Full Press Release Details
Reports Third Quarter 2018 Financial Results and Provides Clinical Development Update
for the Nine Months Ended September 30, 2018 Were $3.5 Million Compared to $0.7 Million for the Same Period in 2017
TIKVA, Israel, November 30, 2018 - Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology
company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases,
today reported financial results for the nine months ended September 30, 2018 and provided recent clinical development
and corporate updates.
"Prolonged longevity of patients in our Namodenoson Phase II advanced liver study was reported this quarter. It is a significant
highlight in our clinical trial progress and because of this development, we now expect to release top-line results during the
first quarter of 2019," said Pnina Fishman, Ph.D., CEO of Can-Fite. "This development provides further encouragement
that this therapy could bring value to patients with chronic liver disease and cirrhosis with a Child Pugh B score, whose disease
has progressed on sorafenib therapy."
Fishman continued, "With the need for better treatments for autoimmune inflammatory conditions such as rheumatoid arthritis
and psoriasis, as well as for liver diseases such as liver cancer and NASH, we are encouraged by the progress we are making in
our ongoing clinical studies. We believe there is a significant role we can play in a market that has been searching for novel
therapeutic solutions for better patient care."
for the Treatment of Liver Diseases
for the Treatment of Rheumatoid Arthritis and Psoriasis
for the nine months ended September 30, 2018 were $3.5 million compared to $0.7 million for the same period in 2017. The increase
in revenue was mainly due to the recognition of the $2 million advance payment received in August 2018 under the distribution
agreement with CMS Medical and from a portion of the $2.2 million advance payment received in January 2018 under the distribution
agreement with Gebro.
and development expenses for the nine months ended September 30, 2018 were $4 million compared with $3.5 million for the same
period in 2017. Research and development expenses for the nine months of 2018 were comprised primarily of expenses associated
with the Phase II studies for Namodenoson as well as expenses for ongoing studies of Piclidenoson. 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. We expect that the research and development expenses will increase through the rest of 2018 and beyond.
and administrative expenses for the nine months ended September 30, 2018 were $2.4 million, compared to $2.1 million for the same
period in 2017. The increase is primarily due to an increase in professional services and investor relations expenses. We expect
that the annual general and administrative expenses for 2018 will be higher compared to 2017.
expenses, net for the nine months ended September 30, 2018 were $0.2 million compared to financial income, net of $0.2 million
for the same period in 2017. The increase in financial expenses, net was mainly due to recognition of interest expenses related
to implementation of revenue recognition accounting standard IFRS 15, while in the same period in 2017, financial income was mainly
due to fair value revaluation of warrants which were offset by financial expenses from exchange rate differences.
net loss for the nine months ended September 30, 2018 was $3.1 million compared with a net loss of $4.7 million for the same period
in 2017. The difference in net loss was primarily attributable to an increase in revenues in 2018.
of September 30, 2018, Can-Fite had cash and cash equivalents of $5.7 million as compared to $3.5 million at December 31, 2017.
The increase in cash during the nine months ended September 30, 2018 is due to U.S. $4.37 million received from the issuance of
shares and warrants, net of issuance expenses, the $2.2 million advance payment received from Gebro, and $2 million advance payment
received from CMS Medical which were offset by our operating expenses.
The Company's consolidated financial results for the
nine months ended September 30, 2018 are presented in accordance with International Financial Reporting Standards.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | Audited | |||||||
| USD | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 5,728 | $ | 3,505 | ||||
| Other receivable and prepaid expenses | 3,977 | 3,159 | ||||||
| Total current assets | 9,705 | 6,664 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Lease deposits | 2 | 5 | ||||||
| Long-term investment | 1,077 | 917 | ||||||
| Property, plant and equipment, net | 41 | 28 | ||||||
| Total long-term assets | 1,120 | 950 | ||||||
| Total assets | $ | 10,825 | $ | 7,614 |
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | Audited | |||||||
| USD | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 828 | $ | 427 | ||||
| Deferred revenues | 857 | 330 | ||||||
| Other accounts payable | 676 | 997 | ||||||
| Total current liabilities | 2,361 | 1,754 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Deferred revenues | 2,077 | 846 | ||||||
| Total long-term liabilities | 2,077 | 846 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Share capital | 2,633 | 2,123 | ||||||
| Share premium | 81,646 | 81,104 | ||||||
| Capital reserve from share-based payment transactions | 5,767 | 5,547 | ||||||
| Warrants exercisable into shares | 12,408 | 8,815 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (97,194 | ) | (93,702 | ) | ||||
| Total equity | 6,387 | 5,014 | ||||||
| Total liabilities and equity | $ | 10,825 | $ | 7,614 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
thousands (except for share and per share data)
| Nine months ended September 30, | ||||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| USD | ||||||||
| Revenues | $ | 3,531 | $ | 704 | ||||
| Research and development expenses | 4,056 | 3,517 | ||||||
| General and administrative expenses | 2,386 | 2,100 | ||||||
| Operating loss | 2,911 | 4,913 | ||||||
| Finance expenses | 428 | 288 | ||||||
| Finance income | (197 | ) | (481 | ) | ||||
| Total Financial income, net | 231 | (193 | ) | |||||
| Loss | 3,142 | 4,720 | ||||||
| Other comprehensive loss: | ||||||||
| Amounts that will not be reclassified subsequently to profit or loss: | ||||||||
| Adjustment arising from translating financial statements from functional currency to presentation currency | - | (388 | ) | |||||
| Total other comprehensive loss | $ | 3,142 | $ | 4,332 | ||||
| Loss attributable to: | ||||||||
| Equity holders of the Company | 3,142 | 4,638 | ||||||
| Non-controlling interests | - | 82 | ||||||
| $ | 3,142 | $ | 4,720 | |||||
| Total comprehensive loss attributable to: | ||||||||
| Equity holders of the Company | 3,142 | 4,250 | ||||||
| Non-controlling interests | - | 82 | ||||||
| $ | 3,142 | $ | 4,332 | |||||
| Loss per share attributable to equity holders of the Company : | ||||||||
| Basic and diluted loss per share | (0.08 | ) | (0.14 | ) |
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology
that is designed to address multibillion-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, is in Phase II trials for hepatocellular carcinoma (HCC), the most common form
of liver cancer, and 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.
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.