Cellect Biotechnology Ltd Provides Corporate Update and Reports Second Quarter 2017 Financial Results
TEL AVIV, Israel, Aug. 21, 2017 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP, TASE: 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 second quarter ended June 30, 2017.
"We are very pleased with our accomplishments in the first half of 2017," said Dr. Shai Yarkoni, Chief Executive Officer. "As planned, 2017 is turning into a transformative year for Cellect Biotechnology. Cellect initiated its Phase I/II study on cancer patients undergoing matched related allogeneic HSCT transplantation and reported positive results in the first patient followed by the approval to recruit two more patients. Further, Cellect held a pre-IND meeting with the FDA that was very positive and Cellect is moving ahead with its plan to submit an IND".
Important progress was achieved with the company's IP portfolio - the major patent covering the composition of matter and use of the Apotainer(Tm) was issued in US and Russia, the collaboration with Entegris was further consolidated by receiving a BIRDF non-equity grant, and the development of the Apotainer was accelerated.
In addition, world renowned leaders joined the Company (i.e KOLs from Harvard Medical school, executives from Pfizer and Merck) and the Company teamed up with Boston based Locust-Walk business development group for planning and launching a business development campaign before the end of the year.
During the second quarter, the Company made the following announcements -
-- the U.S. Food & Drug Administration (FDA) provided Cellect with the
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;
-- David Braun, Head of Merck Group's Medical Device Business, is joining
Cellect's Scientific and Medical Advisory Board;
-- as previously disclosed, the Company is voluntarily delisting its shares
from trading on the Tel-Aviv stock Exchange (the "TASE"), and moving to
trade American Depositary Shares, each of which represents 20 ordinary
shares, exclusively on NASDAQ. The last trading day on TASE will be on
September 3, 2017."
Recent Corporate Highlights:
-- Locust Walk was engaged to seek strategic licensing deals and global
pharma partnerships in order to kick-start the commercialization of
Cellect's ApoGraft as an innovative platform for stem cells selection
for all indications and from all sources of cells.
Second Quarter 2017 Financial Results:
-- Research and development (R&D) expenses for the second quarter of 2017
were $0.69 million, compared to $0.81 million in the first quarter of
2017 and $0.53 million in the second quarter of 2016. The decrease
mainly derived from the grant received from the Bird foundation in the
amount of $0.12 million in the second quarter.
-- General and administrative (G&A) expenses for the second quarter of 2017
were $1.0 million, compared to $0.73 million in the first quarter of
2017 and $0.46 million in the second quarter of 2016. The increase
mainly derived from $0.09 million expenses related to the voluntary
delisting from TASE and increase in share based compensation expenses in
the amount of $0.14 million.
-- Finance income for the second quarter of 2017 was $0.40 million,
compared to finance expense of $1.9 million in the first quarter of
2017. The change was primarily due to changes related to fair value of
the tradable warrants granted in the U.S. IPO.
-- Net loss for the second quarter of 2017 was $1.3 million, or $0.012 per
share, compared to $3.6 million, or $0.039 per share, in the first
quarter of 2017 and $0.91 million, or $0.011 per share, in the second
quarter of 2016.
Balance Sheet Highlights:
-- Cash and cash equivalents, marketable securities and short-term deposits
totaled $6.4 million as of June 30, 2017, compared to $7.4 million on
March 31, 2017, and $8.8 million on December 31, 2016. The decrease from
March 31, 2017, was primarily due to expenses incurred in connection
with the ongoing research and development activities of the company and
the voluntarily delisting from TASE.
-- Tradable warrants exercisable into ADSs totaled $2.1 million as of June
30, 2017, and represented, according to the international financial
reporting standards (IFRS), the fair value of the tradable warrants
granted in the U.S. IPO which closed on August 3, 2016.
-- Shareholders' equity totaled $4.3 million as of June 30, 2017, compared
to $5.0 million on March 31, 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 June 30, 2017 (U.S. $1 = NIS 3.496).
The Company's consolidated financial results for the three and six months ended June 30, 2017 are presented in accordance with International Financial Reporting Standards.
About Cellect Biotechnology Ltd.
The Company is developing an innovative technology which enables the functional selection of stem cells based on their sensitivity to apoptosis. This functional-based selection is a breakthrough technology in the ability to isolate stem cells from any given tissue, and may improve a variety of stem cells applications.
The Company's first planned product line is expected to include unique containers for cell selection in an apoptosis-inducing microenvironment. Cellect's first planned commercial product candidate is a medical kit designed for the cancer treatment bone marrow transplantations market, as well as other markets which require cell selection. The Company plans that in the future its technology will be integrated in many production procedures of stem cell-based products.
The Company's securities are currently traded on both the NASDAQ Capital Market and the Tel Aviv Stock Exchange (NASDAQ: "APOP", "APOPW", TASE: "APOP").
