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, 2020. Subsequent to the end of the third quarter, the Company announced several other key achievements subsequent to the end of the third quarter that position it for continued success in 2021, including clinical and operational objectives:
  • Initiated its clinical trial in the U.S. The trial is being performed at Washington University School of Medicine in St. Louis, Missouri, which is among the leading medical centers in the U.S. The Principal Investigator for the clinical trial is Zhifu Xiang, M.D., of Washington University. He is an Associate Professor in the Division of Oncology's Bone Marrow Transplantation & Leukemia Section in the Department of Medicine. John Dipersio M.D, Ph.D., will act as co-Principal Investigator for the study. He is the chief of the Division of Oncology in the Department of Medicine at Washington University.
  • Entered into a collaborative agreement with the Swedish XNK Therapeutics, enabling it to leverage Cellect’s technology in Natural Killer cell therapies. XNK is a clinical stage Swedish company working with the Karolinska Institute.

“In spite of the COVID-19 challenges we expedited our clinical and business development activities as we successfully achieved several objectives,” commented Dr. Shai Yarkoni, Chief Executive Officer. “Specifically, we recently initiated our U.S. clinical trial and entered into a partnership with a clinical stage biotech company that will leverage our functional cell selection technology. I believe these results reflect our steadfast determination and success progressing our clinical trials, which also includes the trial in Israel, combined with the latest collaboration agreement with XNK Therapeutics gives us multiple shots on goal to maximize shareholder value. We believe, based on our internal evaluation and assessment, that each of these opportunities could potentially represent significant revenue streams in the coming years.”

Separately, Cellect and Canndoc Ltd. have mutually agreed to end previously announced commercial and merger discussions. The Company will continue to pursue a partner that can bring value to its shareholders and progress the development of the Company’s platform technology.

The Company's cash and cash equivalents totaled $6.07 million as of September 30, 2020. The Company will use its resources to progress clinical and business development efforts to advance its functional cell selection technology. The Company has sufficient funds to operate in the next 15 months. Reference is made to Note 1. C (Going Concern) in the Interim Consolidated Financial Statements as of June 30th, 2020, which were filed as an exhibit to a Form 6-K dated August 12, 2020.

Third Quarter 2020 Financial Results:

  • Research and development (R&D) expenses for the third quarter of 2020 were $0.37 million, compared to $0.72 million in the third quarter of 2019. The decrease in the R&D expenses is primarily due to decrease in clinical activities as a result of the COVID-19.
  • General and administrative (G&A) expenses for the third quarter of 2020 were $0.36 million compared to $0.80 million in the third quarter of 2019. The decrease in G&A expenses was primarily due to the decrease in professional expenses.
  • Finance income for the third quarter of 2020 were $0.26 million, compared to finance income of $0.12 million in the third quarter of 2019. The change was primarily due to changes related to the fair value of the tradable and non-tradable warrants issued in a prior fundraising.
  • Net loss for the third quarter of 2020 was $0.47 million, or $0.001 per share compared to $1.40 million, or $0.006 per share in the third quarter of 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, 2020 (U.S. $1 = NIS 3.441).

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 cell based therapies.

The Company's technology is expected to provide researchers, clinical community, and pharma companies with the tools to rapidly isolate specific cells in quantity and quality allowing 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 expectations regarding timing of the commencement of its planned U.S. clinical trial and its plan to reduce operating costs. 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; the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products; and the Company’s ability to pursue any strategic transaction or that any transaction, if pursued, will be completed. 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, 2019 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.

ContactCellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officerwww.cellect.co +972-9-974-1444

Or

EVC Group LLC Michael Polyviou(732) 933-2754mpolyviou@evcgroup.com 

Cellect Biotechnology LtdConsolidated Statement of Operation

    Convenience                
    translation                
    Nine monthsended   Nine months ended   Three months ended
    September 30,   September 30,   September 30,
    2020   2020   2019   2020   2019
         
    Unaudited   Unaudited
    U.S. dollars   NIS
     
    (In thousands, except share and per share data)
                     
Research and development expenses   1,218   4,190   9,551   1,289   2,465
                     
General and administrative expenses   1,727   5,944   7,832   1,241   2,768
                     
Operating loss   2,945   10,134   17,383   2,530   5,233
                     
Financial expenses (income) due to warrants exercisable into shares   790   2,717   (8,020)   (1,090)   (910)
                     
Other financial expenses, net   40   138   1,369   193   489
                     
Total comprehensive loss   3,775     12,989   10,732   1,633   4,812
                     
Loss per share:                    
                     
