Full Press Release Details
Can-Fite Reports First Quarter 2023
Financial Results & Provides Clinical Update
PETACH TIKVA, Israel, June 1, 2023 -- Can-Fite
BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that
address oncology, inflammatory and liver diseases, today announced financial results for the three months ended March 31, 2023.
Clinical and Corporate Development Highlights
Pivotal Phase 3 Liver Cancer Study-Can-Fite's
ongoing pivotal Phase 3 liver cancer study 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 1 or 2 other lines of therapy. The primary endpoint is overall
survival. An interim analysis will be performed.
During the first quarter, a study titled "Targeting
the A3 adenosine receptor to treat hepatocellular carcinoma: anti-cancer and hepatoprotective effects" was published in the peer-reviewed
journal Purinergic Signalling.
Phase 2a Pancreatic Cancer Study-Can-Fite
is preparing for an open-label Phase 2 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. Safety and efficacy endpoints including objective response,
progression-free survival, duration of response, disease control, and overall survival will be monitored. The study will be conducted
by Dr. Salomon Stemmer, an oncology key opinion leader and Professor at the Institute of Oncology, Rabin Medical Center, Israel. In pre-clinical
studies, Namodenoson had a significant anti-cancer effect in pancreatic carcinoma as a monotherapy and an additive effect when combined
with gemcitabine, the standard-of-care chemotherapy for pancreatic cancer. The mechanism of action entails de-regulation of the Wnt signal
transduction pathway, a key modulator of pancreatic carcinoma cell growth.
Can-Fite filed a patent application that covers
the use of Namodenoson for the treatment of pancreatic cancer. Moreover, 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.
Pancreatic cancer is an unmet medical need. According
to the American Society of Clinical Oncology (ASCO), in 2020, an estimated 496,000 people were diagnosed with pancreatic cancer globally
and an estimated 466,000 died from the disease. The 5-year survival rate for people with pancreatic cancer in the U.S. is 11%. Acumen
Research estimates the global pancreatic cancer therapeutics market was valued at approximately $3.6 billion in 2021 and is projected
to grow to approximately $6.6 billion by 2030.
Phase 2b NASH Study-A Phase 2b NASH
study is currently ongoing to evaluate Namodenoson's efficacy as compared to placebo, determined by a histological endpoint. Namodenoson
met its primary endpoint of reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect in a prior Phase 2a
Compassionate Use in Patients with Decompensated
Liver Cirrhosis-Based on data showing that Namodenoson has liver protective effects, Namodenoson is now given to patients with
decompensated cirrhosis, an advanced form of cirrhosis associated with liver failure for which there are no therapeutic options other
than liver transplantation. Patients will be treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use.
Decompensated cirrhosis is an acute deterioration
in liver function in patients with cirrhosis, characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal
hemorrhage. This is an unmet medical need and there is no therapeutic approach that has shown efficacy in slowing disease progression.
An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few
treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. The treatment
of liver cirrhosis in the U.S. is estimated to become an approximately $15 billion market by 2030.
Green Light from EMA for a Pivotal Phase 3
Psoriasis Study-The European Medicines Agency (EMA) gave Can-Fite a positive opinion on its registration plan for a pivotal
Phase 3 clinical trial for Piclidenoson in the treatment of moderate to severe psoriasis. The pivotal study and the safety of the 3 mg
twice daily dose of Piclidenoson are accepted by the agency.
Can-Fite has submitted a comparable data package
to the U.S. Food and Drug Administration (FDA) and expects a similar response.
Corporate Developments
New Management Structure as Advanced Stage
Pipeline Moves Toward Commercialization-Effective June 30, 2023, executive changes go into effect to support the Company's
continued success. Motti Farbstein will lead Can-Fite as Chief Executive Officer and continue to serve as its Chief Financial Officer.
Dr. Pnina Fishman, Can-Fite's Scientific Founder, will move from her position as CEO to become Executive Chairman of the Board as
well as continuing to serve as Chief Scientific Officer.
Raised $7.5 Million-In January 2023,
Can-Fite raised $7.5 million through a concurrent registered direct offering and private placement. The Company's cash and equivalents
on March 31, 2023 was $12.4 million and is expected to cover all clinical development programs and general and administrative expenses
for more than a year from the date of this press release.
