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
March 31, 2022.
Corporate and Clinical Development Highlights
Include:
Fortified Balance Sheet - On March 31, 2022, Can-Fite had
approximately $16.5 million in cash, cash equivalents, and
short-term deposits.
Phase III Psoriasis Study Data Expected Q2 2022 – Topline
results are expected in Q2 2022 in Can-Fite’s Phase III Comfort™
psoriasis study for both its 16 week primary endpoint and 32 week
secondary endpoint. 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.
During the first quarter, a preclinical study showed Piclidenoson
destroyed pathological skin cells, offering further evidence of
potential efficacy in psoriasis.
Developing Topical Psoriasis Treatment - In a preclinical
model, daily treatment with topical Piclidenoson significantly
inhibited psoriasis as measured by the psoriasis area severity
index (PASI) calculated based on observation of erythema,
thickness, scaling, and a score of skin lesions. The topical
treatment may serve as a complementary product to oral
Piclidenoson.
Commenced Enrollment in Phase IIb NASH Study – In
January, Can-Fite enrolled the first patient in its Phase IIb
multicenter, randomized, double-blind, placebo-controlled study in
140 subjects with biopsy-confirmed NASH. The primary objective of
the trial is to evaluate the efficacy of Namodenoson as compared to
placebo 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.
Granted U.S. Patent for Liver Fibrosis and Israeli Patent for
NASH – The U.S. Patent and Trademark Office granted Can-Fite a
patent for its invention titled “Method for Treating Fibrotic Liver
Tissue Using CL-IB MECA”, a broad patent that addresses markets for
the treatment of all advanced liver fibrosis indications. The
patent opens an opportunity for much broader market needs which
entail all clinical conditions with advanced liver fibrosis
including autoimmune hepatitis, primary biliary cirrhosis (PBC),
nonalcoholic fatty liver disease (NAFLD), and alcoholic liver
disease (ALD) among others. The Israel Patent Office granted
Can-Fite a patent titled “An A3 Adenosine Receptor Ligand For Use
In Treating Ectopic Fat Accumulation” which has been issued in
approximately 40 other countries.
Opened Enrollment in Pivotal Phase III Liver Cancer Study
– Can-Fite’s pivotal Phase III liver cancer study for Namodenoson
opened for enrollment of approximately 450 patients diagnosed with
hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7)
who have not responded to other approved therapies. An interim
analysis will be conducted after 50% of patients are enrolled and
treated. The primary endpoint is overall survival. Can-Fite has
received Orphan Drug Designation in both the U.S. and Europe and
has received the U.S. FDA’s Fast Track Status.
Presented Data on Cannabinoids in the Treatment of Liver
Cancer at CannX – In March, Can-Fite delivered a presentation
titled “Inhibition of Hepatocellular Carcinoma Growth and Liver
Fibrosis by Nanomolar Cannabinoids Concentrations” at the CannX
Medical Cannabis Conference in Tel Aviv. The findings were also
published in the peer-reviewed scientific journal Medical Cannabis
and Cannabinoids highlighting the ability of CBD-rich T3/C15 in
nanomolar concentrations to inhibit the growth of hepatocellular
carcinoma and liver stellate cells via A3AR activation and
deregulation of the Wnt/β-catenin pathway.
“We look forward to announcing Phase III psoriasis results
before the end of the second quarter as we enroll patients in our
other advanced stage clinical trials for NASH and liver cancer,”
stated Can-Fite CEO Dr. Pnina Fishman. “Can-Fite is financially
well positioned to conduct all our clinical development programs
over the next year, and we continue to evaluate potential new
distribution partnerships which may provide additional non-dilutive
funding.”
Financial Results
Revenues for the three months ended March 31, 2022 were $0.20
million, an increase of $0.05 million, or 38.5%, compared to $0.15
million for the three months ended March 31, 2021. The increase in
revenues was mainly due to the recognition of a higher portion of
advance payments received under a distribution agreement with
Ewopharma than the advance payment received at the end of the first
quarter of 2021.
Research and development expenses for the three months ended
March 31, 2022 were $1.82 million, an increase of $0.52 million, or
39.8%, compared to $1.30 million for the three months ended March
31, 2021. Research and development expenses for the first quarter
of 2022 comprised primarily of expenses associated with an ongoing
Phase III study of Piclidenoson for the treatment of psoriasis and
two studies for Namodenoson, a Phase III study in the treatment of
liver cancer and a Phase IIb study for NASH. The increase is
primarily due to costs incurred in the first quarter of 2022
associated with the two new studies for Namodenoson.
General and administrative expenses for the three months ended
March 31, 2022 were $0.75 million a decrease of $0.26 million, or
25.8%, compared to $1.01 million for the three months ended March
31, 2021. The decrease is primarily due to the decrease in
professional services for public relations and investor relations.
We expect that general and administrative expenses will remain at
the same level through 2022.
Financial expenses, net for the three months ended March 31,
2022 were $0.06 million compared to finance income, net of $0.29
million for the three months ended March 31, 2021. The decrease in
financial income, net was mainly due to revaluation of our
short-term investment which in 2021 was recorded as income and in
2022 was recorded as expense.
Net loss for the three months ended March 31, 2022 was $2.43
million compared with a net loss of $1.87 million for the three
months ended March 31, 2021. The increase in net loss for the three
months ended March 31, 2022 was primarily attributable to an
increase in research and development expenses which was partly
offset by a decrease in general and administrative expenses and a
decrease in finance income, net.
As of March 31, 2022, Can-Fite had cash and cash equivalents and
short term deposits of $16.5 million as compared to $18.9 million
at December 31, 2021. The decrease in cash during the three months
ended March 31, 2022 is due to the ongoing operation of the
Company.
The Company's consolidated financial results for the three
months ended March 31, 2022 are presented in accordance with US
GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
March 31, 2022
December 31, 2021
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
5,504
$
4,390
Short term deposit
11,016
14,512
Prepaid expenses and other
current assets
971
929
Short-term investment
182
237
Total current
assets
17,673
20,068
NON-CURRENT ASSETS:
Operating lease right of use
assets
125
138
Property, plant and equipment,
net
49
47
Total
long-term assets
174
185
Total
assets
$
17,487
$
20,253
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
March 31,
2022
December 31, 2021
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,124
$
954
Current maturity of operating
lease liability
55
53
Deferred revenues
818
818
Other accounts payable
907
905
Total current
liabilities
2,904
2,730
NON-CURRENT LIABILITIES:
Long-term operating lease
liability
54
71
Deferred revenues
2,865
3,070
Total
Long-term liabilities
2,919
3,141
SHAREHOLDERS’ EQUITY
Ordinary shares of NIS 0.25 par
value - Authorized: 5,000,000,000 shares at March 31, 2022 and
December 31, 2021; Issued and outstanding: 815,746,293 shares as of
March 31, 2022 and December 31, 2021
60,654
60,654
Additional paid-in capital
93,351
93,275
Accumulated other comprehensive
income
1,127
1,127
Accumulated deficit
(143,108
)
(140,674
)
Total
equity
12,024
14,382
Total
liabilities and equity
$
17,847
$
20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share
data)
Three months ended
March 31,
2022
2021
Unaudited
Revenues
$
205
$
148
Research and development expenses
(1,821
)
(1,303
)
General and administrative expenses
(754
)
(1,016
)
Operating loss
(2,370
)
(2,171
)
Total financial income (expense), net
(64
)
293
Net loss
(2,434
)
(1,878
)
Basic and diluted net loss per share
(0.00
)
(0.00
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
815,746,293
483,920,313
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220526005065/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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