- Company to host conference call at 4:15 p.m. ET today,
August 27, 2020
- Piclidenoson Phase III rheumatoid arthritis and psoriasis
interim data expected Q4 2020
- Achieved efficacy and safety endpoints in Phase II NASH
trial
- IND filed with FDA for Phase II study of Piclidenoson in
treatment of COVID-19
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, today announced financial results for the six months
ended June 30, 2020.
Clinical Developments and Corporate Highlights for the Second
Quarter and Recent Weeks Include:
Piclidenoson Phase III Rheumatoid Arthritis and Psoriasis
Interim Data Expected Q4 2020 – Having enrolled over 50% of
patients in its two Phase III studies in rheumatoid arthritis and
psoriasis, Can-Fite plans to announce interim analysis for both
studies in Q4 2020.
Namodenoson Showed Significant Efficacy in Treating Patients
with NAFLD/NASH in a Phase II Study – Can-Fite’s Phase II NASH
study achieved primary and secondary efficacy and safety endpoints
in a dose dependent and statistically significant manner. The study
evaluated 60 patients with non-alcoholic fatty liver disease
(NAFLD) with or without non-alcoholic steatohepatitis (NASH) who
were treated in three arms of the study with either 25mg
Namodenoson, 12mg Namodenoson, or placebo. Namodenoson induced
significant change in primary and secondary study endpoints over
the 12 week study, which is a relatively short period of time. A
robust anti-Inflammatory effect manifested by significant decrease
in the liver enzymes ALT and AST and significant improvement in the
positive cytokine adiponectin was recorded. A reduced liver fat
content (LFC) and a reduction in % of liver fat volume was found
together with a decrease in FIB-4 and FAST, non-invasive tests used
as markers to exclude advanced fibrosis. In addition, a decrease in
body weight has been observed in the 2 doses of Namodenoson, with a
better effect in the higher dose. The 25mg dose of Namodenoson was
found to have optimal efficacy while also having a strong safety
profile and was well tolerated. 25mg has been selected as the dose
to be used in the Company’s next NAFLD/NASH study. The NASH market
is projected to reach at least $35 billion by 2025. There are
currently no other treatment options approved for this growing
unmet need.
Namodenoson Patents for the Treatment of NASH & NAFLD in
U.S. and Europe – During the second quarter, the U.S. Patent
and Trademark Office granted Can-Fite a patent for Namodenoson in
the treatment of NASH and NAFLD. This was followed by the European
Patent Office’s notification to Can-Fite, after the end of the
second quarter, of its intent to grant a similar patent. The
patents cover the use of the A3 adenosine receptor (A3AR) in
reducing ectopic fat accumulation, particularly in fatty liver and
specifically addresses reducing fat accumulation and treating
conditions associated with fat accumulation such as fatty liver
diseases including NASH and NAFLD.
Namodenoson Headed into Pivotal Phase III Liver Cancer Study
in Europe and U.S. – Following a successful meeting with the
European Medicines Agency (EMA) during the second quarter, and a
prior End-of-Phase II Meeting with the U.S. Food and Drug
Administration (FDA), Can-Fite completed its protocol for a pivotal
Phase III study of Namodenoson in the treatment of hepatocellular
carcinoma (HCC), the most common form of liver cancer. The study is
designed to support a New Drug Application submission in the U.S.
and a Marketing Authorization Application in Europe. Namodenoson is
currently being used to treat liver cancer patients in a
compassionate use program in Israel.
IND Filed with FDA for Phase II COVID-19 Study of
Piclidenoson – Based on pre-IND advice and guidance from the
U.S. FDA during the second quarter, Can-Fite developed a clinical
trial protocol and filed an Investigational New Drug (IND)
application in July for Piclidenoson in the treatment of COVID-19.
A 28-day Phase II study will evaluate hospitalized patients with
moderate COVID-19 symptoms. The study titled, “Piclidenoson for
Treatment of COVID-19 – A Randomized, Double Blind,
Placebo-Controlled Trial” will enroll 40 patients who are receiving
standard supportive care and will randomly assign them in a 1:1
ratio to the trial arms of Piclidenoson twice daily or placebo.
After 28 days of treatment, efficacy will be assessed through
standard measures of clinical and respiratory status at day 29,
including the proportion of patients alive and free of respiratory
failure, as well as the proportion discharged home without need for
supplemental oxygen.
Completed Development of Assay to Identify Clinically Active
Cannabis Derived Compounds – Can-Fite completed the development
of a biological cell-based in vitro assay which can identify
clinically active cannabis derived compounds that bind to and
activate A3AR, the target of Can-Fite’s platform technology.
Numerous studies published in peer reviewed scientific journals
demonstrate that cannabis derived compounds bind to the Gi
protein-coupled A3AR, which is over-expressed in pathological cells
and tissues. In addition to using this assay in the development of
its own cannabis derived compound-based therapeutics, Can-Fite
plans to market the assay on a ‘fee for service’ basis to
researchers and other cannabis companies worldwide.
Cash Infusion of $12.9 Million – During the second
quarter of 2020, Can-Fite received $8 million in a registered
direct offering and a further $1.5 million through warrant
exercises. In addition, during July, the Company received $3.4
million from in a registered direct offering.
“Following Namodenoson’s very encouraging Phase II efficacy and
safety results in the treatment of NASH and NAFLD, we are now
planning our next study in this indication which is in dire need of
an effective treatment as the global prevalence of NAFLD is
estimated at 25% and NASH is at 3%–5% of the general population.
Achieving primary and secondary endpoints in the Phase II patients
treated with 25mg of Namodenoson gives us a clear imperative to
advance this clinical program,” stated Can-Fite CEO Pnina
Fishman.
