OREANDA-NEWS. 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, 2016.

Dr. Shai Yarkoni, Chief Executive Officer, said, “During the second quarter, we achieved significant progress in advancing preparations for our phase 1/2 clinical trial and regulatory activities related to the development of our first stem cell selection product, "Powered by Cellect"/Apotainer™. In addition, we recently entered into a collaboration with Accellta in order to evaluate the applicability of our technology to accelerate cell growth. We also received approval of a potential grant from the BIRD Foundation for our co-development program with a U.S.-based company listed on Nasdaq. This grant, if approved by the BIRD Foundation, will enable us to expedite the development of our ApotainerTM product.”

Recent Corporate Highlights:

  • Priced an initial public offering (IPO) in the U.S. resulting in gross proceeds of $8.4 million.
  • Signed a collaboration agreement with leading Israeli stem cell company, Accellta, whereby Accellta will receive a non-exclusive right to evaluate the impact of Cellect’s apoptotic induction-based technology on Accellta’s stem cell culturing technologies.
  • Received notification from the Tel Aviv Stock Exchange (TASE) that it would be included in the TASE Composite Index, the TASE Biomed Index and the TASE BlueTech Index, effective June 15, 2016.
  • Awarded a potential $0.9 million grant, for our co-development program with a U.S. based partner listed on Nasdaq, by the BIRD Foundation, which was established by the U.S. and Israeli governments to stimulate, promote and support industrial research and development mutually beneficial to both countries, in support of the development and commercialization of Cellect’s groundbreaking stem cell selection technology.

Second Quarter 2016 Financial Results:

  • Research and development (R&D) expenses for the second quarter of 2016 were $0.5 million, compared to $0.5 million in the first quarter of 2016 and $0.4 million in the second quarter of 2015. The reasons for this change as compared to the first quarter of 2016 are a slight decrease in pre-clinical and other expenses related to the preparation for the Phase 1/2 clinical trial (mainly the healthy volunteers study), offset by a slight increase in IP related expenses and regulatory and quality assurance consulting expenses.
  • General and administrative (G&A) expenses for the second quarter of 2016 were $0.4 million, compared to $0.5 million in the first quarter of 2016 and $0.2 million in the second quarter of 2015. The decrease from the second quarter of 2016 as compared to the first quarter of 2016 was primarily due to $0.03 million in professional services and $0.04 million in share based compensation.
  • Net loss for the second quarter of 2016 was $0.8 million, or $0.01 per share, compared to $1.0 million, or $0.012 per share, in the first quarter of 2016, and $0.6 million, or $0.006 per share, in the second quarter of 2015.

Balance Sheet Highlights:

  • Cash and cash equivalents (including marketable securities) totaled $3.0 million as of June 30, 2016, compared to $3.1 million on December 31, 2015, and $4.3 million on June 30, 2015. The reason for the change compared to December 31, 2015, is primarily due to NIS 8 million ($2 million) raised through the private placement completed in March 2016, offset by cash used in operations during the period. However, the cash balance as of June 30, 2016 does not include the gross proceeds of $8.4 million raised through the U.S. IPO, which closed on August 3, 2016.
  • Shareholders' equity totaled $3.3 million as of June 30, 2016, compared to $2.7 million on December 31, 2015, and $4.1 million on June 30, 2015.

* For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on June 30, 2016 (U.S. $1 = NIS 3.846).  

About Cellect Biotechnology Ltd.

Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ:APOP) (TASE:APOP). The Company develops 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.

 

Cellect Biotechnology Ltd
Consolidated Statement of Operation
                     
    Convenience                
    translation                
    Six months
ended		   Six months ended   Three months ended
    June 30,   June 30,   June 30,
      2016       2016       2015       2016     2015
    Unaudited   Unaudited
    U.S. dollars   NIS
    (In thousands, except share and per
share data)
                     
Research and development expenses     957       3,679       2,556       1,848     1,372
                     
General and administrative expenses     922       3,547       1,347       1,617     755
                     
Other income     (73 )     (280 )     -       (280 )   -
                     
Operating loss     1,806       6,946       3,903       3,185     2,127
                     
Financial income     (5 )     (18 )     (4 )     (13 )   -
                     
Financial expenses     11       41       64       8     9
                     
Total comprehensive loss     1,812       6,969       3,963       3,180     2,136
                     
Loss per share:                    
                     
Basic and diluted loss per share     0.023       0.088       0.052       0.039     0.026
                     
Weighted average number of shares outstanding used to compute basic and diluted loss per share     79,113,097       79,113,097       72,926,653       81,456,571     74,727,976
                                     

 

Cellect Biotechnology Ltd
Consolidated Balance Sheet Data
             
ASSETS
  Convenience          
  translation          
  June 30,   June 30,   December 31,
    2016       2016       2015  
  Unaudited   Unaudited    Unaudited
  U.S. dollars   NIS
  (In thousands, except share and per
share data)
CURRENT ASSETS:          
Cash and cash equivalents   1,433       5,510       3,913  
Marketable securities   1,598       6,148       7,829  
Accounts receivable   421       1,619       412  
           
    3,452       13,277       12,154  
NON-CURRENT ASSETS:          
Restricted cash   5       20       20  
Property, plant and equipment, net   347       1,335       1,187  
           
    352       1,355       1,207  
           
    3,804       14,632       13,361  
                       
 LIABILITIES AND
SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:          
Trade payables   183       703       466  
Other accounts payable   279       1,074       2,394  
           
    462       1,777       2,860  
EQUITY:          
Ordinary shares of no par value:                      
Authorized: 500,000,000 shares at December 31, 2015, June 30, 2015 and 2016; Issued and outstanding: 75,949,888*) at December 31, 2015 and June 30, 2015 and 81,737,325*) at June 30, 2016.   -       -       -  
Share premium   11,478       44,144       36,725  
Share-based payments   1,432       5,507       3,603  
Treasury shares   (2,451 )     (9,425 )     (9,425 )
Accumulated deficit   (7,117 )     (27,371 )     (20,402 )
           
    3,342       12,855       10,501  
           
    3,804       14,632       13,361  
*)   Net of 2,686,693 treasury shares of the Company held by the Company.