- Cash balance of $18.9 million as of December 31,
2021
- Signed out-licensing deal worth $42.7 million with
Ewopharma
- Phase III psoriasis topline data expected Q2
2022
- Namodenoson induced complete response and cleared all cancer
lesions in advanced liver cancer patient in Can-Fite’s Phase II
study
- Phase IIb NASH study is currently enrolling
patients
- Pivotal Phase III advanced liver cancer study expected to
commence enrollment for Namodenoson H1 2022
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, 2021.
Corporate and Clinical Development Highlights
Include:
Fortified Balance Sheet – On December 31, 2021, Can-Fite
had $18.9 million in cash, cash equivalents, and short-term
deposits. During the year, the Company received $2.25 million in
non-dilutive funding from Ewopharma for an out-licensing deal,
$2.74 million from warrant exercises, and raised $10 million
through a registered direct offering.
Signed Deal Worth $42.7 Million with Ewopharma – In
2021, Can-Fite signed its largest out-licensing agreement to date
with Switzerland-based Ewopharma for distribution of its drug
candidates in Central Eastern Europe and Switzerland. A $2.25
million upfront payment was received with up to an additional
$40.45 million payable upon the achievement of regulatory and sales
milestones, plus 17.5% royalties on net sales. Together with
Ewopharma, Can-Fite’s existing out-licensing deals are worth a
potential $130 million in future milestone payments plus
double-digit royalties on net sales upon regulatory approvals.
Can-Fite has received over $20 million in non-dilutive funding to
date.
Liver Cancer Patient Completely Cleared of Cancer; Pivotal
Phase III Liver Cancer Study Expected to Commence Enrollment H1
2022 – A prior Phase II liver cancer study patient who
continues to be treated with Namodenoson has survived five years
and cleared all cancer lesions, in what the Company sees as a very
positive sign for its upcoming pivotal Phase III liver cancer
study. Enrollment is expected to commence H1 2022 with
approximately 450 patients diagnosed with hepatocellular carcinoma
(HCC) and underlying Child Pugh B7 (CPB7) who have not responded to
other approved therapies.
Phase III Psoriasis Study Data Expected Q2 2022 – The
Phase III Comfort™ study completed enrollment of >400 patients
with moderate to severe plaque psoriasis and completed 16-weeks of
treatment, the primary endpoint duration of the study. Topline
results are expected in Q2 2022. The study is designed to
establish Piclidenoson’s superiority compared to placebo at 16
weeks and non-inferiority compared to Apremilast (Otezla®) at 32
weeks. In a recently completed preclinical study, Piclidenoson
destroyed pathological skin cells, offering further evidence of
potential efficacy in psoriasis.
Phase IIb NASH Study Commenced Enrollment – This Phase II
multicenter, randomized, double-blind, placebo-controlled study in
subjects with biopsy-confirmed NASH enrolled its first patient in
January. The primary objective of the trial is to evaluate the
efficacy of Namodenoson as compared to placebo in 140 subjects with
NASH, as determined by a histological endpoint. In a prior Phase
IIa study, Namodenoson met its primary endpoint by reducing liver
fat, inhibiting fibrosis, and demonstrating an anti-inflammatory
effect. There is currently no U.S. FDA approved treatment for NASH,
an addressable pharmaceutical market estimated to reach $21.9
billion by 2028 driven by increasing incidence.
Several Patents Granted for Liver Diseases – Can-Fite’s
IP for Namodenoson in the treatment of liver diseases continues to
grow. The Company was issued a Notice of Allowance in the U.S. for
a broad patent that addresses markets for the treatment of all
advanced liver fibrosis indications including NASH, NAFLD,
autoimmune hepatitis, primary biliary cirrhosis, and more. Other
patents specific to NASH and NAFLD were granted in 37 countries,
most recently issued and allowed in Japan, Hong Kong, and
Mexico.
A3AR-based Cannabis Compounds Found to Inhibit Liver Cancer
Growth in Preclinical Study – Can-Fite continues to advance its
findings for cannabinoids and its platform technology’s target A3AR
for which the Company has filed a patent. In 2021, Can-Fite
completed pre-clinical studies demonstrating that a CBD rich T3/C15
cannabis fraction induces inhibition of liver cancer cell growth.
These findings were published in peer-reviewed journals and
presented at industry conferences.
“Our advanced-stage pipeline continues to achieve milestones,
with Piclidenoson and Namodenoson both positioned as potentially
safe and effective treatments for very large treatment indications
including psoriasis, NASH, and liver cancer. In 2021 we
signed our largest out-licensing deal to date, and in 2022 we
anticipate additional new agreements as well as the potential of
milestone payments from current agreements based on results from
our current advanced stage trials,” stated Can-Fite CEO Dr. Pnina
Fishman.
Financial Results
Revenues for the year ended December 31, 2021 were $0.85 million
compared to revenues of $0.76 million during the twelve months
ended December 31, 2020. The increase in revenues was mainly due to
the recognition of a portion of an advance payment received under
the Ewopharma distribution agreement entered in 2021 which was
offset by the recognition of a lower portion of advance payments
received under distribution agreements from Gebro, Chong Kun Dung
Pharmaceuticals, and Cipher Pharmaceuticals.
