TEL AVIV, Israel, Nov. 13, 2018 /PRNewswire/ -- Cellect
Biotechnology Ltd. (NASDAQ: APOP), a developer of innovative
technology which enables the functional selection of stem cells,
today provided a corporate update and announced financial results
for the third quarter ended September 30,
2018.
"During the third quarter, we have strengthened significantly
our IP portfolio position with granted patents from the EU and
Korea while closing an important partnership agreement with the
Korean Cell2in and the German denovoMATRIX for collaborations to
further improve stem cell selection," stated Dr. Shai Yarkoni, Cellect's Chief Executive
Officer.
"During the year we opened a second site for the Company's
ongoing clinical trial which allowed us to expedite the recruitment
of additional patients and as a result, half of the patients
planned for the study have finished first month follow up and all
such patients have shown 100% engraftment with no procedure related
adverse events and the first three patients of the trial (cohort I)
have completed the study period (180 days) with full safety and
tolerability," continued Dr. Yarkoni. "We also achieved positive
results on the use of fat derived cells in orthopedic treatments in
an animal model, we completed the first prototype of the Apotainer,
showing stable immobilization and good biological activity of FasL
coated paramagnetic beads and we received a formal Notice of
Allowance from the Japanese and Australian Offices for Patents
& Trademarks," Dr. Yarkoni added.
"As we are getting nearer to commercialization of our
technology, we are putting more and more emphasis on partnerships
with key players in our industry. We intend to continue this path
going forward and build one of the world's strongest IP portfolios
for stem cell therapy related technologies and a line of
partnerships that will take the company to the next level
commercially within the next 24 months," summarized Dr. Yarkoni
During the third quarter, Cellect accomplished the
following: -
- Signed a collaboration and material transfer agreement with the
denovoMATRIX group of the Technische Universität Dresden (TU
Dresden), a leading center for stem cell research in Germany.
- Entered into a strategic manufacturing and supply agreement
with Swiss Biotech Center (SBC) to secure production of FasL
protein - Cellect's main active ingredient in ApoGraft™ and the
ApoTainer™ for planned clinical trials in the U.S.
- European Patent Office has granted the Company a patent for its
ApoTainer™ device which is used in conjunction with its platform
ApoGraft™ technology titled, "Devices and Methods for Selecting
Apoptosis-Signaling Resistant Cells, and Uses Thereof".
- Signed a collaboration agreement with Cell2in, a South Korean
company focused on improving the quality of cells. According to the
agreement, the companies will conduct scientific evaluations
combining Cellect's technology platform ApoGraft™ with Cell2in's
proprietary identification technology FreSHtracer™ which monitors
stem cell quality by utilizing a fluorescent dye to characterize
their oxidative stress state.
- Received a Notice of Allowance from the Korean Intellectual
Property Office for its patent titled, "Devices and Methods for
Selecting Apoptosis-Signaling Resistant Cells and Uses Thereof".
This patent, recently granted to Cellect in Europe, addresses the Company's ApoTainer™
device which is used in conjunction with its platform ApoGraft™
technology.
Recent Corporate Highlights:
- Announced that it has reached half way through study
recruitment - six of the patients finished first month follow up
and all these patients have shown 100% engraftment with no
procedure related adverse events. Further to the six patients
one-month data detailed above, Cellect reported that the first
three patients of the trial (cohort I) have completed the study
period (180 days) with full safety and tolerability.
- Announced that it has achieved positive results on the use of
fat derived cells treated with the ApoGraft™ process in orthopedic
treatments in an animal model.
- Announced that it has successfully developed for
industrialization its first in kind new technology as an integral
part of Cellect's ApoTainer™. The new technology utilizes
FasL-coated magnetic beads for maximizing efficacy and scalability
of stem cell-based products' manufacturing. The Apotainer™ improves
the uniformity and hence quality of the outcome thereby supporting
the safety and efficacy of raw material for all cell therapy.
- Announced that CEO Dr. Shai
Yarkoni will present at the 24th Annual Bio Europe
Conference that was held in Copenhagen,
Denmark from November 5-7,
2018.
- Announced that it has received a formal Notice of Allowance
from the Japanese and Australian Offices for Patents &
Trademarks (Japanese Application No. 2014-560516; Australian
Application No. 20132s29008) covering a key composition of matter
and method of use of Cellect's ApoGraft technology in devices for
stem cell selection.
Third Quarter 2018 Financial Results:
- Research and development (R&D) expenses for the third
quarter of 2018 were $1.13 million,
compared to $0.69 million in the
second quarter of 2018 and $0.79
million in the third quarter of 2017. The increase in the
third quarter of 2018 as compared to the second quarter of 2018 was
primarily due to increased expenses related to the Company's
ongoing clinical trial and product development expenses.
- General and administrative (G&A) expenses for the third
quarter of 2018 were $1.08 million,
compared to $1.00 million in the
second quarter of 2018 and $0.96
million in the third quarter of 2017. The change in the
third quarter of 2018 as compared to the second quarter of 2018
mainly derived from an increase in expenses related to business
development in the third quarter of 2018, offset by a decrease in
costs of share-based compensation.
