Cellect Biotechnology Reports Fourth Quarter and Full Year 2018 Results and Recent Corporate Progress
TEL AVIV, Israel, March 18, 2019 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of a novel stem cell production technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2018, as well as recent corporate progress.
"We made progress in 2018 as we overcame the short-term setback of patient recruitment in our trial in Israel and moved closer to the initiation of our U.S. clinical efforts," commented Dr. Shai Yarkoni, Chief Executive Officer. "We continue to validate our innovative science, and the U.S. Food and Drug Administration's (FDA) recent decision to hire at least 50 clinical assesors to focus on cell and gene therapy companies is precisely why we believe Cellect will be a major beneficiary in the growth of this sector - companies and academics need to source stem cells from a reliable and cost effective supplier to develop their therapies over the next decade and we are positioning Cellect's technology to enable that. Operationally, we recently strengthened our balance sheet through an underwritten public offering, securing interest from sophisticated healthcare investors and participation from senior executives from Cellect, which reflects our continued optimism and outlook for 2019. We look forward to providing an update on our progress in the coming months through a business update conference call."
Recent Operating and Financial Highlights:
-- Validated through an independent third party that the ApoGraft
technology accelerates mesenchymal stem cell (MSC) expansion relative to
processes currently used in research and manufacturing.
-- Concluded the scale-up development and manufacturing of clinical grade
FasL in collaboration with its outsourced supplier, enabling the Company
to expedite U.S. clinical programs into multiple studies.
-- Entered into a collaboration with Washington University, a leading
academic institution based in St. Louis, MO, to determine the safety and
tolerability in a U.S. Phase I/II study using ApoGraft(TM) for bone
marrow transplantations.
-- Strengthened the balance sheet through a $6.5 million underwritten
public offering, providing the Company additional resources to execute
its business strategy.
Anticipated Near-Term Milestones:
-- The Company expects the Investigational New Drug (IND) application to be
submitted to the FDA by the lead investigator, Dr. John DiPersio,
Director of the Center for Gene and Cellular Immunotherapy at Washington
University School of Medicine and President of the American Society for
Blood and Marrow Transplantation, in the second quarter of 2019.
-- The Company expects to report interim data from the Israeli trial in the
second quarter of 2019.
Key 2018 Achievements:
Clinical Results in Israel Continue to Validate the Company's Innovation
-- Reported the results of the first six patients after a one month
follow-up in the clinical trial of Cellect's ApoGraft(TM) stem cell
transplant with 100% acceptance and zero related adverse events.
-- Opened a second clinical trial site at Hadassah Medical Center and
received the approval from the Data and Safety Monitoring Board (DSMB)
for dose escalation in the third of the fourth cohort in the clinical
trial.
-- Successfully completed the proof of concept testing of the Company's
ApoTainer(TM) using its FasL-coated magnetic beads for maximizing
efficacy and scalability of stem cell based products' manufacturing. The
ApoTainer(TM) is designed to replace high risk, complex and expensive
procedures currently used by laboratories (e.g. T cells depeletion),
with a significantly more effective process at a fraction of the time
and cost.
Corporate Development Initiatives to Drive Commercialization Efforts
-- Launched a U.S. subsidiary (Cellect Biotech, Inc.) to oversee business
and clinical development efforts in the U.S. market.
Key Collaboration Agreements
-- 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.
-- Finalized 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 ApoTainerTM for planned
clinical trials in the U.S.
-- Entered into 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.
Protecting and Enhancing the Company's IP Portfolio
-- Granted a patent by the European Patent Office Company 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" and received a
Notice of Allowance from the Korean Intellectual Property Office and the
Japanese and Australian Offices for Patents & Trademarks for the same
patent.
-- Two new patent applications were submitted during 2018 covering further
propriatory inventions in connection with mesenchymal stem cells and
CAR-T cells expansion processes.
Fourth Quarter and Full Year 2018 Financial Results:
-- Research and development (R&D) expenses for the fourth quarter and for
the full year of 2018 were $1.08 million and $3.60 million respectively,
compared to $0.91 million in the fourth quarter of 2017 and $3.07
million for the full year of 2017. The increase in R&D expenses for the
full year of 2018 as compared to the full year of 2017 was primarily due
to an increase from purchasing materials and an increase in salaries and
related expenses reflecting the progress in our research and development
activities and the growth of our employees working on our research and
development activities.
-- General and administrative (G&A) expenses for the fourth quarter and for
the full year of 2018 were $1.26 million and $4.20 million respectively,
compared to $0.91 million in the fourth quarter of 2017 and $3.45
million for the full year of 2017. The increase in G&A expenses for the
full year of 2018 as compared to the full year of 2017 was primarily due
to increase in salaries and related personnel expenses due to an
increase in the number of our business development personnel.
-- Finance income for the fourth quarter and for the full year of 2018 was
$1.34 million, and $2.44 million respectively, compared to $0.92 million
in the fourth quarter of 2017 and expenses of $1.01 million for the full
year of 2017 respectively. The financial income in the full year of 2018
as compared to the expenses in the full year of 2017, is primarily due
to the change in the fair value of the listed warrants granted in our
U.S. initial public offering in 2016 and of the unregistered warrants
granted in our registered direct offerings in 2017 and in 2018.
-- Total Comprehensive loss for the fourth quarter and for the full year of
2018 was $1.00 million and $5.37 million respectively, or $0.008 per
share for the fourth quarter and $0.041 per share for the year of 2018
respectively, compared to $0.90 million, or $0.007 per share, in the
fourth quarter of 2017 and $7.53 million, or $0.067 per share for the
full year of 2017.
