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, 2022.
Corporate and Clinical Development Highlights
Include:
Strong Balance Sheet - On June 30, 2022, Can-Fite had
approximately $12.72 million in cash, cash equivalents, and
short-term deposits.
Namodenoson Approved for Compassionate Use in Romania,
Pivotal Phase III Liver Cancer Study Open for Enrollment – In
August, Can-Fite announced Romania became the second country,
following Israel, to approve Namodenoson for compassionate use in
patients with advanced liver cancer. Namodenoson induced a complete
response with disappearance of all metastases in a Romanian patient
who was enrolled in Can-Fite’s prior Phase IIb liver cancer study,
and the patient will now continue treatment under the compassionate
use program. Can-Fite’s pivotal Phase III liver cancer study for
Namodenoson is open 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.
Phase III COMFORT™ Trial for Psoriasis Meets Primary Endpoint
– Topline results were announced during the second quarter, and
further data are expected in the coming weeks. Piclidenoson,
Can-Fite’s lead drug candidate, successfully met its primary
endpoint in the Phase III COMFORT trial in more than 400 adults
with moderate to severe plaque psoriasis. At week 16, patients
receiving Piclidenoson 3mg demonstrated statistically significant
improvement when compared with placebo, as measured by the
Psoriasis Area and Severity Index (PASI) 75 response (representing
a 75% reduction in psoriasis severity): Piclidenoson 3mg: 9.7% vs.
placebo: 2.6% (P< 0.04). A linear increase in the response of
patients to Piclidenoson was achieved along the study period, on
week 48 reaching a PASI 50 response (50% reduction in psoriasis
severity) in 90% of patients, a PASI 90 response (90% reduction in
psoriasis severity) in 10% of patients, and Psoriasis Disability
Index (PDI) improvement in 60% of patients.
Company to Submit FDA & EMA Registration Plans for
Piclidenoson for the Treatment Psoriasis – Following the
successful COMFORT study, Can-Fite is planning to submit its
marketing registration plans to the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) for
Piclidenoson in the treatment of moderate to severe psoriasis. The
pivotal Phase III study’s protocol is being developed in
conjunction with Dr. Kim Papp, a Key Opinion Leader in dermatology
and an investigator in the COMFORT study. Current chemistry,
manufacturing, and controls (CMC), nonclinical data, and human
pharmacokinetic data will be submitted to the FDA and EMA along
with the pivotal Phase III protocol and other supporting clinical
pharmacology plans.
Data show Piclidenoson’s Superior Safety Profile and Higher
Patient Compliance Compared to Otezla® - In July, Can-Fite
announced that further analysis of the Phase III COMFORT data point
toward a better safety profile for Piclidenoson as compared to
Otezla, which induced gastrointestinal adverse events in 6% of
patients compared with 1% in patients treated with placebo or
Piclidenoson. Discontinuation of treatment amongst patients treated
with Otezla was significantly higher compared to that of the
Piclidenoson treated patients.
Piclidenoson Demonstrates Higher Efficacy in Patients with
More Severe Disease – Also announced in July a sub-analysis of
the efficacy data that divided patients into those who had
PASI>25 (more severe psoriasis) and PASI<25 (less severe) at
baseline revealed that patients who started with higher PASI values
at entry benefitted more from treatment with Piclidenoson as
compared to placebo.
NASH Patent Granted in Israel, Phase IIb Study is Ongoing
– Patient enrollment is ongoing in Can-Fite’s Phase IIb study
evaluating Namodenoson in 140 subjects with biopsy-confirmed NASH.
Can-Fite was granted a patent for NASH titled "An A3 Adenosine
Receptor Ligand For Use In Treating Ectopic Fat Accumulation" in
Israel, adding to the approximately 40 other countries in which the
same patent has been issued.
Piclidenoson to Enter Clinical Trial for Osteoarthritis in
Dogs - Through a development and commercialization agreement
signed with Vetbiolix, a France based veterinary biotech company in
June of 2021, Piclidenoson is set to enter a clinical trial for the
treatment of osteoarthritis in dogs. This follows a successfully
completed safety study in dogs exploring dose-range safety and
pharmacokinetics. Piclidenoson was well tolerated, with the
pharmacokinetic data proportional to dose. Vetbiolix is financially
responsible for the clinical studies. The canine osteoarthritis
market is projected to reach $3 billion by 2028.
