PETACH TIKVA, Israel,
March 31, 2017 /PRNewswire/
-- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a
biotechnology company advancing a pipeline of proprietary small
molecule drugs that address cancer, liver and inflammatory
diseases, today announced it has filed its 2016 Annual Report on
Form 20-F with the U.S. Securities and Exchange Commission.
Clinical Development Program and Corporate Highlights
Include:
- Piclidenoson (CF101) – Phase III Trials in Rheumatoid
Arthritis & Psoriasis to Commence
Rheumatoid Arthritis: Can-Fite expects to be ready to
commence its pivotal Phase III ACRobat trial of Piclidenoson in the
second quarter of 2017. 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. ACRobat will enroll approximately 500 patients in
Europe, Canada and Israel. The estimated cost of the entire Phase
III study is approximately $5
million. This includes the cost of global clinical research
organizations that have been engaged to help conduct ACRobat. The
required supply of Piclidenoson has already been manufactured and
paid.
Rheumatoid arthritis is a treatment market forecast to reach
$34.6 billion by 2020.
Psoriasis: During the fourth quarter of 2016 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 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. Can-Fite expects to submit its
clinical protocol to Institutional Review Boards (IRBs) in the
fourth quarter of 2017.
The psoriasis market is forecast to be $8.9 billion in 2018 and Otezla® sales are
estimated to be $2.35 billion by
2020.
- Namodenoson (CF102) – Phase II NAFLD/NASH Trial to Commence;
Phase II Liver Cancer Trial Nearing Completion; Upfront Payment
Received in $3 million-Plus-Royalties
Distribution Deal in South
Korea
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 during the fourth quarter of 2016.
Can-Fite has received a $500,000
upfront payment from CKD as part of its agreement valued at up to
$3,000,000 in upfront and milestone
payments. Can-Fite is entitled to 23% royalties on net sales
following regulatory approval of Namodenoson in South Korea. CKD also negotiated 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. Completion of patient enrollment is
expected in the second quarter of 2017.
Liver cancer drugs are expected to generate $1.4 billion in sales in 2019.
NAFLD/NASH: Leading IRBs in Israel cleared Can-Fite to commence patient
enrollment in its Phase II clinical trial of Namodenoson in the
treatment of non-alcoholic fatty liver disease (NAFLD), the
precursor to non-alcoholic steatohepatitis (NASH), in January 2017. This approval came shortly
following Can-Fite's submission of the Phase II protocol in the
fourth quarter of 2016 to IRBs, including Hadassah Medical Center
and Rabin Medical Center, which are expected to participate in the
planned study by enrolling and treating patients. Patient
enrollment is expected to begin in the second quarter of 2017.
During the fourth quarter of 2016, Can-Fite announced new
preclinical data showing Namodenoson inhibited, in a dose dependent
manner, the growth and proliferation of liver fibrosis cells. This
suggests Namodenoson has an anti-fibrotic effect and provides
further support for the drug's development as an agent to combat
NAFLD.
By 2025, the addressable pharmaceutical market for NASH is
estimated to reach $35-40
billion.
- CF602 – Patent Estate Expanded in Sexual Dysfunction
The U.S. Patent and Trademark Office issued to Can-Fite a patent
during the fourth quarter of 2016 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 postponed
its planned Investigational New Drug (IND) submission for this
indication.
"In the coming months, we are eager to advance our two Phase III
trials for Piclidenoson in rheumatoid arthritis and psoriasis, both
indications in which there is a dearth of safe and effective drugs
that can be used in the long-term treatment of these auto-immune
diseases. With our Phase II liver cancer trial for Namodenoson
nearing completion, we are ready to start enrolling patients in our
Phase II study of Namodenoson in the treatment of NAFLD/NASH. Both
Piclidenoson and Namodenoson are strong candidates for partnering
and distribution deals in various geographic markets," stated
Can-Fite CEO Dr. Pnina Fishman.
Revenues for the twelve months ended December 31, 2016 were NIS
0.65 million (U.S. $0.17
million) compared to revenues of NIS
0.64 million (U.S. $0.17
million) during the year ended December 31, 2015. The revenues during 2016 were
mainly due to the recognition of a portion of the NIS 5.14 million (CAD 1.65
million) advance payment received in March 2015 under the distribution agreement with
Cipher and a small amount due to the recognition of a portion of
the NIS 1.9 million (U.S.
$0.5 million) advance payment
received in December 2016 under the
distribution agreement with CKD.
