Cellect Biotechnology (APOP) TM · Cellect Biotechnology (NasdaqGS: APOP; TASE: APOP) is developing...

Initiating CoverageDecember 7, 2016

Cellect Biotechnology (APOP)Initiation Report

LifeSci Investment Abstract

Cellect Biotechnology (NasdaqGS: APOP; TASE: APOP) is developing technologies forcompanies in the regenerative medicine space. The Company’s platform technology Poweredby CellectTM is designed to functionally select human stem and progenitor cells from a mixedpopulation of cells in order to optimize allogeneic stem cell transplantation (alloHCT) andreduce the risk of graft-versus-host disease (GvHD). Cellect has initiated a Phase I/II trialin Israel evaluating the safety and efficacy of this technology in leukemia patients undergoingalloHCT. The Company plans to hold a pre-IND meeting with the FDA in the first half of2017. The ongoing trial could serve as an important validation for this platform technology,which has broad potential application beyond this particular setting in large diseases such astype 1 diabetes, Crohn’s disease, psoriasis, and lupus.

Key Points of Discussion

■ Powered by Cellect Technology Has Potential Uses Across the RegenerativeMedicine Space. The Company’s lead candidate is the Apotainer feature the Apograftprocess, a drug/device combination product designed to improve the safety and efficacyof allogeneic hematopoietic stem cell transplantation (alloHCT) by reducing the risk ofdeveloping GvHD through more effective cell selection. This product candidate has thepotential to reduce the length of hospitalization and overall cost of alloHCT treatment.Cellect intends to quickly generate clinical proof-of-concept data for Powered by Cellectin leukemia patients undergoing alloHCT, and with this validation in hand, license thetechnology to other companies in the regenerative medicine space.

■ Multiple Collaborations Validate Platform Technology. Cellect has signedcollaboration agreements with Accellta (private), a leading Israeli stem cell company,and Entegris (NasdaqGS: ENTG), a provider of advanced manufacturing solutions. TheCompany intends to increase its presence in the US by opening an office and bringing inadditional personnel in 2017, a move which should aid in the development of additionaldeals.

Expected Upcoming Milestones

■ Q4 2016 – Enroll first patient in Phase I/II study with Apotainer in leukemia patientsundergoing alloHCT.

■ 2017 – Pursuing additional collaborations with major strategic partners.■ HI 2017 – Pre-IND meeting with the FDA regarding US trials for Apotainer.■ H1 2017 – Opening of US office and hiring of BD personnel to support new and

ongoing discussions with strategic partners■ Q3 2017 – Interim results from Phase I/II trial.■ H2 2017 – Expected IND filing for US Apotainer trial.■ H2 2017 – Complete design and build prototype of Apotainer.■ 2018 – Commencement of US-based Apotainer trial.

Analysts

Jerry Isaacson, Ph.D. (AC)(646) [email protected]

Market Data

Price $2.73Market Cap (M) $15EV (M) $4Shares Outstanding (M) 5.4Avg Daily Vol 7,16452-week Range: $2.55 - $5.40Cash (M) $10.9Net Cash/Share $2.03Annualized Cash Burn (M) $2.0Years of Cash Left >2.0Debt (M) $0.0Short Interest (M) 0.01

Financials

FY Dec 2014A 2015A 2016AEPS Q1 NA NA NA

Q2 NA NA NAQ3 NA NA NAQ4 NA NA NAFY NA NA NA

For analyst certification and disclosures please see page 23

The Accellta agreement allows for Accellta to test the feasibility of incorporating Cellect’s Apograft process

into their stem cell culturing technologies. The tests will initially focus on growing Accellta’s pluripotent cells

more quickly and will explore the potential of these cells to create organs, repair damaged tissue, and for use

in drug development. Cellect received a small upfront payment and the parties intend to expand the agreement

following an initial evaluation of the technology.

Cellect’s partnership with Entegris covers the co-development of a polymer film suitable for use in the

Apotainer selection kit. Cellect and Entegris received a $900,000 conditional grant from the BIRD Foundation

to support their development efforts.

High Rates of Graft Versus Host Disease Following Allogeneic Cell Transplantation. The number of

hematopoietic cell transplantation (HCT) procedures has grown steadily since 1980. In 2012, there were roughly

68,000 transplants performed worldwide, and 47% or 32,000 procedures were allogenic HCTs (alloHCT),1,2 meaning

that the cells were donor-derived and thus can cause graft versus host reactions.3 We estimate peak annual sales of up

to $200 million based on current trends, but also note that the product has the potential to greatly increase the number

of alloHCT procedures. The vast majority of alloHCT are performed in patients with blood cancers.4,5 However, there

would broad potential application for this technology in other indications such as organ transplantation and

autoimmune disorders if it were safer.

Approximately 60% of patients receiving alloHCT are expected to develop GvHD,6 reflecting the high rate of

complications occurring with existing alloHCT procedures. Cellect’s Apograft process may enable for better selection

of stem progenitor cells from the donor cells than possible with existing technology. This could deplete mature,

differentiated lymphocytes from the donor cell population, which may minimize the risk of GvHD and improve the

safety profile of alloHCT, broadening its appeal.

Cellect has begun Clinical Development for Apograft. Cellect recently initiated a Phase I/II study evaluating the

Apograft process in leukemia patients undergoing alloHCT in Israel and plans to enroll the first patient in 2016.

Apograft process in the alloHCT setting. The primary objective of this study is to test the safety and tolerability of

ApoGraft administered to subjects with hematological malignancies who are undergoing alloHCT. The secondary

objective of this trial is to assess ApoGraft engraftment, the donor cells populating patients’ hematological systems,

and prevention of GvHD. In addition, the Company expects to conduct a pre-IND meeting with the FDA in the first

half of 2017 and file an IND in the second half of 2017, which could lead to the commencement of trials in 2018.

No Approved Treatment Options for Steroid-Refractory Graft Versus Host Disease. Prophylactic treatments

are used to prevent GvHD but many alloHCT patients will still develop the condition. When prophylaxis fails,

clinicians are presented with few treatment options to reverse disease progression. The majority of treatment options

for GvHD include steroids and immunosuppressants, which make patients more susceptible to severe infections and

1 CIBMTR. 2014. Current uses and outcomes of hematopoietic stem cell transplantation, 2014 summary slides. 2 http://www.wbmt.org/fileadmin/pdf/01_General/Task_force_Slide_set_2010_July2015-ATT_C2_HB.pdf 3 Niederwieser, D. et al., 2016. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the

Worldwide Network for Blood and Marrow Transplantation Group including the global survey, Bone Marrow Transplantation,

pp1-8. 4CIBMTR. 2014. Current uses and outcomes of hematopoietic stem cell transplantation, 2014 summary slides. 5 http://www.wbmt.org/fileadmin/pdf/01_General/Task_force_Slide_set_2010_July2015-ATT_C2_HB.pdf 6 Won Choi, S. & Reddy, P. 2014. Current and emerging strategies for the prevention of graft versus host disease. Nature Reviews

Clinical Oncology, 11(9), pp536-547.

