Cellect Biotechnology Reports Fourth Quarter and Full Year 2020 Financial and Operating Results
29 Mars 2021 - 3:29PM
Cellect Biotechnology Ltd. (NASDAQ: “APOP”), a developer of
innovative technology that enables the functional selection of stem
cells, today reported financial and operating results for the
fourth quarter and full year ended December 31, 2020 and provided a
corporate update.
On March 24, the Company announced a strategic
merger agreement with privately held Quoin Pharmaceuticals, a U.S.
based specialty pharmaceutical company focused on rare and orphan
diseases. Under the terms of the merger agreement, Quoin has
secured $25 million in committed funding from a highly regarded,
institutional healthcare investor. Current Cellect shareholders
will retain approximately 25% of the combined shares before
investment. The merger is expected to close by the end of the
second quarter of 2021. Cellect has also signed an agreement to
sell its wholly-owned subsidiary company, Cellect Biotherapeutics,
to EnCellX, Inc. - a newly founded biotechnology company based in
San-Diego, CA. - to continue the development of Cellect’s
products.
Recent Clinical Highlights
- Due to the COVID-19 pandemic and
the Company decision to shift attention and resources to the U.S.
Phase I clinical trial, which is expected to enroll the first
patient soon, the Company has elected to close the Phase 1/2
clinical trial being performed in Israel earlier than expected,
since recruitment of the 12th and final patient was not assured in
a timely manner.
- To date, Data from the open label
Israel Phase 1/2 clinical trial supports the Company’s optimism as
it extends its clinical program to the U.S. The Company expects to
publish the top line results of the Israel trial in Q2.
“Concurrent with our plans to seek strategic
alternatives to maximize shareholder value, we also remained focus
on advancing our clinical interests in the U.S.,” commented Dr.
Shai Yarkoni, Chief Executive Officer. “We have signed a compelling
business proposition with Quoin and a privately-held U.S.
biotechnology company that allows our current shareholders to
benefit from Quoin’s promising technology and the fruits of
continued progress of our clinical programs as they reach critical
inflections points through the issuance of contingent value rights
to our shareholders in connection with the sale of Cellect
Biotherapeutics.”
Fourth Quarter and Full Year 2020
Financial Results:
- Research and development (R&D)
expenses for the fourth quarter and for the full year of 2020 were
$0.53 million and $1.83 million respectively, compared to $0.80
million in the fourth quarter of 2019 and $3.77 million for the
full year of 2019. The decrease in R&D expenses for the full
year of 2020 as compared to the full year of 2019 resulted from the
reduction in our research and development activities, as we
decreased the number of our employees engaged in research and
related activities.
- General and administrative
(G&A) expenses for the fourth quarter and for the full year of
2020 were $0.67 million and $2.52 million respectively, compared to
$0.74 million in the fourth quarter of 2019 and $3.18 million for
the full year of 2019. The decrease in G&A expenses for the
full year of 2020 as compared to the full year of 2019 resulted
from the reduction in the company activities resulting from a
decrease in the number of employees.
- Finance expenses for the fourth
quarter of 2020 were $0.38 million, and financial expenses were
$1.27 million for the full year of 2020, compared to finance
expenses of $0.35 million in the fourth quarter of 2019 and
financial income of $1.72 million for the full year of 2019,
respectively. The financial expenses in the full year of 2020 as
compared to the financial income in the full year of 2019 is
primarily due to the change in the fair value of the listed
warrants granted in our U.S. initial public offering in 2016 and of
the unregistered warrants granted in our registered direct
offerings in 2019.
- Total Comprehensive loss for the
fourth quarter and for the full year of 2020 was $1.58 million and
$5.62 million respectively, or $0.004 per share for the fourth
quarter and $0.015 per share for the full year of 2020,
respectively, compared to $1.89 million, or $0.008 per share, in
the fourth quarter of 2019 and $5.23 million, or $0.025 per share,
for the full year of 2019.
* 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 December 31, 2020 (U.S. $1 = NIS
3.215).
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 cell-based
therapies.
The Company’s technology is expected to provide
researchers, clinicians and pharmaceutical companies with the tools
to rapidly isolate specific cells in quantity and quality, allowing
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, 2020
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.
