Can-Fite Reports Second Quarter 2023 Financial Results & Progress in Two Pivotal Phase III Clinical Studies
- Can-Fite's liver cancer study continues enrollment
- Breakthrough Abstract Award for liver cancer treatment
- Preparatory work for psoriasis study
- Development for treatment of Lowe Syndrome
- Revenues slightly decreased compared to previous year
- Net loss decreased due to increase in finance income
- Cash and cash equivalents increased
PETACH TIKVA,
Clinical Progress
Pivotal Phase III Advanced Liver Cancer Study—Can-Fite’s pivotal Phase III liver cancer study, Liveration, which continues enrollment is designed to assess Namodenoson in the treatment of patients with advanced hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to one or two other lines of therapy. The primary endpoint is overall survival. An interim analysis will be conducted by an Independent Data Monitoring Committee (IDMC) after
Breakthrough Abstract Award–Can-Fite was recently granted a prestigious Breakthrough Abstract Award by the American Society of Clinical Oncology (ASCO) Conquer Cancer Foundation for the development of a novel approach to treat advanced liver cancer with the A3 adenosine receptor agonist, Namodenoson.
Exploratory Phase II Pancreatic Cancer Study—Can-Fite is preparing an open-label Phase II exploratory trial to assess the safety and efficacy of Namodenoson in the treatment of patients with pancreatic cancer who have received at least one previous systemic therapy. In pre-clinical studies, Namodenoson demonstrated a robust anti-growth effect against pancreatic carcinoma, reaching
ASCO Recognition—Can-Fite’s pancreatic cancer program received recognition from ASCO when its study titled “Effects of Namodenoson on Pancreatic Carcinoma: Preclinical Evidence” was published in the Journal of Clinical Oncology supplement of the 2023 ASCO Annual Meeting Proceedings.
Preparatory Work for Pivotal Phase III Psoriasis Study; Can Fite Received Green Light from FDA and EMA— Following positive responses from the
Development for Treatment of Lowe Syndrome, a Rare Genetic Disease—Researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine (TIGEM) in
“With two ongoing studies and two more about to commence in large treatment markets with unmet needs, we continue to advance our late-stage development pipeline to bring our potentially game-changing drugs to market,” stated Can-Fite CEO & CFO Motti Farbstein.
Dr. Pnina Fishman, Can-Fite’s CSO and Executive Chairman added, “We are particularly excited about our entry into the rare genetic disease field with the discovery of Piclidenoson’s efficacy in Lowe Syndrome in pre-clinical studies. Given Piclidenoson’s very favorable safety profile, we believe it will be a good candidate for directly entering advanced stage trials in children and adolescents living with Lowe Syndrome. Rare genetic diseases can have a more direct rapid path to regulatory approval with smaller trial sizes due to the pressing need in a small, unserved patient population. “
Financial Results
Revenues for the six months ended June 30, 2023 were
Research and development expenses for the six months ended June 30, 2023 were
General and administrative expenses were
Financial income, net for the six months ended June 30, 2023 was
Net loss for the six months ended June 30, 2023 was
As of June 30, 2023, Can-Fite had cash and cash equivalents and short term deposits of
The Company's consolidated financial results for the six months ended June 30, 2023 are presented in accordance with US GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
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June 30, |
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December 31, |
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2023 |
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2022 |
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Unaudited |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
3,458 |
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$ |
2,978 |
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Short term deposits |
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6,147 |
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5,001 |
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Prepaid expenses and other current assets |
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1,293 |
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1,170 |
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Short-term investment |
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11 |
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8 |
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Total current assets |
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10,909 |
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9,157 |
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NON-CURRENT ASSETS: |
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Operating lease right of use assets |
87 |
84 |
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Property, plant and equipment, net |
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36 |
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42 |
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Total non-current assets |
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123 |
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126 |
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Total assets |
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$ |
11,032 |
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$ |
9,283 |
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CONSOLIDATED BALANCE SHEETS
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June 30, |
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December 31, |
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2023 |
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2022 |
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Unaudited |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Trade payables |
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$ |
810 |
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$ |
896 |
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Current maturity of operating lease liability |
44 |
48 |
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Deferred revenues |
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783 |
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783 |
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Other accounts payable |
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596 |
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775 |
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Total current liabilities |
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2,233 |
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2,502 |
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NON-CURRENT LIABILITIES: |
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Long-term operating lease liability |
22 |
14 |
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Deferred revenues |
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1,903 |
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2,295 |
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Total long-term liabilities |
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1,925 |
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2,309 |
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CONTIGENT 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 June 30, 2023 and December 31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares as of June 30, 2023 and December 31, 2022 |
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- |
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- |
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Additional paid-in capital |
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160,814 |
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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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(155,067 |
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(150,847 |
) |
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Total equity |
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6,874 |
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4,472 |
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Total liabilities and shareholders’ equity |
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$ |
11,032 |
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$ |
9,283 |
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CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
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Six months ended June 30, |
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2023 |
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2022 |
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Unaudited |
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Revenues |
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$ |
392 |
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$ |
409 |
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Research and development expenses |
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(3,417 |
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(3,273 |
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General and administrative expenses |
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(1,471 |
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(1,576 |
) |
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Operating loss |
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(4,496 |
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(4,440 |
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Total financial income (expense), net |
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276 |
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(185) |
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Net loss |
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(4,220 |
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(4,625 |
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Basic and diluted net loss per share |
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(0.00 |
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(0.00 |
) |
Weighted average number of ordinary shares used in computing basic and diluted net loss per share |
1,202,110,110 |
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
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 the COVID-19 pandemic and the Russian invasion of
View source version on businesswire.com: https://www.businesswire.com/news/home/20230831472440/en/
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Source: Can-Fite BioPharma Ltd.