Cellect Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2017 Financial Results
Cellect Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2017 Financial Results
TEL AVIV, Israel, March 19, 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 fourth quarter and full year ended December 31, 2017.
"We are very pleased with our accomplishments in the fourth quarter and the full year of 2017," said Dr. Shai Yarkoni, Chief Executive Officer.
"During the fourth quarter, the Company reported positive results from a 20 patient trial with Tel-Aviv Ichilov Medical Center, in which ApoGraft(TM) significantly improved stem cells derived from fat tissues and the Company announced that Company CEO, Dr. Shai Yarkoni, was chosen to present Cellect technology and recent advancements at the Bio-Europe 2017 conference in Berlin.
"Overall, during 2017, the Company announced the treatment of the first blood cancer patient in its ongoing Phase I/II trial of the Company's stem cell technology ApoGraft(TM) and the successful performance of the procedure using the Company's ApoGraft(TM) technology; received a notice of allowance on a key method of treatment patent (Application No. 13/811,374) from the United States Patent & Trademark Office; announced positive final results from the non-interventional clinical trial of ApoGraft(TM) in healthy donors (104 donor test base); announced that Michael Berelowitz MD., former head, Clinical Development and Medical Affairs, Pfizer Specialty Care Business Unit, joined Cellect's board of directors; announced that Dr. Corey Cutler, Senior Physician at the world-renowned U.S. Dana Farber Cancer Institute and an Associate Professor of Medicine at Harvard Medical School, joined the Company's Scientific and Medical Advisory Board; announced the U.S. Food & Drug Administration (FDA) provided Cellect with pre-Investigational New Drug (IND) meeting minutes supporting an IND submission in the U.S. for Cellect's flagship product, ApoGraft(TM); the Company received a formal notice of Intention to Grant for a patent (Application No. 11751949.6-1466) covering a key method of treatment from the European Patent Office; the Company received a formal notice of allowance for a patent (Application No. 14/383,288) covering a key composition of matter and method of use from the US Patent & Trademark Office (USPTO); further to the notices of allowance received from the USPTO, the Company received further confirmation for grant of its patent by the Russian patent authorities (Application No. 2014138001) for a key composition of matter and method of use covering various devices using the ApoGraft(TM) for selection of stem cells; announced that the FDA granted Orphan Drug Status to Cellect's ApoGraft(TM) for Acute GvHD and Chronic GvHD; announced a $4.3 million raise in a registered direct offering; completed its voluntary de-listing from the Tel Aviv Stock Exchange" continued Dr. Yarkoni.
"We believe Cellect's transformative approach to cell selection represents a significant breakthrough in the ability to achieve much better stem cell preparation, for whatever use. Production of enriched stem cells material with substantially reduced mature immune cells has shown a great promise for reducing the significant risks associated with bone marrow transplantation", continued Dr. Yarkoni. "With this continued development progress, and our two registered direct offerings, Cellect is focused on creating long-term value for our shareholders."
Recent corporate highlights:
-- the Company announced the results of the first group of patients in the
Company's ongoing Phase I/II clinical trial of ApoGraft(TM) after one
month follow-up with 100% acceptance of the stem cell transplant and
zero related adverse events,
-- the Company announced the opening of a second clinical trial site at
Hadassah Medical Center for the Company's ongoing Phase I/II clinical
trial of ApoGraft(TM) and that it received the approval from the Data
and Safety Monitoring Board (DSMB) for dose escalation in the clinical
trial,
-- David Braun, Head of Merck Group's Medical Device Business, joined
Cellect's Board of Directors, and
-- the Company announced a $4 million registered direct offering.
Fourth Quarter and Full Year 2017 Financial Results:
-- Research and development (R&D) expenses for the fourth quarter and for
the full year of 2017 were $0.98 million and $3.32 million respectively,
compared to $0.73 million in the fourth quarter of 2016 and $2.38
million for the full year of 2016. The increase in R&D expenses for the
full year of 2017 as compared to the full year of 2016 was primarily
attributable to an increase from share based payment, salaries and
related personnel expenses reflecting the growth in the Company's
activities resulting from an increase in the number of employees engaged
in research and development related activities from thirteen to
eighteen.
