Advanced liver cancer patient in prior Phase
II study remains cancer-free 6.9 years after starting treatment
with Namodenoson
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 for the nine months ended
September 30, 2023.
Clinical & Development Milestones
Achieved
Namodenoson Drug Candidate:
Complete Response and 6.9 Year Survival Reported in Patient
with Advanced Liver Cancer Treated with Namodenoson
A patient who had participated in Can-Fite’s prior Phase II
liver cancer study who continues to receive treatment with
Namodenoson under a compassionate use program now has overall
survival of 6.9 years with the disappearance of ascites, normal
liver function, and good quality of life, defined as a complete
response. Enrollment is ongoing in Can-Fite’s pivotal Phase III
study of Namodenoson in the treatment of advanced liver cancer.
During the third quarter, the American Society of Clinical Oncology
(ASCO) selected Can-Fite for the prestigious Breakthrough Abstract
Award from Conquer Cancer® for its abstract titled “A novel
approach for the treatment of advanced hepatocellular carcinoma
(HCC)”.
Pancreatic Carcinoma Phase IIa Study with Namodenoson is
Underway
Namodenoson inhibited the growth of pancreatic carcinoma in a
pre-clinical study through a mechanism that entails the Ras
pathway. The Company continues to receive awards and recognition
from leading cancer associations, and articles summarizing
Namodenoson’s robust anti-cancer effect in pancreatic carcinoma
have been published. The American Association of Cancer Research
(AACR) accepted Can-Fite’s study titled “Namodenoson Inhibits the
Growth of Pancreatic Carcinoma via De-regulation of the
Wnt/β-catenin Signaling Pathway” for a poster presentation at the
AACR Special Conference on Pancreatic Cancer. Biomolecules, a
peer-reviewed scientific journal focused on the function and
mechanism of bioactive molecules, published an article titled
“Namodenoson Inhibits the Growth of Pancreatic Carcinoma via
Deregulation of the Wnt/β-catenin, NF-κB, and RAS Signaling
Pathways”.
Piclidenoson Drug Candidate:
Entered Rare Genetic Disease Market with Treatment for Lowe
Syndrome
In preclinical studies, Piclidenoson has been found to be
effective in Lowe Syndrome, a rare genetic disease with no
treatment available, and an estimated $100 million treatment market
in the U.S. alone. Lowe Syndrome usually develops in the first year
of life, causing brain abnormalities associated with intellectual
disabilities and a life span shortened to less than 40 years. The
discovery of Piclidenoson’s efficacy in Lowe Syndrome was made by
researchers at the University of Naples Federico II and The
Telethon Institute of Genetics and Medicine in Italy after testing
thousands of compounds in search of a treatment. Can-Fite and
Fondazione Telethon signed an agreement outlining their
collaboration for the development of Piclidenoson for the treatment
of Lowe Syndrome. As a rare genetic disease in dire need of a
treatment, Lowe Syndrome may qualify for an accelerated approval
path, and Can-Fite plans to move into an advanced stage clinical
study in this indication.
Harnessing Artificial Intelligence (AI) to Identify and
Accelerate New Oncology Programs:
Through an agreement with Collaborations Pharmaceuticals,
Can-Fite is utilizing AI and machine learning (ML) to develop and
bring to market next-generation A3 adenosine receptor (A3AR)
oncology drugs at a significantly reduced development time and
cost. New molecules will be designed with high affinity and
selectivity to A3AR, the target of Can-Fite’s platform
technology.
“In addition to the several major value-driving milestones
achieved during the third quarter, we continue to enroll and treat
patients in our pivotal Phase III liver cancer study and Phase IIb
study for NASH. Our pivotal Phase III study in psoriasis is
expected to commence soon while we also prepare for a Phase IIa
study in pancreatic cancer,” stated Motti Farbstein, Can-Fite’s CEO
and CFO. “We believe our advanced stage pipeline with multiple
indications positions Can-Fite well for partnerships and for
achieving regulatory and market success based on our robust
portfolio.”
Financial Results
Revenues for the nine months ended September 30, 2023 were $0.59
million compared to revenues of $0.61 million for the same period
in 2022. Revenues for the nine months ended September 30, 2023 and
September 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 nine months ended
September 30, 2023 were $4.71 million compared with $5.30 million
for the same period in 2022. Research and development expenses for
the nine months ended September 30, 2023 comprised primarily of
expenses associated with the completion of the Phase III study of
Piclidenoson for the treatment of psoriasis and two ongoing studies
for Namodenoson, a Phase III study in the treatment of advanced
liver cancer and a Phase IIb study for NASH.
General and administrative expenses were $2.23 million for the
nine months ended September 30, 2023 compared to $2.31 million for
the same period in 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 2023.
Financial income, net for the nine months ended September 30,
2023 was $0.38 million compared to financial expense, net of $0.14
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 nine months ended September 30, 2023 was $5.98
million compared with a net loss of $7.15 million for the same
period in 2022. The decrease in net loss for the nine months ended
September 30, 2023 was primarily attributable to the decrease in
research and development expenses and in general and administrative
expenses.
As of September 30, 2023, Can-Fite had cash and cash equivalents
and short term deposits of $7.94 million as compared to $7.98
million at December 31, 2022. The decrease in cash during the nine
months ended nine 30, 2023 is due to the ongoing operations of the
Company which was offset by the Company’s fundraise during January
2023. During November 2023, Can-Fite raised approximately $3
million from the exercise of certain warrants.
The Company's consolidated financial results for the nine months
ended September 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)
September 30,
December 31,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
3,383
$
2,978
Short term deposits
4,556
5,001
Prepaid expenses and other current
assets
1,122
1,170
Short-term investment
3
8
Total current
assets
9,064
9,157
NON-CURRENT ASSETS:
Operating lease right of use assets
72
84
Property, plant and equipment, net
33
42
Total non-current
assets
105
126
Total
assets
$
9,169
$
9,283
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
September 30,
December 31,
2023
2022
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
647
$
896
Current maturity of operating lease
liability
34
48
Deferred revenues
783
783
Other accounts payable
746
775
Total current
liabilities
2,210
2,502
NON-CURRENT LIABILITIES:
Long - term operating lease liability
17
14
Deferred revenues
1,707
2,295
Total long-term
liabilities
1,724
2,309
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value -
Authorized: 5,000,000,000 shares at September 30, 2023 and December
31, 2022; Issued and outstanding: 1,224,837,393 and 815,746,293
shares as of September 30, 2023 and December 31, 2022
-
-
Additional paid-in capital
160,937
154,192
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(156,829
)
(150,847
)
Total shareholders’
equity
5,235
4,472
Total liabilities
and shareholders’ equity
$
9,169
$
9,283
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share
data)
Nine months ended
September 30,
2023
2022
Revenues
$
588
$
613
Research and development expenses
(4,716
)
(5,309
)
General and administrative expenses
(2,233
)
(2,317
)
Operating loss
(6,361
)
(7,013
)
Total financial income (expense), net
379
(141)
Net loss
(5,982
)
(7,154
)
Basic and diluted net loss per share
(0.00
)
(0.01
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
1,209,797,279
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.canfite.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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version on businesswire.com: https://www.businesswire.com/news/home/20231130873648/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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