Cellect Biotechnology Reports Third Quarter Financial and Operating Results; Recent Developments Position Company to Accelera...
November 20 2020 - 8:00AM
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, 2020. Subsequent to the end of
the third quarter, the Company announced several other key
achievements subsequent to the end of the third quarter that
position it for continued success in 2021, including clinical and
operational objectives:
- Initiated its clinical trial in the
U.S. The trial is being performed at Washington University School
of Medicine in St. Louis, Missouri, which is among the leading
medical centers in the U.S. The Principal Investigator for the
clinical trial is Zhifu Xiang, M.D., of Washington University. He
is an Associate Professor in the Division of Oncology's Bone Marrow
Transplantation & Leukemia Section in the Department of
Medicine. John Dipersio M.D, Ph.D., will act as co-Principal
Investigator for the study. He is the chief of the Division of
Oncology in the Department of Medicine at Washington
University.
- Entered into a collaborative
agreement with the Swedish XNK Therapeutics, enabling it to
leverage Cellect’s technology in Natural Killer cell therapies. XNK
is a clinical stage Swedish company working with the Karolinska
Institute.
“In spite of the COVID-19 challenges we
expedited our clinical and business development activities as we
successfully achieved several objectives,” commented Dr. Shai
Yarkoni, Chief Executive Officer. “Specifically, we recently
initiated our U.S. clinical trial and entered into a partnership
with a clinical stage biotech company that will leverage our
functional cell selection technology. I believe these results
reflect our steadfast determination and success progressing our
clinical trials, which also includes the trial in Israel, combined
with the latest collaboration agreement with XNK Therapeutics gives
us multiple shots on goal to maximize shareholder value. We
believe, based on our internal evaluation and assessment, that each
of these opportunities could potentially represent significant
revenue streams in the coming years.”
Separately, Cellect and Canndoc Ltd. have mutually
agreed to end previously announced commercial and merger
discussions. The Company will continue to pursue a partner that can
bring value to its shareholders and progress the development of the
Company’s platform technology.
The Company's cash and cash equivalents totaled
$6.07 million as of September 30, 2020. The Company will use its
resources to progress clinical and business development efforts to
advance its functional cell selection technology. The Company has
sufficient funds to operate in the next 15 months. Reference is
made to Note 1. C (Going Concern) in the Interim Consolidated
Financial Statements as of June 30th, 2020, which were filed as an
exhibit to a Form 6-K dated August 12, 2020.
Third Quarter 2020 Financial
Results:
- Research and development (R&D)
expenses for the third quarter of 2020 were $0.37 million, compared
to $0.72 million in the third quarter of 2019. The decrease in the
R&D expenses is primarily due to decrease in clinical
activities as a result of the COVID-19.
- General and administrative
(G&A) expenses for the third quarter of 2020 were $0.36 million
compared to $0.80 million in the third quarter of 2019. The
decrease in G&A expenses was primarily due to the decrease in
professional expenses.
- Finance income for the third
quarter of 2020 were $0.26 million, compared to finance income of
$0.12 million in the third quarter of 2019. The change was
primarily due to changes related to the fair value of the tradable
and non-tradable warrants issued in a prior fundraising.
- Net loss for the third quarter of
2020 was $0.47 million, or $0.001 per share compared to $1.40
million, or $0.006 per share in the third quarter 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 September 30, 2020 (U.S. $1 =
NIS 3.441).
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, clinical community, and pharma 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. For example, forward-looking statements are
used in this press release when we discuss Cellect's expectations
regarding timing of the commencement of its planned U.S. clinical
trial and its plan to reduce operating costs. 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; the Company's ability to
retain or attract key employees whose knowledge is essential to the
development of its products; and the Company’s ability to pursue
any strategic transaction or that any transaction, if pursued, will
be completed. 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.
ContactCellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officerwww.cellect.co +972-9-974-1444
Or
EVC Group LLC Michael Polyviou(732)
933-2754mpolyviou@evcgroup.com
Cellect Biotechnology LtdConsolidated Statement
of Operation
|
|
Convenience |
|
|
|
|
|
|
|
|
|
|
translation |
|
|
|
|
|
|
|
|
|
|
Nine
monthsended |
|
Nine months ended |
|
Three months ended |
|
|
September 30, |
|
September 30, |
|
September 30, |
|
|
2020 |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
Unaudited |
|
Unaudited |
|
|
U.S. dollars |
|
NIS |
|
|
|
|
|
(In thousands, except share and
per share data) |
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses |
|
1,218 |
|
4,190 |
|
9,551 |
|
1,289 |
|
2,465 |
|
|
|
|
|
|
|
|
|
|
|
General and administrative
expenses |
|
1,727 |
|
5,944 |
|
7,832 |
|
1,241 |
|
2,768 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
2,945 |
|
10,134 |
|
17,383 |
|
2,530 |
|
5,233 |
|
|
|
|
|
|
|
|
|
|
|
Financial expenses (income) due
to warrants exercisable into shares |
|
790 |
|
2,717 |
|
(8,020) |
|
(1,090) |
|
(910) |
|
|
|
|
|
|
|
|
|
|
|
Other financial expenses,
net |
|
40 |
|
138 |
|
1,369 |
|
193 |
|
489 |
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
3,775 |
|
12,989 |
|
10,732 |
|
1,633 |
|
4,812 |
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
0.010 |
|
0.036 |
|
0.051 |
|
0.004 |
|
0.021 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding used to compute basic and diluted loss per share |
|
390,949,079 |
|
390,949,079 |
|
208,771,303 |
|
390,949,079 |
|
224,087,799 |
Cellect Biotechnology Ltd.Consolidated Balance
Sheet Data
|
Convenience |
|
|
|
|
|
|
translation |
|
|
|
|
|
|
September 30, |
|
September 30, |
|
December 31, |
|
2020 |
|
|
2020 |
|
|
2019 |
|
Unaudited |
|
Unaudited |
|
Audited |
|
U.S. dollars |
|
NIS |
|
(In thousands, except share and per share
data) |
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
6,071 |
|
|
20,889 |
|
|
18,106 |
|
Other receivables |
205 |
|
|
707 |
|
|
469 |
|
|
6,276 |
|
|
21,596 |
|
|
18,575 |
|
NON-CURRENT ASSETS: |
|
|
|
|
|
Restricted cash |
96 |
|
|
329 |
|
|
328 |
|
Right-of-use assets |
238 |
|
|
819 |
|
|
1,035 |
|
Other long-term receivables |
19 |
|
|
66 |
|
|
94 |
|
Property, plant and equipment, net |
379 |
|
|
1,304 |
|
|
1,288 |
|
|
732 |
|
|
2,518 |
|
|
2,745 |
|
|
|
|
|
|
|
|
7,008 |
|
|
24,114 |
|
|
21,320 |
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Trade payables |
71 |
|
|
243 |
|
|
158 |
|
Other payables |
579 |
|
|
1,994 |
|
|
3,080 |
|
Current maturities of lease liability |
136 |
|
|
468 |
|
|
396 |
|
|
786 |
|
|
2,705 |
|
|
3,634 |
|
NON-CURRENT LIABILITIES: |
|
|
|
|
|
Warrants to ADS |
354 |
|
|
1,218 |
|
|
2,172 |
|
Lease liability |
112 |
|
|
386 |
|
|
677 |
|
|
466 |
|
|
1,604 |
|
|
2,849 |
|
EQUITY: |
|
|
|
|
|
Ordinary shares of no par value: |
|
|
|
|
|
Authorized: 500,000,000 shares at December 31, 2019 and
September 30, 2020; Issued and outstanding: 390,949,079*) and
224,087,799*) shares as of December 31, 2019 and September 30,
2020, respectively. |
- |
|
|
- |
|
|
- |
|
Additional Paid in Capital |
36,861 |
|
|
126,839 |
|
|
108,598 |
|
Share-based payments |
4,721 |
|
|
16,244 |
|
|
16,528 |
|
Treasury shares |
(2,739 |
) |
|
(9,425 |
) |
|
(9,425 |
) |
Accumulated deficit |
(33,087 |
) |
|
(113,853 |
) |
|
(100,864 |
) |
|
5,756 |
|
|
19,805 |
|
|
14,837 |
|
|
|
|
|
|
|
|
7,008 |
|
|
24,114 |
|
|
21,320 |
|
*) Net of 2,641,693 treasury shares of
the Company held by the Company.