-- General and administrative (G&A) expenses for the fourth quarter and for
the full year of 2017 were $0.98 million and $3.73 million respectively,
compared to $0.50 million in the fourth quarter of 2016 and $2.30
million for the full year of 2016. The increase in G&A expenses for the
full year of 2017 as compared to the full year of 2016 was primarily due
to professional services, share based compensation and expenses related
to business development activities.
-- Finance income, net for the fourth quarter of 2017 were $0.99 million,
and finance expenses, net for the full year of 2017 were $1.09 million,
compared to net finance income, net of $0.39 million in the fourth
quarter of 2016 and $0.18 million for the full year of 2016
respectively. The financial expenses, net in the full year of 2017 as
compared to the financial income, net in the full year of 2016, was
primarily due to the change in the fair value of the listed warrants
granted in the Company's initial public offering in 2016 and the
unregistered warrants granted in the Company's registered direct
offering in 2017.
-- Net loss for the fourth quarter and for the full year of 2017 was $0.97
million and $8.14 million respectively, or $0.008 per share for the
fourth quarter and $0.073 per share for the year of 2017 respectively,
compared to $0.83 million, or $0.008 per share, in the fourth quarter
and $4.41 million, or $0.049 per share for the full year of 2016.
Balance Sheet Highlights:
-- Cash and cash equivalents (including marketable securities and short
terms deposits) totaled $8.0 million as of December 31, 2017, compared
to $9.4 million on September 30, 2017, and $8.9 million as of December
31, 2016. The change in the cash and cash equivalents was primarily due
to net proceeds of $4.0 million (after deducting underwriters' fees)
raised through a registered direct offering completed in September 2017,
offset by cash used in operations during the year.
-- Shareholders' equity totaled $5.4 million as of December 31, 2017,
compared to $6.0 million on September 30 2017, and $8.2 million as of
December 31, 2016.
For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange as of December 31, 2017 (U.S. $1 = NIS 3.467).
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 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 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 belief that its transformative approach to cell selection represents a significant breakthrough in the ability to achieve much better stem cell preparation. 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
Twelve Twelve months ended Three months ended
months
ended
December 31, December 31, December 31,
------------ ------------ ------------
2017 2017 2016 2017 2016
---- ---- ---- ---- ----
Unaudited Audited Audited Unaudited Unaudited
--------- ---------------------------------------------
U.S. dollars NIS
------------ ---
(In thousands, except share and per
share data)
Research and development expenses, net 3,318 11,503 8,256 3,404 2,518
General and administrative expenses 3,729 12,930 7,968 3,406 1,721
Other income - - (280) - -
--- --- ---- --- ---
Total operating loss 7,047 24,433 15,944 6,810 4,239
Financial expenses due to warrants exercisable into ADS 926 3,208 (612) (3,614) (1,144)
Other financial expenses (income), net 168 583 (15) 172 (213)
--- --- --- --- ----
Total comprehensive loss 8,141 28,224 15,317 3,368 2,882
===== ====== ====== ===== =====
Loss per share and ADS:
Basic and diluted loss per share 0.073 0.252 0.168 0.028 0.027
===== ===== ===== ===== =====
Basic and diluted loss per ADS 1.46 5.04 3.36 0.56 0.54
==== ==== ====
Weighted average number of shares outstanding used 111,923,663 111,923,663 91,128,516 120,011,684 107,583,485
to compute basic and diluted loss per share
Cellect Biotechnology Ltd.
