Cellect Biotechnology Provides Corporate Update and Reports Third Quarter 2018 Financial Results
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(TM) and the ApoTainer(TM) for planned
clinical trials in the U.S.
-- European Patent Office has granted the Company a patent for its
ApoTainer(TM) device which is used in conjunction with its platform
ApoGraft(TM) 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(TM) with Cell2in's proprietary
identification technology FreSHtracer(TM) 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(TM) device which is used in conjunction with its platform
ApoGraft(TM) 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(TM) 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(TM). The new technology utilizes FasL-coated magnetic beads
for maximizing efficacy and scalability of stem cell-based products'
manufacturing. The Apotainer(TM) 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 Nine months ended Three months ended
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 (809) (2,935) 6,821 (1,320) 1,509
warrants exercisable into ADS
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 129,139,278 129,139,278 109,188,626 130,192,799 111,476,292
outstanding used to compute
basic and
diluted loss per share
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 Nine months ended Three months ended
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 (79) (288) 140 (140) (149)
assets presented at fair value
through
profit and loss
Depreciation 93 337 278 122 94
Changes in fair value of traded
and not (885) (3,208) 6,650 (1,320) 1,337
traded warrants to ADS
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 3,859 13,999 (5,009) 5,501 (10,000)
measured at fair value through
profit and
loss
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 110 399 1,263 197
shares
Issue of share capital and
warrants, net of 3,408 12,360 14,893 14,893
issue costs
Net cash provided (used) by
financing 3,518 12,759 16,156 15,090
activities
Exchange differences on balances
of cash 240 870 (504) 18 29
and cash equivalents
Increase (decrease) in cash and
cash 2,660 9,651 16,293 2,556 18,223
equivalents
Balance of cash and cash
equivalents at the 13,734 6,279 20,829 4,349
beginning of the period
3,787
Balance of cash and cash
equivalents at 23,385 22,572 23,385 22,572
the end of the period
6,447
Contact:
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co
+ 972-9-974-1444
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SOURCE Cellect Biotechnology Ltd.
