Can-Fite Reports 2020 Financial Results & Provides Clinical Development Update
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) reported a net loss of $14.44 million for the year ended December 31, 2020, an increase from $12.62 million in 2019. Revenues decreased to $0.76 million, down 63% from $2.03 million. Their cash position improved to $8.26 million from $2.69 million due to $17.68 million in financing activities. Can-Fite announced a $42.7 million out-licensing deal with Ewopharma and is progressing with clinical trials for drugs targeting COVID-19, psoriasis, and liver cancer.
- Cash position increased to $8.26 million, up from $2.69 million in 2019.
- Secured $42.7 million out-licensing deal with Ewopharma.
- Phase II COVID-19 study underway, enrolling 40 patients.
- Phase III psoriasis study continues following positive interim analysis.
- Revenues decreased by $1.27 million (63%) compared to 2019.
- Net loss increased to $14.44 million, reflecting higher research and development costs.
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 Highlights Include:
Cash Infusion of
Out-licensing Deal Worth
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 paid.
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.”
Financial Results
Revenues for the year ended December 31, 2020 were
Research and development expenses for the year ended December 31, 2020 were
General and administrative expenses were
Financial expense, net for the year ended December 31, 2020 aggregated
Net loss for the year ended December 31, 2020 was
As of December 31, 2020, Can-Fite had cash and cash equivalents of
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
|
|
|||||||||
|
|
|
|
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 time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. 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. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. 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 risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: 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 impact of the recent outbreak of coronavirus; 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; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210325005513/en/
FAQ
What were Can-Fite's financial results for 2020?
What is the cash position of Can-Fite as of December 2020?
What clinical studies is Can-Fite currently conducting?
What out-licensing agreement did Can-Fite secure recently?