-
Global distribution deals signed in Europe and China, including
Can-Fite’s largest deal to date for up to $74.5 M -
Top-line data from Phase II Namodenoson trial in the treatment
of liver cancer supports continuation into Phase III study -
Top-line Data from Phase II NASH Study with Namodenoson expected
in H2 2019 -
Patient enrollment continues in two Phase III studies for
Piclidenoson in the treatment of rheumatoid arthritis and psoriasis
PETACH TIKVA, Israel–(BUSINESS WIRE)–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 year ended December 31, 2018.
Clinical Development and Corporate Highlights During 2018 Include:
-
In a deal worth up to $74.5 million, Can-Fite signed a License,
Collaboration and Distribution Agreement with CMS Medical Venture
Investment Limited for the commercialization of Piclidenoson in the
treatment of rheumatoid arthritis and psoriasis, and Namodenoson in
the treatment of advanced liver cancer and NAFLD/NASH, in China. -
In another multi-million dollar deal, Can-Fite signed a distribution
deal with Gebro Holding GmBH in Spain, Switzerland, and Austria, to
distribute Piclidenoson in the treatment of rheumatoid arthritis and
psoriasis upon receipt of regulatory approval. - Can-Fite raised $5 million through a registered direct offering.
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Can-Fite recently reported top line result from its Phase II trial of
Namodenoson in the treatment of advanced liver cancer. While the study
did not achieve its primary end point of median overall survival in
the whole population of 78 patients, it did achieve superiority in
median overall survival in the largest study subpopulation of 56
patients and in secondary end points for the whole population. These
data support progression into a Phase III study. -
Phase III clinical studies of Piclidenoson in the treatment of
psoriasis and rheumatoid arthritis continue to enroll patients. -
Top-line Data from Phase II NASH Study with Namodenoson expected in H2
2019
“2018 marked significant achievements for Can-Fite including our largest
distribution deal to date valued at up to $74.5 million. We continued to
build our intellectual property assets, presented new data at scientific
conferences and saw our findings published in peer reviewed journals. We
are particularly pleased to move much closer to commercialization with
both Piclidenoson, now in two Phase III studies, and Namodenoson, now
completing a Phase II study,” stated Can-Fite CEO Pnina Fishman. “We
just announced top line results from our Phase II Namodenoson study in
advanced liver cancer which produced encouraging results to move into a
Phase III, even though the primary end point was not met. We believe our
drugs’ strong safety profile, combined with efficacy in a specific
sub-population within each target disease indication will improve
patient health and longevity.”
Financial Results
Revenues for the year ended December 31, 2018 were $3.8 million, an
increase of $3.0 million, or 384%, compared to $0.8 million for the year
ended December 31, 2017. The increase in revenue was mainly due to the
recognition of a $2 million advance payment received in August 2018
under the License, Collaboration and Distribution Agreement with CMS
Medical and from the recognition of a portion of the $2.2 million
advance payment received in January 2018 under the Distribution and
Supply Agreement with Gebro.
Research and development expenses for the year ended December 31, 2018
were $6.0 million, an increase of $0.9 million, or 19%, compared to $5.1
million for the year ended December 31, 2017. Research and developments
expenses for the year ended 2018 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
2019 and beyond.
General and administrative expenses were $3.1 million for the year ended
December 31, 2018 an increase of $0.3 million, or 10%, compared to $2.8
million for the year ended December 31, 2017. The increase is primarily
due to an increase in professional services and investor relations
expenses. We expect that general and administrative expenses will remain
at the same level through 2019.
Financial expenses, net for the year ended December 31, 2018 aggregated
$1.1 million compared to immaterial financial income, net for the same
period in 2017. The increase in financial expense, net was mainly due to
a loss from long-term investment revaluation and from 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 year ended December 31, 2018 was $6.6 million compared
with a net loss of $6.4 million for the year ended December 31, 2017.
The increase in net loss for the year ended December 31, 2018 was
primarily attributable to increase in revenues in 2018 which were offset
by an increase in research and development expenses and increase in
finance expenses, net.
