- Company to host conference call at 8:30 a.m. ET today, June
1
- Achieved efficacy and safety endpoints in Phase II NASH
trial, with all cases of NASH significantly resolved after 12 weeks
of treatment with 25 mg Namodenoson
- Pre-IND filed with FDA for clinical study of Piclidenoson in
treatment of COVID-19
- Interim results from Phase III Piclidenoson trial for
psoriasis and rheumatoid arthritis expected Q4 2020
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 three months
ended March 31, 2020.
Clinical Developments and Corporate Highlights Include:
Namodenoson Showed Significant Efficacy in Phase II NASH
Study Including Resolving All Cases of NASH – Can-Fite’s Phase
II NASH study achieved efficacy and safety endpoints in a dose
dependent and statistically significant manner. The double-blind,
placebo-controlled, dose-finding efficacy and safety study enrolled
60 patients with non-alcoholic fatty liver disease (NAFLD) with or
without non-alcoholic steatohepatitis (NASH). The optimal dosage
was determined to be 25 mg for both safety and efficacy.
Namodenoson was found to resolve significantly all cases of NASH,
representing 25% of the 25 mg treated group, as compared to an
increase in new NASH cases in the placebo group from a baseline of
0 to 5.9%. Namodenoson was determined to be a very strong candidate
for continued clinical development in the treatment of NAFLD/NASH,
particularly since no other treatment options are currently
approved for this growing unmet need.
Piclidenoson as Potential Treatment for COVID-19 –
Can-Fite filed a pre-Investigational New Drug (IND) meeting request
with the U.S. Food and Drug Administration (FDA) for Piclidenoson
in the treatment of COVID-19 patients with moderate-to-severe
symptoms. Following the FDA’s guidance from the pre-IND meeting,
Can-Fite plans to submit an IND application for Piclidenoson to be
evaluated as a potential addition to the current standard of care
treatment for COVID-19. During the first quarter, Can-Fite also
entered into a collaborative research agreement with the Lewis Katz
School of Medicine at Temple University, Philadelphia to study the
anti-viral activity of Piclidenoson on COVID-19 viral load.
Can-Fite previously announced that it was approved to commence a
COVID-19 clinical study in Israel. While Can-Fite commenced the
trial, it has not enrolled patients due to the decreased number of
COVID-19 cases in Israel.
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 announced it is implementing an interim
analysis for both studies. Data will be monitored by an independent
data monitoring committee (IDMC) which will have un-blinded access
to the data in Q3 2020. Announcement of interim results is expected
in Q4 2020.
Namodenoson is Headed into Pivotal Phase III Liver Cancer
Study – Following a successful End-of-Phase II Meeting with the
U.S. Food and Drug Administration (FDA) regarding Namodenoson in
the treatment of hepatocellular carcinoma (HCC), the most common
form of liver cancer, the FDA agreed with Can-Fite’s proposed
pivotal Phase III trial design to support a New Drug Application
submission and approval. The Phase III study protocol and
registration plan have also been submitted to the European
Medicines Agency (EMA). Namodenoson is currently being used to
treat liver cancer patients in a compassionate use program in
Israel, which has enrolled seven patients. In addition, two
patients who were enrolled in the Company’s former Phase II study,
who responded well to the drug, are continuing treatment. Those two
advanced liver cancer patients have reached an overall survival of
over 2.5 years while being treated with Namodenoson.
Expanded IP – The U.S. Patent and Trademark Office issued
a Notice of Allowance to Can-Fite for Namodenoson in the treatment
of NASH & NAFLD. A patent was issued for Namodenoson in the
treatment of NASH in South Korea, where the drug is out-licensed
for this indication. Can-Fite has also filed a new patent for
Namodenoson to be used as a combination therapy with checkpoint
inhibitors for oncology indications. Based on its recent scientific
findings in cannabinoid-based drugs, Can-Fite has filed patents for
the use of such drugs to treat cancer, autoimmune, inflammatory and
metabolic diseases.
Cash Infusion of $8.4 Million – During the first quarter
of 2020, Can-Fite received a total of $3.4 million through warrant
exercises, and $5 million from an equity offering.
“Namodenoson’s Phase II safety and efficacy results in NASH and
NAFLD is a significant milestone for our company, and for the
medical community seeking a safe and effective treatment for the
rapidly growing number of patients diagnosed with fatty liver
diseases. The fact that Namodenoson was able to not only reverse,
but also resolve NASH in the Phase II NASH patients treated with 25
mg of Namodenoson is very compelling data as we move forward. With
recently issued patents for Namodenoson in this indication, we are
planning our next advanced stage clinical trial in NASH/NAFLD,”
stated Can-Fite CEO Pnina Fishman. “For Namodenoson we are also
preparing a Phase III study protocol in the treatment of HCC.
Piclidenoson is on track for interim Phase III results in
rheumatoid arthritis and psoriasis, as well as a potential
treatment for COVID-19. Can-Fite has a robust clinical pipeline
with significant opportunities for our drugs in multiple
indications.”