December 7, 2016

infection-related deaths. It is estimated that only about 40-50% of Grades II-IV patients will experience improvement

in symptoms, indicating that of the remaining half of these patients will be diagnosed with steroid-refractory GvHD

(sr-GvHD). There are no approved therapies for sr-GvHD, highlighting a significant unmet medical need for these

patients. Current treatment options include a variety of immunosuppressive agents and experimental therapies, which

are associated with low response rates and risk of severe side effects. Better treatment options are clearly needed to

retain general immune system function while selectively blocking graft-vs-host reactions.

Financial Discussion

Second Quarter 2016 Financial Results. On September 1, 2016, Cellect announced financial results for the second

quarter of 2016. Cellect reported research and development expenses of NIS 1.8 million ($0.47 million) in the second

quarter of 2016, compared to NIS 1.4 million ($0.4 million) in second quarter of 2015. The Company also reported

general and administrative expenses of NIS 1.6 million ($0.4 million) for the quarter, an increase from NIS 0.8 million

($0.2 million) for the same period in 2015. The Company reported a net loss of NIS 3.2 million ($0.8 million), or NIS

0.04 ($0.01) per share, compared to a loss of NIS 2.1 million ($0.5 million), or NIS 0.03 ($0.01) per share, for the

second quarter of 2015. As of June 30, 2016, the Company had NIS 11.7 million ($3.1 million) in cash and cash

equivalents.

Initial Public Offering in the US. In July, Cellect closed an initial public offering in the US to sell 1,292,308 American

Depository Shares (ADSs) and warrants to purchase 969,231 ADSs. Each unit was priced at $6.50, and included an

ADS representing 20 ordinary shares of the Company and a warrant. The warrants have an exercise price of $7.50 and

expire in 5 years. This IPO raised $8.4 million in gross proceeds, which Cellect plans to use to fund its ongoing clinical

development. The shares began trading on the Nasdaq Capital Market on July 29th under the symbol APOP.

December 7, 2016

Table of Contents

Company Description .................................................................................................................................................................... 5

Powered By CellectTM: An Enabling Technology for the Functional Selection of Stem Cells .......................................... 5

Functional Selection of Stem Cells ......................................................................................................................................... 6

ApoGraft Process Featuring the Apotainer Selection Kit ....................................................................................................... 8

Allogeneic Stem Cell Transplantation for Oncology ........................................................................................................... 9

The ApoGraft Process .............................................................................................................................................................. 9

Development of Apotainer Selection Kit ............................................................................................................................ 10

Regulatory Path for Apotainer Selection Kit ....................................................................................................................... 10

Preclinical Data .............................................................................................................................................................................. 11

ApoGraft Preclinical Viability Study ..................................................................................................................................... 11

Graft-Versus-Host Disease ......................................................................................................................................................... 14

Causes and Pathogenesis ........................................................................................................................................................ 15

Symptoms, Diagnosis and Staging ........................................................................................................................................ 15

Treatment for GvHD .............................................................................................................................................................. 16

Risks Associated with Current GvHD Treatment ............................................................................................................. 18

GvHD – Market Information ..................................................................................................................................................... 18

Clinical Data Discussion .............................................................................................................................................................. 20

Competitive Advantages of the ApoGraft Process Featuring the Apotainer Selection Kit ........................................ 20

Intellectual Property ..................................................................................................................................................................... 21

Management Team ....................................................................................................................................................................... 21

Risk to an Investment .................................................................................................................................................................. 22

Analyst Certification ..................................................................................................................................................................... 23

Disclosures ..................................................................................................................................................................................... 23

December 7, 2016

Company Description

Cellect is a biotechnology company based in Israel developing technologies for companies in the regenerative medicine

space. The Company’s platform technology Powered by CellectTM is designed to functionally select human stem and

progenitor cells from a mixed population of cells in order to improve the safety and efficacy of cell therapies. The

Company’s lead candidate is the Apograft process featuring the Apotainer, a drug/device combination product

designed to optimize allogeneic hematopoietic stem cell transplantation (alloHCT) and reduce the risk of graft-versus-

host disease (GvHD). Cellect recently initiated a Phase I/II trial in Israel evaluating the Apograft process, and plans

to enroll the first patient in 2016. The Company expects to have a final build of the Apotainer prototype in the second

half of 2017. Cellect’s developmental pipeline is shown in Figure 1. Note that Cellect has two additional products

candidates in development for undisclosed indications based on the Powered by Cellect platform.

Figure 1. Cellect’s Developmental Pipeline

Source: LifeSci Capital

Powered By CellectTM: An Enabling Technology for the Functional Selection of Stem Cells

Powered by Cellect is a technology platform designed to improve the efficacy and safety of cell therapies for

regenerative medicine. This technology platform allows for the selection of human stem progenitor cells from mixed

cell populations and tissues, and has the potential to be the enabling technology-of-choice for companies developing

cell therapies, as well as academic investigators engaged in basic cell therapy research. Powered by Cellect takes

advantage of the unique functional properties of stem progenitors cells in order to create an off-the-shelf cell selection

solution that could be more efficient and cost-effective than methods currently on the market.

Cellect’s first candidate from the Powered by Cellect platform is the Apograft process featuring the Apotainer

Selection Kit. This drug device combination product is made for the selection of human hematopoietic stem cells

(HSCs) and is designed to optimize allogeneic hematopoietic stem cell transplantation (alloHCT) and reduce the risk

of graft-versus-host disease (GvHD). This product candidate has the potential to shorten the length of hospitalization

December 7, 2016

for alloHCT, improve patient outcomes, and reduce the overall treatment cost. Cellect intends to quickly generate

clinical proof-of-concept data for Powered by Cellect with the Apograft process in the alloHCT setting, and with this

validation in hand, license the technology to other companies in the regenerative medicine space. Cellect recently

initiated a Phase I/II study evaluating the Apograft process in Israel and plans to enroll the first patient in 2016. The

Company expects to conduct a pre-IND meeting with the FDA in the first half of 2017 and file an IND to initiate

US-based trials in the second half of 2017, which could lead to the commencement of trials in 2018.

