31, 2022. The decrease
in financial expense, net was mainly due to increase interest from deposits and reduction in expenses related to the revaluation of our
short-term investment.
Net loss for the year ended December 31, 2023
was $7.63 million compared with a net loss of $10.17 million for the same period in 2022. The decrease in net loss for the year ended
December 31, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.
As of December 31, 2023, Can-Fite had cash and
cash equivalents and short term deposits of $8.90 million as compared to $7.98 million at December 31, 2022. The decrease in cash during
the year ended December 31, 2023 is due to the ongoing operations of the Company which was offset by the Company's financing during
January 2023 and exercise of certain warrants during November 2023.
The Company's consolidated financial results
for the year ended December 31, 2023 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, 2023,
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 http://www.sec.gov/ as well as via
the Company's investor relations website at https://ir.canfite.com. 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 26 Ben Gurion Street, Ramat Gan, 5257346, 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, | ||||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 4,278 | $ | 2,978 | ||||
| Short term deposits | 4,625 | 5,001 | ||||||
| Prepaid expenses and other current assets | 986 | 1,170 | ||||||
| Short-term investment | 19 | 8 | ||||||
| Total current assets | 9,908 | 9,157 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Operating lease right of use assets | 52 | 84 | ||||||
| Property, plant and equipment, net | 29 | 42 | ||||||
| Total non-current assets | 81 | 126 | ||||||
| Total assets | $ | 9,989 | $ | 9,283 |
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
| December 31, | ||||||||
| 2023 | 2022 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 427 | $ | 896 | ||||
| Current maturity of operating lease liability | 27 | 48 | ||||||
| Deferred revenues | 622 | 783 | ||||||
| Other accounts payable | 944 | 775 | ||||||
| Total current liabilities | 2,020 | 2,502 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long - term operating lease liability | 13 | 14 | ||||||
| Deferred revenues | 1,713 | 2,295 | ||||||
| Total long-term liabilities | 1,726 | 2,309 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at December 31, 2023 and December 31, 2022; Issued and outstanding: 1,359,837,393 and 815,746,293 shares as of December 31, 2023 and December 31, 2022 | - | - | ||||||
| Additional paid-in capital | 163,597 | 154,192 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (158,481 | ) | (150,847 | ) | ||||
| Total shareholders' equity | 6,243 | 4,472 | ||||||
| Total liabilities and shareholders' equity | $ | 9,989 | $ | 9,283 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
| Year ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues | $ | 743 | $ | 810 | ||||
| Research and development expenses | (5,983 | ) | (7,763 | ) | ||||
| General and administrative expenses | (2,955 | ) | (3,143 | ) | ||||
| Operating loss | (8,195 | ) | (10,096 | ) | ||||
| Total financial income (expense), net | 561 | (77 | ) | |||||
| Net loss | (7,634 | ) | (10,173 | ) | ||||
| Basic and diluted net loss per share | (0.01 | ) | (0.01 | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 1,278,333,912 | 815,746,293 |
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF)
(TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion
dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported
topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug,
Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for
hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan
Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration.
Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's
third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience
in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking
statements, about Can-Fite's expectations, beliefs or intentions regarding, among other things, its product development efforts,
business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those
relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of
forward-looking words such as "believe," "expect," "intend," "plan," "may,"
"should" or "anticipate" or their negatives or other variations of these words or other comparable words or by
the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated
or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that
have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause
Can-Fite's actual results, performance or achievements to be materially different from any future results, performance or achievements
expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements
to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and
needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties