Cellect Biotechnology Reports Third Quarter 2019 Financial and Operating Results
TEL AVIV, Israel, Nov. 19, 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 third quarter ended September 30, 2019 and provided a corporate update.
Recent Highlights
-- Received an Investigational New Drug (IND) approval from the U.S. Food
and Drug Administration (FDA) for the commencement of a clinical trial
to determine the safety and tolerability of the ApoGraft technology for
haploidentical bone marrow transplantations. This development represents
the Company's first-ever clinical trial approval in the U.S. using its
ApoGraft stem cell selection technology, which is designed to
significantly reduce acute graft-versus-host disease (aGVHD) following
bone marrow transplantation.
-- Successfully validated the Company's technology in collaboration with a
regenerative medicine company. The study, when combined with others and
internal findings increase the body of evidence supporting the Company's
technology and add further proof to support Cellect ASCs derived stem
cells program. Biocompatibility with certain collagen-based matrixes
successfully demonstrated that cells grown utilizing the Company's
protocol can be incorporated into matrixes for expansion,
transplantation and tissue regeneration.
"Our clinical and regulatory teams remained focused during the third quarter and the more recent positive developments position us to achieve our goals, both in the U.S. and Israel," commented Dr. Shai Yarkoni, Chief Executive Officer. "In the U.S., the IND approval is a significant achievement and represents our first-ever FDA IND in the U.S., with Washington University School of Medicine. In Israel, our Phase 1/2 clinical study of ApoGraft(TM) is progressing slowly and we expect to complete the recruitment around the end of the year."
"With our prudent use of cash during the third quarter and the anticipated cash usage needs over the coming quarters, we continue to believe we have the resources to execute our clinical and regulatory plans for the foreseeable future," said Eyal Leibovitz, Chief Financial Officer.
Third Quarter 2019 Financial Results:
-- Research and development (R&D) expenses for the third quarter of 2019
were $0.71 million compared to $1.18 million in the third quarter of
2018. The Company remains committed to the ongoing clinical trials in
Israel as well as pursuing the regulatory approval from the FDA to
commence its US-based trial.
-- General and administrative (G&A) expenses for the third quarter of 2019
were $0.80 million compared to $1.13 million in the third quarter of
2018. The decrease reflects the cost cutting initiatives implemented by
the Company during the third quarter of 2019.
-- Finance income for the third quarter of 2019 were $0.12 million compared
to finance income of $0.36 million in the third quarter of 2018. The
decrease was primarily due to changes related to fair value of the
tradable and non-tradable warrants issued in prior fundraising.
-- Net loss for the third quarter of 2019 was $1.4 million, or $0.01 per
share and $0.12 per ADS, compared to $1.9 million, or $0.014 per share
and $0.29 per ADS, in the third quarter of 2018.
-- Cash and cash equivalents, $6.27 million as of September 30, 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, 2019 (U.S. $1 = NIS 3.482).
Strategic Review Progress Update
On May 16, 2019, the Company disclosed that it commenced plans to explore strategic alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include, but are not limited to, an acquisition, merger, business combination, including in other business fields than the Company's in-licensing, or other strategic transaction involving the Company or its assets. The Company continues to evaluate business development opportunities and will keep investors informed as they mature or warrant investor disclosure.