Functional Selection of Stem Cells

Powered by Cellect exploits the unique features of different human stem and progenitor cell populations to create

customizable cell selection solutions for regenerative medicine. Stem cells are best defined by their functional

properties, including the ability to self-renew and differentiate into mature cell types. In addition, each tissue specific

stem progenitor cell population has a unique set of cellular characteristics, which provide specialized functions

depending on the local environment or tissue in which they reside. For example, human hematopoietic progenitor

stem cells (HSCs), which live in the bone marrow and are capable of reconstituting all of the mature cell types of the

immune system, have been shown to be relatively resistant to programmed cell death, or apoptosis.7,8,9,10 This allows

HSCs to survive and differentiate in the bone marrow where, even under normal physiologic conditions, there is

substantial mature cell turnover, and thus high rates of cell death. The ability of HSCs to resist apoptosis is an example

of the type of functional characteristic that the Powered by Cellect platform technology exploits to create customizable

stem cell selection solutions.

Figure 2 illustrates the concept of Powered by Cellect platform technology when applied to the selection of HSCs.

Donor bone marrow is collected and then incubated in a vessel with an apoptosis-inducing signal. This causes the

mature immune cells that cause GvHD to die, but has no effect on HSCs, which are resistant to the apoptotic signal.

This process, which is a form of negative selection by apoptosis, results in a more homogenous HSC population

optimized for transplantation. In addition to bone marrow, negative selection by apoptosis has also been shown to be

an effective method of enriching stem cells obtained from umbilical cord blood.11

7 Pearl-Yafe, M. et al. 2007. Expression of Fas and Fas-ligand in donor hematopoietic stem and progenitor cells is dissociated

from the sensitivity to apoptosis. Experimental Hematology, 35, pp1601–1612. 8 Pearl-Yafe, M. et al. 2010. Tumor necrosis factor receptors support murine hematopoietic progenitor function in the early

stages of engraftment. Stem Cells, 28, pp1270–1280. 9 Mizrahi, K. et al. 2010. Regulatory functions of TRAIL in hematopoietic progenitors: human umbilical cord blood and murine

bone marrow transplantation. Leukemia, 24, pp1325–1334. 10 Mizrahi, K. et al. 2013. Resistance of hematopoietic progenitors to Fas-mediated apoptosis is actively sustained by NFκB with

a characteristic transcriptional signature. Stem Cells and Development, 23, pp676–686. 11 Mizrahi, K. et al. 2014. Negative selection by apoptosis enriches progenitors in naïve and expanded human umbilical cord

blood grafts. Bone Marrow Transplant, 49(7), pp942-949.

December 7, 2016

Figure 2. Powered by Cellect Technology Applied to Bone Marrow Cells

Source: Cellect Presentation

It is important to note that each tissue specific stem or progenitor cell population in our body is likely to have a

defining functional characteristic that can be used for selection. This means that the Powered by Cellect technology

may be able to create selection solutions for a broad range of therapeutically valuable stem and progenitor cell

populations. Figure 3 shows how this technology may be applied to isolate different stem cells, including

mesenchymal stem cells (MSCs) and neural stem cells (NSCs). MSCs and NSCs have generated great interest as

potential treatments for cardiovascular indications and some neurological disorders.

The concept behind these types of treatments is to deliver stem cells to damaged organs, where they can engraft and

potentially regenerate tissue and restore normal organ function. Powered by Cellect is designed to make MSC- and

NSC-based therapies more effective by ensuring that these treatments are comprised of homogeneous cell populations

with known cellular activities. This means that Powered by Cellect has the potential to be the enabling technology-of-

choice for companies developing MSC- and NSC-based cell therapies, as well as academic investigators engaged in

basic cell therapy research.

December 7, 2016

Figure 3. Potential Applications for the Powered by Cellect Technology


ApoGraft Process Featuring the Apotainer Selection Kit

Cellect’s first candidate from the Powered by Cellect platform is the Apotainer, a single-use drug device combination

product candidate for the selection of HSCs that features the Apograft process. The Apotainer is designed to optimize

the selection of stem and progenitor cells for alloHCT and reduce the risk of GvHD. The Apotainer with ApoGraft

has the potential to shorten the average length of hospitalization for alloHCT and reduce the overall treatment cost.

Cellect plans to generate proof-of-concept data for Powered by Cellect with the Apograft process in the alloHCT

setting, and with this validation in hand, license the technology to companies in the regenerative medicine space.

Cellect recently initiated a Phase I/II study evaluating the Apograft process in Israel and plans to enroll the first patient

in 2016. The Company expects to conduct a pre-IND meeting with the FDA in the first half of 2017 and file an IND

in the second half of 2017.This could lead to initiation of a US trial to evaluate the Apograft process with the Apotainer

Selection Kit is expected in early 2018. Eventually, Cellect expects to test the Apotainer Selection Kit for solid organ

transplantation and autoimmune disorders, such as type 1 diabetes, Crohn’s disease, psoriasis, and lupus.

December 7, 2016

Allogeneic Stem Cell Transplantation for Oncology

Allogeneic transplantation of HSCs (alloHCT) is a common procedure with a long history of efficacy for a range of

blood cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid

leukemia (CML), and non-Hodgkin lymphoma (NHL).12,13 Reduced intensity conditioning regimens have significantly

reduced the mortality and morbidity associated with alloHCT; however, GvHD mediated by donor effector T cells

remains the most serious drawback of this therapy. Targeted depletion of all T cells from the transplant eliminates

engraftment support and graft versus tumor (GvT) activity. Therefore approaches that selectively deplete effector T

cells are needed to improve the safety of alloHCT. Preclinical studies over the past decade have demonstrated that

exposure of bone marrow to Fas ligand (FasL) prior to transplantation can eliminate effector T cells and reduce

GvHD.14,15,16,17 Stem and progenitor cells evade death signals due to their low expression of specific death receptors,

including the TNF family member Fas.18,19 With the ApoGraft Process featuring the Apotainer Selection Kit, Cellect

is poised to translate these preclinical observations into a potential clinical product designed to optimize alloHCT and

reduce the risk of GvHD.

The ApoGraft Process

The Apograft process, illustrated in Figure 4, begins with the isolation of mobilized peripheral blood cells (MPBC),

which are collected by apheresis and examined to ensure viability. The MPBCs are then washed with a buffer before

being re-suspended in the Apotainer Selection Kit, a container-like device coated with the apoptosis-inducing cytokine

FasL. This selectively causes mature immune cells such as effector T cells to undergo programmed cell death.

Following a 2-hour incubation, the cell suspension, now referred to as the ApoGraft, is washed several times to remove

cellular debris before being re-suspended and transplanted into the patient. The entire process takes approximately 4

hours, does not require any specialized instrumentation, and can be carried out by the same medical personnel who

perform stem cell transplants.

