Full Press Release Details
Reports First Quarter 2018 Financial Results and Provides Clinical Update
Company Received upfront payment of $2.2M as Part of Distribution Agreement for Piclidenoson in 3 European Countries
Namodenoson Phase II Liver Cancer, Phase II NAFLD/NASH and Phase III Rheumatoid Arthritis studies are Ongoing
TIKVA, Israel, June 1, 2018 - Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company
advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, today reported
financial results for the three months ended March 31, 2018 and provided clinical and corporate updates.
Development Program and Corporate Highlights Include:
Arthritis: In January 2018, Can-Fite signed a distribution agreement with Gebro Holding GmBH to distribute Can-Fite's
lead drug candidate, Piclidenoson (CF101), for the treatment of rheumatoid arthritis and psoriasis, in three European countries
(Spain, Switzerland and Austria), upon receipt of regulatory approvals. Under the terms of the distribution agreement, Gebro is
required to pay additional milestone payments of up to $7,000,000 upon the achievement of certain regulatory, launch and sales
milestones plus double-digit percentage royalty payments on net sales.
arthritis is a treatment market forecast to reach $34.6 billion by 2020.
Psoriasis: In April 2018, Can-Fite published a paper titled "Inhibition of IL-17 and IL-23 in Human Keratinocytes by the A3 Adenosine
Receptor Agonist Piclidenoson" (https://www.hindawi.com/journals/jir/aip/2310970/) in the Journal of Immunology Research.
The Company has completed the preparatory work for its COMFORT Phase III Psoriasis study, designed to evaluate the efficacy and
safety of daily Piclidenoson, administered orally compared to Apremilast (Otezla ) and placebo in around 400 patients
with moderate-to-severe plaque psoriasis. The study will be conducted in 5 countries in Europe, Israel and Canada. The study protocol
has been already submitted and approved by the IRB in Israel, which will be the first country to initiate enrollment.
psoriasis therapeutic market is estimated to reach $11.4B in 2020 according to Visiongain.
Liver Cancer: During the fourth quarter of 2017, Can-Fite reported on the progress of its Phase II liver cancer study with
Namodenoson (CF102) in the treatment of advanced hepatocellular carcinoma (HCC) indicating a 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 Class
B, who failed Nexavar (sorafenib) as a first-line treatment are 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 A3 adenosine receptor expression. The Company anticipates
data release to occur in 2H2018.
to Datamonitor, the HCC market is expected to generate $1.4 billion in sales in 2019.
II clinical study - The Company is currently conducting a Phase II trial with its drug candidate Namodenoson for the treatment
of 60 patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). 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
pre-clinical data - In February 2018, Can-Fite announced new preclinical data supporting a novel anti-NASH mechanism of action
for Namodenoson. Preclinical studies were conducted in hepato-stellate cells in vitro and in an experimental
NASH CCL4 model, showing that in both systems, the molecular mechanism of action of Namodenoson is conferred by decreased expression
levels of the signaling protein phosphoinositol-3-phosphate (PI3K) which confers three downstream signal transduction pathways,
the Wnt, NF-kB and -SMA, altogether, controlling liver inflammation, fibrosis and steatosis. The data were presented
at the European Association for the Study of the Liver (EASL) annual conference.
continue to build positive momentum with our drug candidates. We also secured a significant distribution agreement with Gebro
Holding GmBH to distribute Piclidenoson for the treatment of rheumatoid arthritis and psoriasis in three European countries. This
quarter we also submitted our annual safety summaries on both Piclidenoson and Namodenoson to regulatory authorities around the
world and were pleased to note that both drug candidates continue to demonstrate a favorable safety profile in human clinical
trials. We look forward to providing updates on our Phase II study on Namodenoson during the second half of the year," stated
Can-Fite CEO Dr. Pnina Fishman.
in Functional and Presentation Currency
the Company's inception through January 1, 2018, the Company's functional and presentation currency was the New Israeli
Shekel (NIS). Management conducted a review of the functional currency of the Company and decided to change its functional and
presentation currency to the U.S. dollar from the NIS effective January 1, 2018. This change was based on an assessment by Company
management that the dollar is the primary currency of the economic environment in which the Company operates. Accordingly, the
functional and presentation currency of the Company in the financial results presented in this press release is the U.S. dollar.
determining the appropriate functional currency to be used, the Company followed the guidance in International Accounting
Standard (IAS) 21, which states that factors relating to sales, costs and expenses, financing activities and cash flows, as
well as other potential factors, should be considered. In this regard, the Company is incurring and expects to continue to
incur a majority of its expenses in U.S. dollars as a result of its expanded clinical trials. These changes, as well as the
fact that the majority of the Company's available funds are in U.S. dollars, the Company's principal source of
financing is the U.S. capital market, and all of the Company's budgeting is conducted solely in U.S. dollars, led to
the decision to make the change in functional currency as of January 1, 2018, as indicated above.
