Full Press Release Details
Biotechnology Reports Fourth Quarter and Full Year 2019 Results
Primary Investigational New Drug (IND) Approval in the U.S.; Positioned to Commence Patient Enrollment
Clinical Progress in Israel and Nearing Completion of Phase 1/2 Trial
Commercial Agreement with Canndoc Anticipated to Generate Significant Revenue; Closing of Merger Transaction Progressing as Planned
Aviv, Israel April 3, 2020 - 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, 2019.
achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.,"
commented Dr. Shai Yarkoni, Chief Executive Officer. "We plan to begin enrolling patients for this trial and completing
the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that
our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory.
It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in
the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."
Strategic Development
previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd,
a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR), to
acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated
data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval
by each company's board of directors and definitive agreements.
the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all
of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of
the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party,
negotiation of a definitive agreement, approval of the agreement by the Company's Board of Directors and shareholders, internal
approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis
Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company's
ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest
a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50
on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter
Operating Highlights:
| The Phase 1/2 clinical trial in Israel has successfully recruited 11 of the 12 patients needed to complete the trial, and subject to COVID-19 and resumption of normal activities, , the Company anticipates recruiting the final patient and publishing top line results by the end of 2020. | ||
| Received all the necessary technology and regulatory approvals, including an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to evaluate the safety and tolerability of the ApoGraft technology for haploidentical bone marrow transplantations. | ||
| Prior to the delaying of the Cell & Gene Meeting on the Mediterranean and the International Congress on Autoimmunity due to the ongoing COVID-19 pandemic, the Company was selected to present data via oral presentations, further bolstering the Company's peer-reviewed credentials and growing body of clincal evidence | ||
| Featured article highlighting the safety and tolerability of ApoGraft, Company's novel stem cell selection technology was approved for publication in Bone Marrow Transplantation, a high quality, peer-reviewed journal published monthly by Nature Research and covering all aspects of clinical and bone marrow transplantation | ||
| Expanded intellectual property (IP) portfolio in multiple jurisdictions. The Company now has 65 patent applications worldwide, of which 33 are issued/allowed patents, and plans to continue expanding and protecting its global IP to create further barriers to entry | ||
| Strengthened the balance sheet through a registered direct offering of $7.0 million (February 2019) and a registered direct offering of $3.0 million (January 2020), totaling $10 million, before deducting fees and other offering expenses. |
to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:
Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of
its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is
continuing to perform in-house research, including in the opioid/pain management area.
Quarter and Full Year 2019 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, 2019 (U.S. $1 = NIS 3.456).
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, 2019 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, | ||||||||||||||||||
| 2019 | 2019 | 2018 | 2019 | 2018 | ||||||||||||||||
| Unaudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands, except share and per share data) | ||||||||||||||||||||
| Research and development expenses | 3,508 | 12,122 | 13,513 | 2,571 | 4,040 | |||||||||||||||
| General and administrative expenses | 2,954 | 10,210 | 15,734 | 2,378 | 4,733 | |||||||||||||||
| Operating loss | 6,462 | 22,332 | 29,247 | 4,949 | 8,773 | |||||||||||||||
| Financial expenses (income) due to warrants exercisable into ADS | (2,032 | ) | (7,022 | ) | (7,719 | ) | 998 | (4,784 | ) | |||||||||||
| Other financial expenses (income), net | 433 | 1,498 | (1,415 | ) | 129 | (238 | ) | |||||||||||||
| Total comprehensive loss | 4,863 | 16,808 | 20,113 | 6,076 | 3,751 | |||||||||||||||
| Loss per share: | ||||||||||||||||||||
| Basic and diluted loss per share | 0.023 | 0.079 | 0.155 | 0.027 | 0.029 | |||||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 212,642,505 | 212,642,505 | 129,426,091 | 224,087,799 | 130,274,953 |
| Convenience | ||||||||||||
| translation | ||||||||||||
| December 31, | December 31, | December 31, | ||||||||||
| 2019 | 2019 | 2018 | ||||||||||
| Unaudited | Audited | Audited | ||||||||||
| U.S. dollars | NIS | |||||||||||
| (In thousands, except share and per share data) | ||||||||||||
| ASSETS | ||||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 5,239 | 18,106 | 17,809 | |||||||||
| Other receivables | 136 | 469 | 816 | |||||||||
| 5,375 | 18,575 | 18,625 | ||||||||||
| NON-CURRENT ASSETS: | ||||||||||||
| Restricted cash | 95 | 328 | 337 | |||||||||
| Right of use - Assets under operating lease | 299 | 1,035 | - | |||||||||
| Other long-term assets | 27 | 94 | 132 | |||||||||
| Property, plant and equipment, net | 373 | 1,288 | 1,544 | |||||||||
| 794 | 2,745 | 2,013 | ||||||||||
| 6,169 | 21,320 | 20,638 | ||||||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 46 | 158 | 887 | |||||||||
| Leases liabilities | 115 | 396 | - | |||||||||
| Other payables | 891 | 3,080 | 4,012 | |||||||||
| 1,052 | 3,634 | 4,899 | ||||||||||
| NON-CURRENT LIABILITIES: | ||||||||||||
| Warrants to ADS | 628 | 2,172 | 1,816 | |||||||||
| Leases liabilities | 196 | 677 | - | |||||||||
| 824 | 2,849 | 1,816 | ||||||||||
| EQUITY: | ||||||||||||
| Ordinary shares of no par value: Authorized: 500,000,000 shares at December 31, 2018 and December 31 2019; Issued and outstanding: 130,414,799*) and 224,087,799*) shares as of December 31, 2018 and December 31, 2019, respectively. | - | - | - | |||||||||
| Additional Paid In Capital | 31,423 | 108,598 | 95,085 | |||||||||
| Share-based payments | 4,782 | 16,528 | 12,319 | |||||||||
| Treasury shares | (2,727 | ) | (9,425 | ) | (9,425 | ) | ||||||
| Accumulated deficit | (29,185 | ) | (100,864 | ) | (84,056 | ) | ||||||
| 4,293 | 14,837 | 13,923 | ||||||||||
| 6,169 | 21,320 | 20,638 |
of 2,641,693 treasury shares of the Company held by the Company.
