Can-Fite Reports 2023 Financial Results and Clinical Update
Ewopharma acquired marketing rights for namodenoson in the treatment of pancreatic carcinoma
Recent Clinical & Development Milestones Achieved
Namodenoson Drug Candidate:
-
Ewopharma recently acquired marketing rights for Namodenoson in the treatment of pancreatic carcinoma
This adds up to an out licensing agreement that Can-Fite signed withSwitzerland -based Ewopharma in 2021, for exclusive distribution of both Piclidenoson and Namodenoson in Central Eastern European (CEE) countries (Piclidenoson for the treatment of psoriasis and Namodenoson for the treatment of liver cancer and NASH). Under the terms of the distribution agreement,Ewopharma AG paid Can-Fite an upfront payment ofUS$2.25 million with up to an additionalUS$40.45 million , payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Recently,Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication. -
Can-
Fite Broadens its Strong Intellectual Property (IP) forNASH (MASH) : Received Patent Allowance inCanada
Can-Fite received a Notice of Allowance from theCanadian 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 theU.S. , EU,Japan andChina .
Piclidenoson Drug Candidate:
Positive Data from the COMFORT-1 Phase III Psoriasis Study Published in a
The Journal of the
“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
Financial Results
Revenues for the year ended
Research and development expenses for the year ended
General and administrative expenses were
Financial income (expense), net for the year ended
Net loss for the year ended
As of
The Company's consolidated financial results for the year ended
More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended
CONSOLIDATED BALANCE SHEETS
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2023 |
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2022 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
4,278 |
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$ |
2,978 |
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Short term deposits |
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4,625 |
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5,001 |
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Prepaid expenses and other current assets |
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986 |
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1,170 |
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Short-term investment |
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19 |
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8 |
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Total current assets |
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9,908 |
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9,157 |
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NON-CURRENT ASSETS: |
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Operating lease right of use assets |
52 |
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84 |
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Property, plant and equipment, net |
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29 |
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42 |
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Total non-current assets |
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81 |
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126 |
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Total assets |
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$ |
9,989 |
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$ |
9,283 |
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CONSOLIDATED BALANCE SHEETS
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2023 |
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2022 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Trade payables |
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$ |
427 |
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$ |
896 |
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Current maturity of operating lease liability |
27 |
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48 |
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Deferred revenues |
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622 |
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783 |
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Other accounts payable |
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944 |
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775 |
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Total current liabilities |
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2,020 |
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2,502 |
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NON-CURRENT LIABILITIES: |
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Long - term operating lease liability |
13 |
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14 |
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Deferred revenues |
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1,713 |
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2,295 |
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Total long-term liabilities |
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1,726 |
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2,309 |
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CONTINGENT LIABILITIES AND COMMITMENTS |
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SHAREHOLDERS’ EQUITY: |
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Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at |
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- |
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- |
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Additional paid-in capital |
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163,597 |
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154,192 |
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Accumulated other comprehensive income |
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1,127 |
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1,127 |
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Accumulated deficit |
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(158,481 |
) |
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(150,847 |
) |
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Total shareholders’ equity |
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6,243 |
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4,472 |
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Total liabilities and shareholders’ equity |
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$ |
9,989 |
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$ |
9,283 |
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CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
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Year ended |
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2023 |
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2022 |
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Revenues |
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$ |
743 |
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$ |
810 |
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Research and development expenses |
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(5,983 |
) |
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(7,763 |
) |
General and administrative expenses |
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(2,955 |
) |
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(3,143 |
) |
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Operating loss |
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(8,195 |
) |
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(10,096 |
) |
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Total financial income (expense), net |
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561 |
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(77) |
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Net loss |
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(7,634 |
) |
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(10,173 |
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Basic and diluted net loss per share |
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(0.01 |
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(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
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 of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between
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