TEL AVIV, Israel, May 21, 2019 /PRNewswire/ -- 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 first
quarter ended March 31, 2019 and
provided a corporate update.
"Our technology continues to be validated with our recently
announced mid-study results from our Phase I/II study, further
demonstrating the immense potential to reshape the clinical
development environment for hundreds of corporations and academic
labs by significantly reducing time to market and cost," commented
Dr. Shai Yarkoni, Chief Executive
Officer. "However, notwithstanding our clinical success, we are
undertaking a strategic review of our business and we intend to
explore all value-focused options that better reflect our great
promise and maximize shareholder equity. Therefore, we are
implementing a number of initiatives, including lowering our
operating costs, as we remain committed to our IND application and
US clinical study plans."
First Quarter Clinical Success Continues to Validate Novel
Manufacturing Technology
- Announced mid-study data from the Company's Phase I/II study of
the Company's ApoGraft™ technology being conducted in
Israel. The first half of patients
planned for the study have completed the 180 day follow up, and 8
out of 12 planned subjects have been enrolled. The Company
currently expects its planned human ApoGraft™ Phase I/II trial in
the United States to commence
sometime during the first half of 2020, following the successful
submission of an Investigational New Drug (IND) application with
the U.S. Food and Drug Administration (FDA).
- Announced preliminary results from the Company's collaboration
with Cell2in, a privately held South Korean company, that further
demonstrated that Cellect's Apograft™ technology significantly
improves both proliferation and functional capabilities of
hematopoietic (HSC) and mesenchymal (MSC) stem cells originating
from bone marrow, peripheral blood, umbilical cord, and adipose
tissue.
The Company's cash and cash equivalents totaled $9.6 million as of March
31, 2019, which includes gross proceeds of $7.0 million from an underwritten public offering
completed in February 2019. The
Company is implementing a cost reduction plan, including a
reduction in workforce, which is designed to preserve the Company's
financial resources to allow it to continue its ongoing clinical
program, including its planned Phase I/II trial in the United States in collaboration with
Washington University while exploring
strategic alternatives.
In May 2019, the Company announced
that it commenced plans to explore strategic alternatives focused
on maximizing shareholder value. Potential strategic
alternatives that may be evaluated include, but are not limited to,
an acquisition, merger, business combination, in-licensing, or
other strategic transaction involving the Company or its
assets.
First Quarter 2019 Financial Results:
- Research and development (R&D) expenses for the
first quarter of 2019 were $0.97
million, compared to $1.11
million in the fourth quarter of 2018 and $0.79 million in the first quarter of 2018.
The decrease in the first quarter of 2019 as compared to the fourth
quarter of 2018 was primarily due to a decrease in clinical trial
activity.
- General and administrative (G&A) expenses for the first
quarter of 2019 were $0.65 million,
compared to $1.30 million in the
fourth quarter of 2018 and $0.95
million in the first quarter of 2018. The decrease in the
first quarter of 2019 as compared to the fourth quarter of 2018 was
primarily due to decrease in expenses related to provision for
bonus for 2018 and stock-based compensation.
- Finance income for the first quarter of 2019 were $0.21 million, compared to finance income of
$1.38 million in the fourth quarter
of 2018. The decrease was primarily due to changes related to fair
value of the tradable and non-tradable warrants issued in
a prior fundraising.
- Net loss for the first quarter of 2019 was $1.40 million, or $0.008 per share and $0.16 per ADS, compared to $1.03 million, or $0.008 per share and $0.16 per ADS, in the fourth quarter of 2018, and
$0.98 million, or $0.008 per share and $0.15 per ADS, in the first quarter of 2018.
* 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 March 31, 2019
(U.S. $1 = NIS
3.632).
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 therapies.
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. 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, 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.
|
Consolidated
Statement of Operation
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
Three
months
|
|
Three months
ended
|
ended
|
|
|
March
31,
|
|
March
31,
|
|
|
2019
|
|
2019
|
|
2018
|
|
|
Unaudited
|
|
Unaudited
|
|
|
U.S.
dollars
|
|
NIS
|
|
|
|
|
|
|
|
Research and
development expenses, net
|
|
970
|
|
3,523
|
|
2,857
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
649
|
|
2,355
|
|
3,452
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
loss
|
|
1,619
|
|
5,878
|
|
6,309
|
|
|
|
|
|
|
|
Financial expenses
(income) due to
warrants exercisable into
ADS
|
|
(328)
|
|
(1,192)
|
|
(2,224)
|
|
|
|
|
|
|
|
Other financial
expenses (income), net
|
|
115
|
|
418
|
|
(510)
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
1,406
|
|
5,104
|
|
3,575
|
|
|
|
|
|
|
|
Loss per share and
ADS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per share
|
|
0.008
|
|
0.029
|
|
0.028
|
|
|
|
|
|
|
|
Basic and
diluted loss per ADS
|
|
0.16
|
|
0.58
|
|
0.56
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding used to compute basic
and
diluted loss per share
|
|
177,277,833
|
|
177,277,833
|
|
126,973,049
|
Cellect Biotechnology
Ltd.
