Full Press Release Details
Cellect Biotechnology
Provides Corporate Update and Reports Fourth Quarter and Full Year 2017 Financial Results
Tel Aviv, Israel March 19, 2018 -
Cellect Biotechnology Ltd. (NASDAQ: "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
"We are very pleased with our accomplishments
in the fourth quarter and the full year of 2017," said Dr. Shai Yarkoni, Chief Executive Officer.
"During the fourth quarter, the
Company reported positive results from a 20 patient trial with Tel-Aviv Ichilov Medical Center, in which ApoGraft significantly
improved stem cells derived from fat tissues and the Company announced that Company CEO, Dr. Shai Yarkoni, was chosen to present
Cellect technology and recent advancements at the Bio-Europe 2017 conference in Berlin.
"Overall, during 2017, the Company
announced the treatment of the first blood cancer patient in its ongoing Phase I/II trial of the Company's stem cell technology
ApoGraft and the successful performance of the procedure using the Company's ApoGraft technology; received
a notice of allowance on a key method of treatment patent (Application No. 13/811,374) from the United States Patent & Trademark
Office; announced positive final results from the non-interventional clinical trial of ApoGraft in healthy donors (104 donor
test base); announced that Michael Berelowitz MD., former head, Clinical Development and Medical Affairs, Pfizer Specialty Care
Business Unit, joined Cellect's board of directors; announced that Dr. Corey Cutler, Senior Physician at the world-renowned
U.S. Dana Farber Cancer Institute and an Associate Professor of Medicine at Harvard Medical School, joined the Company's Scientific
and Medical Advisory Board; announced the U.S. Food & Drug Administration (FDA) provided Cellect with pre-Investigational New
Drug (IND) meeting minutes supporting an IND submission in the U.S. for Cellect's flagship product, ApoGraft ; the
Company received a formal notice of Intention to Grant for a patent (Application No. 11751949.6-1466) covering a key method of
treatment from the European Patent Office; the Company received a formal notice of allowance for a patent (Application No. 14/383,288)
covering a key composition of matter and method of use from the US Patent & Trademark Office (USPTO); further to the notices
of allowance received from the USPTO, the Company received further confirmation for grant of its patent by the Russian patent authorities
(Application No. 2014138001) for a key composition of matter and method of use covering various devices using the ApoGraft
for selection of stem cells; announced that the FDA granted Orphan Drug Status to Cellect's ApoGraft for Acute GvHD and
Chronic GvHD; announced a $4.3 million raise in a registered direct offering; completed its voluntary de-listing from the Tel Aviv
Stock Exchange" 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 enriched stem cells material with substantially reduced mature immune cells 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 two registered direct offerings, Cellect is focused on creating long-term value for our
Recent corporate highlights:
Fourth Quarter and Full Year 2017
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 as of December 31, 2017 (U.S. $1 = NIS
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: "APOP",
"APOPW") has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve
a variety of stem cell applications.
The Company's technology is expected
to provide research, hospitals 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 current clinical trial
is aimed at bone marrow transplantations in cancer treatment.
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 belief that its transformative approach to cell selection
represents a significant breakthrough in the ability to achieve much better stem cell preparation. 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, 2017 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.
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
Cellect Biotechnology Ltd.
Consolidated Statement of Operation
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Twelve months ended | Twelve months ended | Three months ended | ||||||||||||||||||
| December 31, | December 31, | December 31, | ||||||||||||||||||
| 2017 | 2017 | 2016 | 2017 | 2016 | ||||||||||||||||
| Unaudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||||||
| Research and development expenses, net | 3,318 | 11,503 | 8,256 | 3,404 | 2,518 | |||||||||||||||
| General and administrative expenses | 3,729 | 12,930 | 7,968 | 3,406 | 1,721 | |||||||||||||||
| Other income | - | - | (280 | ) | - | - | ||||||||||||||
| Total operating loss | 7,047 | 24,433 | 15,944 | 6,810 | 4,239 | |||||||||||||||
| Financial expenses due to warrants exercisable into ADS | 926 | 3,208 | (612 | ) | (3,614 | ) | (1,144 | ) | ||||||||||||
| Other financial expenses (income), net | 168 | 583 | (15 | ) | 172 | (213 | ) | |||||||||||||
| Total comprehensive loss | 8,141 | 28,224 | 15,317 | 3,368 | 2,882 | |||||||||||||||
| Loss per share and ADS: | ||||||||||||||||||||
| Basic and diluted loss per share | 0.073 | 0.252 | 0.168 | 0.028 | 0.027 | |||||||||||||||
| Basic and diluted loss per ADS | 1.46 | 5.04 | 3.36 | 0.56 | 0.54 | |||||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 111,968,663 | 111,968,663 | 91,128,516 | 120,011,684 | 107,583,485 |
Cellect Biotechnology Ltd.
