Market Overview

Can-Fite Reports 2017 Financial Results & Provides Clinical Update

Share:
  • A multi-million dollar agreement has been signed with Gebro
    Holdings for the distribution of Piclidenoson in 3 European Countries
  • Phase III ACRobat trial of Piclidenoson in the treatment of
    rheumatoid arthritis currently enrolling patients
  • Top-line data of Phase II with Namodenoson in the treatment of
    hepatocellular carcinoma (HCC) expected later in 2018
  • Top-line Data from Phase II NASH Study with Namodenoson expected in
    H1 2019Can-Fite Reports 2017 Financial Results & Provides Clinical
    Update

Can-Fite
BioPharma Ltd
. (NYSE:CANF) (TASE:CFBI), a biotechnology
company advancing a pipeline of proprietary small-molecule drugs that
address cancer, liver disease and inflammatory diseases, today announced
it has filed its 2017 Annual Report on Form 20-F with the U.S.
Securities and Exchange Commission.

Clinical Development Program and Corporate Highlights Include:

Piclidenoson (CF101)

A multi-million dollar agreement has been
signed with Gebro Holdings for the distribution of piclidenoson in 3
European Countries

Under the terms of the distribution agreement, Gebro made a total
upfront and milestone payment of approximately $2,200,000 to Can-Fite.
In addition, the agreement provides that additional payments of up to
approximately $7,000,000 will be received by Can-Fite upon the
achievement of certain regulatory, launch and sales milestones plus
double-digit percentage royalty payments on net sales.

Patient enrolment for the ACRobat Phase III
Trial in Rheumatoid Arthritis is ongoing

During the fourth quarter of 2017, Can-Fite commenced enrollment in the
pivotal Phase III ACRobat trial of approximately 500 patients through
clinical sites in Europe, Israel and Canada. The study aims to evaluate
Piclidenoson (CF101) as a first line treatment and replacement for the
current standard of care, Methotrexate (MTX), the most widely used drug
for rheumatoid arthritis. The primary endpoint of ACRobat is low disease
activity after 12 weeks of treatment in patients dosed with Piclidenoson
compared to those dosed with MTX. Piclidenoson at 1 mg and 2 mg, or
placebo, will be administered twice daily, and MTX or placebo will be
administered once weekly. The total study duration will be 24 weeks.

The rheumatoid arthritis market is forecast to reach $34.6 billion by
2020.

A patent for Psoriasis has been approved in
Korea

The Korean Intellectual Property Office issued patent No. 10-1741281
titled, "Pharmaceutical Composition Comprising A3 Adenosine Receptor
Agonist (IB-MECA/CF-101) For Treatment of Psoriasis" for the Company's
lead drug candidate Piclidenoson in its psoriasis indication. Can-Fite
has two distribution agreements in Korea, including one with Kwang Dong
Pharmaceutical for Piclidenoson in the treatment of rheumatoid arthritis
and another with Chong Kun Dang for Namodenoson in the treatment of
liver cancer.

Namodenoson (CF102)

Progress of the Phase II Liver Cancer
Namodenoson (CF102) Study in the treatment of advanced HCC – Data to be
released H2/2018

Current data indicate potentially favorable drug safety profile. The
global Phase II study is being conducted in the U.S., Europe and Israel.
Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib)
as a first line treatment are being treated twice daily with 25 mg of
oral Namodenoson or placebo using a 2:1 randomization. The primary
endpoint of the Phase II study is Overall Survival (OS). Secondary
endpoints include Progression Free Survival (PFS), safety, and the
relationship between outcomes and A3AR expression. A total of
approximately 78 patients have been enrolled in the Phase II study. As
of December 2017, 15 subjects have completed at least 12 cycles of
treatment (each cycle is 28 days of treatment), of which two completed
24 cycles. The Company anticipates data release to occur in 2H 2018.

The market for hepatocellular carcinoma drugs is expected to generate
$1.4 billion in sales in 2019.

Phase II NAFLD/NASH Study is enrolling
patients; Data Release Expected in H1 2019

Can-Fite is currently enrolling patients in a Phase II study in the
treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic
steatohepatitis (NASH) with Namodenoson which plans to enroll 60
patients. Can-Fite's 12-week study is being led by key opinion leaders
in the area of NASH and liver diseases. Clinical trial sites are some of
the most prestigious medical institutions in Israel, including Hadassah
Medical Center and Rabin Medical Center. Patients are being enrolled in
three arms, including two different dosages of oral Namodenoson twice
daily versus placebo. The study's primary endpoints are the mean percent
change from baseline in serum alanine aminotransferase (ALT) levels and
safety. The secondary endpoint is percent change from baseline in
hepatic steatosis measured by magnetic resonance imaging-determined by
proton-density fat-fraction (MRI-PDFF) and additional metabolic
parameters.

