PETACH TIKVA, Israel,
Nov. 25, 2016 /PRNewswire/ -- Can-Fite BioPharma Ltd.
(NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a
pipeline of proprietary small molecule drugs being developed to
treat inflammatory diseases, cancer and sexual dysfunction, today
reported financial results for the nine months ended September 30, 2016 and updates on its drug
development programs.
Clinical Development Program and Corporate Highlights
Include:
- Piclidenoson (CF101) – EMA Clearance Received for Phase III
Trials in Rheumatoid Arthritis & Psoriasis to Commence in
2017
Rheumatoid Arthritis: Piclidenoson is being developed as a
first line therapy and replacement for the current gold standard,
Methotrexate (MTX), the most widely used drug for rheumatoid
arthritis. The Company plans to submit its study protocol to
Institutional Review Boards (IRBs) of clinical sites in the first
quarter of 2017.
Rheumatoid arthritis is a treatment market forecast to reach
$38.5 billion by 2017.
Psoriasis: Can-Fite reached an agreement with the European
Medicines Agency (EMA) on the final design of a global pivotal
Phase III trial for Piclidenoson in the treatment of psoriasis. The
Phase III trial, expected to commence enrollment in the second half
of 2017, will investigate the efficacy and safety of Piclidenoson
compared to placebo as its primary endpoint and as compared to
apremilast (Otezla®) as its secondary endpoint in approximately 400
patients with moderate-to-severe plaque psoriasis.
During the third quarter, Can-Fite received a Notice of
Allowance from the European Patent Office indicating the patent
titled, "Pharmaceutical Composition Comprising A3 Adenosine
Receptor Agonist (IB-MECA/CF-101) for Treatment of Psoriasis" will
be granted.
The Journal of Drugs in Dermatology published data in
August from Can-Fite's Phase II/III trial of Piclidenoson in the
treatment of moderate to severe psoriasis. The study is titled
"Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a
Phase II/III Multicenter, Randomized, Controlled Trial."
The psoriasis market is forecast to be $8.9 billion in 2018.
- Namodenoson (CF102) – Distribution deal in South Korea; Ongoing Phase II in Liver Cancer
& Phase II NAFLD/NASH Protocol Submitted to IRB
In October, Can-Fite signed a distribution agreement with Chong
Kun Dang Pharmaceuticals (CKD) for the exclusive right to
distribute Namodenoson for the treatment of liver cancer in
South Korea. The deal includes up
to $3,000,000 in upfront and
milestone payments, plus a percentage of royalties on net sales in
the low twenties. CKD also negotiated for a right of first refusal
to distribute Namodenoson for other indications for which Can-Fite
develops Namodenoson.
Liver Cancer: Can-Fite continues to enroll and dose patients in
its global Phase II study of Namodenoson in the treatment of
hepatocellular carcinoma, the most common form of liver cancer. A
total of approximately 78 patients are expected to be enrolled in
the U.S., Europe, and Israel.
Molecular Medicine Report published an article titled,
"A3 adenosine receptor agonist, CF102, protects against hepatic
ischemia/reperfusion injury following partial hepatectom" during
the third quarter. The article reports the results of preclinical
studies conducted by Can-Fite, showing Namodenoson protects the
liver from ischemia/reperfusion injury and regenerates liver cells
following partial hepatectomy.
Liver cancer drugs are expected to generate $1.4 billion in sales in 2019.
NAFLD/NASH: In conjunction with world renowned Key Opinion
Leaders in the field of liver diseases, Can-Fite completed the
study design of its upcoming Phase II trial of Namodenoson in the
treatment of non-alcoholic fatty liver disease (NAFLD), the
precursor to non-alcoholic steatohepatitis (NASH).
This Phase II clinical trial protocol was submitted to leading
Institutional Review Boards (IRB) in Israel. Top medical centers in Israel, including Hadassah Medical Center and
Rabin Medical Center are expected to participate in the planned
study by enrolling and treating patients.
By 2025, the addressable pharmaceutical market for NASH is
estimated to reach $35-40
billion.
- CF602 – Broad Patent Estate in Sexual Dysfunction &
Other Indications
A Notice of Allowance was granted to Can-Fite by the U.S. Patent
and Trademark Office in November for the Company's patent
application covering A3 adenosine receptor (A3AR) ligands for use
in the treatment of erectile dysfunction. The patent addresses
methods for treating erectile dysfunction with different A3AR
ligands including Can-Fite's erectile dysfunction drug candidate,
CF602. With this new broader patent protection, Can-Fite has made a
strategic decision to investigate additional compounds, owned by
the Company, for the most effective and safest profile in this
indication. As such, the Company will postpone its planned
Investigational New Drug (IND) submission for this indication.
