UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2021
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________________________ to __________________________
Commission file number 001-38416
ORGENESIS INC.
(Exact name of registrant as specified in its charter)
Nevada
State or other jurisdiction
of incorporation or organization
98-0583166
(I.R.S. Employer
Identification No.)
20271 Goldenrod Lane, Germantown, MD 20876
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (480) 659-6404
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Common Stock, par value $0.0001 per share
Trading Symbol(s)
ORGS
Name of each exchange on which registered
The Nasdaq Capital Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller
reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Non-accelerated filer ☒
Emerging growth company ☐
Accelerated filer ☐
Smaller reporting company ☒
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the
effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by
the registered public accounting firm that prepared or issued its audit report. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The registrant had 24,820,756 shares of common stock outstanding as of March 30, 2022. The aggregate market value of the
common stock held by non-affiliates of the registrant as of the last business day of the registrant’s most recently completed second
fiscal quarter (June 30, 2021) was $109,567,091, as computed by reference to the closing price of such common stock on The
Nasdaq Capital Market on such date.
ORGENESIS INC.
2021 FORM 10-K ANNUAL REPORT
TABLE OF CONTENTS
PART I
ITEM 1. BUSINESS
ITEM 1A. RISK FACTORS
ITEM 1B. UNRESOLVED STAFF COMMENTS
ITEM 2. PROPERTIES
ITEM 3. LEGAL PROCEEDINGS
ITEM 4. MINE SAFETY DISCLOSURES
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
ITEM 9A. CONTROLS AND PROCEDURES
ITEM 9B. OTHER INFORMATION
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
ITEM 11. EXECUTIVE COMPENSATION
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
ITEM 16. FORM 10-K SUMMARY
SIGNATURES
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SPECIAL CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
The following discussion should be read in conjunction with the financial statements and related notes contained elsewhere in this
Annual Report on Form 10-K. Certain statements made in this discussion are “forward-looking statements” within the meaning of
27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements are based upon beliefs of, and information currently available to, the Company’s management as well as
estimates and assumptions made by the Company’s management. Readers are cautioned not to place undue reliance on these
forward-looking statements, which are only predictions and speak only as of the date hereof. When used herein, the words
“anticipate,” “believe,” “estimate,” “expect,” “forecast,” “future,” “intend,” “plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue” or the negative of these terms and similar expressions as they relate to the Company or the
Company’s management identify forward-looking statements. Such statements reflect the current view of the Company with respect
to future events and are subject to risks, uncertainties, assumptions, and other factors, including the risks relating to the Company’s
business, industry, and the Company’s operations and results of operations. Should one or more of these risks or uncertainties
materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated,
believed, estimated, expected, intended, or planned.
Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company
cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the
securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these
statements to actual results.
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States (“GAAP”).
These accounting principles require us to make certain estimates, judgments and assumptions. We believe that the estimates,
judgments and assumptions upon which we rely are reasonable based upon information available to us at the time that these
estimates, judgments and assumptions are made. These estimates, judgments and assumptions can affect the reported amounts of
assets and liabilities as of the date of the financial statements as well as the reported amounts of revenues and expenses during the
periods presented. Our financial statements would be affected to the extent there are material differences between these estimates and
actual results. The following discussion should be read in conjunction with our financial statements and notes thereto appearing
elsewhere in this report.
Unless otherwise indicated or the context requires otherwise, the words “we,” “us,” “our,” the “Company,” “our Company” or
“Orgenesis” refer to Orgenesis Inc., a Nevada corporation, and our majority or wholly-owned subsidiaries, Orgenesis Korea Co. Ltd.
(the “Korean Subsidiary”); Orgenesis Belgium SRL, a Belgian-based entity (the “Belgian Subsidiary”); Orgenesis Ltd., an Israeli
corporation (the “Israeli Subsidiary”); Orgenesis Maryland Inc., a Maryland corporation (the “U.S. Subsidiary”); Orgenesis
Switzerland Sarl, which was incorporated in October 2020 (the “Swiss Subsidiary”); Orgenesis Biotech Israel Ltd. (“OBI”); Koligo
Therapeutics Inc., a Kentucky corporation, purchased in 2020 (“Koligo”); Orgenesis Germany GmbH which was incorporated in
2021 (the “German Subsidiary”); Orgenesis CA, Inc. which was incorporated in 2021 (the “California Subsidiary”); Masthercell
Global Inc. (“Masthercell”) and its wholly owned subsidiaries Cell Therapy Holdings S.A., MaSTherCell, S.A. (“MaSTherCell”), a
Belgian-based subsidiary and a Contract Development and Manufacturing Organization (“CDMO”) specialized in cell therapy
development and manufacturing for advanced medicinal products, and Masthercell U.S., LLC (“Masthercell U.S.”), a U.S.-based
CDMO (collectively, “Masthercell”). The Company sold all of its equity interests in Masthercell and its subsidiaries on February 20,
2020.
3
Forward-looking statements made in this Annual Report on Form 10-K include statements about:
Corporate and Financial
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our ability to generate revenue from the commercialization of our point-of-care cell therapy (“POC”) to reach patients and
to increase such revenues;
our ability to achieve profitability;
our ability to manage our research and development programs that are based on novel technologies;
our ability to grow the size and capabilities of our organization through further collaboration and strategic alliances to
expand our point-of-care cell therapy business;
our ability to control key elements relating to the development and commercialization of therapeutic product candidates
with third parties;
our ability to manage potential disruptions as a result of the continued impact of the coronavirus outbreak;
our ability to manage the growth of our company;
our ability to attract and retain key scientific or management personnel and to expand our management team;
the accuracy of estimates regarding expenses, future revenue, capital requirements, profitability, and needs for additional
financing; and
our belief that our therapeutic related developments have competitive advantages and can compete favorably and profitably
in the cell and gene therapy industry.
Cell & Gene Therapy Business (“CGT”)
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our ability to adequately fund and scale our various collaboration, license, partnership and joint venture agreements for the
development of therapeutic products and technologies;
our ability to advance our therapeutic collaborations in terms of industrial development, clinical development, regulatory
challenges, commercial partners and manufacturing availability;
our ability to implement our POC strategy in order to further develop and advance autologous therapies to reach patients;
expectations regarding our ability to obtain additional and maintain existing intellectual property protection for our
technologies and therapies;
our ability to commercialize products in light of the intellectual property rights of others;
our ability to obtain funding necessary to start and complete such clinical trials;
our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our
obligations under such agreements;
our belief that our systems and therapies are as at least as safe and as effective as other options;
our Subsidiary’s relationship with Tel Hashomer Medical Research Infrastructure and Services Ltd. (“THM”) and the
growing risk that THM may cancel or, at the very least continue to challenge, the License Agreement with Orgenesis Ltd. as
we continue to expand our focus to other therapies;
the outcome of certain legal proceedings that we become involved in;
our license agreements with other institutions;
expenditures not resulting in commercially successful products;
our dependence on the financial results of our POC business;
our ability to complete development, processing and then roll out Orgenesis Mobile Processing Units and Labs
(“OMPULs”); and
our ability to grow our POC business and to develop additional joint venture relationships in order to produce demonstrable
revenues.
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in
the section entitled “Risk Factors” set forth in this Annual Report on Form 10-K for the year ended December 31, 2021, any of
which may cause our Company’s or our industry’s actual results, levels of activity, performance or achievements to be materially
different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking
statements. These risks may cause the Company’s or its industry’s actual results, levels of activity or performance to be materially
different from any future results, levels of activity or performance expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future
results, levels of activity or performance. Moreover, neither we nor any other person assumes responsibility for the accuracy and
completeness of these forward-looking statements. The Company is under no duty to update any forward-looking statements after
the date of this report to conform these statements to actual results.
4
ITEM 1. BUSINESS
Business Overview
PART I
Orgenesis Inc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies
(“CGTs”) in an affordable and accessible format.
CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a
class of medicines referred to as advanced therapy medicinal products (“ATMP”). We are mostly focused on autologous therapies,
with processes and systems that are developed for each therapy using a closed and automated processing system approach that is
validated for compliant production near the patient for treatment of the patient at the point of care (“POCare”). This approach has the
potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial
production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver such treatments to patients
(ultimately limiting the number of patients that can have access to, or can afford, these therapies).
To achieve these goals, we have developed a Point of Care Platform (“POCare Platform”) comprised of three enabling components:
(i) a pipeline of licensed POCare advanced therapies that are designed to be processed and produced, (ii) automated closed POCare
technology systems, and (iii) a collaborative worldwide network of POCare research institutes and hospitals (“POCare Network”).
The POCare Platform relies, in particular, on the development of its own production capacity, known as “POCare Services”, the goal
of which is to ensure that therapies are accessible at the point of treatment (the “POCare Center”). POCare Services, which have
been expanding worldwide, are based on a global approach and local adaptation that allows replication and expansion. Global
harmonization of the POCare Services is ensured by a central quality system, replicability of infrastructure and equipment and
centralized monitoring and data management.
The POCare Services include:
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Process development of therapies that are intended for use of the POCare Network;
Adaptation of automation and closed systems to such therapies;
Incorporation of the processing systems and the Good Manufacturing Practices (“GMP”) in the Orgenesis Mobile
Processing Units and Labs (“OMPULs”);
Tech transfers to required POCare Centers and training of local teams;
Processing and supply of the therapies and required supplies under GMP conditions by the various POCare
Centers, including required quality control testing; and
Contract Research Organization (“CRO”) services for clinical trials.
POCare Centers are the decentralized hubs that provide harmonized services to customers and partners. We are working to provide a
more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. The workflow of a
POCare Center is designed to allow rapid capacities expansion while integrating new technologies. We also draw upon extensive
medical expertise to identify promising new autologous therapies to leverage within the POCare Platform either via ownership or
licensing.
5
The POCare Network brings together patients, doctors and industry partners with a goal of achieving harmonized, regulated clinical
development and production of POCare advanced therapies.
We have worked to develop and validate POCare technologies that can be combined within mobile production units for advanced
therapies. We have made significant investments in the development of several types of OMPULs with the expectation of use and/or
distribution through our POCare Network and/or partners, collaborators, and regional distributors. As of the date of this report, the
OMPULs have been adapted for processing of chimeric antigen receptor (CAR) T-cell therapy (“CAR-T”), tumor infiltrating
lymphocyte (“TIL”) TILS and mesenchymal stem cell (“MSC”) based products and are in the qualification stage for clinical use in
various locations. Additional OMPULs are still in the development stage.
OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of
potential or approved advanced therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the
manufacturing of such CGTs in a consistent and standardized manner in all locations. The OMPUL design delivers a potential
industrial solution for us to deliver CGTs to practically any clinical institution at the point of care.
We have continued to grow our infrastructure and expand our processing sites into new markets and jurisdictions. In addition, we
have continued investing manpower and financial resources to focus on developing, processing and rolling out several types of
OMPULs to be used and/or distributed through our POCare Network and/or partners, collaborators, and regional distributors.
POCare Platform Operations via Subsidiaries
We currently conduct our core business operations ourselves and through our subsidiaries which are all wholly-owned except as
otherwise stated below (collectively, the “Subsidiaries”). The Subsidiaries are as follows:
United States
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Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America and is currently focused on
setting up and providing POCare Services to the POCare Network.
Koligo Therapeutics, Inc. (“Koligo”) is a Kentucky corporation that we acquired in 2020. Koligo is a regenerative medicine
company, specializing in developing personalized cell therapies. It is currently focused on commercializing its metabolic
pipeline via the POCare network throughout the United States and in international markets.
Orgenesis CA, Inc. (the “California subsidiary”) is a Californian subsidiary incorporated in 2021 and is currently focused on
development of our technologies and therapies in California.
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Orgenesis Belgium SRL (the “Belgian Subsidiary”) is currently focused on expanding our POCare network in Europe,
process development and the preparation of European clinical trials.
Orgenesis Switzerland Sarl (the “Swiss Subsidiary”), was incorporated in October 2020, and is currently focused on
providing management services to us.
Orgenesis Germany GmbH (incorporated in 2021) (the “German subsidiary”) is currently focused on providing CRO
services to the POCare Network.
Korea: Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea.
We own 94.12% of the Korean Subsidiary.
Orgenesis Ltd. in Israel (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services in Israel.
Orgenesis Biotech Israel Ltd. (“OBI”) is a provider of process development and cell-processing services in Israel.
Discontinued Operations
In February 2020, we and GPP-II Masthercell LLC (“GPP”) sold 100% of the outstanding equity interests of Masthercell Inc. (the
“Masthercell Business”), which comprised the majority of our CDMO Business, to Catalent Pharma Solutions, Inc. We determined
that the Masthercell Business (“Discontinued Operations”) met the criteria to be classified as a discontinued operation as of the first
quarter of 2020. The Discontinued Operation includes the vast majority of the previous CDMO Business, including majority-owned
Masthercell Inc and its subsidiaries.
Advanced Therapy Medicinal Products Overview
ATMP means one of any of the following medicinal products that are developed and commercialized for human use:
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A somatic cell therapy medicinal product (“STMP”) that contains cells or tissues that have been manipulated to change
their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body.
A tissue engineered product (“TEP”) that contains cells or tissues that have been modified so that they can be used to repair,
regenerate, or replace human tissue.
A gene therapy medicinal product (“GTMP”) that engineers genes that lead to a therapeutic, prophylactic, or diagnostic
effect and, in many cases, work by inserting “recombinant” genes into the body, usually to treat a variety of diseases,
including genetic disorders, cancer, or long-term diseases. In this case, a recombinant gene is a stretch of DNA that is
created in the laboratory, bringing together DNA from different sources.
It is important to note that although STMPs and GTMPs currently dominate the market, in order to access the market potential and
trends in the future, other cell products are likely to be essential in all of these categories.
We believe that autologous therapies represent a substantial segment of the ATMP market. Autologous therapies are produced from a
patient’s own cells versus allogeneic therapies that are mass-cultivated from donor cells via the construction of master and working
cell banks, are then produced on a large scale. Developers and manufacturers of ATMPs (both autologous and allogeneic) currently
rely heavily on production using traditional centralized supply chains and manufacturing sites.
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CGTs are costly and complex to produce. We also refer to CGTs as “living” drugs since they are based on maintaining the cells
vitality. Therefore, there is no possibility to sterilize the products, since such a process involves killing any living organism. Many of
these therapies require sourcing of the patient’s cells, engineering them in a sterile environment and then transplanting them back to
the patient (so-called “autologous” CGT). This presents multiple logistic challenges as each patient requires its own production
batch, and the current processes involve complex laboratory-based types of manipulations requiring highly trained lab technicians.
We are leveraging a unique approach to therapy production using the POCare Platform to potentially overcome some of the
development and supply chain challenges of affordably bringing autologous therapies to patients.
Allogeneic therapies are costly and complex to produce because autologous therapies are derived from the treated patient and
manufactured through a defined protocol before re-administration. We are leveraging a unique approach to therapy production using
the POCare Platform to potentially overcome some of the development and supply chain challenges of bringing autologous therapies
to patients affordably.
Therapies in Development
The following table summarizes our therapies in development, which are discussed in detail below:
Ref
1
Therapy
KYSLECEL
2 & 6
Own
Own
Licensing/Joint
Venture/Collaboration Partner
Licensed from Theracell
Licensed from Theracell
Own
ORG Ltd. Licensed from THM
Indication
TP-IAT
Cell Assisted
Lipotransfer, COVID-19, CLI-
ED
Osteoarthritis
Cartilage Defects
HPV-associated external
anogenital warts (EGW)
Diabetes treatment
3
4
5
7
8
9
10
11
12
13
14
15
16
Tissue Genesis Icellator®
Cartil-S
Chondroseal
RanTop, Ranpirnase Topical
Formulation
Autologous Insulin-Producing
Cells (AIPs) from Adult Liver
Cells
CAR-T CD19
Dual Cellular vaccine
(DUVAC)
Metabolically Optimized T-
Cells (MOTC): Therapy for
melanoma and lung cancer
Autologous Cell-Based Vaccine
for protecting against SARS-
CoV-2
Bioxomes
MSCP
Muscle-derived Mesenchymal
Stem Cells for Human
Regenerative Medicine
Kidney Disease
KT-DM-103 and KT-CP-203
(3D-Printed Pancreatic Islets)
ORG Inc. Licensed from Broaden Bioscience and
Technology Corp
Licensed from Columbia University
B-ALL, Lymphoma
Pancreatic Cancer
Own
Own
Own
Own
Licensed from Revitas
Own
Own
8
Solid Tumors
COVID -19, platform for the
prevention of viral diseases
Various Indications
Wound healing and Psoriasis
Urinary Incontinence
CKD
Type 1 diabetes and chronic
pancreatitis
Products in Clinical Use
1. KYSLECEL® (Autologous Pancreatic Islets)
KYSLECEL is made from a patient’s own pancreatic islets – the cells that make insulin to regulate blood sugar. KYSLECEL is
intended to preserve insulin secretory capacity in chronic or acute recurrent pancreatitis patients after total pancreatectomy (TP-IAT).
KYSLECEL is a minimally manipulated autologous cell-based product available in the United States and regulated by the U.S. Food
and Drug Administration (“FDA”). KYSLECEL is produced according to current good tissue practices (cGTP) and in compliance
with federal and state regulations. We are planning on initiating an observational study in the US to gain insight into KYSLECEL
patient outcomes. Substantial efforts are being invested in promoting the process development and the marketing of KYSLECEL in
the European Union. In May 2021 we submitted a request for classification to Committee for Advanced Therapies (CAT) to the
European Medicines Agency (EMA), who classified KYSLECEL as not being an Advanced Therapy Medicinal Product (ATMP).
We have identified relevant Key Opinion Leaders (KOL) and established contact with islet transplantation/pancreas surgery centers
in Germany and Switzerland. We are adjusting the KYSLECEL Good Manufacturing Practice (GMP) for European requirements for
the initiation for the first clinical application. We are also monitoring the Chinese market for potential partners. Furthermore, we are
training teams who will manage introduction into new markets by supporting the KYSLECEL tech transfer, as well as working on
the OMPUlization process so as to manufacture via automated closed systems.
2. Tissue Genesis Icellator® for Cell Assisted Lipotransfer
The Tissue Genesis Icellator is a point-of-care medical device that isolates stromal and vascular fraction cells (“SVF”) from a
patient’s own (autologous) adipose tissue (fat). The Icellator is commercially available in Korea through a medical device distributor.
The SVF obtained from the Icellator is for use in cell-assisted lipotransfer, a plastic surgery procedure intended to improve fat
engraftments.
3. Cartil-S Autologous Products for the Treatment of Osteoarthritis
Cartil-S is a cell therapy for Osteoarthritis. This product is produced by performing a minimally invasive biopsy of adipose (fat)
tissue from a patient, followed by isolation and expansion of adipose-derived stem cells (ADSCs), to be injected arthroscopically.
The autologous injectable product helps delay/stop the progression of osteoarthritis, involving the patient’s own stem cells.
4. Chondroseal Autologous Products for the Treatment of Cartilage Defects (Osteoarthritis)
Chondroseal is a cell therapy for cartilage defects. Following collection of adipose tissue by minimally invasive biopsy that is
composed of ADSCs, the cells are combined with a natural gel serving as a scaffold for local cartilage regeneration in the joint.
Products in Clinical Trials
5. RanTop, Ranpirnase Topical Formulation
We are currently developing a novel topical formulation of an active RNA-degrading enzyme, called Ranpirnase. Ranpirnase
combats viral infections by targeting double-stranded RNA including miRNA precursors, via RNA degradation catalysis. It acts
through a dual mechanism: 1) Inhibition of viral replication; and 2) induction of host cell apoptosis. Topical Ranpirnase
demonstrated good tolerability and preliminary clinical efficacy in the treatment of HPV-associated external anogenital warts (EGW)
in a Phase 2a clinical study conducted in Bolivia.
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During 2021 we prepared a detailed pre-IND briefing package and received positive pre-IND feedback from the FDA on the
development plan and proposed clinical study under an IND of topical Ranprinase for the treatment of EGW. The FDA generally
confirmed that the proposed preclinical development plan should support a Phase 2b study of topical Ranprinase in EGW. The
proposed plan included a dermal toxicology study using the gel formulation.
We have demonstrated in laboratory experiments the feasibility of Ranprinase encapsulation in the Orgenesis Bioxome delivery
platform. Encapsulation enhanced Ranprinase anti-viral activity in an in-vitro test. We have also shown feasibility of producing an
active recombinant Ranprinase. Recombinant production could in the future replace the sourced Ranprinase to improve
manufacturing scalability, eliminate dependence on procurement of rana pipiens frog oocytes and potentially decrease production
cost.
6. Tissue Geneseis Icellator® for Erectile Dysfunction and COVID-19 (SVF-CLI-ED)
The safety of the Tissue Genesis Icellator, and use of SVF produced by the Icellator, has previously been tested in a number of pilot
clinical trials in the United States. Orgenesis has prioritized the clinical development of the Icellator for potential use in the treatment
of erectile dysfunction and COVID-19 related respiratory complications. In 2021, the FDA approved our investigational device
exemption (IDE) for a Pilot Clinical Trial of the Tissue Genesis Icellator to treat Acute Respiratory Distress Syndrome (ARDS)
resulting from COVID-19 infection.
The Tissue Genesis Icellator is also being used by research collaborators in FDA-regulated clinical trials to test the use of SVF
during rotator cuff surgery.
Products in IND Enabling Studies
7. Generation of Autologous Insulin-Producing Cells (AIPs) from Adult Liver Cells (“trans-differentiation technology”)
Orgenesis Ltd. has trans-differentiation in-vitro technology that has demonstrated in animal models the capacity to induce a shift in
the developmental fate of cells from the liver or other tissues, transdifferentiating them into “pancreatic beta cell-like” AIP cells for
patients with Type 1 Diabetes (“T1D”), acute pancreatitis and other insulin deficient diseases. For the treatment of diabetes, cells are
derived from the liver or other adult tissue and are trans-differentiated to become AIP cells. This technology has shown in relevant
animal models that the human derived AIP cells produce insulin in a glucose-sensitive manner. No adverse effects were observed in
any of the animal studies. This trans-differentiation technology is licensed by the Israeli Subsidiary and is based on the work of Prof.
Sarah Ferber, a researcher at Tel Hashomer Medical Research Infrastructure and Services Ltd. (“THM”) in Israel. The development
plan calls for conducting additional pre-clinical safety and efficacy studies with respect to diabetes and other potential indications
prior to initiating human clinical trials.
With respect to the trans-differentiation technology, we have exclusive rights to eight (8) United States and twenty four (24) foreign
issued patents, two (2) pending patent applications in the United States, eleven (11) pending patent applications in foreign
jurisdictions, including, Brazil, Canada, Europe, Israel, Panama, South Korea, and Singapore. These patents and patent applications
relate, among others, to the trans-differentiation of cells (including hepatic cells) to cells having pancreatic β-cell-like phenotype and
function and to their use in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancer and pancreatitis.
On June 11, 2019, the FDA granted Orphan Drug Designation for our AIP cells as a cell replacement therapy for the treatment of
severe hypoglycemia-prone diabetes resulting from total pancreatectomy (“TP”) due to chronic pancreatitis.
On April 29, 2019, we received Institutional Review Board (“IRB”) approval to collect liver biopsies from patients at Rambam
Medical Center located in Haifa, Israel for a planned study to confirm the suitability of liver cells for personalized cell replacement
therapy for patients with insulin-dependent diabetes resulting from total or partial pancreatectomy. The first patients were enrolled
during 2020. The goal of the proposed study, entitled “Collection of Human Liver Biopsy and Whole Blood Samples from Type 1
Diabetes Mellitus (T1DM), Total or Partial Pancreatectomy Patients for Potential use as an Autologous Source for Insulin Producing
Cells in Future Clinical Studies,” is to confirm the suitability of the liver cells for personalized cell replacement therapy, as well as
eligibility of patients to participate in a future clinical study, as defined by successful AIP cell production from their own liver
biopsy. The secondary objective of the study is to evaluate patients’ immune response to AIPs based on the patient’s blood samples
and followed by subcutaneous implantation into the patients’ arm which would represent the first human trial.
10
We have invested substantial efforts in the feasibility of upscaling the manufacturing process for expansion of liver cells to the
number required for clinical application (i.e. approximately two billion cells). We were successful in developing the expansion
protocols while maintaining the liver cells’ viability. However, the resulting cell expansion hampered the ability of the cells to
efficiently transdifferentiate, as was determined in pre-clinical studies. Furthermore, combining the liver cells with alginate-based 3D
scaffold failed to present significant potential of the scaffolds to support the cells’ survival in pre-clinical studies. We will consider if
other indications require a lower number of cells. To date, we have not been successful in in identification of such other relevant
therapies.
The trans-differentiation technology is from a licensing agreement entered into as of February 2, 2012 by the Israeli Subsidiary and
THM pursuant to which the Israeli Subsidiary, Orgenesis Ltd, was granted a worldwide royalty bearing and exclusive license (the
“THM License Agreement”). By using therapeutic agents that efficiently convert a sub-population of liver cells into pancreatic islets
phenotype and function, this approach allows the diabetic patient to be the donor of his own therapeutic tissue. While we believe that
this provides a major competitive advantage to the cell transformation technology of the Israeli Subsidiary, we also believe that our
expanded focus to other therapies and business activities may continue to prompt THM to inquire of such activities as they may
relate to our compliance with the terms or direction of the THM License Agreement. While we have not received any notice of
cancellation of the THM License Agreement, we have received an allegation regarding the scope of the rights by THM that may
present future challenges for our Israeli Subsidiary to continue to develop, manufacture, sell and market the products pursuant to the
milestones and time schedule specified in the development plan of the THM License Agreement. In addition, THM has filed a
complaint against us in the Tel Aviv District Court relating to the scope of such THM License and the royalties and other payments
that THM is entitled to thereunder. See “Legal Proceedings” in this Annual Report on Form 10-K.
8. CAR-T CD19
ORG-CAR19, Autologous anti CD19 CAR-T Chimeric antigen receptor T cells (known as CAR-T cells) are genetically engineered
to express an artificial T-cell receptor for cancer immunotherapy. The promise of CAR-T immunotherapy is to engineer T cells to
effectively recognize a specific antigen present on cancer cells to destroy those cells. CAR-T cells can be either derived from the
patient’s own T cells (autologous) or from T cells of a healthy donor (allogeneic). Once isolated from a person, these T cells are
genetically engineered to express a specific CAR, which programs them to target an antigen present on the surface of tumors. After
CAR-T cells are infused into a patient, they act as a “living drug” against cancer cells expressing the target antigen.
We are developing a new anti-CD19 CAR-T therapy for treating patients with B-cell malignancies including acute lymphoblastic
leukemia (B-ALL) and non-Hodgkin lymphoma. Malignant B cells of these patients express the CD19 protein on their surface that is
targeted by the CAR-T cells. Orgenesis anti-CD19 CAR-T is based on a clinically used CAR-T therapy licensed from Kecellitics
Biotech.
9. Dual Cellular vaccine (DUVAC), Therapy for Pancreatic Cancer
The DUVAC cell-based immunotherapy, licensed from Columbia University, is based on autologous dendritic cells and
macrophages. These cells are key coordinators of the innate and adaptive immune system and have critical roles in the induction of
antitumor immunity. The cells are exposed to whole cancer cells and constitute the most comprehensive source of cancer antigens,
which may boost the patient immune system and direct it against the tumor. We believe that a vaccine based on DUVAC vaccine can
potentially be developed for a wide range of solid tumors, but our initial focus is on pancreatic cancer. We have signed a Material
Transfer Agreement with a leading medical center in the US for their clinical grade pancreatic tumor cell lines to be used for proof-of
concept
11
10. Metabolically Optimized T-Cells (MOTC): Therapy for melanoma and lung cancer
In the early stages of cancer, some lymphocytes successfully attack and infiltrate the tumor microenvironment, surround the tumor
cells, and mount an anti-tumor response. TIL therapy is a clinically validated personalized cancer treatment based on infusion of
autologous TILs expanded ex vivo from tumors. Once expanded, the TILs are infused back into the patient where they attack the
cancer cells with a high degree of specificity.
We have recently licensed new technology to optimize the manufacturing process from the Yeda Research and Development
Company Limited. The technology was developed as a synthetic immune niche technology. The technology will support and
accelerate the expansion and function of TILs,
Products in Pre-Clinical Studies
11. Autologous Cell-Based Vaccine for protecting against SARS-CoV-2
We continue working on developing a cell-based vaccine platform for the prevention of viral diseases. The initial target for the
platform is SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the causative agent of COVID-19). This cell-based
vaccine platform utilizes an autologous approach. The goal is to enable the COVID-19 engineered cells will have the ability to
activate an endogenous immune response and induce the production of neutralizing antibodies as well as cellular response.
12. Bioxomes
Exosomes are small, membrane-enclosed extracellular vesicles implicated in cell-to-cell communication. Exosomes may serve as a
valuable therapeutic modality because of their ability to transfer a wide variety of therapeutic payloads among cells that can
influence a cell in multiple ways, and they can be designed to reach specific cell types. Natural cell membranes (biomimetics) have
recently emerged as a new source of materials for molecular delivery systems. Because cell membrane-derived vesicles contain the
intrinsic functionalities and signaling networks of their parent cells, they can overcome various obstacles encountered by synthetic
liposomes in vivo (including immunogenecity concerns)
To this end, we have developed a proprietary manufacturing process for preparation of the natural exosome-mimetic/liposome,
termed BioxomeTM, a large-scale GMP-compatible production protocol that will potentially allow us to obtain Bioxome from
various cell types, including human adipose cells, fibroblasts, blood cells, as well as plant cells. Various therapeutic cargos (including
modified mRNA) can be encapsulated into the Bioxome during its manufacture. Once injected systemically, Bioxomes naturally fuse
with the cell membrane and release therapeutic cargo.
In 2021, we assessed Bioxome biodistribution of the non-loaded Bioxome upon its systemic administration in rodents. This study
had demonstrated a rapid and preferential uptake of the Bioxome by the liver, followed (to a lesser extent) by the kidney and lungs.
Further biodistribution studies with Bioxome-encapsulated RNAse and Bioxome-encapsulated mRNA are planned for 2022.
In addition, accelerated anti-COVID19 efficacy was demonstrated for Bioxome-incorporated Ranprinase in an in vitro COVID-19
infection model, and we will conduct further studies to determine if Bioxome can be a vehicle for effective delivery of antiviral
compounds.
13.
.Mesenchymal stem cell Psoriasis (“MSCP”)
We are developing a personalized cell-based therapy product for wound healing and psoriasis. The product is based on allogeneic
Adipose-Derived Stem Cells (ADSCs). Following expansion, the ADSCs are used for the extraction of BioxomeTM. We have
established a process for encapsulation of Topiramate, a well-known substrate used in other indications, during the Bioxome
manufacture. The Bioxome-encapsulated Topiramate (Biox-Top) will be further formulated in commercially available hyaluronic
acid (HA), a well-known dermal filler, for topical application. Regulatory approval is required for this process.
The developed manufacture-encapsulation protocol is currently being scaled-up for the future production of the clinical grade Biox-
Top for topical administration.
Promising anti-inflammatory efficacy of the Biox-Top was demonstrated in the human skin explants that were subjected to
inflammation.
After demonstrating in vivo efficacy in the animal models of psoriasis, we plan to further advance this product to clinical
development.
12
14. Muscle-derived Mesenchymal Stem Cells for Human Regenerative Medicine
An innovative and patented technology licensed from a licensing partner that enables the isolation of pluripotent adult Mesenchymal
Stem Cells (MSCs) from a minimally invasive muscle micro-biopsy. The isolated autologously undifferentiated muscle-derived
MSCs are developed for local administration into the muscle to correct muscle-related clinical indications, such as Stress Urinary
Incontinence (SUI).
In 2021, promising results were obtained in an in-vivo model of SUI demonstrating robust therapeutic efficacy of locally injected
human muscle-derived MSCs (MD-MSCs) in reversing the development of SUI in nude rats. Moreover, both nerve regeneration and
functional restoration of the muscle tissue was observed.
In addition, we are working to establish the regulatory path and are preparing all relevant documentation for potential clinical
implementation of MD-MSCs.
15. Kidney Disease
We are also developing multiple proprietary cell and cell derived products therapies for treating kidney failure and End-Stage Renal
Disease (ESRD). We have made progress in the establishment of the enrichment process of extracellular vesicles (EV) replacement
therapy for chronic kidney disease (CKD) patients.
16. KT-DM-103 and KT-CP-203 (3D-Printed Pancreatic Islets)
We, through our Koligo acquisition, have exclusively licensed patents and technology from the University of Louisville Research
Foundation related to the revascularization and 3D printing of cell and tissue for transplant (“3D-V” technology platform). We are
developing this technology for potential autologous and allogeneic pancreatic islet transplant to treat type 1 diabetes (KT-DM-103)
and chronic pancreatitis (KT-CP-203). The 3D-V technology platform may also support improved transplantation of other cell and
tissue types in additional to pancreatic islets.
POCare Platform Strategy
13
Our aim is to provide a pathway to bring ATMPs in the cell and gene therapy industry from research to patients worldwide through
our POCare Platform. We define point of care as a process of collecting, processing, and administering cells as close as possible to
the clinical setting. We believe that this approach is an attractive proposition for personalized medicine because of our strategic
partnerships with suppliers that help us to customize closed systems into effective mobile clean room facilities. This will potentially
help to minimize or eliminate the need for cell transportation, which is a high-risk and costly aspect of the supply chain, further
allowing flexible production and patient treatment.
The POCare Platform is a unique globally harmonized and decentralized CGT-processing infrastructure that offers cost-effective
processing capacities with ease for scalability and reproducibility. By producing personalized cell and gene therapies (CGTs) at the
point of care, we are able to add new capacity within months instead of years.
Local decentralization: POCare Centers are set up in preferred regions, based on nearby hospitals’ capacity needs, and support the
POCare model by providing POCare Services for the POCare Network.
Global harmonization: the POCare Platform overcomes conventional processing challenges by enabling high quality standards and
sterile, scalable onsite processing of CGTs orchestrated by the POCare centers to service local hospitals. Processing infrastructure is
harmonized and reproducible using the Orgenesis Mobile Processing Unit and Lab technology (“OMPUL”). The use of an OMPUL
can shorten implementation time from approximately 18-24 months to approximately 3-9 months, offers a more cost-effective
environment and enables local scalability by connecting additional OMPULs. The network structure is supported and connected by
the centralization of the harmonized best industry practices and standards to meet the highest quality standards (“QMS”, Quality
Management System). Further global harmonization is implemented through standardization of the training programs, centralized
data management and a unified supply chain.
OMPULization of therapies: strong process development capabilities are critical for any CGT to scale. All therapeutic candidates
must undergo some level of process development to move from the discovery phase to the clinical phase, if only to establish the
same protocols under GMP. The POCare Platform takes process development to the next level, implementing a process we call
OMPULization. OMPULization includes unitizing the process to the exact specifications of the OMPUL so it can be rapidly
implemented in OMPULs around the world. In addition, OMPULization incorporates the latest technology solutions to close and
automate the process whenever possible.
Integrated closed and automated processing systems require fewer Full Time Employees (“FTEs”) to produce GMP batches,
resulting in lower COGs and a process that has the ability to scale in sync with market demand. Full automation may not be
necessary for all clinical phases, but it is important to plan for future incorporation. To this end, we have invested time and capital
into evaluating relevant technology for CGT processing and have developed proprietary equipment that did not exist in the
marketplace.
We aim to build value in various aspects of our company ranging from supply related processes including development and
distribution systems, clinical and regulatory services, engineering and devices such as OMPULs discussed below, delivery systems,
therapies including immuno-oncology, anti-aging, anti-viral, metabolic, nephrology, dermatology, orthopedic, as well as regenerative
technologies.
Over time, we have worked to develop and validate POCare Technologies that can be combined within mobile production units for
advanced therapies.
We have made significant investments in the development of several types of OMPULs and have made significant progress in the
validation, risk analysis, regulatory and other related tasks relating to the OMPULs. We anticipate distributing and using the
OMPULs through our POCare Network of partners, collaborators, and regional partners. OMPULs are designed for the purpose of
validation, development, performance of clinical trials, manufacturing and/or processing of potential or approved cell and gene
therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the manufacturing of such CGTs in a
consistent and standardized manner in all locations. The design delivers a potential industrial solution for us to deliver CGTs to most
clinical institutions at the point of care.
14
Above is a diagram of an OMPUL and partial interior for illustrative purposes only
We have finalized or are in the process of finalizing the development of several POCare centers and, with the assistance of our
partners, we are adapting the local requirements of each partner with the target of achieving a capacity to process and supply CGTs
per our existing manufacturing contracts. As we expand operations, we expect that the OMPUL setup costs will decline over time.
Most of our POC revenue to date is in support of the implementation of our technologies and therapies in our partners’ POC
activities, which we expect will be the basis for future royalties and supply revenues.
We have embarked on a strategy of collaborative arrangements with strategically situated regional distributor partners around the
world. We believe that these partners have the expertise, experience and strategic location to advance our POCare Platform.
Strategic CGT Therapeutics Collaborations
Collaborations, partnerships, joint ventures and license agreements are a key component of our POC strategy.
Our POC technology collaborators and partners include Ori Biotech, Accelix, Columbia University in the City of New York, Caerus
Therapeutics Corporation, UC Davis, The Johns Hopkins University, The Weizman Institute of Science and others.
In addition, we have collaborations and joint ventures for setting up POCare Platform operations facilities in jurisdictions throughout
the world, including various countries in North America, Europe, Latin America, Asia, and Australia. Such partnerships include in-
licensing and out-licensing of therapies, service contracts from the partners under co-development agreements, and development and
manufacturing agreements for POCare products supplied regionally. Such partners/customers include Broaden Bioscience &
Technology Corp, Celleska Pty Ltd, Cure Therapeutics, Educell, Image Securities FZC, Med Centre for Gene and Cell Therapy FZ-
LLC, MIDA Biotech B.V., Mircod Biotech LLC, Theracell, and SBH Sciences.
For more information, see Note 11, “Collaboration and Licensing Agreements” of the “Notes to the Financial Statements” included
in Item 8.
15
Current Development Facilities
OBI
OBI is a specialized process and technology development wholly owned subsidiary focused on custom-made process development,
upscaling design from lab to industry innovation and automation procedures, which are extremely essential in the cell therapy
industry. OBI is located in Bar-Lev Industrial Park utilizing the exclusive Israeli innovative ecosystem and highly experienced and
talented associates including Ph.D. holders and biotechnology engineers. The center provides end to end solutions to cell therapy
industrialization, process development capabilities and proficiency, custom-made engineering and a unique platform for creative
design and process optimization. OBI occupies 1300 square meters of labs and offices resulting in an efficient and unique
environment for cell therapy development. In connection with the Masthercell Sale, for a period of three years in the European
Union and five years in the United States and the rest of the world from the closing date of the Masthercell Sale, we agreed that OBI
will not manufacture products on a contract basis for third-party customers in any jurisdiction other than the State of Israel, but it
may conduct such CDMO business in the State of Israel, solely for customers located within the State of Israel or with respect to
therapies intended for distribution solely within the State of Israel. The Masthercell sale agreement stipulated that OBI may also
conduct, worldwide, (i) point-of-care system, point-of-care products, point-of-care systems, point-of-care processing, and point-of-
care development services for the development, manufacturing or processing of therapeutics, processes, systems and technologies to
treat patients in a point-of-care clinical, hospital or institutional setting, any future point-of-care services substantially related to the
foregoing, and advanced therapy medicinal products either proprietary to us or our affiliates or proprietary to a third-party partner
(including a joint venture partner) or collaborator, which includes research, development, systems, manufacturing and processing of
therapeutic technology products, systems, and processes, methods or services and (ii) research, manufacturing, development and
other activities related to the research, development, manufacturing, discovery and commercialization of therapeutic products or
technologies, and processes, systems, methods or services thereof for its own account or in order to make such products or services
available for the account of their third-party partners (including joint venture partners) or collaborators (including such therapeutic
products, processes or technologies in which we or one of our affiliates has an economic interest or any relationship with any third-
party or that are created, developed, manufactured or sold by a joint venture, partnership or collaboration between us or any of our
affiliates and a third-party (individually and collectively, “Permitted Business”).
The Korean Subsidiary
The Korean Subsidiary has a particular focus on developing innovative cell therapies. Together, with promising in-house research
programs, the technologies are currently under development for the rapidly growing Korean market offering a favorable environment
for the cell therapy industry. Through close collaboration with leading medical and academic facilities, the Korean Subsidiary is
accelerating the development of foreign technologies in Korea. In connection with the Masthercell Sale, for a period of three years in
the European Union and five years in the United States and the rest of the world from the closing date of the Masthercell Sale, we
agreed that the Korean Subsidiary will not manufacture cell and gene products on a contract basis for third-party customers in any
jurisdiction other than South Korea, but it may conduct CDMO business in South Korea, solely for customers located within South
Korea and with respect to therapies intended for distribution solely within South Korea, provided that the Korean Subsidiary may
conduct Permitted Business.
Koligo
Koligo maintains commercial production facilities for KYSLECEL at an FDA-registered establishment in Indiana. Koligo is also
developing new technologies such as bio-degradable 3D structure to deliver islets & other cell/tissue.
The Tissue Genesis Icellators, and associated reagents and kits, are made by contract manufacturers and warehoused at our facility in
Texas. The Tissue Genesis Icellator is used to isolate stromal and vascular fraction cells (“SVF”) from a patient’s own (autologous)
adipose tissue (fat). The SVF obtained from the Icellator is for use in cell-assisted lipotransfer, and other indication such as
orthopedic and COVID-19-induced ARDS. Koligo also maintains development labs at its Indiana and Texas locations to support
continued development.
16
The Belgian Subsidiary
The Belgian subsidiary specializes in developing and validating proprietary and licensed advanced cell and gene therapies such as
the Muscle-derived Mesenchymal Stem Cells therapy for the treatment of SUI. The subsidiary benefits both from its central position
in Europe and its being in the leading Walloon biotech cluster. Located near Namur, at Novalis Science Park, the Belgian subsidiary
collaborates with leading medical and academic facilities which enables it to cover the drug product life cycle from research to
clinical stage through pre-clinical and quality control. It occupies innovative facilities for the development and quality control of
therapies in R&D and GMP grades.
Its talented and highly experienced staff and collaborators, including Ph.D. holders, quality assurance experts and biotechnology
manufacturing engineers, contribute to the POCare platform development and roll-out. The subsidiary supports quality assurance and
supply activities for the global POCare network.
Notable 2021 Activities
In 2021, we have focused on setting up our regional POCare activities. This included the setup of POCare Centers that oversee
regional development and GMP services, local OMPUL deployment and supply of products to the local clinical centers. We are in
the process of setting up POCare Centers in Maryland, Boston, California, Belgium, Greece, Slovenia, Israel, Italy, Spain and Korea.
Future set-up plans include potential sites in the U.S. and EU where we already have initial activity such as in Germany and Texas,
as well as in Australia and China.
As part of our POCare Services, we have developed the relevant GMP processes for a variety of therapies such as CAR-T, TILs, NK
and MSC based therapies. We have developed OMPULs with the required systems for production of CAR-T, TILs and MSC
products, and are working on several other therapies intended for clinical testing.
We have worked closely with technology partners to adapt various systems for closed system production of the above products and
continue our collaboration efforts to develop fully automated systems for integration in the OMPULs.
We expanded our collaboration with UC Davis and have completed the first production batch of GMP grade lentivirus to be utilized
for clinical grade production of CAR-Ts. We have expanded our partnership with Johns Hopkins University and are setting up a
GMP facility with the support of a grant from Maryland. We are providing products to several hospitals in the U.S., are working
closely with leading hospitals in Spain and Italy and are working closely with clinicians from hospitals in Israel, where we have
deployed our OMPULs to set up additional clinical sites where we can provide POCare Services for our customers and partners.
Based on the requests of our customers and partners, we have expanded our POCare Services to include CRO services.
We have collaborated closely with our Greek partner, Theracell, and have set up a partnership in Greece focusing on delivering
advanced therapies to Greek hospitals. The Greek government has granted our Greek joint venture entity a “fast track” status and a
supportive financial grant.
Our POCare Services are expanding to additional geographies, and we are providing services to the U.S., EU, and Asia.
