TEL AVIV, Israel, Nov. 22, 2017 /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, 2017.
"We are very pleased with our accomplishments in the third quarter of 2017" said Dr. Shai
Yarkoni, Chief Executive Officer; "As planned, the third quarter continues to show progress in Cellect's path to global
leadership in the regenerative medicine arena. We were granted an important FDA Orphan Drug Designation Status for Cellect's
ApoGraft™ for the prevention of acute and chronic GvHD which we believe will allow us to efficiently speed up the
commercialization process of ApoGraft™ and with the view to the future, we have successfully completed a voluntary de-listing
from the Tel-Aviv stock exchange and migrated to trade exclusively on the NASDAQ to maximize
shareholders' value from our future endeavors. In this respect we have also successfully raised $4.3M gross during the third quarter of 2017, to finance our strategic business development activities. We
remain confident of our progress and leadership position in the stem cell market."
Recent Corporate Highlights:
- We reported positive results from a 20 patients trial at Tel-Aviv Ichilov Medical Center in which ApoGraft™ significantly
improved stem cells derived from fat tissues. The significance of the findings opens ApoGraft™ up to be used by a much wider
array of companies and medical centers worldwide developing stem cell based products and treatments. Of special importance are
the aesthetic and orthopedic indications where fat-derived stem cells are the main raw material;
- We nominated Dr. Ronit Bakimer-Kleiner as Chief Development Officer replacing Dr.
Yaron Pereg;
- Company's CEO, Dr. Shai Yarkoni, was chosen to present Cellect technology and recent
advancements at the Bio-Europe 2017 conference in Berlin (https://ebdgroup.knect365.com/bioeurope/about-bio-europe) alongside other selected industry leaders including
Andrew Yost, VP, Corporate Development, REGENXBIO Inc., Gabriele
Proetzel, Director, Regenerative Medicine, Takeda and Sharon Brownlow, Head of
Collaborations - Manufacturing Centre, The Cell and Gene Therapy Catapult. The panel was moderated by the Founder of Alliance
of Regenerative Medicine (ARM);
- Company's CEO, Dr. Shai Yarkoni, was selected to provide the keynote (Plenary) presentation
at the 11th world congress of Regenerative Medicine and Stem Cell technologies in Singapore
(http://www.bitcongress.com/rmsc2017/default.asp).
Third Quarter 2017 Financial Results:
- Research and development (R&D) expenses for the third quarter of 2017 were $0.81 million,
compared to $0.69 million in the second quarter of 2017 and $0.58
million in the third quarter of 2016. The increase in the third quarter of 2017 as compared to the second quarter of
2017 mainly derived due to a grant received from the BIRD foundation in the amount of $0.12
million in the second quarter of 2017 which was not received in the third quarter of 2017.
- General and administrative (G&A) expenses for the third quarter of 2017 were $0.99
million, compared to $1.0 million in the second quarter of 2017 and $0.77 million in the third quarter of 2016. The change in the third quarter of 2017 as compared to the second
quarter of 2017 mainly derived from an increase in expenses related to business development and professional fees in the third
quarter of 2017, offset by a decrease in costs of delisting from the second quarter of 2017.
- Finance expenses for the third quarter of 2017 were $0.41 million, compared to finance income
of $0.37 million in the second quarter of 2017. The change was primarily due to changes related
to fair value of the tradable and non-tradable warrants issued in prior financings.
- Net loss for the third quarter of 2017 was $2.2 million, or $0.02 per share and $0.4 per ADS, compared to $1.3
million, or $0.012 per share and $0.24 per ADS, in the
second quarter of 2017 and $1.5 million, or $0.016 per share and
$0.3 per ADS, in the third quarter of 2016.
Balance Sheet Highlights:
- Cash and cash equivalents, marketable securities and short-term deposits totaled $9.2 million
as of September 30, 2017, compared to $6.3 million on June 30, 2017, and $8.8 million on December 31,
2016. The increase from June 30, 2017, was primarily due to proceeds of $4.2 million (after deducting placement agents' fees) raised through a registered direct offering and
concurrent private placement completed in September 2017, offset by cash used in operations
during the period.
- Tradable and non-tradable warrants exercisable into ADSs totaled $3.1 million as of
September 30, 2017, and represented, according to the international financial reporting standards
(IFRS), the fair value of tradable and non-tradable warrants issued in prior financings.
- Shareholders' equity totaled $5.9 million as of September 30,
2017, compared to $4.3 million on June 30, 2017, and
$8.1 million on December 31, 2016.
* 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, 2017 (U.S. $1 = NIS 3.529).
