Full Press Release Details
Can-Fite Reports Third Quarter 2023
Financial Results and Clinical Update
Advanced liver cancer patient in
prior Phase II study remains cancer-free 6.9 years after starting treatment with Namodenoson
PETACH TIKVA, Israel, November 30, 2023 -- 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 for the nine months ended September 30, 2023.
Clinical & Development Milestones Achieved
Namodenoson Drug Candidate:
Complete Response and 6.9 Year Survival Reported
in Patient with Advanced Liver Cancer Treated with Namodenoson
A patient who had participated in Can-Fite's
prior Phase II liver cancer study who continues to receive treatment with Namodenoson under a compassionate use program now has overall
survival of 6.9 years with the disappearance of ascites, normal liver function, and good quality of life, defined as a complete response.
Enrollment is ongoing in Can-Fite's pivotal Phase III study of Namodenoson in the treatment of advanced liver cancer. During the
third quarter, the American Society of Clinical Oncology (ASCO) selected Can-Fite for the prestigious Breakthrough Abstract Award from
Conquer Cancer for its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)".
Pancreatic Carcinoma Phase IIa Study with Namodenoson
Namodenoson inhibited the growth of pancreatic
carcinoma in a pre-clinical study through a mechanism that entails the Ras pathway. The Company continues to receive awards and recognition
from leading cancer associations, and articles summarizing Namodenoson's robust anti-cancer effect in pancreatic carcinoma have
been published. The American Association of Cancer Research (AACR) accepted Can-Fite's study titled "Namodenoson Inhibits
the Growth of Pancreatic Carcinoma via De-regulation of the Wnt/ -catenin Signaling Pathway" for a poster presentation at the
AACR Special Conference on Pancreatic Cancer. Biomolecules, a peer-reviewed scientific journal focused on the function and mechanism
of bioactive molecules, published an article titled "Namodenoson Inhibits the Growth of Pancreatic Carcinoma via Deregulation of
the Wnt/ -catenin, NF- B, and RAS Signaling Pathways".
Piclidenoson Drug Candidate:
Entered Rare Genetic Disease Market with Treatment
In preclinical studies, Piclidenoson has been
found to be effective in Lowe Syndrome, a rare genetic disease with no treatment available, and an estimated $100 million treatment market
in the U.S. alone. Lowe Syndrome usually develops in the first year of life, causing brain abnormalities associated with intellectual
disabilities and a life span shortened to less than 40 years. The discovery of Piclidenoson's efficacy in Lowe Syndrome was made
by researchers at the University of Naples Federico II and The Telethon Institute of Genetics and Medicine in Italy after testing thousands
of compounds in search of a treatment. Can-Fite and Fondazione Telethon signed an agreement outlining their collaboration for the development
of Piclidenoson for the treatment of Lowe Syndrome. As a rare genetic disease in dire need of a treatment, Lowe Syndrome may qualify for
an accelerated approval path, and Can-Fite plans to move into an advanced stage clinical study in this indication.
Harnessing Artificial Intelligence (AI) to
Identify and Accelerate New Oncology Programs:
Through an agreement with Collaborations Pharmaceuticals,
Can-Fite is utilizing AI and machine learning (ML) to develop and bring to market next-generation A3 adenosine receptor (A3AR) oncology
drugs at a significantly reduced development time and cost. New molecules will be designed with high affinity and selectivity to A3AR,
the target of Can-Fite's platform technology.
"In addition to the several major value-driving
milestones achieved during the third quarter, we continue to enroll and treat patients in our pivotal Phase III liver cancer study and
Phase IIb study for NASH. Our pivotal Phase III study in psoriasis is expected to commence soon while we also prepare for a Phase IIa
study in pancreatic cancer," stated Motti Farbstein, Can-Fite's CEO and CFO. "We believe our advanced stage pipeline
with multiple indications positions Can-Fite well for partnerships and for achieving regulatory and market success based on our robust
Revenues for the nine months ended September 30,
2023 were $0.59 million compared to revenues of $0.61 million for the same period in 2022. Revenues for the nine months ended September
30, 2023 and September 30, 2022 comprised of recognition of a portion of advance payments received under distribution agreements with
Gebro, CKD, Cipher and Ewopharma.
Research and development expenses for the nine
months ended September 30, 2023 were $4.71 million compared with $5.30 million for the same period in 2022. Research and development expenses
for the nine months ended September 30, 2023 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.
General and administrative expenses were $2.23
million for the nine months ended September 30, 2023 compared to $2.31 million for the same period in 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 2023.
Financial income, net for the nine months ended
September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022. The decrease in
financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.
Net loss for the nine months ended September 30,
2023 was $5.98 million compared with a net loss of $7.15 million for the same period in 2022. The decrease in net loss for the nine months
ended September 30, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative
As of September 30, 2023, Can-Fite had cash and
cash equivalents and short term deposits of $7.94 million as compared to $7.98 million at December 31, 2022. The decrease in cash during
the nine months ended nine 30, 2023 is due to the ongoing operations of the Company which was offset by the Company's fundraise
during January 2023. During November 2023, Can-Fite raised approximately $3 million from the exercise of certain warrants.
The Company's consolidated financial results
for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 3,383 | $ | 2,978 | ||||
| Short term deposits | 4,556 | 5,001 | ||||||
| Prepaid expenses and other current assets | 1,122 | 1,170 | ||||||
| Short-term investment | 3 | 8 | ||||||
| Total current assets | 9,064 | 9,157 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Operating lease right of use assets | 72 | 84 | ||||||
| Property, plant and equipment, net | 33 | 42 | ||||||
| Total non-current assets | 105 | 126 | ||||||
| Total assets | $ | 9,169 | $ | 9,283 |
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 647 | $ | 896 | ||||
| Current maturity of operating lease liability | 34 | 48 | ||||||
| Deferred revenues | 783 | 783 | ||||||
| Other accounts payable | 746 | 775 | ||||||
| Total current liabilities | 2,210 | 2,502 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long - term operating lease liability | 17 | 14 | ||||||
| Deferred revenues | 1,707 | 2,295 | ||||||
| Total long-term liabilities | 1,724 | 2,309 | ||||||
| CONTIGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at September 30, 2023 and December 31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares as of September 30, 2023 and December 31, 2022 | - | - | ||||||
| Additional paid-in capital | 160,937 | 154,192 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (156,829 | ) | (150,847 | ) | ||||
| Total shareholders' equity | 5,235 | 4,472 | ||||||
| Total liabilities and shareholders' equity | $ | 9,169 | $ | 9,283 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
| Nine months ended September 30, | ||||||||
| 2023 | 2022 | |||||||
| Revenues | $ | 588 | $ | 613 | ||||
| Research and development expenses | (4,716 | ) | (5,309 | ) | ||||
| General and administrative expenses | (2,233 | ) | (2,317 | ) | ||||
| Operating loss | (6,361 | ) | (7,013 | ) | ||||
| Total financial income (expense), net | 379 | (141 | ) | |||||
| Net loss | (5,982 | ) | (7,154 | ) | ||||
| Basic and diluted net loss per share | (0.00 | ) | (0.01 | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 1,209,797,279 | 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:
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