Revenue Model, Business Development and Licenses
The Orgenesis Point of Care (POCare) Platform is comprised of three enabling components: a multitude of licensed cell based
POCare Therapeutics to be produced in closed, automated POCare Technology systems across a collaborative POCare Network. Our
therapies include, but are not limited to, autologous, cell-based immunotherapies, therapeutics for metabolic diseases, anti-viral
diseases, and tissue regeneration. We are establishing and positioning the business to bring point-of-care therapies to patients in a
scalable way working directly with hospitals and through regional JV partners and JVs active in autologous cell therapy product
development, including facilities in various countries in North America, Europe, Asia, the Middle East, and Australia. The POCare
Platform’s goal is to enable a rapid, globally harmonized pathway for these therapies to reach large numbers of patients at lowered
costs through efficient, and decentralized production. The POCare Network brings together industry partners, research institutes and
hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies.
17
We are focused on technology in licensing and therapeutic collaborations, and we out license therapies marketing rights and
manufacturing rights to partners and/or to the JVs. In many cases, the JVs are responsible for the preparation of clinical trials, local
regulatory approvals and regional marketing activities. Such licensing includes exclusive or nonexclusive, sublicensable, royalty
bearing rights and license to the Orgenesis Background IP as required to manufacture, distribute and market and sell Orgenesis
products within the relevant territories. In consideration of the rights and the licenses so granted, we receive a royalty in the range of
ten percent of the net sales generated by the JV Entity and/or its sublicensees (as applicable) with respect to the Orgenesis products.
In addition, in many cases, once the JV entities become profitable, we are entitled (in addition to any of its rights as holder of the JV
Entity and prior to any other distributions of dividends by the JV Entity to shareholders of the JV Entity) and in addition to any
royalties to which we may be entitled pursuant to a Orgenesis License Agreement, to receive from the JV entity royalties at a range
of 10 to 15 percent of the JV entity’s audited US GAAP profit after tax.
Further to revenues generated from out licenses we generate revenues from POCare Services and sales which is comprised of:
●
R&D services provided to out-licensing partners
We have signed POCare Master Services Agreements (“MSAs”) with our JV partners. In terms of the MSAs, we provide certain
broadly defined development services that relate to our licensed therapies designed to develop or enhance the therapy with the
objective of preparing it for clinical use. Such services, per therapy, include regulatory services, pre-clinical studies, intellectual
property services, development services, and GMP process translation. We also provide support services to our customers.
●
Hospital supply
Hospital services includes the sale or lease of products and the performance of processing services to our POCare hospitals or other
medical providers. We either work directly with hospitals or receive payments through our regional JV partnerships.
●
Cell process development revenue
We provide cell process development services in some regions to third party customers. Those services are unique to the customers
who retain the ownership of the intellectual property created through the process.
Our POCare therapy revenue is as follows:
Revenue stream:
POC and hospital services (Mainly POC)
Cell process development services
Total
Years Ended December 31,
2020
2021
(in thousands)
32,819 $
2,683
35,502 $
6,068
1,584
7,652
$
$
Cost of Services and other Research and Development Expenses, net
We incurred $ 36,644and $83,986 thousand in cost of services and other research and development expenses, net in the fiscal years
ended December 31, 2021 and December 31, 2020, respectively, of which $196 thousand was covered by grant funding in the fiscal
year ended December 31, 2020. Part of the expense was funded by share issues. Our research and development scope was expanded
to the evaluation and development of new cell therapies related technologies in the field of immuno-oncology, liver pathologies and
tissue regeneration.
18
Competition in the Cell Therapy Field
The biopharmaceutical industry is intensely competitive. There is continuous demand for innovation and speed, and as the cell-based
therapies market evolves, there is always the risk that a competitor may be able to develop other compounds or drugs that are able to
achieve similar or better results for indications. Potential competition includes major multinational pharmaceutical companies,
established biotechnology companies, specialty pharmaceutical companies, universities, and other research institutions. Many of
these competitors have substantially greater financial, technical, and other resources, such as larger research and development staff
and experienced marketing and manufacturing organizations with established sales forces. Smaller or early-stage companies may
also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
Currently, we are not aware of any other companies pursuing a business model similar to what we are developing under our POCare
Platform. However, our competitors in the CGT field who are significantly larger and better capitalized than us could undertake
strategies similar to what we are pursuing and even develop them at a much more rapid rate. These potential competitors include the
same multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies,
universities, and other research institutions that are operating in the CGT field. In that respect, smaller or early-stage companies may
also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
Intellectual Property
We will be able to protect our technology and products from unauthorized use by third parties only to the extent it is covered by valid
and enforceable claims of our patents or is effectively maintained as trade secrets. Patents and other proprietary rights are thus an
essential element of our business.
Our success will depend in part on our ability to obtain and maintain proprietary protection for our product candidates, technology,
and know-how, to operate without infringing on the proprietary rights of others, and to prevent others from infringing our proprietary
rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications
related to our proprietary technology, inventions, and improvements that are important to the development of our business. We also
rely on trade secrets, know-how, continuing technological innovation, and in-licensing opportunities to develop and maintain our
proprietary position.
In addition, we own or have exclusive rights to thirty-two (32) United States patents, fifty-seven (57) foreign-issued patents, twenty-
six (26) pending patent applications in the United States, fifty-four (54) pending patent applications in foreign jurisdictions,
including Australia, Brazil, Canada, China, Europe, Hong Kong, India, Israel, Japan, Mexico, New Zealand, Russia, Singapore,
South Africa, and South Korea, and six (6) international Patent Cooperation Treaty (“PCT”) patent applications. These patents and
patent applications relate, among others, to (1) dendritic cell based (whole cell) vaccines, and their use for treating cancer and viral
diseases; (2) compositions comprising Ranpirnase and other ribonucleases and their use for treating viral diseases; (3) tumor
infiltrating lymphocytes (TILs) and their use for treating cancer; (4) compositions comprising immune cells, ribonucleases, or
antibodies for treating COVID-19; (5) therapeutic compositions comprising exosomes, bioxomes, and redoxomes; (6) bioreactors for
cell culture automated devices for supporting cell therapies and point-of-care systems; (7) chimeric antigen receptors (CARs); (8)
adoptive immunotherapy using neurotransmitters; (9) Mobile Processing Units; (10) Axial Stem Cells; (11) Cell-delivery devices;
(12) scaffolds, including alginate and sulfated alginate scaffolds, and bioconjugates comprising sulfated polysaccharides and diverse
bioactive peptides, and uses thereof; and (13) skin diseases treatment and anti-aging compositions.
We have a granted U.S. patent, a pending U.S. patent application and pending U.S. provisional patent applications directed, among
others, to dendritic cell-based (whole cell) vaccines, and their use for treating cancer and viral diseases. If issued, any patents based
on these applications will expire between 2037 and 2043. The granted U.S. patent will expire in 2037.
We have pending U.S. patent applications directed, among others, to compositions comprising Ranpirnase and other ribonucleases
for the treatment of viral diseases. If issued, any patents based on these applications will expire between 2031 and 2040. Counterpart
patents applications were filed in Australia, Canada, China, Europe, Hong Kong, Japan, Israel, Mexico, New Zealand, South Korea,
Russian Federation, Singapore, and South Africa. If issued, any patents based on these applications will expire between 2035 and
2041. These expiration dates do not include any patent term extensions that might be available following the grant of marketing
authorizations.
We have pending U.S. patent applications directed, among others, to therapeutic compositions comprising exosomes, bioxomes, and
redoxomes. If issued, any patents based on these applications will expire between 2029 and 2041. Counterpart patents applications
were filed in Australia, Brazil, Canada, China, Europe, India, Israel, Japan and South Korea. If issued, any patents based on these
applications will expire in 2039. These expiration dates do not include any patent term extensions that might be available following
the grant of marketing authorizations.
19
We have a pending International PCT application, pending U.S. patent applications, and pending U.S. provisional patent applications
directed, among others, to bioreactors for cell culture, automated devices for supporting cell therapies, and point-of-care systems. If
issued, any patents based on these applications will expire between 2035 and 2042.
We have pending U.S. provisional patent applications directed, among others, to tumor infiltrating lymphocytes (TILs) and their use
for treating cancer. If converted into non-provisional applications and issued, any patents based on these applications will expire in
2042, without including any patent term extensions that might be available following the grant of marketing authorizations.
We have pending International PCT applications directed, among others, to compositions comprising immune cells, ribonucleases, or
antibodies for treating COVID-19. If converted into national phase applications and issued, any patents based on these applications
will expire in 2042, without including any patent term extensions that might be available following the grant of marketing
authorizations.
We have a pending U.S. provisional patent application and a pending U.S. patent application directed, among others, to chimeric
antigen receptors (CARs), and their use for treating malignancies. If issued, any patents based on these applications would expire
between 2041 and 2043, without including any patent term extensions that might be available following the grant of marketing
authorizations.
We have a granted patent and a pending U.S. patent application directed, among others, to adoptive immunotherapy using
neurotransmitters. If issued, any patent based on this application would expire in 2039. Counterpart patent applications were filed in
Australia, Brazil, Canada, China, Europe, Israel, India, Japan, Russian Federation, Singapore, and South Korea. If issued, any patents
based on these applications would expire in 2039. These expiration dates do not include any patent term extensions that might be
available following the grant of marketing authorizations. The granted U.S. patent will expire in 2024.
We have a pending U.S. provisional patent application directed, among others, to mobile processing laboratories configured for
performing there within a cell therapy process. If converted into non-provisional applications and issued, any patents based on these
applications would expire in 2042, without including any patent term extensions that might be available following the grant of
marketing authorizations.
We have a pending International PCT application directed, among others, to Axial Stem Cells, their preparation, and uses in
treatment or diagnostics of neurodegenerative diseases, bone or cartilage disorders, muscle disorders, and in regenerative treatment
of tissues or organs. If converted into national phase applications and issued, any patents based on these applications would expire in
2042, without including any patent term extensions that might be available following the grant of marketing authorizations.
Granted U.S. patents, which are directed among others to scaffolds, including alginate and sulfated alginate scaffolds, and to
bioconjugates comprising sulfated polysaccharides and diverse bioactive peptides, allowing sustained release of the bioactive
polypeptides and their uses will expire between 2025 and 2036. Counterpart patent applications and patents granted in Australia,
France, Germany, Israel, Switzerland, and the United Kingdom, will expire between 2026 and 2035.
We have a pending U.S. provisional patent application directed, among others, to a composition comprising topiramate and bioxome,
redoxome, HA, extracellular vesicles (EV), or PRP extracellular vesicles and its use for the treatment of a dermatological condition.
If converted into national phase applications and issued, any patents based on these applications would expire in 2042, without
including any patent term extensions that might be available following the grant of marketing authorizations.
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We have pending U.S. provisional patent applications directed, among others, to the use of a combination of natural products, such
as anti-aging, anti-photoaging or anti-inflammatory combination. If converted into national phase applications and issued, any
patents based on these applications would expire in 2042 and 2043, without including any patent term extensions that might be
available following the grant of marketing authorizations.
Orgenesis Ltd, has exclusive rights to eight (8) United States patents, twenty-four (24) foreign-issued patents, two (2) pending patent
applications in the United States, and eleven (11) pending patent applications in foreign jurisdictions, including Australia, Brazil,
Canada, China, Europe, Israel, Japan, Mexico, Panama, Singapore, and South Korea. These patents and patent applications relate,
among others, to the trans-differentiation of cells (including hepatic cells) to cells having pancreatic β-cell-like phenotype and
function and to their use in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancer and pancreatitis.
Granted U.S. patents, which are directed to trans-differentiation to pancreatic β-cell-like phenotype and function cells and to their use
in the treatment of degenerative pancreatic disorders, including diabetes, pancreatic cancer and pancreatitis, will expire between
2024 and 2035. Counterpart patents granted in Australia, France, Germany, Israel, Switzerland, and the United Kingdom, will expire
between 2024 and 2035.
Orgenesis Ltd, has pending U.S. patent applications directed, among others, to the trans-differentiation of cells, to cells having
pancreatic β-cell-like phenotype and function and to their use in the treatment of degenerative pancreatic disorders, including
diabetes, pancreatic cancer and pancreatitis. If issued, any patents based on these applications will expire between 2038 and 2040.
Counterpart patents applications were filed in Australia, Brazil, Canada, China, Europe, Japan, Israel, Mexico, Panama, Singapore,
and South Korea. If issued, any patents based on these applications will expire between 2034 and 2039. These expiration dates do
not include any patent term extensions that might be available following the grant of marketing authorizations.
Government Regulation
Development Business
We are required to comply with the regulatory requirements of various local, state, national and international regulatory bodies
having jurisdiction in the countries or localities where we manufacture products, where our OMPULs are established or where we
plan to supply products. In particular, we are subject to laws and regulations concerning research and development, testing,
manufacturing processes, equipment and facilities, including compliance with GMPs, labeling and distribution, import and export,
facility registration or licensing, and product registration and listing. As a result, our facilities are subject to regulation in Israel and
South Korea. We are also required to comply with environmental, health and safety laws and regulations, as discussed below. These
regulatory requirements impact many aspects of our operations, including manufacturing, developing, labeling, packaging, storage,
distribution, import and export and record keeping related to customers’ products. Noncompliance with any applicable regulatory
requirements can result in government refusal to approve facilities for manufacturing products or products for commercialization.
Our and our customers’ products must undergo pre-clinical and clinical evaluations relating to product safety and efficacy before
they are approved as commercial therapeutic products. The regulatory authorities that have jurisdiction in the countries in which our
and our customers’ products are intended to be marketed may delay or put on hold clinical trials, delay approval of a product or
determine that the product is not approvable. The regulatory agencies can delay approval of a drug if our manufacturing facilities or
OMPULs are not able to demonstrate compliance with cGTPs, pass other aspects of pre-approval inspections (i.e., compliance with
filed submissions) or properly scale up to produce commercial supplies. The government authorities having jurisdiction in the
countries in which our customers intend to market their products have the authority to withdraw product approval or suspend
manufacture if there are significant problems with raw materials or supplies, quality control and assurance or the product is deemed
adulterated or misbranded. In addition, if new legislation or regulations are enacted or existing legislation or regulations are amended
or are interpreted or enforced differently, we may be required to obtain additional approvals or operate according to different
manufacturing or operating standards or pay additional fees. This may require a change in our manufacturing techniques or
additional capital investments in our facilities.
Certain products manufactured by us involve the use, storage and transportation of toxic and hazardous materials. Our operations are
subject to extensive laws and regulations relating to the storage, handling, emission, transportation and discharge of materials into
the environment and the maintenance of safe working conditions. We maintain environmental and industrial safety and health
compliance programs and training at our facilities.
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Prevailing legislation tends to hold companies primarily responsible for the proper disposal of their waste even after transfer to third
party waste disposal facilities. Other future developments, such as increasingly strict environmental, health and safety laws and
regulations, and enforcement policies, could result in substantial costs and liabilities to us and could subject the handling,
manufacture, use, reuse or disposal of substances or pollutants at our facilities to more rigorous scrutiny than at present.
Our development operations involve the controlled use of hazardous materials and chemicals. Although we believe that our
procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, we may incur
significant additional costs to comply with applicable laws in the future. Also, even if we are in compliance with applicable laws, we
cannot completely eliminate the risk of contamination or injury resulting from hazardous materials or chemicals. As a result of any
such contamination or injury, we may incur liability or local, city, state or federal authorities may curtail the use of these materials
and interrupt our business operations. In the event of an accident, we could be held liable for damages or penalized with fines, and
the liability could exceed our resources. Compliance with applicable environmental laws and regulations is expensive, and current or
future environmental regulations may impair our contract manufacturing operations, which could materially harm our business,
financial condition and results of operations.
The costs associated with complying with the various applicable local, state, national and international regulations could be
significant and the failure to comply with such legal requirements could have an adverse effect on our results of operations and
financial condition. See “Risk Factors — Risks Related to Development and Regulatory Approval of Our Therapies and Product
Candidates — Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our
product development, manufacturing and distribution capabilities.” for additional discussion of the costs associated with complying
with the various regulations.
POCare Therapies Portfolio
Our therapeutic portfolio pipeline is diverse and addresses various unmet clinical needs. It is predominantly comprised of
personalized autologous cell therapies, implying that patients receive cells that originate from their own body, virtually eliminating
the risk of an immune response and rejection and thus easing various regulatory hurdles. In addition, by leveraging Orgenesis’ vast
experience and proven track record in developing and optimizing cell processing, these selective therapies are adapted to be
produced in closed, automated systems, reducing the need for high grade cleanroom environments. The systems enable each stage of
the manufacturing process (cell sorting, expansion, genetic modifications, quality control) to be optimized in order to substantially
reduce the cost burden for patients and making the therapies widely accessible. Notably, our therapeutic pipeline is developed by
researchers from our network and are subsequently out-licensed and validated in multi-center clinical trials conducted across point of
care partner sites leveraging the robustness of the Orgenesis network. Once approved these therapies are distributed to leading
medical institutions globally within our network and thus granting the inventors a royalty-based commercialization horizon.
Regulatory Process in the United States
Our potential product candidates are subject to regulation as a biological product under the Public Health Service Act and the Food,
Drug and Cosmetic Act. The FDA generally requires the following steps for pre-market approval or licensure of a new biological
product:
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Pre-clinical laboratory and animal tests conducted in compliance with Good Laboratory Practice, or GLP, requirements to
assess a drug’s biological activity and to identify potential safety problems, and to characterize and document the product’s
chemistry, manufacturing controls, formulation, and stability;
Submission to the FDA of an Investigational New Drug, or IND, application, which must become effective before clinical
testing in humans can start;
Obtaining approval of Institutional Review Boards, or IRBs, of research institutions or other clinical sites to introduce
biologic drug candidates into humans in clinical trials;
Conducting adequate and well-controlled clinical trials to establish the safety and efficacy of the product for its intended
indication conducted in compliance with Good Clinical Practice, or GCP, requirements;
Compliance with current GMP regulations and standards;
Submission to the FDA of a Biologics License Application (“BLA”) for marketing that includes adequate results of pre-
clinical testing and clinical trials;
The FDA reviews the marketing application in order to determine, among other things, whether the product is safe, effective
and potent for its intended uses; and
Obtaining FDA approval of the BLA, including inspection and approval of the product manufacturing facility as compliant
with GMP requirements, prior to any commercial sale or shipment of the pharmaceutical agent. The FDA may also require
post marketing testing and surveillance of approved products or place other conditions on the approvals.
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Regulatory Process in Europe
In the European Union (“EU”) somatic cell and gene therapy products are called Advanced Therapy Medicinal Product (ATMPs).
Since January 2022 the Clinical Trial Regulation (EU) 536/2014 regulates the application of medicinal products including ATMPs to
humans immediately effective in all member states. In conjunction with Regulation 536/2014 the EU commission has released two
delegated acts regulating manufacturing of investigational as well as marketed AMPs. For products that are regulated as an ATMP,
the EU Regulation requires:
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Compliance with current GMP regulations and standards, as described in the delegated acts
Filing a Clinical Trial Application (“CTA”)
in EU member states and EEA countries according to regulation 536/2014 via CTIS (Clinical Trial Information System)
allowing a harmonized approval process among all member states (including multinational clinical trials)
Obtaining approval by ethic committees responsible for medical institutions;
Adequate and well-controlled clinical trials according to GCP standards protecting the well-being of a study participant and
establishing the safety and efficacy of the product for its intended use;
Centralized submission procedure for ATMPs via EMA for Marketing Authorization (“MA”); and
Review and approval of the MAA (“Marketing Authorization Application”).
As in the U.S., prior to the general regulatory process of a new biologic products, we will prosecute an Orphan Drug Designation for
treatment of patients with Established “Diabetes Mellitus” (“DM”) Induced by Total pancreatectomy. In the EU, in order to be
qualified, the prevalence must be below 5 per 10,000 of the EU population, except where the expected return on investment is
insufficient to justify the investment.
Authorized orphan medicines benefit from 10 years of protection from market competition with similar medicines with similar
indications once they are approved. Companies applying for designated orphan medicines pay reduced fees for regulatory activities.
This includes reduced fees for protocol assistance, marketing-authorization applications, inspections before authorization,
applications for changes to marketing authorizations made after approval, and reduced annual fees.
Exemption from the centralized procedure was introduced into the ATMP Regulation to allow marketing of certain ATMPs in
individual EU member states. The so-called “hospital exemption” can only be applied for custom-made ATMPs used in a hospital
setting for a specific patient by a treating physician. In addition, a competent authority must authorize hospital exemption for
ATMPs. Hospital exemption products must comply with the same national requirements concerning quality, traceability and
pharmacovigilance that apply to authorized medicinal products. The “hospital exemption” has to be applied for individually in each
EU member state according to national procedures and control measures.
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Clinical Trials
Typically, both in the U.S. and the EU, clinical testing involves a three-phase process, although the phases may overlap. In Phase I,
clinical trials are conducted with a small number of healthy volunteers or patients and are designed to provide information about
product safety and to evaluate the pattern of drug distribution and metabolism within the body. In Phase II, clinical trials are
conducted with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and
expanded evidence of safety. In some cases, an initial trial is conducted in diseased patients to assess both preliminary efficacy and
preliminary safety and patterns of drug metabolism and distribution, in which case it is referred to as a Phase I/II trial. Phase III
clinical trials are generally large-scale, multi-center, comparative trials conducted with patients afflicted with a target disease in order
to provide statistically valid proof of efficacy, as well as safety and potency. In some circumstances, the FDA or EMA may require
Phase IV or post-marketing trials if it feels that additional information needs to be collected about the drug after it is on the market.
During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities,
clinical data, as well as clinical trial investigators. An agency may, at its discretion, re-evaluate, alter, suspend, or terminate the
testing based upon the data that have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.
Monitoring all aspects of the study to minimize risks is a continuing process. All adverse events must be reported to the FDA or
EMA.
The FDA has granted Orphan Drug designation for our AIP cells as a cell replacement therapy for the treatment of severe
hypoglycemia-prone diabetes resulting from TP due to chronic pancreatitis. The FDA’s Orphan Drug Designation Program provides
orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention
of rare diseases/disorders that affect fewer than 200,000 people in the United States. Orphan designation qualifies the sponsor of the
drug for various development incentives, including eligibility for seven years of market exclusivity upon regulatory approval,
exemption from FDA application fees, tax credits for qualified clinical trials, and other potential assistance in the drug development
process.
Employees
As of December 31, 2021, we had an aggregate of 151 employees working at our company and subsidiaries. In addition, we retain
the services of outside consultants for various functions including clinical work, finance, accounting and business development
services. Most of our senior management and professional employees have had prior experience in pharmaceutical or biotechnology
companies. None of our employees are covered by collective bargaining agreements. We believe that we have good relations with
our employees.
Corporate and Available Information
Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and all amendments to those
reports are available free of charge though our website (http://www.orgenesis.com) as soon as practicable after such material is
electronically filed with, or furnished to, the Securities and Exchange Commission (the “SEC”). Except as otherwise stated in these
documents, the information contained on our website or available by hyperlink from our website is not incorporated by reference
into this report or any other documents we file, with or furnish to, the SEC.
Our common stock is listed and traded on the Nasdaq Capital Market under the symbol “ORGS.”
As used in this Annual Report on Form 10-K and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its
Subsidiaries. Unless otherwise specified, all amounts are expressed in United States Dollars.
ITEM 1A. RISK FACTORS
Summary of Risk Factors
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This
summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary,
and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with
other information in this Annual Report on Form 10-K and our other filings with the SEC, before making an investment decision
regarding our common stock.
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Our POC business has a limited operating history and an unproven business model and faces significant challenges as the
cell therapy industry is rapidly evolving. Our prospects may be considered speculative and any failure to execute our
business strategy could adversely impact our business.
Our research and development efforts on novel technology using cell-based therapy and our future success is highly
dependent on the successful development of that technology.
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We have entered into collaborations and may form or seek collaborations or strategic alliances or enter into additional
licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
Our success will depend on strategic collaborations with third parties to develop and commercialize therapeutic product
candidates, and we may not have control over a number of key elements relating to the development and commercialization
of any such product candidate.
Our business is affected by the ongoing COVID-19 pandemic and may be significantly adversely affected as the pandemic
continues or if other events out of our control disrupt our business or that of our third party partners.
Our success depends on our ability to protect our intellectual property and our proprietary technologies.
Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their
intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the
success of our business.
Our success depends on our ability to develop and roll out our OMPULs.
If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit
commercialization of our product candidates.
We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including
cybersecurity and data storage risks.
There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or
establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United
States or overseas, and as a result, we may not be able to generate product revenue.
Our product candidates may cause undesirable side effects or have other properties that could halt their clinical
development, prevent their regulatory approval, limit their commercial potential, or result in significant negative
consequences.
Our product candidates are biologics and the manufacture of our product candidates is complex and we may encounter
difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities.
Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may
not be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may
rely on sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our
products.
We currently have no marketing and sales organization and have no experience in marketing therapeutic products. If we are
unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product
candidates, we may not be able to generate product revenue.
There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or
establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United
States or overseas, and as a result, we may not be able to generate product revenue.
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We face significant competition from other biotechnology and pharmaceutical companies, many of which have substantially
greater financial, technical and other resources, and our operating results will suffer if we fail to compete effectively.
We are highly dependent on key personnel who would be difficult to replace, and our business plans will likely be harmed if
we lose their services or cannot hire additional qualified personnel.
Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our
product development, manufacturing and distribution capabilities.
Third parties to whom we may license or transfer development and commercialization rights for products covered by
intellectual property rights may not be successful in their efforts and, as a result, we may not receive future royalty or other
milestone payments relating to those products or rights.
Risk Factors
An investment in our common stock involves a number of very significant risks. You should carefully consider the following risks
and uncertainties in addition to other information in this report in evaluating our company and its business before purchasing shares
of our company’s common stock. Our business, operating results and financial condition could be seriously harmed due to any of the
following risks. You could lose all or part of your investment due to any of these risks.
Risks Related to Our Company and POC Business
Our POC business has a limited operating history and an unproven business model and faces significant challenges as the cell
therapy industry is rapidly evolving. Our prospects may be considered speculative and any failure to execute our business
strategy could adversely impact our operations and the price of our common stock.
Our POC business has a limited operating history and an unproven business model. Our plans to continue to grow our POC cell
therapy business and to further the development of ATMPs are subject to significant challenges. Although we have sufficient capital
resources for the next 12 months and the foreseeable future, we may not be able to implement our POC business or commence
clinical trials or respond to competitive pressures due to other non-financial factors beyond our control. Our failure to effectively
execute our business strategy could adversely affect our ability to successfully grow our POC business and develop cell therapy
product candidates, which could cause the value of your investment in our common stock to decline.
We are not profitable as of December 31, 2021, have limited cash flow and, unless we increase revenues and take advantage
of any commercial opportunities that arise to expand our POC business, the perceived value of our company may decrease
and our stock price could be affected accordingly.
For the fiscal year ended December 31, 2021 and as of the date of this report, we assessed our financial condition and concluded that
we have sufficient resources for the next 12 months from the date of this report. Our auditor’s report for the year ended December
31, 2021 does not include a going concern opinion on the matter. However, management is unable to predict if and when we will be
able to generate significant revenues or achieve profitability. Our plan regarding these matters is to continue improving the net results
in our POC business into fiscal year 2022. There can be no assurance that we will be successful in increasing revenues, improving
our POC results or that the perceived value of our company will increase. In the event that we are unable to generate significant
revenues in our POC business, our stock price could be adversely affected.
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Our research and development programs are based on novel technologies and are inherently risky.
We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our cell
therapy technology creates significant challenges with respect to product development and optimization, manufacturing, government
regulation and approval, third-party reimbursement and market acceptance. For example, the FDA and EMA have relatively limited
experience with the development and regulation of cell therapy products and, therefore, the pathway to marketing approval for our
cell therapy product candidates may accordingly be more complex, lengthy and uncertain than for a more conventional product
candidate. The indications of use for which we choose to pursue development may have clinical effectiveness endpoints that have not
previously been reviewed or validated by the FDA or EMA, which may complicate or delay our effort to ultimately obtain FDA or
EMA approval. Because this is a new approach to treating diseases, developing and commercializing our product candidates subjects
us to a number of challenges, including:
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obtaining regulatory approval from the FDA, EMA and other regulatory authorities that have very limited experience with
the commercial development of our technology for treating different diseases;
developing and deploying consistent and reliable processes for removing the cells from the patient engineering cells ex vivo
and infusing the engineered cells back into the patient;
developing processes for the safe administration of these products, including long-term follow-up for all patients who
receive our products;
sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our products;
developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on
investment;
establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance; and
maintaining a system of post marketing surveillance and risk assessment programs to identify adverse events that did not
appear during the drug approval process.
Our efforts to overcome these challenges may not prove successful, and any product candidate we seek to develop may not
be successfully developed or commercialized.
Kyslecel may not achieve patient or market acceptance, which could have a material adverse effect on our business.
Our commercialization strategy for Kyslecel relies on medical specialists, medical facilities and patients adopting TP-IAT with
Kyslecel as an accepted treatment for chronic pancreatitis. However, medical specialists are historically slow to adopt new
treatments, regardless of perceived merits, when older treatments continue to be supported by established providers. Overcoming
such resistance often requires significant marketing expenditure or definitive product performance and/or pricing superiority. The
cost of allocating resources for such requirements might severely impact the potential for profitability of Kyslecel.
There is no guarantee that physician or patient acceptance of TP-IAT with Kyslecel will be substantial. Further, there is no guarantee
that Koligo will be able to achieve patient acceptance or obtain enough customers (clinical providers) to meet its sales objectives. If
we do not meet our sales objectives, our business prospects and financial performance will be materially and adversely affected.
Further, we are partially reliant on published clinical trials and scientific research conducted by third parties to justify the patient
benefit and safety of TP-IAT with Kyslecel and, as such, we rely, in part, on the accuracy and integrity of those third-parties to have
reported the results and correctly collected and interpreted the data from all clinical trials conducted to date. If published data turn
out to later be incorrect or incomplete, our business prospects and financial performance may be materially and adversely affected.
The therapeutic efficacy of Ranpirnase and our other product candidates is unproven in humans, and we may not be able to
successfully develop and commercialize Ranpirnase or any of our other product candidates.
Ranpirnase and our other product candidates are novel compounds and their potential benefit as antiviral drugs or immunotherapies
is unproven. Ranpirnase and our other product candidates may not prove to be effective against the indications for which they are
being designed to act and may not demonstrate in clinical trials any or all of the pharmacological effects that have been observed in
preclinical studies. As a result, our clinical trial results may not be indicative of the results of future clinical trials.
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Ranpirnase and our other product candidates may interact with human biological systems in unforeseen, ineffective or harmful ways.
If Ranpirnase or any of our other product candidates is associated with undesirable side effects or have characteristics that are
unexpected, we may need to abandon the development of such product candidate or limit development to certain uses or
subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a
risk-benefit perspective. Because of these and other risks described herein that are inherent in the development of novel therapeutic
agents, we may never successfully develop or commercialize Ranpirnase or any of our other product candidates, in which case our
business will be harmed.
We will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this
growth.
As of December 31, 2021, we had 151 employees. As our development and commercialization plans and strategies develop, we must
add a significant number of additional managerial, operational, sales, marketing, financial, and other personnel. Future growth will
impose significant added responsibilities on members of management, including:
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identifying, recruiting, integrating, maintaining, and motivating additional employees;
managing our internal development efforts effectively, including the clinical and FDA review process for our product
candidates, while complying with our contractual obligations to contractors and other third parties; and
improving our operational, financial and management controls, reporting systems, and procedures.
Our future financial performance and our ability to commercialize our product candidates will depend, in part, on our ability to
effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away
from day-to-day activities in order to devote a substantial amount of time to managing these growth activities. This lack of long-term
experience working together may adversely impact our senior management team’s ability to effectively manage our business and
growth.
We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations,
advisors and consultants to provide certain services. There can be no assurance that the services of these independent organizations,
advisors and consultants will continue to be available to us on a timely basis when needed, or that we can find qualified
replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services
provided by consultants is compromised for any reason, our clinical trials may be extended, delayed, or terminated, and we may not
be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we
will be able to manage our existing consultants or find other competent outside contractors and consultants on economically
reasonable terms, if at all. If we are not able to effectively expand our organization by hiring new employees and expanding our
groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and
commercialize our product candidates and, accordingly, may not achieve our research, development, and commercialization goals.
We may require additional capital to support our business, and this capital may not be available on acceptable terms or at
all.
We intend to continue to make investments to support our business growth and may require additional funds to respond to business
challenges and to grow our POC cell therapy business and to further the development of ATMPs. Accordingly, we may need to
engage in equity or debt financings to secure additional funds.
Capital and credit market conditions, adverse events affecting our business or industry, the tightening of lending standards, rising
interest rates, negative actions by regulatory authorities or rating agencies, or other factors also could negatively impact our ability to
obtain future financing on terms acceptable to us or at all. If we are unable to obtain adequate financing or financing on terms
satisfactory to us when we require it, our ability to support our business growth and respond to business challenges could be
significantly limited. In addition, the terms of any additional equity or debt issuances may adversely affect the value and price of our
common stock, our results of operations, financial condition and cash flows.
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If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer
significant dilution, and any new securities we issue could have rights, preferences and privileges superior to those of holders of our
common stock. Any financing secured by us in the future could include restrictive covenants relating to our capital raising activities
and other financial and operational matters, which may make it more difficult for us to obtain additional capital and to pursue
business opportunities, including potential acquisitions.
In addition, on February 24, 2022, Russia launched a large-scale invasion of Ukraine. The conflict may adversely impact
macroeconomic conditions and increase volatility in and affect our ability to access capital markets and external financing sources on
acceptable terms or at all.
Our operations may be adversely affected by ongoing developments in the Ukraine and Russia.
The Company has signed agreements with a company whose principal place of business is in Russia that include collaboration in
point of care development in Russia, as well as the development and commercialization of potential key technologies for the
Company’s clinical development and manufacturing projects. The United States, EU, UK, Canada and Japan have imposed sanctions
against and export controls involving Russia, and other potential retaliatory measures could be taken by the United States and other
countries. At this time, we cannot predict the outcome of developments in Russian and the Ukraine on these agreements.
Currency exchange fluctuations may impact the results of our operations.
The results of our operations are affected by fluctuations in currency exchange rates in both sourcing and selling locations. Our
results of operations may still be impacted by foreign currency exchange rates, primarily, the euro-to-U.S. dollar exchange rate. In
recent years, the euro-to-U.S. dollar exchange rate has been subject to substantial volatility which may continue, particularly in light
of recent political events regarding the European Union, or EU. Because we do not hedge against all of our foreign currency
exposure, our business will continue to be susceptible to foreign currency fluctuations.
We have entered into collaborations and joint ventures and may form or seek collaborations or strategic alliances or enter
into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing
arrangements.
We have entered into collaborations and joint ventures and may form or seek strategic alliances, create joint ventures or
collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our
development and commercialization efforts with respect to our product candidates and any future product candidates that we may
develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term
expenditures, issue securities that dilute our existing stockholders, or disrupt our management and business. In addition, we face
significant competition in seeking appropriate strategic partners for which the negotiation process is time-consuming and complex.
Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our
product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties
may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. Further, collaborations
involving our product candidates, such as our collaborations with third-party research institutions, are subject to numerous risks,
which may include the following:
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collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration;
collaborators may not perform their obligations as expected;
collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or
renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the
acquisition of competitive products, availability of funding, or other external factors, such as a business combination that
diverts resources or creates competing priorities;
collaborators may delay clinical trials, provide insufficient funding for a clinical trial, stop a clinical trial, abandon a product
candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;
collaborators could fail to make timely regulatory submissions for a product candidate;
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collaborators may not comply with all applicable regulatory requirements or may fail to report safety data in accordance
with all applicable regulatory requirements;
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with
our products or product candidates;
product candidates developed in collaboration with us may be viewed by our collaborators as competitive with their own
product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of our
product candidates;
a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to their
marketing and distribution;
collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or
proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our
intellectual property or proprietary information or expose us to potential liability;
disputes may arise between us and a collaborator that cause the delay or termination of the research, development or
commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management
attention and resources;
collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further
development or commercialization of the applicable product candidates; and
collaborators may own or co-own intellectual property covering our products that results from our collaborating with them
and, in such cases, we would not have the exclusive right to commercialize such intellectual property.
As a result, if we enter into collaboration agreements and strategic partnerships or license our products or businesses, we may not be
able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and
company culture, which could delay our timelines or otherwise adversely affect our business. The success of our existing and future
collaboration arrangements and strategic partnerships, which include research and development services by our collaborators to
improve our intellectual property, will depend heavily on the efforts and activities of our collaborators and may not be successful. We
also cannot be certain that, following a strategic transaction or license, we will achieve the revenue or specific net income that
justifies such transaction. Any delays in entering into new collaborations or strategic partnership agreements related to our product
candidates could delay the development and commercialization of our product candidates in certain geographies for certain
indications, which would harm our business prospects, financial condition, and results of operations.
Our success will depend on strategic collaborations with third parties to develop and commercialize therapeutic product
candidates, and we may not have control over a number of key elements relating to the development and commercialization
of any such product candidate.
A key aspect of our strategy is to seek collaborations with partners, such as a large pharmaceutical organization, that are
willing to further develop and commercialize a selected product candidate. To date, we have entered into a number of collaborative
arrangements with cell therapy organizations. By entering into any such strategic collaborations, we may rely on our partner for
financial resources and for development, regulatory and commercialization expertise. Our partner may fail to develop or effectively
commercialize our product candidate because they:
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do not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as limited
cash or human resources;
decide to pursue a competitive potential product developed outside of the collaboration;
cannot obtain the necessary regulatory approvals;
determine that the market opportunity is not attractive; or
cannot manufacture or obtain the necessary materials in sufficient quantities from multiple sources or at a reasonable cost.
We may not be able to enter into additional collaborations on acceptable terms, if at all. We face competition in our search for
partners from other organizations worldwide, many of whom are larger and are able to offer more attractive deals in terms of
financial commitments, contribution of human resources, or development, manufacturing, regulatory or commercial expertise and
support. If we are not successful in attracting a partner and entering into a collaboration on acceptable terms, we may not be able to
complete development of or commercialize any product candidate. In such event, our ability to generate revenues and achieve or
sustain profitability would be significantly hindered and we may not be able to continue operations as proposed, requiring us to
modify our business plan, curtail various aspects of our operations or cease operations.
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Our business is affected by the ongoing COVID-19 pandemic and may be significantly adversely affected as the pandemic
continues or if other events out of our control disrupt our business or that of our third party partners.
While the extent of the impact of the COVID-19 pandemic on our business and financial results is uncertain, a continued and
prolonged public health crisis such as the COVID-19 pandemic could have a material negative impact on our business, financial
condition and operating results. We have experienced and may in the future experience disruptions from COVID-19 to our business
in a number of ways, including:
● Delays in supply chain and manufacturing, including the suspension of cell transport, limitations on transfer of
technology, shutdown of manufacturing facilities and delays in delivery of supplies and reagents;
● Delays in discovery and preclinical efforts;
● Changes to procedures or shut down, or reduction in capacity, of clinical trial sites due to limited availability of clinical
trial staff, reduced number of inpatient intensive care unit beds for patients receiving cell therapies, diversion of
healthcare resources away from clinical trials and other business considerations;
● Limited patient access, enrollment and participation due to travel restrictions and safety concerns, as well as housing
and travel difficulties for out of town patients and relatives; and
● Changes in regulatory and other requirements for conducting preclinical studies and clinical trials during the pandemic.
We may be required to develop and implement additional clinical trial policies and procedures designed to help protect subjects from
the COVID-19 virus. For example, in March 2020, the FDA issued a guidance on conducting clinical trials during the pandemic,
which was updated in July 2020, January 2021 and August 2021. The guidance describes a number of considerations for sponsors of
clinical trials impacted by the pandemic, including the requirement to include in the clinical trial report (or as a separate document)
contingency measures implemented to manage the trial and any disruption of the trial as a result of the COVID-19 pandemic; a list of
all subjects affected by the COVID-19 pandemic-related trial disruptions by unique subject identifier and by investigational site and
a description of how the individual’s participation was altered; and analyses and corresponding discussions that address the impact of
implemented contingency measures (e.g., participant discontinuation from investigational product and/or trial, alternative procedures
used to collect critical safety and/or efficacy data) on the safety and efficacy results reported for the trial. In its most recent update to
this guidance, the FDA addressed questions received from clinical practitioners who are adapting their operations in a pandemic
environment. These questions focused on, among other things, when to suspend, continue or initiate a trial and how to submit
changes to protocols for INDs and handle remote site monitoring visits. There is no assurance that this guidance governing clinical
trials during the pandemic will remain in effect or, even if it does, that it will help address the risks and challenges enumerated
above.
Other potential impacts of the COVID-19 pandemic on our ongoing clinical trials include patient dosing and trial monitoring, which
may be paused or delayed due to changes in policies at various clinical sites, federal, state, local or foreign laws, rules and
regulations, including quarantines or other travel restrictions, prioritization of healthcare resources toward pandemic efforts,
including diminished attention of physicians serving as our clinical trial investigators and reduced availability of site staff supporting
the conduct of our clinical trial, interruption or delays in the operations of the FDA, or other reasons related to the COVID-19
pandemic.
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If the COVID-19 pandemic continues, other aspects of our ongoing clinical trial and future planned clinical trials may be adversely
affected, delayed or interrupted, including, for example, site initiation, patient recruitment and enrollment, availability of clinical trial
materials, clinical trial site data monitoring and efficacy, safety and translational data collection, and data analysis. Some patients and
clinical investigators may not be able to comply with clinical trial protocols and patients may choose to withdraw from our trials or
we may have to pause enrollment or we may choose to or be required to pause enrollment and/or patient dosing in our ongoing or
planned clinical trials in order to preserve health resources and protect trial participants. It is unknown how long these pauses or
disruptions could continue. Patients may need to withdraw due to COVID-19 infections or experience increased adverse events and
deaths in our clinical trials due to COVID-19 related infections, which may result in increased complications due to immune
suppression in some of the patients being treated.
In addition, we currently rely on third parties to, among other things, manufacture raw materials, manufacture our product candidates
for our clinical trials, ship investigation drugs and clinical trial samples, perform quality testing and supply other goods and services
to run our business. If any such third party in our supply chain for materials is adversely impacted by effects from the COVID-19
pandemic, including staffing shortages, production slowdowns and disruptions in delivery systems, our supply chain may be
disrupted and our costs could be increased, limiting our ability to manufacture our product candidates for our clinical trials and
planned future clinical trials and conduct our research and development operations as planned.
We previously closed our offices and requested that most of our personnel, including all of our administrative employees, work
remotely, restricted on-site staff to only those personnel and contractors who must perform essential activities that must be completed
on-site and limited the number of staff in any given research and development laboratory. Our increased reliance on personnel
working from home may negatively impact productivity, or disrupt, delay, or otherwise adversely impact our business. In addition,
this could increase our cyber security risk, create data accessibility concerns, and make us more susceptible to communication
disruptions, any of which could adversely impact our business operations or delay necessary interactions with local and federal
regulators, ethics committees, manufacturing sites, research or clinical trial sites and other important agencies and contractors.
Further, we and our third-party service providers, the clinical trial sites, our manufacturers and suppliers, may experience staffing
shortages.
Our employees and contractors conducting research and development activities may not be able to access our laboratory for an
extended period of time as a result of the closure of our offices and the possibility that governmental authorities further modify
current restrictions. In addition, when our facilities are open, we could encounter delays in connection with implementing
precautionary measures to mitigate the risk of exposing our facilities and employees to COVID-19 or otherwise in connection with
addressing an actual or potential exposure to COVID-19 (for example, temporarily closing all or a portion of a facility or disinfecting
all or a portion of a facility that may have been exposed to COVID-19). As a result, this could delay timely completion of preclinical
activities, including completing IND/Clinical Trial Application (CTA)-enabling studies or our ability to select future development
candidates, and initiation of additional clinical trials for our other development programs.
Health regulatory agencies globally may experience disruptions in their operations as a result of the COVID-19 pandemic. The FDA
or foreign health authorities may have slower response times or be under-resourced to continue to monitor our ongoing clinical trial
and, as a result, review, inspection, and other timelines may be materially delayed. It is unknown how long these disruptions could
continue, were they to occur. Any elongation or de-prioritization of our clinical trial or delay in regulatory review resulting from
such disruptions could materially affect the development of our product candidates.