- Financial income for the third quarter of 2018 was $0.35 million, compared to financial income of
$0.03 million in the second quarter
of 2018. The increase was primarily due to changes related to fair
value of the tradable and non-tradable warrants issued in prior
fundraisings.
- Net loss for the third quarter of 2018 was $1.9 million, or $0.014 per share and $0.29 per ADS, compared to $1.6 million, or $0.013 per share and $0.25 per ADS, in the second quarter of 2018, and
$2.2 million, or $0.019 per share and $0.39 per ADS, in the third quarter of 2017.
Balance Sheet Highlights:
- Cash and cash equivalents and marketable securities totaled
$6.45 million as of September 30, 2018, compared to $8.26 million on June 30,
2018, and $7.6 million on
December 31, 2017. The change in the
cash and cash equivalents and marketable securities was primarily
due to net proceeds of $3.5 million
from a registered direct offering completed in January 2018, offset by cash used in operations
during the period.
- Shareholders' equity totaled $4.5
million as of September 30,
2018, compared to $6.1 million
on June 30, 2018, and $5.2 million on December
31, 2017.
* 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, 2018
(U.S. $1 = NIS
3.627).
The Company's consolidated financial results for the three and
nine months ended September 30, 2018
are presented in accordance with International Financial Reporting
Standards.
About Cellect Biotechnology Ltd.
Cellect 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.
The Company's technology is expected to provide research,
hospitals 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 our IP portfolio and potential commercialization of
our 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, 2017 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
|
|
|
|
|
|
|
|
|
|
|
Nine
months
ended
|
|
Nine months
ended
|
|
Three months
ended
|
|
|
September
30,
|
|
September
30,
|
|
September
30,
|
|
|
2018
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
Unaudited
|
|
Unaudited
|
|
|
U.S.
dollars
|
|
NIS
|
|
|
(In thousands,
except share and per
share
data)
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
2,612
|
|
9,473
|
|
8,099
|
|
4,125
|
|
2,872
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
3,033
|
|
11,001
|
|
9,524
|
|
3,929
|
|
3,478
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
5,645
|
|
20,474
|
|
17,623
|
|
8,054
|
|
6,350
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income) due to
warrants exercisable into
ADS
|
|
(809)
|
|
(2,935)
|
|
6,821
|
|
(1,320)
|
|
1,509
|
|
|
|
|
|
|
|
|
|
|
|
Other financial
expenses (income), net
|
|
(325)
|
|
(1,177)
|
|
411
|
|
64
|
|
(57)
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
4,511
|
|
16,362
|
|
24,855
|
|
6,798
|
|
7,802
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
|
0.035
|
|
0.127
|
|
0.228
|
|
0.052
|
|
0.070
|
Basic and diluted loss
per ADS
|
|
0.7
|
|
2.54
|
|
4.56
|
|
1.04
|
|
1.40
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares
outstanding used to compute basic
and
diluted loss per share
|
|
129,139,278
|
|
129,139,278
|
|
109,188,626
|
|
130,192,799
|
|
111,476,292
|
Cellect Biotechnology
Ltd
|
Consolidated Balance
Sheet Data
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
September
30,
|
|
September
30,
|
|
December
31,
|
|
|
|
|
2018
|
|
2018
|
|
2017
|
|
|
|
Unaudited
|
|
Unaudited
|
|
Audited
|
|
|
|
U.S.
dollars
|
|
NIS
|
|
|
|
(In thousands,
except share and per
share
data)
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
6,447
|
|
23,385
|
|
13,734
|
|
Marketable
securities
|
|
-
|
|
-
|
|
13,999
|
|
Other
receivables
|
|
164
|
|
593
|
|
818
|
|
|
|
|
|
|
|
|
|
|
|
6,611
|
|
23,978
|
|
28,551
|
|
NON-CURRENT
ASSETS:
|
|
|
|
|
|
|
|
Restricted
cash
|
|
92
|
|
333
|
|
305
|
|
Other long-term
assets
|
|
39
|
|
142
|
|
173
|
|
Property, plant and
equipment, net
|
|
458
|
|
1,661
|
|
1,344
|
|
|
|
|
|
|
|
|
|
|
|
589
|
|
2,136
|
|
1,822
|
|
|
|
|
|
|
|
|
|
|
|
7,200
|
|
26,114
|
|
30,373
|
|
|
|
LIABILITIES
AND
SHAREHOLDERS'
EQUITY
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Trade
payables
|
|
354
|
|
1,283
|
|
1,703
|
|
Other
payables
|
|
584
|
|
2,120
|
|
2,396
|
|
|
|
938
|
|
3,403
|
|
4,099
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
Warrants to
ADS
|
|
1,745
|
|
6,327
|
|
7,422
|
|
|
|
|
|
|
|
|
|
EQUITY:
|
|
|
|
|
|
|
|
Ordinary shares of no
par value:
Authorized: 500,000,000 shares at December 31,
2017
and September 30 2018; Issued and
outstanding:
120,185,659*) and 130,192,799*)
shares as of
December 31, 2017 and September 30,
2018,
respectively.
