Full Press Release Details
Reports 2020 Financial Results & Provides Clinical Development Update
cash infusion received in warrant exercises and upfront money from a licensing deal
was a pivotal year for Can-Fite as we demonstrated a robust clinical proof of concept for both Piclidenoson and Namodenoson,"
stated Can-Fite CEO Dr. Pnina Fishman
PETACH TIKVA, Israel, March 25, 2021 --
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule
drugs that address inflammatory, cancer and liver diseases, today announced financial results for the year ended December 31, 2020.
Clinical Developments and Corporate
Cash Infusion of $5 Million -
During the first quarter of 2021, Can-Fite received $2.75 million in February and March 2021 through warrant exercises and $2.25
million in an upfront payment in March 2021 from a new distribution agreement with Ewopharma.
Out-licensing Deal Worth $42.7 Million
with Ewopharma - Can-Fite signed its latest out-licensing agreement with Swiss-based Ewopharma for distribution of its
drug candidates in Central Eastern Europe and Switzerland. Can-Fite received $2.25 million upfront with up to an additional $40.45
million payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales.
Phase II COVID-19 Study Enrolling Patients
- Can-Fite is enrolling 40 patients in its Phase II study under a U.S. Food and Drug Administration (FDA) approved protocol
in patients hospitalized with moderate to severe COVID-19. Patients are randomized in a 1:1 ratio to receive 2 mg Piclidenoson
twice daily or placebo, and treated for up to 28 days.
Phase III Psoriasis Study Continues
to Enroll Based on Positive Interim Analysis - In October 2020, the Independent Data Monitoring Committee for Can-Fite's
Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis reviewed the blinded study data and recommended
the Company continue to enroll patients. The majority of costs associated with the Phase III Comfort study have been previously
Phase IIb NASH Study Expected to Commence
Q4 2021 - Based on a successfully concluded Phase IIa NASH/NAFLD study with Namodenoson which met its primary endpoint,
Can-Fite is working closely with top Key Opinion Leaders in liver disease to complete its study design for a Phase IIb study. Can-Fite
expects to commence the study before the end of 2021.
Pivotal Phase III Liver Cancer Study
Expected to Commence Q4 2021 - Can-Fite has reached agreements with the U.S. FDA and the European Medicines Agency on the protocol
of a pivotal Phase III study for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Should
the study meet its efficacy endpoint and be approved by the FDA and EMA, Namodenoson would become one of only a few drugs available
to treat advanced liver cancer patients.
"2020 was a pivotal year for Can-Fite
as we demonstrated a robust clinical proof of concept for both Piclidenoson and Namodenoson," stated Can-Fite CEO Dr. Pnina
Fishman. "We advanced our pipeline and are firmly focused on Psoriasis, NASH, Advanced Liver Cancer, and COVID-19. We continue
to collaborate with distribution and out-licensing partners in select territories, thereby securing distribution for our drugs
upon approval and generating revenues through upfront money and milestone payments. We are excited to potentially deliver on additional
significant milestones in 2021."
Revenues for the year ended December 31,
2020 were $0.76 million, a decrease of $1.27 million, or 63%, compared to $2.03 million for the year ended December 31, 2019. The
decrease in revenues was mainly due to the recognition of 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, 2020 were $11.95 million, an increase of $0.98 million, or 8.9%, compared to $10.97 million for the year
ended December 31, 2019. Research and developments expenses for the year ended 2020 comprised primarily of expenses associated
with the Phase II studies for Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of
Piclidenoson in the treatment of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated
with the accelerating rate of absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid
arthritis and for psoriasis. We expect that the research and development expenses will increase through 2021 and beyond.
General and administrative expenses were
$2.95 million for the year ended December 31, 2020 a decrease of $0.11 million, or 3.6%, compared to $3.06 million for the year
ended December 31, 2019. The decrease is primarily due to the decrease in professional services and travel expenses which was partly
offset by an increase in salaries and related benefits and insurance expenses. We expect that general and administrative expenses
will remain at the same level through 2021.
