Full Press Release Details
Biotechnology Reports Fourth Quarter and Full Year 2018 Results and Recent Corporate Progress
Execution Positions the Company for Expedited Progress in 2019
Aviv, Israel March 18, 2019 - Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production
technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2018, as well
as recent corporate progress.
made progress in 2018 as we overcame the short-term setback of patient recruitment in our trial in Israel and moved closer to
the initiation of our U.S. clinical efforts," commented Dr. Shai Yarkoni, Chief Executive Officer. "We continue to
validate our innovative science, and the U.S. Food and Drug Administration's (FDA) recent decision to hire at least 50 clinical
assesors to focus on cell and gene therapy companies is precisely why we believe Cellect will be a major beneficiary in the growth
of this sector - companies and academics need to source stem cells from a reliable and cost effective supplier to develop
their therapies over the next decade and we are positioning Cellect's technology to enable that. Operationally, we recently
strengthened our balance sheet through an underwritten public offering, securing interest from sophisticated healthcare investors
and participation from senior executives from Cellect, which reflects our continued optimism and outlook for 2019. We look forward
to providing an update on our progress in the coming months through a business update conference call."
Operating and Financial Highlights:
Near-Term Milestones:
Results in Israel Continue to Validate the Company's Innovation
Development Initiatives to Drive Commercialization Efforts
Collaboration Agreements
and Enhancing the Company's IP Portfolio
Quarter and Full Year 2018 Financial Results:
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, 2018 (U.S. $1 = NIS 3.748).
Cellect Biotechnology Ltd.
Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that
aims to improve a variety of stem cell-based therapies.
Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly
isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications
in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.
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 intent regarding the future potential of Cellect's
technology. 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: the Company's history of losses
and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or
at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital
needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical
trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community;
difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks
resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate
collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its
ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies
and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability
to retain or attract key employees whose knowledge is essential to the development of its products. 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, 2018 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.
Leibovitz, Chief Financial Officer
Polyviou / Todd Kehrli
Statement of Operation
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Twelve months ended | Twelve months ended | Three months ended | ||||||||||||||||||
| December 31, | December 31, | December 31, | ||||||||||||||||||
| 2018 | 2018 | 2017 | 2018 | 2017 | ||||||||||||||||
| Unaudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||||||
| Research and development expenses | 3,605 | 13,513 | 11,503 | 4,040 | 3,404 | |||||||||||||||
| General and administrative expenses | 4,198 | 15,734 | 12,930 | 4,733 | 3,406 | |||||||||||||||
| Operating loss | 7,803 | 29,247 | 24,433 | 8,773 | 6,810 | |||||||||||||||
| Financial expenses (income) due to warrants exercisable into ADS | (2,059 | ) | (7,719 | ) | 3,208 | (4,784 | ) | (3,614 | ) | |||||||||||
| Other financial expenses (income), net | (377 | ) | (1,415 | ) | 583 | (238 | ) | 172 | ||||||||||||
| Total comprehensive loss | 5,367 | 20,113 | 28,224 | 3,751 | 3,368 | |||||||||||||||
| Loss per share: | ||||||||||||||||||||
| Basic and diluted loss per share | 0.041 | 0.155 | 0.252 | 0.029 | 0.028 | |||||||||||||||
| Basic and diluted loss per ADS | 0.82 | 3.11 | 5.04 | 0.58 | 0.56 | |||||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 129,426,091 | 129,426,091 | 111,968,663 | 130,274,953 | 120,011,684 |
| Convenience | ||||||||||||
| translation | ||||||||||||