As of December 31, 2018, Can-Fite had cash and cash equivalents of $3.6
million as compared to $3.5 million at December 31, 2017. The increase
in cash during the year ended December 31, 2018 is due to increase in
net cash provided by financing activity which was offset by a decrease
in net cash used in operating activity. In January 2019, Can-Fite raised
$2.35 million in a registered direct offering.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)
| December 31, | ||||||
| 2018 | 2017 | |||||
| Audited | ||||||
| USD | ||||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | 3,615 | 3,505 | ||||
| Other receivable and prepaid expenses | 4,015 | 3,159 | ||||
| Short-term investment | 273 | – | ||||
| Total current assets | 7,903 | 6,664 | ||||
| NON-CURRENT ASSETS: | ||||||
| Lease deposits | 2 | 5 | ||||
| long-term investment | – | 917 | ||||
| Property, plant and equipment, net | 47 | 28 | ||||
| Total long-term assets | 49 | 950 | ||||
| Total assets | 7,952 | 7,614 | ||||
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)
| December 31, | |||||||
| 2018 | 2017 | ||||||
| USD | |||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Trade payables | 1,071 | 427 | |||||
| Deferred revenues | 926 | 330 | |||||
| Other accounts payable | 1,122 | 997 | |||||
| Total current liabilities | 3,119 | 1,754 | |||||
| NON-CURRENT LIABILITIES: | |||||||
| Deferred revenues | 1,818 | 846 | |||||
| Total long-term liabilities | 1,818 | 846 | |||||
| CONTINGENT LIABILITIES AND COMMITMENTS | |||||||
|
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE |
|||||||
| Share capital | 2,635 | 2,123 | |||||
| Share premium | 81,668 | 81,104 | |||||
| Capital reserve from share-based payment transactions | 5,800 | 5,547 | |||||
| Warrants exercisable into shares | 12,408 | 8,815 | |||||
| Accumulated other comprehensive income | 1,127 | 1,127 | |||||
| Accumulated deficit | (100,623) | (93,702) | |||||
| Total equity | 3,015 | 5,014 | |||||
| Total liabilities and equity | 7,952 | 7,614 | |||||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)
| Year Ended December 31, | |||||
| 2018 | 2017 | 2016 | |||
| USD | |||||
| Revenues | 3,820 | 789 | 165 | ||
| Research and development expenses | 6,075 | 5,106 | 6,115 | ||
| General and administrative expenses | 3,159 | 2,868 | 2,733 | ||
| Operating loss | 5,414 | 7,185 | 8,683 | ||
| Other income | – | (769) | – | ||
| Finance expenses | 1,204 | 621 | 55 | ||
| Finance income | (51) | (633) | (374) | ||
| Total financial income, net | 1,153 | (12) | (319) | ||
| Loss before taxes on income | 6,567 | 6,404 | 8,364 | ||
| Taxes on income | 4 | 29 | 29 | ||
| Net loss |
6,571 |
6,433 | 8,393 | ||
|
Other comprehensive loss:
Amounts that will not be reclassified subsequently to profit or |
|||||
|
Adjustment arising from translating financial statements from |
– | (636) | (119) | ||
| Total other comprehensive loss | – | (636) | (119) | ||
| Total comprehensive loss | 6,571 | 5,797 | 8,274 | ||
| Net loss attributable to: | |||||
| Equity holders of the Company | 6,571 | 6,339 | 8,257 | ||
| Non-controlling interests | – | 94 | 136 | ||
| 6,571 | 6,433 | 8,393 | |||
| Total comprehensive loss attributable to: | |||||
| Equity holders of the Company | 6,571 | 5,703 | 8,138 | ||
| Non-controlling interests | – | 94 | 136 | ||
| 6,571 | 5,797 | 8,274 | |||
|
Net loss per share attributable to equity holders of the |
|||||
| Basic and diluted net loss per share | 0.17 | 0.19 | 0.30 | ||
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.
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114