12CIBMTR. 2014. Current uses and outcomes of hematopoietic stem cell transplantation, 2014 summary slides. 13 http://www.wbmt.org/fileadmin/pdf/01_General/Task_force_Slide_set_2010_July2015-ATT_C2_HB.pdf 14 Pearl-Yafe, M. et al. 2007. Expression of Fas and Fas-ligand in donor hematopoietic stem and progenitor cells is dissociated

from the sensitivity to apoptosis. Experimental Hematology, 35, pp1601–1612. 15 Pearl-Yafe, M. et al. 2010. Tumor necrosis factor receptors support murine hematopoietic progenitor function in the early

stages of engraftment. Stem Cells, 28, pp1270–1280. 16 Mizrahi, K. et al. 2010. Regulatory functions of TRAIL in hematopoietic progenitors: human umbilical cord blood and

murine bone marrow transplantation. Leukemia, 24, pp1325–1334. 17 Mizrahi, K. et al. 2013. Resistance of hematopoietic progenitors to Fas-mediated apoptosis is actively sustained by NFκB with

a characteristic transcriptional signature. Stem Cells and Development, 23, pp676–686. 18 Maciejewski, JC et al. 1995Fas antigen expression on CD34+ human marrow cells is induced by interferon gamma and tumor

necrosis factor alpha and potentiates cytokine-mediated hematopoietic suppression in vitro. Blood, 85, pp3183–3190. 19 Nagafuji, K et al. 1995. Functional expression of Fas antigen (CD95) on hematopoietic progenitor cells. Blood 86, p883–889.

December 7, 2016

Figure 4. The Apograft Process Featuring the Apotainer Selection Kit

Source: Corporate Presentation

Development of Apotainer Selection Kit

Cellect is currently developing prototypes of the Apotainer Selection Kit. The Company recently demonstrated proof

of concept for binding FasL to a polymer without impairing the protein's apoptotic activity. A number of polymers

and binding methods were tested and the one best suited for manufacturing was chosen. Cellect, with prototype

development partner Entegris (NasdaqGS: ENTG) expects to complete development of the Apotainer Selection Kit

during the second half of 2017.

Regulatory Path for Apotainer Selection Kit

Cellect has initiated informal communications with the FDA and EMA regarding the regulatory paths forward for

Apotainer Selection Kit in the respective territories. To date, the regulatory agencies have indicated that the Apotainer

Selection Kit has the potential to be considered a combination drug-device product, and that it would fall under

medical device regulation at the Center for Biologics Evaluation and Research (CBER). Note that the combination

drug-device pathway allows for the potential that these candidates could receive Breakthrough, as well as Orphan

designations.

December 7, 2016

Preclinical Data

Cellect has conducted many preclinical studies to characterize cells produced by the ApoGraft process and test them

in animal models. In the first study we describe here, the Company tested the procedure with variable amounts of the

FasL ligand and then tested the cells for viability for transplantation in terms of cell count and other parameters.

Cellect has also run two preclinical studies with ApoGraft in rodent models of alloHCT, one of which was primarily

focused on safety and the other on efficacy. In these studies, untreated human MPBCs or MPBCs processed using

ApoGraft were challenged with FasL and were then transplanted into immuno-deficient mice. In the first study

animals were monitored for short- and long-term HSC engraftment, as well as symptoms of GvHD. The second study

measured the animal’s well-being, measures of disease progression, and OS. Combined, the data from the studies show

that treatment of MPBCs with FasL reduces signs of GvHD while prolonging OS. In this section, we highlight the

key results for each study. Note that the ApoGraft in these studies was prepared according to the protocol which is

currently being used in the ongoing Phase I/II clinical study in Israel.

ApoGraft Preclinical Viability Study

Cellect completed a study to test the ApoGraft process in a preclinical model of alloHCT. Briefly, human MPBCs

were collected by apheresis from healthy donors, washed twice in buffer and then re-suspended. The cells were then

incubated in the presence or absence of increasing concentration of recombinant FasL for 2 hours. Following

incubation, the cells were washed twice. Prior to transplantation, the ApoGraft was filtered and re-suspended in

transplantation buffer, which consisted of 5% human albumin solution in Plasma-Lyte. Samples of each ApoGraft

were collected and analyzed using standard assays for viability and biomarkers.

Figure 5 summarizes the results for each ApoGraft produced during this experiment. AG0, AG10, AG25, and AG50

refer to ApoGrafts generated in the presence of 0 ng/ml, 10 ng/ml, 25 ng/ml and 50 ng/ml of FasL, respectively.

Cellect has indicated that an acceptable yield for leukocytes (CD45+) and HSCs (CD34+) is greater than or equal to

65%. Results show that each ApoGraft consisted of approximately 68-79% of the original CD45+ cells and 64-84%

of CD34+ cells. Viability exceeded 98% for each ApoGraft, which was in line with the viability of untreated MPBCs.

Note that there was up to a 4-fold reduction in the number of T effector cells (CD3+) in the ApoGraft compared to

the untreated MPBCs, and this correlated with the 3- to 5-fold increase in apoptotic CD3+ cells in the ApoGrafts

compared to untreated MPBCs. These important results are highlighted in yellow.

December 7, 2016

Figure 5. Key Findings from Study #1 for ApoGraft

Tested parameter

ApoGraft

Untreated

MPBCs AG0 AG10 AG25 AG50

Cell yield &

Viability

% Leukocytes (CD45+

cells) yield NA 74 75 68 79

% Viability of CD45+

cells 100 99 99 99 98

% CD34+ cell yield NA 64 70 68 84

% Viability of CD34+

cells 100 99.8 99.6 99.9 99.7

Immunophenotype

(% Positive) % CD45+ 96.4 96.4 98.1 98.1 98.2

% CD3+ out of CD45+ 21.7 13.3 13.5 5.4 13.0

% CD34+ out of CD45+ 2.0 1.7 1.9 2.0 2.2

% CD33+ out of CD45+ 59.1 72.3 71.1 82.9 73.3

% CD19+ out of CD45+ 2.8 2.7 2.5 1.0 2.3

Apoptosis

induction

% early apoptosis CD3+ 0.9 3.3 3.0 5.0 3.4

Early apoptosis fold

change CD3+ NA 3.5 3.2 5.4 3.7


Early apoptosis fold

change CD34+ NA 1.5 0.9 1.0 1.8



Functionality and

potency of the

HPCs

CFU 38.2 24.7 35.2 32.0 33.5

CFU fold change NA 0.6 0.9 0.8 0.9

Source: Cellect and LifeSci Capital

The reduction in T effector cells is important because they drive the development of GvHD, so their selective

elimination during the ApoGraft process is highly desirable. In addition, there was no significant loss of colony

forming units (CFU), an indirect measure of cell engraftment, in the ApoGrafts compared to untreated MPBCs. This

means that the ApoGrafts should be able to engraft as well as the untreated MPBCs when transplanted into bone

marrow depleted animals. In summary, the ApoGrafts displayed similar cell viability and CFUs compared to untreated

MPBCs, but with numerically lower CD3+ counts, which means potentially less risk for GvHD.

