UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 2018

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 office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of 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 Regulations S-T Rule 101(b)(1): ☐

 

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

  

The financial statements in this Form 6-K are incorporated by reference into the Registrant’s Registration Registration Statements on Form S-8 (Registration No. 333-214817, 333-220015 and 333-225003) and on Form F-3 (Registration No. 333-219614 and 333-212432).

 

 

 

 

 

  

Attached hereto as Exhibit 99.1 and incorporated by reference herein is a press release issued by the Registrant entitled “Cellect Biotechnology Ltd. Provides Corporate Update and Reports Third Quarter 2018 Financial Results.”

 

Exhibit

 

99.1 Press Release, dated November 13, 2018

  

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SIGNATURES

 

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.

 

  Cellect Biotechnology Ltd.
     
  By: /s/ Eyal Leibovitz
    Name: Eyal Leibovitz
 Date: November 13, 2018   Title: Chief Financial Officer

 

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Exhibit 99.1

 

 

Cellect Biotechnology Provides Corporate Update and Reports Third Quarter 2018 Financial Results

 

Tel Aviv, Israel November 13, 2018 – Cellect Biotechnology Ltd. (NASDAQ: “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 third quarter ended September 30, 2018.

 

“During the third quarter, we have strengthened significantly our IP portfolio position with granted patents from the EU and Korea while closing an important partnership agreement with the Korean Cell2in and the German denovoMATRIX for collaborations to further improve stem cell selection,” stated Dr. Shai Yarkoni, Cellect’s Chief Executive Officer.

 

“During the year we opened a second site for the Company’s ongoing clinical trial which allowed us to expedite the recruitment of additional patients and as a result, half of the patients planned for the study have finished first month follow up and all such patients have shown 100% engraftment with no procedure related adverse events and the first three patients of the trial (cohort I) have completed the study period (180 days) with full safety and tolerability” continued Dr. Yarkoni. “We also achieved positive results on the use of fat derived cells in orthopedic treatments in an animal model, we completed the first prototype of the Apotainer, showing stable immobilization and good biological activity of FasL coated paramagnetic beads and we received a formal Notice of Allowance from the Japanese and Australian Offices for Patents & Trademarks “ Dr. Yarkoni added

 

“As we are getting nearer to commercialization of our technology, we are putting more and more emphasis on partnerships with key players in our industry. We intend to continue this path going forward and build one of the world’s strongest IP portfolios for stem cell therapy related technologies and a line of partnerships that will take the company to the next level commercially within the next 24 months.” summarized Dr. Yarkoni

 

During the third quarter, Cellect accomplished the following: -

 

·Signed a collaboration and material transfer agreement with the denovoMATRIX group of the Technische Universität Dresden (TU Dresden), a leading center for stem cell research in Germany.

 

·Entered into a strategic manufacturing and supply agreement with Swiss Biotech Center (SBC) to secure production of FasL protein - Cellect’s main active ingredient in ApoGraft™ and the ApoTainerTM for planned clinical trials in the U.S.

 

·European Patent Office has granted the Company a patent for its ApoTainer™ device which is used in conjunction with its platform ApoGraft™ technology titled, “Devices and Methods for Selecting Apoptosis-Signaling Resistant Cells, and Uses Thereof”.

 

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·Signed a collaboration agreement with Cell2in, a South Korean company focused on improving the quality of cells. According to the agreement, the companies will conduct scientific evaluations combining Cellect’s technology platform ApoGraft™ with Cell2in’s proprietary identification technology FreSHtracer™ which monitors stem cell quality by utilizing a fluorescent dye to characterize their oxidative stress state.

 

·Received a Notice of Allowance from the Korean Intellectual Property Office for its patent titled, “Devices and Methods for Selecting Apoptosis-Signaling Resistant Cells and Uses Thereof”. This patent, recently granted to Cellect in Europe, addresses the Company’s ApoTainer™ device which is used in conjunction with its platform ApoGraft™ technology.

 

Recent Corporate Highlights:

 

·Announced that it has reached half way through study recruitment - six of the patients finished first month follow up and all these patients have shown 100% engraftment with no procedure related adverse events. Further to the six patients one-month data detailed above, Cellect reported that the first three patients of the trial (cohort I) have completed the study period (180 days) with full safety and tolerability.