The Phase II trial design was based on preclinical studies showing
Namodenoson's efficacy in reducing liver steatosis, inflammation and
fibrosis in experimental NASH models.

There is currently no U.S. FDA approved drug for the treatment of NASH,
which is an addressable pharmaceutical market estimated to reach $35-40
billion by 2025.

"We've made several notable accomplishments during this past year which
validate the strength of our drug portfolio and demonstrate our
commitment in execution. We believe these events position us well for
the year ahead in which we anticipate a marked progress with our
Piclidenoson and Namodenoson drug candidates. We are pleased with the
progress thus far and recently announced the submission of safety
reports for Piclidenoson and Namodenoson to the FDA and other
regulatory authorities so that we may continue with the various clinical
studies. Our drug candidates are highly unique due to our favorable
safety profile and the specific anti-inflammatory and anti-cancer
effects. In the coming year 2018, we remain focused on execution with
the goal of providing our patients a better alternative option and
treatment for autoimmune inflammatory, oncology and NASH/NAFLD," stated
Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the year ended December 31, 2017 were NIS 2.9 million (U.S.
$0.85 million), an increase of NIS 2.3 million (U.S. $0.66 million), or
350%, compared to NIS 0.65 million (U.S. $0.2 million) for the year
ended December 31, 2016. The revenues during 2017 were mainly due to a
portion of the NIS 0.76 million (U.S. $0.22 million or CAD 0.2 million)
advance payment received in March 2015 under the distribution agreement
with Cipher and from the recognition of the milestone payment of NIS 1.8
million (U.S. $0.5 million) and the recognition of a portion of the NIS
0.4 million (U.S. $0.1 million) advance payment received in December
2016 under the distribution agreement with CKD.

Research and development expenses for the year ended December 31, 2017
were NIS 18.3 million (U.S. $5.28 million), a decrease of NIS 5 million
(U.S. 1.44 million), or 22%, compared to NIS 23.4 million (U.S. $6.74
million) for the year ended December 31, 2016. Research and developments
expenses for the year ended 2017 comprised primarily of expenses
associated with the Phase II studies for Namodenoson as well as expenses
for ongoing studies of Piclidenoson. The decrease is primarily due to
costs associated with CF602 expenses that decreased since the
postponement of a planned IND submission for this indication and
decreased costs associated with the ongoing clinical trial of
Namodenoson for treatment in liver cancer. The Company expects that the
research and development expenses will increase through 2018 and beyond.

General and administrative expenses were NIS 10.2 million (U.S. $2.94
million) for the year ended December 31, 2017 a decrease of NIS 0.2
million (U.S. $0.06 million), or 2%, compared to NIS 10.5 million (U.S.
$3.02 million) for the year ended December 31, 2016. The minor decrease
is primarily due to a decrease in investor and public relations
expenses. The Company expects that general and administrative expenses
will remain at the same level through 2018.

Financial income, net for the year ended December 31, 2017 aggregated
NIS 6.6 million (U.S. $1.89 million) compared to financial income, net
of NIS 6.31 million (U.S. $1.82 million) for the same period in 2016.
The slight increase in financial income, net in the year ended December
31, 2017 was mainly due to issuance expenses recorded in 2017 which were
not recorded in 2016, a decrease in net change in fair value of warrants
exercisable into shares and a decrease in exchange rate difference
expenses.

Can-Fite's net loss for the year ended December 31, 2017 was NIS 17.3
million (U.S. $4.99 million) compared with a net loss of NIS 27 million
(U.S. $7.78 million) for the year ended December 31, 2016. The decrease
in net loss for the year ended December 31, 2017 was primarily
attributable to a decrease in research and development expenses.

As of December 31, 2017, Can-Fite had cash and cash equivalents of NIS
12.1 million (U.S. $3.51 million) as compared to NIS 31.2 million (U.S.
$8.99 million) at December 31, 2016. The decrease in cash during the
year ended December 31, 2017 is due to use of cash to fund 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
December 31, 2017 (U.S. $1 = NIS 3.467).