Apograft Preclinical Safety Study

In this study, Cellect administered a single injection of stem cells to mice whose bone marrow was irradiated in order

to assess the potential toxic effects of ApoGraft. Researchers concluded that a single intravenous administration of

December 7, 2016

ApoGraft was not associated with toxicity. Following the experiment, which lasted for 63 days, the animals were

examined for histopathological changes that would indicate both the presence of active GvHD and also successful

engraftment of the cells. In the event, 10 male and 10 female NOD-SCID, immune deficient mice were placed in each

of 2 treatment groups. These mice represent a well-known model for stem cell transplantation. The first group of mice

received untreated human MPBCs and the second group received ApoGraft.

The first result observed in this study was that all of the animals who were administered ApoGraft stem cells survived

the 63 day observation period. On the other hand, half of the mice in the untreated stem cell group died or were

sacrificed on humane grounds 38-55 days after implantation. All mice that survived to the end of the study were

assessed for histopathological changes. Mixed mononuclear cell infiltration was observed in the liver, lungs, kidneys,

femoral bone marrow, and spleen. The infiltrating cells mostly had a relative abundance of eosinophilic cytoplasm and

multinucleated giant cells were also detected. These changes were considered to be consistent with GvHD in mice.

Researchers reported that all other pathology observed in both groups of mice were due to the stem cell transplantation

procedure, and were likely caused either by the irradiation procedure, or were considered to be spontaneous in this

strain of mice.

ApoGraft Preclinical Efficacy Study

This study was designed to assess the initial efficacy of ApoGraft for preventing GvHD in a mouse model. Researchers

used NOD-SCID IL-2Rγ (NSG) immune deficient mice, which are considered a good model for the induction of

GvHD following stem cell transplantation. The NSG mice are similar to the NOD-SCID mice used in the previous

experiment but are even further immune compromised, and are among the most immunocompromised mice

described so far. Engraftment of ApoGraft and non-treated stem cells revealed a significant prolongation of OS as

well as other improvements in the animals’ health.

In this study, mice were divided into six groups, the first of which received transportation vehicle buffer alone as a

control. The next group was engrafted with unaltered human hematopoietic stem cells. The other 4 groups received

IV infusion of ApoGraft processed cells that were treated with 4 different doses of FasL, 0, 10, 25, and 50 ng/ml.

These groups are referred to as AG0, AG10, AG25, and AG50, respectively. The presence of the ApoGraft cells

untreated with FasL is an important control for the experiment in case other factors of the process are affecting cell

viability. After cell engraftment the animals were observed for up to 87 days. In addition to being monitored for

survival, the mice were scored twice a week using a semi-quantitative scale of 0-8 and were also weighed.

The first result to note from this experiment is that all of the mice treated with ApoGraft survived the entire 87 day

observation period. At the end of the period these animals were tested for the presence of human cells, specifically

CD45+ cells, and evidence of successful engraftment was found. Mice in the control group rapidly lost weight and

developed xenogeneic GvHD, both of which likely contributed to the decreased survival. The animals developed

severe clinical signs and weight loss by the third week after transplantation, and all died within 8 weeks. Figure 6

depicts the Kaplan-Meier survival curves for mice engrafted with the untreated stem cells as well as the AG25 and

AG100 groups. As indicated, the treatment groups experienced statistically significantly improved OS with a p-value

less than 0.0001.

December 7, 2016

Figure 6. Survival by Day Post Cell Administration

Source: Cellect

Graft-Versus-Host Disease

Graft-versus-host disease (GvHD) is a potentially life-threatening complication of donor-derived hematopoietic cells

after an allogeneic bone marrow transplant (alloHCT). AlloHCT is most commonly used to treat blood cancers such

as leukemias and lymphomas, and involves the reconstitution of a patient’s immune system with cells from a healthy

donor. GvHD arises when transplanted donor white blood cells called T lymphocytes (T-cells) begin attacking the

patient’s tissues, causing inflammation and organ damage. According to the Worldwide Network for Blood and

Marrow Transplantation Group,20 approximately 32,000 patients undergo alloHCT worldwide each year and

approximately 60% are expected to develop GvHD.21 First-line treatment for GvHD is steroids, however less than

50% of patients will achieve durable responses with this therapy.22 Steroid-refractory GvHD (sr-GvHD) remains a

major cause of alloHCT-related morbidity, and overall mortality estimates are as high as 95%.23,24,25 A large

retrospective analysis of alloHCT cases revealed that GvHD was responsible for 25% of deaths.26 This indicates that

there is a high unmet medical need for a treatment, procedure, or solution that reduces the risk of a graft-vs-host

reaction.

20 Niederwieser, D. et al., 2016. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the


pp1-8. 21 Jagasia, M. et al. 2012. Risk factors for acute GvHD and survival after hematopoietic cell transplantation. Blood, 119(1),

pp296-307. 22 Arai, S. et al., 2002. Poor outcome in steroid refractory graft-versus-host disease with antithymocyte globulin treatment. Biology

of Bone and Marrow Transplantation, 8, pp155-160. 23 Bolanos-Meade, J. et al., 2001. Outcome of 21 patients undergoing unrelated bone marrow transplant for hematologic

malignancies at a single institution. Blood, 98, 382B. 24 Arai, S. et al., 2000. Management of graft-versus-host disease. Blood Reviews, 14, pp190-204. 25 Westin, J.R., et al. 2011. Steroid-Refractory Acute GvHD: Predictors and Outcomes. Advances in Hematology, 2011, pp1-8 26 Gratwohl, A. et al., 2005. Cause of death after allogeneic hematopoietic stem cell transplantation (HSCT) in early leukemia: an

EBMT analysis of lethal infectious complications and changes over calendar time. Bone Marrow Transplantation. 36(9), pp757-769.

December 7, 2016

Causes and Pathogenesis

GvHD occurs following an alloHCT when donor T-cells attack the patient’s organ systems. The immune attack causes

severe and potentially life-threatening organ damage. The condition progresses in three phases,27 which are discussed

below.

Damage Phase – Patients receiving an alloHCT are treated with a conditioning regimen, such as chemotherapy

with or without radiotherapy. The treatment kills cancer cells and creates physical space in the bone marrow to

accommodate the transplanted donor cells. However, chemotherapeutic agents are toxic to all cells within the

body, so these conditioning regimes also damage healthy tissues and organs. The damage leads to the systemic

release of inflammatory cytokines including tumor necrosis factor alpha (TNF-α) and interleukin-1 (IL-1), which

increase the expression of human leukocyte antigen (HLA) proteins and adhesion molecules on the patient’s

antigen-presenting cells (APCs).

