Full Press Release Details
Can-Fite Reports Third Quarter
2020 Financial Results & Provides Clinical Update
Company to host conference
call at 9:15 a.m. ET Monday, November 30, 2020
PETACH TIKVA, Israel, November 30, 2020
-- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small
molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the nine months ended
Clinical Developments and Corporate Highlights
for the Third Quarter and Recent Weeks Include:
Positive Interim Analysis in Phase III
Comfort Trial of Piclidenoson in the Treatment of Psoriasis - The Independent Data Monitoring Committee (IDMC)
for Can-Fite's Phase III trial of Piclidenoson in the treatment of moderate-to-severe plaque psoriasis recommended the Company
continue the study with the original sample size and drop one dose group based on the positive data from its interim analysis.
While the interim data continue to be blinded to Can-Fite, the Company considers the IDMC's recommendations highly encouraging.
As the optimal dose has been identified, Can-Fite believes the study can be concluded earlier than originally planned. The majority
of costs associated with the Phase III Comfort study have been previously paid. Piclidenoson is out-licensed for the indication
of psoriasis in nine countries through agreements that include milestone payments and royalties on revenues upon regulatory approval.
Data from the Interim Analysis of the
Acrobat Rheumatoid Arthritis Study - The IDMC recommended not to continue this study. The Company conducted a detailed
analysis which showed that although Piclidenoson efficacy was significantly superior to placebo, the study missed the primary endpoint
which was non-inferiority vs. the comparator methotrexate. The Company decided to stop this Phase III study and to focus on the
developments that showed promising data including psoriasis, NASH and liver cancer.
Phase II COVID-19 IND Application for
Piclidenoson Approved by FDA - The U.S. Food and Drug Administration (FDA) issued a "safe to proceed" notice for
Can-Fite's Investigational New Drug (IND) application for a Phase II study of Piclidenoson in the treatment COVID-19. The
28-day study will enroll 40 patients hospitalized with "moderate" COVID-19 per U.S. National Institutes of Health Coronavirus
Disease 2019 (COVID-19) Treatment Guidelines. The randomized, double blind study will evaluate patients who will receive Piclidenoson
in addition to standard supportive care, as compared to patients who receive standard supportive care with placebo. The Company
expects to commence patient enrollment in Q4 2020.
Namodenoson Abstract of Phase II Data
Selected as Best of The Liver Meeting' in the NASH Category of the American Association of Liver Diseases (AASLD)
- Dr. Rifaat Safadi, Principal Investigator of Can-Fite's Phase II study of Namodenoson in the treatment of Non-Alcoholic
Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) delivered a late-breaking oral presentation at the prestigious
American Association for the Study of Liver Diseases (AASLD) conference, The Liver Meeting Digital Experience 2020. Presenting
to the world's leading scientists and health care professionals committed to preventing and curing liver diseases, Dr. Safadi
concluded that "Namodenoson's very impressive study data may result in a promising drug for the treatment of NAFLD/NASH
due to the combination of good efficacy and favorable safety." Can-Fite's presentation was selected as Best
of The Liver Meeting' in the NAFLD/NASH category. This selection is a singular honor and indicates the high level with which
the AASLD review committee regards Can-Fite's research.
Patent Protecting Namodenoson in Treatment
of NASH Approved in Europe - A patent titled "An A3 Adenosine Receptor For Use In Treating Ectopic Fat Acculturation"
was issued to Can-Fite by the European Patent Office. The patent's claims include use of the A3 adenosine receptor (A3AR),
the target of Can-Fite's platform technology, in reducing ectopic fat accumulation particularly in fatty liver as manifested
Completed Development of Assay to Identify
Clinically Active Cannabis Derived Compounds - Can-Fite completed the development of a biological cell-based in vitro
assay which can identify clinically active cannabis derived compounds that bind to and activate A3AR, the target of Can-Fite's
platform technology. In addition to using this assay in the development of its own cannabis derived compound-based therapeutics,
Can-Fite plans to market the assay on a fee for service' basis to researchers and other cannabis companies worldwide.
"We are very pleased with the results
of the IDMC's interim analysis and recommendation for our Phase III psoriasis study. Piclidenoson has a clear value proposition
in the psoriasis market we believe, based on its demonstrated safety and efficacy to date, and the benefit of being an oral drug
among a growing number of injectable biologics. Oral drugs are cost effective and more convenient for the patient. Both of these
factors are preferred by psoriasis patients based on a 2018 study published in an industry journal," stated Can-Fite CEO
Dr. Pnina Fishman. "This quarter we anticipate enrolling the first COVID-19 patient in our U.S. FDA Phase II study. Piclidenoson's
anti-inflammatory and anti-viral properties make it a promising candidate in the fight against this pandemic. We are also very
encouraged by the level of interest in Namodenoson in the treatment of NAFLD/NASH from the scientific and business communities."
Revenues for the nine months ended September
30, 2020 were $0.61 million compared with $1.84 million for the same period of 2019. The decrease in revenues was mainly due to
the recognition of a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals,
and Cipher Pharmaceuticals.