The trading prices for shares of other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic.
As a result, we may face difficulties raising capital through sales of our common stock or such sales may be on unfavorable terms. In
addition, a recession, depression or other sustained adverse market event resulting from the spread of the COVID-19 could
materially and adversely affect our business and the value of our common stock.
The COVID-19 pandemic continues to evolve. The ultimate impact of the COVID-19 pandemic on our business operations is highly
uncertain and subject to change and will depend on future developments, which cannot be accurately predicted, including the
duration of the pandemic, additional or modified government actions, and the actions taken to contain COVID-19 or address its
impact, among others. We do not yet know the full extent of potential delays or impacts on our business, our clinical trials, our
research programs, healthcare systems or the global economy. We will continue to monitor the situation closely.
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In addition, our business could be significantly adversely affected by other business disruptions to us or our third party partners or
collaborators that could seriously harm our potential future revenue and financial condition and increase our costs and expenses. Our
operations, and those of our partners and collaborators, contract manufacturing organizations (CMOs) and other contractors,
consultants, and third parties could be subject to other global pandemics, earthquakes, power shortages, telecommunications failures,
water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or man-made
disasters or business interruptions, for which we are predominantly self-insured. The occurrence of any of these business disruptions
could seriously harm our operations and financial condition and increase our costs and expenses. We rely on third-party
manufacturers to produce and process our product candidates. Our ability to obtain clinical supplies of our product candidates could
be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.
Our success depends on our ability to protect our intellectual property and our proprietary technologies.
Our commercial success depends in part on our ability to obtain and maintain patent protection and trade secret protection for our
product candidates, proprietary technologies, and their uses as well as our ability to operate without infringing upon the proprietary
rights of others. We can provide no assurance that our patent applications or those of our licensors will result in additional patents
being issued or that issued patents will afford sufficient protection against competitors with similar technologies, nor can there be
any assurance that the patents issued will not be infringed, designed around or invalidated by third parties. Even issued patents may
later be found unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or
in courts. The degree of future protection for our proprietary rights is uncertain. Only limited protection may be available and may
not adequately protect our rights or permit us to gain or keep any competitive advantage. Composition-of-matter patents on the
biological or chemical active pharmaceutical ingredients are generally considered to offer the strongest protection of intellectual
property and provide the broadest scope of patent protection for pharmaceutical products, as such patents provide protection without
regard to any method of use or any method of manufacturing. While we have issued patents in the United States we cannot be certain
that the claims in our issued patent will not be found invalid or unenforceable if challenged.
We cannot be certain that the claims in our issued United States methods of use patents will not be found invalid or
unenforceable if challenged.
We cannot be certain that the pending applications covering among others the bioconjugates comprising sulfated polysaccharides;
Ranpirnase and other ribonucleases for treating viral diseases; therapeutic compositions comprising exosomes, bioxomes, and
redoxomes; bioreactors for cell culture, automated devices for supporting cell therapies, and point-of-care systems; immune cells,
ribonucleases, or antibodies for treating COVID-19; or chimeric antigen receptors (CARs); will be considered patentable by the
United States Patent and Trademark Office (USPTO), and courts in the United States or by the patent offices and courts in foreign
countries, nor can we be certain that the claims in our issued patents will not be found invalid or unenforceable if challenged. Even if
our patent applications covering these inventions issue as patents, the patents protect specific products and may not be enforced
against competitors making and marketing a product that has the same activity. Method-of-use patents protect the use of a product
for the specified method or for treatment of a particular indication. These types of patents may not be enforced against competitors
making and marketing a product that provides the same activity but is used for a method not included in the patent. Moreover, even if
competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.”
Although off-label prescriptions may infringe or contribute to the infringement of method-of-use patents, the practice is common and
such infringement is difficult to prevent or prosecute.
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The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our
future development partners will be successful in protecting our product candidates by obtaining and defending patents. These risks
and uncertainties include the following:
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the USPTO and various foreign governmental patent agencies require compliance with a number of procedural,
documentary, fee payment and other provisions during the patent process. There are situations in which noncompliance can
result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the
relevant jurisdiction. In such an event, competitors might be able to enter the market earlier than would otherwise have been
the case;
patent applications may not result in any patents being issued;
patents that may be issued or in-licensed may be challenged, invalidated, modified, revoked, circumvented, found to be
unenforceable or otherwise may not provide any competitive advantage;
our competitors, many of whom have substantially greater resources and many of whom have made significant investments
in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our
ability to make, use, and sell our potential product candidates;
there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent
protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy
regarding worldwide health concerns; and
countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts,
allowing foreign competitors a better opportunity to create, develop and market competing product candidates.
In addition, we rely on the protection of our trade secrets and proprietary know-how. Although we have taken steps to protect our
trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential
information and inventions agreements with employees, consultants and advisors, we cannot provide any assurances that all such
agreements have been duly executed, and third parties may still obtain this information or may come upon this or similar information
independently. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient
recourse against third parties for misappropriating its trade secrets. If any of these events occurs or if we otherwise lose protection
for our trade secrets or proprietary know-how, our business may be harmed.
Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their
intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of
our business.
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our
product candidates and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual
property and proprietary rights of third parties. There is considerable patent and other intellectual property litigation in the
pharmaceutical and biotechnology industries. We may become party to, or threatened with, adversarial proceedings or litigation
regarding intellectual property rights with respect to our technology and product candidates, including interference proceedings, post
grant review, inter partes review, and derivation proceedings before the USPTO and similar proceedings in foreign jurisdictions such
as oppositions before the European Patent Office.
The legal threshold for initiating litigation or contested proceedings is low, so that even lawsuits or proceedings with a low
probability of success might be initiated and require significant resources to defend. Litigation and contested proceedings can also be
expensive and time-consuming, and our adversaries in these proceedings may have the ability to dedicate substantially greater
resources to prosecuting these legal actions than we can. The risks of being involved in such litigation and proceedings may increase
if and as our product candidates near commercialization. Third parties may assert infringement claims against us based on existing
patents or patents that may be granted in the future, regardless of merit. We may not be aware of all such intellectual property rights
potentially relating to our technology and product candidates and their uses, or we may incorrectly conclude that third party
intellectual property is invalid or that our activities and product candidates do not infringe such intellectual property. Thus, we do not
know with certainty that our technology and product candidates, or our development and commercialization thereof, do not and will
not infringe, misappropriate or otherwise violate any third party’s intellectual property.
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Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents
or patent applications with claims to materials, formulations or methods, such as methods of manufacture or methods for treatment,
related to the discovery, use or manufacture of the product candidates that we may identify or related to our technologies. Because
patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued
patents that the product candidates that we may identify may infringe. In addition, third parties may obtain patents in the future and
claim that use of our technologies infringes upon these patents. Moreover, as noted above, there may be existing patents that we are
not aware of or that we have incorrectly concluded are invalid or not infringed by our activities. If any third-party patents were held
by a court of competent jurisdiction to cover, for example, the manufacturing process of the product candidates that we may identify,
any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to
block our ability to commercialize such product candidate unless we obtained a license under the applicable patents, or until such
patents expire.
Generally, conducting clinical trials and other development activities in the United States is not considered an act of infringement. If
and when products are approved by the FDA, that certain third party may then seek to enforce its patents by filing a patent
infringement lawsuit against us or our licensee(s). In such lawsuit, we or our licensees may incur substantial expenses defending our
rights or our licensees rights to commercialize such product candidates, and in connection with such lawsuit and under certain
circumstances, it is possible that we or our licensees could be required to cease or delay the commercialization of a product candidate
and/or be required to pay monetary damages or other amounts, including royalties on the sales of such products. Moreover, any such
lawsuit may also consume substantial time and resources of our management team and board of directors. The threat or
consequences of such a lawsuit may also result in royalty and other monetary obligations being imposed on us, which may adversely
affect our results of operations and financial condition.
Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further
develop and commercialize the product candidates that we may identify. Defense of these claims, regardless of their merit, would
involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a
successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees
for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may
be impossible or require substantial time and monetary expenditure.
We may choose to take a license or, if we are found to infringe, misappropriate or otherwise violate a third party’s intellectual
property rights, we could also be required to obtain a license from such third party to continue developing, manufacturing and
marketing our technology and product candidates. However, we may not be able to obtain any required license on commercially
reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and
other third parties access to the same technologies licensed to us and could require us to make substantial licensing and royalty
payments. We could be forced, including by court order, to cease developing, manufacturing and commercializing the infringing
technology or product. In addition, we could be found liable for significant monetary damages, including treble damages and
attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right and could be forced to
indemnify our customers or collaborators. A finding of infringement could prevent us from commercializing our product candidates
or force us to cease some of our business operations, which could materially harm our business. In addition, we may be forced to
redesign our product candidates, seek new regulatory approvals and indemnify third parties pursuant to contractual agreements.
Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material
adverse effect on our business, financial condition, results of operations and prospects.
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If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit
commercialization of our product candidates.
We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater
risk if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury
or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims
may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product,
negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot
successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit
commercialization of our product candidates. Even a successful defense would require significant financial and management
resources. Regardless of the merits or eventual outcome, liability claims may result in:
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decreased demand for our products;
injury to our reputation;
withdrawal of clinical trial participants and inability to continue clinical trials;
initiation of investigations by regulators;
costs to defend the related litigation;
a diversion of management’s time and our resources;
substantial monetary awards to trial participants or patients;
product recalls, withdrawals or labeling, marketing or promotional restrictions;
loss of revenue;
exhaustion of any available insurance and our capital resources;
the inability to commercialize any product candidate; and
a decline in our share price.
Because most of our products have not reached commercial stage, we do not currently need to carry clinical trial or extensive
product liability insurance. In the future, our inability to obtain additional sufficient product liability insurance at an acceptable cost
to protect against potential product liability claims could prevent or inhibit the commercialization of products we develop, alone or
with collaborators. Such insurance policies may also have various exclusions, and we may be subject to a product liability claim for
which we have no coverage.
It may be difficult to enforce a U.S. judgment against us, our officers and directors and the foreign persons named in this
Annual Report on Form 10-K in the United States or in foreign countries, or to assert U.S. securities laws claims in foreign
countries or serve process on our officers and directors and these experts.
While we are incorporated in the State of Nevada, currently a majority of our directors and executive officers are not residents of the
United States, and the foreign persons named in this Annual Report on Form 10-K are located outside of the United States. The
majority of our assets are located outside the United States. Therefore, it may be difficult for an investor, or any other person or
entity, to enforce a U.S. court judgment based upon the civil liability provisions of the U.S. federal securities laws against us or any
of these persons in a U.S. or foreign court, or to effect service of process upon these persons in the United States. Additionally, it
may be difficult for an investor, or any other person or entity, to assert U.S. securities law claims in original actions instituted in
foreign countries in which we operate. Foreign courts may refuse to hear a claim based on a violation of U.S. securities laws on the
grounds that foreign countries are not necessary the most appropriate forum in which to bring such a claim. Even if a foreign court
agrees to hear a claim, it may determine that foreign law and not U.S. law is applicable to the claim. If U.S. law is found to be
applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain
matters of procedure will also be governed by foreign countries law. There is little binding case law in foreign countries addressing
the matters described above.
We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties
and reputational damage.
We are subject to laws and regulations covering data privacy and the protection of personal information, including health
information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an
increasing focus on privacy and data protection issues which may affect our business. In the U.S., numerous federal and state laws
and regulations, including state security breach notification laws, state health information privacy laws, and federal and state
consumer protection laws, govern the collection, use, disclosure, and protection of personal information. Each of these laws is
subject to varying interpretations by courts and government agencies, creating complex compliance issues for us. If we fail to
comply with applicable laws and regulations we could be subject to penalties or sanctions, including criminal penalties if we
knowingly obtain or disclose individually identifiable health information from a covered entity in a manner that is not authorized or
permitted by the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for
Economic and Clinical Health Act, or HIPAA.
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Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as
well. The EU and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance
obligations. In the EU, for example, effective May 25, 2018, the GDPR replaced the prior EU Data Protection Directive (95/46) that
governed the processing of personal data in the European Union. The GDPR imposes significant obligations on controllers and
processors of personal data, including, as compared to the prior directive, higher standards for obtaining consent from individuals to
process their personal data, more robust notification requirements to individuals about the processing of their personal data, a
strengthened individual data rights regime, mandatory data breach notifications, limitations on the retention of personal data and
increased requirements pertaining to health data, and strict rules and restrictions on the transfer of personal data outside of the EU,
including to the U.S. The GDPR also imposes additional obligations on, and required contractual provisions to be included in,
contracts between companies subject to the GDPR and their third-party processors that relate to the processing of personal data. The
GDPR allows EU member states to make additional laws and regulations further limiting the processing of genetic, biometric or
health data.
Adoption of the GDPR increased our responsibility and liability in relation to personal data that we process and may require us to put
in place additional mechanisms to ensure compliance. Any failure to comply with the requirements of GDPR and applicable national
data protection laws of EU member states, could lead to regulatory enforcement actions and significant administrative and/or
financial penalties against us (fines of up to Euro 20,000,000 or up to 4% of the total worldwide annual turnover of the preceding
financial year, whichever is higher), and could adversely affect our business, financial condition, cash flows and results of
operations.
We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including
cybersecurity and data storage risks.
Significant disruptions to our information technology systems or breaches of information security could adversely affect our
business. In the ordinary course of business, we collect, store and transmit confidential information, and it is critical that we do so in
a secure manner in order to maintain the confidentiality and integrity of such confidential information. Our information technology
systems are potentially vulnerable to service interruptions and security breaches from inadvertent or intentional actions by our
employees, partners, vendors, or from attacks by malicious third parties. Maintaining the secrecy of this confidential, proprietary,
and/or trade secret information is important to our competitive business position. While we have taken steps to protect such
information and invested in information technology, there can be no assurance that our efforts will prevent service interruptions or
security breaches in our systems or the unauthorized or inadvertent wrongful access or disclosure of confidential information that
could adversely affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. A
breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination or misappropriation or
misuse of trade secrets, proprietary information, or other confidential information, whether as a result of theft, hacking, or other
forms of deception, or for any other cause, could enable others to produce competing products, use our proprietary technology and/or
adversely affect our business position. Further, any such interruption, security breach, loss or disclosure of confidential information
could result in financial, legal, business, and reputational harm to us and could have a material effect on our business, financial
position, results of operations and/or cash flow.
There can be no assurance that we will be able to develop in-house sales and commercial distribution capabilities or establish
or maintain relationships with third-party collaborators to successfully commercialize any product in the United States or
overseas, and as a result, we may not be able to generate product revenue.
A variety of risks associated with operating our business internationally could materially adversely affect our business. We plan to
seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we, and any
potential collaborators in those jurisdictions, will be subject to additional risks related to operating in foreign countries, including:
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differing regulatory requirements in foreign countries, unexpected changes in tariffs, trade barriers, price and exchange
controls, and other regulatory requirements;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
foreign taxes, including withholding of payroll taxes;
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other
obligations incident to doing business in another country;
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difficulties staffing and managing foreign operations;
workforce uncertainty in countries where labor unrest is more common than in the United States;
potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign laws;
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect
and protect intellectual property rights to the same extent as the United States;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
business interruptions resulting from geo-political actions, including war, and terrorism or disease outbreaks (such as the
recent outbreak of COVID-19, or the novel coronavirus).
These and other risks associated with our planned international operations may materially adversely affect our ability to attain or
maintain profitable operations.
If we are unable to integrate acquired businesses effectively, our operating results may be adversely affected.
From time to time, we seek to expand our business through acquisitions. We may not be able to successfully integrate acquired
businesses and, where desired, their product portfolios into ours, and therefore we may not be able to realize the intended benefits. If
we fail to successfully integrate acquisitions or product portfolios, or if they fail to perform as we anticipate, our existing businesses
and our revenue and operating results could be adversely affected. If the due diligence of the operations of acquired businesses
performed by us and by third parties on our behalf is inadequate or flawed, or if we later discover unforeseen financial or business
liabilities, acquired businesses and their assets may not perform as expected. Additionally, acquisitions could result in difficulties
assimilating acquired operations and, where deemed desirable, transitioning overlapping products into a single product line and the
diversion of capital and management’s attention away from other business issues and opportunities. The failure to integrate acquired
businesses effectively may adversely impact our business, results of operations or financial condition.
Risks Related to Our OMPULs
We may not be able to operate our OMPULs in all cities or desired locations and the sizes and use of our laboratories in such
OMPULs may be restricted due to zoning, environmental, medical waste, or other licensing regulations.
We may be subject to local zoning ordinances or other similar restrictions that may limit where the OMPULs can be located and the
extent of their size and use. In addition, international, federal, state and local environmental and other administrative and licensing
regulations could restrict the ability of the OMPULs to connect with local power, water, sewer, and other infrastructure. Our success
depends on our ability to develop and roll out our OMPULs which may become more difficult or more expensive by such applicable
regulations. Changes in any of these regulations could require us to close or move our OMPULs which would affect our ability to
conduct and grow our business.
If our existing OMPULs facilities become damaged or inoperable or if we are required to vacate our existing facilities, our
ability to perform our tests and pursue our research and development efforts may be jeopardized.
We currently perform a majority of tests relating to our POCare services out of our OMPULs. Our facilities and equipment could be
harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure
or terrorism, which may render it difficult or impossible for us to operate for some period of time. In addition, since there is no
lengthy history of use of OMPULs and the OMPULs are still in the development stage, we are unable to predict the normal wear and
tear on such OMPULs or how many years each OMPUL will remain operational.
The inability to perform our tests or to reduce the backlog that could develop if our facilities are inoperable, for even a short period
of time, may result in the loss of customers or harm to our reputation, and we may be unable to regain those customers or repair our
reputation. Furthermore, our OMPUL facilities and the equipment we use to perform our research and development work could be
unavailable or costly and time-consuming to repair or replace. It would be difficult, time-consuming and expensive to rebuild our
facilities, or to locate and qualify new facilities.
We carry insurance for damage to our property and disruption of our business, but this insurance may not cover all of the risks
associated with damage or disruption to our facility and business, may not provide coverage in amounts sufficient to cover our
potential losses and may not continue to be available to us on acceptable terms, if at all.
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Changes in the price and availability of our raw materials could be detrimental to our OMPUL operations.
Supply chain issues, including limited supply of certain raw material or supply interruptions, delays or shortages of material may
disrupt our daily operations as the OMPULs may be unable to retain an inventory of materials required to maintain operations or to
build or repair OMPULs.
We are dependent on skilled human capital for our OMPULs.
Our ability to innovate and execute is dependent on the ability to hire, replace, and train skilled personnel. The employment market
suffers from shortage of candidates that may continue in future years and cause delays and inabilities to execute our plans.
Additionally, based on current trends in the US labor market, there could be a shortage of available trained staff for the OMPULs in
the United States. Staff retention could also be a significant operational issue.
If we are unable to successfully secure our locations and premises, we may be unable to operate out of our OMPULs or keep
our employees and laboratory equipment safe.
In certain cities and urban markets, homelessness, rising crime rates and decreased police funding, could impact the security of the
OMPULs and the safety of employees and patients. If we are unable to successfully secure our OMPULs, our research and
development could be negatively impacted.
Our OMPULs are operated in a heavily regulated industry, and changes in regulations or violations of regulations may,
directly or indirectly, reduce our revenue, adversely affect our results of operations and financial condition, and harm our
business.
The clinical laboratory testing industry is highly regulated, and there can be no assurance that the regulatory environment in which
we operate will not change significantly and adversely to us in the future. Areas of the regulatory environment that may affect our
ability to conduct our OMPUL business include, without limitation:
●federal and state laws governing laboratory testing, including CLIA, and state licensing laws;
● federal and state laws and enforcement policies governing the development, use and distribution of diagnostic medical devices,
including laboratory developed tests, or LDTs;
●federal, state and local laws governing the handling and disposal of medical and hazardous waste;
●federal and state Occupational Safety and Health Administration rules and regulations; and
● European Union GMP approvals, which may be delayed because of the use OMPULs which could then delay manufacturing for
clinical trials.
Risks Related to Our Trans-Differentiation Technologies for Diabetes and the THM License Agreement
THM is entitled to cancel the THM License Agreement.
Pursuant to the terms of the THM License Agreement with THM, Orgenesis Ltd, the Israeli Subsidiary, must develop, manufacture,
sell and market the products pursuant to the milestones and time schedule specified in the development plan. In the event the Israeli
Subsidiary fails to fulfill the terms of the development plan under the THM License Agreement, THM shall be entitled to terminate
the THM License Agreement by providing the Israeli Subsidiary with written notice of such a breach and if the Israeli Subsidiary
does not cure such breach within one year of receiving the notice. THM may also terminate the THM License Agreement if the
Israeli Subsidiary breaches an obligation contained in the THM License Agreement and does not cure it within 180 days of receiving
notice of the breach. We also run the risk that THM may attempt cancel or, at the very least challenge, the License Agreement with
Orgenesis Ltd. as we continue to expand our focus to other therapies and business activities. We believe that our expanded focus to
such other therapies and business activities may continue to prompt THM to inquire of such activities as they may relate to our
compliance with the terms or direction of resources toward the THM License Agreement. While we have not received any notice of
cancellation of the THM License Agreement, we have received an allegation regarding the scope of the rights by THM that may
present future challenges for our Israeli Subsidiary to continue to develop, manufacture, sell and market the products pursuant to the
milestones and time schedule specified in the development plan of the THM License Agreement. In addition, THM has filed a
complaint against us in the Tel Aviv District Court relating to the scope of such THM license and the royalties and other payments
that THM is entitled to thereunder. See “Legal Proceedings” in this Annual Report on Form 10-K. Such complaint may lead to
further risk of cancellation of the THM License Agreement.
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Orgenesis Ltd. licensed a technology that demonstrates the capacity to induce a shift in the developmental fate of cells from the liver
and differentiating (converting) them into “pancreatic beta cell-like” insulin-producing cells for patients with diabetes. Our intention
is to develop our technology to the clinical stage for regeneration of functional insulin-producing cells, thus enabling normal glucose
regulated insulin secretion, via cell therapy. By using therapeutic agents that efficiently convert a sub-population of liver cells into
pancreatic islets phenotype and function, this approach allows the diabetic patient to be the donor of his/her own therapeutic tissue
and to start producing his/her own insulin in a glucose-responsive manner, thereby eliminating the need for insulin injections.
Because this is a new approach to treating diabetes, developing and commercializing our product candidates subjects us to a number
of challenges, including:
● obtaining regulatory approval regulatory authorities that have very limited experience with the commercial
development of the trans-differentiating technology for diabetes;
● developing and deploying consistent and reliable processes for engineering a patient’s liver cells ex vivo and infusing
the engineered cells back into the patient;
● developing processes for the safe administration of these products, including long-term follow-up for all patients who
receive our products;
● sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our products;
● developing a manufacturing process and distribution network with a cost of goods that allows for an attractive return on
investment;
● establishing sales and marketing capabilities after obtaining any regulatory approval to gain market acceptance; and
● maintaining a system of post marketing surveillance and risk assessment programs to identify adverse events that did
not appear during the drug approval process.
Risks Related to Development and Regulatory Approval of Our Therapies and Product Candidates
Research and development of biopharmaceutical products is inherently risky.
We may not be successful in our efforts to use and enhance our technology platform to create a pipeline of product candidates and
develop commercially successful products. Furthermore, we may expend our limited resources on programs that do not yield a
successful product candidate and fail to capitalize on product candidates or diseases that may be more profitable or for which there is
a greater likelihood of success. If we fail to develop additional product candidates, our commercial opportunity will be limited. Even
if we are successful in continuing to build our pipeline, obtaining regulatory approvals and commercializing additional product
candidates will require substantial additional funding and are prone to the risks of failure inherent in medical product development.
Investment in biopharmaceutical product development involves significant risk that any potential product candidate will fail to
demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, and become commercially viable. We cannot
provide you any assurance that we will be able to successfully advance any of these additional product candidates through the
development process. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield
product candidates for clinical development or commercialization for many reasons, including the following:
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our platform may not be successful in identifying additional product candidates;
we may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;
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our product candidates may not succeed in preclinical or clinical testing;
a product candidate may on further study be shown to have harmful side effects or other characteristics that indicate it is
unlikely to be effective or otherwise does not meet applicable regulatory criteria;
competitors may develop alternatives that render our product candidates obsolete or less attractive;
product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
the market for a product candidate may change during our program so that the continued development of that product
candidate is no longer reasonable;
a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and
a product candidate may not be accepted as safe and effective by patients, the medical community or third- party payers, if
applicable.
If any of these events occur, we may be forced to abandon our development efforts for a program or programs, or we may not be able
to identify, discover, develop, or commercialize additional product candidates, which would have a material adverse effect on our
business and could potentially cause us to cease operations.
Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product
development, manufacturing and distribution capabilities.
All pharmaceutical companies are subject to extensive, complex, costly and evolving government regulation. For the U.S., this is
principally administered by the FDA and to a lesser extent by the Drug Enforcement Administration (“DEA”) and state government
agencies, as well as by varying regulatory agencies in foreign countries where products or product candidates are being
manufactured and/or marketed. The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes
and regulations, and similar foreign statutes and regulations, govern or influence the testing, manufacturing, packing, labeling,
storing, record keeping, safety, approval, advertising, promotion, sale and distribution of our future products. Under these
regulations, we may become subject to periodic inspection of our facilities, procedures and operations and/or the testing of our future
products by the FDA, the DEA and other authorities, which conduct periodic inspections to confirm that we are in compliance with
all applicable regulations. In addition, the FDA and foreign regulatory agencies conduct pre-approval and post-approval reviews and
plant inspections to determine whether our systems and processes are in compliance with current GMP and other regulations.
Following such inspections, the FDA or other agency may issue observations, notices, citations and/or warning letters that could
cause us to modify certain activities identified during the inspection. FDA guidelines specify that a warning letter is issued only for
violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result
in an enforcement action. We may also be required to report adverse events associated with our future products to FDA and other
regulatory authorities. Unexpected or serious health or safety concerns would result in labeling changes, recalls, market withdrawals
or other regulatory actions.
The range of possible sanctions includes, among others, FDA issuance of adverse publicity, product recalls or seizures, fines, total or
partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcement actions,
injunctions, and civil or criminal prosecution. Any such sanctions, if imposed, could have a material adverse effect on our business,
operating results, financial condition and cash flows. Under certain circumstances, the FDA also has the authority to revoke
previously granted drug approvals. Similar sanctions as detailed above may be available to the FDA under a consent decree,
depending upon the actual terms of such decree. If internal compliance programs do not meet regulatory agency standards or if
compliance is deemed deficient in any significant way, it could materially harm our business.
The European Medicines Agency (“EMA”) will regulate our future products in Europe. Regulatory approval by the EMA will be
subject to the evaluation of data relating to the quality, efficacy and safety of our future products for its proposed use. The time taken
to obtain regulatory approval varies between countries. Different regulators may impose their own requirements and may refuse to
grant, or may require additional data before granting, an approval, notwithstanding that regulatory approval may have been granted
by other regulators.
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Regulatory approval may be delayed, limited or denied for a number of reasons, including insufficient clinical data, the
product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not meeting
applicable requirements.
Further trials and other costly and time-consuming assessments of the product may be required to obtain or maintain regulatory
approval. Medicinal products are generally subject to lengthy and rigorous pre-clinical and clinical trials and other extensive, costly
and time-consuming procedures mandated by regulatory authorities. We may be required to conduct additional trials beyond those
currently planned, which could require significant time and expense. In addition, even after the technology approval, both in the U.S.
and Europe, we will be required to maintain post marketing surveillance of potential adverse and risk assessment programs to
identify adverse events that did not appear during the clinical studies and drug approval process. All of the foregoing could require
an investment of significant time and expense.
We have generated limited revenue from therapeutic product sales, and our ability to generate any significant revenue from
product sales and become profitable depends significantly on our success in a number of factors.
We have a limited number of therapeutic products approved for commercial sale, and we have generated only limited revenue from
product sales. Our ability to generate revenue of more significant scale and achieve profitability depends significantly on our success
in many factors, including:
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completing research regarding, and nonclinical and clinical development of, our product candidates;
obtaining regulatory approvals and marketing authorizations for product candidates for which we complete clinical studies;
developing a sustainable and scalable manufacturing process for our product candidates, including establishing and
maintaining commercially viable supply relationships with third parties and establishing our own manufacturing capabilities
and infrastructure;
launching and commercializing product candidates for which we obtain regulatory approvals and marketing authorizations,
either directly or with a collaborator or distributor;
obtaining market acceptance of our product candidates as viable treatment options;
addressing any competing technological and market developments;
identifying, assessing, acquiring and/or developing new product candidates;
negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter;
maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets, and
know-how; and
attracting, hiring, and retaining qualified personnel.
Even if more of the product candidates that we develop are approved for commercial sale, we anticipate incurring significant costs
associated with commercializing any approved product candidate. Our expenses could increase beyond expectations if we are
required by the U.S. Food and Drug Administration, or the FDA, or other regulatory agencies, domestic or foreign, to change our
manufacturing processes or assays, or to perform clinical, nonclinical, or other types of studies in addition to those that we currently
anticipate. If we are successful in obtaining regulatory approvals to market more of our product candidates, our revenue will be
dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the accepted price for the
product, the ability to get reimbursement at any price, and whether we own the commercial rights for that territory. If the number of
our addressable disease patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower
than we expect, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment
guidelines, we may not generate significant revenue from sales of such products, even if approved. If we are not able to generate
revenue from the sale of any approved products, we may never become profitable.
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When we commence any clinical trials, we may not be able to conduct our trials on the timelines we expect.
Clinical testing is expensive, time consuming, and subject to uncertainty. We cannot guarantee that any clinical studies will be
conducted as planned or completed on schedule, if at all. We cannot be sure that we will be able to submit an IND, and we cannot be
sure that submission of an IND will result in the FDA allowing clinical trials to begin. Moreover, even if these trials begin, issues
may arise that could suspend or terminate such clinical trials. A failure of one or more clinical studies can occur at any stage of
testing, and our future clinical studies may not be successful. Events that may prevent successful or timely completion of clinical
development include:
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the inability to generate sufficient preclinical or other in vivo or in vitro data to support the initiation of clinical studies;
delays in reaching a consensus with regulatory agencies on study design;
delays in establishing CMC (Chemistry, Manufacturing, and Controls) which is a cornerstone in clinical study submission
and later on, the regulatory approval;
the FDA not allowing us to use the clinical trial data from a research institution to support an IND if we cannot demonstrate
the comparability of our product candidates with the product candidate used by the relevant research institution in its
clinical studies;
delays in obtaining required Institutional Review Board, or IRB, approval at each clinical study site;
imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review
of an IND application or amendment, or equivalent application or amendment;
a result of a new safety finding that presents unreasonable risk to clinical trial participants;
a negative finding from an inspection of our clinical study operations or study sites;
developments on trials conducted by competitors for related technology that raises FDA concerns about risk to patients of
the technology broadly;
if the FDA finds that the investigational protocol or plan is clearly deficient to meet its stated objectives;
delays in recruiting suitable patients to participate in our clinical studies;
difficulty collaborating with patient groups and investigators;
failure to perform in accordance with the FDA’s current good clinical practices, or cGCPs, requirements, or applicable
regulatory guidelines in other countries;
delays in having patients complete participation in a study or return for post-treatment follow-up;
patients dropping out of a study;
occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;
changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;
the cost of clinical studies of our product candidates being greater than we anticipate;
clinical studies of our product candidates producing negative or inconclusive results, which may result in our deciding, or
regulators requiring us, to conduct additional clinical studies or abandon product development programs; and
delays in manufacturing, testing, releasing, validating, or importing/exporting sufficient stable quantities of our product
candidates for use in clinical studies or the inability to do any of the foregoing.
Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability
to generate revenue. In addition, if we make manufacturing or formulation changes to our product candidates, we may be required to,
or we may elect to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical study delays
could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to
market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our
business and results of operations.
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Our clinical trial results may also not support approval, whether accelerated approval, conditional marketing authorizations, or
regular approval. The results of preclinical and clinical studies may not be predictive of the results of later-stage clinical trials, and
product candidates in later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through
preclinical studies and initial clinical trials. In addition, our product candidates could fail to receive regulatory approval for many
reasons, including the following:
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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full
population for which we seek approval;
we may be unable to demonstrate that our product candidates’ risk-benefit ratios for their proposed indications are
acceptable;
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign
regulatory authorities for approval;
we may be unable to demonstrate that the clinical and other benefits of our product candidates outweigh their safety risks;
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies
or clinical trials;
the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or
comparable foreign regulatory authorities to obtain regulatory approval in the United States or elsewhere;
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, our own
manufacturing facilities, or our third-party manufacturers’ facilities with which we contract for clinical and commercial
supplies; and
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a
manner rendering our clinical data insufficient for approval.
Further, failure to obtain approval for any of the above reasons may be made more likely by the fact that the FDA and other
regulatory authorities have very limited experience with commercial development of our cell therapy for the treatment of Type 1
Diabetes.
Our product candidates may cause undesirable side effects or have other properties that could halt their clinical
development, prevent their regulatory approval, limit their commercial potential, or result in significant negative
consequences.
As with most biological drug products, use of our product candidates could be associated with side effects or adverse events which
can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Any of these occurrences may
materially and adversely harm our business, financial condition and prospects.
Our product candidates are biologics and the manufacture of our product candidates is complex and we may encounter
difficulties in production, particularly with respect to process development or scaling-out of our manufacturing capabilities.
If we encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for
patients, if approved, could be delayed or stopped, or we may be unable to maintain a commercially viable cost structure. Our
product candidates are biologics and the process of manufacturing our products is complex, highly regulated and subject to multiple
risks. As a result of the complexities, the cost to manufacture biologics is generally higher than traditional small molecule chemical
compounds, and the manufacturing process is less reliable and is more difficult to reproduce.
Our manufacturing process will be susceptible to product loss or failure due to logistical issues associated with the collection of liver
cells, or starting material, from the patient, shipping such material to the manufacturing site, shipping the final product back to the
patient, and infusing the patient with the product, manufacturing issues associated with the differences in patient starting materials,
interruptions in the manufacturing process, contamination, equipment or reagent failure, improper installation or operation of
equipment, vendor or operator error, inconsistency in cell growth, failures in process testing and variability in product characteristics.
Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other
supply disruptions. If for any reason we lose a patient’s starting material or later-developed product at any point in the process, the
manufacturing process for that patient will need to be restarted and the resulting delay may adversely affect that patient’s outcome. If
microbial, viral, or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our
product candidates are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and
remedy the contamination. Because our product candidates are manufactured for each particular patient, we will be required to
maintain a chain of identity and tractability of all reagents and viruses involved in the process with respect to materials as they move
from the patient to the manufacturing facility, through the manufacturing process, and back to the patient. Maintaining such a chain
of identity is difficult and complex, and failure to do so could result in adverse patient outcomes, loss of product, or regulatory action
including withdrawal of our products from the market. Further, as product candidates are developed through preclinical to late stage
clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as
manufacturing methods, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they
will not achieve these intended objectives, and any of these changes could cause our product candidates to perform differently and
affect the results of planned clinical trials or other future clinical trials.
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Although we are working to develop commercially viable processes, doing so is a difficult and uncertain task, and there are risks
associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost
overruns, potential problems with process scale-out, process reproducibility, stability issues, lot consistency, and timely availability
of reagents or raw materials. We may ultimately be unable to reduce the cost of goods for our product candidates to levels that will
allow for an attractive return on investment if and when those product candidates are commercialized.
In addition, the manufacturing process for any products that we may develop is subject to FDA and foreign regulatory authority
approval process, and we will need to contract with manufacturers who can meet all applicable FDA and foreign regulatory authority
requirements on an ongoing basis. If we are unable to reliably produce products to specifications acceptable to the FDA or other
regulatory authorities, we may not obtain or maintain the approvals we need to commercialize such products. Even if we obtain
regulatory approval for any of our product candidates, there is no assurance that either we or our subsidiaries and joint ventures will
be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in
sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Any of
these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical
trials, increase clinical trial costs, delay approval of our product candidate, impair commercialization efforts, increase our cost of
goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.
The manufacture of biological drug products is complex and requires significant expertise and capital investment, including the
development of advanced manufacturing techniques and process controls. Manufacturers of biologic products often encounter
difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the
manufacturing process (including the absence of contamination). These problems include logistics and shipping, difficulties with
production costs and yields, quality control, including stability of the product, product testing, operator error, availability of qualified
personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if contaminants are
discovered in our supply of our product candidates or in the manufacturing facilities, such manufacturing facilities may need to be
closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability failures or
other issues relating to the manufacture of our product candidates will not occur in the future. Additionally, our manufacturers may
experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If
our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our
ability to provide our product candidate to patients in clinical trials would be jeopardized. Any delay or interruption in the supply of
clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial
programs and, depending upon the period of delay, require us to begin new clinical trials at additional expense or terminate clinical
trials completely.
Cell-based therapies rely on the availability of reagents, specialized equipment, and other specialty materials, which may not
be available to us on acceptable terms or at all. For some of these reagents, equipment, and materials, we rely or may rely on
sole source vendors or a limited number of vendors, which could impair our ability to manufacture and supply our products.
Manufacturing our product candidates will require many reagents and viruses, which are substances used in our manufacturing
processes to bring about chemical or biological reactions, and other specialty materials and equipment, some of which are
manufactured or supplied by small companies with limited resources and experience to support commercial biologics production. We
currently depend on a limited number of vendors for certain materials and equipment used in the manufacture of our product
candidates. Some of these suppliers may not have the capacity to support commercial products manufactured under GMP by
biopharmaceutical firms or may otherwise be ill-equipped to support our needs. We also do not have supply contracts with many of
these suppliers and may not be able to obtain supply contracts with them on acceptable terms or at all. Accordingly, we may
experience delays in receiving key materials and equipment to support clinical or commercial manufacturing.
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For some of these reagents, viruses, equipment, and materials, we rely and may in the future rely on sole source vendors or a limited
number of vendors. An inability to continue to source product from any of these suppliers, which could be due to regulatory actions
or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or
shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates,
which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of
which could significantly harm our business.
As we continue to develop and scale our manufacturing process, we expect that we will need to obtain rights to and supplies of
certain materials and equipment to be used as part of that process. We may not be able to obtain rights to such materials on
commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use
of such materials or find a suitable substitute, it would have a material adverse effect on our business.
There can be no assurance that we will be able to further develop in-house sales and commercial distribution capabilities or
establish or maintain relationships with third-party collaborators to successfully commercialize any product in the United
States or overseas, and as a result, we may not be able to generate product revenue.
A variety of risks associated with operating our business internationally could materially adversely affect our business. We plan to
seek regulatory approval of our product candidates outside of the United States and, accordingly, we expect that we, and any
potential collaborators in those jurisdictions, will be subject to additional risks related to operating in foreign countries, including:
●
●
●
●
●
●
●
●
●
●
●
differing regulatory requirements in foreign countries, unexpected changes in tariffs, trade barriers, price and exchange
controls, and other regulatory requirements;
economic weakness, including inflation, or political instability in particular foreign economies and markets;
compliance with tax, employment, immigration, and labor laws for employees living or traveling abroad;
foreign taxes, including withholding of payroll taxes;
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other
obligations incident to doing business in another country;
difficulties staffing and managing foreign operations;
workforce uncertainty in countries where labor unrest is more common than in the United States;
potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign laws;
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect
and protect intellectual property rights to the same extent as the United States;
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
business interruptions resulting from geo-political actions, including war and terrorism.
These and other risks associated with our planned international operations may materially adversely affect our ability to attain or
maintain profitable operations.
We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will
suffer if we fail to compete effectively.
The biopharmaceutical industry, and the rapidly evolving market for developing cell-based therapies is characterized by intense
competition and rapid innovation. Our competitors may be able to develop other compounds or drugs that are able to achieve similar
or better results. Our potential competitors include major multinational pharmaceutical companies, established biotechnology
companies, specialty pharmaceutical companies, universities, and other research institutions. Many of our competitors have
substantially greater financial, technical and other resources, such as larger research and development staff and experienced
marketing and manufacturing organizations as well as established sales forces. Smaller or early-stage companies may also prove to
be significant competitors, particularly through collaborative arrangements with large, established companies. Mergers and
acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our
competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater
availability of capital for investment in these industries. Our competitors, either alone or with collaborative partners, may succeed in
developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily
commercialized, or less costly than our product candidates or may develop proprietary technologies or secure patent protection that
we may need for the development of our technologies and products.
46
We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly
qualified personnel, we may not be able to successfully implement our business strategy.
Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract,
motivate and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our senior
management, particularly our Chief Executive Officer, Vered Caplan. The loss of the services of any of our executive officers, other
key employees, and other scientific and medical advisors, and our inability to find suitable replacements, could result in delays in
product development and harm our business. Competition for skilled personnel is intense and the turnover rate can be high, which
may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all.
To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided stock option
grants that vest over time. The value to employees of these equity grants that vest over time may be significantly affected by
movements in our stock price that are beyond our control and may at any time be insufficient to counteract more lucrative offers
from other companies. Although we have employment agreements with our key employees, most these employment agreements
provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without
notice. We do not maintain “key man” insurance policies on the lives of all of these individuals or the lives of any of our other
employees.
If we issue additional shares in the future, it will result in the dilution of our existing stockholders.
Risks Related to our Common Stock
Our articles of incorporation authorizes the issuance of up to 145,833,334 shares of our common stock with a par value of $0.0001
per share. Our Board of Directors may choose to issue some or all of such shares to acquire one or more companies or products and
to fund our overhead and general operating requirements. The issuance of any such shares will reduce the book value per share and
may contribute to a reduction in the market price of the outstanding shares of our common stock. If we issue any such additional
shares, such issuance will reduce the proportionate ownership and voting power of all current stockholders. Further, such issuance
may result in a change of control of our company.
Our stock price and trading volume may be volatile, which could result in losses for our stockholders.
The equity trading markets have recently experienced high volatility resulting in highly variable and unpredictable pricing of equity
securities. If the turmoil in the equity trading markets continues, the market for our common stock could change in ways that may
not be related to our business, our industry or our operating performance and financial condition. In addition, the trading volume in
our common stock may fluctuate and cause significant price variations to occur. Some of the factors that could negatively affect our
share price or result in fluctuations in the price or trading volume of our common stock include:
●
●
●
●
●
●
actual or anticipated quarterly variations in our operating results;
changes in expectations as to our future financial performance or changes in financial estimates, if any;
announcements relating to our business;
conditions generally affecting the biotechnology industry;
the success of our operating strategy; and
the operating and stock performance of other comparable companies.
47
Many of these factors are beyond our control, and we cannot predict their potential effects on the price of our common stock. In
addition, the stock market is subject to extreme price and volume fluctuations. During the past 52 weeks ended December 31, 2021,
our stock price has fluctuated from a low of $2.61 to a high of $8.08. This volatility has had a significant effect on the market price
of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our
common stock.
No assurance can be provided that a purchaser of our common stock will be able to resell their shares of common stock at or above
the price that they acquired those shares. We can provide no assurances that the market price of common stock will increase or that
the market price of common stock will not fluctuate or decline significantly.
We do not intend to pay dividends on any investment in the shares of stock of our company.
We have never paid any cash dividends, and currently do not intend to pay any dividends for the foreseeable future. The Board of
Directors has not directed the payment of any dividends and does not anticipate paying dividends on the shares for the foreseeable
future and intends to retain any future earnings to the extent necessary to develop and expand our business. Payment of cash
dividends, if any, will depend, among other factors, on our earnings, capital requirements, and the general operating and financial
condition, and will be subject to legal limitations on the payment of dividends out of paid-in capital. Because we do not intend to
declare dividends, any gain on an investment in our company will need to come through an increase in the stock’s price. This may
never happen, and investors may lose all of their investment in our company.
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 2. PROPERTIES
We do not own any real property. A description of the leased premises we utilize in several of our facilities is as follows:
Entity
Property Description
Orgenesis Inc.
MD 20876.
● Our principal office is located at 20271 Goldenrod Lane, Germantown,
Orgenesis Maryland Inc.
● FastForward laboratory and office located at 1812 Ashland Ave,
Baltimore, Maryland 21205.
Orgenesis Korea
● Operational production laboratory and office area located at Gwanggyo
business centre 156, Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-
do, Republic of Korea.