T-Cell Activation Phase – After chemotherapy, donor bone marrow cells, including T-cells, are transplanted

into the patient. These cells enter into circulation and interact with APCs. If the donor cells and patient tissues do

not express identical HLA proteins on their cell surfaces, the donor T-cells will identify the patient’s tissues as

foreign, become activated, and launch the graft-versus-host reaction.

Effector Phase – The exact mechanism of organ damage is not known, but the activated donor T cells circulate

throughout the patient’s body and tend to target the patient’s skin, liver, and gut cells. Activated T cells secrete

cytokines that recruit additional immune cells, such as natural killer cells and large granular monocytes, which also

kill healthy cells and contribute to overall organ damage.

Symptoms, Diagnosis and Staging

There is no definitive test for GvHD but a positive diagnosis can be made based on patient symptoms.28 Symptoms

of acute GvHD (aGvHD) typically occur within 100 days post-alloHCT and most commonly involve the skin, liver,

and gastrointestinal tract. Usually the first sign of disease is a skin rash on the neck, ears, shoulders, palms, or feet.

The rash can be followed by upper and lower gastrointestinal track symptoms, which include bloody diarrhea,

abdominal pain, nausea, and vomiting. These features together with elevated levels of the liver biomarker bilirubin

suggest a graft-versus-host reaction and would lead clinicians to suspect aGvHD. A biopsy of the involved organs can

be used to confirm disease and rule out other non-GvHD complications.

The Keystone aGvHD Clinical Grade Scale was established in 1994 and is widely used in the clinic today to

characterize the severity of acute aGvHD.29 In this system, the severity of disease corresponds directly to the degree

of organ involvement. The top half of Figure 7 shows the four stages of disease for each of the three most commonly

affected organs – the skin, liver, and gastrointestinal track. Organ staging is combined with the patient’s performance

to produce an overall grade, which helps clinicians determine prognosis and select appropriate treatment options.

Patients with a Grade II-IV moderate-to-severe aGvHD have a significantly higher mortality rate than those with

27 Ball, L. and Egeler, R. 2008. Acute GvHD: pathogenesis and classification. Bone Marrow Transplantation, 41(2), S58-S64. 28 Firoz, B.F. et al., 2006. Role of skin biopsy to confirm suspected acute graft-vs-host disease: results of decision analysis.

Archives of Dermatology, 142(2), pp175. 29 Przepioka, D. et al., 1995. 1994 Consensus Conference on Acute GvHD Grading. Bone Marrow Transplantation, 15, pp825-864.

December 7, 2016

milder Grade I disease. Estimated five-year survival rates of patients with Grade III and Grade IV disease are 25%

and 5%, respectively.30

Figure 7. Keystone Clinical Grade Scale

Stage Skin Liver GI Tract

1 Rash <25% of body surface

area Bilirubin 2-3 mg/dL Diarrhea >500 ml/day

2 Rash ≥25-50% of body

surface area Bilirubin 3.1-6 mg/dL Diarrhea >1000 ml/day

3 Rash on > 50% of body

surface area Bilirubin 6.1-15 mg/dL Diarrhea >1,500 ml/day

4 Generalized erythroderma

with bullous formation Bilirubin >15 mg/dL

Diarrhea >1,500 ml/day

or severe abdominal pain

Grade

I Stage 1-2 None None

II Stage 3 or Stage 1 or Stage 1

III N/A Stage 2-3 or Stage 2-4

IV Stage 4 or Stage 4 N/A

Source: Przepiorka, D. et al., 1995

Treatment for GvHD

Prophylactic treatments are used to prevent GvHD but approximately 60% of alloHCT patients will still develop the

condition. There is not an agreed upon prophylactic therapy, however most protocols combine methotrexate (MTX)

with a calcineurin inhibitor (CNI) such as tacrolimus or cyclosporine A. When prophylaxis fails, clinicians are

presented with few treatment options to reverse disease progression. Below, we discuss the therapies for Grade I,

Grades II-IV, and steroid-refractory disease, and highlight the potential for Cellect’s Apotainer in reducing the risk of

developing GvHD.

30 Cahn, J.Y. et al., 2005. Prospective evaluation of 2 acute graft-versus-host (GvHD) grading systems: a joint Société Française

de Greffe de Moëlle et Thérapie Cellulaire (SFGM-TC), Dana Farber Cancer Institute (DFCI), and International Bone Marrow

Transplant Registry (IBMTR) prospective study. Blood, 106(4), p1495.

December 7, 2016

Treatment for Grade I GvHD. Patients with Grade I disease present with rash covering less than 50% of their body

and show no signs of liver or gastrointestinal involvement. First-line treatment for this form of the disease usually

involves topical steroids. For the approximately 60-75% of patients with Grade I who become refractory to steroid

treatment, a topical formulation of the CNI tacrolimus has been used as a second-line therapy.31

Treatment for Grades II-IV GvHD. First-line treatment for Grades II-IV GvHD is off-label use of steroids,32 which

have been shown to be superior to immunosuppressants like cyclosporine A and anti-thymocyte globulin (ATG).33,34

Initial treatment is usually systemic glucocorticoids, such as methylprednisolone. Approximately 25%-40% of patients

receiving methylprednisolone experience a complete response, defined as the complete resolution of GvHD

symptoms in all affected organs.35,36 It is estimated that 40-50% of Grades II-IV patients will experience improvement

in symptoms, defined as resolution of skin rashes, and a reduction in gastrointestinal and liver symptoms.37, 38 We note

that response rates decrease as the severity of disease increases with grade IV patients having the lowest overall

response rate. Patients who do not respond to steroids seven days following treatment are diagnosed with sr-GvHD.

Steroid-Refractory GvHD Treatments. There are no approved therapies for sr-GvHD, highlighting a significant

unmet medical need for these patients. Current treatment options include a variety of immunosuppressive agents and

experimental therapies. The most widely used agents for sr-GvHD include antithymocyte globulin (ATG) and TNF-

α inhibitors. Approximately 20-50% of patients respond to ATG therapy,39 however less than 20% achieve durable

responses. ATG treatment can cause severe side effects, including acute febrile reactions, hypotension,

thrombocytopenia, and, in rare instances, the development of post-transplantation lymphoproliferative disorders40

While this highlights the a need for safer and more durable treatment options, it would be prefable to pursue

prevention of GvHD in the first place.

Other immunosuppressants available for the treatment of sr-GvHD include TNF-α inhibitors, as well as anti-IL-2

receptor–, anti-IL6 receptor–, anti-CD20–, and anti-CD52–targeted therapies. These agents have not been rigorously

tested in clinical trials, making it very difficult to establish efficacy. There is also a significant safety risk with these

therapies, since they broadly suppress immune function and leave patients susceptible to opportunistic bacterial and

viral infections.

