CAN-FITE BIOPHARMA LTD. PETACH TIKVA, Israel, Aug. 27, 2015 /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 six months ended June 30, 2015 and updates on its drug development programs.
Clinical Development Program and Corporate Highlights Include:
-- CF101 - Favorable Psoriasis Data, New U.S. Patent, Proposed Generic
Name, and Next Advanced Clinical Studies in Rheumatoid Arthritis &
PsoriasisDuring the second quarter of 2015, Can-Fite reported positive
data from further analysis of its completed Phase II/III study that
suggests CF101 as a potential systemic therapy for patients with
moderate-severe psoriasis, this despite the study not meeting its
primary endpoint, as previously announced during the first quarter of
2015. Based on these findings, the Company is preparing the protocol for
its next advanced psoriasis trial. During the second quarter of 2015,
Can-Fite also completed the design of a Phase III clinical study for the
treatment of rheumatoid arthritis and plans to submit the protocol to
Institutional Review Boards (IRBs) for approval in the fourth quarter of
2015. The Company is discussing the protocol and the registration plan
with its EU notified body. Further, the U.S. Patent and Trademark Office
granted Can-Fite a patent covering the manufacturing process for CF101
in the U.S. and the World Health Organization accepted "piclidenoson" as
the proposed generic name for CF101, both important steps prior to
bringing a new drug to market.
-- CF102 - Ongoing Phase II Liver Cancer Trial & Application for Orphan
Drug Status in EuropeCan-Fite is continuing to enroll and dose patients
in its global Phase II liver cancer study. Approximately 78 patients are
expected to be enrolled in the trial in the U.S., Europe, and Israel by
the end of the first half of 2016. Can-Fite previously received Orphan
Drug Designation in the U.S. for CF102 in the treatment of
hepatocellular carcinoma (HCC), the most common form of liver cancer.
-- CF602 - New Pre-clinical Data Supports Upcoming IND Submission for
Sexual Dysfunction DrugAs Can-Fite prepares to file an investigational
new drug (IND) application with the U.S. Food and Drug Administration
prior to a Phase I clinical study of CF602 in the treatment of sexual
dysfunction, the Company announced new data showing efficacy in a
diabetic rat preclinical study. The animals were treated twice daily
with CF602 for a period of 1 and 5 days. Treated animals showed a
significant response rate resulting in a 188% and 250% increase in
penial intra-cavernosal pressure, respectively compared to placebo.
-- Update on Licensing and Distribution Agreements in Canada and
JapanDuring the second quarter of 2015, Can-Fite received an upfront
payment of CDN$1.7 million following its entry into a distribution
agreement with Canada-based Cipher Pharmaceuticals. In addition, on
August 27, 2015, Can-Fite entered into an agreement with Japan-based
Seikagaku Corporation terminating its license agreement. Seikagaku
informed Can-Fite that it is strategically focused on expanding its core
research and development activities in the field of glyco-science. Under
the license agreement, Seikagaku was granted a license for the use,
development and marketing of CF101 in Japan with respect to inflammatory
indications, except for ophthalmic disease indications. The termination
agreement provides, among other things, that all licenses and rights
granted to Seikagaku terminate and all clinical and non-clinical studies
conducted by Seikagaku shall be transferred free of charge to Can-Fite.
Over the life of the license, Can-Fite received an aggregate of
approximately $8 million from Seikagaku. Can-Fite recently participated
in an Israeli life sciences delegation to Japan with Israel's Office of
the Chief Scientist and signed Non-Disclosure Agreements with selected
Japanese companies interested in licensing CF101 and CF102. The
Company's agreement with Korea-based Kwang Dong remains in place.
-- Definitive Agreement to Acquire Improved Vision System by Can-Fite
Subsidiary OphthaliX During the second quarter of 2015, OphthaliX,
Can-Fite's subsidiary, which develops ophthalmic indications of CF101,
signed a definitive agreement to acquire Israel-based Improved Vision
Systems, LTD. (I.V.S.). The strategic acquisition aims to combine
medical devices and pharmaceutical products to address multi-billion
dollar markets in treating ophthalmic diseases.
-- Ongoing Phase II Study in Glaucoma by Can-Fite Subsidiary OphthaliX
OphthaliX continues to enroll patients in a Phase II clinical study of
CF101 for glaucoma and data release is expected during the first half of
2016.
"We look forward to starting advanced stage trials in the coming quarters for CF101 for both the treatment of rheumatoid arthritis and psoriasis, addressing multi-billion dollar markets. Prior advanced trials for both of these indications have produced valuable data that have helped us optimize the design of the pivotal studies, which move us closer towards applying for marketing approval," stated Can-Fite CEO Dr. Pnina Fishman. "With CF102 in Phase II for liver cancer and our anticipated IND filing for CF602 in sexual dysfunction in the third quarter of 2016, we believe we are well positioned with four distinct clinical programs. During the first half of 2015, we have forged a strategic partnership in Canada and are excited about new opportunities in the Japanese market."
Research and development expenses for the six months ended June 30, 2015 were NIS 5.75 million (U.S. $1.53 million) compared with NIS 8.64 million (U.S. $2.29 million) for the same period in 2014. Research and developments expenses for the first half of 2015 comprised primarily of expenses associated with the Phase II study for CF102 as well as expenses for ongoing studies of CF101. The decrease is primarily due to the completion of the psoriasis Phase II/III study during the first quarter of 2015 and a decrease in the scope of the non-clinical expenses during the first six months of 2015 compared to the same period in 2014.