Research and development expenses for the twelve months ended
December 31, 2016 were NIS 23.38 million (U.S. $6.08 million) compared with NIS 15.05 million (U.S. $3.91 million) for the same period in 2015.
Research and development expenses for the year ended 2016 comprised
primarily of expenses associated with the Phase II study for
Namodenoson as well as expenses for ongoing studies of
Piclidenoson. The increase is primarily due to costs associated
with preparations of the Piclidenoson Phase III studies in the
treatment of rheumatoid arthritis and psoriasis and costs
associated with the ongoing clinical trial of Namodenoson for
treatment of liver cancer. We expect that research and development
expenses will increase through 2017 and beyond.
General and administrative expenses were NIS 10.48 million (U.S. $2.73 million) for the twelve months ended
December 31, 2016 compared to
NIS 10.63 million (U.S. $2.76 million) for the same period in 2015. The
minor decrease is primarily due to a decrease in professional
services. We expect that general and administrative expenses will
remain at the same level through 2017.
Financial income, net for the twelve months ended December 31, 2016 aggregated NIS 6.31 million (U.S. $1.64 million) compared to financial income, net
of NIS 5.29 million (U.S.
$1.38 million) for the same period in
2015. The increase in financial income, net in the year ended
December 31, 2016 was mainly due to
the fact that during 2016 we did not record any share issuance
expenses unlike in 2015.
Can-Fite's net loss for the twelve months ended December 31, 2016 was NIS
27.01 million (U.S. $7.02
million) compared with a net loss of NIS 19.77 million (U.S. $5.14 million) for the same period in 2015. The
increase in net loss for 2016 was primarily attributable to an
increase in research and development expenses.
As of December 31, 2016, Can-Fite
had cash and cash equivalents of NIS 31.2
million (U.S. $8.12 million)
as compared to NIS 66.03 million
(U.S. $17.17 million) at December 31, 2015. In addition, in January of
2017, Can-Fite raised U.S. $5 million
in a registered direct offering. The decrease in cash during the
twelve months ended December 31, 2016
is mainly due to an increase in research and development
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 December 31, 2016 (U.S.
$ 1 = NIS
3.845).
The Company's consolidated financial results for the twelve
months ended December 31, 2016 are
presented in accordance with International Financial Reporting
Standards.
The 2016 Annual Report can be found on the Company's website at
www.canfite.com as well as on the SEC website at www.sec.gov. In
addition, security holders may request a hard copy of the Annual
Report, which includes the Company's complete audited financial
statements, free of charge. Requests can be made by contacting
Can-Fite Investor Relations at 10 Bareket Street, Kiryat Matalon, Petah-Tikva 4951778,
Israel or by phone at
+972-3-9241114.
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 autoimmune-inflammatory indications, oncology
and liver diseases as well as sexual dysfunction. The Company's
lead drug candidate, Piclidenoson, is headed into Phase III trials
for two indications, rheumatoid arthritis and psoriasis. Can-Fite's
liver cancer drug Namodenoson is in a Phase II trial for patients
with liver cancer and is slated to enter another Phase II for the
treatment of non-alcoholic fatty liver disease (NAFLD), the
precursor to 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 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
CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
|
In thousands
(except for share and per share data)
|
|
|
|
|
December
31,
|
|
|
|
|
2016
|
|
2016
|
|
2015
|
|
|
|
|
USD
|
|
NIS
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
8,115
|
|
31,203
|
|
66,026
|
Other accounts
receivable and prepaid expenses
|
|
|
|
1,993
|
|
7,664
|
|
2,419
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
|
10,108
|
|
38,867
|
|
68,445
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Lease
deposit
|
|
|
|
10
|
|
37
|
|
27
|
Property, plant and
equipment, net
|
|
|
|
53
|
|
205
|
|
236
|
|
|
|
|
|
|
|
|
|
Total long-term
assets
|
|
|
