On May 27, 2016 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, reported financial results for the three months ended March 31, 2016 and updates on its drug development programs (Filing, Q1, Can-Fite BioPharma, 2016, MAY 27, 2016, View Source [SID:1234512832]).
Clinical Development Program and Corporate Highlights Include:
● CF101 – Phase II Glaucoma Results Expected in June; Phase III Trials in Rheumatoid Arthritis & Psoriasis Scheduled to Commence in 2016
In June 2016, Can-Fite plans to report data from a Phase II trial of CF101, conducted by its subsidiary OphthaliX, in the treatment of glaucoma and related syndromes of ocular hypertension.
During the first quarter of 2016, Can-Fite submitted a Phase III trial protocol for CF101 in the treatment of rheumatoid arthritis to the European Medicines Agency (EMA) and is currently expecting EMA input.
On March 7, 2016, Can-Fite presented data at the American Academy of Dermatology’s 74th Annual Meeting in Washington D.C. in a poster titled, "Treatment of Plaque-type Psoriasis with Oral CF101: Data from a Phase II/III Clinical Trial." The Company plans to file a Phase III trial protocol for CF101 in the treatment of psoriasis with the EMA in the first half of 2016 and commence the study by the end of 2016.
● CF102 – Conducting Phase II Trial in Liver Cancer & Plans to Commence Phase II Trial in NASH
Can-Fite continues to enroll and dose patients in its global Phase II liver cancer study in the U.S., Europe, and Israel. Completion of enrollment with approximately 78 patients is expected in the second half of 2016. The Company is preparing to file its Phase II protocol for CF102 in the treatment of non-alcoholic steatohepatitis (NASH), with institutional review boards (IRBs) in the second quarter of 2016.
● CF602 – Reports New Pre-Clinical Data & Preparing to Submit an IND to FDA for Treatment of Sexual Dysfunction
Following the end of the first quarter, in April 2016 Can-Fite reported new data for CF602, showing a statistically significant full recovery from erectile dysfunction after one single dose treatment in a pre-clinical diabetic model.
Can-Fite plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration for a Phase I study of CF602 in the treatment of sexual dysfunction during the fourth quarter of 2016.
"During the first quarter, we made advancements in both our drugs heading into Phase III and our earlier stage indications. For CF101, we look forward to reporting data from our Phase II glaucoma trial and anticipate receiving input from the EMA on our pivotal Phase III rheumatoid arthritis trial in the coming month," stated Can-Fite CEO Dr. Pnina Fishman.
Revenues for the three months ended March 31, 2016 were NIS 0.21 million (U.S. $0.06 million). We did not record any revenues during the three months ended March 31, 2015. The increase in revenue was due to the recognition of a portion of the NIS 5.14 million (U.S. $1.36 million) upfront payment received in March 2015 under the distribution agreement with Cipher Pharmaceuticals.
Research and development expenses for the three months ended March 31, 2016 were NIS 4.08 million (U.S. $1.08 million) compared with NIS 2.33 million (U.S. $0.62 million) for the same period in 2015. Research and development expenses for the first quarter of 2016 comprised primarily of expenses associated with the Phase II study for CF102 as well as expenses for ongoing studies of CF101. The increase is primarily due to costs associated with preparations of the CF101 Phase III studies in the treatment of rheumatoid arthritis and psoriasis.
General and administrative expenses were NIS 2.36 million (U.S. $0.63 million) for the three months ended March 31, 2016 compared to NIS 2.48 million (U.S. $0.66 million) for the same period in 2015. The minimal decrease is primarily due to a reduction in professional services expenses.
Financial income, net for the three months ended March 31, 2016 aggregated NIS 0.44 million (U.S. $0.12 million) compared to financial income, net of NIS 3.3 million (U.S. $0.88 million) for the same period in 2015. The decrease in financial income, net in the first quarter of 2016 was mainly due to a smaller decrease in the fair value of warrants that are accounted as financial liability as compared to the same period in 2015. In addition, the decrease in financial income, net in the first quarter of 2016 was attributable to an increase in expenses due to exchange rate differences as compared to the same period in 2015.
