Full Press Release Details
Reports Third Quarter 2017 Financial Results & Provides Clinical Update
TIKVA, Israel, November 27, 2017 -- 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 reported financial
results for the nine months ended September 30, 2017 and provided clinical and corporate updates.
Development Program and Corporate Highlights Include:
(CF102): Advances Phase II Trials and Receives Milestone Payment
enrollment has commenced in Can-Fite's Phase II trial of Namodenoson in the treatment of non-alcoholic fatty liver disease
(NAFLD) and non-alcoholic steatohepatitis (NASH). The 12-week trial is enrolling approximately 60 patients and is estimated to
cost less than $1 million. There is currently no U.S. FDA approved drug for the indication of NASH, which is an addressable pharmaceutical
market estimated to reach $35-40 billion by 2025.
the third quarter of 2017, Can-Fite received a milestone payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD), which
licensed the exclusive right to distribute Namodenoson for the treatment of liver cancer in Korea upon receipt of regulatory approvals.
The payment is part of a deal worth up to $3,000,000 in upfront and milestone payments plus 23% royalties.
completed enrollment during the third quarter of 2017 and randomized all 78 patients in its global Phase II study of Namodenoson
in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. Patients with advanced HCC, Child Pugh
B, were enrolled in the U.S., Europe and Israel. The primary endpoint of the Phase II study is overall survival. Can-Fite is following
the survival data closely and plans to perform the survival analysis at the earliest possible opportunity. The HCC market is expected
to generate $1.4 billion in sales in 2019.
Pnina Fishman, Can-Fite's CEO, joined global thought-leaders in the treatment of NASH at the NASH Summit Europe in October,
in Frankfurt, Germany, where she delivered a presentation titled, "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson
(CF102): From Preclinical to Human Studies".
also presented two scientific posters at the American Association for the Study of Liver Diseases (AASLD) annual conference, The
Liver Meeting in Washington, D.C. in October. The posters were titled "Namodenoson (CF102) Prevents Liver Fibrosis
in the CCL4 Model" and "The Anti-Fibrogenic and Liver Protective Effects of Namodenoson (CF102) in a Non-Alcoholic
Steatohepatitis model".
(CF101): Commences Patient Enrollment and Dosing in ACRobat Phase III Trial in Rheumatoid Arthritis
enrollment and dosing has commenced in Can-Fite's Phase III ACRobat trial that is evaluating Piclidenoson as a first line
treatment and replacement for the current standard of care, Methotrexate (MTX), the most widely used drug for rheumatoid arthritis.
The trial is enrolling approximately 500 patients in Europe, Canada and Israel. The estimated cost of the entire 24-week Phase
III study is approximately $5 million. An estimated 90% of rheumatoid arthritis patients receive MTX at some point in their disease.
However, studies show that up to 50% of patients stop taking MTX due to reasons including drug intolerance, minor and major side
effects, and lack of efficacy, creating a significant need for a new, safe and effective treatment option in the rheumatoid arthritis
treatment market which is forecast to reach $34.6 billion by 2020.
is also advancing Piclidenoson towards a Phase III trial in the treatment of psoriasis which is expected to commence in 2018.
The upcoming 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.
The psoriasis market is forecast to be $8.9 billion in 2018 and Otezla sales are estimated to be $2.35 billion by 2020.
Intellectual Property
was issued a new patent from the Korean Intellectual Property Office for Piclidenoson titled, "Pharmaceutical Composition
Comprising A3 Adenosine Receptor Agonist (IB-MECA/CF-101) For Treatment of Psoriasis".
new patent application was filed by Can-Fite to protect the use of its drugs and other ligands which target the A3 adenosine receptor
(A3AR) in the treatment of cytokine release syndrome (CRS), a potentially life-threatening complication of CAR-T cell therapy.
CAR-T is viewed by the medical community as a very promising cancer immunotherapy, however, CRS, which is caused by an overactive
immune response to the treatment, has been identified as a potentially severe and life-threatening side effect of CAR-T. Can Fite's
platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation in CRS, and
as such, Can-Fite believes that A3AR targeting may serve as an important treatment option for patients in reducing the risk
of CRS without limiting the utility of the underlying cancer immunotherapy.