|
63
|
|
242
|
|
263
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
|
10,171
|
|
39,109
|
|
68,708
|
CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
|
In thousands
(except for share and per share data)
|
|
|
|
|
December
31,
|
|
|
|
|
2016
|
|
2016
|
|
2015
|
|
|
|
|
USD
|
|
NIS
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
|
1,249
|
|
4,804
|
|
1,803
|
Deferred
revenues
|
|
|
|
322
|
|
1,237
|
|
857
|
Other accounts
payable
|
|
|
|
933
|
|
3,588
|
|
4,279
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
|
2,504
|
|
9,629
|
|
6,939
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Warrants exercisable
into shares
|
|
|
|
2,618
|
|
10,068
|
|
16,725
|
Deferred
revenues
|
|
|
|
1,173
|
|
4,510
|
|
3,641
|
Severance pay,
net
|
|
|
|
-
|
|
-
|
|
630
|
|
|
|
|
|
|
|
|
|
Total Long-term
liabilities
|
|
|
|
3,791
|
|
14,578
|
|
20,996
|
|
|
|
|
|
|
|
|
|
CONTIGENT LIABILITIES
AND COMMITMENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY ATTRIBUTABLE TO
EQUITY HOLDERS OF THE
COMPANY:
|
|
|
|
|
|
|
|
|
Share
capital
|
|
|
|
1,831
|
|
7,039
|
|
7,030
|
Share
premium
|
|
|
|
86,573
|
|
332,873
|
|
332,873
|
Capital reserve from
share-based payment transactions
|
|
|
|
5,315
|
|
20,438
|
|
19,288
|
Warrants exercisable
into shares (Series 10-12)
|
|
|
|
2,336
|
|
8,983
|
|
8,983
|
Treasury shares, at
cost
|
|
|
|
(943)
|
|
(3,628)
|
|
(3,628)
|
Accumulated other
comprehensive loss
|
|
|
|
(229)
|
|
(883)
|
|
(1,401)
|
Accumulated
deficit
|
|
|
|
(91,015)
|
|
(349,953)
|
|
(322,876)
|
|
|
|
|
|
|
|
|
|
Total equity
attributable to equity holders of the company
|
|
|
|
3,868
|
|
14,869
|
|
40,269
|
|
|
|
|
|
|
|
|
|
Non-controlling
interests
|
|
|
|
8
|
|
33
|
|
504
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
|
3,876
|
|
14,902
|
|
40,773
|
|
|
|
|
|
|
|
|
|
Total liabilities and
equity
|
|
|
|
10,171
|
|
39,109
|
|
68,708
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
|
In thousands
(except for share and per share data)
|
|
|
|
|
Year ended December
31,
|
|
|
|
|
2016
|
|
2016
|
|
2015
|
|
2014
|
|
|
|
|
USD
|
|
NIS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
170
|
|
652
|
|
643
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
|
6,081
|
|
23,380
|
|
15,052
|
|
16,200
|
General and
administrative expenses
|
|
|
|
2,726
|
|
10,483
|
|
10,633
|
|
11,573
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
|
8,637
|
|
33,211
|
|
25,042
|
|
27,773
|
|
|
|
|
|
|
|
|
|
|
|
Financial
expenses
|
|
|
|
178
|
|
685
|
|
2,203
|
|
1,228
|
Financial
income
|
|
|
|
(1,820)
|
|
(6,999)
|
|
(7,492)
|
|
(4,500)
|
|
|
|
|
|
|
|
|
|
|
|
Loss before taxes on
income
|
|
|
|
6,995
|
|
26,897
|
|
19,753
|
|
24,501
|
Taxes on
income
|
|
|
|
29
|
|
112
|
|
17
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
7,024
|
|
27,009
|
|
19,770
|
|
24,524
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments arising
from translating financial statements of foreign
operations
|
|
|
|
9
|
|
33
|
|
1
|
|
939
|
Remeasurement loss from
defined benefit plans
|
|
|
|
-
|
|
-
|
|
385
|
|
94
|
|
|
|
|
|
|
|
|
|
|
|
Total other
comprehensive loss
|
|
|
|
9
|
|
33
|
|
386
|
|
1,033
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
|
7,033
|
|
27,042
|
|
20,156
|
|
25,557
|
|
|
|
|
|
|
|
|
|
|
|
Net loss Attributable
to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
|
|
6,900
|
|
26,532
|
|
18,726
|
|
23,759
|
Non-controlling
interests
|
|
|
|
124
|
|
477
|
|
1,044
|
|
765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,024
|
|
27,009
|
|
19,770
|
|
24,524
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss attributable to:
|
|
|
|
|
|
|
|
|
|
|
Equity holders of the
Company
|
|
|
|
6,907
|
|
26,559
|
|
19,112
|
|
24,623
|
Non-controlling
interests
|
|
|
|
126
|
|
483
|
|
1,044
|
|
934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,033
|
|
27,042
|
|
20,156
|
|
25,557
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to equity holders of the Company:
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
|
0.25
|
|
0.96
|
|
0.81
|
|
1.35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/can-fite-reports-2016-financial-results--provides-clinical-update-300432356.html
SOURCE Can-Fite BioPharma Ltd.