SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of: May 2017
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 of Form 20-F or Form 40-F.
Form 20-F x 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): ¨
This Report of Foreign Private Issuer on Form 6-K of the Registrant consists of the press release issued by the Registrant on May 3, 2017, entitled “Cellect Gets Green Light from FDA for ApoGraft IND submission in the U.S.”, which is attached hereto as Exhibit 99.1.
The first and second paragraphs and “Forward Looking Statements” of the press release attached to this Form 6-K of the Registrant are incorporated by reference into the registration statement on Form S-8 (Registration No. 333-214817) of the Registrant, filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
|99.1||Press Release issued by Cellect Biotechnology Ltd. on May 3, 2017|
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
Title: Chief Financial Officer
Date: May 3, 2017
Cellect Gets Green Light from FDA
For ApoGraft IND submission in the U.S.
Cellect’s CEO, Dr. Shai Yarkoni commented “The U.S. market is key for our planned commercial expansion and this will allow us to work tightly with the top U.S. institutes and global pharma companies on enabling stem cells for regenerative medicine.”
Tel Aviv, Israel – May 3, 2017 – Cellect Biotechnology Ltd. (Nasdaq: APOP, TASE: APOP), a developer of stem cell isolation technology, announced today that the U.S. Food & Drug Administration (FDA) provided Cellect with the pre-Investigational New Drug (IND) meeting minutes supporting an IND submission in the U.S. for Cellect’s flagship product, ApoGraft™.
The pre-IND meeting took place with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) regarding its product, ApoGraft™. Cellect’s management worked closely with FDA officials to gain approval for the IND submission’s content. The submission review included the manufacturing (CMC ) aspects, the pre-clinical data and the scope and design of the future clinical program.
Cellect’s chairman, Mr. Nuriel Chirich Kasbian stated that “The U.S. is a prime target market for our products. Our collaboration with the FDA team provides us essential guidance and a potential path to successful commercialization of our technology.”
About Cellect Biotechnology Ltd.
Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ: “APOP”, “APOPW”, TASE: “APOP”). The Company has developed a breakthrough technology for the isolation of stem cells from any given tissue that aims to improve a variety of stem cells applications.
The Company’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stems cell related treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine and current clinical trials are aimed at the cancer treatment of bone marrow transplantations.
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 that the U.S. market is key for Cellect’s planned commercial expansion and an IND submission will allow it to work tightly with the top U.S. institutes and global pharma companies on helping stem cells for generarative medicine, Cellect’s planned IND submission, that Cellect has developed a breakthrough technology for the isolation of stem cells from any given tissue and that Cellect’s technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stems cell related treatments and procedures. 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: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. 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, 2016 f 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 period filings with the SEC and the Tel-Aviv Stock Exchange.
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
Bob Yedid, Managing Director