Koligo Therapeutics Inc.
● Production facility and development labs in New Albany, Indiana and
medical device maintenance and development labs in Leander, Texas.
Orgenesis Biotech Israel
● Laboratories and offices located in the Bar Lev Industrial Park M.P.
MISGAV, Israel.
Orgenesis Belgium
● Laboratories and offices located near Namur, at Novalis Science Park,
Belgium
We believe that our facilities are generally in good condition and suitable to carry on our business. We also believe that, if required,
suitable alternative or additional space will be available to us on commercially reasonable terms.
ITEM 3. LEGAL PROCEEDINGS
On January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against us and our
subsidiary Orgenesis Ltd., Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Asa Kunik (collectively, the “defendants”) by plaintiffs the
State of Israel, as the owner of Chaim Sheba Medical Center at Tel HaShomer (“Sheba”), and Tel Hashomer Medical Research,
Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the plaintiffs are seeking that the Court issue a
declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of the sales and 24% of
any and all revenues in consideration for sublicenses related to any product, service or process that contain know-how and
technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber in the field of cell
therapy, including in the category of the point-of-care platform and any and all services and products in relation to the defendants’
CDMO activity. In addition, the plaintiffs seek that the defendants provide financial statements and pay NIS 10 million to the
plaintiffs due to the royalty provisions of the license agreement, dated February 2, 2012, between Orgenesis Ltd. and Tel Hashomer
Medical Research, Infrastructure and Services Ltd. (the “License Agreement”). The Complaint alleges that Orgenesis Inc. and
Orgenesis Ltd. used know-how and technology of Sheba and know-how and technology either developed or supervised by Prof.
Ferber while employed by Sheba in the field of cell therapy, including in the category of the point-of-care platform and the services
and products in relation to the defendants’ CDMO activity and are entitled to the payment of certain royalties pursuant to the terms
of the License Agreement. The defendants are required to file their statement of defense responding to this Complaint by March 20,
2022. We believe that the allegations in this Complaint are without merit and intend to vigorously defend against the claims.
Except as described above, we are not involved in any pending material legal proceedings.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
48
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
Market Information
Until March 13, 2018, our common shares were traded under OTC Market Group’s OTCQB. Since March 13, 2018, our
common stock has been listed for trading on the Nasdaq Capital Market (“Nasdaq CM”) under the symbol “ORGS.”
As of March 30, 2022, there were 185 holders of record of our common stock, and the last reported sale price of our
common stock on the Nasdaq CM on March 29, 2022 was $3.35. A significant number of shares of our common stock are held in
either nominee name or street name brokerage accounts, and consequently, we are unable to determine the total number of beneficial
owners of our common stock.
Dividend Policy
To date, we have paid no dividends on our common stock and do not expect to pay cash dividends in the foreseeable future.
We plan to retain all earnings to provide funds for the operations of our company. In the future, our Board of Directors will decide
whether to declare and pay dividends based upon our earnings, financial condition, capital requirements, and other factors that our
Board of Directors may consider relevant. We are not under any contractual restriction as to present or future ability to pay
dividends.
Unregistered Sales of Equity Securities
On December 31, 2021, we issued 25,000 shares of common stock to a service provider. We relied upon the exemption from the
registration requirements of the Securities Act of 1933, as amended (the “Act”) by virtue of Section 4(a)(2) thereof and/or
Regulation S promulgated by the SEC under the Act with respect to the issuance of such shares in exchange for service provided to
us.
Issuer Purchases of Equity Securities
On May 14, 2020, our Board of Directors approved the stock repurchase plan (the “Stock Repurchase Plan”) pursuant to which we
may, from time to time, purchase up to $10 million of our outstanding shares of common stock. The shares may be repurchased from
time to time in privately negotiated transactions or the open market, including pursuant to Rule 10b5-1 trading plans, and in
accordance with applicable regulations of the SEC. The timing and exact amount of any repurchases will depend on various factors
including, general and business market conditions, corporate and regulatory requirements, share price, alternative investment
opportunities and other factors. The Repurchase Plan commenced on May 29, 2020 and does not obligate us to acquire any specific
number of shares in any period, and may be expanded, extended, modified, suspended or discontinued by the Board of Directors at
any time.
The following table summarizes the share repurchase activity during the three months ended December 31, 2021.
Total Number of
Shares
Purchased
Average Price
Paid per Share
Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
Maximum Value
that May Yet Be
Purchased Under
the Plans or
Programs
(in thousands)
November 2021
24,477
4.32
105,806
8,734
ITEM 6. [RESERVED]
49
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide
information necessary to understand our audited consolidated financial statements for the fiscal years ended December 31, 2021 and
December 31, 2020 and highlight certain other information which, in the opinion of management, will enhance a reader’s
understanding of our financial condition, changes in financial condition and results of operations. In particular, the discussion is
intended to provide an analysis of significant trends and material changes in our financial position and the operating results of our
business during the year ended December 31, 2021, as compared to the fiscal year ended December 31, 2020.
This discussion should be read in conjunction with our consolidated financial statements for the fiscal years ended December 31,
2021 and December 31, 2020 and related notes included elsewhere in this Annual Report on Form 10-K. These historical financial
statements may not be indicative of our future performance. This Management’s Discussion and Analysis of Financial Condition and
Results of Operations contains numerous forward-looking statements, all of which are based on our current expectations and could
be affected by the uncertainties and risks described throughout this filing, particularly in “Item 1A. Risk Factors.”
See below for a discussion on the extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of
operations and financial condition.
Corporate Overview
Orgenesis Inc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies
(“CGTs”) in an affordable and accessible format.
CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a
class of medicines referred to as advanced therapy medicinal products (“ATMP”). We are mostly focused on autologous therapies,
with processes and systems that are developed for each therapy using a closed and automated processing system approach that is
validated for compliant production near the patient for treatment of the patient at the point of care (“POCare”). This approach has the
potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial
production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver such treatments to patients
(ultimately limiting the number of patients that can have access to, or can afford, these therapies).
To achieve these goals, we have developed a Point of Care Platform (“POCare Platform”) comprised of three enabling components:
(i) a pipeline of licensed POCare advanced therapies that are designed to be processed and produced, (ii) automated closed POCare
technology systems, and (iii) a collaborative worldwide network of POCare research institutes and hospitals (“POCare Network”).
The POCare Platform relies in particular on the development of its own production capacity, known as “POCare Services”, whose
goal is to ensure that therapies are accessible at the point of treatment (the “POCare Center”). POCare Services, which have been
expanding worldwide, are based on a global approach and local adaptation that allows replication and expansion. Global
harmonization of the POCare Services is ensured by a central quality system, replicability of infrastructure and equipment and
centralized monitoring and data management.
POCare Centers are the decentralised hubs that provide harmonized services to customers and partners. We are working to provide a
more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. The workflow of a
POCare Center is designed to allow rapid capacities expansion while integrating new technologies. We also draw on extensive
medical expertise to identify promising new autologous therapies to leverage within the POCare Platform either via ownership or
licensing.
The POCare Network brings together patients, doctors and industry partners with a goal of achieving harmonized, regulated clinical
development and production of POCare advanced therapies.
50
We have worked to develop and validate POCare technologies that can be combined within mobile production units for advanced
therapies. We have made significant investments in the development of several types of Orgenesis Mobile Processing Units and Labs
(“OMPULs”) with the expectation of use and/or distribution through our POCare Network and/or partners, collaborators, and
regional distributors. As of the date of this report, the OMPULs have been adapted for processing of CAR-T, TILS and MSC based
products and are in the qualification stage for clinical use in various locations. Additional OMPULs are still in the development
stage.
OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of
potential or approved advanced therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the
manufacturing of such CGTs in a consistent and standardized manner in all locations. The OMPUL design delivers a potential
industrial solution for us to deliver CGTs to practically any clinical institution at the point of care.
The Chief Executive Officer is our chief operating decision-maker who reviews financial information prepared on a consolidated
basis. All of our operations are in one segment, being the point-of-care business via our POCare Platform. Therefore, no segment
information has been presented.
POCare Platform Operations via Subsidiaries
We currently conduct our core business operations ourselves and through our subsidiaries which are all wholly owned except as
otherwise stated below (collectively, the “Subsidiaries”). The Subsidiaries are listed in this annual report in Item 8.
Discontinued Operations
Until December 31, 2019, we operated the POCare Platform as one of two business separate business segments.
The second separate business segment was operated as a Contract Development and Manufacturing Organization (“CDMO”)
platform, providing third party contract manufacturing and development services for biopharmaceutical companies (the “CDMO
Business”). The CDMO platform was historically operated mainly through majority owned Masthercell Global Inc.
In February 2020, we and GPP-II Masthercell LLC (“GPP”) sold 100% of the outstanding equity interests of Masthercell (the
“Masthercell Business”), which comprised the majority of our CDMO Business, to Catalent Pharma Solutions, Inc. for an aggregate
nominal purchase price of $315 million, subject to customary adjustments (the “Masthercell Sale”).
We determined that the Masthercell Business (“Discontinued Operations” or “Discontinued Operation”) meets the criteria to be
classified as a discontinued operation as of the first quarter of 2020. The Discontinued Operation includes the vast majority of the
previous CDMO Business, including majority owned Masthercell, including MaSTherCell, Masthercell U.S. and all of the
Masthercell Global Subsidiaries.
Impact of the COVID-19 Pandemic
The COVID-19 pandemic continues to present substantial public health and economic challenges around the world, and to date has
led to the implementation of various responses, including government-imposed quarantines, stay-at-home orders, travel restrictions,
mandated business closures and other public health safety measures.
We continue to closely monitor the impact of the COVID-19 pandemic on all aspects of our business, including how it has and will
continue to impact our operations and the operations of our suppliers, vendors and business partners, and may take further
precautionary and preemptive actions as may be required by federal, state or local authorities. In addition, we have taken steps to
minimize the current environment’s impact on our business and strategy, including devising contingency plans and securing
additional resources from third party service providers. For the safety of our employees and families, we have introduced enhanced
safety measures in our facilities.
51
Beyond the impact on our product development efforts, the extent to which COVID-19 ultimately impacts our business, results of
operations and financial condition will depend on future developments, which remain highly uncertain and cannot be predicted with
confidence, such as the duration of the outbreak, the emergence of new variants, new information that may emerge concerning the
severity of COVID-19 or the effectiveness of actions taken to contain COVID-19 or treat its impact, including vaccination
campaigns, among others. If we or any of the third parties with whom we engage, however, were to experience any additional
shutdowns or other prolonged business disruptions, our ability to conduct our business in the manner and on the timelines presently
planned could be materially or negatively affected, which could have a material adverse impact on our business, financial condition
and results of operations. Although to date, our business has not been materially impacted by COVID-19, it is possible that our
clinical development timelines could be negatively affected by COVID-19, which could materially and adversely affect our business,
financial condition and results of operations. See “Risk Factors” for additional discussion of the potential adverse impact of the
COVID-19 pandemic on our business, financial condition and results of operations.
Developments During Fiscal 2021
License, Collaboration and Joint Venture Agreements
During 2021, we executed several license, collaboration and joint venture agreements, the most significant of which are summarized
below. For a more complete description, see notes 11 and 12 to our consolidated financial statements included in Item 8 of this
annual report on Form 10-K.
Description
Neuro-immunotherapy exclusive license
agreement
Savicell Collaboration Agreement
Stromatis Pharma Inc. Collaboration
and Sublicense Agreement
Neuro-immunotherapy.
Field / Territory
Evaluation, continued development, validation, and use of
Savicell’s platform designed for the early detection and
diagnosis of diseases and conditions and for quality control and
monitoring purposes, in conjunction with our systems.
Collaboration in refining methods for GMP manufacturing of
CAR-T/CAR-NK CT109 and the development and validation
of the Stromatis technology as it relates to the CAR-T/CAR-
NK CT109 antibody up to and inclusive of filing of
Investigational New Drug Application relating to Stromatis’
CAR-T/CAR-NK CT109 antibody.
Exclusive license to us in the field of human stem cells.
Zentrum
Forschungszentrum
München
für
(GmbH)
Helmholtz
Deutsches
Gesundheit und Umwelt
Exclusive License
Celleska LTD Joint Venture Agreement POCare in Australia.
Johns Hopkins University Sublease and
Construction Agreement
Deep Med
Agreement
IO Ltd Joint Venture
of care center in Maryland.
Establishment of a clinical therapeutic development and point
Development and commercialization of an AI-powered system
to be used in the manufacturing and/or quality control of CGTs.
Theracell Laboratories Grant
In November 2021, Theracell Laboratories (“Theracell”), our joint venture entity in Greece, was designated as a “Priority Investment
of Strategic National Importance” by Enterprise Greece, the official Greek national investment and trade promotion agency, which is
responsible for the allocation of Greek government funding. As a result of this designation, Theracell will be inducted into Greece’s
fast-track licensing and approval process. This is expected to help advance development and clinical use of Theracell’s CGT at
POCare, subject to regulatory requirements.
52
Theracell has been approved to receive a grant of up to €32 million from the Greek government subject to compliance with
budgetary conditions, spread over five years. The proceeds are expected to be used for:
● Installation of OMPULs throughout Greece (Point of Care Mode), which includes the completion of industrial research for
the operation and automation of OMPULs intended for mass production of cell and gene therapies and experimental
development of novel therapies through clinical trials towards regulatory approval.
● Clinical development, production and distribution of novel cell and gene therapies such as immunological therapies, CAR-T
genetic modification therapies and Mesenchymal Stem Cells (MSCs) based therapies.
Revacel Joint Venture
During 2021, we, together with our joint venture partner, Revitas SA, incorporated our joint venture entity Revacel Srl in Belgium.
Revacel will develop products in the field of muscle-derived mesenchymal stem/progenitor cells.
Results of Operations
Comparison of the Year Ended December 31, 2021 to the Year Ended December 31, 2020.
Our financial results for the year ended December 31, 2021 are summarized as follows in comparison to the year ended December
31, 2020:
Revenues
Revenues from related party
Total revenues
Cost of services and other research and development expenses,
net
Amortization of intangible assets
Selling, general and administrative expenses
Operating loss
Other income
Loss from extinguishment in connection with convertible loan
(see note 7 a of Item 8)
Financial expense, net
Share in income of associated company
Loss from continuing operation before income taxes
Tax (income) expense
Net loss from continuing operation
Net income from discontinued operations, net of tax
Net loss (income)
53
Years Ended December 31,
2020
2021
$
(in thousands)
31,646 $
3,856
35,502
36,644
948
14,710
16,800
(2,278)
1,865
1,292
272
17,951
108
18,059
-
$
18,059 $
6,177
1,475
7,652
83,986
478
18,973
95,785
(4)
-
1,061
(106)
96,736
(1,609)
95,127
(95,706)
(579)
Revenues
The following table shows our revenues by major revenue streams:
Revenue stream:
POC and hospital services (Mainly POC)
Cell process development services
Total
Years Ended December 31,
2020
2021
(in thousands)
$
$
32,819 $
2,683
35,502 $
6,068
1,584
7,652
Our revenues for the year ended December 31, 2021 were $35,502 thousand, as compared to $7,652 thousand for the year ended
December 31, 2020, representing an increase of 364%. The increase in revenues for the year ended December 31, 2021 compared to
the year ended December 31, 2020 was attributable to the increase in point-of-care services revenue as a result of increased activity
under master service agreements with our customers.
POC services are mainly the result of agreements between us and our joint venture partners (See note 11 in Item 8). Pursuant to the
agreements, we provide certain services in support of our joint venture partners’ activity.
Of such $32,819 thousand of revenue during the year ended December 31, 2021, we recognized $3,856 thousand of point-of-care
development service revenue from a related party as compared to $1,475 thousand during the year ended December 31, 2020,
representing an increase of 161%. The increase is attributable to expanded activities and additional services provided in the territory.
A breakdown of the revenues per customer that constituted at least 10% of revenues is as follows:
Revenue earned:
Customer A (Korea)
Customer B (United Arab Emirates)
Customer C (China)
Customer D (India) – related party
Customer E (Greece)
Cost of services and other research and development expenses
Salaries and related expenses
Stock-based compensation
Subcontracting, professional and consulting services
Lab expenses
Tamir Purchase Agreement (See Note 4)
Depreciation expenses, net
Other research and development expenses
Less – grant
Total
Years Ended December 31,
2020
2021
(in thousands)
7,703 $
6,969
6,491
3,856
4,693
2,857
-
1,577
1,475
1,412
Years Ended December 31,
2020
2021
(in thousands)
10,977 $
729
12,796
3,513
-
874
7,755
-
36,644 $
5,175
481
3,463
2,348
19,225
603
52,887
(196)
83,986
$
$
$
Cost of services and other research and development expenses for the year ended December 31, 2021 were $36,644 thousand, as
compared to $83,986 thousand for the year ended December 31, 2020, representing a decrease of 56%.
The changes contributing to the net decrease were mainly attributable to the following:
● We experienced a significant decrease (in the amount of $45.3 million) in other research and development
expenses during 2021. In 2020, we made significant investments in the development of several types of OMPULs,
accounted for in other research and development expenses, with the expectation of use and/or distribution through
our POCare Network of partners, collaborators, and joint ventures. The majority of our OMPUL development
work was completed in 2021 and we expect that such OMPULs will be placed into service during 2022.
54
● Salaries and related expenses increased by $5,802 thousand, as a result of additional staff hired to continue the
development of our CGT product pipeline as we expand our POC operations globally. We continue to invest in the
development of automated processing units and processes, owned and licensed advanced therapies to enable
commercial production, and additional work with partners that address POCare needs.
● We experienced an increase in subcontracting, professional and consulting services of $9,333 thousand. As
indicated above, we continue to invest in the development of automated processing units and processes, owned and
licensed advanced therapies to enable commercial production, and additional work with partners that address
POCare needs.
Selling, General and Administrative Expenses
Salaries and related expenses
Stock-based compensation
Accounting and legal fees
Professional fees
Rent and related expenses
Business development
Depreciation expenses, net
Other general and administrative expenses
Total
Years Ended December 31,
2020
2021
(in thousands)
6,277 $
945
3,293
1,107
249
577
42
2,220
14,710 $
3,379
1,915
6,946
1,571
407
3,477
101
1,177
18,973
$
$
Selling, general and administrative expenses for the year ended December 31, 2021 were $14,710 thousand, as compared to $18,973
thousand for the year ended December 31, 2020, representing a decrease of 22%. The decrease for the year ended December 31,
2021 is primarily attributable to:
● A decrease in accounting and legal fees as a result of decreased corporate investment activities in 2021 compared to 2020;
and
● A decrease in business development of $2,900 thousand as a result of reduced business development expenditures in 2021
Such decreases were countered by an increase in salaries and related expenses of $2,898 thousand, mainly as a result of a
discretionary bonus to our Chief Executive Officer, Vered Caplan, in the amount of $3.6 million pursuant to the discretionary bonus
provisions of the Personal Employment Agreement between Ms. Caplan and Orgenesis Services Sàrl
Financial Expenses, net
Interest expense on convertible loans and loans
Foreign exchange loss, net
Other income
Total
$
55
Years Ended December 31,
2020
2021
(in thousands)
943
574
(225)
1,292 $
1,254
160
(353)
1,061
Financial expenses, net for the year ended December 31, 2021 were $1,292 thousand, as compared to $1,061 thousand for the year
ended December 31, 2020, representing an increase of 22%.
Tax expense (income)
Tax expense (income)
Total
Years Ended December 31,
2020
2021
$
$
(in thousands)
108 $
108 $
(1,609)
(1,609)
Tax expenses (income), net for the year ended December 31, 2021 were $108 thousand, as compared to $1,609 thousand for the year
ended December 31, 2020, representing an increase of 107%. The increase for the year ended December 31, 2021 is primarily
attributable due to the release of a tax asset up to the amount of Koligo’s net tax liability in the year ended December 31, 2020.
Discontinued Operations
Discontinued operations relate to the Masthercell Business. The following table presents the financial results associated
with the Masthercell Business operation as reflected in our Consolidated Comprehensive loss:
OPERATIONS
Revenues
Cost of revenues
Cost of services and other research and development expenses, net
Amortization of intangible assets
Selling, general and administrative expenses
Operating loss
Other expenses, net
Financial income, net
Loss before income taxes
Tax income
Net loss from discontinuing operation, net of tax
Year Ended
December 31,
2020
(in thousands)
$
$
2,556
1,482
7
137
1,896
966
305
(29)
1,242
(30)
1,212
Revenues are attributable to the extension of existing customer service contracts with biotechnology clients and from revenues
generated from existing manufacturing agreements. Cost of revenues were in line with the growth in revenues and employment of
additional operational staff. Selling, general and administrative expenses included additional managerial appointments, increased
professional fees, additional rental space including in the U.S., and an increase of business development expenses.
Working Capital
Current assets
Current liabilities
Working capital
December 31,
2021
2020
(in thousands)
$
$
$
25,758 $
15,365 $
10,393 $
50,077
16,285
33,792
56
Current assets decreased by $24,319 thousand between December 31, 2020 and December 31, 2021, which was primarily
attributable to a decrease in cash and cash equivalents as the we continued to invest in the expansion of our POC operations globally
and in the development of our CGT product pipeline and development of automated processing units and processes, and owned and
licensed advanced therapies to enable commercial production; and an increase in accounts receivable as a result of increased POC
revenues.
Current liabilities decreased by $920 thousand between December 31, 2020 and December 31, 2021, which was primarily
attributable to the following: (i) an decrease in accounts payable and accrued expenses due to the reduction of certain expenses; and
(ii) an increase in current maturities of convertible loans.
Liquidity and Capital Resources
Years Ended December 31,
2020
2021
(in thousands)
Net loss
$
(18,059) $
579
Net cash used in operating activities
Net cash provided by (used in) investing activities
Net cash provided by (used in) financing activities
Net change in cash and cash equivalents and restricted cash
$
(26,866)
(12,384)
(106)
(39,356) $
(78,046)
105,610
5,881
33,445
During year ended December 31, 2021, we funded our operations from existing funds.
Net cash used in operating activities for the year ended December 31, 2021 was approximately $27 million, as compared to net cash
used in operating activities of approximately $78 million for the year ended December 31, 2020. Since the Masthercell Sale, and
particularly in the year ended December 31, 2020, we entered into new joint venture agreements with new partners in various
jurisdictions that allowed us to grow our infrastructure and expand our processing sites into new markets and jurisdictions. In
addition, we engaged some of these joint venture partners to perform research and development services to further develop and adapt
our systems and devices for specific purposes. We invested manpower and financial resources to focus on developing, manufacturing
and rolling out several types of OMPULs to be used and/or distributed through our POCare Network of partners, collaborators, and
joint ventures.
Net cash used in investing activities for the year ended December 31, 2021 was approximately $12 million, as compared to net cash
provided by investing activities of approximately $106 million for the year ended December 31, 2020. The net cash provided in the
year ended December 31, 2020 was mainly attributable to the Masthercell Sale.
Liquidity and Capital Resources Outlook
Through December 31, 2021, the Company had an accumulated deficit of $106.4 million as of December 31, 2021 and negative
operating cashflows of $26.9 million in the year ended December 31, 2021. The Company’s activities have been funded by
generating revenue, through offerings of the Company’s securities and selling its Contract Development and Manufacturing
Organization (“CDMO”) business. There is no assurance that the Company’s business will generate sustainable positive cash flows
to fund its business. See also note 21 with respect to an investment agreement in the amount of approximately $14.8 million (before
deducting related offering expenses), which has been entered into subsequent to December 31, 2021.
Based on its current cash resources and commitments, including such investment agreement discussed in note 21, the Company
believes it will be able to maintain its current planned development activities and expected level of expenditures for at least 12
months from the date of the issuance of these financial statements, although no assurance can be given that it will not need additional
funds prior to such time.
57
If there are further increases in operating costs for facilities expansion, research and development, commercial and clinical activity or
decreases in revenues from customers, the Company will need to use mitigating actions as to seek additional financing or postpone
expenses that are not based on firm commitments. In addition, in order to fund the Company’s operations until such time that the
Company can generate sustainable positive cash flows, the Company may need to raise additional funds.
In December 2018, we entered into a Controlled Equity Offering Sales Agreement, or Sales Agreement, with Cantor Fitzgerald &
Co., or Cantor, pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock having an
aggregate offering price of up to $25.0 million. We will pay Cantor a commission rate equal to 3.0% of the aggregate gross proceeds
from each sale. Shares sold under the Sales Agreement will be offered and sold pursuant to our Shelf Registration Statement on Form
S-3 (Registration No. 333-223777) that was declared effective by the Securities and Exchange Commission on March 28, 2018, or
the Shelf Registration Statement, and a prospectus supplement and accompanying base prospectus that we filed with the Securities
and Exchange Commission on December 20, 2018. We have not yet sold any shares of our common stock pursuant to the Sales
Agreement.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial
condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital
resources that is material to stockholders.
Critical Accounting Policies and Estimates
Our significant accounting policies are more fully described in the notes to our financial statements included in this Annual Report
on Form 10-K for the fiscal year ended December 31, 2021. We believe that the accounting policies below are critical for one to fully
understand and evaluate our financial condition and results of operations.
Income Taxes
Deferred income tax assets and liabilities are computed for differences between the financial statement and tax basis of assets and
liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods
in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce
deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable or refundable for the period plus or
minus the change during the period in deferred tax assets and liabilities.
58
In addition, our management performs an evaluation of all uncertain income tax positions taken or expected to be taken in the course
of preparing our income tax returns to determine whether the income tax positions meet a “more likely than not” standard of being
sustained under examination by the applicable taxing authorities. This evaluation is required to be performed for all open tax years,
as defined by the various statutes of limitations, for federal and state purposes.
Revenue from Contracts with Customers
Our agreements are primarily service contracts that range in duration. We recognize revenue when control of these services is
transferred to the customer for an amount, referred to as the transaction price, which reflects the consideration to which we are
expected to be entitled in exchange for those goods or services.
A contract with a customer exists only when:
●
●
●
●
the parties to the contract have approved it and are committed to perform their respective obligations;
we can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”);
we can determine the transaction price for the goods or services to be transferred; and
the contract has commercial substance and it is probable that we will collect the consideration to which it will be entitled in
exchange for the goods or services that will be transferred to the customer.
Nature of Revenue Streams
We have two main revenue streams being POC development services which includes hospital supplies, and cell process development
services.
POC Development Services
Revenue recognized under contracts for POC development services may, in some contracts, represent multiple performance
obligations (where promises to the customers are distinct) in circumstances in which the work packages are not interrelated or the
customer is able to complete the services performed.
For arrangements that include multiple performance obligations, the transaction price is allocated to the identified performance
obligations based on their relative standalone selling prices.
We recognize revenue when, or as, it satisfies a performance obligation. At contract inception, we determine whether the services are
transferred over time or at a point in time. Performance obligations that have no alternative use and that we have the right to payment
for performance completed to date, at all times during the contract term, are recognized over time. All other Performance obligations
are recognized as revenues by us at point of time (upon completion).
Included in POC development services is hospital supplies revenue which is derived principally from the sale or lease of products
and the performance of services to hospitals or other medical providers. Revenue is earned and recognized when product and
services are received by the customer.
Significant Judgement and Estimates
Significant judgment is required to identifying the distinct performance obligations and estimating the standalone selling price of
each distinct performance obligation, and identifying which performance obligations create assets with alternative use to us, which
results in revenue recognized upon completion, and which performance obligations are transferred to the customer over time.
59
Cell Process Development Services
Revenue recognized under contracts for cell process development services may, in some contracts, represent multiple performance
obligations (where promises to the customers are distinct) in circumstances in which the work packages and milestones are not
interrelated or the customer is able to complete the services performed independently or by using our competitors. In other contracts
when the above circumstances are not met, the promises are not considered distinct and the contract represents one performance
obligation. All performance obligations are satisfied over time, as there is no alternative use to the services it performs, since, in
nature, those services are unique to the customer, which retain the ownership of the intellectual property created through the process.
For arrangements that include multiple performance obligations, the transaction price is allocated to the identified performance
obligations based on their relative standalone selling prices. For these contracts, the standalone selling prices are based on our normal
pricing practices when sold separately with consideration of market conditions and other factors, including customer demographics
and geographic location.
We measure the revenue to be recognized over time on a contract by contract basis, determining the use of either a cost-based input
method or output method, depending on whichever best depicts the transfer of control over the life of the performance obligation.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information called for by Item 8 is included following the “Index to Financial Statements” on page F-1 contained in this Annual
Report on Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness
of our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act and regulations
promulgated thereunder) as of December 31, 2021, or the Evaluation Date. Based on such evaluation, our Chief Executive Officer
and Chief Financial Officer have concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective.
Management’s Report on Internal Control over Financial Reporting
Our management, under the supervision of the Chief Executive Officer and Chief Financial Officer, is responsible for establishing
and maintaining adequate internal control over financial reporting for our company. Internal control over financial reporting is
defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of,
our principal executive and principal financial officers and effected by our board of directors, management and other personnel, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with GAAP and includes those policies and procedures that: (i) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of our company are being made only in accordance with authorizations of our
management and directors; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of our company’s assets that could have a material effect on the financial statements.
60
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of
our internal control over financial reporting as of December 31, 2021. In making this evaluation, our management used the criteria
set forth in the Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission.
Based on this evaluation, management concluded that our internal control over financial reporting was effective as of December 31,
2021 based on those criteria.
This annual report does not include an attestation report of our registered public accounting firm on internal control over financial
reporting because we are a smaller reporting company and non-accelerated filer.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2021 that
have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
None.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
PART III
The following table sets forth certain information regarding our each of our current Directors and Executive Officers as of March 30,
2022.
Name
Vered Caplan
Neil Reithinger
Efrat Assa Kunik
David Sidransky (1) (2) (4)
Guy Yachin (1) (2) (3) (4)
Yaron Adler (2) (3)
Ashish Nanda (3)
Mario Philips (1)
Age
53
52
47
61
54
51
56
52
Position
Chief Executive Officer and Chairperson of the Board of
Directors
Chief Financial Officer, Secretary and Treasurer
Chief Development Officer
Director
Director
Director
Director
Director
(1)
(2)
(3)
(4)
A member on the audit committee.
A member on the compensation committee.
A member on the nominating and corporate governance committee.
A member of the research and development committee.
Our Executive Officers
Vered Caplan – Chief Executive Officer and Chairperson of the Board of Directors
Ms. Caplan has served as our CEO and Chairperson of the Board of Directors since August 14, 2014, prior to which she served as
Interim President and CEO commencing on December 23, 2013. She joined our Board of Directors in February 2012. She has 26
years of industry experience, previously holding positions as CEO of Kamedis Ltd. from 2009 to 2014, CEO of GammaCan
International Inc. from 2004 to 2007. She also served as a director of the following companies: Opticul Ltd., Inmotion Ltd., Nehora
Photonics Ltd., Ocure Ltd., Eve Medical Ltd., and Biotech Investment Corp. Ms. Caplan holds a M.Sc. in biomedical engineering
from Tel Aviv University specializing in signal processing; management for engineers from Tel Aviv University specializing in
business development; and a B.Sc. in mechanical engineering from the Technion– Israel Institute of Technology specialized in
software and cad systems.
61
Neil Reithinger – Chief Financial Officer, Secretary and Treasurer
Mr. Reithinger was appointed Chief Financial Officer, Secretary and Treasurer on August 1, 2014. Mr. Reithinger is the Founder and
President of Eventus Advisory Group, LLC, a private, CFO-services firm incorporated in Delaware, which specializes in capital
advisory and SEC compliance for publicly-traded and emerging growth companies. He is also the President of Eventus Consulting,
P.C. Prior to forming Eventus, Mr. Reithinger was Chief Operating Officer & CFO from March 2009 to December 2009 of New Leaf
Brands, Inc., a branded beverage company, CEO of Nutritional Specialties, Inc. from April 2007 to October 2009, a nationally
distributed nutritional supplement company that was acquired by Nutraceutical International, Inc., Chairman, CEO, President and
director of Baywood International, Inc. from January 1998 to March 2009, a publicly-traded nutraceutical company and Controller of
Baywood International, Inc. from December 1994 to January 1998. Mr. Reithinger earned a B.S. in Accounting from the University
of Arizona and is a Certified Public Accountant. He is a Member of the American Institute of Certified Public Accountants and the
Arizona Society of Certified Public Accountants.
Efrat Assa-Kunik – Chief Development Officer
Dr. Assa-Kunik was appointed as our Chief Development Officer in December 2021. Dr. Assa-Kunik joined the Company in
September 2016 as Head of Pre-Clinical Development. In August 2017, she was appointed General Manager of the Israeli subsidiary.
Dr Assa-Kunik earned her PhD at the Weizmann Institute of Science in the fields of genetics and developmental biology and a
Masters from the Ben-Gurion University in immunology and cancer research. Additionally, Dr Assa-Kunik was a postdoctoral fellow
at the Weizmann Institute in the department of neural biology. After completing her postdoc, Dr. Assa-Kunik joined BioGenCell as a
Senior Scientist. In 2012, she joined Pharmaseed as the director of the Business Development Unit, VP business development and
manager of the business development activity in USA.
Our Directors
Dr. David Sidransky – Director
Dr. Sidransky has served as a director since his appointment on July 18, 2013. Dr. Sidransky is a renowned oncologist and research
scientist named and profiled by TIME magazine in 2001 as one of the top physicians and scientists in America, recognized for his
work with early detection of cancer. Since 1994, Dr. Sidransky has been the Director of the Head and Neck Cancer Research
Division at Johns Hopkins University School of Medicine’s Department of Otolaryngology and Professor of Oncology, Cellular &
Molecular Medicine, Urology, Genetics, and Pathology at the John Hopkins University School of Medicine. Dr. Sidransky is one of
the most highly cited researchers in clinical and medical journals in the world in the field of oncology during the past decade, with
over 600 peer reviewed publications. Dr. Sidransky is a founder of a number of biotechnology companies and holds numerous
biotechnology patents. Dr. Sidransky has served as Vice Chairman of the board of directors, and was, until the merger with Eli Lilly,
a director of ImClone Systems, Inc., a global biopharmaceutical company committed to advancing oncology care. He is currently on
the board of Directors of Ascentage Pharma, Galmed and Champions Oncology. and chairs the board of directors of Advaxis and
Ayala. Dr. Sidransky served as Director from 2005 until 2008 of the American Association for Cancer Research (AACR). He was the
chairperson of AACR International Conferences during the years 2006 and 2007 on Molecular Diagnostics in Cancer Therapeutic
Development: Maximizing Opportunities for Personalized Treatment. Dr. Sidransky is the recipient of a number of awards and
honors, including the 1997 Sarstedt International Prize from the German Society of Clinical Chemistry, the 1998 Alton Ochsner
Award Relating Smoking and Health by the American College of Chest Physicians, and the 2004 Richard and Hinda Rosenthal
Award from the American Association of Cancer Research. Dr. Sidransky received his BS in Chemistry from Brandies University
and his medical degree from Baylor College of medicine where he also completed his residency in internal medicine. His specialty in
Medical Oncology was completed at Johns Hopkins University and Hospital.
We believe Dr. Sidransky is qualified to serve on our Board of Directors because of his education, medical background, experience
within the life science industry and his business acumen in the public markets.
62
Guy Yachin – Director
Mr. Yachin has served as a director since his appointment on April 2, 2012. Mr. Yachin serves, since November 2020, as the
executive chairman of Xerient Pharma which develops a drug for the treatment of abdominal cancers. He served as the President and
CEO of Serpin Pharma, a clinical stage Virginia-based company focused on the development of anti-inflammatory drugs, from April
2013 until October 2020. Prior to that, Mr. Yachin was the CEO of NasVax Ltd., a company focused on the development of improved
immunotherapeutics and vaccines. Prior to joining NasVax, Mr. Yachin served as CEO of MultiGene Vascular Systems Ltd (a.k.a.
Vessl), a cell therapy company focused on blood vessels disorders, leading the company through clinical studies in the U.S. and
Israel, financial rounds, and a keystone strategic agreement with Teva Pharmaceuticals Industries Ltd. He was CEO and founder of
Chiasma Inc., a biotechnology company focused on the oral delivery of macromolecule drugs, where he built the company’s
presence in Israel and the U.S., concluded numerous financial rounds, and guided the company’s strategy and operation for over six
years. Earlier, he was CEO of Naiot Technological Center Ltd., and provided seed funding and guidance to more than a dozen
biomedical startups such as Remon Medical Technologies Ltd., Enzymotec Ltd. and NanoPass Technologies Ltd. He holds a BSc. in
Industrial Engineering and Management and an MBA from the Technion – Israel Institute of Technology.
We believe Mr. Yachin is qualified to serve on our Board of Directors because of his education, experience within the life science
industry and his business acumen in the public markets.
Yaron Adler – Director
Mr. Adler has served as a director since his appointment on April 17, 2012. Mr. Adler is the co-founder of a startup incubator, We
Group Ltd. In 1999, Mr. Adler co-founded IncrediMail Ltd. and served as its CEO until 2008 and President until 2009. In 1999, prior
to founding IncrediMail, Mr. Adler consulted Israeli startup companies regarding Internet products, services and technologies. Mr.
Adler served as a product manager from 1997 to 1999, and as a software engineer from 1994 to 1997, at Tecnomatix Technologies
Ltd., a software company that develops and markets production engineering solutions to complex automated manufacturing lines that
fill the gap between product design and production, and which was acquired by UGS Corp. in April 2005. In 1993, Mr. Adler held a
software engineer position at Intel Israel Ltd. He has a B.A. in computer sciences and economics from Tel Aviv University.
We believe Mr. Adler is qualified to serve on our Board of Directors because of his education, success with early-stage enterprises
and his business acumen in the public markets.
Ashish Nanda – Director
Mr. Nanda has served as a director since his appointment on February 22, 2017. Since 1998, Mr. Nanda has been the Managing
Director of Innovations Group, one of the largest outsourcing companies in the financial sector that employs close to 14,000 people
working across various financial sectors. Since 1992, Mr. Nanda has served as the Managing Partner of Capstone Insurance Brokers
LLC and, since 2009, has served as Managing Partner of Dive Tech Marine Engineering Services L.L.C. From 1991 to 1994, Mr.
Nanda held the position of Asst. Manager Corporate Banking at Emirates Banking Group where he was involved in establishing
relationships with business houses owned by UAE nationals and expatriates in order to set up banking limits and also where he
managed portfolios of USD $26 billion. Mr. Nanda holds a Chartered Accountancy from the Institute of Chartered Accountants from
India.
We believe that Mr. Nanda is qualified to serve on our Board of Directors because of his business experience and strategic
understanding of advancing the valuation of companies in emerging industries.
There are no family relationships between any of the above executive officers or directors or any other person nominated or chosen
to become an executive officer or a director. Pursuant to an agreement entered into between us and Image Securities fzc. (“Image”),
for so long as Image’s ownership of our company is 10% or greater, it was granted the right to nominate a director to our Board of
Directors. Mr. Nanda was nominated for a directorship at the 2017 annual meeting in compliance with our contractual undertakings.
63
Mario Philips – Director
Mr. Philips has served as a director since his appointment on January 9, 2020. Since November 2020, Mr. Philips has been Chief
Executive Officer of Polyplus, a leading Biotech supplier of transfection reagents for cell & gene therapy as well as the research life
sciences market. Mario is also chairmen of the Board of PLL Therapeutics, a drug company based in France that has developed a
diagnostic platform technology for neurodegenerative diseases in combination with a therapy to cure neurodegenerative diseases
such as ALS and Parkinson’s.
Prior to that Mario acted as VP/GM for Danaher Pall Biotech business with full P&L responsibility for a $1,3B business unit. Mario
joined Pall in February 2014, as part of the Pall acquisition of ATMI Life Sciences, and was appointed to Vice President and General
Manager to lead the Single-Use Technologies BU. In this role he was responsible for leading and executing an aggressive investment
and growth strategy.
Mario joined ATMI in 1999 with ATMI’s acquisition of MST Analytics, Inc., serving as European Sales Manager for ATMI
Analytical Systems. In 2004, Mario was appointed to General Manager of ATMI Packaging, a role he held through 2010 when he
was promoted to the position of Senior Vice President and General Manager, ATMI Life Sciences. In that role, he was responsible
for developing and executing all business strategies, including the introduction of new products and service solutions for the Life
Sciences industry. A strong leading innovative IP portfolio was created, Pall acquired the business in 2014.
Mario also held in the past several board member positions in the life sciences industry with Clean Biologics, Austar Life Sciences
(China), Disposable Lab (France) and Artelis (Belgium).
We believe that Mr. Philips is qualified to serve on our Board of Directors because of his business experience and strategic
understanding of advancing the valuation of companies in emerging industries.
Board of Directors
Our Board of Directors currently consists of six (6) members. All directors hold office until the next annual meeting of stockholders.
At each annual meeting of stockholders, the successors to directors whose terms then expire are elected to serve from the time of
election and qualification until the next annual meeting following election.
Management has been delegated the responsibility for meeting defined corporate objectives, implementing approved strategic and
operating plans, carrying on our business in the ordinary course, managing cash flow, evaluating new business opportunities,
recruiting staff and complying with applicable regulatory requirements. The Board of Directors exercises its supervision over
management by reviewing and approving long-term strategic, business and capital plans, material contracts and business
transactions, and all debt and equity financing transactions and stock issuances.
Director Independence
Our Board of Directors is comprised of a majority of independent directors. In determining director independence, we use the
definition of independence in Rule 5605(a)(2) of the listing standards of The Nasdaq Stock Market.
The Board has concluded that each of Dr. Sidransky, and Messrs. Yachin, Adler, Philips and Nanda is “independent” based on the
listing standards of the Nasdaq Stock Market, having concluded that any relationship between such director and our company, in its
opinion, does not interfere with the exercise of independent judgment in carrying out the responsibilities of a director.
64
Board Committees
Our Board of Directors has established an Audit Committee, a Compensation Committee and a Nominating and Corporate
Governance Committee, with each comprised of independent directors in accordance with the rules of The Nasdaq Stock Market and
applicable federal securities laws and regulations. The members of the Audit Committee are Dr. Sidransky and Messrs. Yachin and
Philips. The members of the Compensation Committee are Dr. Sidransky and Messrs. Adler and Yachin. The members of the
Nominating and Corporate Governance Committee are Messrs. Nanda, Adler and Yachin. The members of the Research and
Development Committee are Mr. Yachin and Dr. Sidransky. We have also established a Research and Development Committee.
Each committee operates under a written charter that has been approved by our Board of Directors. Copies of our committee charters
are available on the investor relations section of our website, which is located at http://www.orgenesis.com.
Audit Committee
The Audit Committee (a) assists the Board of Directors in fulfilling its oversight of: (i) the quality and integrity of our financial
statements; (ii) our compliance with legal and regulatory requirements relating to our financial statements and related disclosures;
(iii) the qualifications and independence of our independent auditors; and (iv) the performance of our independent auditors; and (b)
prepares any reports that the rules of the SEC require be included in our proxy statement for our annual meeting.
The Audit Committee held 7 meetings in fiscal 2021. In addition, the Audit Committee reviewed and approved various corporate
items by way of written consent during the fiscal year 2021. The Board has determined that each member of the Audit Committee is
an independent director in accordance with the rules of The Nasdaq Stock Market and applicable federal securities laws and
regulations. In addition, the Board has determined that Dr. Sidransky is an “audit committee financial expert” within the meaning of
Item 407(d)(5) of Regulation S-K and has designated him to fill that role. See “Directors, Executive Officers and Corporate
Governance – Directors” above for descriptions of the relevant education and experience of each member of the Audit Committee.
At no time since the commencement of our most recently completed fiscal year was a recommendation of the Audit Committee to
nominate or compensate an external auditor not adopted by the Board of Directors.
The Audit Committee is responsible for the oversight of our financial reporting process on behalf of the Board of Directors and such
other matters as specified in the Audit Committee’s charter or as directed by the Board of Directors. Our Audit Committee is directly
responsible for the appointment, compensation, retention and oversight of the work of any registered public accounting firm engaged
by us for the purpose of preparing or issuing an audit report or performing other audit, review or attest services for us (or to nominate
the independent registered public accounting firm for stockholder approval), and each such registered public accounting firm must
report directly to the Audit Committee. Our Audit Committee must approve in advance all audit, review and attest services and all
non-audit services (including, in each case, the engagement and terms thereof) to be performed by our independent auditors, in
accordance with applicable laws, rules and regulations.