Former Subsidiary OphthaliX Successfully Completes Merger with Wize Pharma
former majority-owned subsidiary, OphthaliX Inc. (since renamed Wize Pharma, Inc.) recently completed a merger with Wize Pharma
Ltd. As a result of the merger, Can-Fite's ownership of OphthaliX, immediately post-merger, became approximately 8% of the
outstanding shares of common stock. In addition, immediately prior to the merger, OphthaliX sold on an "as is" basis
to Can-Fite all the ordinary shares of Eyefite Ltd., a former wholly owned subsidiary of OphthaliX, in exchange for the irrevocable
cancellation and waiver of all indebtedness owed by OphthaliX and Eyefite to Can-Fite, including approximately $5 million of deferred
payments and, as part of the purchase of Eyefite, Can-Fite also assumed certain accrued milestone payments in the amount of $175,000
under a license agreement previously entered into with the U.S. National Institutes of Health (NIH). In addition, as a result
of the merger, an exclusive license of Piclidenoson (CF101) for the treatment of ophthalmic diseases previously granted by Can-Fite
to OphthaliX and a related services agreement was terminated.
are pleased to be on target with commencing patient enrollment in our Phase III rheumatoid arthritis and Phase II in NAFLD/NASH
studies. Namodenoson is gaining increasing recognition in the medical community, as evidenced by our recent scientific presentations,
for its liver protective properties in both NASH and liver cancer. In 2018, we look forward to initiating our Phase III study
of Piclidenoson in psoriasis, as well as potentially announcing top line data on our Phase II liver cancer study of Namodenoson,"
for the nine months ended September 30, 2017 were NIS 2.61 million (U.S. $0.74 million) compared to NIS 0.64 million (U.S. $0.18
million) in the first nine months of 2016. The increase in revenue was mainly due to payment received of NIS 1.8 million (U.S.
$0.5 million) in August 2017 under the distribution agreement with CKD.
and development expenses for the nine months ended September 30, 2017 were NIS 12.7 million (U.S. $3.6 million) compared with
NIS 15.45 million (U.S. $4.38 million) for the same period in 2016. Research and development expenses for the nine months ended
September 30, 2017 comprised primarily of expenses associated with the Phase II study for Namodenoson as well as expenses for
ongoing studies of Piclidenoson. The decrease is primarily due to a reduction in preclinical studies of CF602 conducted during
the nine months ended September 30, 2017.
and administrative expenses were NIS 7.48 million (U.S. $2.12 million) for the nine months ended September 30, 2017, compared
to NIS 7.88 million (U.S. $2.23 million) for the same period in 2016. The decrease in general and administrative expenses was
mainly due to a decrease in investor relations expenses.
income, net for the nine months ended September 30, 2017 aggregated NIS 3.91 million (U.S. $1.11 million) compared to financial
income, net of NIS 3.12 million (U.S. $0.88 million) for the same period in 2016. The increase in financial income, net in the
nine months ended September 30, 2017 was mainly from a larger decrease in the fair value of warrants that are accounted for as
financial liability as compared to the same period in 2016, offset by exchange rate differences as compared to the same period
in 2016 and from issuance expenses.
net loss for the nine months ended September 30, 2017 was NIS 13.75 million (U.S. $3.90 million) compared with a net loss of NIS
19.56 million (U.S. $5.54 million) for the same period in 2016. The decrease in net loss for the nine months ended September 30,
2017 was primarily attributable to a decrease in research and development expenses.
of September 30, 2017, Can-Fite had cash and cash equivalents of NIS 18.02 million (U.S. $5.11 million) as compared to NIS 31.2
million (U.S. $8.84 million) at December 31, 2016. The decrease in cash during the nine months ended September 30, 2017 is due
to use of cash to fund operating expenses.
the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of
exchange on September 30, 2017 (U.S. $1 = NIS 3.529).
Company's consolidated financial results for the nine months ended September 30, 2017 are presented in accordance with International
Financial Reporting Standards.
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 multi-billion 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 in early 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.
press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among