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 quarter ended
September 30, 2021.
Corporate and Clinical Development Highlights
Include:
Completed Patient Enrollment in Phase III Psoriasis Study
– The Phase III Comfort™ study completed patient enrollment.
Topline results are expected in Q1 2022. The study is designed to
establish Piclidenoson’s superiority compared to placebo and
non-inferiority compared to Apremilast (Otezla®) in patients with
moderate to severe plaque psoriasis.
Can-Fite Ends Phase II COVID-19 Trial to Focus on Core
Indications - In 2020, with the aim of developing a much-needed
drug to treat manifestations of COVID-19, mainly the Cytokine
Release Syndrome, Can-Fite initiated a Phase II COVID-19 study of
its lead drug candidate, Piclidenoson, with patient enrollment in
Israel and Europe. With the anticipated launch of Pfizer’s oral
COVID-19 antiviral drug candidate, Can-Fite has made a strategic
decision to end its COVID-19 program and to focus its resources on
its other clinical programs, all in advanced clinical trials.
Patents Granted for NASH in Japan, Hong Kong, and Mexico
– Can-Fite continues to build its IP portfolio for NASH which
now includes patents granted and allowed in 37 countries. Most
recently, patents were issued and allowed in Japan, Hong Kong, and
Mexico for the patent titled "An A3 Adenosine Receptor Ligand for
Use In Treating Ectopic Fat Accumulation". This patent addresses
the use of the A3 Adenosine Receptor (A3AR) ligand, the target
receptor for Can-Fite's drug platform technology, in the treatment
of NASH.
Data on A3AR-based Cannabis Compounds in the Treatment of
Liver Diseases Presented at AASLD and Published in HEPATOLOGY –
Can-Fite delivered a poster presentation titled “Growth Inhibition
of Hepatocellular Carcinoma (HCC) by CBD Rich T3/C15 Cannabis
Fraction is Mediated via the A3 Adenosine Receptor” at the American
Association for the Study of Liver Diseases (AASLD) The Liver
Meeting® during the Hepatobiliary Neoplasia: Experimental
Hepatocarcinogenesis; Diagnostics and Liver Imaging session. The
findings were also published in an abstract in the October 2021
supplement of HEPATOLOGY, a premier peer-reviewed publication in
the field of liver disease published on behalf of the AASLD.
Positive Phase IIa NASH Data Published in Alimentary
Pharmacology & Therapeutics – The peer-reviewed scientific
journal focused on gastroenterology and hepatology published an
article titled “Randomised clinical trial: A phase 2 double-blind
study of namodenoson in non-alcoholic fatty liver disease and
steatohepatitis". The article includes highlights from Can-Fite’s
Phase IIa NASH study of Namodenoson which achieved its study
endpoints including significant anti-steatotic, anti-fibrotic, and
anti-inflammatory effects.
Fortified Balance Sheet
On September 30, 2021, Can-Fite had approximately $13.3 million
in cash, cash equivalents, and short-term deposits.
“Our NASH program has received a high level of interest at
scientific conferences based on our positive Phase IIa results, and
we continue to fortify our IP around this indication. We expect to
commence enrollment in our pivotal Phase III liver cancer and Phase
IIb NASH studies, as we look forward to topline results from our
Phase III in psoriasis in the first quarter of 2022. Our advanced
pipeline with a growing body of safety and efficacy data has
significant potential to help patients with unmet needs,” stated
Can-Fite CEO Dr. Pnina Fishman.
Financial Results
Revenues for the nine months ended September 30, 2021 were $0.65
million compared to revenues of $0.61 million during the nine
months ended September 30, 2020. The increase is considered
immaterial.
Research and development expenses for the nine months ended
September 30, 2021 were $6.75 million compared with $9.06 million
for the same period in 2020. Research and development expenses for
the nine months period ended September 30, 2021 comprised primarily
of expenses associated with two studies for Piclidenoson, a Phase
II study in COVID-19 and a Phase III study in the treatment of
psoriasis. The decrease is primarily due to costs incurred in the
first nine months of 2020 associated with Phase II studies for
Namodenoson in the treatment of liver cancer and NASH, and a Phase
III study of Piclidenoson for the treatment of rheumatoid
arthritis, partially offset by the two ongoing studies of
Piclidenoson in the first nine months of 2021. We expect research
and development expenses will increase for the remainder of 2021
and beyond.
General and administrative expenses were $2.71 million for the
nine months ended September 30, 2021 compared to $2.14 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 public relations expenses and
insurance expenses. We expect general and administrative expenses
will remain at the same level for the remainder of 2021 and
beyond.
Financial income, net for the nine months ended September 30,
2021 was $0.31 million compared to financial expense, net of $0.22
million for the same period in 2020. The decrease in financial
expense, net was mainly due to finance income recorded from
revaluation of our short-term investments.
Can-Fite's net loss for the nine months ended September 30, 2021
was $8.49 million compared with a net loss of $10.81 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 expenses,
net.
As of September 30, 2021, Can-Fite had cash, cash equivalents
and short-term deposits of $13.3 million as compared to $8.26
million at December 31, 2020. The increase in cash during the nine
months ended September 30, 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 Company’s operating activity.
The Company's consolidated financial results for the nine months
ended September 30, 2021 are presented in accordance with US GAAP
Reporting Standards.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
September 30,
December 31,
2021
2020
Unaudited
Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
5,806
$
8,268
Short-term deposits
7,503
-
Other receivable and prepaid expenses
811
1,057
Short-term investment
354
75
Total current
assets
14,474
9,400
NON-CURRENT ASSETS:
Operating lease right of use assets
116
73
Property, plant and equipment, net
49
50
Total long-term
assets
165
123
Total
assets
$
14,639
$
9,523
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
September 30,
December 31,
2021
2020
Unaudited
Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
806
$
561
Current maturity of operating lease
liability
40
43
Deferred revenues
1,002
334
Other accounts payable
305
331
Total current
liabilities
2,153
1,269
NON-CURRENT LIABILITIES:
Long - term operating lease liability
62
24
Deferred revenues
3,090
2,156
Total long-term
liabilities
3,152
2,180
CONTINGENT 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 September 30,
2021 and December 31, 2020, respectively; Issued and outstanding:
601,996,293 shares as of September 30, 2021; 463,769,463 shares as
of December 31, 2020
43,716
33,036
Additional paid-in capital
98,457
97,380
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(133,966
)
(125,469
)
Total
equity
9,334
6,074
Total liabilities
and shareholders’ equity
$
14,639
$
9,523
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
U.S dollars in thousands (except for share and per share
data)
Nine months ended
September 30,
2021
2020
Unaudited
Revenues
$
649
$
613
Research and development expenses
(6,749
)
(9,055
)
General and administrative expenses
(2,714
)
(2,144
)
Operating loss
(8,814
)
(10,586
)
Total financial income (expenses), net
317
(224
)
Net loss
(8,497)
(10,810
)
Total comprehensive loss
(8,497
)
(10,810
)
Deemed dividend
-
(715
)
Net loss attributed to ordinary
shareholders
$
(8,497
)
$
(11,525
)
Basic and diluted net loss per share
(0.02
)
(0.04
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
515,918,123
323,360,926
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, inflammatory disease and
COVID-19. The Company's lead drug candidate, Piclidenoson, is
currently in a Phase III trial for psoriasis and a Phase II study
in the treatment of moderate COVID-19. Can-Fite's liver drug,
Namodenoson, is headed into a Phase III trial for hepatocellular
carcinoma (HCC), the most common form of liver cancer, and a Phase
IIb 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211126005005/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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