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, the expected characteristics of our first product line, our beliefs about the future integration of our technology into the production procedures of stem cell-based products 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
Six months Six months ended Three months ended
ended
June 30, June 30, June 30,
-------- -------- --------
2017 2017 2016 2017 2016
---- ---- ---- ---- ----
Unaudited Unaudited
--------- ---------
U.S. dollars NIS
------------ ---
(In thousands, except share and per
share data)
Research and
development expenses 1,495 5,227 3,679 2,405 1,848
General and
administrative
expenses 1,729 6,046 3,547 3,497 1,617
Other income - - (280) - (280)
--- --- ---- --- ----
Operating loss 3,224 11,273 6,946 5,902 3,185
Financial expenses
(income) due to
warrants exercisable
into shares 1,519 5,312 - (1,461) -
Other financial
expenses (income), net 135 468 23 161 (5)
--- --- --- --- ---
Total comprehensive
loss 4,878 17,053 6,969 4,602 3,180
===== ====== ===== ===== =====
Loss per share:
Basic and diluted loss
per share 0.045 0.158 0.088 0.042 0.039
===== ===== ===== ===== =====
Weighted average number
of shares outstanding
used to compute basic
and diluted loss per
share 108,034,218 108,034,218 79,113,097 108,462,728 81,456,571
=========== =========== ========== =========== ==========
Cellect Biotechnology Ltd
Consolidated Balance Sheet Data
ASSETS
Convenience
translation
June 30, June 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 1,244 4,349 6,279
Short term deposits 5,111 17,867 19,660
Marketable securities - - 4,997
Other accounts receivable 316 1,106 1,461
--- ----- -----
6,671 23,322 32,397
----- ------ ------
NON-CURRENT ASSETS:
Restricted cash 87 305 140
Other long-term assets 34 119 -
Property, plant and equipment, net 373 1,305 1,373
--- ----- -----
494 1,729 1,513
--- ----- -----
7,165 25,051 33,910
===== ====== ======
LIABILITIES AND
SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables 435 1,521 1,401
Other accounts payable 382 1,335 2,084
--- ----- -----
817 2,856 3,485
--- ----- -----
NON-CURRENT LIABILITIES:
Traded Warrants to ADS 2,074 7,251 1,938
----- ----- -----
EQUITY:
Ordinary shares of no par value: - - -
Authorized: 500,000,000 shares at December 31, 2016 and June 30 2017;
Issued and outstanding: 107,583,485*) at December 31, 2016;
108,804,540*) at June 30, 2017.
Share premium 19,258 67,328 67,414
Capital funds 2,807 9,813 6,217
Treasury shares (2,696) (9,425) (9,425)
Accumulated deficit (15,095) (52,772) (35,719)
------- ------- -------
4,274 14,944 28,487
----- ------ ------
7,165 25,051 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
Six months Six months ended Three months ended
ended
June 30, June 30, June 30,
-------- -------- --------
2017 2017 2016 2017 2016
---- ---- ---- ---- ----
Unaudited Unaudited
--------- ---------
U.S. dollars NIS
------------ ---
(In thousands)
Cash flows from
operating activities:
----------------------
Total comprehensive
loss (4,878) (17,053) (6,969) (4,602) (3,180)
------ ------- ------ ------ ------
Adjustments to
reconcile net loss to
net cash used in
operating activities:
Net financing expenses 152 533 9 200 (11)
Loss (gain) from
revaluation of
financial assets
presented at fair
value through profit
and loss 83 289 (1) 113 -
Depreciation 53 184 180 94 103
Capital loss from sell
of property, plant and
equipment - - 9 - 9
Changes in fair value
of traded warrants to
ADS 1,519 5,313 - (1,460) -
Share-based payment 699 2,444 1,510 1,597 633
Decrease (increase) in
other receivables 68 236 (760) 280 (291)
Increase (decrease) in
other payables (180) (629) (495) 263 (134)
---- ---- ---- --- ----
Net cash used in
operating activities (2,484) (8,683) (6,517) (3,515) (2,871)
------ ------ ------ ------ ------
Cash flows from
investing activities:
----------------------
Proceeds received from
the sale of fixed
assets - - 95 - 95
Short term deposits 432 1,510 - - -
Restricted deposit, net (47) (165) - (165) -
Sales of marketable
securities measured at
fair value through
profit and loss 1,427 4,991 1,681 2,183 -
Purchase of property,
plant and equipment (33) (116) (1,124) (47) (77)
--- ---- ------ --- ---
Net cash provided by
investing activities 1,779 6,220 652 1,971 18
----- ----- --- ----- ---
Cash flows from
financing activities:
----------------------
Exercise of stock
options 305 1,066 7 423 7
Issue of share capital,
net of issue costs - - 7,464 - (370)
--- --- ----- --- ----
Net cash provided
(used) by financing
activities 305 1,066 7,471 423 (363)
--- ----- ----- --- ----
Exchange differences on
balances of cash and
cash equivalents (152) (533) (9) (200) 11
Increase (decrease) in
cash and cash
equivalents (552) (1,930) 1,597 (1,321) (3,205)
Balance of cash and
cash equivalents at
the beginning of the
period 6,279 3,913 5,670 8,715
1,796
-----
Balance of cash and
cash equivalents at
the end of the period 4,349 5,510 4,349 5,510
1,244
=====
Contact
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
www.cellect.co
+972-9-974-1444
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SOURCE Cellect Biotechnology Ltd.