The Company's consolidated financial results for the year ended December
31, 2017 are presented in accordance with International Financial
Reporting Standards.

The 2017 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:CANF) (TASE: CFBI) is an
advanced clinical stage drug development Company with a platform
technology that is designed to address multibillion-dollar markets in
the treatment of cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is currently in a Phase
III trial for rheumatoid arthritis and is expected to enter a Phase III
trial for psoriasis during 2018. Can-Fite's liver cancer drug,
Namodenoson, is in Phase II trials for hepatocellular carcinoma (HCC),
the most common form of liver cancer, and 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 in preclinical studies and the Company
is investigating additional compounds, targeting A3AR, for the treatment
of sexual dysfunction. 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, 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: 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 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; estimates
of our expenses, future revenues, capital requirements and our needs for
additional financing; 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.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per share data)

      Convenience translation into

U.S. dollars

December 31,   December 31,   December 31,
2017 2017 2016
Audited
USD NIS
 
ASSETS
 
CURRENT ASSETS:
 
Cash and cash equivalents 3,506 12,154 31,203
Other receivable and prepaid expenses 3,378 11,711 7,664
 
Total current assets 6,884 23,865 38,867
 
NON-CURRENT ASSETS:
 
Lease deposits 5 18 37
long-term investment 917 3,179 -
Property, plant and equipment, net 46 160 205
 
Total long-term assets 968 3,357 242
 
Total assets 7,852 27,222 39,109

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per share data)

      Convenience translation into

U.S. dollars

   
December 31, December 31,   December 31,
2017 2017 2016
Audited
USD NIS
 
LIABILITIES AND SHAREHOLDERS' EQUITY
 
CURRENT LIABILITIES:
 
Trade payables 427 1,479 4,804
Deferred revenues 374 1,299 1,237
Other accounts payable 1,001 3,469 3,588
 
Total current liabilities 1,802 6,247 9,629
 
 
NON-CURRENT LIABILITIES:
 
Warrants exercisable into shares 2,030 7,037 10,068
Deferred revenues 959 3,324 4,510
 
Total long-term liabilities 2,989 10,361 14,578
 
CONTINGENT LIABILITIES AND COMMITMENTS
 
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:
 
Share capital 2,401 8,324 7,039
Share premium 100,283 347,684 332,873
Capital reserve from share-based payment transactions 6,296 21,828 20,438
Warrants exercisable into shares (series 10-12) - - 8,983
Treasury shares, at cost - - (3,628)
Accumulated other comprehensive loss - - (883)
Accumulated deficit (105,919) (367,222) (349,953)
 
Total equity attributable to equity holders of the Company 3,061 10,614 14,869
 
Non-controlling interests - - 33
 
Total equity 3,061 10,614 14,902
 
Total liabilities and equity 7,852 27,222 39,109

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

In thousands (except for share and per share data)

Convenience translation into

U.S. dollars

Year ended

December 31,

2017 2017   2016   2015
Audited
USD NIS NIS   NIS
 
Revenues 847 2,936 652   643
 
Research and development expenses 5,285 18,322 23,380 15,052
General and administrative expenses 2,956 10,249 10,483   10,633
 
Operating loss 7,394 25,635 33,211   25,042
 
Other income (534) (1,853) - -
 
Finance expenses 1,102 3,822 685 2,203
Finance income (2,999) (10,397) (6,999)   (7,492)
 
Total financial income, net (1,897) (6,575) (6,314) (5,289)
 
Loss before taxes on income 4,963 17,207 26,897 19,753
Taxes on income 30 104 112   17
 
Net loss 4,993 17,311 27,009   19,770
 
Other comprehensive loss:

Total components that will be or that have been reclassified to
profit or loss:

Adjustments arising from translating financial statements of foreign
operations
27 95 33 1
Remeasurement loss from defined benefit plans - - -   385
 
Total other comprehensive 27 95 33 386
         
Total comprehensive loss 5,020 17,406 27,042   20,156
 
Net loss attributable to:
Equity holders of the Company 4,981 17,269 26,532 18,726
Non-controlling interests 12 42 477   1,044
 
4,993 17,311 27,009   19,770
Total comprehensive loss attributable to:
Equity holders of the Company 5,015 17,388 26,559 19,112
Non-controlling interests 5 18 483   1,044
 
5,020 17,406 27,042   20,156
Net loss per share attributable to equity holders of the Company :
Basic and diluted net loss per share 0.15 0.53 0.96   0.81

View Comments and Join the Discussion!