Research and development expenses for the
nine months ended September 30, 2020 were $9.05 million compared with $7.01 million for the same period of 2019. Research and development
expenses for the nine months ended September 30, 2020 comprised primarily of expenses associated with the Phase II studies for
Namodenoson in the treatment of NASH and HCC, as well as expenses for ongoing Phase III studies of Piclidenoson in the treatment
of rheumatoid arthritis and psoriasis. The increase is primarily due to increased costs associated with the accelerating rate of
absorption of patients for the Phase III clinical trial of Piclidenoson for the treatment of rheumatoid arthritis and for psoriasis
General and administrative expenses were
$2.14 million for the nine months ended September 30, 2020 compared to $2.22 million for the same period in 2019. The decrease
is primarily due to a decrease in professional services and travel expenses which was partly offset by an increase in salaries
and related benefits and insurance expenses.
Financial expenses, net for the nine months
ended September 30, 2020 was $0.22 million compared to $0.44 million for the same period in 2019. The decrease in financial expenses,
net is mainly due to fair value revaluation of the investment in Wize Pharma Inc's shares which is classified under short
Can-Fite's net loss for the nine months
ended September 30, 2020 was $10.81 million compared with a net loss of $7.84 million for the same period in 2019. As of September
30, 2020, Can-Fite had cash and cash equivalents of $10.22 million as compared to $2.69 million at December 31, 2019. The increase
in cash during the nine months ended September 30, 2020 is due to an aggregate of $17.68 million net proceeds received through
a warrant exercise transaction in January 2020, a public offering in February 2020, partial exercises in March, April and May 2020
of warrants issued in the February 2020 public offering, and a registered direct offering in June and July 2020 which was offset
by net cash used in operating activity of $10.16 million.
The Company's consolidated financial results for the nine months
ended September 30, 2020 are presented in accordance with US GAAP Reporting Standards.
Management will host a conference call
today, November 30, 2020 at 9:15 a.m. ET. Investors in the U.S. are invited to dial 877-423-9813. International investors may dial
201-689-8573. The conference ID is 13713545. Investors may also participate via webcast: http://public.viavid.com/index.php?id=142533
A replay of the webcast will be archived
on Can-Fite's website for a period of time.
CONSOLIDATED STATEMENTS OF BALANCE SHEETS
In thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 10,222 | $ | 2,697 | ||||
| Other receivable and prepaid expenses | 2,961 | 4,383 | ||||||
| Short-term investment | 57 | 64 | ||||||
| Total current assets | 13,240 | 7,144 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Other non-current receivables | - | 912 | ||||||
| Operating lease right of use assets | 58 | 82 | ||||||
| Property, plant and equipment, net | 28 | 36 | ||||||
| Total long-term assets | 86 | 1,030 | ||||||
| Total assets | $ | 13,326 | $ | 8,174 |
CONSOLIDATED STATEMENTS OF BALANCE SHEETS
In thousands (except for share and per share data)
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 784 | $ | 2,156 | ||||
| Current maturity of operating lease liability | 34 | 36 | ||||||
| Deferred revenues | 603 | 469 | ||||||
| Other accounts payable | 398 | 610 | ||||||
| Total current liabilities | 1,819 | 3,271 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long-term operating lease liability | 15 | 39 | ||||||
| Deferred revenues | 1,951 | 2,422 | ||||||
| Total long-term liabilities | 1,966 | 2,461 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY: | ||||||||
| Ordinary shares of NIS 0.25 par value - Authorized: 500,000,000 shares at September 30, 2020 and December 31, 2019; Issued and outstanding: 462,419,463 shares as of September 30, 2020; 120,652,683 shares as of December 31, 2019 | 32,936 | 8,225 | ||||||
| Additional paid-in capital | 97,314 | 103,401 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (121,836 | ) | (110,311 | ) | ||||
| Total equity | 9,541 | 2,442 | ||||||
| Total liabilities and equity | $ | 13,326 | $ | 8,174 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)
| Nine months ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| Unaudited | ||||||||
| Revenues | $ | 613 | $ | 1,840 | ||||
| Research and development expenses | (9,055 | ) | (7,016 | ) | ||||
| General and administrative expenses | (2,144 | ) | (2,220 | ) | ||||
| Operating loss | (10,586 | ) | (7,396 | ) | ||||
| Total financial expenses, net | (224 | ) | (445 | ) | ||||
| Net loss | (10,810 | ) | (7,841 | ) | ||||
| Total comprehensive loss | (10,810 | ) | (7,841 | ) | ||||
| Deemed dividend | (715 | ) | - | |||||
| Net loss attributed to ordinary shareholders | $ | (11,525 | ) | $ | (7,841 | ) | ||
| Basic and diluted net loss per share | (0.03 | ) | (0.11 | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 323,360,926 | 74,451,754 |
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, liver, inflammatory disease and COVID-19. The Company's lead drug candidate,