“Positive data from our Phase III COMFORT study further supports
our belief that Piclidenoson’s excellent safety profile, combined
with its efficacy as compared to placebo, position it very
favorably in the market for psoriasis patients who seek an oral
drug that can be used long-term,” stated Can-Fite CEO Dr. Pnina
Fishman. “As we prepare for a Phase III registration trial for
Piclidenoson in psoriasis, we are concurrently advancing our
portfolio in several other indications with an aim toward
monetizing our significant progress through distribution and
collaboration agreements.”
Financial Results
Revenues for the six months ended June 30, 2022 were $0.40
million, an increase of $0.01 million, or 2.7%, compared to $0.39
million for the six months ended June 30, 2021. The increase
considered to be not material.
Research and development expenses for the six months ended June
30, 2022 were $3.27 million, a decrease of $0.54 million, or 14.2%,
compared to $3.81 million for the six months ended June 30, 2021.
Research and development expenses for the six months ended June 30,
2022 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. The decrease is primarily due to lower costs
incurred in 2022 associated with the two studies for Namodenoson
and due to the wrap up of the Phase III study of Piclidenoson for
the treatment of psoriasis in 2022.
General and administrative expenses for the six months ended
June 30, 2022 were $1.57 million a decrease of $0.32 million, or
16.9%, compared to $1.89 million for the six months ended June 30,
2021. The decrease is primarily due to the decrease in professional
services and public and investor relations expenses. We expect that
general and administrative expenses will remain at the same level
through 2022.
Financial expenses, net for the six months ended June 30, 2022
were $0.18 million compared to finance income, net of $0.20 million
for the six months ended June 30, 2021. The decrease in financial
income, net was mainly due to revaluation of the Company’s
short-term investment which in 2021 was recorded as income and in
2022 was recorded as expense.
Net loss for the six months ended June 30, 2022 was $4.62
million compared with a net loss of $5.09 million for the six
months ended June 30, 2021. The decrease in net loss for the six
months ended June 30, 2022 was primarily attributable to a decrease
in research and development expenses and a decrease in general and
administrative expenses.
As of June 30, 2022, Can-Fite had cash and cash equivalents and
short term deposits of $12.72 million as compared to $18.90 million
at December 31, 2021. The decrease in cash during the six months
ended June 30, 2022 is due to the ongoing operations of the
Company.
The Company's consolidated financial results for the six months
ended June 30, 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)
June 30,
December 31,
2022
2021
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
1,712
$
4,390
Short term deposit
11,015
14,512
Prepaid expenses and other current
assets
1,823
929
Short-term investment
39
237
Total current
assets
14,589
20,068
NON-CURRENT ASSETS:
Operating lease right of use assets
111
138
Property, plant and equipment, net
46
47
Total non-current
assets
157
185
Total
assets
$
14,746
$
20,253
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
June 30,
December 31,
2022
2021
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
824
$
954
Current maturity of operating lease
liability
47
53
Deferred revenues
818
818
Other accounts payable
464
905
Total current
liabilities
2,153
2,730
NON-CURRENT LIABILITIES:
Long - term operating lease liability
40
71
Deferred revenues
2,661
3,070
Total non-current
liabilities
2,701
3,141
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par value -
Authorized: 5,000,000,000 shares at June 30, 2022 and December 31,
2021; Issued and outstanding: 815,746,293 shares as of June 30,
2022 and December 31, 2021
60,654
60,654
Additional paid-in capital
93,410
93,275
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(145,299)
(140,674
)
Total shareholders'
equity
9,892
14,382
Total liabilities
and shareholders’ equity
$
14,746
$
20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share
data)
Six months ended
June 30,
2022
2021
Revenues
$
409
$
398
Research and development expenses
(3,273)
(3,810
)
General and administrative expenses
(1,576)
(1,892
)
Operating loss
(4,440)
(5,304
)
Total financial income (expense), net
(185)
207
Net loss
$
(4,625)
$
(5,097
)
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
815,746,293
500,010,114
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, 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
24, 2022 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/20220825005061/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Aug 2024 to Sep 2024
Can Fite BioPharma (AMEX:CANF)
Historical Stock Chart
From Sep 2023 to Sep 2024