TEL AVIV, Israel, March 23, 2017 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ:APOP) (TASE:APOP), a developer of innovative technology which enables the functional selection of stem cells, today provided a corporate update and announced financial results for the fourth quarter and full year ended December 31, 2016.
“We are very pleased with our accomplishments in the fourth quarter and the full year of 2016," said Dr. Shai Yarkoni, Chief Executive Officer. “During the fourth quarter, we inspected and qualified a clean room at the Rambam Hospital, our Phase I/II clinical site; completed collecting samples of healthy volunteers and optimized the clinical process; presented at the world Stem Cell Summit in Florida; and initiated a series of Non-Deal Road Shows (NDRS) in the U.S. and Europe in order to increase the awareness of Cellect Biotechnology among investors and analysts in those financial markets, which we expect to continue in 2017. Moreover, we were pleased to strengthen the management team of the company by hiring a new Chief Financial Officer and Chief Development Officer, both bringing years of experience in the U.S. and Israeli financial communities and the research and development of the stem cell industry, respectively."
“Overall, during 2016, we received the Israeli Ministry of Health’s approval to begin a Phase I/II clinical trial in leukemia patients to evaluate the safety and efficacy of Cellect’s cell selection technology, and received the approval of the board of the BIRD Foundation for a $1.8 million budget for the joint development project of our ApoTainer together with Entegris, our strategic partner, of which its final agreement is expected to be signed during Q1-17. We were also pleased to complete a U.S. IPO with a NASDAQ listing, raising $8.4 million before related expenses and we believe that we have sufficient funds to expedite our development plan and conclude the clinical trial," continued Dr. Yarkoni.
"We believe Cellect’s transformative approach to cell selection represents a significant breakthrough in the ability to achieve much better stem cell preparation, for whatever use. Production of transplantation material devoid of mature immune cell populations has shown a great promise for reducing the significant risks associated with bone marrow transplantation,” continued Dr. Yarkoni. “With this continued development progress, and our recent U.S. IPO, Cellect has never been in a stronger operating position. Our focus remains on creating long-term value for our shareholders.”
Recent corporate highlights:
Fourth Quarter and Full Year 2016 Financial Results:
Balance Sheet Highlights:
For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2016 (U.S. $1 = NIS 3.845).
About Cellect Biotechnology Ltd.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (NASDAQ:APOPW) (TASE:APOP). The Company is developing an innovative technology which enables the functional selection of stem cells based on their sensitivity to apoptosis. This functional-based selection is a breakthrough technology in the ability to isolate stem cells from any given tissue, and may improve a variety of stem cells applications.
The Company’s first planned product line is expected to include unique containers for cell selection in an apoptosis-inducing microenvironment. Cellect’s first planned commercial product candidate is a medical kit designed for the bone marrow transplantations market, as well as other markets which require cell selection. The Company plans that in the future its technology will be integrated in many production procedures of stem cell-based products.
Forward Looking Statements
This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect’s expectation to continue NDRS in 2017, Cellect’s belief that its transformative approach to cell selection represents a significant breakthrough in the ability to achieve much better stem cell preparation, Cellect’s intent to voluntarily delist from the Tel Aviv Stock Exchange, that Cellect has developed a breakthrough technology for the isolation of stem cells from any given tissue that aims to improve a variety of stem cells applications, that the BIRD agreement will be finalize and executed and timing thereof and that Cellect’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells for in quantity and quality that will allow stems cell related treatments and procedures. These forward-looking statements and their implications are based on the current expectations of the management of the Company only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
Cellect Biotechnology Ltd | |||||||||||||
Consolidated Statement of Operation | |||||||||||||
Convenience | |||||||||||||
translation | |||||||||||||
Year ended | Year ended | Three months ended | |||||||||||
December 31, | December 31, | December 31, | |||||||||||
2016 | 2016 | 2015 | 2016 | 2015 | |||||||||
Unaudited | Audited | Audited | Unaudited | Unaudited | |||||||||
U.S. dollars | NIS | ||||||||||||
(In thousands, except share and per share data) | |||||||||||||
Research and development expenses | 2,147 | 8,256 | 5,893 | 2,518 | 1,820 | ||||||||
General and administrative expenses | 2,072 | 7,968 | 4,204 | 1,721 | 1,835 | ||||||||
Other income | (73 | ) | (280 | ) | - | - | - | ||||||
