Ewopharma acquired marketing rights for
namodenoson in the treatment of pancreatic carcinoma
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address oncological and inflammatory diseases,
today announced financial results and clinical updates for the
twelve months ended December 31, 2023.
Recent Clinical & Development
Milestones Achieved
Namodenoson Drug Candidate:
- Ewopharma recently acquired marketing rights for Namodenoson
in the treatment of pancreatic carcinoma This adds up to an out
licensing agreement that Can-Fite signed with Switzerland-based
Ewopharma in 2021, for exclusive distribution of both Piclidenoson
and Namodenoson in Central Eastern European (CEE) countries
(Piclidenoson for the treatment of psoriasis and Namodenoson for
the treatment of liver cancer and NASH). Under the terms of the
distribution agreement, Ewopharma AG paid Can-Fite an upfront
payment of US$2.25 million with up to an additional US$40.45
million, payable upon the achievement of regulatory and sales
milestones, plus 17.5% royalties on net sales. Recently, Ewopharma
AG exercised its right to expand the distribution agreement to
include the indication of pancreatic cancer and the transaction
terms of the distribution agreement are applicable to such
indication.
- Can-Fite Broadens its Strong Intellectual Property (IP) for
NASH (MASH): Received Patent Allowance in Canada Can-Fite
received a Notice of Allowance from the Canadian Intellectual
Property Office for its patent application titled “An A3 Adenosine
Receptor Ligand For Use In Treating Ectopic Fat Accumulation”. This
invention addresses the use of Namodenoson for the reduction of
liver fat in patients with NASH a clinical indication that is being
developed by Can-Fite. In a successfully concluded Phase IIa study,
Namodenoson, one of the Company’s two drugs in advanced clinical
development, reduced liver fat content, showed anti-inflammatory
effects manifested by a significant decrease in the liver enzymes
ALT & AST, and decreased body weight in patients with NASH. A
Company-sponsored study for Namodenoson for this indication is
currently enrolling patients for a Phase IIb study which will
include 140 patients, in whom liver pathology is the primary
endpoint. Patent has already been issued in other major markets
including the U.S., EU, Japan and China.
Piclidenoson Drug Candidate:
Positive Data from the COMFORT-1 Phase III Psoriasis Study
Published in a Top Scientific Journal The Journal of the
European Academy of Dermatology and Venereology (EADV) published an
article titled “Efficacy and safety of piclidenoson in plaque
psoriasis: Results from a randomized phase 3 clinical trial
(COMFORT-1)”. EADV is a top ranked peer reviewed journal (impact
factor 9.2) that publishes articles on clinical and basic science
topics in dermatology. The article’s first author, Dr. K.A Papp, is
an internationally renowned key opinion leader in the psoriasis
field and was the engine for some registered drugs on the market
for this devastating skin disease. The EADV article presents the
safety and efficacy of Piclidenoson in the randomized, placebo- and
active-controlled, double-blind Phase III COMFORT-1 trial. As
previously reported, the study met its primary endpoint which was
the proportion of patients achieving ≥75% improvement in Psoriasis
Area and Severity Index (PASI) from baseline (PASI-75) at Week 16
(3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for Piclidenoson vs.
placebo, p=0.037). Piclidenoson’s efficacy continued to increase
throughout the study period in a linear manner with an excellent
safety and tolerability profile. Currently, Piclidenoson is being
evaluated in COMFORT-2 a pivotal Phase III study that has been
approved by both the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA).
“Our advanced-stage pipeline continues to achieve milestones,
with Piclidenoson and Namodenoson both positioned as potentially
safe and effective treatments for the oncological diseases liver
cancer & pancreatic carcinoma and the inflammatory and
metabolic diseases psoriasis and NASH. We anticipate additional
clinical progress and new out licensing deals in this year,” stated
Can-Fite CEO Motti Farbstein.
Financial Results
Revenues for the year ended December 31, 2023 were $0.74
million, a decrease of $0.07 million, or 8.6%, compared to $0.81
million for the year ended December 31, 2022. The decrease in
revenues was mainly due to the recognition a lower portion of
advance payments received under the Ewopharma distribution
agreement entered in 2021 and 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, 2023 were $5.98 million, a decrease of $1.78 million, or 22.9%,
compared to $7.76 million for the year ended December 31, 2022.
Research and development expenses for the year ended December 31,
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 NASH.
The decrease is primarily due to a decrease in expenses associated
with Piclidenosnon.
General and administrative expenses were $2.95 million for the
year ended December 31, 2023 a decrease of $0.19 million, or 6.05%,
compared to $3.14 million for the year ended December 31, 2022. The
decrease is primarily due to the decrease in directors and
officer’s insurance policy premium. We expect that general and
administrative expenses will remain at the same level through
2024.
Financial income (expense), net for the year ended December 31,
2023 aggregated $0.56 million compared to financial expense, net of
$(0.07) for the year ended December 31, 2022. The decrease in
financial expense, net was mainly due to increase interest from
deposits and reduction in expenses related to the revaluation of
our short-term investment.
Net loss for the year ended December 31, 2023 was $7.63 million
compared with a net loss of $10.17 million for the same period in
2022. The decrease in net loss for the year ended December 31, 2023
was primarily attributable to the decrease in research and
development expenses and in general and administrative
expenses.
As of December 31, 2023, Can-Fite had cash and cash equivalents
and short term deposits of $8.90 million as compared to $7.98
million at December 31, 2022. The decrease in cash during the year
ended December 31, 2023 is due to the ongoing operations of the
Company which was offset by the Company’s financing during January
2023 and exercise of certain warrants during November 2023.
The Company's consolidated financial results for the year ended
December 31, 2023 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, 2023, 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
26 Ben Gurion Street, Ramat Gan, 5257346, 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,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
4,278
$
2,978
Short term deposits
4,625
5,001
Prepaid expenses and other current
assets
986
1,170
Short-term investment
19
8
Total current
assets
9,908
9,157
NON-CURRENT ASSETS:
Operating lease right of use assets
52
84
Property, plant and equipment, net
29
42
Total non-current
assets
81
126
Total
assets
$
9,989
$
9,283
CONSOLIDATED BALANCE SHEETS U.S dollars in thousands
(except for share and per share data)
December 31,
2023
2022
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
427
$
896
Current maturity of operating lease
liability
27
48
Deferred revenues
622
783
Other accounts payable
944
775
Total current
liabilities
2,020
2,502
NON-CURRENT LIABILITIES:
Long - term operating lease liability
13
14
Deferred revenues
1,713
2,295
Total long-term
liabilities
1,726
2,309
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value -
Authorized: 5,000,000,000 shares at December 31, 2023 and December
31, 2022; Issued and outstanding: 1,359,837,393 and 815,746,293
shares as of December 31, 2023 and December 31, 2022
-
-
Additional paid-in capital
163,597
154,192
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(158,481
)
(150,847
)
Total shareholders’
equity
6,243
4,472
Total liabilities
and shareholders’ equity
$
9,989
$
9,283
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S
dollars in thousands (except for share and per share data)
Year ended December
31,
2023
2022
Revenues
$
743
$
810
Research and development expenses
(5,983
)
(7,763
)
General and administrative expenses
(2,955
)
(3,143
)
Operating loss
(8,195
)
(10,096
)
Total financial income (expense), net
561
(77)
Net loss
(7,634
)
(10,173
)
Basic and diluted net loss per share
(0.01
)
(0.01
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
1,278,333,912
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 any resurgence of the COVID-19 pandemic and the war
between Israel and Hamas; 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 28, 2024 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240328586605/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Mar 2024 to Apr 2024
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Apr 2023 to Apr 2024