As
filed with the Securities and Exchange Commission on March 26, 2021
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
ORGENESIS
INC.
(Exact
name of registrant as specified in its charter)
Nevada
(State
or other jurisdiction of
incorporation
or organization)
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98-0583166
(I.R.S.
Employer
Identification
Number)
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20271
Goldenrod Lane
Germantown,
Maryland 20876
(480)
659-6404
(Address,
including zip code, and telephone number, including area
code,
of registrant’s principal executive offices)
Vered
Caplan, Chief Executive Officer
Orgenesis
Inc.
20271
Goldenrod Lane
Germantown,
Maryland 20876
(480)
659-6404
(Name,
address, including zip code, and telephone number, including area
code,
of agent for service)
Copies
to:
Kenneth
R. Koch, Esq.
Jeffrey
P. Schultz, Esq.
Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Chrysler
Center, 666 Third Avenue
New
York, NY 10017
Tel:
212-935-3000
Approximate
date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement
as determined by the registrant.
If
the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please
check the following box: [ ]
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check
the following box: [X]
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
If
this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. [ ]
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following
box. [ ]
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 [X]
|
Accelerated
filer [ ]
Smaller
reporting company [X]
Emerging
growth company [ ]
|
If
an emerging growth company, indicate by check mark 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 7(a)(2)(B) of Securities Act. [ ]
CALCULATION
OF REGISTRATION FEE
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Proposed
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Maximum
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Proposed Maximum
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Title of Each Class of
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Amount to
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Offering Price
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Aggregate
Offering
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Amount of
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Securities
to be Registered
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be
Registered
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per
Unit
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Price
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Registration
Fee (1)
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Common Stock, $0.0001 par value
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(2)
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(3)
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(3)
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0
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Debt Securities
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(2)
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(3)
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(3)
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0
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Warrants
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(2)
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(3)
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(3)
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0
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Rights
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(2)
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(3)
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(3)
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0
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Units
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(2)
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(3)
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(3)
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0
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Total
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$
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100,000,000
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$
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12,980.00
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(1)
Calculated pursuant to Rule 457(o) under the Securities Act of 1933, as amended, based on the proposed maximum aggregate offering
price. The $100,000,000 of securities registered hereunder includes $100,000,000 of securities (the “Unsold Securities”)
registered pursuant to Registration Statement No. 333-223777 initially filed by the Registrant on March 19, 2018 and declared
effective on March 28, 2018 (the “Prior Registration Statement”). Pursuant to Rule 415(a)(6) under the Securities Act,
$12,980 of filing fees previously paid in connection with the Unsold Securities will continue to be applied to the Unsold Securities.
Accordingly, no filing fee is due herewith. Pursuant to Rule 415(a)(6), the offering of securities under the Prior Registration
Statement will be deemed terminated as of the date of effectiveness of this Registration Statement.
(2)
There are being registered hereunder such indeterminate number of shares of common stock, such indeterminate principal amount
of debt securities, such indeterminate number of warrants and rights to purchase common stock or debt securities, and such indeterminate
number of units, as shall have an aggregate initial offering price not to exceed $100,000,000. If any debt securities are issued
at an original issue discount, then the offering price of such debt securities shall be in such greater principal amount as shall
result in an aggregate initial offering price not to exceed $100,000,000, less the aggregate dollar amount of all securities previously
issued hereunder. Any securities registered hereunder may be sold separately or as units with other securities registered hereunder.
The proposed maximum initial offering price per unit will be determined, from time to time, by the registrant in connection with
the issuance by the registrant of the securities registered hereunder. The securities registered also include such indeterminate
number of shares of common stock and amount of debt securities as may be issued upon conversion of or exchange for debt securities
that provide for conversion or exchange, upon exercise of warrants or rights or pursuant to the anti-dilution provisions of any
such securities. In addition, pursuant to Rule 416 under the Securities Act of 1933, as amended, the shares being registered hereunder
include such indeterminate number of shares of common stock as may be issuable with respect to the shares being registered hereunder
as a result of stock splits, stock dividends or similar transactions.