 

·Announced that it has achieved positive results on the use of fat derived cells treated with the ApoGraft™ process in orthopedic treatments in an animal model.

 

·Announced that it has successfully developed for industrialization its first in kind new technology as an integral part of Cellect’s ApoTainer™. The new technology utilizes FasL-coated magnetic beads for maximizing efficacy and scalability of stem cell-based products’ manufacturing. The Apotainer™ improves the uniformity and hence quality of the outcome thereby supporting the safety and efficacy of raw material for all cell therapy.

 

·Announced that CEO Dr. Shai Yarkoni will present at the 24th Annual Bio Europe Conference that was held in Copenhagen, Denmark from November 5-7, 2018.

 

·Announced that it has received a formal Notice of Allowance from the Japanese and Australian Offices for Patents & Trademarks (Japanese Application No. 2014-560516; Australian Application No. 20132s29008) covering a key composition of matter and method of use of Cellect’s ApoGraft technology in devices for stem cell selection.

  

Third Quarter 2018 Financial Results:

 

·Research and development (R&D) expenses for the third quarter of 2018 were $1.13 million, compared to $0.69 million in the second quarter of 2018 and $0.79 million in the third quarter of 2017. The increase in the third quarter of 2018 as compared to the second quarter of 2018 was primarily due to increased expenses related to the Company’s ongoing clinical trial and product development expenses.

 

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·General and administrative (G&A) expenses for the third quarter of 2018 were $1.08 million, compared to $1.00 million in the second quarter of 2018 and $0.96 million in the third quarter of 2017. The change in the third quarter of 2018 as compared to the second quarter of 2018 mainly derived from an increase in expenses related to business development in the third quarter of 2018, offset by a decrease in costs of share-based compensation.

 

·Financial income for the third quarter of 2018 was $0.35 million, compared to financial income of $0.03 million in the second quarter of 2018. The increase was primarily due to changes related to fair value of the tradable and non-tradable warrants issued in prior fundraisings.

 

·Net loss for the third quarter of 2018 was $1.9 million, or $0.014 per share and $0.29 per ADS, compared to $1.6 million, or $0.013 per share and $0.25 per ADS, in the second quarter of 2018, and $2.2 million, or $0.019 per share and $0.39 per ADS, in the third quarter of 2017.

 

Balance Sheet Highlights:

 

·Cash and cash equivalents and marketable securities totaled $6.45 million as of September 30, 2018, compared to $8.26 million on June 30, 2018, and $7.6 million on December 31, 2017. The change in the cash and cash equivalents and marketable securities was primarily due to net proceeds of $3.5 million from a registered direct offering completed in January 2018, offset by cash used in operations during the period.

 

·Shareholders’ equity totaled $4.5 million as of September 30, 2018, compared to $6.1 million on June 30, 2018, and $5.2 million on December 31, 2017.

 

* 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, 2018 (U.S. $1 = NIS 3.627).

 

The Company’s consolidated financial results for the three and nine months ended September 30, 2018 are presented in accordance with International Financial Reporting Standards.

 

About Cellect Biotechnology Ltd.

 

Cellect Biotechnology (NASDAQ: 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.

 

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The Company’s technology is expected to provide research, hospitals 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. For example, forward-looking statements are used in this press release when we discuss our IP portfolio and potential commercialization of our technology. 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; 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, 2017 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

 

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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, 
   2018   2018   2017   2018   2017 
   Unaudited   Unaudited 
   U.S. dollars   NIS 
  

(In thousands, except share and per share data)

 
                     
Research and development expenses   2,612    9,473    8,099    4,125    2,872 
                          
General and administrative expenses   3,033    11,001    9,524    3,929    3,478 
                          
Operating loss   5,645    20,474    17,623    8,054    6,350 
                          
Financial expenses (income) due to warrants exercisable into ADS   (809)   (2,935)   6,821    (1,320)   1,509 
                          
Other financial expenses (income), net   (325)   (1,177)   411    64    (57)
                          
Total comprehensive loss   4,511    16,362    24,855    6,798    7,802 
                          
Loss per share:                         
                          
