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Thursday, May 26, 2022 8:06:37 AM
https://finance.yahoo.com/news/fite-reports-first-quarter-2022-110000598.html
PETACH TIKVA, Israel, May 26, 2022--(BUSINESS WIRE)--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 quarter ended March 31, 2022.
Corporate and Clinical Development Highlights Include:
Fortified Balance Sheet - On March 31, 2022, Can-Fite had approximately $16.5 million in cash, cash equivalents, and short-term deposits.
Phase III Psoriasis Study Data Expected Q2 2022 – Topline results are expected in Q2 2022 in Can-Fite’s Phase III Comfort™ psoriasis study for both its 16 week primary endpoint and 32 week secondary endpoint. The study is designed to establish Piclidenoson’s superiority compared to placebo at 16 weeks and non-inferiority compared to Apremilast (Otezla®) at 32 weeks. During the first quarter, a preclinical study showed Piclidenoson destroyed pathological skin cells, offering further evidence of potential efficacy in psoriasis.
Developing Topical Psoriasis Treatment - In a preclinical model, daily treatment with topical Piclidenoson significantly inhibited psoriasis as measured by the psoriasis area severity index (PASI) calculated based on observation of erythema, thickness, scaling, and a score of skin lesions. The topical treatment may serve as a complementary product to oral Piclidenoson.
Commenced Enrollment in Phase IIb NASH Study – In January, Can-Fite enrolled the first patient in its Phase IIb multicenter, randomized, double-blind, placebo-controlled study in 140 subjects with biopsy-confirmed NASH. The primary objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo as determined by a histological endpoint. In a prior Phase IIa study, Namodenoson met its primary endpoint by reducing liver fat, inhibiting fibrosis, and demonstrating an anti-inflammatory effect.
Granted U.S. Patent for Liver Fibrosis and Israeli Patent for NASH – The U.S. Patent and Trademark Office granted Can-Fite a patent for its invention titled "Method for Treating Fibrotic Liver Tissue Using CL-IB MECA", a broad patent that addresses markets for the treatment of all advanced liver fibrosis indications. The patent opens an opportunity for much broader market needs which entail all clinical conditions with advanced liver fibrosis including autoimmune hepatitis, primary biliary cirrhosis (PBC), nonalcoholic fatty liver disease (NAFLD), and alcoholic liver disease (ALD) among others. The Israel Patent Office granted Can-Fite a patent titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation" which has been issued in approximately 40 other countries.
Opened Enrollment in Pivotal Phase III Liver Cancer Study – Can-Fite’s pivotal Phase III liver cancer study for Namodenoson opened for enrollment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies. An interim analysis will be conducted after 50% of patients are enrolled and treated. The primary endpoint is overall survival. Can-Fite has received Orphan Drug Designation in both the U.S. and Europe and has received the U.S. FDA’s Fast Track Status.
Presented Data on Cannabinoids in the Treatment of Liver Cancer at CannX – In March, Can-Fite delivered a presentation titled "Inhibition of Hepatocellular Carcinoma Growth and Liver Fibrosis by Nanomolar Cannabinoids Concentrations" at the CannX Medical Cannabis Conference in Tel Aviv. The findings were also published in the peer-reviewed scientific journal Medical Cannabis and Cannabinoids highlighting the ability of CBD-rich T3/C15 in nanomolar concentrations to inhibit the growth of hepatocellular carcinoma and liver stellate cells via A3AR activation and deregulation of the Wnt/ß-catenin pathway.
"We look forward to announcing Phase III psoriasis results before the end of the second quarter as we enroll patients in our other advanced stage clinical trials for NASH and liver cancer," stated Can-Fite CEO Dr. Pnina Fishman. "Can-Fite is financially well positioned to conduct all our clinical development programs over the next year, and we continue to evaluate potential new distribution partnerships which may provide additional non-dilutive funding."
Financial Results
Revenues for the three months ended March 31, 2022 were $0.20 million, an increase of $0.05 million, or 38.5%, compared to $0.15 million for the three months ended March 31, 2021. The increase in revenues was mainly due to the recognition of a higher portion of advance payments received under a distribution agreement with Ewopharma than the advance payment received at the end of the first quarter of 2021.
Research and development expenses for the three months ended March 31, 2022 were $1.82 million, an increase of $0.52 million, or 39.8%, compared to $1.30 million for the three months ended March 31, 2021. Research and development expenses for the first quarter of 2022 comprised primarily of expenses associated with an ongoing Phase III study of Piclidenoson for the treatment of psoriasis and two studies for Namodenoson, a Phase III study in the treatment of liver cancer and a Phase IIb study for NASH. The increase is primarily due to costs incurred in the first quarter of 2022 associated with the two new studies for Namodenoson.
General and administrative expenses for the three months ended March 31, 2022 were $0.75 million a decrease of $0.26 million, or 25.8%, compared to $1.01 million for the three months ended March 31, 2021. The decrease is primarily due to the decrease in professional services for public relations and investor relations. We expect that general and administrative expenses will remain at the same level through 2022.
Financial expenses, net for the three months ended March 31, 2022 were $0.06 million compared to finance income, net of $0.29 million for the three months ended March 31, 2021. The decrease in financial income, net was mainly due to revaluation of our short-term investment which in 2021 was recorded as income and in 2022 was recorded as expense.
Net loss for the three months ended March 31, 2022 was $2.43 million compared with a net loss of $1.87 million for the three months ended March 31, 2021. The increase in net loss for the three months ended March 31, 2022 was primarily attributable to an increase in research and development expenses which was partly offset by a decrease in general and administrative expenses and a decrease in finance income, net.
As of March 31, 2022, Can-Fite had cash and cash equivalents and short term deposits of $16.5 million as compared to $18.9 million at December 31, 2021. The decrease in cash during the three months ended March 31, 2022 is due to the ongoing operation of the Company.
The Company's consolidated financial results for the three months ended March 31, 2022 are presented in accordance with US GAAP Reporting Standards.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
March 31, 2022
December 31, 2021
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
5,504
$
4,390
Short term deposit
11,016
14,512
Prepaid expenses and other current assets
971
929
Short-term investment
182
237
Total current assets
17,673
20,068
NON-CURRENT ASSETS:
Operating lease right of use assets
125
138
Property, plant and equipment, net
49
47
Total long-term assets
174
185
Total assets
$
17,487
$
20,253
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
March 31,
2022
December 31, 2021
Unaudited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,124
$
954
Current maturity of operating lease liability
55
53
Deferred revenues
818
818
Other accounts payable
907
905
Total current liabilities
2,904
2,730
NON-CURRENT LIABILITIES:
Long-term operating lease liability
54
71
Deferred revenues
2,865
3,070
Total Long-term liabilities
2,919
3,141
SHAREHOLDERS’ EQUITY
Ordinary shares of NIS 0.25 par value - Authorized: 5,000,000,000 shares at March 31, 2022 and December 31, 2021; Issued and outstanding: 815,746,293 shares as of March 31, 2022 and December 31, 2021
60,654
60,654
Additional paid-in capital
93,351
93,275
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(143,108
)
(140,674
)
Total equity
12,024
14,382
Total liabilities and equity
$
17,847
$
20,253
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Three months ended
March 31,
2022
2021
Unaudited
Revenues
$
205
$
148
Research and development expenses
(1,821
)
(1,303
)
General and administrative expenses
(754
)
(1,016
)
Operating loss
(2,370
)
(2,171
)
Total financial income (expense), net
(64
)
293
Net loss
(2,434
)
(1,878
)
Basic and diluted net loss per share
(0.00
)
(0.00
)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
815,746,293
483,920,313
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