Full Press Release Details
Cellect Biotechnology
Reports Third Quarter 2019 Financial and Operating Results
Tel Aviv, Israel November 19, 2019 -
Cellect Biotechnology Ltd. (NASDAQ: "APOP"), a developer of innovative technology which enables the functional selection
of stem cells, today reported financial and operating results for the third quarter ended September 30, 2019 and provided a corporate
"Our clinical and regulatory teams remained
focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and
Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement
and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical
study of ApoGraft is progressing slowly and we expect to complete the recruitment around the end of the year."
"With our prudent use of cash during
the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to
execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.
Third Quarter 2019 Financial Results:
* For the convenience of the reader, the amounts
above have been translated from NIS into U.S. dollars, at the representative rate of exchange on September 30, 2019 (U.S. $1 =
Strategic Review Progress Update
On May 16, 2019, the Company disclosed that
it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be
evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than
the Company's in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to
evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (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
The 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.
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. 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; or maintain its current
operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current
efforts to explore new strategic alternatives; 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.
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
Cellect Biotechnology
Consolidated Statement
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Nine months ended | Nine months ended | Three months ended | ||||||||||||||||||
| September 30, | September 30, | September 30, | ||||||||||||||||||
| 2019 | 2019 | 2018 | 2019 | 2018 | ||||||||||||||||
| Unaudited | Unaudited | |||||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||||||
| Research and development expenses | 2,743 | 9,551 | 9,473 | 2,465 | 4,125 | |||||||||||||||
| General and administrative expenses | 2,249 | 7,832 | 11,001 | 2,768 | 3,929 | |||||||||||||||
| Operating loss | 4,992 | 17,383 | 20,474 | 5,233 | 8,054 | |||||||||||||||
| Financial expenses (income) due to warrants exercisable into shares | (2,303 | ) | (8,020 | ) | (2,935 | ) | (910 | ) | (1,320 | ) | ||||||||||
| Other financial expenses (income), net | 393 | 1,369 | (1,177 | ) | 489 | 64 | ||||||||||||||
| Total comprehensive loss | 3,082 | 10,732 | 16,362 | 4,812 | 6,798 | |||||||||||||||
| Loss per share: | ||||||||||||||||||||
| Basic and diluted loss per share | 0.015 | 0.051 | 0.127 | 0.021 | 0.052 | |||||||||||||||
| Basic and diluted loss per ADS | 0.30 | 1.02 | 2.54 | 0.42 | 1.04 | |||||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 208,771,303 | 208,771,303 | 129,139,278 | 224,087,799 | 130,192,799 |
Cellect Biotechnology Ltd.
Consolidated Balance
| Convenience | ||||||||||||
| translation | ||||||||||||
| September 30, | September 30, | December 31, | ||||||||||
| 2019 | 2019 | 2018 | ||||||||||
| Unaudited | Unaudited | Audited | ||||||||||
| U.S. dollars | NIS | |||||||||||
| (In thousands, except share and per share data) | ||||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 6,275 | 21,849 | 17,809 | |||||||||
| Other receivables | 201 | 700 | 816 | |||||||||
| 6,476 | 22,549 | 18,625 | ||||||||||
| NON-CURRENT ASSETS: | ||||||||||||
| Restricted cash | 94 | 329 | 337 | |||||||||
| Right-of-use assets | 332 | 1,156 | - | |||||||||
| Other long-term receivables | 30 | 103 | 132 | |||||||||
| Property, plant and equipment, net | 396 | 1,379 | 1,544 | |||||||||
| 852 | 2,967 | 2,013 | ||||||||||
| 7,328 | 25,516 | 20,638 |
SHAREHOLDERS' EQUITY
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 245 | 852 | 887 | |||||||||
| Other payables | 629 | 2,192 | 4,012 | |||||||||
| Current maturities of lease liability | 123 | 428 | - | |||||||||
| 997 | 3,472 | 4,899 | ||||||||||
| NON-CURRENT LIABILITIES: | ||||||||||||
| Warrants | 808 | 2,812 | 1,816 | |||||||||
| Lease liability | 219 | 764 | - | |||||||||
| 1,027 | 3,576 | 1,816 | ||||||||||
| EQUITY: | ||||||||||||
| Ordinary shares of no par value: | ||||||||||||
| Authorized: 500,000,000 shares at December 31, 2018 and 10,000,000 shares at September 30, 2019; Issued and outstanding: 130,414,799*) and 224,087,799*) shares as of December 31, 2018 and September 30, 2019, respectively. | - | - | - | |||||||||
| Additional Paid in Capital | 31,104 | 108,305 | 95,085 | |||||||||
| Share-based payments | 4,129 | 14,375 | 12,319 | |||||||||
| Treasury shares | (2,707 | ) | (9,425 | ) | (9,425 | ) | ||||||
| Accumulated deficit | (27,222 | ) | (94,787 | ) | (84,056 | ) | ||||||
| 5,304 | 18,468 | 13,923 | ||||||||||
| 7,328 | 25,516 | 20,638 |
of 2,641,693 treasury shares of the Company held by the Company.
