Full Press Release Details
Can-Fite Reports Second Quarter 2019
Financial Results & Provides Clinical Update
PETACH TIKVA, Israel, August 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 six months ended June 30,
Clinical Development and Corporate Highlights
During Q2 2019 Include:
"As we advance our clinical pipeline
into Phase III studies, the demand for safe and effective drugs in our chosen indications is evidenced through the distribution
agreements that we continue to enter for Piclidenoson and Namodenoson in the global market. In the coming months, we expect to
announce top line results from our Phase II study of Namodenoson in the treatment of NASH," stated Can-Fite CEO Pnina Fishman.
Revenues for the six months ended June
30, 2019 were $0.7 million compared to revenues of $0.9 million during the first six months of 2018. The decrease in revenues was
mainly due to the recognition of a higher portion of the $2.2 million advance payment received in January 2018 under the distribution
agreement with Gebro in the six month period ended June 30, 2018.
Research and development expenses for the
six months ended June 30, 2019 were $3.9 million compared with $2.6 million for the same period of 2018. Research and development
expenses for the first six months of 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
$1.3 million for the six months ended June 30, 2019 compared to $1.8 million for the same period in 2018. The decrease is primarily
due to a decrease in professional services and investor relations expenses.
Financial expense, net for the six months
ended June 30, 2019 was $0.3 million compared to financial income, net of $0.6 million for the same period in 2018. The increase
in financial expense, net in the first six months of 2019 is mainly due to fair value revaluation of the Wize Pharma Inc. shares
which are classified under short term investment.
Can-Fite's net loss for the six months
ended June 30, 2019 was $4.9 million compared with a net loss of $3.0 million for the same period in 2018. As of June 30, 2019,
Can-Fite had cash and cash equivalents of $8.2 million as compared to $3.62 million at December 31, 2018. The increase in cash
during the six months ended June 30, 2019 is due to net cash provided by financing activity of $10.1 million which was offset by
net cash used in operating activity of $5.5 million. As of the date hereof, the Company estimates that it has approximately $6
million in cash and cash equivalents.
In April and May 2019, the Company raised
$3.2 million and $6 million in gross proceeds, respectively, in registered direct offerings.
The Company's consolidated financial results
for the six months ended June 30, 2019 are presented in accordance with International Financial Reporting Standards.
STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Unaudited | Audited | |||||||
| USD | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | 8,202 | 3,615 | ||||||
| Other receivable and prepaid expenses | 5,239 | 4,015 | ||||||
| Short-term investment | 178 | 273 | ||||||
| Total current assets | 13,619 | 7,903 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Lease deposits | 8 | 2 | ||||||
| Property, plant and equipment, net | 40 | 47 | ||||||
| Total long-term assets | 48 | 49 | ||||||
| Total assets | 13,667 | 7,952 |
STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per
| June 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Unaudited | Audited | |||||||
| USD | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 1,510 | $ | 1,071 | ||||
| Deferred revenues | 1,963 | 926 | ||||||
| Other accounts payable | 445 | 1,122 | ||||||
| Total current liabilities | 3,918 | 3,119 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Deferred revenues | 1,308 | 1,818 | ||||||
| Total long-term liabilities | 1,308 | 1,818 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Share capital | 6,747 | 2,635 | ||||||
| Share premium | 100,132 | *94,076 | ||||||
| Capital reserve from share-based payment transactions | 5,951 | 5,800 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (105,516 | ) | (100,623 | ) | ||||
| Total equity | 8,441 | 3,015 | ||||||
| Total liabilities and equity | $ | 13,667 | $ | 7,952 |
(*) Warrants exercisable into shares as
of December 31, 2018 were reclassified into Share premium.
STATEMENTS OF COMPREHENSIVE LOSS
In thousands (except for share and per
| Six months ended June 30, | ||||||||
| 2019 | 2018 | |||||||
| Unaudited | ||||||||
| USD | ||||||||
| Revenues | $ | 688 | $ | 902 | ||||
| Research and development expenses | (3,960 | ) | (2,638 | ) | ||||
| General and administrative expenses | (1,333 | ) | (1,819 | ) | ||||
| Operating loss | (4,605 | ) | (3,555 | ) | ||||
| Finance expenses | (324 | ) | (346 | ) | ||||
| Finance income | 36 | 936 | ||||||
| Total financial income (expenses), net | (288 | ) | 590 | |||||
| Net loss | (4,893 | ) | (2,965 | ) | ||||
| Net loss per share attributable to equity holders of the Company: | ||||||||
| Basic and diluted net loss per share | (0.08 | ) | (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.