Can-Fite’s net loss for the three months ended March 31, 2016 was NIS 5.79 million (U.S. $1.54 million) compared with a net loss of NIS 1.51 million (U.S. $0.40 million) for the same period in 2015. The increase in net loss for the first quarter of 2016 was primarily attributable to an increase in research and development expenses and a decrease in financial income, net.
As of March 31, 2016, Can-Fite had cash and cash equivalents of NIS 56.61 million (U.S. $15.03 million) as compared to NIS 66.03 million (U.S. $17.53 million) at December 31, 2015. The decrease in cash during the three months ended March 31, 2016 is due to operating expenses.
For the convenience of the reader, the reported NIS amounts have been translated into U.S. dollars, at the representative rate of exchange on March 31, 2016 (U.S. $1 = NIS 3.766).
The Company’s consolidated financial results for the three months ended March 31, 2016 are presented in accordance with International Financial Reporting Standards.
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INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)
Convenience translation into
U.S. dollars
March 31, March 31, December 31,
2016 2016 2015
Unaudited
USD NIS
ASSETS
CURRENT ASSETS:
Cash and cash equivalents 15,032 56,610 66,026
Other receivable and prepaid expenses 1,384 5,213 2,419
Total current assets 16,416 61,823 68,445
NON-CURRENT ASSETS:
Lease deposits 7 27 27
Property, plant and equipment, net 68 254 236
Total long-term assets 75 281 263
Total assets 16,491 62,104 68,708
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
In thousands (except for share and per share data)
Convenience translation into
U.S. dollars
March 31, March 31, December 31,
2016 2016 2015
Unaudited
USD NIS
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables 1,005 3,784 1,803
Deferred revenues 227 857 857
Other accounts payable 843 3,174 4,279
Total current liabilities 2,075 7,815 6,939
NON-CURRENT LIABILITIES:
Warrants exercisable into shares 3,968 14,942 16,725
Deferred revenues 910 3,427 3,641
Severance pay, net 169 636 630
Total long-term liabilities 5,047 19,005 20,996
CONTINGENT LIABILITIES AND COMMITMENTS
EQUITY ATTRIBUTABLE TO EQUITY HOLDERS OF THE COMPANY:
Share capital 1,867 7,030 7,030
Share premium 88,389 332,873 332,873
Capital reserve from share-based payment transactions 5,192 19,552 19,288
Warrants exercisable into shares (series 10-12) 2,385 8,983 8,983
Treasury shares, at cost (964 ) (3,628 ) (3,628 )
Accumulated other comprehensive loss (366 ) (1,380 ) (1,401 )
Accumulated deficit (87,267 ) (328,647 ) (322,876 )
Total equity attributable to equity holders of the Company 9,236 34,783 40,269
Non-controlling interests 133 501 504
Total equity 9,369 35,284 40,773
Total liabilities and equity 16,491 62,104 68,708
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
In thousands (except for share and per share data)
Convenience translation into
U.S. dollars
Three months ended March 31,
2016 2016 2015
Unaudited
USD NIS NIS
Revenues 57 214 -
Research and development expenses 1,083 4,077 2,328
General and administrative expenses 628 2,364 2,476
Operating loss 1,654 6,227 4,804
Finance expenses 382 1,438 18
Finance income (499 ) (1,878 ) (3,316 )
Net loss 1,537 5,787 1,506
Other comprehensive loss (income):
Adjustments arising from translating financial statements of foreign operations (7 ) (26 ) 234
Total comprehensive loss 1,530 5,761 1,740
Net loss attributable to:
Equity holders of the Company 1,533 5,771 1,359
Non-controlling interests 4 16 147
1,537 5,787 1,506
Total comprehensive loss attributable to:
Equity holders of the Company 1,527 5,750 1,551
Non-controlling interests 3 11 189
1,530 5,761 1,740
Net loss per share attributable to equity holders of the Company :
Basic and diluted net loss per share 0.06 0.21 0.06