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
June 30, 2021.
Corporate and Clinical Development Highlights
Include:
Can-Fite Entered into Development and Commercialization
Agreement in $3 Billion Veterinary Osteoarthritis Market –
Can-Fite entered into a development and commercialization agreement
with Vetbiolix, a France-based veterinary biotech company, for the
development of Piclidenoson for the treatment of osteoarthritis in
companion animals including dogs and cats. Vetbiolix will have the
exclusive right to Piclidenoson in the veterinary osteoarthritis
market for two years, during which time Vetbiolix will conduct
proof-of-concept studies and cover all associated costs. If the
studies yield positive data and Vetbiolix exercises its option to
obtain the license from Can-Fite, then Vetbiolix will be obligated
to pay Can-Fite upfront and milestone payments, in addition to
royalties on sales upon regulatory approval for veterinary use. The
canine osteoarthritis market is projected to reach $3 billion by
2024.
Can-Fite Received a Notice Allowance in China for its
NASH Patent - During the second quarter, Can-Fite received a
Notice Allowance in China for its patent titled “An A3 Adenosine
Receptor Ligand For Use In Treating Ectopic Fat Accumulation”. This
patent, which has subsequently been issued to Can-Fite, addresses
the use of the A3 Adenosine Receptor (A3AR) ligand, the target
receptor for Can-Fite’s drug platform technology, to reduce liver
fat particularly in patients with NASH.
Patent Filed for A3AR-based Cannabis Compounds in the
Treatment of Liver Diseases - Can-Fite’s preclinical studies of
cannabis compounds found CBD rich T3/C15 induced inhibition of
liver cancer cell growth and also had an inhibitory effect on liver
fibrosis, which is associated with NAFLD/NASH, cirrhosis, and liver
cancer. Can-Fite has filed patent applications to protect its
discovery of cannabinoid-based therapies where the A3AR target is
overexpressed.
Phase III Psoriasis Study Nears Completion of Enrollment
– The Phase III Comfort™ study completed enrollment of 75% of
planned patients during the second quarter, with full enrollment
expected in the coming weeks. 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. Topline results are expected Q1 2022.
Phase II COVID-19 Study Expands into Europe – Can-Fite’s
ongoing Phase II study, under a U.S. FDA protocol, has been
enrolling patients in Israel and expanded enrollment into Europe
during the second quarter. The randomized, double blind,
placebo-controlled study is evaluating the benefits of treatment
with Piclidenoson plus standard supportive care (SSC) vs. placebo
plus SSC in 40 patients hospitalized with moderate to severe
COVID-19, as defined by the U.S. National Institutes of Health
Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.
Phase IIb NASH Study Receives Clearance from Israeli Ministry
of Health – Can-Fite received clearance from the Israeli
Ministry of Health to commence a Phase IIb study of its drug
candidate Namodenoson in the treatment of NASH. Patient enrollment
is expected to commence Q3 2021, ahead of the prior expected start
date of Q4 2021. The Company expects to expand the study to
additional clinical sites in Europe. A prior Phase IIa clinical
trial of Namodenoson in the treatment of NASH met study endpoints
showing anti-steatotic, anti-inflammatory, and anti-fibrotic
effects.
Pivotal Phase III Liver Cancer Study Expected to Commence Q4
2021 - Can-Fite has completed preparatory work for its pivotal
Phase III study and plans to submit its study protocol and plans to
Institutional Review Boards (IRBs) at potential clinical sites. The
double blind, placebo-controlled trial will enroll 450 patients
diagnosed with HCC and underlying Child Pugh B7 (CPB7) through
clinical sites worldwide. Patients will be randomized to oral
treatment with either 25 mg Namodenoson or matching placebo given
twice daily. The primary efficacy endpoint of the trial is overall
survival.
Fortified Balance Sheet
On June 30, 2021 Can-Fite had approximately $7.5 million in
cash, cash equivalents, and short-term deposits. The Company closed
an additional $10 million registered direct offering in August
2021.
“We expect multiple milestones in the coming months including
topline results from our Phase III psoriasis study, in addition to
the commencement of our pivotal Phase III in liver cancer and Phase
IIb in NASH. We believe positive topline results may lead to
further expansion of our global distribution strategy which has
included significant non-dilutive funding,” stated Can-Fite CEO Dr.
Pnina Fishman.
Financial Results
Revenues for the six months ended June 30, 2021 were $0.39
million compared to revenues of $0.40 million during the six months
ended June 30, 2020. The decrease is considered immaterial.
Research and development expenses for the six months ended June
30, 2021 were $3.81 million compared with $7.05 million for the
same period in 2020. Research and development expenses for the
first half of 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 six 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 six months of 2021. We
expect research and development expenses will increase through 2021
and beyond.
General and administrative expenses were $1.89 million for the
six months ended June 30, 2021 compared to $1.45 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. We expect general and administrative expenses will
remain at the same level through 2021.
Financial income, net for the six months ended June 30, 2021 was
$0.20 million compared to financial expense, net of $0.12 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 investment.
Can-Fite's net loss for the six months ended June 30, 2021 was
$5.09 million compared with a net loss of $8.23 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 June 30, 2021, Can-Fite had cash, cash equivalents and
short-term deposits of $7.53 million as compared to $8.26 million
at December 31, 2020. The decrease in cash during the six months
ended June 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 and from an advance payment of $2.25 million
from a distribution agreement with Ewopharma which were offset by
Company’s operating activity.
The Company's consolidated financial results for the six months
ended June 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)
June 30,
December
2021
31, 2020
Unaudited
Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
1,025
$
8,268
Short-term deposits
6,512
-
Other receivable and prepaid expenses
1,745
1,057
Short-term investment
271
75
Total current
assets
9,553
9,400
NON-CURRENT ASSETS:
Operating lease right of use assets
77
73
Property, plant and equipment, net
50
50
Total long-term
assets
127
123
Total
assets
$
9,680
$
9,523
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
June 30,
December
2021
31, 2020
Unaudited
Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,005
$
561
Current maturity of operating lease
liability
43
43
Deferred revenues
1,002
334
Other accounts payable
309
331
Total current
liabilities
2,359
1,269
NON-CURRENT LIABILITIES:
Long - term operating lease liability
25
24
Deferred revenues
3,341
2.156
Total long-term
liabilities
3,366
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 June 30, 2021
and December 31, 2020, respectively; Issued and outstanding:
515,746,293 shares as of June 30, 2021; 463,769,463 shares as of
December 31, 2020
37,008
33,036
Additional paid-in capital
96,386
97,380
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(130,566
)
(125,469
)
Total
equity
3,955
6,074
Total liabilities
and shareholders’ equity
$
9,680
$
9,523
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
U.S dollars in thousands (except for share and per share
data)
Six months ended
June 30,
2021
2020
Unaudited
Revenues
$
398
$
402
Research and development expenses
(3,810
)
(7,054
)
General and administrative expenses
(1,892
)
(1,455
)
Operating loss
(5,304
)
(8,107
)
Total financial income (expenses), net
207
(128
)
Net loss
(5,097)
(8,235
)
Total comprehensive loss
(5,097
)
(8,235
)
Deemed dividend
-
(715
)
Net loss attributed to ordinary
shareholders
$
(5,097
)
$
(8,950
)
Basic and diluted net loss per share
(0.01
)
(0.04
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
500,010,114
254,940,675
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/20210826005269/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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