Basic and diluted loss per share   0.035    0.127    0.228    0.052    0.070 
Basic and diluted loss per ADS   0.7    2.54    4.56    1.04    1.40 
                          
Weighted average number of shares outstanding used to compute basic and diluted loss per share   129,139,278    129,139,278    109,188,626    130,192,799    111,476,292 

 

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Cellect Biotechnology Ltd

Consolidated Balance Sheet Data

  

   Convenience         
   translation         
   September 30,   September 30,   December 31, 
   2018   2018   2017 
   Unaudited   Unaudited   Audited 
   U.S. dollars   NIS 
  

(In thousands, except share and per

share data)

 
ASSETS    
CURRENT ASSETS:            
Cash and cash equivalents   6,447    23,385    13,734 
Marketable securities   -    -    13,999 
Other receivables   164    593    818 
                
    6,611    23,978    28,551 
NON-CURRENT ASSETS:               
Restricted cash   92    333    305 
Other long-term assets   39    142    173 
Property, plant and equipment, net   458    1,661    1,344 
                
    589    2,136    1,822 
                
    7,200    26,114    30,373 
                

LIABILITIES AND SHAREHOLDERS’ EQUITY

               
CURRENT LIABILITIES:               
Trade payables   354    1,283    1,703 
Other payables   584    2,120    2,396 
    938    3,403    4,099 
NON-CURRENT LIABILITIES:               
Warrants to ADS   1,745    6,327    7,422 
                
EQUITY:               
Ordinary shares of no par value:               
Authorized: 500,000,000 shares at December 31, 2017 and September 30 2018; Issued and outstanding: 120,185,659*) and 130,192,799*) shares as of December 31, 2017 and September 30, 2018, respectively.   -    -    - 
Additional Paid In Capital   26,135    94,793    82,839 
Share-based payments   3,121    11,321    9,381 
Treasury shares   (2,598)   (9,425)   (9,425)
Accumulated deficit   (22,141)   (80,305)   (63,943)
                
    4,517    16,384    18,852 
                
    7,200    26,114    30,373 

 

*)       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, 
   2018   2018   2017   2018   2017 
   Unaudited   Unaudited 
   U.S. dollars   NIS 
   (In thousands) 
Cash flows from operating activities:                    
Total comprehensive loss   (4,511)   (16,362)   (24,855)   (6,798)   (7,802)
                          
Adjustments to reconcile net loss to net cash used in operating activities:                         
Net financing expenses   (227)   (823)   504    14    (29)
Loss (gain) from revaluation of financial assets presented at fair value through profit and loss   (79)   (288)   140    (140)   (149)
Depreciation   93    337    278    122    94 
Changes in fair value of traded and not traded warrants to ADS   (885)   (3,208)   6,650    (1,320)   1,337 
Share-based payment   895    3,247    4,016    1,063    1,572 
Decrease (increase) in other receivables   70    256    362    343    126 
Increase (decrease) in other payables   (195)   (706)   (633)   409    (4)
Interest received   (13)   (47)   -    (32)   - 
Net cash used in operating activities   (4,852)   (17,594)   (13,538)   (6,339)   (4,855)
                          
Cash flows from investing activities:                         
Short term deposits, net   78    282    19,530    3,785    18,020 
Restricted deposit, net   (6)   (22)   (167)   6    (2)
(Purchase) Sales of marketable securities measured at fair value through profit and loss   3,859    13,999    (5,009)   5,501    (10,000)
Purchase of property, plant and equipment   (177)   (643)   (175)   (415)   (59)
Net cash provided by investing activities   3,754    13,616    14,179    8,877    7,959 
                          
Cash flows from financing activities:                         
Exercise of warrants and stock options into shares   110    399    1,263    -    197 
Issue of share capital and warrants, net of issue costs   3,408    12,360    14,893    -    14,893 
Net cash provided (used) by financing activities   3,518    12,759    16,156    -    15,090 
Exchange differences on balances of cash and cash equivalents   240    870    (504)   18    29 
Increase (decrease) in cash and cash equivalents   2,660    9,651    16,293    2,556    18,223 
Balance of cash and cash equivalents at the beginning of the period   3,787    13,734    6,279    20,829    4,349 
Balance of cash and cash equivalents at the end of the period   6,447    23,385    22,572    23,385    22,572 

 

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