(3)
The proposed maximum aggregate offering price per class of security will be determined from time to time by the registrant in
connection with the issuance by the registrant of the securities registered hereunder and is not specified as to each class of
security pursuant to General Instruction II.D. of Form S-3 under the Securities Act of 1933, as amended.
The
Prior Registration Statement was declared effective on March 28, 2018 and expires on March 28, 2021, pursuant to SEC rules. Accordingly,
the Registrant is filing this new shelf Registration Statement for the purpose of continuing to provide the Registrant with the
ability to sell securities from time to time covered by this Registration Statement. There are no “selling stockholders”
named in the prospectus, which forms a part of this Registration Statement. The Registrant has included in this Registration Statement
the Unsold Securities registered pursuant to Registration Statement No. 333-223777. Pursuant to Rule 415(a)(6) under the Securities
Act, $12,980 of filing fees previously paid in connection with the Unsold Securities will continue to be applied to the Unsold
Securities. In accordance with SEC rules, the Registrant may continue to offer and sell the Unsold Securities during the grace
period afforded by Rule 415(a)(5). If the Registrant sells any Unsold Securities during the grace period, the Registrant will
identify in a pre-effective amendment to this Registration Statement the new amount of Unsold Securities to be carried forward
to this Registration Statement in reliance upon Rule 415(a)(6).
THE
REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL
THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME
EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933, AS AMENDED, OR UNTIL THE REGISTRATION STATEMENT SHALL
BECOME EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
THE
INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY NOT SELL THESE SECURITIES UNTIL THE REGISTRATION STATEMENT
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION IS EFFECTIVE. THIS PROSPECTUS IS NOT AN OFFER TO SELL THESE SECURITIES AND IS
NOT SOLICITING AN OFFER TO BUY THESE SECURITIES IN ANY STATE WHERE THE OFFER OR SALE IS NOT PERMITTED.
SUBJECT
TO COMPLETION, DATED MARCH 26, 2021
PROSPECTUS
ORGENESIS
INC.
$100,000,000
COMMON
STOCK
DEBT
SECURITIES
WARRANTS
RIGHTS
UNITS
This
prospectus will allow us to issue, from time to time at prices and on terms to be determined at or prior to the time of the offering,
up to $100,000,000 of any combination of the securities described in this prospectus, either individually or in units. We may
also offer common stock upon conversion of or exchange for the debt securities; common stock or debt securities upon the exercise
of warrants or rights.
This
prospectus describes the general terms of these securities and the general manner in which these securities will be offered. We
will provide you with the specific terms of any offering in one or more supplements to this prospectus. The prospectus supplements
will also describe the specific manner in which these securities will be offered and may also supplement, update or amend information
contained in this document. You should read this prospectus and any prospectus supplement, as well as any documents incorporated
by reference into this prospectus or any prospectus supplement, carefully before you invest.
Our
securities may be sold directly by us to you, through agents designated from time to time or to or through underwriters or dealers.
For additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution”
in this prospectus and in the applicable prospectus supplement. If any underwriters or agents are involved in the sale of our
securities with respect to which this prospectus is being delivered, the names of such underwriters or agents and any applicable
fees, commissions or discounts and over-allotment options will be set forth in a prospectus supplement. The price to the public
of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a prospectus supplement.
Our
common stock is listed on The Nasdaq Capital Market, under the symbol “ORGS.” On March 26, 2021, the last reported
sale price of our common stock on The Nasdaq Capital Market was $5.64 per share.
Investing
in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully
the risks that we have described on page [4] of this prospectus under the caption “Risk Factors.” We may include specific
risk factors in supplements to this prospectus under the caption “Risk Factors.” This prospectus may not be used to
sell our securities unless accompanied by a prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The
date of this prospectus is , 2021.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or SEC, utilizing a
“shelf” registration process. Under this shelf registration process, we may offer shares of our common stock, various
series of debt securities and/or warrants or rights to purchase any of such securities, either individually or in units, in one
or more offerings, with a total value of up to $100,000,000. This prospectus provides you with a general description of the securities
we may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement
that will contain specific information about the terms of that offering.