ContactCellect Biotechnology
Ltd.Eyal Leibovitz, Chief Financial
Officerwww.cellect.co+972-9-974-1444
Or
EVC Group LLCMichael Polyviou(732)
933-2754mpolyviou@evcgroup.com
Cellect Biotechnology LtdConsolidated Statement
of Operation
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve months ended |
|
|
Twelve months ended |
|
|
Three months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
Unaudited |
|
|
Audited |
|
|
Audited |
|
|
Unaudited |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars |
|
|
NIS |
|
|
|
|
|
|
|
|
|
|
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
1,830 |
|
|
|
5,883 |
|
|
|
12,122 |
|
|
|
1,693 |
|
|
|
2,571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
2,523 |
|
|
|
8,111 |
|
|
|
10,210 |
|
|
|
2,167 |
|
|
|
2,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
4,353 |
|
|
|
13,994 |
|
|
|
22,332 |
|
|
|
3,860 |
|
|
|
4,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses (income) due to warrants exercisable into
ADS |
|
|
846 |
|
|
|
2,721 |
|
|
|
(7,022 |
) |
|
|
4 |
|
|
|
998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other financial expenses (income), net |
|
|
424 |
|
|
|
1,362 |
|
|
|
1,498 |
|
|
|
1,224 |
|
|
|
129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
5,623 |
|
|
|
18,077 |
|
|
|
16,808 |
|
|
|
5,088 |
|
|
|
6,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
|
0.015 |
|
|
|
0.049 |
|
|
|
0.079 |
|
|
|
0.013 |
|
|
|
0.027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding used to compute basic
and diluted loss per share |
|
|
368,078,786 |
|
|
|
368,078,786 |
|
|
|
212,642,505 |
|
|
|
390,949,079 |
|
|
|
224,087,799 |
|
Cellect Biotechnology LtdConsolidated Balance
Sheet Data
|
|
Convenience |
|
|
|
|
|
|
|
|
|
translation |
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2020 |
|
|
2019 |
|
|
|
Unaudited |
|
|
Audited |
|
|
Audited |
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars |
|
|
NIS |
|
|
|
|
|
|
|
|
ASSETS |
|
(In thousands, except share and per share
data) |
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
5,277 |
|
|
|
16,964 |
|
|
|
18,106 |
|
Other receivables |
|
|
88 |
|
|
|
284 |
|
|
|
469 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,365 |
|
|
|
17,248 |
|
|
|
18,575 |
|
NON-CURRENT ASSETS: |
|
|
|
|
|
|
|
|
|
|
|
|
Restricted cash |
|
|
100 |
|
|
|
322 |
|
|
|
328 |
|
Right of use - Assets under operating lease |
|
|
219 |
|
|
|
705 |
|
|
|
1,035 |
|
Other long-term assets |
|
|
22 |
|
|
|
72 |
|
|
|
94 |
|
Property, plant and equipment, net |
|
|
384 |
|
|
|
1,232 |
|
|
|
1,288 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
725 |
|
|
|
2,331 |
|
|
|
2,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,090 |
|
|
|
19,579 |
|
|
|
21,320 |
|
LIABILITIES ANDSHAREHOLDERS’
EQUITY |
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Trade payables |
|
|
121 |
|
|
|
389 |
|
|
|
158 |
|
Leases liabilities |
|
|
115 |
|
|
|
369 |
|
|
|
396 |
|
Other payables |
|
|
693 |
|
|
|
2,228 |
|
|
|
3,080 |
|
|
|
|
929 |
|
|
|
2,986 |
|
|
|
3,634 |
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to ADS |
|
|
380 |
|
|
|
1,222 |
|
|
|
2,172 |
|
Leases liabilities |
|
|
122 |
|
|
|
391 |
|
|
|
677 |
|
|
|
|
502 |
|
|
|
1,613 |
|
|
|
2,849 |
|
EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares of no par value: |
|
|
|
|
|
|
|
|
|
|
|
|
Authorized: 500,000,000 shares at December 31, 2019 and
December 31 2020; Issued and outstanding: 224,087,799*) and
390,949,079*) shares as of December 31, 2019 and December 31, 2020,
respectively. |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Additional Paid In Capital |
|
|
39,452 |
|
|
|
126,838 |
|
|
|
108,598 |
|
Share-based payments |
|
|
5,135 |
|
|
|
16,508 |
|
|
|
16,528 |
|
Treasury shares |
|
|
(2,932 |
) |
|
|
(9,425 |
) |
|
|
(9,425 |
) |
Accumulated deficit |
|
|
(36,996 |
) |