Cellect Biotechnology
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Nine months ended | Nine months ended | Three months ended | ||||||||||||||||||
| September 30, | September 30, | September 30, | ||||||||||||||||||
| 2019 | 2019 | 2018 | 2019 | 2018 | ||||||||||||||||
| Unaudited | Unaudited | |||||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands) | ||||||||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||||||
| Total comprehensive loss | (3,082 | ) | (10,732 | ) | (16,362 | ) | (4,812 | ) | (6,798 | ) | ||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||
| Net financing expenses | 312 | 1,087 | (823 | ) | 272 | 14 | ||||||||||||||
| Loss (gain) from revaluation of financial assets presented at fair value through profit and loss | 2 | 8 | (288 | ) | 2 | (140 | ) | |||||||||||||
| Depreciation | 82 | 285 | 337 | 93 | 122 | |||||||||||||||
| Changes in fair value of traded and not traded warrants | (2,686 | ) | (9,351 | ) | (3,208 | ) | (910 | ) | (1,320 | ) | ||||||||||
| Share-based payment | 546 | 1901 | 3,247 | 1,371 | 1,063 | |||||||||||||||
| Decrease (increase) in other receivables | 42 | 146 | 256 | - | 343 | |||||||||||||||
| Increase (decrease) in other payables | (533 | ) | (1,855 | ) | (706 | ) | (1,138 | ) | 409 | |||||||||||
| Decrease in right-of-use assets | 131 | 457 | - | 143 | - | |||||||||||||||
| Interest received during the period | (21 | ) | (75 | ) | (47 | ) | (29 | ) | (32 | ) | ||||||||||
| Net cash used in operating activities | (5,207 | ) | (18,129 | ) | (17,594 | ) | (5,008 | ) | (6,339 | ) | ||||||||||
| Cash flows from investing activities: | ||||||||||||||||||||
| Short term deposits, net | - | - | 282 | - | 3,785 | |||||||||||||||
| Restricted deposit, net | - | - | (22 | ) | - | 6 | ||||||||||||||
| Sales of marketable securities measured at fair value through profit and loss | - | - | 13,999 | - | 5,501 | |||||||||||||||
| Purchase of property, plant and equipment | (34 | ) | (120 | ) | (643 | ) | - | (415 | ) | |||||||||||
| Net cash provided by investing activities | (34 | ) | (120 | ) | 13,616 | - | 8,877 | |||||||||||||
| Cash flows from financing activities: | ||||||||||||||||||||
| Exercise of warrants and stock options into shares | - | - | 399 | - | - | |||||||||||||||
| Leases liabilities | (121 | ) | (422 | ) | - | (143 | ) | - | ||||||||||||
| Issue of share capital and warrants, net of issue costs | 6,813 | 23,723 | 12,360 | - | - | |||||||||||||||
| Net cash provided (used) by financing activities | 6,692 | 23,301 | 12,759 | (143 | ) | - | ||||||||||||||
| Exchange differences on balances of cash and cash equivalents | (291 | ) | (1,012 | ) | 870 | (243 | ) | 18 | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 1,160 | 4,040 | 9,651 | (5,394 | ) | 2,556 | ||||||||||||||
| Balance of cash and cash equivalents at the beginning of the period | 5,115 | 17,809 | 13,734 | 27,243 | 20,829 | |||||||||||||||
| Balance of cash and cash equivalents at the end of the period | 6,275 | 21,849 | 23,385 | 21,849 | 23,385 |