The Company's unaudited consolidated financial results for the three and nine months ended September
30, 2017 are presented in accordance with International Financial Reporting Standards.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: "APOP", "APOPW") has developed a breakthrough technology for the selection of stem cells from
any given tissue that aims to improve a variety of stem cell applications.
The Company's technology is expected to provide pharma companies, medical research centers and hospitals with the tools to
rapidly isolate stem cells in quantity and quality that will allow stem cell related treatments and procedures. Cellect's
technology is applicable to a wide variety of stem cell related treatments in regenerative medicine and that current clinical
trials are aimed at the cancer treatment of bone marrow transplantations.
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 anticipated performance in
2017 and the potential of our technology and its proposed uses. 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: changes in technology and market requirements; we may encounter delays or obstacles in launching
and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may
not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to
retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific
difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the
laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate
with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in
legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual
results or performance of the Company to differ materially from those contemplated in such forward-looking statements. 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, 2016 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 and the Tel-Aviv Stock Exchange.
Cellect Biotechnology Ltd.
|
Consolidated Statement of Operation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
|
|
Nine months
|
|
|
|
|
|
|
ended
|
|
Nine months ended
|
|
Three months ended
|
|
|
September 30,
|
|
September 30,
|
|
September 30,
|
|
|
2017
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
Unaudited
|
|
Unaudited
|
|
|
U.S. dollars
|
|
NIS
|
|
|
(In thousands, except share and per
share data)
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses
|
|
2,295
|
|
8,099
|
|
5,738
|
|
2,872
|
|
2,059
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses
|
|
2,699
|
|
9,524
|
|
6,247
|
|
3,478
|
|
2,700
|
|
|
|
|
|
|
|
|
|
|
|
Other income
|
|
-
|
|
-
|
|
(280)
|
|
-
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
4,994
|
|
17,623
|
|
11,705
|
|
6,350
|
|
4,759
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses due to warrants
exercisable into ADS
|
|
1,933
|
|
6,821
|
|
532
|
|
1,509
|
|
532
|
|
|
|
|
|
|
|
|
|
|
|
Other financial expenses (income), net
|
|
116
|
|
411
|
|
198
|
|
(57)
|
|
175
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
7,043
|
|
24,855
|
|
12,435
|
|
7,802
|
|
5,466
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share and ADS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share
|
|
0.065
|
|
0.228
|
|
0.145
|
|
0.070
|
|
0.055
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per ADS
|
|
1.292
|
|
4.56
|
|
2.90
|
|
1.40
|
|
1.10
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding used to compute basic and
diluted loss per share
|
|
109,188,626
|
|
109,188,626
|
|
85,583,252
|
|
111,476,292
|
|
98,494,725
|
Cellect Biotechnology Ltd.
|
Consolidated Balance Sheet Data
|
ASSETS
|
|
|
Convenience
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
September 30,
|
|
September 30,
|
|
December 31,
|
|
|
2017
|
|
2017
|
|
2016
|
|
|
Unaudited
|
|
Unaudited
|
|
Audited
|
|
|
U.S. dollars
|
|
NIS
|
|
|
(In thousands, except share and per
share data)
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
Cash and cash equivalents
|
6,396
|
|
22,572
|
|
6,279
|
|
Short term deposits, net
|
-
|
|
-
|
|
19,660
|
|
Marketable securities
|
2,833
|
|
9,996
|
|
4,997
|
|
Other accounts receivable
|
284
|
|
1,004
|
|
1,461
|
|
|
|
|
|
|
|
|
|
9,513
|
|
33,572
|
|
32,397
|
|
NON-CURRENT ASSETS:
|
|
|
|
|
|
|
Restricted cash
|
87
|
|
307
|
|
140
|
|
Other long-term assets
|
27
|
|
95
|
|
-
|
|
Property, plant and equipment, net
|
360
|
|
1,270
|
|
1,373
|
|
|
|
|
|
|
|
|
|
474
|
|
1,672
|
|
1,513
|
|
|
|
|
|
|
|
|
|
9,987
|
|
35,244
|
|
33,910
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
Trade payables
|
575
|
|
2,027
|
|
1,401
|
|
Other accounts payable
|
368
|
|
1,297
|
|
2,084
|
|
Non Traded Warrants to ADS
|
693
|
|
2,447
|
|
-
|
|
|
1,636
|
|
5,771
|
|
3,485
|
|
NON-CURRENT LIABILITIES:
|
|
|
|
|
|
|
Traded Warrants to ADS
|
2,443
|
|
8,622
|
|
1,938
|
|
EQUITY:
|
|
|
|
|
|
|
Ordinary shares of no par value:
Authorized: 500,000,000 shares at December 31, 2016
and September 30 2017; Issued and outstanding:
107,583,485*) at December 31, 2016;
119,843,679*) at September 30, 2017.