Financial expense, net for the year ended
December 31, 2020 aggregated $0.3 million compared to $0.6 million for the year ended December 31, 2019. The decrease in financial
expense, net was mainly due to a decrease in the revaluation of our short-term investment.
Net loss for the year ended December 31,
2020 was $14.44 million compared with a net loss of $12.62 million for the year ended December 31, 2019. The increase in net loss
for the year ended December 31, 2020 was primarily attributable to a decrease in revenues in 2020 and an increase in research and
development expenses which were partly offset by a decrease in finance expenses, net.
As of December 31, 2020, Can-Fite had cash
and cash equivalents of $8.26 million as compared to $2.69 million at December 31, 2019. The increase in cash during the year ended
December 31, 2020 is due to an aggregate of $17.68 million in net proceeds received through a warrant exercise transaction in January
2020, a public offering in February 2020, partial exercises in March, April, and May 2020 of warrants issued in the February 2020
public offering, and a registered direct offering in June and July 2020 which was offset by net cash used in operating activity
More detailed information can be found
in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2020, 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 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778,
Israel or by phone at +972-3-9241114.
CONSOLIDATED BALANCE SHEETS
In thousands (except for share and per share data)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| USD | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 8,268 | $ | 2,697 | ||||
| Other accounts receivables and prepaid expenses | 1,057 | 4,383 | ||||||
| Short-term investment | 75 | 64 | ||||||
| Total current assets | 9,400 | 7,144 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Other non-current receivables | - | 912 | ||||||
| Right to use asset | 73 | 82 | ||||||
| Property, plant and equipment, net | 50 | 36 | ||||||
| Total long-term assets | 123 | 1,030 | ||||||
| Total assets | $ | 9,523 | $ | 8,174 |
CONSOLIDATED BALANCE SHEETS
In thousands (except for share and per share data)
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| USD | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 561 | $ | 2,156 | ||||
| Lease liability - current | 43 | 36 | ||||||
| Deferred revenues | 334 | 469 | ||||||
| Other accounts payable | 331 | 610 | ||||||
| Total current liabilities | 1,269 | 3,271 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Lease liability - non current | 24 | 39 | ||||||
| Deferred revenues | 2,156 | 2,422 | ||||||
| Total Long-term liabilities | 2,180 | 2,461 | ||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Ordinary shares of NIS 0.25 par value - Authorized:1,000,000,000 shares as of December 31, 2020; 500,000,000 shares as of December 31, 2019; Issued and outstanding: 463,769,463 shares as of December 31, 2020; 120,652,683 shares as of December 31, 2019 | 33,036 | 8,225 | ||||||
| Additional paid-in capital | 97,380 | 103,401 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (125,469 | ) | (110,311 | ) | ||||
| Total equity | 6,074 | 2,442 | ||||||
| Total liabilities and equity | $ | 9,523 | $ | 8,174 |
CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)
| Year ended December 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| USD | ||||||||||||
| Revenues | $ | 763 | $ | 2,032 | $ | 3,820 | ||||||
| Research and development expenses | (11,951 | ) | (10,976 | ) | (6,075 | ) | ||||||
| General and administrative expenses | (2,951 | ) | (3,063 | ) | (3,159 | ) | ||||||
| Operating loss | (14,139 | ) | (12,007 | ) | (5,414 | ) | ||||||
| Financial expense, net | (304 | ) | (618 | ) | (1,153 | ) | ||||||
| Loss before taxes on income | (14,443 | ) | (12,625 | ) | (6,567 | ) | ||||||
| Taxes on income | - | - | (4 | ) | ||||||||
| Net loss and other comprehensive loss | (14,443 | ) | (12,625 | ) | (6,571 | ) | ||||||
| Basic and diluted net loss per share | $ | (0.04 | ) | $ | (0.14 | ) | $ | (0.17 | ) | |||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 358,411,297 | 85,909,859 | 38,902,214 |
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American:
CANF) (TASE: CFBI) 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, inflammatory disease and COVID-19. The Company's lead drug candidate,
Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite's
liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer,
and successfully achieved its primary endpoint in a Phase II trial for the treatment of non-alcoholic steatohepatitis (NASH). 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 1,500 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, market risks and uncertainties,
its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from