This
prospectus does not contain all of the information included in the registration statement. For a more complete understanding of
the offering of the securities, you should refer to the registration statement, including its exhibits. The prospectus supplement
may also add, update or change information contained or incorporated by reference in this prospectus. However, no prospectus supplement
will offer a security that is not registered and described in this prospectus at the time of its effectiveness. This prospectus,
together with the applicable prospectus supplements and the documents incorporated by reference into this prospectus, includes
all material information relating to the offering of securities under this prospectus. You should carefully read this prospectus,
the applicable prospectus supplement, the information and documents incorporated herein by reference and the additional information
under the heading “Where You Can Find More Information” before making an investment decision.
You
should rely only on the information we have provided or incorporated by reference in this prospectus or any prospectus supplement.
We have not authorized anyone to provide you with information different from that contained or incorporated by reference in this
prospectus. No dealer, salesperson or other person is authorized to give any information or to represent anything not contained
or incorporated by reference in this prospectus. You must not rely on any unauthorized information or representation. This prospectus
is an offer to sell only the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to
do so. You should assume that the information in this prospectus or any prospectus supplement is accurate only as of the date
on the front of the document and that any information we have incorporated herein by reference is accurate only as of the date
of the document incorporated by reference, regardless of the time of delivery of this prospectus or any sale of a security.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any
document that is incorporated by reference in the accompanying prospectus were made solely for the benefit of the parties to such
agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be
deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate
only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately
representing the current state of our affairs.
This
prospectus may not be used to consummate sales of our securities, unless it is accompanied by a prospectus supplement. To the
extent there are inconsistencies between any prospectus supplement, this prospectus and any documents incorporated by reference,
the document with the most recent date will control.
Unless
the context indicates otherwise, all references in this registration statement to “Orgenesis,” the “Company,”
“we,” “us” and “our” refer to Orgenesis Inc.
PROSPECTUS
SUMMARY
The
following is a summary of what we believe to be the most important aspects of our business and the offering of our securities
under this prospectus. We urge you to read this entire prospectus, including the more detailed consolidated financial statements,
notes to the consolidated financial statements and other information incorporated by reference from our other filings with the
SEC or included in any applicable prospectus supplement. Investing in our securities involves risks. Therefore, carefully consider
the risk factors set forth in any prospectus supplements and in our most recent annual and quarterly filings with the SEC, as
well as other information in this prospectus and any prospectus supplements and the documents incorporated by reference herein
or therein, before purchasing our securities. Each of the risk factors could adversely affect our business, operating results
and financial condition, as well as adversely affect the value of an investment in our securities.
Overview1
We
are a global biotech company working to unlock the potential of cell and gene therapies in an affordable and accessible format
(“CGTs”).
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 (ATMPs). We mostly focus 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 at their point of care for treatment of the patient. 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 the 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 comprised of three enabling components: a pipeline of licensed
POCare Therapies that are designed to be processed and produced in closed, automated POCare Technology systems across a collaborative
POCare Network. Via a combination of science, technology, engineering, and networking, we are working to provide a more efficient
and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. 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, industry partners, research institutes and hospitals worldwide with a goal of
achieving harmonized, regulated clinical development and production of the therapies.
Recent
Developments
On
April 7, 2020, we entered into an Asset Purchase Agreement (the “Tamir Purchase Agreement”) with Tamir Biotechnology,
Inc. (“Tamir” or “Seller”), pursuant to which we 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 ranpirnase and use for antiviral therapy (collectively, the “Purchased Assets and Assumed Liabilities”
and such acquisition, the “Tamir Transaction”). The Tamir Transaction closed on April 23, 2020. We paid $2.5 million
in cash and issued an aggregate of 3,400,000 shares (the “Shares”) of our common stock to Tamir resulting in a total
consideration of $20.2 million. In November 2020, we filed a registration statement on Form S-3 to register the resale of the
Shares as required by the Tamir Purchase Agreement.