presentation purposes, comparative figures in the financial results have been translated into dollars on the following basis:
(i) monetary assets and liabilities of the Company were translated using the current rate method, using the dollar exchange rate
as of December 31, 2017, (ii) non-monetary assets and liabilities of the Company and equity were translated using historical exchange
rates at the relevant transaction dates, (iii) profit and loss accounts were recorded at the exchange rate at the date of the
transaction, and (iv) translation differences resulting from the change in functional currency have been reported as a component
of shareholders' equity.
for the three months ended March 31, 2018 were U.S. $0.63 million compared to revenues of U.S. $0.07 million during the three
months ended March 31, 2017. The increase in revenues for the first quarter of 2018 was mainly due to the recognition of a portion
of the U.S. $2.2 million advance payment received in January 2018 under the distribution agreement with Gebro Holding GmbH.
and development expenses for the three months ended March 31, 2018 were U.S. $1.31 million compared with U.S. $1.22 million for
the same period in 2017. Research and development expenses for the first quarter of 2018 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. The Company expects that the research and development expenses will increase through 2018 and beyond.
and administrative expenses were U.S. $0.90 million for the three months ended March 31, 2018 compared to U.S. $0.76 million for
the same period in 2017. The increase is primarily due to an increase in investor relations expenses. We expect that the annual
general and administrative expenses will remain at the same level as 2017.
expense, net for the three months ended March 31, 2018 aggregated U.S. $0.13 million compared to financial income, net of U.S.
$0.17 million for the same period in 2017. The increase in financial expense, net in the first quarter of 2018 was mainly due
to an increase in interest expenses related to advance payment recognition and an increase in exchange rate differences on balances
of cash and cash equivalents.
net loss for the three months ended March 31, 2018 was U.S. $1.72 million compared with a net loss of U.S. $1.74 million for the
same period in 2017. The slight difference in net loss for the first quarter of 2018 was primarily attributable to an increase
in revenues which was offset by an increase in general and administrative expenses and in financial expenses, net.
of March 31, 2018, Can-Fite had cash and cash equivalents of U.S. $8.31 million as compared to U.S. $3.5 million at December 31,
2017. The increase in cash during the three months ended March 31, 2018 is due to U.S. $4.37 million received from the issuance
of shares and warrants, net of issuance expenses, and the $2.2 million advance payment received from Gebro.
Company's consolidated financial results for the three months ended March 31, 2018 are presented in accordance with International
Financial Reporting Standards.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
thousands (except for share and per share data)
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| USD | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | 8,314 | 3,505 | ||||||
| Other receivable and prepaid expenses | 3,205 | 3,159 | ||||||
| Total current assets | 11,519 | 6,664 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Lease deposits | 5 | 5 | ||||||
| long-term investment | 927 | 917 | ||||||
| Property, plant and equipment, net | 24 | 28 | ||||||
| Total long-term assets | 956 | 950 | ||||||
| Total assets | 12,475 | 7,614 |
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
thousands (except for share and per share data)
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| USD | ||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | 752 | 427 | ||||||
| Deferred revenues | 730 | 330 | ||||||
| Other accounts payable | 1,065 | 997 | ||||||
| Total current liabilities | 2,547 | 1,754 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Deferred revenues | 2,499 | 846 | ||||||
| Total long-term liabilities | 2,499 | 846 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Share capital | 2,605 | 2,123 | ||||||
| Share premium | 81,416 | 81,104 | ||||||
| Capital reserve from share-based payment transactions | 5,646 | 5,547 | ||||||
| Warrants exercisable into shares | 12,408 | 8,815 | ||||||
| Accumulated deficit | (94,646 | ) | (92,575 | ) | ||||
| Total equity | 7,429 | 5,014 | ||||||
| Total liabilities and equity | 12,475 | 7,614 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
thousands (except for share and per share data)
| Three months ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Unaudited | ||||||||
| USD | ||||||||
| Revenues | 632 | 68 | ||||||
| Research and development expenses | 1,313 | 1,220 | ||||||
| General and administrative expenses | 907 | 762 | ||||||
| Operating loss | (1,588 | ) | (1,914 | ) | ||||
| Finance expenses | (139 | ) | (31 | ) | ||||
| Finance income | 6 | 206 | ||||||
| Total Financial income, net | (133 | ) | 175 | |||||
| Net loss | (1,721 | ) | (1,739 | ) | ||||
| Net loss attributable to: | ||||||||
| Equity holders of the Company | (1,721 | ) | (1,718 | ) | ||||
| Non-controlling interests | - | (21 | ) | |||||
| (1,721 | ) | (1,739 | ) | |||||
| Net loss per share attributable to equity holders of the Company : | ||||||||
| Basic and diluted net loss per share | (0.05 | ) | (0.05 | ) |
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE American: 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).