UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of November 2020 (No. 3)

 

Commission File Number 001-37846

 

CELLECT BIOTECHNOLOGY LTD.

(Translation of registrant’s name into English)

 

23 Hata’as Street

Kfar Saba, Israel 44425

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

 

Form 20-F     Form 40-F 

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):                

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):                 

 

 

 

 

On November 20, 2020, Cellect Biotechnology Ltd. (the “Company”) issued a press release entitled “Cellect Biotechnology Reports Third Quarter Financial and Operating Results; Recent Developments Position Company to Accelerate Progress in 2021.”

 

The text appearing under the heading “Third Quarter 2020 Financial Results” and the accompanying financial statements included in Exhibit 99.1 to this Form 6-K are hereby incorporated by reference into the Registrant’s Registration Statements on Form S-8 (Registration Nos. 333-214817, 333-220015, 333-225003 and 333-232230) and on Form F-3 (Registration Nos. 333-219614 and 333-229083).

 

 

Exhibit No.   Description

 99.1

Cellect Biotechnology Reports Third Quarter Financial and Operating Results; Recent Developments Position Company to Accelerate Progress in 2021

 

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: November 20, 2020 CELLECT BIOTECHNOLOGY, LTD.
     
  By: /s/ Eyal Leibovitz
    Eyal Leibovitz
    Chief Financial Officer

 

 

 

Exhibit 99.1

 

 

 

Cellect Biotechnology Reports Third Quarter Financial and Operating Results; Recent Developments Position Company to Accelerate Progress in 2021

 

Promising Progress on Clinical Development Progress, Collaborations and Partnering

 

Mutually Ended Discussion on Medical Cannabis Commercial and Merger Agreements

 

Tel Aviv, Israel -November 20, 2020 – 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.

 

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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.

 

 

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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.

 

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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Cellect Biotechnology Ltd

Consolidated Statement of Operation

 

   Convenience                 
   translation                 
  

Nine months

       
  ended   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 

 

 

 

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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.

 

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Cellect Biotechnology Ltd

Consolidated Cash Flow Data

 

   Convenience                 
   translation                 
  

Nine months

       
   ended   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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