|
-
|
|
-
|
|
-
|
|
Share premium
|
22,773
|
|
80,367
|
|
67,414
|
|
Capital funds
|
2,971
|
|
10,483
|
|
6,217
|
|
Treasury shares
|
(2,671)
|
|
(9,425)
|
|
(9,425)
|
|
Accumulated deficit
|
(17,165)
|
|
(60,574)
|
|
(35,719)
|
|
|
|
|
|
|
|
|
|
5,908
|
|
20,851
|
|
28,487
|
|
|
|
|
|
|
|
|
|
9,987
|
|
35,244
|
|
33,910
|
|
*) Net of 2,686,693 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,
|
|
|
|
2017
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
Unaudited
|
Unaudited
|
|
|
|
U.S. dollars
|
NIS
|
|
|
|
(In thousands)
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
(7,043)
|
(24,855)
|
|
(12,435)
|
|
(7,802)
|
|
(5,466)
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net
cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
Net financing expenses
|
|
143
|
504
|
|
146
|
|
(29)
|
|
137
|
|
Loss (gain) from revaluation of financial
assets presented at fair value through
profit and loss
|
|
40
|
140
|
|
21
|
|
(149)
|
|
22
|
|
Depreciation
|
|
79
|
278
|
|
218
|
|
94
|
|
38
|
|
Capital loss from sell of property, plant and
equipment
|
|
-
|
-
|
|
9
|
|
-
|
|
-
|
|
Changes in fair value of traded and not
traded warrants to ADS
|
|
1,884
|
6,650
|
|
(77)
|
|
1,337
|
|
(77)
|
|
Share-based payment
|
|
1,138
|
4,016
|
|
2,086
|
|
1,572
|
|
576
|
|
Decrease (increase) in other receivables
|
|
103
|
362
|
|
(743)
|
|
126
|
|
17
|
|
Increase (decrease) in other payables
|
|
(179)
|
(633)
|
|
595
|
|
(4)
|
|
1,090
|
|
Net cash used in operating activities
|
|
(3,835)
|
(13,538)
|
|
(10,180)
|
|
(4,855)
|
|
(3,663)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
Proceeds received from the sale of fixed
assets
|
|
-
|
-
|
|
95
|
|
-
|
|
-
|
|
Short term deposits, net
|
|
5,534
|
19,530
|
|
(19,635)
|
|
18,020
|
|
(19,515)
|
|
Purchase of marketable securities measured
at fair value through profit and loss
|
|
(2,834)
|
(10,000)
|
|
-
|
|
(10,000)
|
|
-
|
|
Restricted cash, net
|
|
(47)
|
(167)
|
|
-
|
|
(2)
|
|
-
|
|
Sales of marketable securities measured at
fair value through profit and loss
|
|
1,414
|
4,991
|
|
1,801
|
|
-
|
|
-
|
|
Purchase of property, plant and equipment
|
|
(50)
|
(175)
|
|
(1,183)
|
|
(59)
|
|
(59)
|
|
Net cash provided by (used in) investing activities
|
|
4,017
|
14,179
|
|
(18,922)
|
|
7,959
|
|
(19,574)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
358
|
1,263
|
|
7
|
|
197
|
|
-
|
|
Issue of share capital and warrants, net of
issue costs
|
|
4,220
|
14,893
|
|
35,084
|
|
14,893
|
|
27,620
|
|
Net cash provided by financing activities
|
|
4,578
|
16,156
|
|
35,091
|
|
15,090
|
|
27,620
|
|
Exchange differences on balances of cash
and cash equivalents
|
|
(143)
|
(504)
|
|
(146)
|
|
29
|
|
(137)
|
|
Increase in cash and cash equivalents
|
|
4,617
|
16,293
|
|
5,843
|
|
18,223
|
|
4,246
|
|
Balance of cash and cash equivalents at the
beginning of the period
|
|
1,779
|
6,279
|
|
3,913
|
|
4,349
|
|
5,510
|
|
Balance of cash and cash equivalents at
the end of the period
|
|
6,396
|
22,572
|
|
9,756
|
|
22,572
|
|
9,756
|
|
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-ltd-provides-corporate-update-and-reports-third-quarter-2017-financial-results-300560863.html
SOURCE Cellect Biotechnology Ltd.