"Today Can-Fite stands poised to enter two pivotal Phase III
trials in autoimmune disease where there is a clear need for an
effective oral drug that can be taken safely, on a long-term basis.
In the treatment of liver diseases, we look forward to completing
our Phase II trial in liver cancer and commencing a Phase II trial
in NAFLD/NASH. We believe our small molecule oral drug candidates
offer very clear advantages over other drugs on the market that
patients cannot tolerate longer term due to safety and IV
administration issues. Along with benefits to patients, it is our
strong belief that our drug candidates will improve healthcare
economics and create growing value for our shareholders," stated
Can-Fite CEO Dr. Pnina Fishman.
Revenues for the nine months ended September 30, 2016 were NIS 0.64 million (U.S. $0.17 million) compared to NIS 0.54 million (U.S. $0.14 million) in the first nine months of 2015.
The increase in revenue was due to the recognition of a portion of
the NIS 5.14 million (U.S.
$1.36 million) upfront payment
received in March 2015 under the
distribution agreement with Cipher Pharmaceuticals.
Research and development expenses for the nine months ended
September 30, 2016 were NIS 15.45 million (U.S. $4.11 million) compared with NIS 9.58 million (U.S. $2.55 million) for the same period in 2015.
Research and development expenses for the first nine months of 2016
comprised primarily of expenses associated with the Phase II study
for CF102, preclinical study for CF602, as well as expenses for
ongoing studies of CF101. The increase is due to costs associated
with preparations of the aforementioned studies.
General and administrative expenses were NIS 7.88 million (U.S. $2.1 million) for the nine months ended
September 30, 2016 compared to
NIS 6.79 million (U.S. $1.81 million) for the same period in 2015. The
increase is primarily due to an increase in share based
compensation expense.
Financial income, net for the nine months ended September 30, 2016 aggregated NIS 3.12 million (U.S. $0.83 million) compared to financial expenses,
net of NIS 4.7 million (U.S.
$1.25 million) for the same period in
2015. The increase in financial income, net in the first nine month
of 2016 was mainly due to a decrease in the fair value of warrants
that are accounted for as financial liability as compared to an
increase in the fair value of these warrants in the same period in
2015. In addition, the increase in financial income, net in the
first nine months of 2016 was offset by an increase in financial
expenses due to exchange rate differences as compared to
insignificant financial income from exchange rate differences and
capital issuance expenses for the same period in 2015.
Can-Fite's net loss for the nine months ended September 30, 2016 was NIS
19.56 million (U.S. $5.2
million) compared with a net loss of NIS 20.53 million (U.S. $5.46 million) for the same period in 2015. The
decrease in net loss for the first nine month of 2016 was primarily
attributable to an increase in financial income, net offset by an
increase in research and development expenses.
As of September 30, 2016, Can-Fite
had cash and cash equivalents of NIS 37.57
million (U.S. $10 million) as
compared to NIS 66.03 million (U.S.
$17.57 million) at December 31, 2015. The decrease in cash during
the nine months ended September 30,
2016 is due to operating expenses.
For the convenience of the reader, the reported NIS amounts have
been translated into U.S. dollars, at the representative rate of
exchange on September 30, 2016 (U.S.
$1 = NIS
3.758).
The Company's consolidated financial results for the nine months
ended September 30, 2016 are
presented in accordance with International Financial Reporting
Standards.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT: 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
scheduled to enter Phase III trials in 2016 for two indications,
rheumatoid arthritis and psoriasis. The rheumatoid arthritis Phase
III protocol has recently been agreed with the European Medicines
Agency. Can-Fite's liver cancer drug Namodenoson is in Phase II
trials for patients with liver cancer and is slated to enter Phase
II 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 hepatocellular carcinoma
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 in preclinical studies and is being prepared for an IND
submission to the FDA and a Phase I trial. These drugs have
an excellent safety profile with experience in over 1,000 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. 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, including, but not limited to, the
factors summarized 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.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
In thousands
(except for share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
translation into U.S.
dollars
|
|
|
|
|
|
|
September
30,
|
|
September
30,
|
|
December
31,
|
|
|
|
|
2016
|
|
2016
|
|
2015
|
|
|
|
|
Unaudited
|
|
Audited
|
|
|
|
|
USD
|
|
NIS
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
9,997
|
|
37,571
|
|
66,026
|
Other receivable and
prepaid expenses
|
1,744
|
|
6,553
|
|
2,419
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
11,741
|
|
44,124
|
|
68,445
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease
deposits
|
10
|
|
37
|
|
27
|
Property, plant and
equipment, net
|
58
|
|
219
|
|
236
|
|
|
|
|
|
|
|
|
|
Total long-term
assets
|
68
|
|
256
|
|
263
|
|
|
|
|
|
|
|
|
|
Total assets
|
11,809
|
|
44,380
|
|
68,708
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
|
In thousands
(except for share and per share data)
|
|
|
|
|
Convenience
translation into U.S.