31 Antin, J. et al., 2004. Novel approaches to the therapy of steroid-resistant acute graft-versus-host disease. Biology of Blood and

Marrow Transplantation, 10(10), pp655-668. 32 Martin, P.J. et al., 2012. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the

American Society of Blood and Marrow Transplantation. Biology of Blood and Marrow Transplantation. 18(8), pp1150-1163. 33 Martin, P.J. et al., 1991. A retrospective analysis of therapy for acute graft-versus-host disease: secondary treatment. Blood, 77,

pp1821- 1828. 34 Martin, P.J. et al., 1990. A retrospective analysis of therapy for acute graft-versus-host disease: initial treatment. Blood, 76,

pp1464-1472. 35 Hings, I.M. et al., 1994. Treatment of moderate and severe acute GvHD after allogeneic bone marrow transplantation.

Transplantation, 58(4), pp437. 36 Lee, S.J. et al., 2004. Effect of up-front daclizumab when combined with steroids for the treatment of acute graft-versus-host

disease: results of a randomized trial. Blood, 104(5), pp1559. 37 Chao, N. et al., 2015. Treatment of acute graft-versus-host disease. Wolters Kluwer. 38 Deeg, J., 2007. How I treat refractory acute GvHD. Blood. 109(10), pp4119-4126. 39 Doney, K. et al., 1985. A randomized trial of antihuman thymocyte globulin versus murine monoclonal antihuman T-cell

antibodies as immunosuppressive therapy for aplastic anemia. Experimental Hematology. 13(6), pp520-524. 40 Curtis, R.E. et al., 1999. Risk of lymphoproliferative disorders after bone marrow transplantation: a multi-institutional study.

Blood, 94(7), pp2208-2216.

December 7, 2016

Risks Associated with Current GvHD Treatment. The majority of treatment options for GvHD include

immunosuppressants. These drugs uniformly suppress the patient’s immune system, which makes them more

susceptible to severe infections and infection-related deaths. Antimicrobial and antiviral prophylactic treatments are

administered to mitigate infections; however, these therapies are not always effective. A large retrospective study

compared infection rates following alloHCT in 14,403 patients between 1980-2001.41 Results showed that 11%

(597/5,377) of deaths were due to infections. The proportion of deaths associated with each infectious agent is shown

in Figure 8. The median time of death after alloHCT due to infection was determined to be 3 months, with a range

of 0 months to 158 months. These data once again highlight the desirability of GvHD prevention.

Figure 8. Lethal Infections Following alloHCT

Infectious Agent Proportion of Total Deaths

Bacteria 36% (217/597)

Virus 31% (183/597)

Fungi 28% (166/597)

Parasite 5% (32/597)

Source: Gratwohl et al., 2005

GvHD – Market Information

The number of HCTs has grown steadily since 1980. There were roughly 68,000 transplants performed worldwide in

2012 with 47% or 32,000 of the procedures being alloHCT.42 Figure 9 shows the number of alloHCTs in the US by

indication in 2012. The vast majority of alloHCT are performed in patients with blood cancers, including AML, ALL,

CML and NHL.43,44

41 Gratwohl, A. et al., 2005. Cause of death after allogeneic hematopoietic stem cell transplantation (HSCT) in early leukemia: an

EBMT analysis of lethal infectious complications and changes over calendar time. Bone Marrow Transplantation. 36(9), pp757-769. 42 Niederwieser, D. et al., 2016. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the


pp1-8. 43CIBMTR. 2014. Current uses and outcomes of hematopoietic stem cell transplantation, 2014 summary slides. 44 http://www.wbmt.org/fileadmin/pdf/01_General/Task_force_Slide_set_2010_July2015-ATT_C2_HB.pdf

December 7, 2016

Figure 9. Hematopoietic Stem Cell Transplants in the US by Indication in 2012

Source: Center for International Blood & Marrow Transplant Research

Figure 10 shows that there were roughly 32,000 alloHCTs performed worldwide in 2012.45,46 Approximately 60% of

patients receiving alloHCT are expected to develop GvHD,47 indicating that there are approximately 19,200 cases

worldwide each year. Cellect’s Apograft process featuring the Apotainer is designed to reduce or possibly eliminate

the risk of GvHD.

Figure 10. alloHCTs Performed Worldwide 2012

Percent of

Case

Number of

Cases

Number of Allogeneic HCTs Performed Worldwide 32,000

Transplant cases developing GvHD 60% 19,200


45 CIBMTR. 2014. Current uses and outcomes of hematopoietic stem cell transplantation, 2014 summary slides. 46 http://www.wbmt.org/fileadmin/pdf/01_General/Task_force_Slide_set_2010_July2015-ATT_C2_HB.pdf 47 Won Choi, S. & Reddy, P. 2014. Current and emerging strategies for the prevention of graft versus host disease. Nature

Reviews Clinical Oncology, 11(9), pp536-547.

December 7, 2016

Apotainer Selection Kit Market Potential. We conducted a scenario analysis to estimate the worldwide market

potential for Apotainer. This analysis is based on several assumptions listed below:

Number of alloHCTs Performed Worldwide – We used the assumptions detailed above in Figure 10.

Adjustments were made to account for population growth.

Market Penetration – Given the need for effective procedures that reduce or eliminate the risk of GvHD,

we assume a market penetration ramp of 5% to 40% for Apotainer.

Pricing – We assume a price per Apotainer starting at $7,500, which is a significant discount to current

products on the market.

Figure 11 shows our estimates for worldwide sales of Apotainer Selection Kit our based on the assumptions above.

Our scenario includes a fairly rapid launch and peak penetration of 40%. This yields estimated peak sales of $200

million in 2026.

Figure 11. Worldwide Sales Estimates for Apotainer Selection Kit in alloHCT

2022 2023 2024 2025 2026

# of alloHCTs worldwide 48,429 50,071 51,714 53,357 55,000

Apotainer Penetration Rate 5% 15% 25% 35% 40%

Procedures with Apotainer 2,421 7,510 12,929 18,675 22,000

Cost Per Apotainer $7,500 $7,875 $8,269 $8,682 $9,116

Potential Sales $18 M $59 M $107 M $162 M $201 M


Clinical Data Discussion

Cellect has initiated an open-label Phase I/II pilot study evaluating the Apograft process in the alloHCT setting. The

primary objective of this study is to test the safety and tolerability of ApoGraft administered to subjects with

hematological malignancies undergoing alloHSCT. The secondary objective of this trial is to assess ApoGraft

engraftment, the donor cells populating patients’ hematological systems, and prevention of GvHD. The Company

expects to conduct a pre-IND meeting with the FDA in the first half of 2017 and file an IND in the second half of

2017.This could lead to initiation of a US trial to evaluate the Apograft process with the Apotainer Selection Kit is

expected in early 2018.