Consolidated Balance Sheet Data
ASSETS
Convenience
translation
December 31, December 31, December 31,
------------ ------------ ------------
2017 2017 2016
---- ---- ----
Unaudited Audited Audited
--------- ------- -------
U.S. dollars NIS
------------ ---
(In thousands, except share and per
share data)
CURRENT ASSETS:
Cash and cash equivalents 3,961 13,734 6,279
Short term deposits - - 19,660
Marketable securities 4,038 13,999 4,997
Other receivables 236 818 1,461
--- --- -----
8,235 28,551 32,397
----- ------ ------
NON-CURRENT ASSETS:
Restricted cash 88 305 140
Other long-term assets 50 173 -
Property, plant and equipment, net 388 1,344 1,373
--- ----- -----
526 1,822 1,513
--- ----- -----
8,761 30,373 33,910
===== ====== ======
LIABILITIES AND
SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables 491 1,703 1,401
Other payables 691 2,396 2,084
--- ----- -----
1,182 4,099 3,485
----- ----- -----
NON-CURRENT LIABILITIES:
Warrants to ADS 2,141 7,422 1,938
----- ----- -----
EQUITY:
Ordinary shares of no par value: - - -
Authorized: 500,000,000 shares at December 31, 2016
and 2017; Issued and outstanding: 107,583,485*) and
120,140,659*) shares as of December 31, 2016 and
2017, respectively.
Additional Paid In Capital 23,894 82,839 67,414
Share-based payments 2,706 9,381 6,217
Treasury shares (2,718) (9,425) (9,425)
Accumulated deficit (18,444) (63,943) (35,719)
------- ------- -------
5,438 18,852 28,487
----- ------ ------
8,761 30,373 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
Twelve Twelve months ended Three months ended
months
ended
December 31, December 31, December 31,
------------ ------------ ------------
2017 2017 2016 2017 2016
---- ---- ---- ---- ----
Unaudited Audited Audited Unaudited Unaudited
--------- ---------------------------------------------
U.S. dollars NIS
------------ ---
(In thousands)
Cash flows from operating activities:
-------------------------------------
Total comprehensive loss (8,141) (28,224) (15,317) (3,368) (2,882)
------ ------- ------- ------ ------
Adjustments to reconcile net loss to net cash used in
operating activities:
Net financing expenses 154 532 134 175 (12)
Loss (gain) from revaluation of financial assets presented 40 139 (106) (1) (142)
at fair value through profit and loss
Depreciation 107 372 350 94 123
Share-based payment 1,553 5,384 1,552 1,368 (534)
Changes in fair value of traded and not traded 866 3,003 (1,235) (3,647) (1,158)
warrants to ADS
Decrease (increase) in other receivables 136 470 (1,049) 107 (306)
Increase in other payables 117 407 1,259 1,040 664
Interest received 42 147 - - -
--- --- --- --- ---
Net cash used in operating activities (5,126) (17,770) (14,412) (4,232) (4,247)
------ ------- ------- ------ ------
Cash flows from investing activities:
-------------------------------------
Proceeds received from the sale of fixed assets - - 95 - -
Short term deposits, net 5,633 19,530 (19,530) - 120
Restricted deposit (47) (165) (120) 2 (120)
Marketable securities measured at fair value (2,599) (9,008) 2,808 (4,001) 1,007
through profit and loss, net
Purchase of property, plant and equipment (77) (266) (1,265) (91) (82)
Net cash provided by (used in) investing activities 2,910 10,091 (18,012) (4,090) 925
----- ------ ------- ------ ---
Cash flows from financing activities:
-------------------------------------
Exercise of warrants and stock options into shares 414 1,432 7 169 -
Issue of share capital and warrants, net of issue costs 4,148 14,381 34,917 (510) (167)
----- ------ ------ ---- ----
Net cash provided (used in) by financing activities 4,562 15,813 34,924 (341) (167)
----- ------ ------ ---- ----
Exchange differences on balances of cash and (196) (679) (134) (175) 12
cash equivalents
Increase (decrease) in cash and cash equivalents 2,150 7,455 2,366 (8,838) (3,477)
Balance of cash and cash equivalents at the 6,279 3,913 22,572 9,756
beginning of the period
1,811
-----
Balance of cash and cash equivalents at the 13,734 6,279 13,734 6,279
end of the period
3,961
=====
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co
+972-9-974-1444
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SOURCE Cellect Biotechnology Ltd.