Balance Sheet Highlights:
-- Cash and cash equivalents and marketable securities totaled $4.75
million as of December 31, 2018, compared to $6.24 million on September
30, 2018, and $7.40 million on December 31, 2017. The change compared to
December 31, 2017 was primarily due to a net proceeds of $3.6M in a
registered direct offering in January 2018, offset by ongoing
operational expenses.
-- Shareholders' equity totaled $3.71 million as of December 31, 2018,
compared to $4.37 million on September 30, 2018, and $5.03 million on
December 31, 2017.
For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2018 (U.S. $1 = NIS 3.748).
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 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 intent regarding the future potential of Cellect's 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, 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
Twelve months Twelve months ended Three months ended
ended
December 31, December 31, December 31,
2018 2018 2017 2018 2017
Unaudited
Audited
Audited
Unaudited
Unaudited
U.S. dollars
NIS
(In thousands, except share and per
share data)
Research and development expenses 3,605 13,513 11,503 4,040 3,404
General and administrative expenses 4,198 15,734 12,930 4,733 3,406
Operating loss 7,803 29,247 24,433 8,773 6,810
Financial expenses (income) due to (2,059) (7,719) 3,208 (4,784) (3,614)
warrants exercisable into ADS
Other financial expenses (income), net (377) (1,415) 583 (238) 172
Total comprehensive loss 5,367 20,113 28,224 3,751 3,368
Loss per share:
Basic and diluted loss per share 0.041 0.155 0.252 0.029 0.028
Basic and diluted loss per ADS 0.82 3.11 5.04 0.58 0.56
Weighted average number of shares 129,426,091 129,426,091 111,968,663 130,274,953 120,011,684
outstanding used to compute basic and
diluted loss per share
Cellect Biotechnology Ltd
Consolidated Balance Sheet Data
ASSETS
Convenience
translation
December 31,
December 31, December 31,
2018 2018 2017
Unudited
Audited Audited
U.S. dollars
NIS
(In thousands, except share and per
share data)
CURRENT ASSETS:
Cash and cash equivalents 4,752 17,809 13,734
Marketable securities - 13,999
Other receivables 218 816 818
4,970 18,625 28,551
NON-CURRENT ASSETS:
Restricted cash 90 337 305
Other long-term assets 35 132 173
Property, plant and equipment,
net 412 1,544 1,344
537 2,013 1,822
5,507 20,638 30,373
LIABILITIES AND
SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables 237 887 1,703
Other payables 1,070 4,012 2,396
1,307 4,899 4,099
NON-CURRENT LIABILITIES:
Warrants to ADS 485 1,816 7,422
EQUITY:
Ordinary shares of no par
value: -
Authorized: 500,000,000 shares at December 31, 2017 a
nd December 31 2018; Issued and outstanding:
120,185,659*) and 130,414,799*) shares as of
December 31, 2017 and December 31, 2018,
respectively.
Additional Paid In Capital 25,370 95,085 82,839
Share-based payments 3,287 12,319 9,381
Treasury shares (2,515) (9,425) (9,425)
Accumulated deficit (22,427) (84,056) (63,943)
3,715 13,923 18,852
5,507 20,638 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
Twelve months Twelve months ended Three months ended
ended
December 31, December 31, December 31,
2018 2018 2017 2018 2017
Unaudited Audited Audited Unaudited Unaudited
U.S. dollars
NIS
(In thousands)
Cash flows from operating
activities:
---
Total comprehensive loss (5,367) (20,113) (28,224) (3,751) (3,368)
Adjustments to reconcile net
loss to net
cash used in operating
activities:
Exchange rate difference (345) (1,297) 532 (380) 175
Loss (gain) from revaluation of
financial (106) (397) 139 (109) (1)
assets presented at fair value
through
profit and loss
Depreciation 122 459 372 122 94
Changes in fair value of traded
and non (2,059) (7,719) 3,003 (4,511) 1,368
traded warrants to ADS
Share-based payment 1,210 4,537 5,384 1,290 (3,647)
Decrease (increase) in other
receivables 12 43 470 (214) 107
Increase (decrease) in other
payables 213 798 407 1,505 1,040
Interest received 14 54 147 7
Net cash used in operating
activities (6,306) (23,635) (17,770) (6,041) (4,232)
Cash flows from investing
activities:
---
Short term deposits, net 103 387 19,530 105
Restricted deposit, net (6) (22) (165) 2
(Purchase) Sales of marketable
securities 3,735 13,999 (9,008) (4,001)
measured at fair value through
profit and loss
Purchase of property, plant and
equipment (175) (656) (266) (13) (91)
Net cash provided by investing
activities 3,657 13,708 10,091 92 (4,090)
Cash flows from financing
activities:
---
Exercise of warrants and stock
options into shares 106 399 1,432 169
Issue of share capital and
warrants, net of issue costs 3,299 12,360 14,381 (510)
Net cash provided (used) by
financing activities 3,405 12,759 15,813 (341)
Exchange differences on balances
of cash and cash equivalents 332 1,243 (679) 373 (175)
Increase (decrease) in cash and
cash equivalents 1,088 4,075 7,455 (5,576) (8,838)
Balance of cash and cash
equivalents at the beginning of
the period 13,734 6,279 23,385 22,572
3,664
Balance of cash and cash
equivalents at the end of the
period 17,809 13,734 17,809 13,734
4,752
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co
+972-9-974-1444
Or
EVC Group LLC
Michael Polyviou / Todd Kehrli
+1(732) 933-2754
mpolyviou@evcgroup.com / tkehrli@evcgroup.com
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SOURCE Cellect Biotechnology Ltd.
