Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncology, inflammatory and liver
diseases, today announced financial results for the six months
ended June 30, 2023.
Clinical Progress
Pivotal Phase III Advanced Liver Cancer Study—Can-Fite’s
pivotal Phase III liver cancer study, Liveration, which continues
enrollment is designed to assess Namodenoson in the treatment of
patients with advanced hepatocellular carcinoma (HCC) and
underlying Child Pugh B7 (CPB7) who have not responded to one or
two other lines of therapy. The primary endpoint is overall
survival. An interim analysis will be conducted by an Independent
Data Monitoring Committee (IDMC) after 50% of the planned 450
patients are enrolled and treated.
Breakthrough Abstract Award–Can-Fite was recently granted
a prestigious Breakthrough Abstract Award by the American Society
of Clinical Oncology (ASCO) Conquer Cancer Foundation for the
development of a novel approach to treat advanced liver cancer with
the A3 adenosine receptor agonist, Namodenoson.
Exploratory Phase II Pancreatic Cancer Study—Can-Fite is
preparing an open-label Phase II exploratory trial to assess the
safety and efficacy of Namodenoson in the treatment of patients
with pancreatic cancer who have received at least one previous
systemic therapy. In pre-clinical studies, Namodenoson demonstrated
a robust anti-growth effect against pancreatic carcinoma, reaching
90% growth inhibition. The mechanism of action entails
de-regulation of the Wnt signal transduction pathway, a key
modulator of pancreatic carcinoma cell growth.
ASCO Recognition—Can-Fite’s pancreatic cancer program
received recognition from ASCO when its study titled “Effects of
Namodenoson on Pancreatic Carcinoma: Preclinical Evidence” was
published in the Journal of Clinical Oncology supplement of the
2023 ASCO Annual Meeting Proceedings.
Preparatory Work for Pivotal Phase III Psoriasis Study; Can
Fite Received Green Light from FDA and EMA— Following positive
responses from the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA) for its registration plan and
pivotal Phase III study protocol for Piclidenoson in the treatment
of moderate to severe psoriasis, the Company is preparing for study
initiation. The FDA requested two Phase III studies and also
encouraged the Company to enroll adolescent patients due to
Piclidenoson’s strong safety profile demonstrated over its
development history and prior clinical studies. Can-Fite has
submitted to the FDA a pediatric plan to allow the registration of
Piclidenoson for the treatment of adolescents. Inclusion of
adolescents for the psoriasis Indication is expected to broaden the
market.
Development for Treatment of Lowe Syndrome, a Rare Genetic
Disease—Researchers at the University of Naples Federico II and
The Telethon Institute of Genetics and Medicine (TIGEM) in Italy
found Piclidenoson to be effective in pre-clinical studies for the
treatment of Lowe Syndrome. Can-Fite and Fondazione Telethon signed
an agreement outlining their collaboration for the development of
Piclidenoson for the treatment Lowe Syndrome, a rare genetic
disease with no treatment available, and an estimated $100 million
treatment market in the U.S. alone.
“With two ongoing studies and two more about to commence in
large treatment markets with unmet needs, we continue to advance
our late-stage development pipeline to bring our potentially
game-changing drugs to market,” stated Can-Fite CEO & CFO Motti
Farbstein.
Dr. Pnina Fishman, Can-Fite’s CSO and Executive Chairman added,
“We are particularly excited about our entry into the rare genetic
disease field with the discovery of Piclidenoson’s efficacy in Lowe
Syndrome in pre-clinical studies. Given Piclidenoson’s very
favorable safety profile, we believe it will be a good candidate
for directly entering advanced stage trials in children and
adolescents living with Lowe Syndrome. Rare genetic diseases can
have a more direct rapid path to regulatory approval with smaller
trial sizes due to the pressing need in a small, unserved patient
population. “
Financial Results
Revenues for the six months ended June 30, 2023 were $0.39
million compared to revenues of $0.41 million during the six months
ended June 30, 2022. Revenues for the six months ended June 30,
2023 and June 30, 2022 comprised of recognition of a portion of
advance payments received under distribution agreements with Gebro,
CKD, Cipher and Ewopharma.
Research and development expenses for the six months ended June
30, 2023 were $3.41 million compared with $3.27 million for the
same period in 2022. Research and development expenses for the
first half of 2023 comprised primarily of expenses associated with
the completion of the Phase 3 study of Piclidenoson for the
treatment of psoriasis and two ongoing studies for Namodenoson, a
Phase 3 study in the treatment of advanced liver cancer and a Phase
2b study for SLD. The increase is primarily due to an increase in
expenses associated with Namodenoson.