Competitive Advantages of the ApoGraft Process Featuring the Apotainer Selection Kit

As we’ve described, ApoGraft offers numerous potential improvements over the existing standard of care for

hematopoietic stem cell transplant. Some of these features include a simple and cost-effective procedure, no need for

a specialized laboratory, and shorter hospital stays. The table in Figure 12 outlines some of these benefits. Of course,

December 7, 2016

the most important feature is the potential benefit to patients in terms of improved engraftment and a reduction of

GvHD. Although it is still too early to know ApoGraft can yield these benefits, and a corresponding improvement in

survival, the data collected to date suggest strong potential for this to be a game-changing technology, first for

alloHSCT, and eventually for other diseases as well.

Figure 12. Comparison of ApoGraft and Current Procedures

Current Procedures ApoGraft

GvHD 60% Less

Rate of Infection High Low

Length of Procedure Months Several Days

Procedure Cost ~ $70,000/transplant Significantly Lower

Total Cost of Care ~ $300,000/transplant Significantly Lower


Intellectual Property

Cellect has multiple patents in the US, Europe, India, and Israel covering the Powered by Cellect technology platform

and its associated products. The Company also has a global patent covering the use of apoptosis as a selection tool in

the harvesting of stem progenitor cells. Within the US, this patent provides IP protection through 2029. In addition,

Cellect has patents protecting their special-purpose containers, methods of use, and manufacturing methods.

Management Team

Shai Yarkoni, MD, Ph.D.

Chief Executive Officer

Dr. Yarkoni has over 15 years of clinical and management experience in the biopharmaceutical industry. He is the

founder of 5 start-ups in the life-sciences field, and serves on the board of noted institutes in Israel and the world.

Prior to joining Cellect, he served as CEO of Target-In Ltd., and as CTO and VP R&D of Collgard Biopharmaceutical,

a tissue therapeutics company. Dr. Yarkoni has M.D Ph.D from the Hadassah Medical School, Jerusalem, Israel, and

is a board certified Ob/Gyn. Dr. Yarkoni is the author of over 60 scientific papers.

Ronen Twito

Deputy Chief Executive Officer and Chief Financial Officer

Possesses 15 years of finance and management experience and is an Israeli CPA. Prior to Cellect, served as VP Finance

at BioBlast Pharma, a clinical-stage company, as Deputy CEO And CFO at XTL Biopharmaceuticals, a company

focusing on late stage clinical technologies and as CEO of InterCure Ltd, a medical device company. Also served as

December 7, 2016

CFD at Leadcom Integrated Solutions Ltd., a telecommunications company And as an audit manager at E&Y. Holds

a BSc in Business & Management – Accounting, and a B.Ed in Teaching Accounting, both from the Collman

Management College.

Nadir Arkenasy, MD, Ph.D.

Chief Scientist Officer and Co-Founder

Leads research and clinical activity in the field of cellular therapies. An author of more than 100 peer-reviewed

publications, serves on the editorial boards of stem cell and medical journals, and in advisory committees of medical

institutes worldwide. Specialized in internal medicine and owns a Ph.D. in Physical Chemistry from Tel Aviv

University. The Principal Investigator at the Frankel Laboratory of Experimental Bone Marrow Transplantation,

Schneider Children’s Medical Center of Israel and performs clinical work at the International Center of Cell Therapy.

Risk to an Investment

We consider an investment in Cellect to be a high-risk investment. Cellect is a clinical-stage company with no history

of commercializing a product and currently has no FDA approved products in its portfolio. Although Cellect has

generated positive results to date, these results need to be confirmed in large, pivotal trials. Positive data do not

necessarily translate into FDA approval or the successful commercialization of a product. Regulatory risks remain, as

the approval by the FDA and similar regulatory bodies is not guaranteed despite significant time and financial

investment. Even if regulatory approval is granted, there is no guarantee that expectations of market penetration and

sales will come to fruition.

December 7, 2016

Analyst CertificationThe research analyst denoted by an “AC” on the cover of this report certifies (or, where multiple research analysts are primarily responsiblefor this report, the research analyst denoted by an “AC” on the cover or within the document individually certifies), with respect to eachsecurity or subject company that the research analyst covers in this research, that: (1) all of the views expressed in this report accuratelyreflect his or her personal views about any and all of the subject securities or subject companies, and (2) no part of any of the researchanalyst's compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the researchanalyst(s) in this report.

DISCLOSURESThis research contains the views, opinions and recommendations of LifeSci Capital, LLC (“LSC”) research analysts. LSC (or an affiliate)has received compensation from the subject company for producing this research report. Additionally, LSC may provide investmentbanking and other broker-dealer services to the subject company and may receive compensation from the subject company for suchservices. LSC (or an affiliate) has also provided non-investment banking securities-related services, non-securities services, and otherproducts or services other than investment banking services to the subject company and received compensation for such services withinthe past 12 months.

Neither the research analyst(s), a member of the research analyst’s household, nor any individual directly involved in the preparation ofthis report, has a financial interest in the securities of the subject company. Neither LSC nor any of its affiliates beneficially own 1% ormore of any class of common equity securities of the subject company.

LSC is a member of FINRA and SIPC. Information has been obtained from sources believed to be reliable but LSC or its affiliates (LifeSciAdvisors, LLC) do not warrant its completeness or accuracy except with respect to any disclosures relative to LSC and/or its affiliates andthe analyst's involvement with the company that is the subject of the research. Any pricing is as of the close of market for the securitiesdiscussed, unless otherwise stated. Opinions and estimates constitute LSC’s judgment as of the date of this report and are subject to changewithout notice. Past performance is not indicative of future results. This material is not intended as an offer or solicitation for the purchaseor sale of any financial instrument. The opinions and recommendations herein do not take into account individual client circumstances,objectives, or needs and are not intended as recommendations of particular securities, companies, financial instruments or strategies toparticular clients. The recipient of this report must make his/her/its own independent decisions regarding any securities or financialinstruments mentioned herein. Periodic updates may be provided on companies/industries based on company specific developments orannouncements, market conditions or any other publicly available information. Additional information is available upon request.

No part of this report may be reproduced in any form without the express written permission of LSC. Copyright 2014.

December 7, 2016

Cellect Biotechnology (APOP) TM · Cellect Biotechnology (NasdaqGS: APOP; TASE: APOP) is developing...

Documents

Transcript of Cellect Biotechnology (APOP) TM · Cellect Biotechnology (NasdaqGS: APOP; TASE: APOP) is developing...