1
This disclosure has been pulled directly from the Form 10-K.
On
September 26, 2020, we entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with
Orgenesis Merger Sub, Inc., a Delaware corporation and our wholly-owned subsidiary (“Merger Sub”), Koligo Therapeutics
Inc., a Kentucky corporation (“Koligo”), the shareholders of Koligo (collectively, the “Shareholders”)
and Long Hill Capital V, LLC, solely in its capacity as the representative, agent and attorney-in-fact of the Shareholders. The
Merger Agreement provided for the acquisition of Koligo by us through the merger of Merger Sub with and into Koligo, with Koligo
surviving as our wholly-owned subsidiary (the “Merger”). The Merger closed on October 15, 2020.
Koligo’s
operations include (a) the manufacture and sale of KYSLECEL® (autologous pancreatic islets) for chronic and acute recurrent
pancreatitis diseases in the United States; (b) development and commercialization of the Tissue Genesis Icellator® platform,
a cell isolation system acquired by Koligo from Tissue Genesis, LLC prior to our acquisition of Koligo; and (c) preclinical development
of the “3D-V” technology platform, a system exclusively licensed by Koligo from the University of Louisville Research
Foundation intended for the revascularization and 3D printing of cell and tissue for transplant applications. Koligo maintains
facilities in Indiana and Texas.
The
Tissue Genesis assets acquired by Koligo included 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.
Pursuant
to the terms of the Merger Agreement, an aggregate of 2,061,713 shares of our common stock were issued to Koligo’s Shareholders
who were accredited investors (with certain Shareholders who were not accredited investors being paid solely in cash in the amount
of approximately $20 thousand) in accordance with the terms of the Merger Agreement. In connection with the Merger, we assumed
an aggregate of approximately $1.9 million of Koligo’s liabilities, which were substantially all of Koligo’s liabilities
at the closing of the Merger. In addition, we issued 66,910 shares to Maxim Group LLC for advisory services in connection with
the Merger. In November 2020, we filed a registration statement on Form S-3 to register the resale of 1,425,962 shares of our
common stock as required by the Merger Agreement.
In
addition, according to the agreement between the parties, we also 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. The Icellator device is already commercially available in Korea and the Bahamas, and is expected to gain regulatory
approval in Japan during the first quarter of 2021, subject to completion of manufacturing tests requested by the Japanese Pharmaceutics
and Medical Devices Agency. Tissue Genesis already initiated U.S. FDA IDE Phase 1 pilot trials SVF cells in the treatment of erectile
dysfunction, critical limb ischemia, tissue repair, and other therapeutic indications.
Corporate
Information
We
were incorporated in the state of Nevada on June 5, 2008 under the name Business Outsourcing Services, Inc. Effective August 31,
2011, we completed a merger with our subsidiary, Orgenesis Inc., a Nevada corporation, which was incorporated solely to effect
a change in its name. As a result, we changed our name from “Business Outsourcing Services, Inc.” to “Orgenesis
Inc.”
Our
website address is www.orgenesis.com. The information contained on, or that can be accessed through, our website does not
constitute part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.
Our
executive offices are located at 20271 Goldenrod Lane, Germantown, MD 20876, and our telephone number is (480) 659-6404.
Offerings
Under This Prospectus
Under
this prospectus, we may offer shares of our common stock, various series of debt securities and/or warrants or rights to purchase
any of such securities, either individually or in units, with a total value of up to $100,000,000, from time to time at prices
and on terms to be determined by market conditions at the time of the offering. This prospectus provides you with a general description
of the securities we may offer. Each time we offer a type or series of securities under this prospectus, we will provide a prospectus
supplement that will describe the specific amounts, prices and other important terms of the securities, including, to the extent
applicable:
The
prospectus supplement also may add, update or change information contained in this prospectus or in documents we have incorporated
by reference into this prospectus. However, no prospectus supplement will fundamentally change the terms that are set forth in
this prospectus or offer a security that is not registered and described in this prospectus at the time of its effectiveness.
