Full Press Release Details
Can-Fite CEO Issues Letter to Shareholders
PETACH TIKVA, Israel, January 06, 2020
-- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule
drugs that address inflammatory, cancer and liver diseases, issued a Letter to Shareholders from the Company's Chief Executive
Officer, Pnina Fishman, Ph.D.
Dear Can-Fite Shareholders,
We made significant progress in our drug
development programs during 2019 and are entering 2020 with the expectation of major value-driving events over the next 12 months.
Namodenoson NASH top line results expected Q1 2020 -
Namodenoson's Phase II study in NASH (non-alcoholic steatohepatitis) completed enrollment, and we expect to announce top
line results in the first quarter of 2020.
Namodenoson Phase III study design for
liver cancer receives FDA's agreement - We successfully concluded an End of Phase II meeting with the U.S. FDA
for Namodenoson in the treatment of advanced liver cancer. We are now preparing a Phase III study in this indication. The FDA has
agreed with our Phase III study design, which is based on the efficacy shown from our Phase II data in the sub-population of patients
with underlying Child Pugh B7 cirrhosis.
Namodenoson is approved for use in Israel
under Compassionate Use Program - We recently initiated Namodenoson's Compassionate Use Program in Israel, which
allows doctors and their patients the option of early access to investigational new drugs under closely controlled and monitored
circumstances when a patient who is facing serious illness has exhausted all available treatment options. Namodenoson has been
out-licensed for the indications of liver cancer and NASH in South Korea, China, Hong Kong, Macau, and Taiwan.
Namodenoson has potential utilization
as anti-obesity drug based on new data - New pre-clinical studies of Namodenoson conducted at Hadassah Medical Center demonstrate
the drug induces weight loss and normalizes glucose levels in experimental models. Based on these results, Can-Fite filed a PCT
patent for Namodenoson as an anti-obesity drug. The global obesity treatment market is expected to exceed $12 billion by 2023 according
to Market Research Future.
Piclidenoson progresses in Phase III
studies - Piclidenoson is now being evaluated in two Phase III trials in psoriasis and rheumatoid arthritis, enrolling approximately
400 and 500 patients in each study, respectively. We completed enrollment of over 50% of patients in our psoriasis study. Prior
Phase II data of Piclidenoson have been thoroughly reviewed by regulatory agencies prior to the start of our Phase III studies,
and the data have been vetted by our distribution partners who have paid upfront and milestone payments in exchange for the right
to market Piclidenoson, upon regulatory approval, in their respective markets in Canada, Spain, Austria, Switzerland, South Korea,
Hong Kong, Macau, Taiwan, and China. We look forward to announcing updates for the ongoing trials during the year.
Out-licensing our drugs for non-dilutive
funding - Our business strategy is strongly supported by our advanced stage Phase II and Phase III clinical trials and results.
The efficacy and safety data produced in over 1,000 patients gives our distribution partners the confidence to enter into partnership
agreements with Can-Fite. Upfront and milestone payments from our distribution partners provide non-dilutive funding for Can-Fite,
while also building a global distribution network for our drugs. To date, we have received over $18 million in upfront and milestone
payments from distribution partners. These established agreements include double-digit royalties upon regulatory approval, as well
as the potential for numerous additional payments to Can-Fite based upon achieving clinical regulatory milestones. While we are
very pleased to have partnered in some key territories, we aim to sign additional agreements in the largest markets including the
U.S., South America, Europe, and Asia. Our clinical development pipeline targets indications with multi-billion-dollar markets.
Additional value creating opportunities
with strategic partners - (a) Erectile dysfunction: We have built strong IP assets and preclinical data around our erectile
dysfunction drug candidate, CF602 which is well positioned for a development partnership with a pharma company looking to develop
a drug in this indication that can safely be used by people living with diabetes; (b) Osteoarthritis in canines: Piclidenoson
has recently garnered attention and interest from veterinary medicine companies for osteoarthritis in canines; and (c) Cannabis:
We are working with our strategic partner Univo Pharmaceutics to develop new cannabis-based pharmaceuticals. This partnership was
strengthened in December 2019, when Univo's CEO Golan Bitton joined Can-Fite's board of directors. Each of these opportunities
have the potential to create additional value for Can-Fite through partnerships, without entering clinical trials directly managed
We thank all of our shareholders for their
ongoing support as we execute on our out-licensing strategy. Leveraging our advanced-stage clinical assets into distribution deals
that generate near and long-term non-dilutive funds, we aim to build value for shareholders while developing much needed treatments
for people living with chronic diseases.
Pnina Fishman, Ph.D.
Chief Executive Officer
About Can-Fite BioPharma Ltd.
Can-Fite 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 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 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.