Full Press Release Details
Can-Fite Reports Third Quarter 2019 Financial
Results & Provides Clinical Update
PETACH TIKVA, Israel, November 29, 2019 - Can-Fite BioPharma
Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address
cancer, liver and inflammatory diseases, today announced financial results for the nine months ended September 30, 2019.
Clinical and corporate developments during Q3 2019 and shortly
after the end of the quarter include:
"We are very pleased with the outcome of our End-of-Phase
II meeting with FDA regarding Namodenoson in the treatment of liver cancer. As we advance towards a pivotal Phase III study in
liver cancer, HCC patients in Israel now have access to Namodenoson through our approved compassionate use program. We look forward
to several milestones in 2020, including topline results from our Phase II NASH study, initiation of our Phase III liver cancer
study, ongoing enrollment in our Phase III studies for Piclidenoson, as well as our development agreement with Univo, to develop
cannabis derived pharmaceuticals and screening based assays" stated Can-Fite CEO Pnina Fishman.
Revenues for the nine months ended September
30, 2019 were $1.84 million compared with $3.53 million for the same period of 2018. The decrease in revenues was mainly due to
the recognition of $2 million advance payment received in August 2018 under the distribution agreement with CMS Medical.
Research and development expenses for the
nine months ended September 30, 2019 were $7.01 million compared with $4.05 million for the same period of 2018. Research and development
expenses for the nine months ended 2019 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 initiation of the Phase III clinical
trial of Piclidenoson for the treatment of rheumatoid arthritis.
General and administrative expenses were
$2.22 million for the nine months ended September 30, 2019 compared to $2.39 million for the same period in 2018. The decrease
is primarily due to a decrease in professional services and investor relations an expense which was partly offset by an increase
in insurance expenses.
Financial income, net for the nine months
ended September 30, 2019 was $0.44 million compared to financial income, net of $0.23 million for the same period in 2018. The
increase in financial income, net is mainly due to fair value revaluation of the investment in Wize Pharma's shares which
is classified under short term investment.
Can-Fite's net loss for the nine months
ended September 30, 2019 was $7.84 million compared with a net loss of $3.14 million for the same period in 2018. As of September
30, 2019, Can-Fite had cash and cash equivalents of $4.68 million as compared to $3.62 million at December 31, 2018. The increase
in cash and cash equivalents is due to net cash provided by financing activity of $10.1 million which was offset by net cash used
in operating activity of $9.1 million.
The Company's consolidated financial results for the nine months
ended September 30, 2019 are presented in accordance with International Financial Reporting Standards.
CONSOLIDATED STATEMENTS
OF FINANCIAL POSITION
In thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Unaudited | Audited | |||||||
| USD | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | 4,682 | 3,615 | ||||||
| Other receivable and prepaid expenses | 5,160 | 4,015 | ||||||
| Short-term investment | 111 | 273 | ||||||
| Total current assets | 9,953 | 7,903 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Other receivables | 1,750 | - | ||||||
| Lease deposits | 11 | 2 | ||||||
| Property, plant and equipment, net | 37 | 47 | ||||||
| Total long-term assets | 1,798 | 49 | ||||||
| Total assets | 11,751 | 7,952 |
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Unaudited | Audited | |||||||
| USD | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,364 | $ | 1,071 | ||||
| Deferred revenues | 1,410 | 926 | ||||||
| Other accounts payable | 351 | 1,122 | ||||||
| Total current liabilities | 3,125 | 3,119 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Deferred revenues | 1,570 | 1,818 | ||||||
| Total long-term liabilities | 1,570 | 1,818 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Share capital | 8,153 | 2,635 | ||||||
| Share premium | 100,225 | *94,076 | ||||||
| Capital reserve from share-based payment transactions | 6,015 | 5,800 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (108,464 | ) | (100,623 | ) | ||||
| Total equity | 7,056 | 3,015 | ||||||
| Total liabilities and equity | $ | 11,751 | $ | 7,952 |
(*) Warrants exercisable into shares as of December 31, 2018
were reclassified into Share premium.
CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)
| Nine months ended September 30, | ||||||||
| 2019 | 2018 | |||||||
| Unaudited | ||||||||
| USD | ||||||||
| Revenues | $ | 1,840 | $ | 3,531 | ||||
| Research and development expenses | (7,016 | ) | (4,056 | ) | ||||
| General and administrative expenses | (2,220 | ) | (2,386 | ) | ||||
| Operating loss | (7,396 | ) | (2,911 | ) | ||||
| Finance expenses | (508 | ) | (428 | ) | ||||
| Finance income | 63 | 197 | ||||||
| Total financial income (expenses), net | (445 | ) | (231 | ) | ||||
| Net loss | (7,841 | ) | (3,142 | ) | ||||
| Net loss per share attributable to equity holders of the Company : | ||||||||
| Basic and diluted net loss per share | (0.11 | ) | (0.08 | ) |
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, inflammatory disease and sexual dysfunction. The Company's lead drug candidate,
Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis. Can-Fite's liver cancer drug, Namodenoson,
recently completed a Phase II trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and is 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 in preclinical studies and the Company is investigating
additional compounds, targeting A3AR, for the treatment of sexual dysfunction. These drugs have an excellent safety profile with
experience in over 1,000 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 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.