General and administrative expenses were NIS 4.67 million (U.S. $1.24 million) for the six months ended June 30, 2015 compared to NIS 5.43 million (U.S. $1.44 million) for the same period in 2014. The decrease is primarily due to a reduction in salary and professional services expenses.
Financial income, net for the six months ended June 30, 2015 was NIS 1.88 million (U.S. $0.50 million) compared to NIS 1.71 million (U.S. $0.45 million) for the same period in 2014. The increase in financial income, net in the first half of 2015 was mainly due to a decrease in the fair value of warrants that are accounted as financial liability.
Can-Fite's loss for the six months ended June 30, 2015 was NIS 8.27 million (U.S. $2.19 million) compared with a loss of NIS 12.36 million (U.S. $3.28 million) for the same period in 2014. The decrease in net loss for the first half of 2015 was attributable mainly to a decrease in operating expenses.
As of June 30, 2015, Can-Fite had cash and cash equivalents of NIS 29.20 million (U.S. $7.75 million) as compared to NIS 36.09 million (U.S. $9.58 million) at December 31, 2014. The decrease in cash during the six months ended June 30, 2015 is due to operating expenses offset by NIS 5.14 million (U.S. $1.36 million) received from Cipher Pharmaceuticals as upfront payment for entering into the distribution agreement with Cipher.
For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on June 30, 2015 (U.S. $ 1 = NIS 3.769).
The Company's consolidated financial statements for the six months ended June 30, 2015 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 is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 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
CAN-FITE BIOPHARMA LTD.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
---------------------------------------------------------------
In thousands (except share and per share data)
Convenience
translation
into
U.S. dollars
------------
June 30, June 30, December 31,
-------- -------- ------------
2015 2015 2014
---- ---- ----
Unaudited Unaudited Audited
--------- --------- -------
USD NIS
--- ---
ASSETS
CURRENT ASSETS:
Cash and cash
equivalents 7,747 29,199 36,091
Accounts receivable
and prepaid
expenses 758 2,856 3,417
--- ----- -----
Total current assets 8,505 32,055 39,508
-------------------- ----- ------ ------
NON-CURRENT ASSETS:
Lease deposits 7 26 26
Property, plant and
equipment, net 65 246 133
--- --- ---
Total long-term
assets 72 272 159
---------------
Total assets 8,577 32,327 39,667
------------ ===== ====== ======
CAN-FITE BIOPHARMA LTD.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
---------------------------------------------------------------
In thousands (except share and per share data)
Convenience
translation
into
U.S. dollars
------------
June 30, June 30, December 31,
-------- -------- ------------
2015 2015 2014
---- ---- ----
Unaudited Unaudited Audited
--------- --------- -------
USD NIS
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables 356 1,342 1,024
Deferred revenues 287 1,082 -
Other accounts payable 763 2,876 4,750
Total current liabilities 1,406 5,300 5,774
------------------------- ----- ----- -----
NON-CURRENT LIABILITIES:
Warrants exercisable into
shares 1,087 4,097 6,969
Deferred revenues 1,005 3,788 -
Severance pay, net 57 214 224
--- --- ---
Total long-term liabilities 2,149 8,099 7,193
--------------------------- ----- ----- -----
COMMITMENTS AND CONTINGENT LIABILITIES
SHAREHOLDERS' EQUITY
Share capital 1,444 5,441 5,441
Share premium 80,248 302,456 301,787
Capital reserve from share-
based payment transactions 4,570 17,225 17,153
Warrants exercisable into
shares (series 9-12) 2,384 8,983 9,652
Treasury shares (963) (3,628) (3,628)
Accumulated other
comprehensive loss (189) (711) (1,015)
Accumulated deficit (82,794) (312,048) (304,150)
------- -------- --------
Equity attributable to
equity holders of the
Company 4,700 17,718 25,240
---------------------- ----- ------ ------
Non-controlling interests 321 1,210 1,460
--- ----- -----
Total shareholders' equity 5,021 18,928 26,700
-------------------------- ----- ------ ------
Total liabilities and
shareholders' equity 8,577 32,327 39,667
--------------------- ===== ====== ======
CAN-FITE BIOPHARMA LTD.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
---------------------------------------------------------------
In thousands (except
share and per share
data)
Convenience
translation
into
U.S. dollars
------------
Six months ended June 30,
-------------------------
2015 2015 2014
---- ---- ----
Unaudited
---------
USD NIS NIS
--- --- ---
Revenues 72 271 -
Research and development
expenses 1,526 5,751 8,636
General and
administrative expenses 1,239 4,670 5,425
----- -----
Operating loss 2,693 10,150 14,061
Finance expenses 267 1,005 780
Finance income (766) (2,886) (2,485)
---- ------ ------
Net loss 2,194 8,269 12,356
----- ----- ------
Other comprehensive loss
(income):
Adjustments arising from
translating financial
statements of foreign
operations (98) (370) (65)
Total comprehensive loss 2,096 7,899 12,291
===== ===== ======
Loss attributable to:
Equity holders of the
Company 2,095 7,898 12,014
Non-controlling
interests 99 371 342
--- --- ---
2,194 8,269 12,356
===== ===== ======
Comprehensive loss
attributable to:
Equity holders of the
Company 2,015 7,594 11,962
Non-controlling
interests 81 305 329
--- --- ---
2,096 7,899 12,291
===== ===== ======
Net loss per share
attributable to equity
holders of the Company
:
Basic and diluted net
loss per share 0.09 0.37 0.71
==== ==== ====
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SOURCE Can-Fite BioPharma Ltd.
