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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™ 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

ended


Nine months ended


Three months 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
warrants exercisable into shares


(2,303)


(8,020)


(2,935)


(910)


(1,320)












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
outstanding used to compute basic and
diluted loss per share


208,771,303


208,771,303


129,139,278


224,087,799


130,192,799

 

 

 

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

ended

Nine months ended


Three months 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
assets presented at fair value through
profit and loss


2

8


(288)


2


(140)


Depreciation


82

285


337


93


122


Changes in fair value of traded and not
traded warrants


(2,686)

(9,351)


(3,208)


(910)


(1,320)


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
at fair value through profit and loss


-

-


13,999


-


5,501


Purchase of property, plant and
equipment


(34)

(120)


(643)


-


(415)


Net cash provided by investing activities


(34)

(120)


13,616


-


8,877


 

Cash flows from financing activities:











Exercise of warrants and stock options
into shares


-

-


399


-


-


Leases liabilities


(121)

(422)


-


(143)


-


Issue of share capital and warrants, net
of issue costs


6,813

23,723


12,360


-


-


Net cash provided (used) by financing
activities


6,692

23,301


12,759


(143)


-


Exchange differences on balances of
cash and cash equivalents


(291)

(1,012)


870


(243)


18


Increase (decrease) in cash and cash
equivalents


1,160

4,040


9,651


(5,394)


2,556


Balance of cash and cash equivalents at
the beginning of the period


 

5,115

17,809


13,734


27,243


20,829


Balance of cash and cash equivalents
at the end of the period


 

6,275

21,849


23,385


21,849


23,385


 

 

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.