Cellect Biotechnology LtdConsolidated Cash Flow
Data
|
Convenience |
|
|
|
|
|
|
|
|
|
translation |
|
|
|
|
|
|
|
|
|
Nine monthsended |
Nine months ended |
|
Three months ended |
|
September 30, |
September 30, |
|
September 30, |
|
2020 |
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
Unaudited |
Unaudited |
|
U.S. dollars |
NIS |
|
(In thousands) |
Cash flows from operating
activities: |
|
|
|
|
|
|
|
|
Total comprehensive loss |
(3,775 |
) |
(12,989 |
) |
|
(10,732 |
) |
|
(1,633 |
) |
|
(4,812 |
) |
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Exchange rate difference |
(61 |
) |
(211 |
) |
|
- |
|
|
(216 |
) |
|
- |
|
Net financing expenses |
14 |
|
48 |
|
|
1,087 |
|
|
11 |
|
|
272 |
|
Loss (gain) from revaluation of
financial assets presented at fair value through profit and
loss |
- |
|
- |
|
|
8 |
|
|
- |
|
|
2 |
|
Depreciation |
75 |
|
256 |
|
|
285 |
|
|
86 |
|
|
93 |
|
Changes in fair value of traded
and not traded warrants |
790 |
|
2,718 |
|
|
(9,351 |
) |
|
(1,089 |
) |
|
(910 |
) |
Share-based payment |
138 |
|
476 |
|
|
1,901 |
|
|
(353 |
) |
|
1,371 |
|
Decrease (increase) in other
receivables |
(61 |
) |
(210 |
) |
|
146 |
|
|
263 |
|
|
- |
|
Decrease in other payables |
(334 |
) |
(1,149 |
) |
|
(1,855 |
) |
|
(396 |
) |
|
(1,138 |
) |
Depreciation of Right of use -
Assets under operating lease |
79 |
|
272 |
|
|
457 |
|
|
89 |
|
|
143 |
|
Interest received during the
period |
16 |
|
56 |
|
|
(75 |
) |
|
21 |
|
|
(29 |
) |
Net cash used in
operating activities |
(3,119 |
) |
(10,733 |
) |
|
(18,129 |
) |
|
(3,217 |
) |
|
(5,008 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Restricted deposit, net |
- |
|
(1 |
) |
|
- |
|
|
1 |
|
|
- |
|
Sales (Purchase) of property,
plant, and equipment |
(36 |
) |
(124 |
) |
|
(120 |
) |
|
(155 |
) |
|
- |
|
Net cash provided by
investing activities |
(36 |
) |
(125 |
) |
|
(120 |
) |
|
(154 |
) |
|
- |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
|
Exercise of warrants and stock
options into shares |
1,341 |
|
4,615 |
|
|
- |
|
|
(92 |
) |
|
- |
|
Leases liabilities |
(94 |
) |
(324 |
) |
|
(422 |
) |
|
(112 |
) |
|
(143 |
) |
Issue of share capital and
warrants, net of issue costs |
2,672 |
|
9,194 |
|
|
23,723 |
|
|
- |
|
|
- |
|
Net cash provided (used)
by financing activities |
3,919 |
|
13,485 |
|
|
23,301 |
|
|
(204 |
) |
|
(143 |
) |
Exchange differences on balances
of cash and cash equivalents |
45 |
|
156 |
|
|
(1,012 |
) |
|
195 |
|
|
(243 |
) |
Increase (decrease) in cash and
cash equivalents |
809 |
|
2,783 |
|
|
4,040 |
|
|
(3,380 |
) |
|
(5,394 |
) |
Balance of cash and cash
equivalents at the beginning of the period |
5,262 |
|
18,106 |
|
|
17,809 |
|
|
24,269 |
|
|
27,243 |
|
Balance of cash and
cash equivalents at the end of the period |
6,071 |
|
20,889 |
|
|
21,849 |
|
|
20,889 |
|
|
21,849 |
|
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