“I am happy to report that our operations have not been
materially impacted by the COVID-19 outbreak to date. Our ongoing
clinical trials and clinical trial preparation work 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,” added Dr. Fishman.
Financial Results
Revenues for the three months ended March 31, 2020 were $ 0.20
million compared to revenues of $0.30 million during the three
months ended March 31, 2019. The decrease in revenues for the first
quarter of 2020 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.
Research and development expenses for the three months ended
March 31, 2020 were $3.77 million compared with $1.44 million for
the same period in 2019. Research and development expenses for the
first quarter of 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 enrollment of patients for
the Phase III clinical trial of Piclidenoson for the treatment of
rheumatoid arthritis and for psoriasis.
General and administrative expenses were $0.70 million for the
three months ended March 31, 2020 compared to $0.57 million for the
same period in 2019. The increase is primarily due to an increase
in professional services and insurance expenses which was partly
offset by a decrease in travel expenses.
Financial expense, net for the three months ended March 31, 2020
was $0.07 million compared to financial expense, net of $0.12
million for the same period in 2019. The decrease in financial
expense, net in the first quarter of 2020 is primarily due to a
decrease in exchange rate expenses.
Can-Fite's net loss for the three months ended March 31, 2020
was $4.34 million compared with a net loss of $1.83 million for the
same period in 2019. As of March 31, 2020, Can-Fite had cash and
cash equivalents of $5.76 million as compared to $2.7 million at
December 31, 2019. The increase in cash during the three months
ended March 31, 2020 is due to an aggregate of $8.4 million
received through the exercise of certain outstanding warrants
following their repricing in January 2020, a public offering in
February 2020, and the partial exercise, in March 2020, of warrants
issued in the February 2020 public offering.
Following the end of the first quarter of 2020, the Company
determined to change its accounting method from IFRS to U.S. GAAP
and accordingly has reissued its audited financial statements for
all periods covered by its 2019 financial statements under U.S.
GAAP. A copy of the reissued financial statements and accompanying
financial data has been filed with the Securities and Exchange
Commission on Form 6-K. The Company's consolidated financial
results for the three months ended March 31, 2020 are presented in
accordance with US GAAP Reporting Standards.
Conference Call
Management will host a conference call today, June 1, 2020 at
8:30 a.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 13704594. Investors may also participate via
webcast: http://public.viavid.com/index.php?id=140108
A replay of the webcast will be archived on Can-Fite’s website
for a period of time.
INTERIM CONDENSED CONSOLIDATED BALANCE
SHEETS
U.S dollars in thousands (except for
share and per share data)
March 31,
December 31,
2020
2019
Unaudited
Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
5,767
$
2,697
Other receivable and prepaid expenses
2,730
4,383
Short-term investment
46
64
Total current
assets
8,543
7,144
NON-CURRENT ASSETS:
Other non-current receivables
1,198
912
Operating lease right of use assets
74
82
Property, plant and equipment, net
33
36
Total long-term
assets
1,305
1,030
Total
assets
$
9,848
$
8,174
INTERIM CONDENSED CONSOLIDATED BALANCE
SHEETS
U.S dollars in thousands (except for
share and per share data)
March 31,
December 31,
2020
2019
Unaudited
Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,425
$
2,156
Current maturity of operating lease
liability
36
36
Deferred revenues
511
469
Other accounts payable
501
610
Total current
liabilities
2,473
3,271
NON-CURRENT LIABILITIES:
Long - term operating lease liability
29
39
Deferred revenues
2,277
2,422
Total long-term
liabilities
2,306
2,461
CONTIGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par value -
Authorized: 500,000,000 shares at March 31, 2020 and December 31,
2019; Issued and outstanding: 263,181,243 shares as of March 31,
2020; 120,652,683 shares as of December 31, 2019
18,560
8,225
Additional paid-in capital
100,750
103,401
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(115,368
)
(110,311
)
Total
equity
5,069
2,442
Total liabilities
and shareholders’ equity
$
9,848
$
8,174
INTERIM CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for
share and per share data)
Three months ended March
31,
2020
2019
Unaudited
Revenues
$
198
$
299
Research and development expenses
(3,771
)
(1,443
)
General and administrative expenses
(703
)
(567
)
Operating loss
(4,276
)
(1,711
)
Total financial expense, net
(66
)
(121
)
Net loss
(4,342
)
(1,832
)
Deemed dividend
(715)
-
Net loss applicable to shareholders’ of
Ordinary shares
$
(5,057)
$
(1,832)
Basic and diluted net loss per share
(0.03
)
(0.04
)
Weighted average number of ordinary shares
used in computing basic and diluted net loss per share
201,433,936
44,020,479
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, inflammatory disease and sexual
dysfunction. The Company's lead drug candidate, Piclidenoson, is
currently in Phase III trials for rheumatoid arthritis and
psoriasis. Can-Fite's liver cancer drug, Namodenoson, recently
completed a Phase II trial for hepatocellular carcinoma (HCC), the
most common form of liver cancer, and is 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 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/20200601005332/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