| Convenience | ||||||||||||||||||||
| translation | ||||||||||||||||||||
| Twelve months ended | Twelve months ended | Three months ended | ||||||||||||||||||
| December 31, | December 31, | December 31, | ||||||||||||||||||
| 2019 | 2019 | 2018 | 2019 | 2018 | ||||||||||||||||
| Unaudited | Audited | Audited | Unaudited | Unaudited | ||||||||||||||||
| U.S. dollars | NIS | |||||||||||||||||||
| (In thousands) | ||||||||||||||||||||
| Cash flows from operating activities : | ||||||||||||||||||||
| Total comprehensive loss | (4,863 | ) | (16,808 | ) | (20,113 | ) | (6,076 | ) | (3,751 | ) | ||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||
| Exchange rate difference | 300 | 1,036 | (1,297 | ) | (50 | ) | (380 | ) | ||||||||||||
| Loss (gain) from revaluation of financial assets presented at fair value through profit and loss | - | - | (397 | ) | (8 | ) | (109 | ) | ||||||||||||
| Depreciation of Right of use - Assets under operating lease | 125 | 433 | - | (24 | ) | - | ||||||||||||||
| Depreciation | 108 | 373 | 459 | 88 | 122 | |||||||||||||||
| Finance expenses | 37 | 128 | - | 128 | - | |||||||||||||||
| Issuance expenses | 469 | 1,621 | - | 1,621 | - | |||||||||||||||
| Changes in fair value of traded and non traded warrants to ADS | (2,501 | ) | (8,643 | ) | (7,719 | ) | 708 | (4,511 | ) | |||||||||||
| Share-based payment | 784 | 2,708 | 4,537 | 807 | 1,290 | |||||||||||||||
| Decrease (increase) in other receivables | 111 | 385 | 43 | 239 | (214 | ) | ||||||||||||||
| Increase (decrease) in other payables | (481 | ) | (1,663 | ) | 798 | 192 | 1,505 | |||||||||||||
| Interest received | 27 | 93 | 54 | 168 | 7 | |||||||||||||||
| Net cash used in operating activities | (5,884 | ) | (20,337 | ) | (23,635 | ) | (2,207 | ) | (6,041 | ) | ||||||||||
| Cash flows from investing activities: | ||||||||||||||||||||
| Short term deposits, net | - | - | 387 | - | 105 | |||||||||||||||
| Restricted deposit, net | 3 | 9 | (22 | ) | 9 | - | ||||||||||||||
| Proceeds received from the sale of fixed assets | 2 | 6 | 6 | |||||||||||||||||
| (Purchase) Sales of marketable securities measured at fair value through profit and loss | - | - | 13,999 | - | - | |||||||||||||||
| Purchase of property, plant and equipment | (36 | ) | (123 | ) | (656 | ) | (3 | ) | (13 | ) | ||||||||||
| Net cash provided by investing activities | (31 | ) | (108 | ) | 13,708 | 12 | 92 | |||||||||||||
| Cash flows from financing activities: | ||||||||||||||||||||
| Exercise of warrants and stock options into shares | - | - | 399 | - | - | |||||||||||||||
| Repayment on account of lease liabilities | (151 | ) | (522 | ) | - | (101 | ) | - | ||||||||||||
| Issue of share capital and warrants, net of issue costs | 6,479 | 22,393 | 12,360 | (1,330 | ) | - | ||||||||||||||
| Net cash provided (used) by financing activities | 6,328 | 21,871 | 12,759 | (1,431 | ) | - | ||||||||||||||
| Exchange differences on balances of cash and cash equivalents | (327 | ) | (1,129 | ) | 1,243 | (117 | ) | 373 | ||||||||||||
| Increase (decrease) in cash and cash equivalents | 86 | 297 | 4,075 | (3,743 | ) | (5,576 | ) | |||||||||||||
| Balance of cash and cash equivalents at the beginning of the period | 5,153 | 17,809 | 13,734 | 21,849 | 23,385 | |||||||||||||||
| Balance of cash and cash equivalents at the end of the period | 5,239 | 18,106 | 17,809 | 18,106 | 17,809 |