General and administrative expenses were $1.47 million for the
six months ended June 30, 2023 compared to $1.57 million for the
same period in 2022. The decrease is primarily due to the decrease
in public and investor relations expenses and in directors and
officer’s insurance policy premium. We expect that general and
administrative expenses will remain at the same level through
2023.
Financial income, net for the six months ended June 30, 2023 was
$0.27 million compared to financial expense, net of $0.18 million
for the same period in 2022. The decrease in financial expense, net
was mainly due to revaluation of our short-term investment and
increase in interest income from deposits in 2023.
Net loss for the six months ended June 30, 2023 was $4.22
million compared with a net loss of $4.62 million for the six
months ended June 30, 2022. The decrease in net loss for the six
months ended June 30, 2023 was primarily attributable to the
increase in finance income, net.
As of June 30, 2023, Can-Fite had cash and cash equivalents and
short term deposits of $9.60 million as compared to $7.98 million
at December 31, 2022. The decrease in cash during the six months
ended June 30, 2023 is due to the ongoing operations of the
Company.
The Company's consolidated financial results for the six months
ended June 30, 2023 are presented in accordance with US GAAP
Reporting Standards.
CONSOLIDATED BALANCE SHEETS U.S dollars in thousands
(except for share and per share data)
June 30,
December 31,
2023
2022
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
3,458
$
2,978
Short term deposits
6,147
5,001
Prepaid expenses and other current
assets
1,293
1,170
Short-term investment
11
8
Total current
assets
10,909
9,157
NON-CURRENT ASSETS:
Operating lease right of use assets
87
84
Property, plant and equipment, net
36
42
Total non-current
assets
123
126
Total
assets
$
11,032
$
9,283
CONSOLIDATED BALANCE SHEETS U.S dollars in thousands
(except for share and per share data)
June 30,
December 31,
2023
2022
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
810
$
896
Current maturity of operating lease
liability
44
48
Deferred revenues
783
783
Other accounts payable
596
775
Total current
liabilities
2,233
2,502
NON-CURRENT LIABILITIES:
Long-term operating lease liability
22
14
Deferred revenues
1,903
2,295
Total long-term
liabilities
1,925
2,309
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value -
Authorized: 5,000,000,000 shares at June 30, 2023 and December 31,
2022; Issued and outstanding: 1,224,837,393 and 815,746,293 shares
as of June 30, 2023 and December 31, 2022
-
-
Additional paid-in capital
160,814
154,192
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(155,067
)
(150,847
)
Total
equity
6,874
4,472
Total liabilities
and shareholders’ equity
$
11,032
$
9,283
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S
dollars in thousands (except for share and per share data)
Six months ended
June 30,
2023
2022
Unaudited
Revenues
$
392
$
409
Research and development expenses
(3,417
)
(3,273
)
General and administrative expenses
(1,471
)
(1,576
)
Operating loss
(4,496
)
(4,440
)
Total financial income (expense), net
276
(185)
Net loss
(4,220
)
(4,625
)
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
1,202,110,110
815,746,293
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) 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 recently reported
topline results in a Phase III trial for psoriasis and is expected
to commence a pivotal Phase III. Can-Fite's cancer and liver drug,
Namodenoson, is being evaluated in a Phase IIb trial for the
treatment of steatotic liver disease (SLD), a Phase III pivotal
trial for hepatocellular carcinoma (HCC), and the Company is
planning a Phase IIa study in pancreatic 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
1,600 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, its product development efforts, business, financial
condition, results of operations, strategies or prospects. All
statements in this communication, other than those relating to
historical facts, are “forward looking statements”. 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.
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 known and
unknown risks, uncertainties and other factors that may cause
Can-Fite’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Important factors that could cause actual results,
performance or achievements to differ materially from those
anticipated in these forward-looking statements include, among
other things, 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; risks
related to the COVID-19 pandemic and the Russian invasion of
Ukraine; risks related to not satisfying the continued listing
requirements of NYSE American; and statements as to the impact of
the political and security situation in Israel on our business.
More information on these risks, uncertainties and other factors is
included from time to time in the “Risk Factors” section of
Can-Fite’s Annual Report on Form 20-F filed with the SEC on March
30, 2023 and other public reports filed with the SEC and in its
periodic filings with the TASE. Existing and prospective investors
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Can-Fite
undertakes no obligation to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by any
applicable securities laws.
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Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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