Consolidated Balance Sheet Data
| Convenience | ||||||||||||
| translation | ||||||||||||
| December 31, | December 31, | December 31, | ||||||||||
| 2017 | 2017 | 2016 | ||||||||||
| Unaudited | Audited | Audited | ||||||||||
| U.S. dollars | NIS | |||||||||||
| (In thousands, except share and per share data) | ||||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 3,961 | 13,734 | 6,279 | |||||||||
| Short term deposits | - | - | 19,660 | |||||||||
| Marketable securities | 4,038 | 13,999 | 4,997 | |||||||||
| Other receivables | 236 | 818 | 1,461 | |||||||||
| 8,235 | 28,551 | 32,397 | ||||||||||
| NON-CURRENT ASSETS: | ||||||||||||
| Restricted cash | 88 | 305 | 140 | |||||||||
| Other long-term assets | 50 | 173 | - | |||||||||
| Property, plant and equipment, net | 388 | 1,344 | 1,373 | |||||||||
| 526 | 1,822 | 1,513 | ||||||||||
| 8,761 | 30,373 | 33,910 | ||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 491 | 1,703 | 1,401 | |||||||||
| Other payables | 691 | 2,396 | 2,084 | |||||||||
| 1,182 | 4,099 | 3,485 | ||||||||||
| NON-CURRENT LIABILITIES: | ||||||||||||
| Warrants to ADS | 2,141 | 7,422 | 1,938 | |||||||||
| EQUITY: | ||||||||||||
| Ordinary shares of no par value: Authorized: 500,000,000 shares at December 31, 2016 and 2017; Issued and outstanding: 107,628,485*) and 120,185,659*) shares as of December 31, 2016 and 2017, respectively. | - | - | - | |||||||||
| Additional Paid In Capital | 23,894 | 82,839 | 67,414 | |||||||||
| Share-based payments | 2,706 | 9,381 | 6,217 | |||||||||
| Treasury shares | (2,718 | ) | (9,425 | ) | (9,425 | ) | ||||||
| Accumulated deficit | (18,444 | ) | (63,943 | ) | (35,719 | ) | ||||||
| 5,438 | 18,852 | 28,487 | ||||||||||
| 8,761 | 30,373 | 33,910 |
of 2,641,693 treasury shares of the Company held by the Company.
Cellect Biotechnology Ltd.
Consolidated Cash Flow Data
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Twelve months ended | Twelve months ended | Three months ended | ||||||||||||||||||
| December 31, | December 31, | December 31, | ||||||||||||||||||
| 2017 | 2017 | 2016 | 2017 | 2016 | ||||||||||||||||
| Unaudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands) | ||||||||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||||||
| Total comprehensive loss | (8,141 | ) | (28,224 | ) | (15,317 | ) | (3,368 | ) | (2,882 | ) | ||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||
| Net financing expenses | 154 | 532 | 134 | 175 | (12 | ) | ||||||||||||||
| Loss (gain) from revaluation of financial assets presented at fair value through profit and loss | 40 | 139 | (106 | ) | (1 | ) | (142 | ) | ||||||||||||
| Depreciation | 107 | 372 | 350 | 94 | 123 | |||||||||||||||
| Share-based payment | 1,553 | 5,384 | 1,552 | 1,368 | (534 | ) | ||||||||||||||
| Changes in fair value of traded and not traded warrants to ADS | 866 | 3,003 | (1,235 | ) | (3,647 | ) | (1,158 | ) | ||||||||||||
| Decrease (increase) in other receivables | 136 | 470 | (1,049 | ) | 107 | (306 | ) | |||||||||||||
| Increase in other payables | 117 | 407 | 1,259 | 1,040 | 664 | |||||||||||||||
| Interest received | 42 | 147 | - | - | - | |||||||||||||||
| Net cash used in operating activities | (5,126 | ) | (17,770 | ) | (14,412 | ) | (4,232 | ) | (4,247 | ) | ||||||||||
| Cash flows from investing activities: | ||||||||||||||||||||
| Proceeds received from the sale of fixed assets | - | - | 95 | - | - | |||||||||||||||
| Short term deposits, net | 5,633 | 19,530 | (19,530 | ) | - | 120 | ||||||||||||||
| Restricted deposit | (47 | ) | (165 | ) | (120 | ) | 2 | (120 | ) | |||||||||||
| Marketable securities measured at fair value through profit and loss, net | (2,599 | ) | (9,008 | ) | 2,808 | (4,001 | ) | 1,007 | ||||||||||||
| Purchase of property, plant and equipment | (77 | ) | (266 | ) | (1,265 | ) | (91 | ) | (82 | ) | ||||||||||
| Net cash provided by (used in) investing activities | 2,910 | 10,091 | (18,012 | ) | (4,090 | ) | 925 | |||||||||||||
| Cash flows from financing activities: | ||||||||||||||||||||
| Exercise of warrants and stock options into shares | 414 | 1,432 | 7 | 169 | - | |||||||||||||||
| Issue of share capital and warrants, net of issue costs | 4,148 | 14,381 | 34,917 | (510 | ) | (167 | ) | |||||||||||||
| Net cash provided (used in) by financing activities | 4,562 | 15,813 | 34,924 | (341 | ) | (167 | ) | |||||||||||||
| Exchange differences on balances of cash and cash equivalents | (196 | ) | (679 | ) | (134 | ) | (175 | ) | 12 | |||||||||||
| Increase (decrease) in cash and cash equivalents | 2,150 | 7,455 | 2,366 | (8,838 | ) | (3,477 | ) | |||||||||||||
| Balance of cash and cash equivalents at the beginning of the period | 1,811 | 6,279 | 3,913 | 22,572 | 9,756 | |||||||||||||||
| Balance of cash and cash equivalents at the end of the period | 3,961 | 13,734 | 6,279 | 13,734 | 6,279 |