dollars
|
|
|
September
30,
|
|
September
30,
|
|
December
31,
|
|
2016
|
|
2016
|
|
2015
|
|
Unaudited
|
|
Audited
|
|
USD
|
|
NIS
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
600
|
|
2,254
|
|
1,803
|
Deferred
revenues
|
228
|
|
857
|
|
857
|
Other accounts
payable
|
785
|
|
2,950
|
|
4,279
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
1,613
|
|
6,061
|
|
6,939
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercisable
into shares
|
3,315
|
|
12,458
|
|
16,725
|
Deferred
revenues
|
798
|
|
2,999
|
|
3,641
|
Severance pay,
net
|
174
|
|
650
|
|
630
|
|
|
|
|
|
|
|
|
|
Total long-term
liabilities
|
4,287
|
|
16,107
|
|
20,996
|
|
|
|
|
|
|
|
|
|
CONTINGENT
LIABILITIES AND COMMITMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY ATTRIBUTABLE TO
EQUITY HOLDERS OF THE COMPANY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
capital
|
|
1,873
|
|
7,039
|
|
7,030
|
Share
premium
|
|
88,577
|
|
332,873
|
|
332,873
|
Capital reserve from
share-based payment transactions
|
5,390
|
|
20,256
|
|
19,288
|
Warrants exercisable
into shares (series 10-12)
|
2,390
|
|
8,983
|
|
8,983
|
Treasury shares, at
cost
|
(965)
|
|
(3,628)
|
|
(3,628)
|
Accumulated
other comprehensive loss
|
(371)
|
|
(1,393)
|
|
(1,401)
|
Accumulated
deficit
|
(91,051)
|
|
(342,170)
|
|
(322,876)
|
|
|
|
|
|
|
|
|
|
Total equity
attributable to equity holders of the Company
|
5,843
|
|
21,960
|
|
40,269
|
|
|
|
|
|
|
|
|
|
Non-controlling
interests
|
66
|
|
252
|
|
504
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
|
5,909
|
|
22,212
|
|
40,773
|
|
|
|
|
|
|
|
|
|
Total liabilities and
equity
|
11,809
|
|
44,380
|
|
68,708
|
INTERIM CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
In thousands
(except for share and per share data)
|
|
|
|
|
|
Convenience
translation into U.S.
dollars
|
|
|
Nine months ended
September 30,
|
|
2016
|
|
2016
|
|
2015
|
|
Unaudited
|
|
USD
|
|
NIS
|
|
NIS
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
171
|
|
643
|
|
541
|
|
|
|
|
|
|
Research and
development expenses
|
4,111
|
|
15,449
|
|
9,580
|
General and
administrative expenses
|
2,096
|
|
7,878
|
|
6,793
|
|
|
|
|
|
|
Operating
loss
|
6,036
|
|
22,684
|
|
15,832
|
|
|
|
|
|
|
Finance
expenses
|
375
|
|
1,411
|
|
4,862
|
Finance
income
|
(1,207)
|
|
(4,535)
|
|
(167)
|
|
|
|
|
|
|
Net loss
|
5,204
|
|
19,560
|
|
20,527
|
|
|
|
|
|
|
Other comprehensive
loss (income):
|
|
|
|
|
|
Adjustments arising
from translating financial statements
of foreign operations
|
(3)
|
|
(10)
|
|
117
|
|
|
|
|
|
|
Total comprehensive
loss
|
5,201
|
|
19,550
|
|
20,644
|
|
|
|
|
|
|
Net loss attributable
to:
|
|
|
|
|
|
Equity holders of the
Company
|
5,134
|
|
19,294
|
|
19,911
|
Non-controlling
interests
|
70
|
|
266
|
|
616
|
|
|
|
|
|
|
|
5,204
|
|
19,560
|
|
20,527
|
|
|
|
|
|
|
Total comprehensive
loss attributable to:
|
|
|
|
|
|
Equity holders of the
Company
|
5,132
|
|
19,286
|
|
20,007
|
Non-controlling
interests
|
69
|
|
264
|
|
637
|
|
|
|
|
|
|
|
5,201
|
|
19,550
|
|
20,644
|
|
|
|
|
|
|
Net loss per share
attributable to equity holders of the Company :
|
|
|
|
|
|
Basic and diluted net
loss per share
|
0.19
|
|
0.70
|
|
0.93
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/can-fite-reports-financial-results-for-nine-months-ended-september-30-2016--provides-clinical-update-300367548.html
SOURCE Can-Fite BioPharma Ltd.