Compensation Committee
The Compensation Committee (i) assists the Board of Directors in discharging its responsibilities with respect to compensation of
our executive officers and directors, (ii) evaluates the performance of our executive officers, and (iii) administers our stock and
incentive compensation plans and recommends changes in such plans to the Board as needed.
The Compensation Committee held 5 meetings in fiscal 2021. In addition, the Compensation Committee reviewed and approved
various corporate items by way of written consent during the fiscal year 2021. The Board of Directors has determined that each
member of the Compensation Committee is an independent director in accordance with the rules of The Nasdaq Stock Market and
applicable federal securities laws and regulations.
65
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committee assists the Board in (i) identifying qualified individuals to become directors,
(ii) determining the composition of the Board and its committees, (iii) developing succession plans for executive officers, (iv)
monitoring a process to assess Board effectiveness, and (v) developing and implementing our corporate governance procedures and
policies.
The Nominating and Corporate Governance Committee held 4 meeting in fiscal 2021. In addition, the Nominating and Corporate
Governance Committee reviewed and approved various corporate items by way of written consent during the fiscal year 2021. The
Board has determined that each member of the Nominating and Corporate Governance Committee is an independent director in
accordance with the rules of The Nasdaq Stock Market and applicable federal securities laws and regulations.
Research and Development Committee
The Research and Development Committee assists the Board in fulfilling the Board’s responsibilities to oversee our research and
development programs, and strategies.
The Research and Development Committee was established in January 2021. The Research and Development Committee held 3
meeting in fiscal 2021.
DELINQUENT SECTION 16(a) REPORTS
Section 16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), requires our officers and directors and
persons who beneficially own more than ten percent (10%) of the Common Stock outstanding to file initial statements of beneficial
ownership of Common Stock (Form 3) and statements of changes in beneficial ownership of Common Stock (Forms 4 or 5) with the
SEC. Officers, directors and greater than 10% stockholders are required by SEC regulation to furnish us with copies of all such
forms they file.
Our records reflect that all reports which were required to be filed pursuant to Section 16(a) of the Securities Exchange Act of 1934,
as amended, were filed on a timely basis, except that three reports, covering an aggregate of five transactions, were filed late by
David Sidransky, one report on Form 3 was filed late by Efrat Assa-Kunik, one report was filed late by Yaron Adler, one report was
filed late by Mario Philips, one report was filed late by Guy Yachin, and one report was filed late by Ashish Nanda.
Corporate Code of Conduct and Ethics
Our Board of Directors has adopted a written code of business conduct and ethics that applies to our directors, officers and
employees, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons
performing similar functions. Copies of our corporate code of conduct and ethics are available, without charge, upon request in
writing to Orgenesis Inc., 20271 Goldenrod Lane, Germantown, MD, 20876, Attn: Secretary and are posted on the investor relations
section of our website, which is located at www.orgenesis.com. The inclusion of our website address in this Annual Report on Form
10-K does not include or incorporate by reference the information on our website into this Annual Report on Form 10-K. We also
intend to disclose any amendments to the Corporate Code of Conduct and Ethics, or any waivers of its requirements, on our website.
ITEM 11. EXECUTIVE COMPENSATION
The following table shows the total compensation paid or accrued during the last two fiscal years ended December 31, 2021 to our
Chief Executive Officer, Chief Financial Officer and Chief Development Officer. As of December 31, 2021, there were no other
executive officers who earned more than $100,000 during the fiscal year ended December 31, 2021 and were serving as executive
officers as of such date (the “named executive officers”).
66
Summary Compensation Table
Non-
Equity
Incentive
Plan
Compensa-
tion
($)
Non-qualified
Deferred
Compensation
Earnings
($)
Option
Awards
($) (1)
Stock
Awards
($)
-
-
- 171,349
-
-
-
-
-
All Other
Compensa-
tion
($) (2)
Total ($)
112,345 3,976,828
215,640 1,036,98
- 239,670
-
-
-
Salary
($)
Bonus
($)
Year
2021 264,483 3,600,000
2020 250,000 400,000
-
2021 239,670
2020 255,231 200,000
- 30,238
2021 169,533
-
-
-
-
-
-
- 485,469
-
46,387 215,919
Name and
Principal
Position
Vered Caplan
CEO(3)
Neil Reithinger
CFO, Treasurer &
Secretary
Efrat Assa-Kunik,
Chief Development
Officer
(1)
In accordance with SEC rules, the amounts in this column reflect the fair value on the grant date of the option awards granted
to the named executive, calculated in accordance with ASC Topic 718. Stock options were valued using the Black-Scholes
model. The grant-date fair value does not necessarily reflect the value of shares which may be received in the future with
respect to these awards. The grant-date fair value of the stock options in this column is a non-cash expense for us that reflects
the fair value of the stock options on the grant date and therefore does not affect our cash balance. The fair value of the stock
options will likely vary from the actual value the holder receives because the actual value depends on the number of options
exercised and the market price of our Common Stock on the date of exercise. For a discussion of the assumptions made in the
valuation of the stock options, see Note 15 to this Annual Report on Form 10-K for the year ended December 31, 2021. No
executive officers received options awards in the year ended December 31, 2021. See below for a summary of options
awarded in previous years.
(2)
For 2021 and 2020, represents the compensation as described under the caption “All Other Compensation” below.
All Other Compensation
The following table provides information regarding each component of compensation for fiscal years 2021 and 2020 included in the
All Other Compensation column in the Summary Compensation Table above. Represents amounts paid in New Israeli Shekels (NIS)
or Swiss Franks and converted at average exchange rates for the year.
Name
Vered Caplan
Efrat Assa Kunik
Automobile and
Communication
Related
Expenses
$ (1)
Social
Benefits
$ (2)
-
13,172
924
112,345
202,468
45,462
Total
$
112,345
215,640
46,387
Year
2021
2020
2021
(1)
(2)
Represents for Ms. Caplan, a leased automobile and communication expenses.
These are comprised of contributions by us to savings, health, severance, pension, disability and insurance plans generally
provided in Israel and Switzerland, including health, education, managerial insurance funds, and redeemed vacation pay. This
amount represents Israeli and Swiss severance fund payments, managerial insurance funds, disability insurance, supplemental
education fund contribution and social securities. See discussion below under “Narrative Disclosure to Summary
Compensation Table – Vered Caplan.”
67
Outstanding Equity Awards at December 31, 2021
The following table summarizes the outstanding equity awards held by each named executive officer of our company as of
December 31, 2021.
Name
Grant Date
Vered Caplan
Neil Reithinger
Efrat Assa Kunik
02-Feb-12(1)
22-Aug-14(1)
09-Dec-16(1)
06-Jun-17(1)
28-Jun-18(1)
22-Oct-18(2)
19-Mar-20(1)
09-Dec-16(1)
08-Mar-19(1)
19-Mar-20(1)
09-Dec-16(1)
22-Oct-18(2)
19-Mar-20(1)
Number of
Shares
Underlying
Unexercised
Options (#)
Exercisable
Number of
Shares
Underlying
Unexercised
Options (#)
Unexercisable
Option Exercise
Price ($)
Option Expiration
Date
278,191
230,189
166,667
83,334
250,000
63,750
85,000
83,334
25,000
15,000
16,667
11,250
15,000
-
-
-
-
-
21,250
-
-
-
-
-
3,750
-
0.012
0.0012
4.80
7.20
8.36
5.99
2.99
4.80
5.07
2.99
4.8
5.99
2.99
02-Feb-22
22-Aug-24
09-Dec-26
06-Jun-27
28-Jun-28
22-Oct-28
18-Mar-30
09-Dec-26
08-Mar-29
18-Mar-30
09-Dec-26
22-Oct-28
18-Mar-30
(1)
(2)
The options were fully vested as of December 31, 2021.
The options vest on a quarterly basis over a period of four years from the date of grant.
There were no option exercises by our named executive officers during our fiscal year ended December 31, 2020 and 2021.
Narrative Disclosure to Summary Compensation Table
Vered Caplan
On August 14, 2014, our Board of Directors confirmed that Ms. Vered Caplan, who had served as our President and Chief Executive
Officer on an interim basis since December 23, 2013, was appointed as our President and Chief Executive Officer.
On March 30, 2017, we and Ms. Caplan entered into an employment agreement replacing a previous employment agreement dated
August 22, 2014 (the “Amended Caplan Employment Agreement”). Under the Amended Caplan Employment Agreement, which
took effect April 1, 2017, Ms. Caplan’s annual salary continued at $160,000 per annum, subject to adjustment to $250,000 per annum
upon the listing of the Company’s securities on an Exchange. On May 10, 2017, we and Ms. Caplan further amended the Amended
Caplan Employment Agreement pursuant to which Ms. Caplan became entitled to a grant under the 2017 of options (the “Initial
Option”) to purchase 83,334 shares of the Company’s common stock at a per share exercise price equal to the Fair Market Value (as
defined in our 2017 Equity Incentive Plan (the “2017 Plan”)) of the Company’s common stock on the date of grant. The amendment
further provided that beginning in fiscal 2018, subject to approval by the compensation committee, Ms. Caplan became entitled to an
additional option (the “Additional Option”; together with the Initial Option, the “Options”) under the 2017 Plan for up to 250,000
shares of common stock of the Company to be awarded in such amounts per fiscal year as shall be consistent with the Plan, in each
case at a per share exercise price equal to the Fair Market Value (as defined in the Plan) of the Company’s common stock on the date
of grant. In 2018, following the listing of the Company’s securities on Nasdaq, Ms. Caplan’s annual salary was raised to $250,000.
68
For additional information regarding Ms. Caplan’s stock options awards, see the Outstanding Equity Awards table above.
On November 19, 2020, we and Ms. Caplan entered into an executive directorship agreement, effective as of October 1, 2020 (the
“Executive Directorship Agreement”), that supersedes and replaces the Amended Caplan Employment Agreement (the “Prior
Agreement”). Pursuant to the Executive Directorship Agreement, Ms. Caplan will continue to serve the Company as its Chairperson
of the Board of Directors (the “Board”) and shall receive in consideration for her serving as Chairperson of the Board an annual
regular Board fee in the amount of $75,000 payable by the Company in equal quarterly installments in advance. In addition, Ms.
Caplan may be eligible for non-recurring special Board fees as reviewed and approved by the Compensation Committee of the Board
(the “Compensation Committee”) and then reviewed and ratified by the Board. In addition, Ms. Caplan may be granted option
awards from time to time at the discretion of the Compensation Committee.
Ms. Caplan’s position as Chairperson of the Board under the Executive Directorship Agreement may be terminated for any reason by
either Ms. Caplan or the Company upon 90 days prior written notice (the “Notice Period”), provided that the Company may
terminate such appointment as Chairperson at any time during the Notice Period subject to certain conditions. Such termination as
Chairperson of the Board will be deemed a termination even if Ms. Caplan remains as a regular director of the Board. Upon
termination by the Company of Ms. Caplan’s employment other than for cause or by Ms. Caplan for any reason whatsoever, in
addition to any Accrued Obligations (as defined therein) she shall be entitled to receive a lump sum payment equal to the sum of (i)
the annual regular Board fee (the “Board Fee”) and (ii) the greater of actual or target annual performance bonus to which she may
have been entitled to as of the termination date (in each case, less all customary and required taxes and related deductions).
Ms. Caplan’s position under the Executive Directorship Agreement may be terminated in the event of a Change of Control (as
defined therein) by the Company other than for cause or by Ms. Caplan for any reason whatsoever. In the event of a Change of
Control and if, within one year following such Change of Control, employment under the Executive Directorship Agreement is
terminated by the Company other than for cause or by Ms. Caplan for any reason whatsoever, in addition to any Accrued
Obligations, she shall be entitled to receive a lump sum payment equal to one and a half times the sum of (i) the Board Fee and (ii)
the target annual performance remuneration to which she may have been entitled as of the termination date (in each case, less all
customary and required taxes and related deductions).
In addition, on November 19, 2020, Orgenesis Services Sàrl, a Swiss corporation and wholly-owned, direct subsidiary of the
Company (“Orgenesis Services”), and Ms. Caplan entered into a personal employment agreement (the “Swiss Employment
Agreement” and together with the Executive Directorship Agreement, the “Agreements”), pursuant to which Ms. Caplan will serve
as Chief Executive Officer, President and Chairperson of the Board of Directors of Orgenesis Services and will be a material
provider of services to the Company pursuant to a services agreement between the Company and Orgenesis Services. The Swiss
Employment Agreement provides that Ms. Caplan is entitled to a monthly base salary of CHF 13,345.05 (equivalent to $14,583
based on the current exchange rate at signing), and an annual representation fee of CHF 24,000 (equivalent to $26,226 based on the
current exchange rate at signing), payable in monthly installments of CHF 2,000. Ms. Caplan is eligible to receive a bonus at the
absolute discretion of Orgenesis Services and its compensation committee. Ms. Caplan may also be granted option awards from time
to time, as per the recommendation of the compensation committee of Orgenesis Services as reviewed and approved by the
Compensation Committee. Under the Swiss Employment Agreement, Ms. Caplan is entitled to be paid annual vacation days,
monthly travel allowance, sick leave, expenses reimbursement and a mobile phone. The Swiss Employment Agreement has an
effective date as of October 1, 2020.
69
Employment under the Swiss Employment Agreement may be terminated for any reason by Ms. Caplan or by Orgenesis Services
other than for just cause (as defined therein) upon six months prior written notice or by Orgenesis Services other than for just cause
in the event of a Change of Control (as defined therein) of the Company upon at least 12 months prior written notice. Upon
termination by Orgenesis Services of Ms. Caplan’s employment without just cause or by Ms. Caplan for any reason whatsoever, in
addition to any Accrued Obligations (as defined therein), she shall be entitled to receive a lump sum payment equal to the sum of (i)
her Base Salary (as defined therein) at the rate in effect as of the termination date and (ii) the greater of actual or target annual
performance bonus to which she may have been entitled to for the year in which employment terminates (in each case, less all
customary and required taxes and employment-related deductions). In the event of a Change of Control and if, within one year
following such Change of Control, employment is terminated by Orgenesis Services other than for cause or by Ms. Caplan for any
reason whatsoever, in addition to any Accrued Obligations she shall be entitled to receive a lump sum payment equal to one and a
half times the sum of (i) her Base Salary and (ii) the target annual performance bonus to which she may have been entitled to for the
year in which employment terminates (in each case, less all customary and required taxes and employment-related deductions).
The Swiss Employment Agreement provides for customary protections of Orgenesis’ confidential information and intellectual
property.
Ms. Caplan received an aggregate salary and board fee of $264,483 during 2021. On November 19, 2020, the Compensation
Committee approved a special remuneration of $400,000 to Ms. Caplan for her outstanding service in the business development of
the Company and its affiliates. The payment of such remuneration was made at the time of entry into the Agreements. On July 28,
2021, the Compensation Committee approved a discretionary bonus to Ms. Caplan in the amount of $3.6 million pursuant to the
discretionary bonus provisions of the Personal Employment Agreement between Ms. Caplan and Orgenesis Services Sàrl. The bonus
was paid during September 2021.
Neil Reithinger
Mr. Reithinger was appointed Chief Financial Officer, Treasurer and Secretary on August 1, 2014. Mr. Reithinger’s employment
agreement stipulates a monthly salary of $1,500; payment of an annual bonus as determined by the Company in its sole discretion,
participation in the Company’s pension plan; grant of stock options as determined by the Company; and reimbursement of expenses.
In addition, on August 1, 2014, the Company entered into a financial consulting agreement with Eventus Consulting, P.C., an
Arizona professional corporation, of which Mr. Reithinger is the sole shareholder (“Eventus”), pursuant to which Eventus has agreed
to provide financial consulting services to the Company. In consideration for Eventus’ services, the Company agreed to pay Eventus
according to its standard hourly rate structure. The term of the consulting agreement was for a period of one year from August 1,
2014 and automatically renews for additional one-year periods upon the expiration of the term unless otherwise terminated. Eventus
is owned and controlled by Mr. Reithinger. On December 16, 2020, the Compensation Committee of the Board of Directors of the
Company, approved a special one-time bonus of $200,000 that was paid prior to December 31, 2020. As of December 31, 2021,
Eventus was owed $56 thousand for accrued and unpaid services under the financial consulting agreement.
Efrat Assa-Kunik
Ms. Assa-Kunik was appointed Chief Development Officer in December 2021. According to the terms of Ms. Assa-Kunik’s
Employment Agreement Ms. Assa Kunik is entitled to a monthly salary of 45 thousand New Israeli Shekels, customary contributions
to a pension and training fund, participation in cellphone expenses, and annual leave of 24 days.
Potential Payments upon Change of Control or Termination following a Change of Control
Our employment agreements with our named executive officers provide incremental compensation in the event of termination, as
described herein. Generally, we currently do not provide any severance specifically upon a change in control nor do we provide for
accelerated vesting upon change in control. Termination of employment also impacts outstanding stock options.
70
Due to the factors that may affect the amount of any benefits provided upon the events described below, any actual amounts paid or
payable may be different than those shown in this table. Factors that could affect these amounts include the basis for the termination,
the date the termination event occurs, the base salary of an executive on the date of termination of employment and the price of our
common stock when the termination event occurs.
The following table sets forth the compensation that would have been received by each of our executive officers had they been
terminated as of December 31, 2021.
Name
Vered Caplan
Salary
Continuation
*
$
(*) Termination by Company without cause: $250,000
Termination without cause following a change in control: $375,000
Director Compensation
The following table sets forth for each non-employee director that served as a director during the year ended December 31, 2021:
Year Ended December 31, 2021
Fees
Earned
or
Paid in
Cash
($)
100,000
60,000
105,000
65,000
50,000
Stock
Awards
($)
-
-
-
-
-
Option
Awards
($) (1)
34,518(2)
26,417(3)
36,015(4)
27,914(5)
24,216(6)
Non-equity
Incentive Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All Other
Compensation
($)
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Total
($)
134,518
86,417
141,015
92,914
74,216
Name
Guy Yachin
Yaron Adler
Dr. David Sidransky
Ashish Nanda
Mario Philips
(1)
(2)
(3)
(4)
(5)
(6)
In accordance with SEC rules, the amounts in this column reflect the fair value on the grant date of the option awards granted
to the named executive, calculated in accordance with ASC Topic 718. Stock options were valued using the Black-Scholes
model. The grant-date fair value does not necessarily reflect the value of shares which may be received in the future with
respect to these awards. The grant-date fair value of the stock options in this column is a non-cash expense for us that reflects
the fair value of the stock options on the grant date and therefore does not affect our cash balance. The fair value of the stock
options will likely vary from the actual value the holder receives because the actual value depends on the number of options
exercised and the market price of our common stock on the date of exercise. For a discussion of the assumptions made in the
valuation of the stock options, see Note 15 (Stock Based Compensation) to our financial statements, which are included in this
Annual Report on Form 10-K.
In respect of 19,600 options which will vest on December 17, 2022.
In respect of 15,000 options which will vest on December 17, 2022.
In respect of 20,450 options which will vest on December 17, 2022.
In respect of 15,850 options which will vest on December 17, 2022.
In respect of 13,750 options which will vest on December 17, 2022.
71
All directors receive reimbursement for reasonable out of pocket expenses in attending Board of Directors meetings and for
participating in our business.
Compensation Policy for Non-Employee Directors.
In January 2021, the Board of Directors adopted an updated compensation policy for non-employee directors which replaced the
previous non-employee director compensation terms and which became effective January 2021. Under the policy, each director is to
receive an annual cash compensation of $40,000 and the Chairman or lead director is paid an additional $20,000 per annum. Each
committee member will be paid an additional $10,000 per annum and the committee chairman of the Audit and Research and
Development committees is to receive $20,000 per annum while the chairman of the other committees is to receive $15,000 per
annum. Cash compensation will be made on a quarterly basis.
All newly appointed directors also receive options to purchase up to 6,250 shares of our common stock. All directors are entitled to
an annual bonus of options for 12,500 shares and each committee member is entitled to a further option to purchase up to 1,250
shares of common stock and each committee chairperson to options for an additional 2,100 shares of common stock. In addition, the
Chairman and Vice Chairman shall be granted an option to purchase 4,200 shares of our ordinary shares. In all cases, the options are
granted at a per share exercise price equal to the closing price of our publicly traded stock on the date of grant and the vesting
schedule is determined by the compensation committee at the time of grant.
Compensation Committee Interlocks and Insider Participation
None of our executive officers has served as a member of the Board of Directors, or as a member of the compensation or similar
committee, of any entity that has one or more executive officers who served on our Board of Directors or Compensation Committee
during the fiscal year ended December 31, 2021.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
The following table sets forth certain information with respect to the beneficial ownership of our common stock as of March 30,
2022 for (a) the named executive officers, (b) each of our directors, (c) all of our current directors and executive officers as a group
and (d) each stockholder known by us to own beneficially more than 5% of our common stock. Beneficial ownership is determined
in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. We deem shares of
common stock that may be acquired by an individual or group within 60 days of March 30, 2022 pursuant to the exercise of options
or warrants to be outstanding for the purpose of computing the percentage ownership of such individual or group but are not deemed
to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. Except as indicated
in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respect to
all shares of common stock shown to be beneficially owned by them based on information provided to us by these stockholders.
Percentage of ownership is based on 24,820,756 shares of common stock outstanding on March 30, 2022.
Security Ownership of Greater than 5% Beneficial Owners
Name and Address of
Beneficial Owner
Image Securities fzc.
2310, 23rd floor, Tiffany
Towers, JLT
Dubai, UAE
Yehuda Nir
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Security Ownership of Directors and Executive Officers
Name and Address of
Beneficial Owner
Vered Caplan
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Amount and
Nature of
Beneficial
Ownership (1)
Percent(1)
2,070,919(2)
8.34%
2,182,164(3)
8.79%
Amount and
Nature of
Beneficial
Ownership (1)
Percent(1)
1,167,756(4)
4.70%
Neil Reithinger
14201 N. Hayden Road, Suite A-1
Scottsdale, AZ 85260
Efrat Assa Kunik
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Guy Yachin
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Dr. David Sidransky
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Yaron Adler
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Ashish Nanda
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Mario Philips
c/o Orgenesis Inc.
20271 Goldenrod Lane
Germantown, MD 20876
Directors & Executive Officers as a Group (8 persons)
123,334(5)
<1%
44,792(6)
<1%
150,934(7)
<1%
133,401(8)
<1%
232,629(9)
<1%
66,700(10)
<1%
30,417(11)
1,949,963
<1%
7.86%
Notes:
(1) Percentage of ownership is based on 24,820,756 shares of our common stock outstanding as of March 30, 2022. Except as
otherwise indicated, we believe that the beneficial owners of the common stock listed above, based on information furnished by
such owners, have sole investment and voting power with respect to such shares, subject to community property laws where
applicable. Beneficial ownership is determined in accordance with the rules of the SEC and generally includes voting or
investment power with respect to securities. Shares of common stock subject to options or warrants currently exercisable or
exercisable within 60 days, are deemed outstanding for purposes of computing the percentage ownership of the person holding
such option or warrants but are not deemed outstanding for purposes of computing the percentage ownership of any other
person.
72
(2) Consists of (i) 1,830,534 ordinary shares and (ii) 240,385 ordinary shares issuable upon exercise of outstanding warrants at a
price of $6.24 per share. The warrants are exercisable over a three-year period from the date of issuance.
(3) Consists of (i) 10,016 ordinary shares, (ii) 50,000 ordinary shares issuable upon exercise of outstanding warrants at a price of $7
per share, exercisable until, October 3, 2022, (iii) 453,294 ordinary shares issuable upon exercise of outstanding warrants at a
price of $6.24 per share, exercisable until, June 30, 2023 and (iv) 1,668,854 ordinary shares issuable upon exercise of
convertible debt at a price of $7 per share.
(4) Consists of (i) 278,191 ordinary shares, (ii) 230,189 ordinary shares issuable upon exercise of outstanding options at a price of
$0.0012 per share, (iii)166,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.8 per share, (iv)
83,334 ordinary shares issuable upon exercise of outstanding options at a price of $7.2 per share, (v) 250,000 ordinary shares
issuable upon exercise of outstanding options at a price of $8.36 per share, (vi) 74,375 ordinary shares issuable upon exercise of
outstanding options at a price of $5.99 per share and (vii) 85,000 ordinary shares issuable upon exercise of outstanding options
at a price of $2.99 per share. Does not include option for 10,625 shares of common stock with an exercise price of $5.99 per
share that are exercisable quarterly after July 22, 2022.
(5) Consists of (i) 83,334 ordinary shares issuable upon exercise of outstanding options at a price of $4.8 per share, (ii) 25,000
ordinary shares issuable upon exercise of outstanding options at a price of $5.07 per share and (iii) 15,000 ordinary shares
issuable upon exercise of outstanding options at a price of $2.99 per share.
(6) Consists of (i) 16,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.8 per share, (ii) 13,125
ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share and (iii) 15,000 ordinary shares
issuable upon exercise of outstanding options at a price of $2.99 per share. Does not include option for 1,875 shares of common
stock with an exercise price of $5.99 per share that are exercisable quarterly after July 22, 2022.
(7) Consists of (i) 39,267 ordinary shares issuable upon exercise of outstanding options at a price of $10.2 per share, (ii) 41,667
ordinary shares issuable upon exercise of outstanding options at a price of $4.8 per share, (iii) 28,750 ordinary shares issuable
upon exercise of outstanding options at a price of $5.99 per share, (iv) 25,000 ordinary shares issuable upon exercise of
outstanding options at a price of $2.99 per share and (v) 16,250 ordinary shares issuable upon exercise of outstanding options at
a price of $4.6 per share. Does not include (i) option for 19,600 shares of common stock with an exercise price of $2.89 per
share that are exercisable on December 16, 2022 and options exercisable at a price per share of $7.00 into 70,000 ordinary
shares held by Caerus Therapeutics LLC for which Mr. Yachin does not have beneficial control.
(8) Consists of (i) 20,834 ordinary shares issuable upon exercise of outstanding options at a price of $9 per share, (ii) 41,667
ordinary shares issuable upon exercise of outstanding options at a price of $4.8 per share, (iii) 29,200 ordinary shares issuable
upon exercise of outstanding options at a price of $5.99 per share, (iv) 25,000 ordinary shares issuable upon exercise of
outstanding options at a price of $2.99 per share and (v) 16,700 ordinary shares issuable upon exercise of outstanding options at
a price of $4.6 per share. Does not include option for 20,450 shares of common stock with an exercise price of $2.89 per share
that are exercisable on December 16, 2022.
(9) Consists of (i) 63,304 ordinary shares, (ii) 58,908 ordinary shares issuable upon exercise of outstanding options at a price of
$9.48 per share, (iii) 41,667 ordinary shares issuable upon exercise of outstanding options at a price of $4.8 per share, (iv)
28,750 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share, (v) 25,000 ordinary shares
issuable upon exercise of outstanding options at a price of $2.99 per share and (vi) 15,000 ordinary shares issuable upon exercise
of outstanding options at a price of $4.6 per share. Does not include option for 15,000 shares of common stock with an exercise
price of $2.89 per share that are exercisable on December 16, 2022.
73
(10) Consists of (i) 27,100 ordinary shares issuable upon exercise of outstanding options at a price of $5.99 per share, (ii) 25,000
ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share and (iii) 14,600 ordinary shares
issuable upon exercise of outstanding options at a price of $4.6 per share. Does not include option for 15,850 shares of common
stock with an exercise price of $2.89 per share that are exercisable on December 16, 2022. Does not include option for 15,850
shares of common stock with an exercise price of $2.89 per share that are exercisable on December 16, 2022.
(11) Consists of (i) 4,167 ordinary shares issuable upon exercise of outstanding options at a price of $4.7 per share, (ii) 12,500
ordinary shares issuable upon exercise of outstanding options at a price of $2.99 per share and (iii) 13,750 ordinary shares
issuable upon exercise of outstanding options at a price of $4.6 per share. Does not include (i) option for 2,083 shares of
common stock with an exercise price of $4.7 per share that are exercisable in three equal instalments over three anniversaries
starting on January 9, 2023 and (ii) option for 13,750 shares of common stock with an exercise price of $2.89 per share that are
exercisable on December 16, 2022.
Securities Authorized for Issuance Under Existing Equity Compensation Plans
The following table summarizes certain information regarding our equity compensation plans as of December 31, 2021:
Number of Securities
to be Issued Upon
Exercise of
Weighted-Average
Exercise Price of
Plan Category
Outstanding Options
Outstanding Options
(a)
(b)
Number of Securities
Remaining Available
for
Future Issuance Under
Equity Compensation
Plans (Excluding
Securities Reflected in
Column (a))
(c)
Equity compensation plans approved by
security holders (1)
Equity compensation plans not approved by
security holders
Total
3,030,916 $
726,780 $
3,757,696 $
4.23
4.68
4.31
969,084
-
1,347,778
(1) Consists of the 2017 Equity Incentive Plan and the Global Share Incentive Plan (2012). For a short description of those plans,
see Note 15 to our 2021 Consolidated Financial Statements included in this Annual Report on Form 10-K for the year ended
December 31, 2021.
74
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Transactions with Related Persons
Except as set out below, as of December 31, 2021, there have been no transactions, or currently proposed transactions, in which we
were or are to be a participant and the amount involved exceeds the lesser of $120,000 or one percent of the average of our total
assets at year-end for the last two completed fiscal years, and in which any of the following persons had or will have a direct or
indirect material interest:
●
●
●
●
any director or executive officer of our company;
any person who beneficially owns, directly or indirectly, shares carrying more than 5% of the voting rights attached to our
outstanding shares of common stock;
any promoters and control persons; and
any member of the immediate family (including spouse, parents, children, siblings and in laws) of any of the foregoing
persons.
Pursuant to a financial consulting agreement with Eventus Consulting, P.C., an Arizona professional corporation, of which Mr.
Reithinger is the sole shareholder (“Eventus”), dated as of August 1, 2014, Mr. Reithinger received $240 thousand during the year
ended December 31, 2021 and $255 thousand during the year ended December 31, 2020 for financial consulting services. Such
amounts are included in Mr. Reithinger’s executive compensation presented in the Summary Compensation Table in Item 11 of this
Annual Report on Form 10-K. Eventus has agreed to provide financial consulting services to the Company and in consideration for
Eventus’ services, the Company agreed to pay Eventus according to its standard hourly rate structure. The term of the consulting
agreement was for a period of one year from August 1, 2014 and automatically renews for additional one-year periods upon the
expiration of the term unless otherwise terminated. Eventus is owned and controlled by Mr. Reithinger
Pursuant to an agreement entered into between us and Image Securities fzc. (“Image”), so long as Image’s ownership of our
Common Stock is 10% or greater, it is entitled to nominate a director to our Board of Directors. Mr. Nanda was nominated for a
directorship at the 2018 annual meeting in compliance with our contractual undertakings.
Pursuant to agreements with Image, we procured services from Image in the amount of $4.8 million during the year ended December
31, 2020, and earned revenues from Image in the amount of $3.9 million and $1.5 million for the years ended December 31, 2021
and December 31, 2020, respectively. In addition, we earned interest income in the amount of $64 thousand and $169 thousand for
the years ended December 31, 2021 and December 31, 2020, respectively.
On August 24, 2021, we entered into a convertible loan agreement with Image whereby, pursuant to the terms of the Image joint
venture agreement, we agreed to loan Image up to $5 million. The loan bears interest at the rate of 6% and is subject to repayment by
August 21, 2022, unless we agree to an extension or the loan is converted into shares of Image or, if established, Image’s Indian joint
venture. As of December 31, 2021, we transferred $3 million to Image under the loan agreement, and this has been reflected as a
short-term asset on our balance sheet. Such loan is senior to any and all other indebtedness of Image or, after its establishment,
Image’s joint venture entity. The Company shall have a first priority security interest on all of Image’s or, if established, Image’s
joint venture entity’s, present and future assets.
Pursuant to our Audit Committee charter adopted in March 2017, the Audit Committee is responsible for reviewing and approving,
prior to our entry into any such transaction, all transactions in which we are a participant and in which any parties related to us have
or will have a direct or indirect material interest.
Named Executive Officers and Current Directors
For information regarding compensation for our named executive officers and current directors, see “Executive Compensation.”
75
Director Independence
See “Directors, Executive Officers and Corporate Governance – Director Independence” and “Directors, Executive Officers and
Corporate Governance – Board Committees” in Item 10 above.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Our Board of Directors has appointed Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited
(“PwC”) as our independent registered public accounting firm for the fiscal year ended December 31, 2021. The following table sets
forth the fees billed to us for professional services rendered by PwC for the years ended December 31, 2021 and December 31, 2020:
Services:
Audit Fees (1)
Audit-Related Fees (2)
Tax Fees (3)
All Other Fees
Total fees
Years Ended December 31,
2021
2020
$
$
228,188 $
16,634
29,863
-
274,685 $
267,231
67,405
12,500
10,000
357,136
(1)
(2)
Audit fees consisted of audit work performed in the preparation of financial statements, as well as work generally only
the independent registered public accounting firm can reasonably be expected to provide, such as statutory audits.
Audit related fees consisted principally of audits of employee benefit plans and special procedures related to regulatory
filings in 2021.
(3)
The tax fees were paid for reviewing various tax related matters.
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Public Accountant
Consistent with SEC policies regarding auditor independence, the Audit Committee has responsibility for appointing, setting
compensation and overseeing the work of our independent registered public accounting firm. In recognition of this responsibility, the
Audit Committee has established a policy to pre-approve all audit and permissible non-audit services provided by our independent
registered public accounting firm.
Prior to engagement of an independent registered public accounting firm for the next year’s audit, management will submit an
aggregate of services expected to be rendered during that year for each of four categories of services to the Audit Committee for
approval.
1. Audit services include audit work performed in the preparation of financial statements, as well as work that generally
only an independent registered public accounting firm can reasonably be expected to provide, including comfort letters, statutory
audits, and attest services and consultation regarding financial accounting and/or reporting standards.
2. Audit-Related services are for assurance and related services that are traditionally performed by an independent
registered public accounting firm, including due diligence related to mergers and acquisitions, employee benefit plan audits, and
special procedures required to meet certain regulatory requirements.
3. Tax services include all services performed by an independent registered public accounting firm’s tax personnel except
those services specifically related to the audit of the financial statements, and includes fees in the areas of tax compliance, tax
planning, and tax advice.
76
4. Other Fees are those associated with services not captured in the other categories. We generally do not request such
services from our independent registered public accounting firm.
Prior to engagement, the Audit Committee pre-approves these services by category of service. The fees are budgeted and the Audit
Committee requires our independent registered public accounting firm and management to report actual fees versus the budget
periodically throughout the year by category of service. During the year, circumstances may arise when it may become necessary to
engage our independent registered public accounting firm for additional services not contemplated in the original pre-approval. In
those instances, the Audit Committee requires specific pre-approval before engaging our independent registered public accounting
firm.
The Audit Committee may delegate pre-approval authority to one or more of its members. The member to whom such authority is
delegated must report, for informational purposes only, any pre-approval decisions to the Audit Committee at its next scheduled
meeting.
ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES
PART IV
(a)
c. Financial Statements
Our consolidated financial statements are set forth in Part II, Item 8 of this Annual Report on Form 10-K and are
incorporated herein by reference.
d. Financial Statement Schedules
No financial statement schedules have been filed as part of this Annual Report on Form 10-K because they are not
applicable or are not required or because the information is otherwise included herein.
e. Exhibits required by Regulation S-K
No.
Description
2.1
2.2
3.1
3.2
4.1
4.2
4.3
4.4
4.5
Stock Purchase Agreement, dated February 2, 2020, by and among Orgenesis, Inc., GPP-II Masthercell LLC,
Masthercell Global Inc. and Catalent Pharma Solutions, Inc. (incorporated by reference to Exhibit 2.1 to the
Registrant’s Current Report on Form 8-K filed with the SEC on February 3, 2020)
Agreement and Plan of Merger and Reorganization, dated as of September 26, 2020 by and among Orgenesis Inc.,
Orgenesis Merger Sub, Inc., Koligo Therapeutics Inc., the Shareholders of Koligo and Long Hill Capital V, LLC,
solely in its capacity as representative of the Shareholders (incorporated by reference to an exhibit to our current
report on Form 8-K, filed on October 2, 2020)
Articles of Incorporation, as amended (incorporated by reference to an exhibit to our registration statement on Form
S-8, filed on August 7, 2020)
Amended and Restated Bylaws (incorporated by reference to an exhibit to our current report on Form 8-K, filed on
September 21, 2011)
Description of Securities (incorporated by reference to an exhibit to our annual report on Form 10-K filed on March
9, 2020)
Form of Warrant (incorporated by reference to an exhibit to our current report on Form 8-K, filed on January 22,
2020)
Form of Stock Option Agreement (incorporated by reference to an exhibit to our registration statement on Form S-8,
filed on August 7, 2020)
Form of Warrant, dated as of September 13, 2021, issued in connection with Convertible Note Extension Agreements
(incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on November 4, 2021)
Form of Warrant, dated as of September 13, 2021, issued in connection with Convertible Note Extension Agreements
(incorporated by reference to an exhibit to our quarterly report filed on Form 10-Q, filed November 4, 2021)
77
No.
10.1
10.2
10.3
10.4
10.5
10.6
10.7
10.8
10.9
10.10
10.11
10.12
10.13
10.14
10.15
10.16
10.17
Description
Financial Consulting Agreement, dated August 1, 2014, with Eventus Consulting, P.C. (incorporated by reference to
an exhibit to our current report on Form 8-K, filed on August 5, 2014)
Personal Employment Agreement, dated August 1, 2014, by and between Orgenesis Inc. and Neil Reithinger
(incorporated by reference to an exhibit to our current report on Form 8-K, filed on August 5, 2014)
2017 Equity Incentive Plan (incorporated by reference to an exhibit to our definitive proxy statement on Schedule
14A, filed on March 30, 2017)
Collaboration and License Agreement, dated as of June 8, 2018, between Orgenesis Inc. and Mircod Limited
(incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on October 12, 2018)
Controlled Equity Offering Sales Agreement, dated December 20, 2018, between Orgenesis Inc. and Cantor
Fitzgerald & Co. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on December 20,
2018)
Joint Venture Agreement between the Company and First Choice International Company, Inc. dated March 12, 2019
(incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on May 8, 2019)
Convertible Loan Agreement between Orgenesis Maryland Inc. and Yosef Ram dated April 12, 2019 (incorporated by
reference to an exhibit to our quarterly report on Form 10-Q, filed on May 8, 2019)
Convertible Loan Agreement, dated April 10, 2019, by and between the Company and Investor (incorporated by
reference to an exhibit to our quarterly report on form 10-Q, filed on November 7, 2019)
Form of Subscription Agreement, dated May 17, 2019, by and between the Company and Investor (incorporated by
reference to an exhibit to our quarterly report on form 10-Q, filed on November 7, 2019)
Form of Subscription Agreement, dated May 30, 2019, by and between the Company and Investor (incorporated by
reference to an exhibit to our quarterly report on form 10-Q, filed on November 7, 2019)
Form of Subscription Agreement, dated June 6, 2019, by and between the Company and Investor (incorporated by
reference to an exhibit to our quarterly report on Form 10-Q, filed on November 7, 2019)
Transfer Agreement, dated as of August 7, 2019 by and among Masthercell Global, Orgenesis Inc. and GPP-II
Masthercell, LLC (incorporated by reference to our current report on Form 8-K, filed on August 13, 2019)
Securities Purchase Agreement, dated January 20, 2020, by and among the Company and the Investors (incorporated
by reference to an exhibit to our current report on Form 8-K, filed on January 22, 2020)
Registration Rights Agreement, dated January 20, 2020, by and among the Company and the Investors (incorporated
by reference to an exhibit to our current report on Form 8-K, filed on January 22, 2020)
Asset Purchase Agreement by and between Orgenesis Inc. and Tamir Biotechnology, Inc, dated April 12, 2020
(incorporated by reference to an exhibit to our current report on Form 8-K, filed on April 13, 2020)
Form of Registration Rights and Lock-Up Agreement between the Company, Long Hill Capital V, LLC and Maxim
Group, LLC (incorporated by reference to an exhibit to our current report on Form 8-K, filed on October 1, 2020)
Form of Shareholders Lock-Up Agreement between the Company and Shareholders other than Long Hill Capital V,
LLC (incorporated by reference to an exhibit to our current report on Form 8-K, filed on October 1, 2020)
78
No.
Description
10.18
10.19
10.20
10.21
10.22
10.23
10.24*
21.1*
23.1*
31.1*
31.2*
32.1**
32.2**
99.1
99.2
Executive Directorship Agreement between the Company and Vered Caplan dated November 19, 2020 (incorporated
by reference to an exhibit to our annual report on Form 10-K filed on March 9, 2021)
Swiss Employment Agreement between the Company and Vered Caplan dated November 19, 2020 (incorporated by
reference to an exhibit to our annual report on Form 10-K filed on March 9, 2021)
Convertible Loan Agreement, dated as of August 24, 2021, between the Company and Image Securities FCZ
(incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on November 4, 2021)
Convertible Credit Line and Unsecured Convertible Note Extension Agreement, dated as of September 13, 2021,
between the Company and Yosef Dotan (incorporated by reference to an exhibit to our quarterly report on Form 10-Q,
filed on November 4, 2021)
Convertible Credit Line Extension Agreement, dated as of September 13, 2021, between the Company and Aharon
Lukach (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on November 4, 2021)
Unsecured Convertible Note Extension Agreement, dated as of September 13, 2021, between the Company and
Yehuda Nir (incorporated by reference to an exhibit to our quarterly report on Form 10-Q, filed on November 4,
2021)
Employment Agreement, dated as of December 16, 2021, between the Company and Efrat Assa Kunik
List of Subsidiaries of Orgenesis Inc.
Consent of independent registered public accounting firm
Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
Certification Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002
Certification Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
Certification Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002
Global Share Incentive Plan (2012) (incorporated by reference to an exhibit to our current report on Form 8-K, filed
on May 31, 2012)
Appendix – Israeli Taxpayers Global Share Incentive Plan (2012) (incorporated by reference to an exhibit to our
current report on Form 8-K, filed on May 31, 2012)
*Filed herewith
**Furnished herewith
ITEM 16. FORM 10-K SUMMARY
Not applicable.
79
Pursuant to the requirements of Section 13 or 15(d) 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.
SIGNATURES
ORGENESIS INC.
By:
/s/ Vered Caplan
Vered Caplan
Chief Executive Officer and Chairperson of the
Board of Directors (Principal Executive Officer)
Date: March 30, 2022
By:
/s/ Neil Reithinger
Neil Reithinger
Chief Financial Officer, Treasurer and Secretary
(Principal Financial and Accounting Officer)
Date: March 30, 2022
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following
persons on behalf of the registrant and in the capacities and on the dates indicated.
By:
/s/ Vered Caplan
Vered Caplan
Chief Executive Officer and Chairperson of the Board of
Directors (Principal Executive Officer)
Date: March 30, 2022
By:
/s/ Neil Reithinger
Neil Reithinger
Chief Financial Officer, Treasurer and Secretary (Principal
Financial and Accounting Officer)
Date: March 30, 2022
By:
/s/ Guy Yachin
Guy Yachin
Director
Date: March 30, 2022
By:
/s/ David Sidransky
David Sidransky
Director
Date: March 30, 2022
By:
/s/ Yaron Adler
Yaron Adler
Director
Date: March 30, 2022
By:
/s/ Ashish Nanda
Ashish Nanda
Director
Date: March 30, 2022
By:
/s/ Mario Philips
Mario Philips
Director
Date: March 30, 2022
80
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
ORGENESIS INC.
CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2021
TABLE OF CONTENTS
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name: Kesselman &
Kesselman C.P.A.s; PCAOB ID: 1309)
CONSOLIDATED FINANCIAL STATEMENTS:
Consolidated Balance Sheets
Consolidated Statements of Comprehensive Loss (Income)
Consolidated Statements of Changes in Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-1
Page
F-2
F-3
F-5
F-6
F-8
F-9
Report of Independent Registered Public Accounting Firm
To the Board of Directors and shareholders of Orgenesis Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Orgenesis Inc. and its subsidiaries (the “Company”) as of
December 31, 2021 and 2020, and the related consolidated statements of comprehensive loss (income), changes in equity and cash
flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our
opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of
December 31, 2021 and 2020, and the results of its operations and its cash flows for the years then ended in conformity with
accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the
Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the
Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards
require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are
free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test
basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating
the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the
consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or
disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or
complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial
statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the
critical audit matter or on the accounts or disclosures to which it relates.