Operating loss | 4,146 | 15,944 | 10,097 | 4,239 | 3,655 | ||||||||
Financial (income) due to Traded Warrants to ADS | (159 | ) | (612 | ) | - | (1,144 | ) | - | |||||
Other financial expenses (income), net | (4 | ) | (15 | ) | 75 | (213 | ) | 30 | |||||
Total comprehensive loss | 3,983 | 15,317 | 10,172 | 2,882 | 3,685 | ||||||||
Loss per share: | |||||||||||||
Basic and diluted loss per share | 0.044 | 0.168 | 0.137 | 0.027 | 0.048 | ||||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share | 91,128,516 | 91,128,516 | 74,475,109 | 107,583,485 | 75,989,903 | ||||||||
Cellect Biotechnology Ltd | ||||||||||
Consolidated Balance Sheet Data | ||||||||||
ASSETS | ||||||||||
Convenience | ||||||||||
translation | ||||||||||
December 31, | December 31, | December 31, | ||||||||
2016 | 2016 | 2015 | ||||||||
Unaudited | Audited | Audited | ||||||||
U.S. dollars | NIS | |||||||||
(In thousands, except share and per share data) | ||||||||||
CURRENT ASSETS: | ||||||||||
Cash and cash equivalents | 1,633 | 6,279 | 3,913 | |||||||
Short term deposits | 5,113 | 19,660 | - | |||||||
Marketable securities | 1,300 | 4,997 | 7,829 | |||||||
Accounts receivable | 380 | 1,461 | 412 | |||||||
8,426 | 32,397 | 12,154 | ||||||||
NON-CURRENT ASSETS: | ||||||||||
Restricted cash | 36 | 140 | 20 | |||||||
Property, plant and equipment, net | 357 | 1,373 | 1,187 | |||||||
393 | 1,513 | 1,207 | ||||||||
8,819 | 33,910 | 13,361 | ||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||
CURRENT LIABILITIES: | ||||||||||
Trade payables | 364 | 1,401 | 466 | |||||||
Other accounts payable | 542 | 2,084 | 2,394 | |||||||
906 | 3,485 | 2,860 | ||||||||
NON-CURRENT LIABILITIES: | ||||||||||
Traded Warrants to ADS | 504 | 1,938 | - | |||||||
EQUITY: | ||||||||||
Ordinary shares of no par value: | ||||||||||
Authorized: 500,000,000 shares at December 31, 2015, and 2016, Issued and outstanding: 75,949,888*) and 107,583,485*) shares as of December 31, 2015 and 2016, respectively. | - | - | - | |||||||
Share premium | 17,533 | 67,414 | 36,725 | |||||||
Share-based payments | 1,617 | 6,217 | 3,603 | |||||||
Treasury shares | (2,451 | ) | (9,425 | ) | (9,425 | ) | ||||
Accumulated deficit | (9,290 | ) | (35,719 | ) | (20,402 | ) | ||||
7,409 | 28,487 | 10,501 | ||||||||
8,819 | 33,910 | 13,361 | ||||||||
*) Net of 2,686,693 treasury shares of the Company held by the Company.
Cellect Biotechnology Ltd | ||||||||||||||||
Consolidated Cash Flow Data | ||||||||||||||||
Convenience | ||||||||||||||||
translation | ||||||||||||||||
Year ended | Year ended | Three months ended | ||||||||||||||
December 31, | December 31, | December 31, | ||||||||||||||
2016 | 2016 | 2015 | 2016 | 2015 | ||||||||||||
Unaudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||
U.S. dollars | NIS | |||||||||||||||
(In thousands) | ||||||||||||||||
Cash flows from operating activities: | ||||||||||||||||
Net loss | (3,983 | ) | (15,317 | ) | (10,172 | ) | (2,882 | ) | (3,685 | ) | ||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||
Financial expenses, net | 35 | 134 | 69 | (12 | ) | 33 | ||||||||||
Loss (gain) from revaluation of financial assets presented at fair value through profit and loss | (28 | ) | (106 | ) | (2 | ) | (142 | ) | 1 | |||||||
Depreciation | 91 | 350 | 71 | 123 | 31 | |||||||||||
Changes in fair value of Traded Warrants to ADS | (321 | ) | (1,235 | ) | - | (1,158 | ) | - | ||||||||
Share-based payment | 404 | 1,552 | 1,318 | (534 | ) | 544 | ||||||||||
Increase in accounts receivable | (273 | ) | (1,049 | ) | (328 | ) | (306 | ) | (144 | ) | ||||||
Increase in accounts payable | 327 | 1,259 | 1,333 | 664 | 1,020 | |||||||||||
Interest received | - | - | 1 | - | - | |||||||||||
Net cash used in operating activities | (3,748 | ) | (14,412 | ) | (7,710 | ) | (4,247 | ) | (2,200 | ) | ||||||
Cash flows from investing activities: | ||||||||||||||||
Proceeds from the sale of property, plant and equipment | 25 | 95 | 77 | - | - | |||||||||||
Short term deposits | (5,079 | ) | (19,530 | ) | - | 120 | - | |||||||||
Restricted deposit, | (31 | ) | (120 | ) | - | (120 | ) | - | ||||||||
Marketable securities measured at fair value through profit and loss, Net | 730 | 2,808 | 3,430 | 1,007 | - | |||||||||||
Purchase of property, plant and equipment | (329 | ) | (1,265 | ) | (332 | ) | (82 | ) | (283 | ) | ||||||
Net cash provided by (used in) investing activities | (4,684 | ) | (18,012 | ) | 3,175 | 925 | (283 | ) | ||||||||
Cash flows from financing activities: | ||||||||||||||||
Exercise of stock options | 2 | 7 | 104 | - | - | |||||||||||
Issue of share capital, net of issue costs | 9,081 | 34,917 | 6,292 | (167 | ) | - | ||||||||||
Net cash provided by (used in) financing activities | 9,083 | 34,924 | 6,396 | (167 | ) | - | ||||||||||
Exchange differences on balances of cash and cash equivalents | (35 | ) | (134 | ) | (70 | ) | 12 | (33 | ) | |||||||
Increase (decrease) in cash and cash equivalents | 616 | 2,366 | 1,791 | (3,477 | ) | (2,516 | ) | |||||||||
Balance of cash and cash equivalents at the beginning of the period | 1,018 | 3,913 | 2,122 | 9,756 | 6,429 | |||||||||||
Balance of cash and cash equivalents at the end of the period | 1,634 | 6,279 | 3,913 | 6,279 | 3,913 | |||||||||||