"During 2023 we plan to increase our efforts
towards establishing additional distribution deals and partnerships. We continue to make progress with our two main indications, liver
cancer and psoriasis, as we open additional avenues with niche indications based on evidence of the efficacy and safety of our drugs,"
stated Can-Fite CEO Dr. Pnina Fishman.
Revenues for the three months ended March 31,
2023 were $0.19 million, a decrease of $0.01 million, or 4.40%, compared to $0.20 million for the three months ended March 31, 2022. The
decrease in revenues is considered to be immaterial.
Research and development expenses for the three
months ended March 31, 2023 were $2.06 million, an increase of $0.24 million, or 13.17%, compared to $1.82 million for the three months
ended March 31, 2022. Research and development expenses for the first quarter of 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 increase is primarily due to an increase in expenses
associated with Namodenoson.
General and administrative expenses for the three
months ended March 31, 2023 were $0.84 million an increase of $0.09 million, or 12.33%, compared to $0.75 million for the three months
ended March 31, 2022. The increase is primarily due to the increase in travel expenses and increase in accrued bonuses to the Company's
employees. We expect that general and administrative expenses will remain at the same level through 2023.
Financial income, net for the three months ended
March 31, 2023 was $0.16 million compared to finance expense, net of $0.06 million for the three months ended March 31, 2022. The increase
in financial income, net was mainly due to exchange rate differences which in 2023 was recorded as income and in 2022 was recorded as
expense and revaluation of our short-term investment which in 2023 was recorded as income and in 2022 was recorded as expense.
Net loss for the three months ended March 31,
2023 was $2.55 million compared with a net loss of $2.43 million for the three months ended March 31, 2022. The increase in net loss for
the three months ended March 31, 2023 was primarily attributable to an increase in research and development expenses which was partly
offset by an increase in finance income, net.
As of March 31, 2023, Can-Fite had cash and cash
equivalents and short term deposits of $12.4 million as compared to $7.98 million at December 31, 2022. The increase in cash during the
three months ended March 31, 2023 is due to the issuance of share capital and warrants which was offset by ongoing operations of the Company.
The Company's consolidated financial results for
the three months ended March 31, 2023 are presented in accordance with US GAAP Reporting Standards.
U.S. dollars in thousands (except for share
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 1,264 | $ | 2,978 | ||||
| Short term deposit | 11,135 | 5,001 | ||||||
| Prepaid expenses and other current assets | 962 | 1,170 | ||||||
| Short-term investment | 18 | 8 | ||||||
| Total current assets | 13,379 | 9,157 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Operating lease right of use assets | 70 | 84 | ||||||
| Property, plant and equipment, net | 40 | 42 | ||||||
| Total non-current assets | 110 | 126 | ||||||
| Total assets | $ | 13,489 | $ | 9,283 |
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except for share and per share data)
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 963 | $ | 896 | ||||
| Current maturity of operating lease liability | 42 | 48 | ||||||
| Deferred revenues | 783 | 783 | ||||||
| Other accounts payable | 1,103 | 775 | ||||||
| Total current liabilities | 2,891 | 2,502 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long - term operating lease liability | 6 | 14 | ||||||
| Deferred revenues | 2,099 | 2,295 | ||||||
| Total long-term liabilities | 2,105 | 2,309 | ||||||
| CONTIGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS' EQUITY: | ||||||||
| Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at March 31, 2023 and December 31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares as of March 31, 2023 and December 31, 2022 | - | - | ||||||
| Additional paid-in capital | 160,763 | 154,192 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (153,397 | ) | (150,847 | ) | ||||
| Total equity | 8,493 | 4,472 | ||||||
| Total liabilities and shareholders' equity | $ | 13,489 | $ | 2,983 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
U.S. dollars in thousands (except for share and per share data)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | ||||||||
| Revenues | $ | 196 | $ | 205 | ||||
| Research and development expenses | (2,061 | ) | (1,821 | ) | ||||
| General and administrative expenses | (847 | ) | (754 | ) | ||||
| Operating loss | (2,712 | ) | (2,370 | ) | ||||
| Total financial income (expense), net | 162 | (64 | ) | |||||
| Net loss attributed to ordinary shareholders | (2,550 | ) | (2,434 | ) | ||||
| Basic and diluted net loss per share | (0.00 | ) | (0.00 | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 1,178,872,101 | 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