Research and development expenses for the year ended December
31, 2021 were $9.85 million compared to $11.95 million for the year
ended December 31, 2020. Research and development expenses in 2021
comprised primarily of expenses associated with two studies for
Piclidenoson, a Phase III study in the treatment of psoriasis and a
Phase II study in COVID-19 and Phase II studies for Namodenoson in
the treatment of liver cancer and NASH. The decrease is primarily
due to costs incurred in 2020 associated with the Univo research
project which was completed by the end of that year and a Phase III
study of Piclidenoson for the treatment of rheumatoid arthritis
which was ongoing during 2020, partially offset the pre-clinical
projects and the two ongoing studies of Piclidenoson. We expect
research and development expenses will increase through 2022 and
beyond.
General and administrative expenses were $3.84 million for the
year ended December 31, 2021 compared to $2.95 million for the same
period in 2020. The increase is primarily due to the increase in
salaries and related benefits due to the distribution of bonuses to
employees, increase in employee salaries, increase in public
relations expenses, and insurance expenses. We expect general and
administrative expenses will remain at the same level for the
remainder of 2022 and beyond.
Financial income, net for the year ended December 31, 2021 was
$0.23 million compared to financial expense, net of $0.3 million
for the same period in 2020. The decrease in financial expense, net
was mainly due to an increase in the revaluation of our short-term
investment.
Can-Fite's net loss for the year ended December 31, 2021 was
$12.6 million compared with a net loss of $14.4 million for the
same period in 2020. The decrease in net loss was primarily
attributable to a decrease in research and development expenses
which were partly offset by an increase in general and
administrative expenses and a decrease in finance income, net.
As of December 31, 2021, Can-Fite had cash, cash equivalents,
and short-term deposits of $18.9 million as compared to $8.3
million at December 31, 2020. The increase in cash during the year
ended December 31, 2021 is due to an aggregate of $2.74 million in
net proceeds received through warrant exercise transactions during
the first quarter of 2021, an advance payment of $2.25 million from
a distribution agreement with Ewopharma and from a $10 million
registered direct offering in August 2021 which were offset by the
Company’s operating activity.
The Company's consolidated financial results for the twelve
months ended December 31, 2021 are presented in accordance with US
GAAP Reporting Standards.
More detailed information can be found in the Company’s Annual
Report on Form 20-F for the fiscal year ended December 31, 2021, 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
U.S dollars in thousands (except for share and per share
data)
December 31,
2021
2020
USD
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
4,390
$
8,268
Short-term deposits
14,512
-
Prepaid expenses, and other
current assets
929
1,057
Short-term investment
237
75
Total current
assets
20,068
9,400
NON-CURRENT ASSETS:
Operating lease right of use
assets
138
73
Property, plant and equipment,
net
47
50
Total
long-term assets
185
123
Total
assets
$
20,253
$
9,523
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
December 31,
2021
2020
USD
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
954
$
561
Current maturity of operating
lease liability
53
43
Deferred revenues
818
334
Other accounts payable
905
331
Total current
liabilities
2,730
1,269
NON-CURRENT LIABILITIES:
Long-term operating lease
liability
71
24
Deferred revenues
3,070
2,156
Total
Long-term liabilities
3,141
2,180
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par
value - Authorized: 5,000,000,000 and 1,000,000,000 shares at
December 31, 2021 and December 31, 2020, respectively; Issued and
outstanding: 815,746,293 shares as of December 31, 2021;
463,769,463 shares as of December 31, 2020
60,654
33,036
Additional paid-in capital
93,275
97,380
Accumulated other comprehensive
income
1,127
1,127
Accumulated deficit
(140,674
)
(125,469
)
Total
shareholders’ equity
14,382
6,074
Total
liabilities and shareholders’ equity
$
20,253
$
9,523
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share
data)
Year ended December
31,
2021
2020
2019
USD
Revenues
$
853
$
763
$
2,032
Research and development expenses
(9,850
)
(11,951
)
(10,976
)
General and administrative expenses
(3,845
)
(2,951
)
(3,063
)
Operating loss
(12,842
)
(14,139
)
(12,007
)
Total financial income (expense), net
227
(304
)
(618
)
Loss before taxes on income
(12,615
)
(14,443
)
(12,625
)
Taxes on income
-
-
-
Net loss
$
(12,615
)
$
(14,443
)
$
(12,625
)
Deemed dividend
(2,590)
(715
)
-
Total comprehensive loss
$
(15,205
)
$
(15,158
)
$
(12,625
)
Basic and diluted net loss per share
$
(0.03
)
$
(0.04
)
$
(0.14
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
553,079,638
358,411,297
85,909,859
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, and inflammatory disease. The Company's lead drug
candidate, Piclidenoson has completed enrollment in a Phase III
trial for psoriasis. Can-Fite's liver drug, Namodenoson, is being
evaluated in a Phase IIb trial for the treatment of non-alcoholic
steatohepatitis (NASH), and enrollment is expected to commence in a
Phase III trial for hepatocellular carcinoma (HCC), the most common
form of liver cancer. 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 COVID-19
pandemic; 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/20220324005121/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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