Full Press Release Details
Biotechnology Announces Positive Data Demonstrating Robust Engraftment Using ApoGraft Was Featured in Bone Marrow Transplantation;
Primary Data Points Were Submitted to the FDA During Investigational New Drug Approval Process
Aviv, Israel May 11, 2020 - Cellect Biotechnology Ltd. (NASDAQ: "APOP"), a developer of innovative technology
which enables the functional selection of stem cells, today announced the publication of an article in Bone Marrow Transplantation,
a peer-reviewed medical journal (member of the Nature publishing house) covering transplantation of bone marrow in humans and
published monthly by the prestigious Nature Research, entitled "Ex-vivo FAS-ligand to Improve Allograft Safety".
The article is co-authored by researchers at Cellect and its academic partners.
paper highlights the pre-clinical research and demonstrates that engraftment is robust following transplantation of treated graft,
and the graft retains its immune reconstitution and anti-leukemic effects. The Company has initiated a Phase 1/2 study in adults
undergoing stem cell transplant for the treatment of hematological malignancies. The primary endpoint of the study is to evaluate
the overall incidence, frequency, and severity of adverse events potentially related to ApoGraft at 180-days post-transplant.
All patients transplanted through present time using the ApoGraft process were engrafted and time to engraftment was similar
to the standard of care. To date, there have not been any safety and tolerability concerns during the study and patient enrollment
is continuing. Both, the principal investigator (PI) and independent data safety monitoring board (DSMB) agree that no serious
adverse events (SAEs) reported during the course of the study were related to the ApoGraft process.
data from the pre-clinical research, and published in this paper, was included in the Company's Investigational New Drug
(IND) application, which was approved by the U.S. Food and Drug Administration in late 2019. The Company has received all the
necessary approvals to initiate the trial with its academic partner, Washington University, and plans to begin patient recruitment
once the COVID-19 pandemic is mitigated and clinics can resume normal practices.
Cellect Biotechnology Ltd.
Biotechnology (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.
Company's technology is expected to provide researchers, clinical community 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 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.
Leibovitz, Chief Financial Officer