|
|
(118,941 |
) |
|
|
(100,864 |
) |
|
|
|
4,659 |
|
|
|
14,980 |
|
|
|
14,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,090 |
|
|
|
19,579 |
|
|
|
21,320 |
|
|
*) |
Net of 2,641,693 treasury shares of the Company held by the
Company. |
Cellect Biotechnology LtdConsolidated Cash Flow
Data
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve months ended |
|
|
Twelve months ended |
|
|
Three months ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
Unaudited |
|
|
Audited |
|
|
Audited |
|
|
Unaudited |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. dollars |
|
|
NIS |
|
|
|
|
|
|
(In thousands) |
|
Cash flows from
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
(5,623 |
) |
|
|
(18,077 |
) |
|
|
(16,808 |
) |
|
|
(5,088 |
) |
|
|
(6,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchange rate difference |
|
|
(412 |
) |
|
|
(1,326 |
) |
|
|
1,036 |
|
|
|
(1,115 |
) |
|
|
(50 |
) |
Loss (gain) from revaluation
of financial assets presented at fair value through profit and
loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(8 |
) |
Depreciation of Right of use -
Assets under operating lease |
|
|
115 |
|
|
|
369 |
|
|
|
433 |
|
|
|
97 |
|
|
|
(24 |
) |
Depreciation |
|
|
109 |
|
|
|
350 |
|
|
|
373 |
|
|
|
94 |
|
|
|
88 |
|
Finance expenses |
|
|
27 |
|
|
|
88 |
|
|
|
128 |
|
|
|
40 |
|
|
|
128 |
|
Issuance expenses |
|
|
- |
|
|
|
- |
|
|
|
1,621 |
|
|
|
- |
|
|
|
1,621 |
|
Changes in fair value of
traded and non traded warrants to ADS |
|
|
847 |
|
|
|
2,722 |
|
|
|
(8,643 |
) |
|
|
4 |
|
|
|
708 |
|
Share-based payment |
|
|
229 |
|
|
|
738 |
|
|
|
2,708 |
|
|
|
262 |
|
|
|
807 |
|
Decrease (increase) in other
receivables |
|
|
65 |
|
|
|
207 |
|
|
|
385 |
|
|
|
417 |
|
|
|
239 |
|
Increase (decrease) in other
payables |
|
|
(193 |
) |
|
|
(621 |
) |
|
|
(1,663 |
) |
|
|
528 |
|
|
|
192 |
|
Interest received |
|
|
20 |
|
|
|
64 |
|
|
|
93 |
|
|
|
8 |
|
|
|
168 |
|
Net cash used in
operating activities |
|
|
(4,816 |
) |
|
|
(15,486 |
) |
|
|
(20,337 |
) |
|
|
(4,753 |
) |
|
|
(2,207 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted deposit, net |
|
|
2 |
|
|
|
6 |
|
|
|
9 |
|
|
|
7 |
|
|
|
9 |
|
Proceeds received from the
sale of fixed assets |
|
|
11 |
|
|
|
35 |
|
|
|
6 |
|
|
|
- |
|
|
|
6 |
|
(Purchase) Sales of marketable
securities measured at fair value through profit and loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Purchase of property, plant
and equipment |
|
|
(103 |
) |
|
|
(329 |
) |
|
|
(123 |
) |
|
|
(170 |
) |
|
|
(3 |
) |
Net cash provided by
investing activities |
|
|
(90 |
) |
|
|
(288 |
) |
|
|
(108 |
) |
|
|
(163 |
) |
|
|
12 |
|
Cash flows from
financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants and stock
options into shares |
|
|
1,435 |
|
|
|
4,615 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Repayment on account of lease
liabilities |
|
|
(137 |
) |
|
|
(441 |
) |
|
|
(522 |
) |
|
|
(117 |
) |
|
|
(101 |
) |
Issue of share capital and
warrants, net of issue costs |
|
|
2,860 |
|
|
|
9,194 |
|
|
|
22,393 |
|
|
|
- |
|
|
|
(1,330 |
) |
Net cash provided
(used) by financing activities |
|
|
4,158 |
|
|
|
13,368 |
|
|
|
21,871 |
|
|
|
(117 |
) |
|
|
(1,431 |
) |
Exchange differences on
balances of cash and cash equivalents |
|
|
393 |
|
|
|
1,264 |
|
|
|
(1,129 |
) |
|
|
1,108 |
|
|
|
(117 |
) |
Increase (decrease) in cash
and cash equivalents |
|
|
(355 |
) |
|
|
(1,142 |
) |
|
|
297 |
|
|
|
(3,925 |
) |
|
|
(3,743 |
) |
Balance of cash and cash
equivalents at the beginning of the period |
|
|
5,632 |
|
|
|
18,106 |
|
|
|
17,809 |
|
|
|
20,889 |
|
|
|
21,849 |
|
Balance of cash and
cash equivalents at the end of the period |
|
|
5,277 |
|
|
|
16,964 |
|
|
|
18,106 |
|
|
|
16,964 |
|
|
|
18,106 |
|
Cellect Biotechnology (NASDAQ:APOP)
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