We
may sell the securities directly to investors or to or through agents, underwriters or dealers. We, and our agents or underwriters,
reserve the right to accept or reject all or part of any proposed purchase of securities. If we offer securities through agents
or underwriters, we will include in the applicable prospectus supplement:
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the names
of those agents or underwriters;
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applicable
fees, discounts and commissions to be paid to them;
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details
regarding over-allotment options, if any; and
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the net
proceeds to us.
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This
prospectus may not be used to consummate a sale of any securities unless it is accompanied by a prospectus supplement.
RISK
FACTORS
Please
carefully consider the risk factors described in our periodic reports filed with the SEC, which are incorporated by reference
in this prospectus. Before making an investment decision, you should carefully consider these risks as well as other information
we include or incorporate by reference in this prospectus or include in any applicable prospectus supplement. Additional risks
and uncertainties not presently known to us or that we deem currently immaterial may also impair our business operations or adversely
affect our results of operations or financial condition.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus and the documents incorporated by reference contain forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended,
or the Exchange Act. These statements are based on our management’s beliefs and assumptions and on information currently
available to us. Discussions containing these forward-looking statements may be found, among other places, in the sections entitled
“Business,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition
and Results of Operations” incorporated by reference from our most recent Annual Report on Form 10-K and in our most recent
Quarterly Report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC.
Examples
of forward-looking statements in this prospectus include, but are not limited to, our expectations regarding our business strategy,
business prospects, operating results, operating expenses, working capital, liquidity and capital expenditure requirements. Important
assumptions relating to the forward-looking statements include, among others, assumptions regarding demand for our products, the
cost, terms and availability of components, pricing levels, the timing and cost of capital expenditures, competitive conditions
and general economic conditions. These statements are based on our management’s expectations, beliefs and assumptions concerning
future events affecting us, which in turn are based on currently available information. These assumptions could prove inaccurate.
Although we believe that the estimates and projections reflected in the forward-looking statements are reasonable, our expectations
may prove to be incorrect.
Forward-looking
statements made in this prospectus include statements about:
Corporate
and Financial
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our
ability to increase revenues;
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our
ability to achieve profitability;
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our
ability to manage our research and development programs that are based on novel technologies;
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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;
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our
ability to control key elements relating to the development and commercialization of
therapeutic product candidates with third parties;
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our
ability to manage potential disruptions as a result of the coronavirus outbreak;
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our
ability to manage the growth of our company;
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our
ability to attract and retain key scientific or management personnel and to expand our
management team;
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the
accuracy of estimates regarding expenses, future revenue, capital requirements, profitability,
and needs for additional financing; and
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our
belief that our therapeutic related developments have competitive advantages and can
compete favorably and profitably in the cell and gene therapy industry.
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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;
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our
ability to advance our therapeutic collaborations in terms of industrial development,
clinical development, regulatory challenges, commercial partners and manufacturing availability;
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our
ability to implement our point-of-care cell therapy (“POC”) strategy in order
to further develop and advance autologous therapies to reach patients;
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expectations
regarding our ability to obtain additional and maintain existing intellectual property
protection for our technologies and therapies;
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our
ability to commercialize products in light of the intellectual property rights of others;
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our
ability to obtain funding necessary to start and complete such clinical trials;
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our
ability to further our CGT development projects, either directly or through our JV partner
agreements, and to fulfill our obligations under such agreements;
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our
belief that our systems and therapies are as at least as safe and as effective as other
options;
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our
Subsidiary’s relationship with Tel Hashomer Medical Research Infrastructure and
Services Ltd. (“THM”) and the 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;
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our
license agreements with other institutions;
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expenditures
not resulting in commercially successful products;
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our
dependence on the financial results of our POC business; and
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our
ability to grow our POC business and to develop additional joint venture relationships
in order to produce demonstrable revenues.
