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Can-Fite Reports First Quarter 2019 Financial Results & Provides Clinical Update

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  • Preparatory work for an end-of-Phase II FDA meeting to initiate
    a Phase III study in liver cancer is ongoing
  • Top-line data from Phase II NASH study with Namodenoson expected
    in H2 2019
  • Patient enrollment continues in two Phase III studies for
    Piclidenoson in the treatment of rheumatoid arthritis and psoriasis

Can-Fite
BioPharma Ltd. (NYSE: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, 2019.

Clinical Development and Corporate Highlights During Q1 2019 Include:

  • Top Line Results from Phase II Trial of Namodenoson in Liver Cancer
    - Namodenoson was found to increase overall survival in hepatocellular
    carcinoma (HCC) patients with Child Pugh B7, the largest subpopulation
    of the study, as compared to placebo, even though the trial did not
    meet its primary endpoint. The Company is now preparing for an
    end-of-Phase II meeting with the FDA to initiate a Phase III study in
    liver cancer.
  • Liver Cancer Data Presentations Accepted at Leading Scientific
    Conferences
    - Findings from the Phase II study have been accepted
    for presentation at two medical conferences that are highly
    influential in the field of liver cancer. Can-Fite is scheduled to
    deliver a late-breaking oral presentation at the American Society of
    Clinical Oncology (ASCO) annual meeting on June 2 and is scheduled to
    deliver an oral presentation at the International Liver Cancer
    Association (ILCA) annual meeting on September 22.
  • Additional Distribution Deal for Namodenoson in Korea -
    Can-Fite expanded its distribution deal for Namodenoson with Chong Kun
    Dang Pharmaceuticals (CKD) in South Korea to include the indication of
    NASH, in addition to the original distribution deal with CKD for
    Namodenoson in the treatment of liver cancer. For the expanded
    distribution, CKD paid Can-Fite $1,000,000 upfront, with up to an
    additional $5,000,000 due upon completion of milestones.
  • Manuscript on Can-Fite's Drugs in CAR-T Published - Drug
    Design, Development and Therapy published an article about Can-Fite's
    drugs' potential ability to treat Cytokine Release Syndrome (CRS), a
    potentially fatal side effect of CAR-T and other immune-oncology
    therapies.
  • New Patent Granted in U.S. - The U.S. Patent and Trademark
    Office issued a Notice of Allowance for Can-Fite's patent application
    titled, "Use of A3 adenosine receptor agonist in the treatment of
    Osteoarthritis." The patent addresses methods for treating
    osteoarthritis with A3 adenosine receptor (A3AR) agonists and has been
    granted to Can-Fite in major global markets including North and South
    America, Europe and Asia.
  • Up-Front Money from Newly Signed Deal and Equity Fund Raise -
    Following the end of the first quarter, Can-Fite received
    approximately $10.2 million in gross proceeds of which $1 million was
    received from CKD for the expanded distribution of Namodenoson in
    South Korea in April and $9.2 million was raised through two
    registered direct offerings that were completed in April and May.
    Effective May 10, 2019, Can-Fite changed the ratio of its American
    Depository Shares (ADSs) to ordinary shares from one ADS representing
    two ordinary shares to a new ratio of one ADS representing 30 ordinary
    shares.

"We are effectively advancing our drug pipeline through late stage
clinical trials including two Phase III studies for Piclidenoson in auto
immune diseases and a planned Phase III for Namodenoson in liver cancer.
In the coming months we expect to announce top line results from our
Phase II study of Namodenoson in the treatment of NASH," stated Can-Fite
CEO Pnina Fishman. "Each one of the four indications we are pursuing
addresses unmet needs in multi-billion dollar markets."

Financial Results

Revenues for the three months ended March 31, 2019 were $0.30 million
compared to revenues of $0.63 million during the three months ended
March 31, 2018. The decrease in revenues for the first quarter of 2019
was mainly due to the recognition of a $0.3 million advance payment
received in January 2018 under the Distribution and Supply Agreement
with Gebro compared to none in 2019.

Research and development expenses for the three months ended March 31,
2019 were $1.44 million compared with $1.31 million for the same period
in 2018. Research and development expenses for the first quarter of 2019
comprised primarily of expenses associated with the Phase II studies for
Namodenoson as well as expenses for ongoing studies of Piclidenoson. The
increase is primarily due to increased costs associated with the
initiation of the Phase III clinical trial of Piclidenoson for the
treatment of rheumatoid arthritis.

General and administrative expenses were $0.57 million for the three
months ended March 31, 2019 compared to $0.90 million for the same
period in 2018. The decrease is primarily due to a decrease in
professional services and investor relations expenses.

Financial expense, net for the three months ended March 31, 2019 was
$0.12 million compared to financial expense, net of $0.13 million for
the same period in 2018. The decrease in financial expense, net in the
first quarter of 2019 is considered immaterial.

Can-Fite's net loss for the three months ended March 31, 2019 was $1.83
million compared with a net loss of $1.72 million for the same period in
2018. As of March 31, 2019, Can-Fite had cash and cash equivalents of
$2.96 million as compared to $3.62 million at December 31, 2018. The
decrease in cash during the three months ended March 31, 2019 is due to
a decrease in net cash used in operating activity of $1.46 million and a
decrease in net cash provided by financing activity of $2.4 million.

In April and May 2019, the Company raised $3.2 million and $6 million in
gross proceeds, respectively, in registered direct offerings.

The Company's consolidated financial results for the three months ended
March 31, 2019 are presented in accordance with International Financial
Reporting Standards.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per share data)

   
March 31, December 31,
2019 2018
Unaudited Audited
USD
 
ASSETS
 
CURRENT ASSETS:
 
Cash and cash equivalents 2,956 3,615
Other receivable and prepaid expenses 4,234 4,015
Short-term investment 250 273
 

Total current assets

7,440 7,903
 
NON-CURRENT ASSETS:
 
Lease deposits 5 2
Property, plant and equipment, net 44 47
 

Total long-term assets

49 49
 

Total assets

7,489 7,952
 

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

In thousands (except for share and per share data)

   
March 31, December 31,
2018 2018
Unaudited Audited
USD
 
LIABILITIES AND SHAREHOLDERS' EQUITY  
 
CURRENT LIABILITIES:
 
Trade payables $ 1,296 $ 1,071
Deferred revenues 1,000 926
Other accounts payable 409 1,122
 

Total current liabilities

2,705 3,119
 
 
NON-CURRENT LIABILITIES:
 
Deferred revenues 1,539 1,818
 

Total long-term liabilities

1,539 1,818
 
CONTINGENT LIABILITIES AND COMMITMENTS
 
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:
 
Share capital 2,939 2,635
Share premium 95,761 * 94,076
Capital reserve from share-based payment transactions 5,873 5,800
Accumulated other comprehensive income 1,127 1,127
Accumulated deficit (102,455) (100,623)
 

Total equity

3,245 3,015
 
Total liabilities and equity $ 7,489 $ 7,952

(*) Warrants exercisable into shares as of December 31, 2018 were
reclassified into Share premium.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

In thousands (except for share and per share data)

Three months ended

March 31,

2019   2018
Unaudited
USD
 
Revenues $ 299 $ 632
 
Research and development expenses 1,443 1,313
General and administrative expenses 567 907
 
Operating loss 1,711 1,588
 
Finance expenses 130 139
Finance income (9) (6)
 
Total Financial expenses, net 121 133
 
 
Net loss 1,832 1,721
 
Net loss per share attributable to equity holders of the Company :
Basic and diluted net loss per share (0.04) (0.05)

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 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 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: 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 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.

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