|
|
-
|
|
-
|
|
-
|
|
Additional Paid In
Capital
|
|
26,135
|
|
94,793
|
|
82,839
|
|
Share-based
payments
|
|
3,121
|
|
11,321
|
|
9,381
|
|
Treasury
shares
|
|
(2,598)
|
|
(9,425)
|
|
(9,425)
|
|
Accumulated
deficit
|
|
(22,141)
|
|
(80,305)
|
|
(63,943)
|
|
|
|
|
|
|
|
|
|
|
|
4,517
|
|
16,384
|
|
18,852
|
|
|
|
|
|
|
|
|
|
|
|
7,200
|
|
26,114
|
|
30,373
|
|
|
|
*)
Net of 2,641,693 treasury shares of the Company held by the
Company.
|
|
Cellect Biotechnology
Ltd
|
Consolidated Cash
Flow Data
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
|
|
|
Nine
months
ended
|
Nine months
ended
|
|
Three months
ended
|
|
|
|
September
30,
|
September
30,
|
|
September
30,
|
|
|
|
2018
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
Unaudited
|
Unaudited
|
|
|
|
U.S.
dollars
|
NIS
|
|
|
|
(In
thousands)
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
(4,511)
|
(16,362)
|
|
(24,855)
|
|
(6,798)
|
|
(7,802)
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to
reconcile net loss to net
cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
Net financing
expenses
|
|
(227)
|
(823)
|
|
504
|
|
14
|
|
(29)
|
|
Loss (gain) from
revaluation of financial
assets presented at fair value
through
profit and loss
|
|
(79)
|
(288)
|
|
140
|
|
(140)
|
|
(149)
|
|
Depreciation
|
|
93
|
337
|
|
278
|
|
122
|
|
94
|
|
Changes in fair value
of traded and not
traded warrants to ADS
|
|
(885)
|
(3,208)
|
|
6,650
|
|
(1,320)
|
|
1,337
|
|
Share-based
payment
|
|
895
|
3,247
|
|
4,016
|
|
1,063
|
|
1,572
|
|
Decrease (increase) in
other receivables
|
|
70
|
256
|
|
362
|
|
343
|
|
126
|
|
Increase (decrease) in
other payables
|
|
(195)
|
(706)
|
|
(633)
|
|
409
|
|
(4)
|
|
Interest
received
|
|
(13)
|
(47)
|
|
-
|
|
(32)
|
|
-
|
|
Net cash used in
operating activities
|
|
(4,852)
|
(17,594)
|
|
(13,538)
|
|
(6,339)
|
|
(4,855)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities:
|
|
|
|
|
|
|
|
|
|
|
Short term deposits,
net
|
|
78
|
282
|
|
19,530
|
|
3,785
|
|
18,020
|
|
Restricted deposit,
net
|
|
(6)
|
(22)
|
|
(167)
|
|
6
|
|
(2)
|
|
(Purchase) Sales of
marketable securities
measured at fair value through profit
and
loss
|
|
3,859
|
13,999
|
|
(5,009)
|
|
5,501
|
|
(10,000)
|
|
Purchase of property,
plant and equipment
|
|
(177)
|
(643)
|
|
(175)
|
|
(415)
|
|
(59)
|
|
Net cash provided by
investing activities
|
|
3,754
|
13,616
|
|
14,179
|
|
8,877
|
|
7,959
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants
and stock options into
shares
|
|
110
|
399
|
|
1,263
|
|
-
|
|
197
|
|
Issue of share capital
and warrants, net of
issue costs
|
|
3,408
|
12,360
|
|
14,893
|
|
-
|
|
14,893
|
|
Net cash provided
(used) by financing
activities
|
|
3,518
|
12,759
|
|
16,156
|
|
-
|
|
15,090
|
|
Exchange differences on
balances of cash
and cash equivalents
|
|
240
|
870
|
|
(504)
|
|
18
|
|
29
|
|
Increase (decrease) in
cash and cash
equivalents
|
|
2,660
|
9,651
|
|
16,293
|
|
2,556
|
|
18,223
|
|
Balance of cash and
cash equivalents at the
beginning of the period
|
|
3,787
|
13,734
|
|
6,279
|
|
20,829
|
|
4,349
|
|
Balance of cash and
cash equivalents at
the end of the period
|
|
6,447
|
23,385
|
|
22,572
|
|
23,385
|
|
22,572
|
|
Contact:
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial
Officer
www.cellect.co
+ 972-9-974-1444
View original
content:http://www.prnewswire.com/news-releases/cellect-biotechnology-provides-corporate-update-and-reports-third-quarter-2018-financial-results-300749009.html
SOURCE Cellect Biotechnology Ltd.