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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 our Annual Report on Form 10-K for the year ended December 31, 2020,
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
prospectus to conform these statements to actual results.
You
should also consider carefully the statements set forth in the sections titled “Risk Factors” or elsewhere in this
prospectus, in the accompanying prospectus and in the documents incorporated or deemed incorporated herein or therein by reference,
which address various factors that could cause results or events to differ from those described in the forward-looking statements.
All subsequent written and oral forward-looking statements attributable to us or to persons acting on our behalf are expressly
qualified in their entirety by the applicable cautionary statements. We have no plans to update these forward-looking statements.
USE
OF PROCEEDS
We
cannot assure you that we will receive any proceeds in connection with securities which may be offered pursuant to this prospectus.
Unless otherwise indicated in the applicable prospectus supplement, we intend to use any net proceeds from the sale of securities
under this prospectus for our operations and for other general corporate purposes, including, but not limited to, our research
and development programs and the development of new programs, general working capital and possible future acquisitions. We have
not determined the amounts we plan to spend on any of the areas listed above or the timing of these expenditures. As a result,
our management will have broad discretion to allocate the net proceeds, if any, we receive in connection with securities offered
pursuant to this prospectus for any purpose. Pending application of the net proceeds as described above, we may initially invest
the net proceeds in short-term, investment-grade, interest-bearing securities or apply them to the reduction of short-term indebtedness.
PLAN
OF DISTRIBUTION
General
Plan of Distribution
We
may offer securities under this prospectus from time to time pursuant to underwritten public offerings, negotiated transactions,
block trades or a combination of these methods. We may sell the securities (1) through underwriters or dealers, (2) through agents
or (3) directly to one or more purchasers, or through a combination of such methods. We may distribute the securities from time
to time in one or more transactions at:
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a
fixed price or prices, which may be changed from time to time;
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market
prices prevailing at the time of sale;
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prices
related to the prevailing market prices; or
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We
may directly solicit offers to purchase the securities being offered by this prospectus. We may also designate agents to solicit
offers to purchase the securities from time to time. We will name in a prospectus supplement any underwriter or agent involved
in the offer or sale of the securities.
If
we utilize a dealer in the sale of the securities being offered by this prospectus, we will sell the securities to the dealer,
as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the
time of resale.
If
we utilize an underwriter in the sale of the securities being offered by this prospectus, we will execute an underwriting agreement
with the underwriter at the time of sale, and we will provide the name of any underwriter in the prospectus supplement which the
underwriter will use to make re-sales of the securities to the public. In connection with the sale of the securities, we, or the
purchasers of the securities for whom the underwriter may act as agent, may compensate the underwriter in the form of underwriting
discounts or commissions. The underwriter may sell the securities to or through dealers, and the underwriter may compensate those
dealers in the form of discounts, concessions or commissions.
With
respect to underwritten public offerings, negotiated transactions and block trades, we will provide in the applicable prospectus
supplement information regarding any compensation we pay to underwriters, dealers or agents in connection with the offering of
the securities, and any discounts, concessions or commissions allowed by underwriters to participating dealers. Underwriters,
dealers and agents participating in the distribution of the securities may be deemed to be underwriters within the meaning of
the Securities Act of 1933, as amended, or the Securities Act, and any discounts and commissions received by them and any profit
realized by them on resale of the securities may be deemed to be underwriting discounts and commissions. We may enter into agreements
to indemnify underwriters, dealers and agents against civil liabilities, including liabilities under the Securities Act, or to
contribute to payments they may be required to make in respect thereof.