Liquidity
As discussed in Note 1 to the consolidated financial statements, the Company had an accumulated deficit of $106.4 million as of
December 31, 2021 and negative operating cashflows of $26.9 million in the year ended December 31, 2021. The Company’s
activities have been funded by generating revenue, through offerings of the Company’s securities and selling its Contract
Development and Manufacturing Organization (“CDMO”) business.
The principal considerations for our determination that performing procedures related to liquidity is a critical audit matter are the
estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions in
estimating these cash flows to conclude the Company would have sufficient liquidity to fund its operations for at least the next 12
months form the date of the issuance of the financial statements. This in turn led to a high degree of auditor subjectivity and
judgment to evaluate the audit evidence supporting the liquidity conclusions.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with our overall opinion on the
consolidated financial statements. Our audit procedures included, among others, testing the reasonableness of the forecasted revenue,
operating expenses, and uses and sources of cash used in management’s assessment of whether the Company has sufficient liquidity
to fund operations for at least the next 12 months form the date of the issuance of the financial statements. This testing included
assessing the appropriateness of forecast assumptions by comparing prior period forecasts to actual results, comparing forecasted
revenue to recent historical financial information and signed contracts, inquiring of management regarding the mitigating actions to
reduce costs and manage cash flows and assessing whether the mitigating actions were within the Company’s control, testing the
underlying data generated to prepare the forecast scenarios and determining whether there was adequate support for the assumptions
underlying the forecast, considering the terms of the Company’s existing convertible loans, and evaluating management’s analysis of
the impact of the above assumptions on the forecasted cash flows.
We assessed the adequacy of the Company’s liquidity disclosures included in Note 1 to the consolidated financial statements.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member of PricewaterhouseCoopers International Limited
Tel-Aviv, Israel
March 30, 2022
We have served as the Company’s auditor since 2012.
Kesselman & Kesselman, 146 Derech Menachem Begin St. Tel-Aviv 6492103, Israel,
P.O Box 7187 Tel-Aviv 6107120, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
F-2
ORGENESIS INC.
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands, except share and per share amounts)
Assets
CURRENT ASSETS:
Cash and cash equivalents
Restricted cash
Accounts receivable, net
Prepaid expenses and other receivables
Convertible Loan to related parties
Grants receivable
Inventory
Total current assets
NON CURRENT ASSETS:
Deposits
Investments in associates, net
Loan to associates
Loans receivable
Property, plants and equipment, net
Intangible assets, net
Operating lease right-of-use assets
Goodwill
Other assets
Total non-current assets
TOTAL ASSETS
F-3
December 31,
2021
2020
5,473 $
501
15,245
1,188
3,064
169
118
25,758
363 $
152
432
821
10,271
11,821
1,015
8,403
805
34,083
59,841 $
44,923
645
3,085
1,070
-
169
185
50,077
296
175
-
-
3,073
13,023
1,474
8,745
821
27,607
77,684
$
$
$
ORGENESIS INC.
CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands, except share and per share amounts)
December 31,
2021
2020
Liabilities and equity
CURRENT LIABILITIES:
Accounts payable
Accrued expenses and other payables
Income tax payable
Employees and related payables
Advance payments on account of grant
Short-term loans and current maturities of long-term loans
Contract liabilities
Current maturities of finance leases
Current maturities of operating leases
Current maturities of convertible loans
TOTAL CURRENT LIABILITIES
LONG-TERM LIABILITIES:
Non-current operating leases
Convertible loans
Retirement benefits obligation
Long-term debt and finance leases
Other long-term liabilities
TOTAL LONG-TERM LIABILITIES
TOTAL LIABILITIES
EQUITY:
Common stock of $0.0001 par value:
Authorized at December 31, 2021 and December 31, 2020: 145,833,334 shares;
Issued at December 31, 2021 and December 31, 2020: 24,567,366 and 24,223,093
shares, respectively; Outstanding at December 31, 2021 and December 31, 2020:
24,280,799 and 24,167,784 shares, respectively.
Additional paid-in capital
Accumulated other comprehensive income
Treasury stock 231,258 shares and 55,309 as of December 31, 2021 and December
31, 2020
Accumulated deficit
Equity attributable to Orgenesis Inc.
Non-controlling interests
TOTAL EQUITY
TOTAL LIABILITIES AND EQUITY
$
The accompanying notes are an integral part of these consolidated financial statements.
F-4
$
5,238 $
485
54
1,907
1,238
-
59
18
481
5,885
15,365
$
561 $
4,854
101
41
288
5,845
21,210
3
145,916
207
(1,266)
(106,372)
38,488
143
38,631
59,841 $
8,649
792
7
1,463
692
145
59
19
485
3,974
16,285
1,020
7,200
74
64
313
8,671
24,956
3
140,397
748
(250)
(88,319)
52,579
149
52,728
77,684
ORGENESIS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME)
(U.S. Dollars, in thousands, except share and per share amounts)
Revenues
Revenues from related party
Total revenues
Cost of services and other research and development expenses, net
Amortization of intangible assets
Selling, general and administrative expenses
Operating loss
Other income, net
Loss from extinguishment in connection with convertible loan
Financial expenses, net
Share in net loss (income) of associated companies
Loss from continuing operation before income taxes
Tax (income) expense
Net loss from continuing operation
Net income from discontinued operations, net of tax
Net loss (income)
Net loss attributable to non-controlling interests from continuing operation
Net loss attributable to non-controlling interests from discontinued operations
Net loss (income) attributable to Orgenesis Inc.
Loss (income) per share:
Basic and diluted from continuing operation
Basic and diluted from discontinued operation
Basic and diluted
$
$
$
$
$
$
Years ended December 31,
2020
2021
31,646 $
3,856
35,502
36,644
948
14,710
16,800
(2,278)
1,865
1,292
272
17,951
108
18,059
-
18,059 $
(6)
-
18,053 $
0.74 $
- $
0.74 $
6,177
1,475
7,652
83,986
478
18,973
95,785
(4)
-
1,061
(106)
96,736
(1,609)
95,127
(95,706)
(579)
(39)
(492)
(1,110)
4.46
(4.75)
(0.29)
Weighted average number of shares used in computation of Basic and Diluted
loss per share:
Basic and diluted
24,273,658
21,320,314
Comprehensive loss (income):
Net loss from Continuing Operation
Net loss income from Discontinued Operation, Net of Tax
Other Comprehensive (income) loss – Translation adjustment
Release of translation adjustment due to sale of subsidiary
Comprehensive loss (income)
Comprehensive loss attributed to non-controlling interests
Comprehensive loss attributed to non-controlling interests from discontinued
operations
Comprehensive loss (income) attributed to Orgenesis Inc.
$
18,059 $
$
-
541
-
18,600 $
(6)
-
$
18,594 $
95,127
(95,706)
(341)
(194)
(1,114)
(39)
(492)
(1,645)
The accompanying notes are an integral part of these consolidated financial statements.
F-5
ORGENESIS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(U.S. Dollars, in thousands, except share amounts)
Common Stock
Balance at
January 1, 2020
Changes during the Year ended
December 31, 2020:
Stock-based compensation to
employees and directors
Stock-based compensation to
service providers
Stock-based compensation for Tamir
purchase agreement (See Note 4)
Exercise of options
Beneficial conversion
feature of convertible loans
Issuance of shares and warrants
Issuance of shares related to acquisition
of Koligo
Sale of subsidiaries
Adjustment to redemption value of
redeemable non-controlling interest
Repurchase of treasury stock
Comprehensive income (loss) for the
period
Balance at December 31, 2020
Number
Par
Value
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
Income
Treasury
Shares
Accumulated
Deficit
Equity
Attributable
to
Orgenesis
Inc.
Non-
Controlling
Interest
Par
Value
16,140,962
$
2 $
94,691 $
213 $
-
$
(89,429) $
5,477
$
601
$
6,078
-
**270,174
3,400,000
83,334
-
2,200,000
2,128,623
-
-
(55,309)
-
1
*
*
-
-
*
-
-
-
1,470
1,376
17,748
300
42
8,438
11,172
-
5,160
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
(250)
-
-
-
-
-
-
-
-
-
-
1,470
1,377
17,748
300
42
8,438
11,172
-
-
-
-
-
-
-
1,470
1,377
17,748
300
42
8,438
-
(413)
11,172
(413)
5,160
(250)
-
-
5,160
(250)
-
24,167,784
$
-
3 $ 140,397 $
-
535
748 $
-
(250) $
1,110
(88,319) $
1,645
52,579
$
(39)
149
1,606
$ 52,728
* Represents an amount lower than $1 thousand
** out of which 30,000 shares have additional restrictions on transfer until services have been provided.
The accompanying notes are an integral part of these consolidated financial statement
F-6
ORGENESIS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(U.S. Dollars, in thousands, except share amounts)
Common Stock
Additional
Paid-in
Capital
Par
Value
Number
Accumulated
Other
Comprehensive
Income
(loss)
Treasury
Shares
Accumulated
Deficit
Equity
Attributable
to
Orgenesis
Inc.
Non-
Controlling
Interest
Par
Value
24,167,784 $
3 $ 140,397 $
748 $
(250) $
(88,319) $
52,579 $
149 $ 52,728
Balance at
January 1,
2021
Changes
during the
Year ended
December 31,
2021:
Stock-based
compensation
to
employees and
directors
Stock-based
compensation
to
service
providers
Exercise of
options
Extinguishment
in connection
with
convertible
loan
restructuring
Issuance of
Shares due to
exercise of
warrants
Repurchase of
treasury stock
Comprehensive
loss for the
period
Balance at
December 31,
2021
-
-
1,349
-
-
-
1,349
-
1,349
25,000
*
396
13,750
*
64
-
-
-
-
-
-
396
64
-
-
396
64
-
-
1,848
-
-
-
1,848
-
1,848
305,523
*
1,862
-
-
-
(1,016)
-
-
1,862
-
1,862
(1,016)
-
(1,016)
(231,258)
-
-
-
-
-
(541)
-
(18,053)
(18,594)
(6) (18,600)
24,280,799 $
3 $ 145,916 $
207 $ (1,266) $
(106,372) $
38,488 $
143 $ 38,631
* Represents an amount lower than $1 thousand
The accompanying notes are an integral part of these consolidated financial statements.
F-7
ORGENESIS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS(*)
(U.S. Dollars, in thousands)
Years ended December 31,
2020
2021
$
(18,059) $
579
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)
Adjustments required to reconcile net income (loss) to net cash used in operating
activities:
Stock-based compensation
Stock-based compensation for Tamir Purchase Agreement (See Notes 4)
Capital loss (gain), net
Gain on disposal of subsidiaries
Share in loss (income) of associated company
Depreciation and amortization expenses
Effect of exchange differences on inter-company balances
Net changes in operating leases
Interest expense accrued on loans and convertible loans (including amortization
of beneficial conversion feature)
Loss from extinguishment in connection with convertible loan restructuring
Changes in operating assets and liabilities:
Increase in accounts receivable
Decrease (increase) in inventory
Increase in other assets
Increase in prepaid expenses, other accounts receivable
Increase (decrease) in accounts payable
Decrease in accrued expenses and other payable
Increase (decrease) in employee and related payables
Decrease in contract liabilities
Change in advance payments and receivables on account of grant, net
Decrease in deferred taxes
Net cash used in operating activities
CASH FLOWS FROM INVESTING ACTIVITIES:
Increase in loan to JV partner, a related party
Repayment in loan to JV partner, a related party
Investment in convertible loan to related party
Loan to associate
Loan granted
Sale of property, plants and equipment
Purchase of property, plants and equipment
Acquisition of Koligo, net of cash acquired (See Note 4)
Proceed from sale of subsidiaries, net
Investment in associated company
Investment in deposits
Repayment from deposits
Net cash provided by (used in) investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
1,745
-
25
-
272
1,864
341
(4)
482
1,865
(12,178)
55
(18)
(173)
(3,755)
(248)
487
-
433
-
$
(26,866) $
-
-
(3,000)
(430)
(818)
-
(7,866)
-
-
(242)
(28)
-
$
(12,384) $
Repurchase of treasury stock
Proceeds from issuance of shares, warrants and exercise of options (net of
transaction costs)
Proceeds from issuance of convertible loans (net of transaction costs)
Repayment of convertible loans and convertible bonds
Repayment of short and long-term debt
Net cash provided by financing activities
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED
CASH
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH
EQUIVALENTS
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT
BEGINNING OF YEAR
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF
YEAR
$
$
$
$
(1,016)
1,926
-
(1,000)
(16)
(106) $
(39,356)
(238) $
45,568 $
5,974 $
2,847
17,048
22
(96,918)
(106)
1,435
(618)
14
927
-
(1,350)
(84)
(24)
(1,073)
1,985
(1,156)
(170)
(166)
140
(1,378)
(78,046)
(500)
3,000
-
-
-
7
(1,525)
(955)
105,634
(69)
-
18
105,610
(250)
8,738
250
(2,400)
(457)
5,881
33,445
82
12,041
45,568
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES
Finance Leases of property, plant and equipment
Right-of-use assets acquired in exchange for right-of-use liabilities
Purchase of property, plant and equipment included in accounts payable
Acquisition of other asset in exchange for common stocks
Issuance of common stocks in connection with the acquisition of Koligo
Extinguishment in connection with convertible loan restructuring
$
$
$
$
$
- $
- $
331 $
- $
- $
1,848 $
366
967
241
700
11,172
-
(*) See Note 3 for information regarding the discontinued operations.
The accompanying notes are an integral part of these consolidated financial statements.
F-8
ORGENESIS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – DESCRIPTION OF BUSINESS
a. General
Orgenesis Inc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene
therapies (“CGTs”) in an affordable and accessible format.
CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are
part of a class of medicines referred to as advanced therapy medicinal products (“ATMP”). The Company mostly focused on
autologous therapies, with processes and systems that are developed for each therapy using a closed and automated processing
system approach that is validated for compliant production near the patient for treatment of the patient at the point of care
(“POCare”). This approach has the potential to overcome the limitations of traditional commercial manufacturing methods that do
not translate well to commercial production of advanced therapies due to their cost prohibitive nature and complex logistics to
deliver such treatments to patients (ultimately limiting the number of patients that can have access to, or can afford, these therapies).
To achieve these goals, the Company has developed a Point of Care Platform (“POCare Platform”) comprised of three
enabling components: (i) a pipeline of licensed POCare advanced therapies that are designed to be processed and produced, (ii)
automated closed POCare technology systems, and (iii) a collaborative worldwide network of POCare research institutes and
hospitals (“POCare Network”).
The POCare Platform relies in particular on the development of its own production capacity, known as “POCare Services”,
whose goal is to ensure that therapies are accessible at the point of treatment (the “POCare Center”). POCare Services, which have
been expanding worldwide, are based on a global approach and local adaptation that allows replication and expansion. Global
harmonization of the POCare Services is ensured by a central quality system, replicability of infrastructure and equipment and
centralized monitoring and data management.
The POCare Services include:
●
●
●
●
●
●
Process development of therapies that are intended for use of the POCare Network,
Adaptation of automation and closed systems to such therapies,
Incorporation of the processing systems and the Good Manufacturing Processes (“GMP”) in the OMPULs,
Tech transfers to required POCare Centers and training of local teams,
Processing and supply and of the therapies and required supplies under GMP conditions by the various POCare centers,
including required quality control testing,
CRO services for clinical trials.
POCare Centers are the decentralised hubs that provide harmonized services to customers and partners. The Company is
working to provide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. The
workflow of a POCare Center is designed to allow rapid capacities expansion while integrating new technologies. The Company also
draws on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform either
via ownership or licensing.
The POCare Network brings together patients, doctors and industry partners with a goal of achieving harmonized, regulated
clinical development and production of POCare advanced therapies.
The Company has worked to develop and validate POCare technologies that can be combined within mobile production
units for advanced therapies. The Company has made significant investments in the development of several types of Orgenesis
Mobile Processing Units and Labs (“OMPULs”) with the expectation of use and/or distribution through the Company’s POCare
Network and/or partners, collaborators, and regional distributors. As of the date of this report, the OMPULs have been adapted for
processing of CAR-T (chimeric antigen receptor T-cell) therapy, TIL (tumor infiltrating lymphocyte) and MSC (mesenchymal stem
cell) based products, and are in the qualification stage for clinical use in various locations. Additional OMPULs are still in the
development stage.
F-9
OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of
potential or approved advanced therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the
manufacturing of such CGTs in a consistent and standardized manner in all locations. The OMPUL design delivers a potential
industrial solution for us to deliver CGTs to practically any clinical institution at the point of care.
The Company has continued to grow its infrastructure and expand its processing sites into new markets and jurisdictions. In
addition, the Company has continued investing manpower and financial resources to focus on developing, processing and rolling out
several types of OMPULs to be used and/or distributed through its POCare Network and/or partners, collaborators, and regional
distributors.
The Chief Executive Officer is the Company’s chief operating decision-maker who reviews
financial information prepared on a consolidated basis. All of our continuing operations are in one segment, being the point-of-care
business via our POCare Platform. Therefore, no segment information has been presented.
The Company currently conducts its core CGT business operations through itself and its subsidiaries which are all wholly
owned except as otherwise stated (collectively, the “Subsidiaries”). The Subsidiaries are as follows:
●
●
●
●
●
●
●
●
●
●
Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America and is currently focused on
setting up and providing POCare Services to the POCare Network.
Koligo Therapeutics, Inc. (“Koligo”) is a Kentucky corporation that we acquired in 2020. Koligo is a leading regenerative
medicine company, specializing in developing personalized cell therapies. It is currently focused on commercialising its
metabolic pipeline via the POCare network throughout the United States and in international markets.
Orgenesis CA, Inc. (the “California subsidiary”) is a Californian subsidiary incorporated in 2021 and is currently focussed
on development of the Company’s technologies and therapies in California.
Orgenesis Belgium SRL (the “Belgian Subsidiary”) is currently focused on expanding our POCare network in Europe,
process development and the preparation of European clinical trials.
Orgenesis Switzerland Sarl (the “Swiss Subsidiary”), was incorporated in October 2020, and is currently focused on
providing management services to us.
Orgenesis Germany GmbH (incorporated in 2021) (the “German subsidiary”) is currently focused on providing CRO
services to the POCare Network.
Korea: Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea.
The Company owns 94.12% of the Korean Subsidiary.
Orgenesis Ltd. in Israel (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services in Israel.
Orgenesis Biotech Israel Ltd. (“OBI”) is a provider of process development and cell-processing services in Israel.
These consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries including the
Discontinued Operations.
The Company’s common stock, par value $0.0001 per share (the “Common Stock”) is listed and traded on the Nasdaq
Capital Market under the symbol “ORGS.”
F-10
As used in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries.
Unless otherwise specified, all amounts are expressed in United States Dollars.
b.
Liquidity
Through December 31, 2021, the Company had an accumulated deficit of $106.4 million as of December 31, 2021 and
negative operating cashflows of $26.9 million in the year ended December 31, 2021. The Company’s activities have been funded by
generating revenue, through offerings of the Company’s securities and selling its Contract Development and Manufacturing
Organization (“CDMO”) business. There is no assurance that the Company’s business will generate sustainable positive cash flows
to fund its business. See also note 21 with respect to an investment agreement in the amount of approximately $14.8 million (before
deducting related offering expenses), which has been entered into subsequent to December 31, 2021.
Based on its current cash resources and commitments, including such investment agreement discussed in note 21, the
Company believes it will be able to maintain its current planned development activities and expected level of expenditures for at
least 12 months from the date of the issuance of these financial statements, although no assurance can be given that it will not need
additional funds prior to such time. If there are further increases in operating costs for facilities expansion, research and
development, commercial and clinical activity or decreases in revenues from customers, the Company will need to use mitigating
actions as to seek additional financing or postpone expenses that are not based on firm commitments. In addition, in order to fund the
Company’s operations until such time that the Company can generate sustainable positive cash flows, the Company may need to
raise additional funds.
The estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and
assumptions in estimating these cash flows to conclude that the Company would have sufficient liquidity to fund its operations for at
least the next 12 months is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating
expenses, and uses and sources of cash.
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES
The consolidated financial statements are prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”).
a.
Use of Estimates in the Preparation of Financial Statements
The preparation of our consolidated financial statements in conformity with U.S. GAAP requires us to make estimates,
judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related
disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, judgments and methodologies. We
base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which
form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses
and determining whether an acquisition is a business combination or a purchase of asset. Actual results could differ from those
estimates.
The full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and
financial condition, will depend on future developments that are uncertain, including as a result of new information that may emerge
concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional,
national and international customers and markets. We examined the impact of COVID-19 on our financial statements, and although
there is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ from these
estimates.
b.
Business Combination
The Company allocates the purchase price of an acquired business to the tangible and intangible assets acquired and
liabilities assumed based upon their estimated fair values on the acquisition date. Any excess of the purchase price over the fair value
of the net assets acquired is recorded as goodwill. Acquired in-process backlog, customer relations, technology, IPR&D, brand name
and know how are recognized at fair value. The purchase price allocation process requires management to make significant estimates
and assumptions, especially at the acquisition date with respect to intangible assets. Direct transaction costs associated with the
business combination are expensed as incurred. The allocation of the consideration transferred in certain cases may be subject to
revision based on the final determination of fair values during the measurement period, which may be up to one year from the
acquisition date. The Company includes the results of operations of the business that it has acquired in its consolidated results
prospectively from the date of acquisition.
If the business combination is achieved in stages, the acquisition date carrying value of the acquirer’s previously held equity
interest in the acquire is re-measured to fair value at the acquisition date; any gains or losses arising from such re-measurement are
recognized in profit or loss.
F-11
c.
Discontinued operations
Upon divestiture of a business, the Company classifies such business as a discontinued operations, if the divested business
represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results. For disposals other
than by sale such as abandonment, the results of operations of a business would not be recorded as a discontinued operations until the
period in which the business is actually abandoned.
The Masthercell Business divestiture qualifies as a discontinued operations and therefore has been presented as such.
The results of businesses that have qualified as a discontinued operations have been presented as such for all reporting
periods. Results of discontinued operations include all revenues and expenses directly derived from such businesses; general
corporate overhead is not allocated to discontinued operations. Any loss or gain that arose from the divestiture of a business that
qualifies as discontinued operations is included within the results of the discontinued operations. The Company included information
regarding cash flows from discontinued operations (See Note 3).
d.
Cash Equivalents
The Company considers cash equivalents to be all short-term, highly liquid investments, which include money market
instruments, that are not restricted as to withdrawal or use, and short-term bank deposits with original maturities of three months or
less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash.
e.
Cost of services and other research and development expenses, net
Cost of services and other research and development expenses, net include costs directly attributable to the conduct of
research and development activities, including the cost of salaries, stock-based compensation expenses, payroll taxes and other
employees’ benefits, lab expenses, consumable equipment, courier fees, travel expenses, professional fees and consulting fees. All
costs associated with research and developments are expensed as incurred. Participation from government departments and from
research foundations for development of approved projects is recognized as a reduction of expense as the related costs are incurred.
Research and development in-process acquired as part of an asset purchase, which has not reached technological feasibility and has
no alternative future use, is expensed as incurred.
f.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its Subsidiaries. All intercompany
transactions and balances have been eliminated in consolidation.
g.
Non-Marketable Equity Investments
The Company’s investments in certain non-marketable equity securities in which it has the ability to exercise significant
influence, but it does not control through variable interests or voting interests. These are accounted for under the equity method of
accounting and presented as Investment in associates, net, in the Company’s consolidated balance sheets. Under the equity method,
the Company recognizes its proportionate share of the comprehensive income or loss of the investee. The Company’s share of
income and losses from equity method investments is included in share in losses of associated company.
The Company reviews its investments accounted for under the equity method for possible impairment, which generally
involves an analysis of the facts and changes in circumstances influencing the investments.
For other investments, the Company applies the measurement alternative upon the adoption of ASU 2016-01, and elected to
record equity investments without readily determinable fair values at cost, less impairment, adjusted for subsequent observable price
changes. In this measurement alternative method, changes in the carrying value of the equity investments are reflected in current
earnings. Changes in the carrying value of the equity investment are required to be made whenever there are observable price
changes in orderly transactions for the identical or similar investment of the same issuer.
F-12
h.
Functional Currency
The currency of the primary economic environment in which the operations of the Company and part of its Subsidiaries are
conducted is the U.S. dollar (“$” or “dollar”). The functional currency of the Belgian Subsidiaries is the Euro (“€” or “Euro”). The
functional currency of Orgenesis Korea is the Won (“KRW”). Most of the Company’s expenses are incurred in dollars, and the
source of the Company’s financing has been provided in dollars. Thus, the functional currency of the Company and its other
subsidiaries is the dollar. Transactions and balances originally denominated in dollars are presented at their original amounts.
Balances in foreign currencies are translated into dollars using historical and current exchange rates for nonmonetary and monetary
balances, respectively. For foreign transactions and other items reflected in the statements of operations, the following exchange rates
are used: (1) for transactions – exchange rates at transaction dates or average rates and (2) for other items (derived from nonmonetary
balance sheet items such as depreciation) – historical exchange rates. The resulting transaction gains or losses are recorded as
financial income or expenses. The financial statements of the Belgian Subsidiaries and Orgenesis Korea are included in the
consolidated financial statements, translated into U.S. dollars. Assets and liabilities are translated at year-end exchange rates, while
revenues and expenses are translated at yearly average exchange rates during the year. Differences resulting from translation of
assets and liabilities are presented as other comprehensive income.
i.
Inventory
The Company’s inventory consists of raw material for use for the services provided. The Company periodically evaluates
the quantities on hand. Cost of the raw materials is determined using the weighted average cost method. The inventory is recorded at
the lower of cost or net realizable value.
j.
Property, plant and Equipment
Property, plant and equipment are recorded at cost and depreciated by the straight-line method over the estimated useful
lives of the related assets.
Annual rates of depreciation are presented in the table below:
Production facility
Laboratory equipment
Office equipment and computers
k.
Intangible assets
Intangible assets and their useful lives are as follows:
Customer Relationships
Know-How
Technology
In-process research and development
Useful Life (Years)
10
12
15
Indefinite
Weighted Average
Useful Life (Years)
5 – 10
2 – 10
3 – 17
Amortization Recorded at Comprehensive Loss
Line Item
Amortization of intangible assets
Amortization of intangible assets
Amortization of intangible assets
Intangible assets are recorded at acquisition less accumulated amortization and impairment. Definite lived intangible assets
are amortized over their estimated useful life using the straight-line method, which is determined by identifying the period over
which the cash flows from the asset are expected to be generated. The Company capitalizes IPR&D projects acquired as part of a
business combination. On successful completion of each project, IPR&D assets are reclassified to developed technology and
amortized over their estimated useful lives.
F-13
l.
Goodwill
Goodwill represents the excess of consideration transferred over the value assigned to the net tangible and identifiable intangible
assets of businesses acquired. Goodwill is allocated to reporting units expected to benefit from the business combination. Goodwill is
not amortized but rather tested for impairment at least annually in the fourth quarter, or more frequently if events or changes in
circumstances indicate that goodwill may be impaired. Following the sale of Masthercell the Company manages the business as one
operating segment and one reporting unit. Goodwill impairment is recognized when the quantitative assessment results in the
carrying value exceeding the fair value, in which case an impairment charge is recorded to the extent the carrying value exceeds the
fair value.
There were no impairment charges to goodwill during the periods presented.
m.
Impairment of Long-lived Assets
The Company reviews its property, plants and equipment, intangible assets subject to amortization and other long-lived
assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset class may not be
recoverable. Indicators of potential impairment include: an adverse change in legal factors or in the business climate that could affect
the value of the asset; an adverse change in the extent or manner in which the asset is used or is expected to be used, or in its physical
condition; and current or forecasted operating or cash flow losses that demonstrate continuing losses associated with the use of the
asset. If indicators of impairment are present, the asset is tested for recoverability by comparing the carrying value of the asset to the
related estimated undiscounted future cash flows expected to be derived from the asset. If the expected cash flows are less than the
carrying value of the asset, then the asset is considered to be impaired and its carrying value is written down to fair value, based on
the related estimated discounted cash flows. There were no impairment charges in the years ended December 31, 2021 and 2020. For
indefinite life intangible assets, The Company performs an impairment test annually in the fourth quarter and whenever events or
changes in circumstances indicate the carrying value of an asset may not be recoverable. The Company determines the fair value of
the asset based on discounted cash flows and records an impairment loss if its book value exceeds fair value.
n.
Income Taxes
1) With respect to deferred taxes, income taxes are computed using the asset and liability method. Under the asset and
liability method, deferred income tax assets and liabilities are determined based on the differences between the financial reporting
and tax bases of assets and liabilities and are measured using the currently enacted tax rates and laws. A valuation allowance is
recognized to the extent that it is more likely than not that the deferred taxes will not be realized in the foreseeable future.
2) The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to
evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the
position will be sustained on examination. If this threshold is met, the second step is to measure the tax position as the largest amount
that is greater than 50% likely of being realized upon ultimate settlement.
3) Taxes that would apply in the event of disposal of investment in Subsidiaries and associated companies have not been
taken into account in computing the deferred income taxes, as it is the Company’s intention to hold these investments and not realize
them.
o.
Stock-based Compensation
The Company recognizes stock-based compensation for the estimated fair value of share-based awards. The Company
measures compensation expense for share-based awards based on estimated fair values on the date of grant using the Black-Scholes
option-pricing model. This option pricing model requires estimates as to the option’s expected term and the price volatility of the
underlying stock. The Company amortizes the value of share-based awards to expense over the vesting period on a straight-line
basis.
F-14
p.
Redeemable Non-controlling Interest
Non-controlling interests with embedded redemption features, whose settlement is not at the Company’s discretion, are
considered redeemable non-controlling interest. Redeemable non-controlling interests are considered to be temporary equity and are
therefore presented as a mezzanine section between liabilities and equity on the Company’s consolidated balance sheets. Subsequent
adjustment of the amount presented in temporary equity is required only if the Company’s management estimates that it is probable
that the instrument will become redeemable. Adjustments of redeemable non-controlling interest to its redemption value are recorded
through additional paid-in capital.
q.
Loss (income) per Share of Common Stock
Basic net loss (income) per share is computed by dividing the net loss (income) for the period by the weighted average
number of shares of common stock outstanding for each period. Diluted net loss (income) per share is based upon the weighted
average number of common shares and of common shares equivalents outstanding when dilutive. Common share equivalents
include: (i) outstanding stock options and warrants which are included under the treasury share method when dilutive, and (ii)
common shares to be issued under the assumed conversion of the Company’s outstanding convertible loans and debt, which are
included under the if-converted method when dilutive (See Note 14).
r.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of principally cash and
cash equivalents, bank deposits and certain receivables. The Company held these instruments with highly rated financial institutions
and the Company has not experienced any significant credit losses in these accounts and does not believe the Company is exposed to
any significant credit risk on these instruments apart of accounts receivable. The Company performs ongoing credit evaluations of its
customers for the purpose of determining the appropriate allowance for doubtful accounts. An appropriate allowance for doubtful
accounts is included in the accounts and netted against accounts receivable. In the year ended December 31, 2021 the Company has
not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these
instruments.
Bad debt allowance is created when objective evidence exists of inability to collect all sums owed it under the original terms
of the debit balances. Material customer difficulties, the probability of their going bankrupt or undergoing economic reorganization
and insolvency, material delays in payments and other objective considerations by management that indicate expected risk of
payment are all considered indicative of reduced debtor balance value.
s.
Treasury shares
The Company repurchases its ordinary shares from time to time on the open market and holds such shares as treasury stock.
The Company presents the cost to repurchase treasury stock as a reduction of shareholders’ equity. The Company did not reissue nor
cancel treasury shares during the year ended December 31, 2021 and December 31, 2020.
t.
Beneficial Conversion Feature (“BCF”)
When the Company issues convertible debt, if the stock price is greater than the effective conversion price (after allocation
of the total proceeds) on the measurement date, the conversion feature is considered “beneficial” to the holder. If there is no
contingency, this difference is treated as issued equity and reduces the carrying value of the host debt; the discount is accreted as
deemed interest on the debt (See Note 7).
u.
Other Comprehensive Loss
Other comprehensive loss represents adjustments of foreign currency translation.
F-15
v.
Revenue from Contracts with Customers
The Company recognizes revenue from contracts with customers according to ASC 606, Revenue from Contracts with
Customers and the related amendments (“New Revenue Standard”) to all contracts.
The Company’s agreements are primarily service contracts that range in duration from a few months to one year. The
Company recognizes revenue when control of these services is transferred to the customer for an amount, referred to as the
transaction price, which reflects the consideration to which the Company is expected to be entitled in exchange for those goods or
services.
A contract with a customer exists only when:
●
●
●
●
the parties to the contract have approved it and are committed to perform their respective obligations;
the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance
obligations”);
the Company can determine the transaction price for the goods or services to be transferred; and
the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be
entitled in exchange for the goods or services that will be transferred to the customer.
The Company does not adjust the promised amount of consideration for the effects of a significant financing component
since the Company expects, at contract inception, that the period between the time of transfer of the promised goods or services to
the customer and the time the customer pays for these goods or services to be generally one year or less. The Company’s credit terms
to customers are in average between thirty and one hundred and fifty days.
Nature of Revenue Streams
The Company’s main revenue streams from continuing operations are POC development services and Cell Process
Development Services.
POC Development Services
Revenue recognized under contracts for POC development services may, in some contracts, represent multiple performance
obligations (where promises to the customers are distinct) in circumstances in which the work packages are not interrelated or the
customer is able to complete the services performed.
For arrangements that include multiple performance obligations, the transaction price is allocated to the identified
performance obligations based on their relative standalone selling prices.
The Company recognizes revenue when, or as, it satisfies a performance obligation. At contract inception, the Company
determines whether the services are transferred over time or at a point in time. Performance obligations that have no alternative use
and that the Company has the right to payment for performance completed to date, at all times during the contract term, are
recognized over time. All other performance obligations are recognized as revenues by the Company at point of time (upon
completion). In addition, during 2021, the Company started providing support services to its customers. These revenues are
recognized as and when the services are provided because the customer simultaneously receives and consumes the benefits provided.
Also included in POC development services is Hospital supplies revenue which is derived principally from the performance
of services to hospitals or other medical providers. Revenue is earned and recognized when product and services are received by the
customer.
Significant Judgement and Estimates
Significant judgment is required to identifying the distinct performance obligations and estimating the standalone selling
price of each distinct performance obligation and identifying which performance obligations create assets with alternative use to the
Company, which results in revenue recognized upon completion, and which performance obligations are transferred to the customer
over time.
F-16
Cell Process Development Services
Revenue recognized under contracts for cell process development services may, in some contracts, represent multiple
performance obligations (where promises to the customers are distinct) in circumstances in which the work packages and milestones
are not interrelated or the customer is able to complete the services performed independently or by using competitors of the
Company. In other contracts when the above circumstances are not met, the promises are not considered distinct and the contract
represents one performance obligation. All performance obligations are satisfied over time, as there is no alternative use to the
services it performs, since, in nature, those services are unique to the customer, which retain the ownership of the intellectual
property created through the process. Additionally, due to the non-refundable upfront payment feature which may exist in certain
contracts and which the customer pays together with the payment term and cancellation fine, Company has a right to payment (which
includes a reasonable margin), at all times, for work completed to date, which is enforceable by law.
For arrangements that include multiple performance obligations, the transaction price is allocated to the identified
performance obligations based on their relative standalone selling prices. For these contracts, the standalone selling prices are based
on the Company’s normal pricing practices when sold separately with consideration of market conditions and other factors, including
customer demographics and geographic location.
The Company measures the revenue to be recognized over time on a contract-by-contract basis, determining the use of
either a cost-based input method or output method, depending on whichever best depicts the transfer of control over the life of the
performance obligation.
Change Orders
Changes in the scope of work are common and can result in a change in transaction price, equipment used and payment
terms. Change orders are evaluated on a contract-by-contract basis to determine if they should be accounted for as a new contract or
as part of the existing contract. Generally, services from change orders are not distinct from the original performance obligation. As a
result, the effect that the contract modification has on the contract revenue, and measure of progress, is recognized as an adjustment
to revenue when they occur.
w.
Leases
The Company recognizes lease expenses according to the lease standard ASC 842 and related amendments.
The Company determines if an arrangement is a lease at inception. Lease classification is governed by five criteria in ASC
842-10-25-2. If any of these five criteria is met, The Company classifies the lease as a finance lease; otherwise, the Company
classifies the lease as an operating lease. When determining lease classification, the Company’s approach in assessing two of the
mentioned criteria is: (i) generally 75% or more of the remaining economic life of the underlying asset is a major part of the
remaining economic life of that underlying asset; and (ii) generally 90% or more of the fair value of the underlying asset comprises
substantially all of the fair value of the underlying asset.
Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the
consolidated balance sheet.
ROU assets represent Orgenesis’ right to use an underlying asset for the lease term and lease liabilities represent its
obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the
commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing
rate based on the information available at the commencement date to determine the present value of the lease payments.
The standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term
lease recognition exemption for all leases with a term shorter than 12 months. This means that for those leases, the Company does
not recognize ROU assets or lease liabilities, including not recognizing ROU assets or lease liabilities for existing short-term leases
of those assets in transition, but recognizes lease expenses over the lease term on a straight-line basis.
Lease terms will include options to extend or terminate the lease when it is reasonably certain that Orgenesis will exercise
or not exercise the option to renew or terminate the lease.
F-17
x.
Recently issued accounting pronouncements, not yet adopted
In June 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on
Financial Instruments.” This guidance replaces the current incurred loss impairment methodology with a methodology that reflects
expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss
estimates. The guidance will be effective for Smaller Reporting Companies (SRCs, as defined by the SEC) for the fiscal year
beginning on January 1, 2023, including interim periods within that year. The Company is currently evaluating this guidance to
determine the impact it may have on its consolidated financial statements.
In August 2020, the FASB issued Accounting Standards Update (“ASU”) 2020-06, Debt with Conversion and Other
Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40)-Accounting For
Convertible Instruments and Contracts in an Entity’s Own Equity. The ASU simplifies accounting for convertible instruments by
removing major separation models required under current GAAP. Consequently, more convertible debt instruments will be reported
as a single liability instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement
conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity
contracts to qualify for it. The ASU also simplifies the diluted net income per share calculation in certain areas. The new guidance is
effective for annual and interim periods beginning after December 15, 2021, and early adoption is permitted for fiscal years
beginning after December 15, 2020, and interim periods within those fiscal years. The Company expects to apply modified
retrospective basis adoption of this guidance, which will not have a significant impact on the Company’s consolidated financial
statements.
In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments
(Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own
Equity (Subtopic 815- 40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written
Call Options (“ASU 2021-04”). The guidance is effective for the Company on January 1, 2022. The Company expects that this
guidance, will not have a significant impact on the Company’s consolidated financial statements.
In October 2021, the FASB issued ASU 2021-08 “Business Combinations (Topic 805), Accounting for Contract Assets and
Contract Liabilities from Contracts with Customers”, which requires contract assets and contract liabilities acquired in a business
combination to be recognized and measured by the acquirer on the acquisition date in accordance with ASC 606, Revenue from
Contracts with Customers. The guidance will result in the acquirer recognizing contract assets and contract liabilities at the same
amounts recorded by the acquiree. The guidance should be applied prospectively to acquisitions occurring on or after the effective
date. The guidance is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal
years. Early adoption is permitted, including in interim periods, for any financial statements that have not yet been issued. The
Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.
In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic 832)”, which requires annual
disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the
accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this
update are effective for financial statements issued for annual periods beginning after December 15, 2021. The Company is currently
evaluating this guidance to determine the impact it may have on its consolidated financial statements.
F-18
NOTE 3 – DISCONTINUED OPERATION
On February 2, 2020, the Company entered into a Purchase Agreement with GPP, Masthercell and the Buyer. Pursuant to
the terms and conditions of the Purchase Agreement, Sellers agreed to sell 100% of the outstanding equity interests of Masthercell
to Buyer for an aggregate nominal purchase price of $315 million. The Company has determined that the Masthercell Business
meets the criteria to be classified as discontinued operations.
On February 10, 2020, the Masthercell Sale was consummated in accordance with the terms of the Purchase Agreement.
After accounting for GPP’s liquidation preference and equity stake in Masthercell, as well as SFPI – FPIM’s interest in
MaSTherCell, distributions to Masthercell option holders and transaction costs, the Company received approximately $126.7
million at the closing of the Masthercell Sale, of which $7.2 million was used for the repayment of intercompany loans and
payables, including $4.6 million of payables to MaSTherCell.
Due to the sale of the controlling interest in Masthercell, the Company retrospectively reclassified the assets and liabilities
of these entities as assets and liabilities of discontinued operations and included the financial results of these entities as discontinued
operations in the Company’s consolidated financial statements.
Discontinued operations relate to the Masthercell Business. The comprehensive loss and balance sheet for this operation
are separately reported as discontinued operations for all periods presented.
The financial results of the Masthercell Business are presented as income (loss) from discontinued operations, net of
income taxes on the Company’s consolidated statement of comprehensive loss. The following table presents the financial results
associated with the Masthercell Business operation as reflected in the Company’s Consolidated Comprehensive loss (in thousands):
OPERATIONS
Revenues
Cost of revenues
Cost of services and other research and development expenses, net
Amortization of intangible assets
Selling, general and administrative expenses
Operating loss
Other expenses, net
Financial income, net
Loss before income taxes
Tax income
Net loss from discontinuing operation, net of tax
DISPOSAL
Gain on disposal before income taxes
Provision for income taxes
Gain on disposal
Net profit from discontinuing operation, net of tax
F-19
Year Ended
December 31,
2020
2,556
1,482
7
137
1,896
966
305
(29)
1,242
(30)
1,212
96,918
-
96,918
95,706
$
$
$
$
$
The following table represents the components of the cash flows from discontinued operations (in thousands):
Net cash flows used in operating activities
Net cash flows used in investing activities
Net cash flows used in financing activities
Disaggregation of Revenue
Year Ended
December 31,
2020
$
$
$
(2,409)
(579)
(51)
The following table disaggregates the Company’s revenues by major revenue streams related to discontinued operations (in
thousands):
Revenue stream:
Cell process development services
Total
Redeemable Non-Controlling Interest of Discontinued Operations
Year Ended
December 31,
2020
$
$
2,556
2,556
a.
Subscription and Shareholders Agreement with Belgian Sovereign Funds Société Fédérale de Participations et
d’Investissement (“SFPI(“.
On November 15, 2017, the Company, MaSTherCell and SFPI entered into a Subscription and Shareholders Agreement
(“SFPI Agreement”) pursuant to which SFPI made an equity investment in MaSTherCell.
Due to the embedded redemption feature of the SFPI agreement whose settlement was not at the Company discretion, the
Company had accounted for the investment made by GPP as a redeemable non-controlling interest.
b.
Stock Purchase Agreement and Stockholders’ Agreement with Great Point Partners, LLC (“GPP”)
On June 28, 2018, the Company, Masthercell Global GPP, and certain of GPP’s affiliates, entered into a series of definitive
strategic agreements intended to finance, strengthen and expand Orgenesis’ CDMO business.
Due to the embedded redemption feature of the GPP agreement whose settlement was not at the Company discretion, the
Company had accounted for the investment made by GPP as a redeemable non-controlling interest.
NOTE 4 – ACQUISITION AND REORGANIZATION
Tamir Biotechnology, Inc.
On April 7, 2020, the Company entered into the Tamir Purchase Agreement with Tamir, pursuant to which the Company
agreed to acquire certain assets and liabilities of Tamir related to the discovery, development and testing of therapeutic products for
the treatment of diseases and conditions in humans, including all rights to Ranprinase and use for antiviral therapy. The Tamir
Transaction closed on April 23, 2020.
As aggregate consideration for the acquisition, the Company paid $2.5 million in cash and issued an aggregate of 3,400,000
shares (the “Shares”) of Common Stock to Tamir resulting in a total consideration of $20.2 million based on the Company’s share
price at the closing date. $4.5 million of the consideration was attributable to research and development related inventory and most
of the remaining amount reflected the cost of intangible assets. The Shares were registered for resale by the Company in November
2020.