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. 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; or maintain its current operations; uncertainties involving any strategic transaction the Company may decide to enter into as the result of its current efforts to explore new strategic alternatives; 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, 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
Nine
months Nine months ended Three months ended
ended
September 30, September 30, September 30,
2019 2019 2018 2019 2018
Unaudited
Unaudited
U.S. dollars
NIS
(In thousands, except share and per
share data)
Research and development
expenses 2,743 9,551 9,473 2,465 4,125
General and administrative
expenses 2,249 7,832 11,001 2,768 3,929
Operating loss 4,992 17,383 20,474 5,233 8,054
Financial expenses (income) due
to (2,303) (8,020) (2,935) (910) (1,320)
warrants exercisable into shares
Other financial expenses
(income), net 393 1,369 (1,177) 489 64
Total comprehensive loss 3,082 10,732 16,362 4,812 6,798
Loss per share:
Basic and diluted loss per share 0.015 0.051 0.127 0.021 0.052
Basic and diluted loss per ADS 0.30 1.02 2.54 0.42 1.04
Weighted average number of
shares 208,771,303 208,771,303 129,139,278 224,087,799 130,192,799
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,
2019 2019 2018
Unaudited Unaudited Audited
U.S. dollars
NIS
(In thousands, except share and per
share data)
CURRENT ASSETS:
Cash and cash equivalents 6,275 21,849 17,809
Other receivables 201 700 816
6,476 22,549 18,625
NON-CURRENT ASSETS:
Restricted cash 94 329 337
Right-of-use assets 332 1,156
Other long-term receivables 30 103 132
Property, plant and equipment, net 396 1,379 1,544
852 2,967 2,013
7,328 25,516 20,638
LIABILITIES AND
SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables 245 852 887
Other payables 629 2,192 4,012
Current maturities of lease liability 123 428
997 3,472 4,899
NON-CURRENT LIABILITIES:
Warrants 808 2,812 1,816
Lease liability 219 764
1,027 3,576 1,816
EQUITY:
Ordinary shares of no par value: -
Authorized: 500,000,000 shares at December 31, 2018
and 10,000,000 shares at September 30, 2019; Issued
and outstanding: 130,414,799*) and 224,087,799*)
shares as of December 31, 2018 and September 30,
2019, respectively.
Additional Paid in Capital 31,104 108,305 95,085
Share-based payments 4,129 14,375 12,319
Treasury shares (2,707) (9,425) (9,425)
Accumulated deficit (27,222) (94,787) (84,056)
5,304 18,468 13,923
7,328 25,516 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
Nine months Nine months ended Three months ended
ended
September 30, September 30, September 30,
2019 2019 2018 2019 2018
Unaudited
Unaudited
U.S. dollars
NIS
(In thousands)
Cash flows from operating
activities:
---
Total comprehensive loss (3,082) (10,732) (16,362) (4,812) (6,798)
Adjustments to reconcile net
loss to net cash used in
operating activities:
Net financing expenses 312 1,087 (823) 272 14
Loss (gain) from revaluation of
financial 2 8 (288) 2 (140)
assets presented at fair value
through
profit and loss
Depreciation 82 285 337 93 122
Changes in fair value of traded
and not (2,686) (9,351) (3,208) (910) (1,320)
traded warrants
Share-based payment 546 1901 3,247 1,371 1,063
Decrease (increase) in other
receivables 42 146 256 343
Increase (decrease) in other
payables (533) (1,855) (706) (1,138) 409
Decrease in right-of-use
assets 131 457 143
Interest received during the
period (21) (75) (47) (29) (32)
Net cash used in operating
activities (5,207) (18,129) (17,594) (5,008) (6,339)
Cash flows from investing
activities:
---
Short term deposits, net 282 3,785
Restricted deposit, net (22) 6
Sales of marketable securities
measured 13,999 5,501
at fair value through profit and
loss
Purchase of property, plant and (34) (120) (643) (415)
equipment
Net cash provided by investing
activities (34) (120) 13,616 8,877
Cash flows from financing
activities:
---
Exercise of warrants and stock
options 399
into shares
Leases liabilities (121) (422) (143)
Issue of share capital and
warrants, net 6,813 23,723 12,360
of issue costs
Net cash provided (used) by
financing 6,692 23,301 12,759 (143)
activities
Exchange differences on balances
of (291) (1,012) 870 (243) 18
cash and cash equivalents
Increase (decrease) in cash and
cash 1,160 4,040 9,651 (5,394) 2,556
equivalents
Balance of cash and cash
equivalents at 17,809 13,734 27,243 20,829
the beginning of the period
5,115
Balance of cash and cash
equivalents 21,849 23,385 21,849 23,385
at the end of the period
6,275
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
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SOURCE Cellect Biotechnology Ltd.