| December 31, | December 31, | December 31, | ||||||||||
| 2018 | 2018 | 2017 | ||||||||||
| Unudited | Audited | Audited | ||||||||||
| U.S. dollars | NIS | |||||||||||
| (In thousands, except share and per share data) | ||||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 4,752 | 17,809 | 13,734 | |||||||||
| Marketable securities | - | - | 13,999 | |||||||||
| Other receivables | 218 | 816 | 818 | |||||||||
| 4,970 | 18,625 | 28,551 | ||||||||||
| NON-CURRENT ASSETS: | ||||||||||||
| Restricted cash | 90 | 337 | 305 | |||||||||
| Other long-term assets | 35 | 132 | 173 | |||||||||
| Property, plant and equipment, net | 412 | 1,544 | 1,344 | |||||||||
| 537 | 2,013 | 1,822 | ||||||||||
| 5,507 | 20,638 | 30,373 | ||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 237 | 887 | 1,703 | |||||||||
| Other payables | 1,070 | 4,012 | 2,396 | |||||||||
| 1,307 | 4,899 | 4,099 | ||||||||||
| NON-CURRENT LIABILITIES: | ||||||||||||
| Warrants to ADS | 485 | 1,816 | 7,422 | |||||||||
| EQUITY: | ||||||||||||
| Ordinary shares of no par value: | ||||||||||||
| Authorized: 500,000,000 shares at December 31, 2017 and December 31 2018; Issued and outstanding: 120,185,659*) and 130,414,799*) shares as of December 31, 2017 and December 31, 2018, respectively. | - | - | - | |||||||||
| Additional Paid In Capital | 25,370 | 95,085 | 82,839 | |||||||||
| Share-based payments | 3,287 | 12,319 | 9,381 | |||||||||
| Treasury shares | (2,515 | ) | (9,425 | ) | (9,425 | ) | ||||||
| Accumulated deficit | (22,427 | ) | (84,056 | ) | (63,943 | ) | ||||||
| 3,715 | 13,923 | 18,852 | ||||||||||
| 5,507 | 20,638 | 30,373 |
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Twelve months ended | Twelve months ended | Three months ended | ||||||||||||||||||
| December 31, | December 31, | December 31, | ||||||||||||||||||
| 2018 | 2018 | 2017 | 2018 | 2017 | ||||||||||||||||
| Unudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands) | ||||||||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||||||
| Total comprehensive loss | (5,367 | ) | (20,113 | ) | (28,224 | ) | (3,751 | ) | (3,368 | ) | ||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||
| Exchange rate difference | (345 | ) | (1,297 | ) | 532 | (380 | ) | 175 | ||||||||||||
| Loss (gain) from revaluation of financial assets presented at fair value through profit and loss | (106 | ) | (397 | ) | 139 | (109 | ) | (1 | ) | |||||||||||
| Depreciation | 122 | 459 | 372 | 122 | 94 | |||||||||||||||
| Changes in fair value of traded and non traded warrants to ADS | (2,059 | ) | (7,719 | ) | 3,003 | (4,511 | ) | 1,368 | ||||||||||||
| Share-based payment | 1,210 | 4,537 | 5,384 | 1,290 | (3,647 | ) | ||||||||||||||
| Decrease (increase) in other receivables | 12 | 43 | 470 | (214 | ) | 107 | ||||||||||||||
| Increase (decrease) in other payables | 213 | 798 | 407 | 1,505 | 1,040 | |||||||||||||||
| Interest received | 14 | 54 | 147 | 7 | - | |||||||||||||||
| Net cash used in operating activities | (6,306 | ) | (23,635 | ) | (17,770 | ) | (6,041 | ) | (4,232 | ) | ||||||||||
| Cash flows from investing activities: | ||||||||||||||||||||
| Short term deposits, net | 103 | 387 | 19,530 | 105 | - | |||||||||||||||
| Restricted deposit, net | (6 | ) | (22 | ) | (165 | ) | - | 2 | ||||||||||||
| (Purchase) Sales of marketable securities measured at fair value through profit and loss | 3,735 | 13,999 | (9,008 | ) | - | (4,001 | ) | |||||||||||||
| Purchase of property, plant and equipment | (175 | ) | (656 | ) | (266 | ) | (13 | ) | (91 | ) | ||||||||||
| Net cash provided by investing activities | 3,657 | 13,708 | 10,091 | 92 | (4,090 | ) | ||||||||||||||
| Cash flows from financing activities: | ||||||||||||||||||||
| Exercise of warrants and stock options into shares | 106 | 399 | 1,432 | - | 169 | |||||||||||||||
| Issue of share capital and warrants, net of issue costs | 3,299 | 12,360 | 14,381 | - | (510 | ) | ||||||||||||||
| Net cash provided (used) by financing activities | 3,405 | 12,759 | 15,813 | - | (341 | ) | ||||||||||||||
| Exchange differences on balances of cash and cash equivalents | 332 | 1,243 | (679 | ) | 373 | (175 | ) | |||||||||||||
| Increase (decrease) in cash and cash equivalents | 1,088 | 4,075 | 7,455 | (5,576 | ) | (8,838 | ) | |||||||||||||
| Balance of cash and cash equivalents at the beginning of the period | 3,664 | 13,734 | 6,279 | 23,385 | 22,572 | |||||||||||||||
| Balance of cash and cash equivalents at the end of the period | 4,752 | 17,809 | 13,734 | 17,809 | 13,734 |