The Company’s acquired right to Tamir’s intellectual property represents a single identifiable asset sourced from the
agreement. Because substantially all (more than 90%) of the fair value of the gross assets acquired are concentrated in a single asset
being the right to Tamir’s intellectual property and related assets (“IPR&D”), the Company determined that the acquisition is not
considered a business in accordance with ASC 805-10-55-5A. Therefore, the Company accounted the transaction as an asset
acquisition. The fair value associated with Tamir’s IPR&D in the amount of $19.5 million was charged to research and development
expenses under ASC 730. The remaining amount was attributed to the above-mentioned share in a private company, which is
presented in the balance sheet as long term “other assets”.
F-20
Included in the purchased assets of Tamir was the assumption by us of a worldwide license to a private company of certain
Tamir technologies in the field of treatment, amelioration, mitigation or prevention of diseases or conditions of the eye and its adnexa
in return for certain development and sales milestone payments to be paid to Tamir. We also received a less than 10% share interest
in said private company in addition to the license fee and right to receive future milestone payments and royalties.
Koligo Therapeutics Acquisition
On September 26, 2020, the Company entered into an Agreement and Plan of Merger and Reorganization (the “Merger
Agreement”) by and among the Company, Orgenesis Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of the
Company (“Merger Sub”), Koligo Therapeutics Inc., a Kentucky corporation (“Koligo”), the shareholders of Koligo (collectively,
the “Shareholders”), and Long Hill Capital V, LLC (“Long Hill”), solely in its capacity as the representative, agent and attorney-in-
fact of the Shareholders. The Merger Agreement provides for the acquisition of Koligo by the Company through the merger of
Merger Sub with and into Koligo, with Koligo surviving as a wholly-owned subsidiary of the Company (the “Merger”). The
acquisition was completed on October 15, 2020 (the “Effective Time”).
Koligo was a privately-held US regenerative medicine company. Koligo’s first commercial product is KYSLECEL®
(autologous pancreatic islets) for chronic and acute recurrent pancreatitis. Koligo’s 3D-V technology platform incorporates the use of
advanced 3D bioprinting techniques and vascular endothelial cells to support development of transformational cell and tissue
products for serious diseases.
Pursuant to the terms of the Merger Agreement, at the Effective Time, the shares of capital stock of Koligo that were issued
and outstanding immediately prior to the Effective Time were automatically cancelled and converted into the right to receive, subject
to customary adjustments, an aggregate of 2,061,713 shares of Company common stock which have been issued to Koligo’s
accredited investors (with certain non-accredited investors being paid solely in cash in the amount of approximately $20 thousand).
In addition, the Company issued 66,910 shares to Maxim Group LLC for advisory services in connection with the Merger. The share
price was $5.26 at the day of the closing.
As partial security for the indemnification and purchase price adjustment obligations of Koligo shareholders under the
Merger Agreement, $7 thousand in cash and 328,587 shares of Company common stock of the merger consideration otherwise
payable in the Merger to the Shareholders were placed in a third party escrow account until April 2022. The aggregate
indemnification obligations of the Koligo shareholders under the Merger Agreement is capped at the amounts in escrow, subject to
certain limited exceptions.
In addition, according to the agreement between the parties, the Company funded an additional cash consideration of $500
thousand (with $100 thousand of such reducing the ultimate consideration payable to Koligo) for the acquisition of the assets of
Tissue Genesis, LLC (“Tissue Genesis”) by Koligo that was consummated on October 14, 2020. The Tissue Genesis assets include
the entire inventory of Tissue Genesis Icellator® devices, related kits and reagents, a broad patent portfolio to protect the technology,
registered trademarks, clinical data, and existing business relationships for commercial and development stage use of the Icellator
technology.
In connection with the Merger Agreement, the Company, Long Hill and Maxim Group LLC (“Maxim”) entered into a
Registration Rights and Lock-Up Agreement. All of the shares required to be registered by the Company pursuant to the Registration
Rights and Lock-Up Agreement were registered by the Company in November 2020.
In addition, pursuant to separate Lock-Up Agreements entered into by the Shareholders other than Long Hill with the
Company (the “Shareholders Lock-Up Agreement”), such Shareholders agreed that they will not transfer any of their shares received
in the Merger except in accordance with the following lock-up release schedule whereby one fifth of such holder’s respective shares
will be released from such restriction every six months, starting six months from the closing of the Merger. Each holder’s sales of
such shares are subject to a resale limit of its pro rata portion of 10% of the average daily trading volume, allocated to the
Shareholders other than Long Hill pro-rata.
F-21
The acquisition was accounted in accordance with Accounting Standards Codification Topic 805, “Business Combinations”.
The allocation of the consideration transferred in certain cases may be subject to revision based on the final determination of fair
values during the measurement period, which may be up to one year from the acquisition date. The Company includes the results of
operations of the business that it has acquired in its consolidated results prospectively from the date of acquisition.
Fair Value of Consideration Transferred
The following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities
assumed as of the transaction date:
(in thousands)
Fair value of 8.8% of shared issued *
Cash payment
Total consideration transferred
* Fair value of the consideration is based on the company’s market share price.
Total assets acquired:
Cash and cash equivalents
Restricted Cash
Accounts Receivable
Inventory
Other assets
Property, plants and equipment, net
Kyslecel Technology (a)
IPR&D (a)
Operating lease right-of-use assets
Goodwill (b)
Total assets
Total liabilities assumed:
Operating leases
Accounts Payable
Accrued Expenses
Orgenesis Inc loan
Deferred taxes
Notes Payable
Other liabilities
Total liabilities
Total consideration transferred
11,172
1,115
12,287
8
152
228
34
25
482
9,340
641
238
3,704
14,852
238
216
4
651
1,293
162
1
2,565
12,287
$
$
$
a. The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of other
intangible assets which comprised of: Kyslecel Technology of $9,340 and IPR&D of 641. Kyslecel Technology has a useful life
of 15 years. The useful life of these intangible assets for amortization purposes was determined considering the period of
expected cash flows generated by the assets used to measure the fair value of the intangible assets adjusted as appropriate for the
entity-specific factors, including legal, regulatory, contractual, competitive, economic or other factors that may limit the useful
life of intangible assets.
These intangible assets were estimated using a discounted cash flow method with the application of the multi-period excess
earnings method. Under this method, an intangible asset’s fair value is equal to the present value of the incremental after-tax cash
flows attributable only to the subject intangible asset after deducting contributory asset charges. An income and expenses forecast
were built based upon revenue and expense estimates.
b. The primary items that generate goodwill include the value of the synergies between the acquired company and the Company
and the acquired assembled workforce, neither of which qualifies for recognition as an intangible asset. The Goodwill is not
deductible for tax purposes.
F-22
Pro forma Impact of Business Combination
The unaudited pro forma financial results have been prepared using the acquisition method of accounting and are based on
the historical financial information of the Company and Koligo. The unaudited pro forma condensed financial results have been
prepared for illustrative purposes only and do not purport to be indicative of the results of operations that actually would have
resulted had the acquisition of Koligo occurred at the beginning of the fiscal year, or of future results of the combined entities. The
unaudited pro forma condensed financial information does not reflect any operating efficiencies and expected realization of cost
savings or synergies associated with the acquisition.
Unaudited supplemental pro forma combined results of operations (in thousands):
Revenues
Net loss
Loss per share:
Basic
Year ended
December 31,
2020
$
$
$
8,239
318
0.05
Koligo’s related actual results from the date of acquisition to December 31, 2020 resulted in a loss of $513 thousand.
Koligo’s Acquisition-related Costs
Acquisition-related expenses consist of transaction costs which represent external costs directly related to the acquisition of
Koligo and primarily include expenditures for professional fees such as legal, accounting and other directly related incremental costs
incurred to close the acquisition by both the Company and Koligo.
Acquisition-related expenses for the year ended December 31, 2020 were $682 thousand. These expenses were recorded to
selling and general administrative expense in the consolidated statements of comprehensive loss.
Extracellular Vesicle (“EV”) Technology License
During the third quarter of 2020, the Company purchased IP and related EV technology pursuant to an EV agreement (the
“EV agreement”). According to the EV agreement, the Company received all of the rights in the EV technology purchased, in the
amount of $500 thousand, which was paid during 2020 and 2021. The $500 thousand was recorded in R&D expenses. In addition,
the Company received an exclusive worldwide license to use the EV IP technology for any purpose.
F-23
NOTE 5 – PROPERTY, PLANTS AND EQUIPMENT
The following table represents the components of property, plants and equipment:
Cost:
Production facility
Office furniture and computers
Lab equipment
Advance payment
Subtotal
Less – accumulated depreciation
Total
December 31,
2021
2020
(in thousands)
$
$
4,040 $
555
2,435
6,181
13,211
(2,940)
10,271 $
2,801
697
1,483
281
5,262
(2,189)
3,073
Depreciation expense for the years ended December 31, 2021 and December 31, 2020 were $916 thousand and $705
thousand, respectively.
Property, plants and equipment, net by geographical location were as follows:
Belgium
Korea
Israel
U.S.
Total
December 31,
2021
2020
(in thousands)
$
$
1,149 $
694
2,602
5,826
10,271 $
358
839
1,386
490
3,073
NOTE 6 – INTANGIBLE ASSETS AND GOODWILL
Changes in the carrying amount of the Company’s goodwill for the years ended December 31, 2021 and 2020 are as
follows:
Goodwill as of December 31, 2019
Goodwill as acquired, (Koligo) see note 4
Translation differences
Goodwill as of December 31, 2020
Translation differences
Goodwill as of December 31, 2021
(in thousands)
$
$
$
4,812
3,704
229
8,745
(342)
8,403
Goodwill Impairment
See Note 2(l) for the Company’s goodwill impairment analysis.
Other Intangible Assets
Other intangible assets consisted of the following:
Gross Carrying Amount:
Know How
Customer relationships
Kyslecel Technology
IPR&D
Subtotal
Less – Accumulated amortization
December 31,
2021
2020
(in thousands)
$
2,904 $
811
9,340
641
13,696
(1,875)
3,170
886
9,340
641
14,037
(1,014)
Net carrying amount of other intangible assets
$
11,821 $
13,023
F-24
Intangible assets amortization expenses were approximately $948 thousand and $478 thousand for the years ended
December 31, 2021 and December 31, 2020, respectively.
Estimated aggregate amortization expenses for the five succeeding years ending on December 31st are as follows:
Amortization expenses
$
2022
2023 to 2026
(in thousands)
323 $
1,390
NOTE 7 – CONVERTIBLE LOANS
a.Long term convertible loans outstanding as of December 31, 2021 and December 31, 2020 are as follows:
Principal
Amount
(in
thousands)
Issuance
Year
Interest
Rate
Maturity
Period
Exercise
Price
NOTE
BCF
(Years)
Convertible Loans Outstanding as of December 31, 2021
$
*2018
*2019
*2020
2%
6%-8%
8%
5
3-5
3
7.00
7.00
7.00
(1)+(4)
(2)+(4)
(3)
750
8,750
250
9,750
$
* Extended during the year ended December 31, 2021
Convertible Loans Outstanding as of December 31, 2020
$
$
1,000
9,500
250
10,750
2018
2019
2020
2%
6%-8%
8%
3
2-5
2
7.00
7.00
7.00
(1)+(4)
(2)+(4)
(3)
Convertible Loans repaid during the year ended December 31, 2021
Principal
Amount
750
250
1,000
Issuance Year
2019
2018
Interest Rate
8%
2%
Maturity
Period
2 $
3
Exercise
Price
7
7
BCF
Convertible Loans repaid during the year ended December 31, 2020
Principal
Amount
Issuance Year
2018
2019
2019
500
500
1,400
2,400
Interest Rate
Maturity
Period
Exercise
Price
BCF
2 $
2
3
7
7
7
2%
6%
8%
F-25
39
-
-
71
-
-
31
-
53
-
-
Apart from the items mentioned below there were no repayments of convertible loans during the fiscal years ended
December 31, 2020 and December 31, 2021. In addition, there were no conversions during the fiscal years ended December 31, 2020
and December 31, 2021.
(1)
(2)
(3)
(4)
The holders, at their option, may convert the outstanding principal amount and accrued interest under this note into a total of
113,775 shares and 113,775 three-year warrants to purchase up to an additional 113,775 shares of the Company’s common
stock at a per share exercise price of $7. As of December 31, 2021, the loans are presented in current maturities of
convertible notes in the balance sheet (See Notes 10(f) and 10(g)).
The holders, at their option, may convert the outstanding principal amount and accrued interest under this note into a total of
1,363,206 shares and 1,070,176 three-year warrants to purchase up to an additional 1,070,176 shares of the Company’s
common stock at a per share exercise price of $7. As of December 31, 2021, $3,750 thousand of the principal amount is
included in current maturities of convertible loans in the balance sheet and the remainder in long-term convertible loans. See
also Notes 7(b), 7(c), 7(d) and 7(e).
The holders, at their option, may convert the outstanding principal amount and accrued interest under this note into a total of
41,416 shares at a per share exercise price of $7. As of December 31, 2021, all the principal amount is included in short-term
convertible loans in the balance sheet. See also Notes 7(f).
During the year ended December 31, 2021, the Company and certain convertible loan holders (including certain credit line
investors, see note 7 (e)) agreed to extend the maturity date on loans due during the fourth quarter of 2021 to June 30, 2023.
The principal amount extended was $2.25 million excluding the credit line investors. The loan holders may request that the
Company repay them on November 21, 2022 (the “Early Redemption Option”). In consideration for the extension, including
for the credit line investors, warrants to purchase 926,413 shares of common stock of the Company were issued to the loan
holders at an exercise price of $6.24 per share. If the Early Redemption Option is exercised, the warrants will be cancelled.
The latest date to exercise the warrants is June 30, 2023. During March 2022 the loan holders waived the early redemption
option.
The Company concluded that the change in the terms (including for the credit line investors extension) does not constitute a troubled
debt restructuring. The Company therefore applied the guidance in ASC 470-50, Modifications and Extinguishments. The
accounting treatment is determined by whether terms of the new debt and original debt are substantially different. The new debt and
the old debt are considered “substantially different” pursuant to ASC 470-50 when the change in the fair value of the embedded
conversion option is at least 10% of the carrying amount of the original debt instrument immediately before the modification or
exchange or the value of the cash flows under the terms of the new debt instrument is at least 10% different from the present value of
the remaining cash flows under the terms of the original instrument (including the incremental fair value resulting from issuing new
warrants held by the lender). If the original and new debt instruments are substantially different, the original debt is derecognized and
the new debt should be initially recorded at fair value, with the difference recognized as an extinguishment gain or loss. Based on the
analysis, the Company concluded that the change in terms should be accounted for as an extinguishment. The extinguishment
resulted in a loss of $1,865 thousand. The Company concluded that, since the warrants cannot be exercised prior to the expiry date of
the Early Redemption Option, the warrants are considered embedded in the convertible loan and not freestanding instruments. It also
concluded that the prepayment option and the embedded warrants should not be bifurcated from the debt host. In accordance with
ASC 470-20-25-13, if a convertible debt instrument is issued at a substantial premium, there is a presumption that such premium
represents paid-in capital. Since the fair value of the new convertible loan instrument issued as part of the change in terms are higher
than the par value of the loan and the premium is substantial, the Company allocated the premium to paid in capital and the reminder
to the convertible loan.
The fair value of the conversion feature was estimated using the binomial model. The total fair value of the new instruments is
$4.4M (including the credit line agreements).
F-26
Following are the main estimates and assumptions that were used for the valuation of the new instruments as of the
valuation date:
Parameter
Notional (USD)
Accrued Coupon (USD)
Coupon Rate
Conversion Ratio (USD)
Exercise Price (USD)
Stock Price (USD)
Expected Term (years)
Risk Free Rate
Volatility
Yield
8% Note
1,500,000
224,603
2% Note
750,000
41,945
Warrants
926,413
-
-
-
6.24
5.02
1.79
0.20%
72.84%
-
2.00%
7.00
-
5.02
1.79
0.20%
72.84%
7.84%
8.00%
7.00
-
5.02
1.79
0.20%
72.84%
7.87%
b. During May 2019, the Company entered into a private placement subscription agreement with an investor for $5 million. The
lender shall be entitled, at any time prior to or no later than the maturity date, to convert the outstanding amount, into units of (1)
shares of common stock of the Company at a conversion price per share equal to $7.00 and (2) warrants to purchase an equal number
of additional shares of the Company’s common stock at a price of $7.00 per share.
The transaction costs were approximately $497 thousand, out of which $97 thousand are stock-based compensation due to
issuance of warrants.
c. In June 2019, the Company entered into private placement subscription agreements with investors for an aggregate amount of $2
million. The lenders shall be entitled, at any time prior to or no later than the maturity date, to convert the outstanding amount, into
units of (1) shares of common stock of the Company at a conversion price per share equal to $7.00 and (2) warrants to purchase an
equal number of additional shares of the Company’s common stock at a price of $7.00 per share.
d. During October 2019, the Company entered into a Private Placement Subscription Agreement and Convertible Credit Line
Agreement (collectively, the “Credit Line Agreements”) with four non-U.S. investors (the “Lenders”), pursuant to which the Lenders
furnished to the Company access to an aggregate $5.0 million credit line (which consists of $1.25 million from each Lender)
(collectively, the “Credit Line”). Pursuant to the Credit Line Agreements, the Company was entitled to draw down an aggregate of
$1 million (consisting of $250 thousand from each Lender) of the Credit Line in each of October 2019 and November 2019. In each
of December 2019, January 2020 and February 2020, the Company may draw down an additional aggregate of $1 million (consisting
of $250 thousand from each Lender), until the total amount drawn down under the Credit Line reaches an aggregate of $5 million
(consisting of $1.25 million from each Lender), subject to the approval of the Lenders.
Pursuant to the terms of the Credit Line Agreements and the Notes, the total loan amount, and all accrued but unpaid
interest thereon, became due and payable on the second anniversary of the Effective Date (the “Maturity Date”). The Maturity Date
may be extended by each Lender in its sole discretion and shall be in writing signed by the Company and the Lender. Interest on any
amount that has been drawn down under the Credit Line accrues at a per annum rate of eight percent (8%). At any time prior to or on
the Maturity Date, by providing written notice to the Company, each of the Lenders is entitled to convert its respective drawdown
amounts and all accrued interest, into shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”),
at a conversion price equal to $7.00 per share.
Furthermore, upon the drawdown of $500 thousand from each Lender and, together with the other Lenders, a drawdown of
an aggregate of $2 million under the Credit Line, the existing warrants of the Lenders to purchase shares of Common Stock shall be
amended to extend their exercise date to June 30, 2021 and the Company will issued to each of the Lenders warrants to purchase
50,000 shares of Common Stock at an exercise price of $7.00 per share. The new warrants will be exercisable for three (3) years
from the Effective Date. During October 2019, such drawdown was reached and the warrants were issued.
During the year ended December 2020, the Company repaid principal amount of $2,400 thousand and a total interest
amount of $372 thousand to certain of the credit line investors.
F-27
During the year ended December 2021, the company repaid principal amount of $1,000 thousand and a total interest amount
of $140 thousand to certain of the credit line investors.
See note 7 (a) (4) regarding the extension of certain of the Credit Line Agreements.
e. In December 2019, the Company entered into private placement subscription agreements with investors for an aggregate amount
of $250 thousand. The lenders shall be entitled, at any time prior to or no later than the maturity date, to convert the outstanding
amount, into units of 1 share of common stock of the Company at a conversion price per share equal to $7.00. In addition, the
Company granted the investors 183,481 warrants to purchase an equal number of additional shares of Common Stock at a price of
$7.00 per share. The fair value of the warrants was $124 thousand using the fair value of the shares on the grant date. During 2021,
the Company and the investors agreed to extend the maturity of the loans to December 2022. Based on the analysis, the Company
concluded that the change in terms should be accounted for as a modification.
f. On January 2, 2020, the Company entered into private placement subscription agreements with investors for an aggregate amount
of $250 thousand of convertible loans. The lenders shall be entitled, at any time prior to or no later than the maturity date, to convert
the outstanding amount, into shares of Common Stock of the Company at a conversion price per share equal to $7.00. In addition,
the Company granted the investors 151,428 warrants to purchase an equal number of additional shares of Common Stock at a price
of $7.00 per share. During 2021, the Company and the investors agreed to extend the maturity of the loans to December 2022. Based
on the analysis, the Company concluded that the change in terms should be accounted for as a modification.
h . On November 2, 2016, the Company entered into unsecured convertible note agreements with accredited or offshore investors for
an aggregate amount of NIS 1 million ($280 thousand). The loan bears a monthly interest rate of 2% and mature on May 1, 2017,
unless converted earlier. On April 27, 2017 and November 2, 2017, the Company entered into extension agreements through
November 2, 2017 and May 2, 2018, respectively.
In March 2018, the investor submitted a notice of its intention to convert into shares of the Company’s common stock the
principal amount and accrued interest of approximately $383 thousand outstanding. A related party of such investor at the same time,
exercised warrants issued in November 2016 to purchase shares of the Company’s Common Stock. The exercise price of the
warrants and conversion price were fixed at $0.52 per share (pre-reverse stock split implemented by the Company in November
2017). There is a significant disagreement between the Company and these two entities as to the number of shares of Common Stock
issuable to these entities, and they contend that the number of shares of Common Stock issuable to them should not consider the
reverse stock split. The Company rejects these contentions in their entirety and, based on the advice of specially retained counsel,
believes that these claims are without legal merit and not made in good faith. The Company intends to vigorously defend its interests
and pursue other avenues of legal address. Through its counsel, the Company has advised these entities that unless they withdraw
their request within a specified period, the Company will cancel the above referenced agreements and these parties’ right to receive
any shares of the Company’s Common Stock. In April 2018, the Company withdrew the agreements and deposited the shares in total
amount of 107,985 issued under those agreements and the principal amount and accrued interest of the loan in escrow account. The
deposit of the principal amount and accrued interest presented as restricted cash in the balance sheet as of December 31, 2021.
NOTE 8 – LOANS
Terms of Short-term Loans
Short term loans
Currency
Interest Rate
2021
2020
December 31,
1.00%
$
(in thousands)
-
- $
145
145
USD
F-28
NOTE 9 – LEASES
The Company leases research and development facilities, equipment and offices under finance and operating leases. For
leases with terms greater than 12 months, the Company record the related asset and obligation at the present value of lease payments
over the term. Many of the leases include rental escalation clauses, renewal options and/or termination options that are factored into
the determination of lease payments when appropriate.
The Company’s leases do not provide a readily determinable implicit rate. Therefore, the Company estimated the
incremental borrowing rate to discount the lease payments based on information available at lease commencement.
Manufacturing facilities
The Company leases space for its manufacturing facilities in Israel under operating lease agreements. The leasing contracts
are for a period of 3 – 5 years.
Research and Development facilities
The Company leases space for its research and development facilities in South Korea under an operating lease agreement.
The leasing contracts are for a period of 2 – 5 years.
Offices
The Company leases space for offices in Israel under operating leases. The leasing contracts are valid for terms of 5 years.
These contracts are considered as operational leasing and under operating lease right-of-use assets.
Lease Position
The table below presents the lease-related assets and liabilities recorded on the balance sheet:
Assets
Operating Leases
Operating lease right-of-use assets
Finance Leases
Property, plants and equipment, gross
Accumulated depreciation
Property and equipment, net
Liabilities
Current liabilities
Current maturities of operating leases
Current maturities of long-term finance leases
Long-term liabilities
Non-current operating leases
Long-term finance leases
Weighted Average Remaining Lease Term
Operating leases
Finance leases
Weighted Average Discount Rate
Operating leases
Finance leases
F-29
December 31,
2021
2020
$
1,015
$
1,474
$
$
$
$
$
91
(33)
58
$
481
18
$
$
99
(17)
82
485
19
561
41
$
$
1,020
64
2.3 years
3.2 years
3.4 years
4.2 years
6.9%
2.0%
6.7%
2.0%
Lease Costs
The table below presents certain information related to lease costs and finance and operating leases:
Operating lease cost:
Finance lease cost:
Amortization of leased assets
Interest on lease liabilities
Total finance lease cost
Years ended December 31,
2021
2020
$
514
547
20
1
21
$
17
3
20
515
42
967
366
The table below presents supplemental cash flow information related to lease:
Years ended December 31,
2021
2020
(in Thousands)
Cash paid for amounts included in the measurement of leases liabilities:
Operating leases
Finance leases
$
$
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
Finance leases
$
526 $
20 $
- $
-
Undiscounted Cash Flows
The table below reconciles the undiscounted cash flows for each of the first five years and total of the remaining years to the
finance lease liabilities and operating lease liabilities recorded on the balance sheet.
Year ended December 31,
2022
2023
2024
2025
Total minimum lease payments
Less: amount of lease payments representing interest
Present value of future minimum lease payments
Less: Current leases obligations
Long-term leases obligations
F-30
Operating
Leases
Finance
Leases
$
$
516 $
338
181
54
1,089
(47)
1,042
(481)
561 $
19
19
19
4
61
(2)
59
(18)
41
Right-of-use assets by geographical location were as follows:
Korea
Israel
U.S.
Total
December 31,
2021
2020
(in thousands)
$
$
432 $
365
218
1,015 $
683
496
295
1,474
NOTE 10 – COMMITMENTS AND LICENSE AGREEMENTS
See Note 11 for additional commitments for funding of the ventures of the company.
a.
Tel Hashomer Medical Research, Infrastructure and Services Ltd (“THM”)
On February 2, 2012, the Company’s Israeli Subsidiary entered into a licensing agreement with THM. According to the
agreement, the Israeli Subsidiary was granted a worldwide, royalty bearing, exclusive license to trans-differentiation of cells to
insulin producing cells, including the population of insulin producing cells, methods of making this population, and methods of using
this population of cells for cell therapy or diabetes treatment developed by Dr. Sarah Ferber of THM.
As consideration for the license, the Israeli Subsidiary will pay the following to THM:
1)
2)
3)
4)
A royalty of 3.5% of net sales;
16% of all sublicensing fees received;
An annual license fee of $15 thousand, which commenced on January 1, 2012 and shall be paid once every year
thereafter. The annual fee is non-refundable, but it shall be paid each year against the royalty noted above, to the
extent that such are payable, during that year; and
Milestone payments as follows:
a.
b.
c.
d.
e.
$50 thousand on the date of initiation of Phase I clinical trials in human subjects;
$50 thousand on the date of initiation of Phase II clinical trials in human subjects;
$150 thousand on the date of initiation of Phase III clinical trials in human subjects;
$750 thousand on the date of initiation of issuance of an approval for marketing of the first product by the
FDA; and
$2 million when worldwide net sales of Products (as defined in the agreement) have reached the amount
of $150 million for the first time, (the “Sales Milestone”).
As of December 31, 2021, the Israeli Subsidiary had not reached any of these milestones.
In the event of closing of an acquisition of all of the issued and outstanding share capital of the Israeli Subsidiary and/or
consolidation of the Israeli Subsidiary or the Company into or with another corporation (“Exit”), the THM shall be entitled to choose
whether to receive from the Israeli Subsidiary a one-time payment based, as applicable, on the value of either 463,651 shares of
common stock of the Company at the time of the Exit or the value of 1,000 shares of common stock of the Israeli Subsidiary at the
time of the Exit.
b. Department De La Gestion Financiere Direction De L’analyse Financiere (“DGO6”)
(1) On November 17, 2014, the Belgian Subsidiary, received the formal approval from the DGO6 for a Euro 2 million ($2.4
million) support program for the research and development of a potential cure for Type 1 Diabetes. The financial support was
composed of Euro 1.085 million (70% of budgeted costs) grant for the industrial research part of the research program and a further
recoverable advance of Euro 930 thousand (60% of budgeted costs) of the experimental development part of the research program.
In December 2014, the Belgian Subsidiary received advance payment of Euro 1.209 million under the grant. The grants are subject
to certain conditions with respect to the Belgian Subsidiary’s work in the Walloon Region. In addition, the DGO6 is also entitled to a
royalty upon revenue being generated from any commercial application of the technology. In 2017 the Company received by the
DGO6 final approval for Euro 1.8 million costs invested in the project out of which Euro 1.2 million funded by the DGO6. As of
December 31, 2021, the Company repaid to the DGO6 a total amount of approximately $145 thousand and amount of $264 thousand
was recorded in other payables.
F-31
(2) In April 2016, the Belgian Subsidiary received the formal approval from DGO6 for a Euro 1.3 million ($1.5 million)
support program for the development of a potential cure for Type 1 Diabetes. The financial support was awarded to the Belgium
Subsidiary as a recoverable advance payment at 55% of budgeted costs, or for a total of Euro 717 thousand ($800 thousand). The
grant will be paid over the project period. The Belgian Subsidiary received advance payment of Euro 438 thousand ($537 thousand).
Up through December 31, 2021, an amount of Euro 358 thousand ($406 thousand) was recorded as deduction of research and
development expenses and an amount of Euro 74 thousand was recorded as advance payments on account of grant.
(3) On October 8, 2016, the Belgian Subsidiary received the formal approval from the DGO6 for a Euro 12.3 million ($12.8
million) support program for the GMP production of AIP cells for two clinical trials that will be performed in Germany and
Belgium. The project will be conducted during a period of three years commencing January 1, 2017. The financial support is
awarded to the Belgium subsidiary at 55% of budgeted costs, a total of Euro 6.8 million ($7 million). The grant will be paid over the
project period. On December 19, 2016, the Belgian Subsidiary received a first payment of Euro 1.7 million ($2 million). As of
December 31, 2021 the program is pending for extension approval.
(4) In December 2020, the Belgian Subsidiary received the formal approval from DGO6 for a Euro 2.9 million ($3.5
million) support program for research on Dermatitis Treatments and Wound Healing Using Cell Regenerative Technologies. The
financial support was awarded to the Belgium Subsidiary as a recoverable advance payment at 60% of budgeted costs, or for a total
of Euro 1.7 million ($2.1 million). The grant will be paid over the project period. The Belgian Subsidiary received advance payments
of Euro 301 thousand ($366 thousand) in 2020 and of Euro 392 thousand ($445 thousand) in 2021. The research program started in
2021.
c. Israel-U.S. Binational Industrial Research and Development Foundation (“BIRD”)
On September 9, 2015, the Israeli Subsidiary entered into a pharma Cooperation and Project Funding Agreement (CPFA)
with BIRD and Pall Corporation, a U.S. company. BIRD awarded a conditional grant of up to $400 thousand each (according to
terms defined in the agreement), for a joint research and development project for the use of Autologous Insulin Producing (AIP)
Cells for the Treatment of Diabetes (the “Project”). Company received a total of $299 thousand under the grant. The project was
completed in 2019. The grant is to be repaid at the rate of 5% of gross sales generated from the Project. To date no sales have been
generated.
d. Korea-Israel Industrial Research and Development Foundation (“KORIL”)
On May 26, 2016, the Israeli Subsidiary and the Korean Subsidiary entered into a pharma Cooperation and Project Funding
Agreement (CPFA) with KORIL. KORIL will make a conditional grant of up to $400 thousand to each company (according to terms
defined in the agreement), for a joint research and development project for the use of AIP Cells for the Treatment of Diabetes (the
“Project”). The Project started on June 1, 2016. The project was completed in 2021 and the Company is currently awaiting the grant
audit report from KORIL. The grant is to be repaid at the yearly rate of 2.5% of gross sales. To date no sales have been generated. As
of December 31, 2021, the Israeli Subsidiary and the Korean Subsidiary received $440 thousand under the grant.
e. BIRD Secant
On July 30, 2018, Orgenesis Inc and OBI entered into a collaboration agreement with Secant Group LLC (“Secant”). Under
the agreement, Secant will engineer and prototype 3D scaffolds based on novel biomaterials and technologies involving
bioresorbable polymer microparticles, while OBI will provide expertise in cell coatings, cell production, process development and
support services. Under the agreement, Orgenesis is authorized to utilize the jointly developed technology for its autologous cell
therapy platform, including its Autologous Insulin Producing (“AIP”) cell technology for patients with Type 1 Diabetes, acute
pancreatitis and other insulin deficient diseases. In 2018, OBI entered into a Cooperation and Project Funding Agreement (CPFA)
with the BIRD fund, which provided certain grant funding, and Secant.
As of December 31, 2021, OBI had received a total amount of $425 thousand under the grant and the project was
completed. The grant is to be repaid at the yearly rate of 5% of gross sales. To date no sales have been generated.
F-32
f. Hemogenyx Pharmaceuticals PLC.
On October 18, 2018, the Company and Hemogenyx Pharmaceuticals PLC., a corporation with its registered office in the
United Kingdom and Hemogenyx-Cell (“H-Cell”), a corporation with its registered office in Belgium (together “Hemo”), who are
engaged in the development of cell replacement bone marrow therapy technology, entered into a Collaboration Agreement (the
“Hemo Agreement”) pursuant to which the parties will collaborate in the funding, continued development, and commercialization of
the Hemo technology via Hemo. Pursuant to the Hemo agreement the Company and Hemogenyx LLC (“Hemo-LLC”) (a wholly
owned US subsidiary of Hemo) entered into a loan agreement on November 7, 2018 according to which the Company agreed to loan
Hemo-LLC not less than $1 million by way of a convertible loan. On November 25, 2018 the Company and Hemo entered into a
License and Distribution agreement according to which Company received the worldwide rights to market the products under the
agreement in consideration for the payment of a 12% royalty all subject to the terms of the agreement. As of December 31, 2021, no
royalty incurring sales were made. On November 25, 2018, the Company and H-Cell signed an Exclusive Manufacturing agreement
according to which the Company will receive the exclusive right to manufacture certain of H-Cell products. The Company recorded
the loan amounts as research and development expenses under ASC 730-10-50 and 20-50 in 2018 and 2019. The loan amounts were
repaid in 2021 and presented as other income.
g. Immugenyx LLC.
On October 16, 2018, the Company and Immugenyx LLC., a corporation with its registered office in the USA (“Immu”),
which is engaged in the development of technology related to the production and use of humanized mice entered into a Collaboration
Agreement (the “Immu Agreement”) pursuant to which the parties will collaborate in the funding, continued development, and
commercialization of the Immu technology. Pursuant to the agreement, the Company received the worldwide rights to market the
products under the agreement in consideration for the payment of a 12% royalty all subject to the terms of the agreement. As of
December 31, 2021 no royalty incurring sales were made. Pursuant to the Immu agreement the Company and Immu entered into a
loan agreement on November 7, 2018 according to which the Company agreed to loan Immu not less than US$1 million by way of a
convertible loan. The Company recorded the loan amounts as research and development expenses under ASC 730-10-50 and 20-50
in 2018 and 2019. The loan amounts were repaid in 2021 and were presented as other income.
h. BG Negev Technologies and Applications (“BGN”).
On August 2, 2018, Company entered into a licensing agreement with BGN. According to the agreement, the Company was
granted a worldwide, royalty bearing, exclusive license to develop and commercialize a novel alginate scaffold technology for cell
transplantation focused on autoimmune diseases.
On November 25, 2018, the Company entered into a further licensing agreement with BGN. According to the agreement,
the U.S. Subsidiary was granted a worldwide, royalty bearing, exclusive license to develop and commercialize technology directed to
RAFT modification of polysaccharides and use of a bioreactor for supporting cell constructs.
As of December 31, 2021 no royalty incurring sales were made.
In January 2022, the Company terminated both of the licensing agreements with BGN effective April 26, 2022.
i. Sponsored Research and Exclusive License Agreement with Columbia University
Effective April 2, 2019, the Company and The Trustees of Columbia University in the City of New York, a New York
corporation, (“Columbia”) entered into a Sponsored Research Agreement (the “SRA”) whereby the Company will provide financial
support for studying the utility of serological tumor marker for tumor dynamics monitoring. Under the terms of the SRA, the
Company shall pay $300 thousand per year for three years, or for a total of $900 thousand, with payments of $150 thousand due
every six months.
F-33
Effective April 2, 2019, the Company and Columbia entered into an Exclusive License Agreement (the “Columbia License
Agreement”) whereby Columbia granted to the Company an exclusive license to discover, develop, manufacture, sell, and otherwise
distribute certain product in the field of cancer therapy. In consideration of the licenses granted under the Columbia License
Agreement, the Company shall pay to Columbia (i) a royalty of 5% of net sales of any product sold which incorporates a licensed
Columbia patent and (ii) 2.5% of net sales of other products. In addition, the Company shall pay a flat $100 thousand fee to
Columbia upon the achievement of each regulatory milestone. As of December 31, 2021, no royalty incurring sales were made.
j. Regents of the University of California
In December 2019, the Company and the Regents of the University of California (“University”) entered into a joint research
agreement in the field of therapies and processing technologies according to an agreed upon work plan. According to the agreement,
the Company will pay the University royalties of up to 5% (or up to 20% of sub-licensing sales) in the event of sales that includes
certain types of University owned IP. As of December 31, 2021, no royalty incurring sales were made.
k. Caerus Therapeutics Inc
In October 2019, the Company and Caerus Therapeutics (“Caerus”), a Virginia company, concluded a license agreement
whereby Caerus granted the Company an exclusive license to all Caerus IP relating to Advance Chemeric Antigen Vectors for
Targeting Tumors for the development and/or commercialization of certain licensed products. In consideration for the License
granted to the Company under this Agreement, the Company shall pay Caerus annual maintenance fees and royalties of sales of up to
5% and up to 18% of sub-license fees. As of December 31, 2021, no royalty incurring sales were made.
l. Tissue Genesis, LLC (“Tissue Genesis”)
Included in the Koligo acquisition (See Note 4) were the assets of Tissue Genesis. The Company is committed to paying the
previous owners of Tissue Genesis up to $500 thousand upon the achievement of certain performance milestones and earn-out
payments on future sales provided that in no event will the aggregate of the earn-out payments exceed $4 million. To date, no
milestones have been reached.
m. University of Louisville research foundation (“ULRF”)
Koligo had exclusively licensed patents and technology from the ULRF related to the revascularization and 3D printing of
cell and tissue for transplant (“ULRF licensed products”). The Company is committed to utilizing commercial reasonable efforts to
achieving certain milestones regarding the ULRF licensed products. Pursuant to the license, Company will pay ULRF royalties of
3.5% of sales and certain performance milestones. During the year ended December 31, 2021, Company paid $40 thousand under its
obligations.
n. Neuro-Immunotherapy Exclusive License Agreement
During the twelve months ended December 31, 2021, the Company entered into an exclusive license agreement in the field
of neuro-immunotherapy. Pursuant to the agreement, the Company received an exclusive, worldwide, sublicensable, royalty-bearing
license of certain technology and patents for the purpose of developing, manufacturing, using, and commercializing the licenced
technology. Royalties of between 0.5% and 5% on royalty-bearing sales are payable for up to 15 years from the date of first sale in
any country in which licensed products are sold, and sublicense fees are payable at the rate of 12% on sublicense income (but no less
than two percent (2.0%) of sublicenses’ net sales). Pursuant to the agreement, the Company is required to invest within thirty-six
(36) months of the effective date an aggregate amount of at least $2 million in its efforts to develop the licensed technology.
o. Savicell
On June 14, 2021, the Company and Savicell Ltd (“Savicell”) entered into a collaboration agreement (the “Savicell
Agreement”) to collaborate in the evaluation, continued development, validation, and use of Savicell’s platform designed for the
early detection and diagnosis of diseases and conditions and for quality control and monitoring purposes, in conjunction with the
Company’s systems. Pursuant to the Savicell Agreement, the Company will provide to Savicell funding for the performance of
certain tasks agreed upon by the parties in a work plan. In consideration for such funding, Savicell will supply the Company with
products developed under the Savicell Agreement at preferential rates and grant to the Company a worldwide exclusive licence to
sell such products in the Company’s point-of-care network of hospitals, clinics and institutions for quality control and monitoring of
manufacturing and processing of autologous immune cells manipulated by cell and gene therapies. The Company will be required to
pay a 10% royalty for all gross sales of such products developed under the Savicell Agreement. As of December 31, 2021, no royalty
incurring sales were made.
F-34
p. Stromatis Pharma
On June 15, 2021, the Company and Stromatis Pharma Inc. (“Stromatis”) entered into a Collaboration and Sublicense
Agreement (the “Stromatis Agreement”) to collaborate in refining methods for GMP manufacturing of CAR-T/CAR-NK CT109; and
the development and validation of the Stromatis technology as it relates to the CAR-T/CAR-NK CT109 antibody up to and inclusive
of filing of Investigational New Drug Application relating to Stromatis’ CAR-T/CAR-NK CT109 antibody (“Licensed Product”), in
accordance with the agreed project plan (“Project”). The Company will fund the Project by providing Stromatis an amount of $1.2
million such funding to be provided based on approved projects. Stromatis will grant the Company certain perpetual, irrevocable
royalty free and fully paid-up exclusive rights to manufacture, process and supply the Licensed Product (“Manufacturing Rights”)
and perpetual, irrevocable, royalty bearing exclusive rights to market and sell and offer for sale the Licensed Product within the
Company’s point of care network (“Marketing Rights”). As of December 31, 2021, no royalty incurring sales were made.
Stromatis has the option to convert the exclusive Manufacturing Rights to non-exclusive rights subject to repayment by
Stromatis of an amount equal to funding provided by the Company and an additional payment by Stromatis of an ongoing revenue
share of five percent (5%) of revenues of any kind received by Stromatis or its affiliates from the sale or transfer of Licensed
Products or license of rights under the licensed technology in relation to the Licensed Products. The Company shall pay Stromatis in
consideration for the Marketing Rights and royalties equal to 12% of net revenues of Licensed Products received by the Company.
The Company advanced to Stromatis an initial sum of $500 thousand under the Stromatis Agreement, which was recorded as cost of
services and other research and development expenses, net.
q. Helmholtz Zentrum München Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)) (“HMGU”)
During September 2021, HMGU granted an exclusive licence under HGMU owned patent rights and non-exclusive license
under HGMU know how and licensed materials, to the Company in the field of certain human stem cells. The Company incurred a
one-time up-front payment of approximately $60 thousand and annual license maintenance fees of between $18 thousand and $36
thousand. In addition, payments will be due by the Company upon certain milestones. The agreement also includes payment of
royalties of between 3% and 4% on net sales of licensed product (with a minimum annual royalty of Euro 200,000, creditable against
royalties on net sales incurred during such contract year) and 5% in service revenues and payment of between 10% and 18% on
sublicense revenues.
NOTE 11 – COLLABORATIONS
a. Adva Biotechnology Ltd.
On January 28, 2018, the Company and Adva Biotechnology Ltd. (“Adva”), entered into a Master Services Agreement
(“MSA”), pursuant to which the Company and/or its affiliates provided certain services relating to development of products for
Adva.
In consideration for and subject to the fulfillment by the Company of certain funding commitments which were completed
in 2019, Adva agreed that upon completion of the development of the products, the Company and/or its affiliates and Adva shall
enter into a supply agreement pursuant to which for a period of eight (8) years following execution of such supply agreement, the
Company and/or its affiliates (as applicable) is entitled (on a non-exclusive basis) to purchase the products from Adva at a specified
discount pricing from their then standard pricing. The Company and/or its affiliates were also granted a non-exclusive worldwide
right to distribute such products, directly or indirectly. The MSA shall remain in effect for 10 years unless earlier terminated in
accordance with its terms.
F-35
b. IRB Approval for Liver Cell Collection
On April 29, 2019, the Company received Institutional Review Board (“IRB”) approval to collect liver biopsies from
patients at Rambam Medical Center located in Haifa, Israel for a planned study to confirm the suitability of liver cells for
personalized cell replacement therapy for patients with insulin-dependent diabetes resulting from total or partial pancreatectomy. The
liver cells are intended to be bio-banked for potential future clinical use.
The goal of the proposed study, entitled “Collection of Human Liver Biopsy and Whole Blood Samples from Type 1
Diabetes Mellitus (T1DM), Total or Partial Pancreatectomy Patients for Potential use as an Autologous Source for Insulin Producing
Cells in Future Clinical Studies,” is to confirm the suitability of the liver cells for personalized cell replacement therapy, as well as
eligibility of patients to participate in a future clinical study, as defined by successful AIP cell production from their own liver
biopsy. The secondary objective of the study is to evaluate patients’ immune response to AIPs based on the patient’s blood samples
and followed by subcutaneous implantation into the patients’ arm which would represent the first human trial. The Company has
developed a novel technology based on technology licensed from Tel Hashomer Medical Research Infrastructure and Services Ltd.,
utilizing liver cells as a source for AIP cells as replacement therapy for islet transplantation.