Basic and diluted loss per share   0.010   0.036   0.051   0.004   0.021
                     
Weighted average number of shares outstanding used to compute basic and diluted loss per share   390,949,079   390,949,079   208,771,303   390,949,079   224,087,799

Cellect Biotechnology Ltd.Consolidated Balance Sheet Data

  Convenience          
  translation          
  September 30,   September 30,   December 31, 
  2020     2020     2019
  Unaudited   Unaudited   Audited
  U.S. dollars   NIS
  (In thousands, except share and per share data)
CURRENT ASSETS:          
Cash and cash equivalents 6,071     20,889     18,106  
Other receivables 205     707     469  
  6,276     21,596     18,575  
NON-CURRENT ASSETS:          
Restricted cash 96     329     328  
Right-of-use assets 238     819     1,035  
Other long-term receivables 19     66     94  
Property, plant and equipment, net 379     1,304     1,288  
  732     2,518     2,745  
           
  7,008     24,114     21,320  
 
CURRENT LIABILITIES:          
Trade payables 71     243     158  
Other payables 579     1,994     3,080  
Current maturities of lease liability 136     468     396  
  786     2,705     3,634  
NON-CURRENT LIABILITIES:          
Warrants to ADS 354     1,218     2,172  
Lease liability 112     386     677  
  466     1,604     2,849  
EQUITY:          
Ordinary shares of no par value:           
Authorized: 500,000,000 shares at December 31, 2019 and September 30, 2020; Issued and outstanding: 390,949,079*) and 224,087,799*) shares as of December 31, 2019 and September 30, 2020, respectively. -     -     -  
Additional Paid in Capital 36,861     126,839     108,598  
Share-based payments 4,721     16,244     16,528  
Treasury shares (2,739 )   (9,425 )   (9,425 )
Accumulated deficit (33,087 )   (113,853 )   (100,864 )
  5,756     19,805     14,837  
           
  7,008     24,114     21,320  

*)    Net of 2,641,693 treasury shares of the Company held by the Company.

Cellect Biotechnology LtdConsolidated Cash Flow Data

  Convenience                
  translation                
  Nine monthsended Nine months ended   Three months ended
  September 30, September 30,   September 30,
  2020  2020    2019    2020    2019
     
  Unaudited Unaudited
  U.S. dollars NIS
  (In thousands)
Cash flows from operating activities:                
Total comprehensive loss (3,775 ) (12,989 )   (10,732 )   (1,633 )   (4,812 )
                 
Adjustments to reconcile net loss to net cash used in operating activities:                
Exchange rate difference (61 ) (211 )   -     (216 )   -  
Net financing expenses 14   48     1,087     11     272  
Loss (gain) from revaluation of financial assets presented at fair value through profit and loss -   -     8     -     2  
Depreciation 75   256     285     86     93  
Changes in fair value of traded and not traded warrants 790   2,718     (9,351 )   (1,089 )   (910 )
Share-based payment 138   476     1,901     (353 )   1,371  
Decrease (increase) in other receivables (61 ) (210 )   146     263     -  
Decrease in other payables (334 ) (1,149 )   (1,855 )   (396 )   (1,138 )
Depreciation of Right of use - Assets under operating lease 79   272     457     89     143  
Interest received during the period 16   56     (75 )   21     (29 )
Net cash used in operating activities (3,119 ) (10,733 )   (18,129 )   (3,217 )   (5,008 )
                 
Cash flows from investing activities:                
Restricted deposit, net -   (1 )   -     1     -  
Sales (Purchase) of property, plant, and equipment (36 ) (124 )   (120 )   (155 )   -  
Net cash provided by investing activities (36 ) (125 )   (120 )   (154 )   -  
                 
Cash flows from financing activities:                
Exercise of warrants and stock options into shares 1,341   4,615     -     (92 )   -  
Leases liabilities (94 ) (324 )   (422 )   (112 )   (143 )
Issue of share capital and warrants, net of issue costs 2,672   9,194     23,723     -     -  
Net cash provided (used) by financing activities 3,919   13,485     23,301     (204 )   (143 )
Exchange differences on balances of cash and cash equivalents 45   156     (1,012 )   195     (243 )
Increase (decrease) in cash and cash equivalents 809   2,783     4,040     (3,380 )   (5,394 )
Balance of cash and cash equivalents at the beginning of the period 5,262   18,106     17,809     24,269     27,243  
Balance of cash and cash equivalents at the end of the period 6,071   20,889     21,849     20,889     21,849  
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