|
Consolidated Balance
Sheet Data
|
ASSETS
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
March
31,
|
|
March
31,
|
|
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
|
9,598
|
|
34,862
|
|
17,809
|
Other
receivables
|
209
|
|
757
|
|
816
|
|
|
|
|
|
|
|
9,807
|
|
35,619
|
|
18,625
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
Restricted
cash
|
92
|
|
333
|
|
337
|
Right of use
assests
|
413
|
|
1,499
|
|
-
|
Other long-term
receivables
|
33
|
|
123
|
|
132
|
Property, plant and
equipment, net
|
431
|
|
1,566
|
|
1,544
|
|
|
|
|
|
|
|
969
|
|
3,521
|
|
2,013
|
|
|
|
|
|
|
|
10,776
|
|
39,140
|
|
20,638
|
|
LIABILITIES
AND
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
Trade
payables
|
233
|
|
848
|
|
887
|
Other
payables
|
1,425
|
|
5,176
|
|
4,012
|
Current maturities of
lease liability
|
135
|
|
492
|
|
-
|
|
1,793
|
|
6,516
|
|
4,899
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
Warrants to
ADS
|
2,648
|
|
9,617
|
|
1,816
|
Lease
liability
|
281
|
|
1,021
|
|
-
|
|
2,929
|
|
10,638
|
|
1,816
|
EQUITY:
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized: 500,000,000
shares at December 31, 2018
and March 31, 2019; Issued and
outstanding:
130,414,799*) and 224,087,799*)
shares as of
December 31, 2018 and March 31, 2019,
respectively.
|
-
|
|
-
|
|
-
|
Additional Paid in Capital
|
29,810
|
|
108,269
|
|
95,085
|
Share-based
payments
|
3,387
|
|
12,302
|
|
12,319
|
Treasury
shares
|
(2,595)
|
|
(9,425)
|
|
(9,425)
|
Accumulated deficit
|
(24,548)
|
|
(89,160)
|
|
(84,056)
|
|
|
|
|
|
|
|
6,054
|
|
21,986
|
|
13,923
|
|
|
|
|
|
|
|
10,776
|
|
39,140
|
|
20,638
|
|
*)
Net of 2,641,693 treasury shares of the Company held by the
Company.
|
Cellect Biotechnology
Ltd.
|
Consolidated Cash
Flow Data
|
|
|
Convenience
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
Three
months
ended
|
Three months
ended
|
|
|
|
|
March
31,
|
March
31,
|
|
|
|
|
2019
|
2019
|
|
2018
|
|
|
|
|
Unaudited
|
Unaudited
|
|
|
|
|
U.S.
dollars
|
NIS
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
(1,406)
|
(5,104)
|
|
(3,575)
|
|
|
|
|
|
|
|
|
|
|
Adjustments to
reconcile net loss to net
cash used in operating
activities:
|
|
|
|
|
|
|
|
Exchange rate
difference
|
|
103
|
372
|
|
(523)
|
|
|
Loss from revaluation
of financial assets
presented at fair value through
profit and
loss
|
|
1
|
4
|
|
-
|
|
|
Depreciation
|
|
27
|
98
|
|
105
|
|
|
Share-based
payment
|
|
(59)
|
(215)
|
|
1,247
|
|
|
Changes in fair value
of traded and not
traded warrants to ADS
|
|
(701)
|
(2,546)
|
|
(2,496)
|
|
|
Decrease (increase) in
other receivables
|
|
19
|
70
|
|
63
|
|
|
Depreciation in right
of use assets
|
|
31
|
114
|
|
-
|
|
|
Increase (decrease) in
other payables
|
|
4
|
15
|
|
(911)
|
|
|
Net cash used in
operating activities
|
|
(1,981)
|
(7,192)
|
|
(6,090)
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
Restricted
deposit
|
|
-
|
-
|
|
(163)
|
|
|
Marketable securities
measured at fair value
through profit and loss,
net
|
|
-
|
-
|
|
4,500
|
|
|
Purchase of property,
plant and equipment
|
|
(33)
|
(120)
|
|
(140)
|
|
|
Net cash provided by
investing activities
|
|
(33)
|
(120)
|
|
4,197
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
Exercise of warrants
and stock options into
shares
|
|
-
|
-
|
|
399
|
|
|
Issue of share
capital and warrants, net of
issue costs
|
|
6,839
|
24,837
|
|
12,365
|
|
|
Interest
paid
|
|
11
|
37
|
|
-
|
|
|
Repayment of lease
liability
|
|
(38)
|
(137)
|
|
-
|
|
|
Net cash provided by
financing activities
|
|
6,812
|
24,737
|
|
12,764
|
|
|
Exchange differences on
balances of cash
and cash equivalents
|
|
(103)
|
(372)
|
|
523
|
|
|
Increase (decrease) in
cash and cash
equivalents
|
|
4,695
|
17,053
|
|
11,394
|
|
|
Balance of cash and
cash equivalents at the
beginning of the period
|
|
4,903
|
17,809
|
|
13,734
|
|
|
Balance of cash and
cash equivalents at
the end of the period
|
|
9,598
|
34,862
|
|
25,128
|
|
|
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officer
www.cellect.co
+972-9-974-1444
Or
EVC Group LLC
Michael Polyviou
(732) 933-2754
mpolyviou@evcgroup.com
View original
content:http://www.prnewswire.com/news-releases/cellect-biotechnology-reports-first-quarter-2019-financial-and-operating-results-300853850.html
SOURCE Cellect Biotechnology Ltd.