During the study, liver samples will be collected and then processed and stored in specialized, clinical grade, tissue banks
for potential clinical use. The propagated cells will be maintained in a tissue bank and are intended to be utilized in a future clinical
study, in which the cells will be transdifferentiated and administered back to the patients as a potential treatment. This personalized
autologous process will be performed under our POC platform in which the patient liver samples are processed, cryopreserved and
potentially re-injected, all in the medical center under clinical grade/GMP level conditions.
In June 2019, the Company received additional Institutional Review Board (“IRB”) approval to collect liver biopsies from
patients at a leading medical center in USA for a planned study to confirm the suitability of liver cells for personalized cell
replacement therapy for patients with insulin-dependent diabetes resulting from total pancreatectomy (the granted Orphan Drug
Designation indication). Two liver samples have been processed and stored for potential clinical use.
c. FDA Approval for Orphan Drug Designation for AIP Cells
On June 11, 2019, the FDA granted Orphan Drug Designation for the Company’s AIP cells as a cell replacement therapy for
the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy (“TP”) due to chronic pancreatitis.
d. Johns Hopkins University
During the year ended December 31, 2021, the Company and Johns Hopkins University entered into a sublease and
construction agreement for the establishment of a clinical therapeutic development and point of care center in Maryland of
approximately 6,830 rentable square feet. Pursuant to the agreement, the Company will pay for certain leasehold improvements in
the premises according to plans and specifications to be agreed upon. The Company advanced an initial $510 thousand for this
purpose. The costs of the leasehold improvements will be offset by up to $5 million pursuant to a grant from the Board of Public
Works of the State of Maryland to Johns Hopkins University. The annual base rent is initially $260 thousand per year, increasing to
$324 thousand per year over the 10-year initial lease term. The Company has an option to renew the sublease for two additional
periods of five years each under the same terms and conditions. The Company is expected to gain occupancy of the premises during
the second quarter of 2022.
e. Joint venture agreements
The Company has entered into joint venture agreements (“JVAs”) with its joint venture partners (Company and partner are
referred to as “Parties”) to facilitate the collaboration in the field of CGT development and development of the Company’s
worldwide POCare network. During 2021, the Company and / or JV partner continued the POCare network expansion in each of the
territories as relevant. The provisos and the table below summarize the major agreements. CGT and POCare activities covered by the
JVAs include the development, marketing, clinical development, and commercialization of the Company’s and / or partner’s products
within defined territories. The extent of the collaboration is set out in each agreement.
F-36
Unless otherwise stated in the table below the JVAs include the following provisos (“Provisos”):
1.
2.
3.
4.
5.
6.
7.
8.
9.
The incorporation of a joint venture entity (“JVE”) in which the Company will hold between 49% and 51% of the equity.
The partner will manage the joint venture activities until the JVE is incorporated.
The JVE will be managed by a steering committee consisting of 3 members which will act as the entity’s board of directors.
The Company is entitled to appoint 1 member, the partner is entitled to appoint 1 member, and Company and partner will
jointly appoint the third member.
The Company has the right to exercise a call option to acquire the partner’s share in the JVE based on the occurrence of
certain events and according to an agreed upon mechanism.
The funding of the parties’ investment in the joint venture share may be made in the form of cash investment and / or in-
kind services. The Company’s cash investment may be in the form of additional shares, a convertible loan, and/or procured
services.
Each of the parties may agree to provide additional funding to the JVE to cover the operation costs and such additional
funding may be in the form of in-kind contributions. The Company’s investments may be made in the form of a cash
investment for additional shares, a convertible loan, and/or procured services. Procured services refer to certain services that
the Company has engaged the partner or the JVE to provide the Company with, in support of Company’s activity. All results
of these procured services shall be owned by Company.
As appropriate, the parties will grant to the JVE an exclusive or nonexclusive, sublicensable, royalty-bearing, right and
license to the relevant party’s background IP as required solely to manufacture, distribute and market and sell the party’s
products within the territory. Each party shall receive royalties in an amount of ten percent (10%) of the net sales generated
by the JVE and/or its sublicensees.
Once the JVE is profitable, the Company will be entitled (in addition to any of its rights as the holder of the JVE) to an
additional share of fifteen percent (15%) of the JVE’s GAAP profit after tax, over and above all rights granted pursuant to
Company’s participating interest in the JVE.
Unless otherwise stated, the relevant JVE had not been incorporated by December 31, 2021.
Name of party (and country of origin)
Theracell Advanced Biotechnology SA (Greece)
POC Territory
Greece, Turkey, Cyprus, Israel and
Balkans
Broaden Bioscience and Technology Corp (USA)
Certain projects in China and the
Mircod LLC (US)
Image Securities FZC (UAE) (a related party)
Cure Therapeutics (Korea)
Kidney Cure Ltd (Israel)
Sescom Ltd (Israel)
Educell D.O.O
(Slovenia)
Med Centre for Gene and Cell Therapy FZ-LLC
(UAE)
Mida Biotech B.V.
(Netherlands)
First Choice International Company, Inc (USA)
SBH Sciences Inc (USA)
Celleska Pty Ltd (Australia)
Revitas SA (Belgium)
Deep Med IO Ltd. (UK)
Middle East
Russia
India
Korea and Japan
N / A
N / A
Croatia, Serbia and Slovenia
UAE
Netherlands, Lithuania,
Spain,
Switzerland, Germany, Belgium or
any other countries within West
Europe
Panama and certain other Latin
American countries
N / A
Australia
N / A
N / A
F-37
Notes
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(1)
(2)
(3)
(4)
(5)
(6)
The Theracell JVE was incorporated in Greece under the name of Theracell Laboratories Ltd. (See Note 12). In November
2021, the Company loaned approximately $800 thousand to Theracell the proceeds of which will be used to by Theracell to
guarantee its obligations under a lease agreement for a biopark facility in Greece which may also be used for the Company’s
POC activities. The loan bears 8% annual interest and will be repaid at the termination of the lease. The lease period is 20
years. The loan is shown as a long-term asset on the balance sheet. The Company also loaned approximately $287 thousand
as part of its obligations under the JVA to Theracell Laboratories Ltd. The 3-year loan bears interest at the annual rate of 8%
and has been shown as a long-term asset on the balance sheet.
Under the Mircod JVA, provisos 7 and 8 do not apply. Subject to payment by the Company of the contribution amount, the
JVA will grant Company an exclusive, perpetual, irrevocable, royalty free and fully paid up and sublicensable license to use
the Project IP for research and development and for the manufacturing, processing, supplying, and use of products based on
point of care manufacturing and/or processing of treatments for patients and for use in hospitals, medical centers and
academic institution settings solely outside the territory. In order for the Company to fulfil its obligations pursuant to
proviso 6, the Parties concluded a convertible loan agreement pursuant to which Company shall lend to Mircod Biotech Inc
up to $5 million. Mircod Biotech Inc., performs technological development work ordered by Company. The loan bears
simple interest in the amount of 6% annually. During 2021, the Company had transferred $1,640 thousand under the loan
agreement. The Company recorded the loan amounts as research and development expenses under ASC 730.
On August 24, 2021, the Company entered into a convertible loan agreement with Image whereby, pursuant to the terms of
the Image joint venture agreement, the Company agreed to loan Image up to $5 million. The loan bears interest at the rate of
6% and is subject to repayment by August 21, 2022, unless the Company agrees to an extension or the loan is converted
into shares of Image or, if established, Image’s Indian joint venture. As of December 31, 2021, the Company transferred $3
million to Image under the loan agreement, and this has been reflected as a short-term asset on the Company’s balance
sheet.
The Kidney Cure JVE was incorporated in Switzerland under the name of Butterfly Biosciences Sarl (“BB”) (See Note 12).
The Company recorded the expenses paid to BB as research and development expenses under ASC 730.
Under the Sescom JVA, the parties will collaborate in the field of the assessment of relevant tools and technologies to be
used in the Company’s information security system (the “ISS”); (ii) the implementation of the ISS within the Company and
in the Company’s point-of-care network; and (iii) the operation and maintenance of the ISS. Provisos 7 and 8 do not apply
to this JVA. Company has agreed to provide the Sescom JVE with: (a) a non-exclusive, not transferable and non-
sublicensable worldwide royalty-free license to use its background IP to the extent required for carrying out certain
activities by the Sescom JVE; and (b) access to its point-of-care network and relevant data to be used for the certain
activities. The Company recorded the expenses paid to Sescom under the JVA as research and development expenses under
ASC 730.
During 2021, the Company and Educell entered into a convertible loan agreement whereby the Company, pursuant to its
obligations under the JVA, agreed to loan up to $1.2 million. As at December 31, 2021, the Company had transferred $970
thousand under the loan agreement. The Company recorded the loan amounts as research and development expenses under
ASC 730. The loan bears interest at the annual rate of 4.5% and is repayable after 5 years. At Company’s election, the loan
is convertible into equity of borrower, or JVE entity if incorporated, at a valuation to be determined by an independent third
party.
(7)
See note 21.
F-38
(8)
(9)
Under the First Choice JVA, each party shall, subject to fulfilment of the party’s JVA, grant the Panama JV Entity an
exclusive license to certain intellectual property of the part to develop and commercialize the party’s products in the
territory, subject to minimum sales obligations. In consideration of such license, the Panama JV shall pay the relevant part
royalties at the rate of 15% of the Panama JVE net sales of party’s products sold in the territory. The First Choice JVE will
be managed by a steering committee consisting of 5 members which will act as the entity’s board of directors. Each of the
Partners is entitled to appoint 2 members, and Company and partner will jointly appoint the fifth member. Under the First
Choice JVA, provisos 5,6,7 and 8 do not apply. There was no material activity under the First Choice JVA during 2021.
Pursuant to the SBH JVA the parties will collaborate in the field of gene and cell therapy development, process and services
of bio-exosome therapy products and services in the areas of diabetes, liver cells and skin applications, including wound
healing. According to the JVA, the board of directors of the SBH JVE shall be comprised of three directors with one
appointed by SBH and two appointed by the Company. Provisos 7 and 8 do not apply to the SBH JVA. There was no
material activity under the SBH JVA during 2021.
(10)
The Celleska JVA was signed in 2021.
(11)
(12)
The Revitas JVE was incorporated in Belgium under the name of RevaCel Srl during 2021 (See Note 12). The Company
holds 51% of the share capital of RevaCel and has the right to appoint two members to the RevaCel board of directors. The
Company’s partner, Revatis SA, (a Belgian entity) holds the remaining 49% and has the right to appoint two members to the
Revacel board of directors. The fifth RevaCel board member will be an independent industry expert appointed with the
mutual agreement of the Company and Revatis SA. The Company recorded the expenses paid to Revitas and RevaCel under
the JVA as research and development expenses under ASC 730.
In November 2021, Deep Med IO Ltd (“Deep Med”) and Company entered into a JVA. The parties agreed to collaborate in
the development and commercialization of an AI-powered system to be used in the manufacturing and/or quality control of
CGTs, in accordance with an agreed upon work plan. Under the JVA, the Company committed to provide Deep Med with
funding in the amount of up to $3 million at an agreed upon valuation (the “Funding”), for carrying out the Project in
accordance with the work plan. Company was granted an option, during the period ending upon the earlier of (i) three years
after the effective date of the JVA or (ii) the next financing round of the Deep Med (in which at least $1 million is invested
in the capital of Deep Med), to invest additional amounts of up to $3 million in Deep Med based on a pre-money valuation
of $6 million. The Company recorded the expenses paid to Deep Med under the JVA as research and development expenses
under ASC 730.
NOTE 12 – INVESTMENTS IN ASSOCIATES, NET
a. Theracell Laboratories Private Company
During 2020, the Company and Theracell, pursuant to the Greek JVA (See Note 11) incorporated the Greek JVA entity
known as Theracell Laboratories Private Company (“TLABS”). The Theracell Project activities will be run through TLABS. The
Company and Theracell each hold a 50% participating interest in TLABS. Due to the Company’s significant influence over the JVE
the Company applies the equity method of accounting.
b. Butterfly Biosciences Sarl
During 2020, the Company and Kidney Cure (“KC”), pursuant to the Kidney Cure JVA (See Note 11) incorporated the KC
JV Entity known as Butterfly Biosciences Sarl (“BB”) in Switzerland. BB will be involved in the (i) implementation of a point-of-
care strategy; (ii) assessment of the options for development and manufacture of various cell-based types (including kidney derived
cells, MSC cells, exosomes, gene therapies) development; and (iii) development of protocols and tests for kidney therapies (the “BB
Project”). The Company holds a 49% participating interest in BB and Kidney Cure holds the remaining 51%. Due to the Company’s
significant influence over the JVE the Company applies the equity method of accounting.
F-39
c. RevaCel
During 2021, the Company and Revatis S.A (“Revatis”), pursuant to the Revatis JVA (See Note 11) incorporated the
Revatis JV Entity known as RevaCel Srl (“RevaCel”) in Belgium. RevaCel will develop products in the field of muscle-derived
mesenchymal stem/progenitor cells. The Company holds a 51% participating interest in RevaCel and Revatis holds the remaining
49% and is entitled to appoint 2 of the 5 members of RevaCel’s board. Due to the Company’s significant influence over the JVE the
Company applies the equity method of accounting.
d. The table below sets forth a summary of the changes in the investments for the years ended December 31, 2021 and December 31,
2020:
December 31,
2021
2020
(in thousands)
Opening balance
Investments during the period
Share in net loss of associated companies
Exchange rate differences
Total
$
$
175 $
260
(272)
(11)
152 $
-
69
106
-
175
NOTE 13 – EQUITY
a. Financings
On January 20, 2020, the Company entered into a Securities Purchase Agreement (the “January Purchase Agreement”) with
certain investors pursuant to which the Company issued and sold, in a private placement (the “Offering”), 2,200,000 shares of
Common Stock at a purchase price of $4.20 per share (the “Shares”) and warrants to purchase up to 1,000,000 shares of Common
Stock at an exercise price of $5.50 per share (the “Warrants”) which are exercisable between June 2021 and January 2023. The
Company received gross proceeds of approximately $9.24 million before deducting related offering expenses in the amount of $0.8
million. The fair value of those warrants as of the date of grant using the Black-Scholes valuation model was $1.911 million.
b. Tamir Biotechnology, Inc.
For the acquisition of Tamir, see Note 4.
As aggregate consideration for the acquisition, the Company issued an aggregate of 3,400,000 shares of Common Stock to
Tamir.
c. Koligo Therapeutics Inc.
For the acquisition of Koligo, see Note 4.
Pursuant to the terms of the Merger Agreement, at the Effective Time, the shares of capital stock of Koligo that were issued
and outstanding immediately prior to the Effective Time were automatically cancelled and converted into the right to receive, subject
to customary adjustments, an aggregate of 2,063,713 shares of Company common stock which have been issued to Koligo’s
accredited investors (with certain non-accredited investors being paid solely in cash in the amount of approximately $20 thousand).
In addition, the Company issued 66,910 shares to Maxim Group LLC for advisory services in connection with the Merger.
F-40
d. Warrants
A summary of the Company’s warrants granted to investors and as finder’s fees as of December 31, 2021, and December
31, 2020 and changes for the periods then ended is presented below:
December 31,
2021
2020
Warrants outstanding at the
beginning of the period
Changes during the period:
Issued
Exercised
Expired
Warrants outstanding and
exercisable at end of the
period*
Weighted
Average
Exercise Price
$
Number of
Warrants
Weighted
Average
Exercise Price
$
Number of
Warrants
7,070,241
926,413
(319,811)
(4,634,323)
6.20
6.24
6.19
6.29
6,010,087
1,344,606
-
(284,452)
6.35
5.64
-
6.53
6.20
3,042,521
6.09
7,070,241
During the year ended December 31, 2021, the Company received approximately $1.9 million from the exercise of warrants
for the purchase of the Company’s Common Stock at a weighted average price of $6.24, and 305,523 shares were issued accordingly.
As of December 31, 2021 and December 31, 2020, there are no warrants that are subject to exercise price adjustments.
e. Treasury shares
During the year ended December 31, 2021, the Company repurchased its shares under a stock repurchase plan (the “Stock
Repurchase Plan”). The following table summarizes the share repurchase activity pursuant to the Stock Repurchase Plan during the
year ended December 31, 2021.
Total Number of
Shares
Purchased
Average Price
Paid per Share
Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
Maximum Value that
May Yet Be Purchased
Under the Plans or
Programs
(in thousands)
January 2021
April 2021
May 2021
November 2021
2,306 $
8,850
195,625
24,477
231,258 $
4.45 $
4.49
4.34
4.32
4.34 $
10,255 $
39,730
848,234
105,806
1,004,025 $
9,740
9,699
8,841
8,734
8,734
The following table summarizes the share repurchase activity from the inception of the Stock Repurchase Plan through
December 31, 2020.
Total Number of
Shares
Purchased
Average Price
Paid per Share
October 2020
November 2020
December 2020
$
8,807 $
101
46,401
55,309$ $
4.47 $
4.50
4.47
4.47 $
F-41
Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
Maximum Value that
May Yet Be Purchased
Under the Plans or
Programs
(in thousands)
8,807 $
101
46,401
55,309 $
9,960
9,960
9,750
9,750
g. Controlled Equity Offering Sales Agreement In December 2018, the Company entered into a Controlled Equity Offering
Sales Agreement, or Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, pursuant to which the Company may offer
and sell, from time to time through Cantor, shares of its common stock having an aggregate offering price of up to $25.0
million. The Company will pay Cantor a commission rate equal to 3.0% of the aggregate gross proceeds from each sale.
Shares sold under the Sales Agreement will be offered and sold pursuant to the Company’s Shelf Registration Statement on
Form S-3 (Registration No. 333-223777) that was declared effective by the Securities and Exchange Commission on March
28, 2018, or the Shelf Registration Statement, and a prospectus supplement and accompanying base prospectus that the
Company filed with the Securities and Exchange Commission on December 20, 2018. The Company has not yet sold any
shares of its common stock pursuant to the Sales Agreement.
NOTE 14 – INCOME (LOSS) PER SHARE
The following table sets forth the calculation of basic and diluted loss per share for the periods indicated:
Years ended December 31,
2021
2020
(in thousands, except per share data)
Basic and diluted:
Net loss from continuing operations attributable to Orgenesis Inc.
$
18,053 $
95,088
Net income from discontinued operations attributable to Orgenesis Inc. for
loss per share
Adjustment of redeemable non-controlling interest to redemption amount
Net (income) loss attributable to Orgenesis Inc. for loss per share
Weighted average number of common shares outstanding
Loss per common share from continuing operations
Net income common share from discontinued operations
Net (income) loss per share
$
$
$
-
-
-
18,053
24,273,658
0.74 $
- $
0.74 $
(96,198)
(5,160)
(101,358)
(6,270)
21,320,314
4.46
(4.75)
(0.29)
For the year ended December 31, 2021, and December 31, 2020, all outstanding convertible notes, options and warrants
have been excluded from the calculation of the diluted net loss per share since their effect was anti-dilutive. Diluted loss per share
does not include 5,919,739 shares underlying outstanding options and warrants and 1,518,397 shares upon conversion of convertible
loans for the year ended December 31, 2021, because the effect of their inclusion in the computation would be anti-dilutive. Diluted
loss per share does not include 10,212,789 shares underlying outstanding options and warrants and 1,630,857 shares upon conversion
of convertible loans for the year ended December 31, 2020, because the effect of their inclusion in the computation would be
antidilutive.
F-42
NOTE 15 – STOCK-BASED COMPENSATION
a.
Global Share Incentive Plan
The Company’s stockholders have approved the 2017 Equity Incentive Plan (the “2017 Plan”) under which, the Company
had reserved a pool of 3,000,000 shares of the Company’s common stock, which may be issued at the discretion of the Company’s
board of directors from time to time. Under this Plan, each option is exercisable into one share of common stock of the Company.
The options may be exercised after vesting and in accordance with the vesting schedule that will be determined by the Company’s
board of directors for each grant. The maximum contractual life term of the options is 10 years. As of December 31, 2021, total
options granted under this plan are 2,470,283 and the total options that are available for grants under this plan are 900,901.
On May 23, 2012, the Company’s board of directors adopted the Global Share Incentive Plan 2012 (the “2012 Plan”) under
which, the Company had reserved a pool of 1,000,000 shares of the Company’s common stock, which may be issued at the discretion
of the Company’s board of directors from time to time. Under this plan, each option is exercisable into one share of common stock of
the Company. The options may be exercised after vesting and in accordance with the vesting schedule that will be determined by the
Company’s board of directors for each grant. The maximum contractual life term of the options is 10 years. As of December 31,
2021, total options granted under this plan are 1,415,008 and the total options that are available for grants under this plan are 16,198.
b.
Options Granted to Employees and Directors
Below is a table summarizing all of the options grants to employees and Directors made during the years ended December
31, 2021, and December 31, 2020:
No. of
options
granted
Year
Ended
December
31, 2021
December
31, 2021
December
31, 2020
Employees
Directors
Employees
Exercise
price
Vesting period
Fair value at
grant
(in thousands)
Expiration
period
277,000 $2.96-$5.12 Quarterly over a period of two years $
812
10 years
84,650 $
2.89
On the one-year anniversary
$
149
10 years
531,450 $2.99-$6.84 Quarterly over a period of two years $
1,312
10 years
Directors
December
31,2020
145,050 $ 2.99-$4.7
96% on the one-year anniversary, and
the remaining 4% in three equal
instalments on the first, second and
third year anniversaries
$
377
10 years
The fair value of each stock option grant is estimated at the date of grant using a Black Scholes option pricing model. The
volatility is based on historical volatility of the Company, by statistical analysis of the weekly share price for past periods based on
expected term. The expected option term is calculated using the simplified method, as the Company concludes that its historical
share option exercise experience does not provide a reasonable basis to estimate its expected option term. The fair value of each
option grant is based on the following assumptions:
Value of one common share
Dividend yield
Expected stock price volatility
Risk free interest rate
Expected term (years)
F-43
Years Ended December 31,
2020
2021
$2.99-$6.84
$2.89-$5.12
0%
71%-77%
0.96%-1.34%
5.5-5.56
0%
80%-86%
0.36%-1.71%
5.50-6.00
A summary of the Company’s stock options granted to employees and directors as of December 31, 2021 and December 31,
2020 is presented below:
Years Ended December 31
2021
2020
Weighted
Average
Exercise Price
$
Number of
Options
Number of
Options
Weighted
Average
Exercise
Price
$
2,917,667
4.05
2,465,522
361,650
*(13,750)
(20,813)
(34,749)
-
4.19
4.63
5.67
4.67
-
676,500
-
(11,876)
(57,042)
(155,437)
3,210,005
4.05
2,917,667
2,777,563
4.00
2,299,937
4.44
3.74
-
7.88
4.52
8.38
4.05
4.03
Options outstanding at the
beginning of the period
Changes during the period:
Granted
Exercised
Expired
Forfeited
Cancelled
Options outstanding at
end of the period
Options exercisable at
end of the period
* During the year ended December 31, 2021, the Company received $64 thousand from the exercise of employee options for the
purchase of 13,750 shares of the Company’s Common Stock at a weighted average price of $4.63.
The following table presents summary information concerning the options granted and exercisable to employees and
directors outstanding as of December 31, 2021 (in thousands, except per share data):
Exercise
Price
$
Number of
Outstanding
Options
Weighted
Average
Remaining
Contractual
Life
Aggregate
Intrinsic
Value
$
(in thousands)
Number of
Exercisable
Options
Aggregate
Exercisable
Options
Value $
(in thousands)
0.0012
0.012
2.89
2.96
2.99
3.14
4.42
4.5
4.6
4.7
4.8
5.02
5.07
5.1
5.99
6
6.84
7.2
8.36
8.91
9
9.48
10.2
230,189
510,017
84,650
63,500
432,200
2,500
50,000
34,000
174,800
6,250
483,337
78,500
52,500
60,500
327,050
16,667
15,125
83,334
250,001
15,000
20,834
58,908
39,267
3,210,005
2.64
0.09
9.96
9.96
8.15
7.91
5.93
7.17
8.68
8.03
4.94
9.71
7.00
8.34
6.61
2.59
6.79
5.43
6.50
6.46
1.54
0.52
0.42
5.45
663
1,463
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
2,126
230,189
510,017
-
-
431,638
2,500
50,000
34,000
112,488
2,083
483,337
-
52,500
44,750
297,425
16,667
12,453
83,334
250,001
15,000
20,834
58,908
39,267
2,777,563
-
6
-
-
1,291
8
221
153
517
10
2,320
-
266
228
1,782
100
85
600
2,090
134
187
558
401
11,111
Costs incurred with respect to stock-based compensation for employees and directors for the years ended December 31,
2021 and December 31, 2020 were $1,349 thousand and $1,470 thousand, respectively, out of which $450 thousand related to
options granted to employees of Masthercell Global, for the years ended December 31, 2020, and presented as part of net loss from
discontinued operations in the consolidated statements of comprehensive loss. As of December 31, 2021, there was $1,093 thousand
of unrecognized compensation costs related to non-vested employees and directors stock options, to be recorded over the next 1.75
years.
F-44
c. Options Granted to Consultants and service providers
Below is a table summarizing all the compensation granted to consultants and service providers during the years ended
December 31, 2021 and December 31, 2020:
Year of
grant
No. of
options
granted
Exercise
price
Vesting period
Non-
employees
Non-
employees
2021
7,500 $
2.96
Quarterly over a period of two years
2020
62,500 $2.99-$6.84
Quarterly over a period of two years
Fair value at
grant
(in thousands)
Expiration
period
$
$
22
10 years
209
10 years
The fair value of options granted during 2021 and 2020 to consultants and service providers, was computed using the
Black-Scholes model. The fair value of each stock option grant is estimated at the date of grant using a Black Scholes option pricing
model. The volatility is based on historical volatility of the Company, by statistical analysis of the weekly share price for past periods
based on the expected term period, the expected term is the contractual term of each grant. The underlying data used for computing
the fair value of the options are as follows:
Value of one common share
Dividend yield
Expected stock price volatility
Risk free interest rate
Expected term (years)
$
Years Ended December 31,
2020
2021
2.99-$6.84
2.96
$
0%
145%
1.47%
10
0%
86%-89%
0.73%-1.12%
10
A summary of the Company’s stock options granted to consultants and service providers as of December 31, 2021, and
December 31, 2020 is presented below:
Options outstanding at the
beginning of the year
Changes during the year:
Granted
Exercised
Forfeited
Cancelled
Options outstanding at end of the year
Options exercisable at end of the year
Years Ended December 31,
2021
2020
Weighted
Average
Exercise
Price
$
Number of
Options
549,141
7,500
-
(8,950)
-
547,691
467,689
F-45
5.89
2.96
-
3.88
-
5.89
6.20
Weighted
Average
Exercise
Price
$
5.76
3.97
3.60
5.99
5.30
5.89
6.28
Number of
Options
598,310
62,500
(83,334)
(8,335)
(20,000)
549,141
450,972
The following table presents summary information concerning the options granted and exercisable to consultants and
service providers outstanding as of December 31, 2021 (in thousands, except per share data):
Exercise
Price
$
Number of
Outstanding
Options
Weighted
Average
Remaining
Contractual
Life
2.96
2.99
3.14
3.36
4.09
4.42
4.5
4.6
4.8
5.07
5.3
5.99
6
6.84
7
7.32
8.34
8.43
11.52
16.8
7,500
35,000
11,250
136,775
25,000
5,125
13,335
20,000
16,668
5,000
15,000
16,670
90,000
7,500
70,000
8,334
8,600
8,333
8,334
39,267
547,691
9.96
8.22
7.91
4.32
7.76
5.93
7.53
8.96
4.94
7.19
6.70
6.81
2.59
8.38
7.83
0.89
6.52
6.05
1.26
0.28
5.22
Aggregate
Intrinsic
Value*
$
(in thousands)
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Number of
Exercisable
Options
-
-
11,250
136,775
25,000
5,125
5,000
4,000
16,668
1,000
15,000
16,670
90,000
-
70,000
8,334
8,600
6,666
8,334
39,267
467,689
Aggregate
Exercisable
Options
Value $
(in thousands)
-
-
35
459
102
23
23
18
80
5
80
100
540
-
490
61
72
56
96
660
2,900
Costs incurred with respect to options granted to consultants and service providers for the years ended December 31, 2021
and December 31, 2020 were $122 thousand and $113 thousand, respectively. As of December 31, 2021, there was $109 thousands
of unrecognized compensation costs related to non-vested consultants and service providers, to be recorded over the next 3.58 years.
d. Warrants and Shares Issued to Non-Employees
The fair value of Common Stock issued was the share price of the shares issued at the day of grant.
1) On January 2, 2020, the Company entered into private placement subscription agreements with investors for an aggregate
amount of $250 thousand of convertible loans. The lenders shall be entitled, at any time prior to or no later than the maturity date, to
convert the outstanding amount, into shares of Common Stock of the Company at a conversion price per share equal to $7.00. In
addition, the Company granted the investors 151,428 warrants to purchase an equal number of additional shares of the Company’s
Common Stock at a price of $7.00 per share. The fair value of those warrants as of the date of grant using the Black-Scholes
valuation model was $210 thousand.
F-46
2) During the year ended December 31, 2020, the Company granted to several consultants 193,178 warrants each
exercisable between $3.14 and $5.34 per share for three years. The fair value of those options as of the date of grant using the Black-
Scholes valuation model was $378 thousand, out of which $350 thousand is related to 179,428 warrants granted as a success fee with
respect to the issuance of the convertible notes and private Investment.
3) During the twelve months ended December 31, 2021, the Company issued 25,000 shares of common stock to a service
provider. As of December 31, 2021, 25,000 shares have restrictions on transfer until such services have been provided.
NOTE 16 – TAXES
a. Corporate taxation in the U.S.
The corporate U.S. Federal Income tax rate applicable to the Company and its US subsidiaries is 21%.
As of December 31, 2021, the Company has an accumulated tax loss carryforward of approximately $29 million (as of
December 31, 2020, approximately $18 million).
For U.S. federal income tax purposes, net operating losses (“NOLs”) arising in tax years beginning after December 31,
2017, the Internal Revenue Code of 1986, as amended (the “Code”) limits the ability to utilize NOL carryforwards to 80% of taxable
income in tax years beginning after December 31, 2020. In addition, NOLs arising in tax years ending after December 31, 2017 can
be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years beginning before January 1, 2018
will not be subject to the taxable income limitation, and NOLs generated in tax years ending before January 1, 2018 will continue to
have a two-year carryback and twenty-year carryforward period. Deferred tax assets for NOLs will need to be measured at the
applicable tax rate in effect when the NOL is expected to be utilized. The changes in the carryforward/carryback periods as well as
the new limitation on use of NOLs may significantly impact the Company’s valuation allowance assessments for NOLs generated
after December 31, 2017.
In addition, utilization of the NOLs may be subject to substantial annual limitation under Section 382 of the Code due to an
“ownership change” within the meaning of Section 382(g) of the Code. An ownership change subjects pre-ownership change NOL
carryforwards to an annual limitation, which significantly restricts the ability to use them to offset taxable income in periods
following the ownership change. In general, the annual use limitation equals the aggregate value of the Company’s stock at the time
of the ownership change multiplied by a specified tax-exempt interest rate.
On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted into law. The
CARES Act is aimed at providing emergency relief and health care for individuals and businesses affected by the COVID-19
pandemic. The CARES Act, among other things, includes provisions related to refundable payroll tax credits, deferral of the
employer portion of social security payments, expanded net operating loss application, modifications to the net interest deduction
limitations, and technical corrections to tax depreciation methods for qualified improvement property. The CARES act allowed the
Company to utilize 100% of NOLs arising in tax years after December 31, 2017 and before January1, 2021. The Company has
assessed all other provisions of the CARES Act and notes no other material impact to the Company.
b. Corporate taxation in Israel
The Israeli Subsidiaries are taxed in accordance with Israeli tax laws. The corporate tax rate applicable to 2021 and 2020 are
23%.
As of December 31, 2021, the Israeli Subsidiaries has an accumulated tax loss carryforward of approximately $11 million
(as of December 31, 2020, approximately $11 million). Under the Israeli tax laws, carryforward tax losses have no expiration date.
F-47
c. Corporate taxation in Belgium
The Belgian Subsidiary are taxed according to Belgian tax laws. The corporate tax rates applicable to 2021, 2020 are 25%.
As of December 31, 2021, the Belgian Subsidiary has an accumulated tax loss carryforward of approximately $8 million (€7
million), (as of December 31, 2020 $8 million). Under the Belgian tax laws there are limitation on accumulated tax loss carryforward
deductions of Euro 1 million per year.
d. Corporate taxation in Korea
The basic Korean corporate tax rates are currently: 10% on the first KRW 200 million of the tax base, 20% up to KRW 20
billion, 22% up to KRW 300 billion and 25% for tax base above KRW 300 billion. In addition, the local income tax rate is 1% on the
first KRW 200 million of taxable income, 2% on taxable income over KRW 200 million up to KRW 20 billion, 2.2% of taxable
income over KRW 20 billion up to 300 billion and 2.5% on taxable income over KRW 300 billion.
As of December 31, 2021, the Korean subsidiary has an accumulated tax loss carryforward of approximately $3 million
(KRW 3,023 million), (as of December 31, 2020, approximately $4 million). Under the Korean tax laws accumulated tax loss can be
carry forwarded for 15 years.
e. Deferred Taxes
The following table presents summary of information concerning the Company’s deferred taxes as of the years ending
December 31, 2020 and December 31, 2020 (in thousands):
Deferred tax assets (liabilities), net:
Net operating loss carry forwards
Research and development expenses
Equity compensation
Employee benefits
Property, plant and equipment
Leases asset
Lease liability
Loans
Intangible assets
Other
Total
Valuation allowance
Net deferred tax liabilities
December 31,
2020
2021
(U.S. dollars in thousands)
$
$
11,451 $
1,273
2,631
197
(206)
186
(134)
26
(2,738)
119
12,805
(12,805)
- $
9,606
1,684
2,747
252
-
533
(324)
-
(2,863)
297
11,932
(11,932)
-
Realization of deferred tax assets is contingent upon sufficient future taxable income during the period that deductible
temporary differences and carry forwards losses are expected to be available to reduce taxable income. As the achievement of
required future taxable income is not considered more likely than not achievable, the Company and all its subsidiaries except the
Korean Subsidiary have recorded full valuation allowance.
F-48
The changes in valuation allowance are comprised as follows:
Balance at the beginning of year
Change during the year
Balance at end of year
f. Reconciliation of the Theoretical Tax Expense to Actual Tax Expense
December 31,
2020
2021
(U.S dollars in thousands)
$
$
(11,932) $
(873)
(12,805) $
(14,939)
3,007
(11,932)
The main reconciling item between the statutory tax rate of the Company and the effective rate is the provision for valuation
allowance with respect to tax benefits from carry forward tax losses.
g. Uncertain Tax Provisions
ASC Topic 740, “Income Taxes” requires significant judgment in determining what constitutes an individual tax position as
well as assessing the outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions can
materially affect the estimate of the effective tax rate and consequently, affect the operating results of the Company. As of December
31, 2021, the Company has not accrued a provision for uncertain tax positions.
F-49
NOTE 17 – REVENUES
Disaggregation of Revenue
The following table disaggregates the Company’s revenues by major revenue streams.
Revenue stream:
POC and hospital services (Mainly POC)
Cell process development services
Total
Years Ended December 31,
2020
2021
(in thousands)
$
$
32,819 $
2,683
35,502 $
6,068
1,584
7,652
POC development services are the result of agreements between Company and its partners (See Note 11).
A breakdown of the revenues per customer what constituted at least 10% of revenues is as follows:
Revenue earned:
Customer A (Korea)
Customer B (United Arab Emirates)
Customer C (China)
Customer D (India) – related party
Customer E (Greece)
Contract Assets and Liabilities
Years Ended December 31,
2020
2021
(in thousands)
$
7,703 $
6,969
6,491
3,856
4,693
2,857
-
1,577
1,475
1,412
Contract assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts
billed and currently due from customers.
The activity for trade receivables is comprised of:
Balance as of beginning of period
Acquisition of Koligo
Additions
Collections
Exchange rate differences
Balance as of end of period
$
$
F-50
Years Ended December 31,
2020
2021
(in thousands)
3,085 $
-
34,570
(22,333)
(77)
15,245 $
1,831
228
6,997
(5,982)
11
3,085
The activity of the related party included in the trade receivables activity above is comprised of:
Balance as of beginning of period
Additions
Collections
Balance as of end of period
The activity for contract liabilities is comprised of:
Balance as of beginning of period
Additions
Realizations
Exchange rate differences
Balance as of end of period
Years Ended December 31,
2020
2021
(in thousands)
744 $
3,856
(2,628)
1,972 $
Years Ended December 31,
2020
2021
(in thousands)
59 $
-
-
-
59 $
-
1,244
(500)
744
325
597
(862)
(1)
59
$
$
$
$
The activity of the related party included in the contract liabilities activity above is comprised of:
Balance as of beginning of period
Additions
Collections
Balance as of end of period
Year Ended
December 31,
2020
(in thousands)
$
$
-
231
(231)
-
NOTE 18 – COST OF SERVICES AND OTHER RESEARCH AND DEVELOPMENT EXPENSES, NET
Total expenses
Less grants
Total
Years Ended December 31,
2020
2021
(in thousands)
$
$
36,644 $
-
36,644 $
84,182
(196)
83,986
F-51
NOTE 19 – FINANCIAL EXPENSES, NET
Years Ended December 31,
2020
2021
(in thousands)
Interest expense on convertible loans
Foreign exchange loss, net
Other income
Total
$
$
943 $
574
(225)
1,292 $
1,254
160
(353)
1,061
NOTE 20 – RELATED PARTIES TRANSACTIONS
a. Related Parties presented in the consolidated statements of comprehensive loss
Continuing operations:
Stock-based compensation expenses to executive officers
Stock-based compensation expenses to Board Members
Compensation of executive officers
Management and consulting fees to Board Members
Revenues from customer
Cost of services and other research and development
expenses, net
Financial income
b. Related Parties presented in the consolidated balance sheets
Executive officers’ payables
Non-executive directors’ payable
Loan to Related Party
Accounts receivable, net
F-52
Years ended December 31,
2020
2021
(in thousands)
247 $
265 $
4,422 $
380 $
3,856 $
- $
64 $
December 31,
2021
2020
(in thousands)
51 $
178 $
3,064 $
1,972 $
221
209
1,321
264
1,475
4,772
169
170
13
-
744
$
$
$
$
$
$
$
$
$
$
$
NOTE 21 – SUBSEQUENT EVENTS
a) On January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against us and the
Israeli subsidiary, Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Asa Kunik (collectively, the “defendants”) by plaintiffs the
State of Israel, as the owner of Chaim Sheba Medical Center at Tel HaShomer (“Sheba”), and Tel Hashomer Medical
Research, Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the plaintiffs are seeking that the
Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs at the rate of 7% of
the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process that
contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by
Prof. Ferber in the field of cell therapy, including in the category of the point-of-care platform and any and all services and
products in relation to the defendants’ CDMO activity. In addition, the plaintiffs seek that the defendants provide financial
statements and pay NIS 10 million to the plaintiffs due to the royalty provisions of the license agreement, dated February 2,
2012, between the Israeli subsidiary and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (the “License
Agreement”). The Complaint alleges that the Company and the Israeli subsidiary used know-how and technology of Sheba
and know-how and technology either developed or supervised by Prof. Ferber while employed by Sheba in the field of cell
therapy, including in the category of the point-of-care platform and the services and products in relation to the defendants’
CDMO activity and are entitled to the payment of certain royalties pursuant to the terms of the License Agreement. The
defendants were required to file their statement of defense responding to this Complaint by March 20, 2022. The Company
believes that the allegations in this Complaint are without merit and intend to vigorously defend itself against the claims.
Since a loss is not considered probable, no provision was made in the financial statements.
b) License and research agreement Yeda Research and Development Company Limited
On January 25, 2022, the Company and Yeda Research and Development Company Limited (“Yeda”), an Israeli
corporation, entered into a license and research agreement. Pursuant to the agreement, Yeda granted to the Company an exclusive,
worldwide license to its licensed information and the licensed patents, for the development, manufacture, use, offer for sale, sale and
import of products in the Field a field of tumor-infiltrating lymphocytes (TIL) and Chimeric antigen receptor (CAR) T cell
immunotherapy platforms (excluding CAR-Cytokine Induced Killer cell immunotherapy). The Company undertakes to make
commercially reasonable efforts to develop and commercialize products in the field, and to achieve certain milestones. In
consideration for the grant of the License, the Company shall pay Yeda:
A non-refundable annual license fee of $10 thousand;
Royalties of up to 2% on sales of licensed products;
25% of all Other Receipts received in respect of a Sublicense first granted or an assignment of rights made prior to the
achievement of the dosing of a first patient in a Phase I Clinical Trial; and (ii) 12.5% of all Other Receipts received in respect of a
Sublicense first granted or an assignment of rights made on or after the date described in subclause (i)
Milestone Events payments:
$50 thousand upon the dosing of a first patient in a Phase I Clinical Trial;
$500 thousand upon the receipt of FDA marketing approval in respect of a product 350 thousand upon receipt of marketing
approval from a non-FDA regulatory agency in a major market territory (namely, a regulatory agency in Europe, Japan, China or
Canada);
$250 thousand upon receipt of marketing approval from an additional non-FDA major regulatory agency (namely, a
regulatory agency in Europe, Japan, China or Canada);
Patent fees already incurred by Yeda in connection with the Licensed Patents in the amount of $27 thousand, and all future
costs and fees relating to the filing, prosecution, and maintenance of the Licensed Patents, Research related expenses based on an
agreed research budget.
c)
Joint venture agreement with Proterna Inc
On January 26, 2022, the Company and Proterna, Inc. a Delaware corporation, (“Proterna”) (together, the “Parties”), entered
into a joint venture agreement (“JVA”). Pursuant to the JVA, the Parties agreed to collaborate with each other and expand their
activities in the development and commercialization of mRNA based vaccines and cellular immunotherapies for respiratory diseases,
including, without limitation, COVID-19. The JVA provides that Proterna will grant to the JV Entity (“JVE”), under a separate
license agreement, an exclusive, sublicensable right and license to its background IP as required to carry out the terms of the JVA
including to develop, manufacture, distribute and market and sell mRNA vaccines and cellular immunotherapies for respiratory
diseases, including COVID-19. In consideration for such license, the JVE will pay Proterna a 5% royalty on sales. The Company
will provide funding for the joint venture of up to $5 million, based on a work plan to be approved, of which $2.5 million will be in
the form of services to be procured from Proterna. Until the JVE is formed, the activities of the collaboration will be performed by
Proterna. The Parties will each hold 50% of the JVE. In addition, once JVE is profitable, Company shall have the rights to additional
profit share. The Board of the JVE will be comprised of three directors, one to be appointed by the Company, one to be appointed by
Proterna, and a third board member to be appointed upon mutual agreement of the Parties. Company shall have the right to purchase
all of Proterna’s then issued and outstanding equity interests in the JVE in return for, at Company’s option: payment of cash and/or
issuance of shares of common stock of Company. In the event that Company seeks to exercise this right, JVE’s valuation shall be
determined by an independent third-party expert to be mutually selected by the Parties, provided that in no event may such valuation
be lower than US $2,000,000. As at the date of this report the JVE has not been incorporated.
d) On February 22, 2022, the Company, pursuant to the joint venture agreement between itself and Mida Biotech BV,
purchased all the issued shares in the latter for a consideration of $100 thousand. The consideration will be paid via
Company shares to be issued to Mida Biotech BV;s shareholders.
e) On March 30, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain
investors (collectively, the “Investors”), pursuant to which the Company agreed to issue and sell to the Investors, in a
private placement (the “Offering”), an aggregate of 4,933,333 shares of the Company’s Common Stock at a purchase price
of $3.00 per share and warrants to purchase up to an aggregate of 1,000,000 shares of Common Stock at an exercise price of
$4.50 per share. The warrants are not exercisable until after six months and expire three years from the date of issuance. The
Company expects to receive gross proceeds of approximately $14.8 million before deducting related offering expenses. The
Offering is expected to close on or about April 30, 2022, subject to customary closing conditions.
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