“In the U.S., we anticipate starting a Phase II COVID-19 study
of Piclidenoson upon the FDA’s response to our IND filing. As the
spread of COVID-19 infections appears to be difficult to contain,
it is more important than ever to rapidly develop and make
available effective treatments in parallel with the massive efforts
that are going into vaccine development. Looking ahead to the
balance of 2020, Can-Fite has several upcoming milestones including
interim results from our Phase III studies in rheumatoid arthritis
and psoriasis,” Dr. Fishman added.
“The COVID-19 outbreak has had a limited impact on our
operations to date. Our ongoing clinical trials and clinical trial
preparation work continue to remain on track. We have implemented
remote working and workplace protocols for our employees in
accordance with Israel Health Ministry guidelines and we continue
to closely evaluate the pandemic as it unfolds,” Dr. Fishman
concluded.
Financial Results
Revenues for the six months ended June 30, 2020 were $0.40
million compared to revenues of $0.68 million during the six months
ended June 30, 2019. The decrease in revenues was mainly due to the
recognition of 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 six months ended June
30, 2020 were $7.05 million compared with $3.96 million for the
same period in 2019. Research and development expenses for the six
months ended June 30, 2020 comprised primarily of expenses
associated with the Phase II studies for Namodenoson in the
treatment of NASH and HCC, as well as expenses for ongoing Phase
III studies of Piclidenoson in the treatment of rheumatoid
arthritis and psoriasis. The increase is primarily due to increased
costs associated with the accelerating rate of absorption of
patients for the Phase III clinical trial of Piclidenoson for the
treatment of rheumatoid arthritis and for psoriasis.
General and administrative expenses were $1.45 million for the
six months ended June 30, 2020 compared to $1.33 million for the
same period in 2019. The increase is primarily due to an increase
in salaries and related benefits and insurance expenses which was
partly offset by a decrease in travel expenses and professional
services.
Financial expenses, net for the six months ended June 30, 2020
was $0.12 million compared to financial expenses, net of $0.28
million for the same period in 2019. The decrease in financial
expenses, net is primarily due to a decrease in exchange rate
expenses.
Can-Fite's net loss for the six months ended June 30, 2020 was
$8.23 million compared with a net loss of $4.89 million for the
same period in 2019. As of June 30, 2020, Can-Fite had cash and
cash equivalents of $9.05 million as compared to $2.69 million at
December 31, 2019. The increase in cash during the six months ended
June 30, 2020 is due to an aggregate of $17.9 million received
through a warrant exercise transaction in January 2020, a public
offering in February 2020, partial exercises in March, April and
May 2020 of warrants issued in the February 2020 public offering,
and a registered direct offering in June 2020.
The Company's consolidated financial results for the six months
ended June 30, 2020 are presented in accordance with US GAAP
Reporting Standards.
Conference Call
Management will host a conference call today, August 27, 2020 at
4:15 p.m. ET. Investors in the U.S. are invited to dial
877-423-9813. International investors may dial 201-689-8573. The
conference ID is 13708494. Investors may also participate via
webcast: http://public.viavid.com/index.php?id=141284
A replay of the webcast will be archived on Can-Fite’s website
for a period of time.
INTERIM CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
June 30,
December 31,
2020
2019
Unaudited
Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
9,059
$
2,697
Other receivable and prepaid expenses
3,567
4,383
Short-term investment
78
64
Total current
assets
12,704
7,144
NON-CURRENT ASSETS:
Other non-current receivables
-
912
Operating lease right of use assets
66
82
Property, plant and equipment, net
30
36
Total long-term
assets
96
1,030
Total
assets
$
12,800
$
8,174
INTERIM CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share
data)
June 30,
December 31,
2020
2019
Unaudited
Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
437
$
2,156
Current maturity of operating lease
liability
36
36
Deferred revenues
556
469
Other accounts payable
472
610
Total current
liabilities
1,501
3,271
NON-CURRENT LIABILITIES:
Long - term operating lease liability
22
39
Deferred revenues
2,121
2,422
Total long-term
liabilities
2,143
2,461
.
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par value -
Authorized: 500,000,000 shares at June 30, 2020 and December 31,
2019; Issued and outstanding: 411,254,463 shares as of June 30,
2020; 120,652,683 shares as of December 31, 2019
29,234
8,225
Additional paid-in capital
98,056
103,401
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(119,261
)
(110,311
)
Total
equity
9,156
2,442
Total liabilities
and shareholders’ equity
$
12,800
$
8,174
INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share
data)
Six months ended
June 30,
2020
2019
Unaudited
Revenues
$
402
$
688
Research and development expenses
(7,054
)
(3,960
)
General and administrative expenses
(1,455
)
(1,333
)
Operating loss
(8,107
)
(4,605
)
Total financial expenses, net
(128
)
(288
)
Net loss
(8,235
)
(4,893
)
.
Total comprehensive loss
(8,235
)
(4,893
)
.
Deemed dividend
(715)
-
.
Net loss attributed to ordinary
shareholders
$
(8,950)
$
(4,893)
Basic and diluted net loss per share
(0.04
)
(0.08
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
254,940,675
59,321,108
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, inflammatory disease, and
COVID-19. The Company's lead drug candidate, Piclidenoson, is
currently in Phase III trials for rheumatoid arthritis and
psoriasis. Can-Fite's liver drug, Namodenoson, is headed into a
Phase III trial for hepatocellular carcinoma (HCC), the most common
form of liver cancer, and successfully achieved its primary
endpoint in a Phase II trial for the treatment of non-alcoholic
steatohepatitis (NASH). 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 recent outbreak of coronavirus;
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200827005341/en/
Can-Fite BioPharma Motti Farbstein info@canfite.com
+972-3-9241114
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