Full Press Release Details
Biotechnology Reports Clinical and Regulatory Milestone Targets
FDA Hiring Decision Highlights Growing Importance of Cell and Gene Therapy Companies
Aviv, Israel - January 23, 2019 - Cellect Biotechnology Ltd. (Nasdaq: APOP), a novel regenerative and cell therapy
company with production technology, today provided its milestone targets through the second quarter of 2020. After achieving milestones
during 2018, Cellect Biotechnology is positioned to achieve the following milestones in order to maximize shareholder valuation.
expect 2019 to be a significant year for Cellect and the progression of our global clinical development program, and the recent
decision by the US Food and Drug Administration (FDA) to hire 50 new clinical reviewers to assess cell and gene therapies, gives
us greater confidence we can achieve our clinical and regulatory milestones for the next 12 to 18 months," commented Shai
Yarkoni, Chief Executive Officer. "I believe the special attention and resources being allocated by the FDA will allow us
to further advance our cell therapy programs as we intend to submit an IND for a Phase I/II study in the United States and an
IDE for our second product (the Apotainer ) and complete the preclinical effort towards a third indication by the end of
TARGETS THROUGH JUNE 2020*
- Hematopoietic Stem Cells (blood cancers, such as leukemia and lymphoma)
- Mesenchymal Stem Cells (broad stem cell applications)
Subject to sufficient financing.
Cellect Biotechnology Ltd.
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. 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.
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 the Company's
milestone targets and the timing thereof. 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 the Company's Annual
Report on Form 20-F for the fiscal year ended December 31, 2017 filed with the U.S. Securities and Exchange Commission
("SEC"), which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic
filings with the SEC.
Cellect Biotechnology Ltd.
Eyal Leibovitz, Chief Financial Officer
Polyviou / Todd Kehrli