Full Press Release Details
Reports First Quarter 2016 Financial Results & Provides Clinical Pipeline Update
TIKVA, Israel, 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, today reported
financial results for the three months ended March 31, 2016 and updates on its drug development programs.
Development Program and Corporate Highlights Include:
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.
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
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.
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.
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.
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.
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
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.
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.
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
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).
Company's consolidated financial results for the three months ended March 31, 2016 are presented in accordance with International
Financial Reporting Standards.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
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 |
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
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 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
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 |
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE MKT: 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 CF101 drug candidate is scheduled to enter Phase III trials in 2016 for two indications, rheumatoid arthritis
and psoriasis. Can-Fite's liver cancer drug CF102 is in Phase II trials for patients with liver cancer and is slated to enter
Phase II for the treatment of non-alcoholic steatohepatitis (NASH). CF102 has been granted Orphan Drug Designation in the U.S.
and Europe and Fast Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration.
CF102 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 is being prepared
for an IND submission to the FDA and a Phase I trial. 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 other
things, 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, including, but not limited to, the factors summarized
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.