If
so indicated in the applicable prospectus supplement, we will authorize underwriters or other persons acting as our agents to
solicit offers by certain institutions to purchase securities from us pursuant to delayed delivery contracts providing for payment
and delivery on the date stated in the prospectus supplement. Each contract will be for an amount not less than, and the aggregate
amount of securities sold pursuant to such contracts shall not be less nor more than, the respective amounts stated in the prospectus
supplement. Institutions with whom the contracts, when authorized, may be made include commercial and savings banks, insurance
companies, pension funds, investment companies, educational and charitable institutions and other institutions, but shall in all
cases be subject to our approval. Delayed delivery contracts will not be subject to any conditions except that:
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the
purchase by an institution of the securities covered under that contract shall not at the time of delivery be prohibited under
the laws of the jurisdiction to which that institution is subject; and
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if
the securities are also being sold to underwriters acting as principals for their own account, the underwriters shall have
purchased such securities not sold for delayed delivery. The underwriters and other persons acting as our agents will not
have any responsibility in respect of the validity or performance of delayed delivery contracts.
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Shares
of our common stock sold pursuant to the registration statement of which this prospectus is a part will be authorized for quotation
and trading on The Nasdaq Capital Market. The applicable prospectus supplement will contain information, where applicable, as
to any other listing, if any, on The Nasdaq Capital Market or any securities market or other securities exchange of the securities
covered by the prospectus supplement. We can make no assurance as to the liquidity of or the existence of trading markets for
any of the securities.
In
order to facilitate the offering of the securities, certain persons participating in the offering may engage in transactions that
stabilize, maintain or otherwise affect the price of the securities. This may include over-allotments or short sales of the securities,
which involve the sale by persons participating in the offering of more securities than we sold to them. In these circumstances,
these persons would cover such over-allotments or short positions by making purchases in the open market or by exercising their
over-allotment option. In addition, these persons may stabilize or maintain the price of the securities by bidding for or purchasing
the applicable security in the open market or by imposing penalty bids, whereby selling concessions allowed to dealers participating
in the offering may be reclaimed if the securities sold by them are repurchased in connection with stabilization transactions.
The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which
might otherwise prevail in the open market. These transactions may be discontinued at any time.
In
compliance with the guidelines of the Financial Industry Regulatory Authority, Inc., or FINRA, the maximum consideration or discount
to be received by any FINRA member or independent broker dealer may not exceed 8% of the aggregate amount of the securities offered
pursuant to this prospectus and any applicable prospectus supplement.
The
underwriters, dealers and agents may engage in other transactions with us, or perform other services for us, in the ordinary course
of their business.
DESCRIPTION
OF CAPITAL STOCK
General
As
of the date of this prospectus, our authorized capital stock consists of 145,833,334 shares of common stock, $0.0001 par value
per share. As of March 26, 2021, there were 24,411,791 shares of our common stock outstanding.
The
following summary description of our capital stock is based on the provisions of our certificate of incorporation and bylaws,
the applicable provisions of the Nevada Revised Business Corporations Act, and the agreements described below. This information
may not be complete in all respects and is qualified entirely by reference to the provisions of our certificate of incorporation
and bylaws, Nevada law and such agreements. For information on how to obtain copies of our certificate of incorporation, bylaws
and such agreements, which are exhibits to the registration statement of which this prospectus is a part, see the section entitled
“Where You Can Find More Information.”
Common
Stock
Each
share of common stock entitles the holder to one vote on all matters submitted to a vote of the stockholders including the election
of directors. Except as otherwise required by law the holders of our common stock possess all voting power. According to our bylaws,
in general, each director is to be elected by a majority of the votes cast with respect to the directors at any meeting of our
stockholders for the election of directors at which a quorum is present. According to our bylaws, in general, the affirmative
vote of a majority of the shares represented at the meeting and entitled to vote on any matter (which shares voting affirmatively
also constitute at least a majority of the required quorum), except for the election of directors, is to be the act of our stockholders.
Our bylaws provide that stockholders holding at least 33.3% of the shares entitled to vote, represented in person or by proxy,
constitute a quorum at the meeting of our stockholders. Our bylaws also provide that any action which may be taken at any annual
or special meeting of our stockholders may be taken without a meeting and without prior notice if a consent in writing, setting
forth the action so taken, is signed by the holders of outstanding shares having not less than the minimum number of votes that
would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and
voted.
Our
articles of incorporation and bylaws do not provide for cumulative voting in the election of directors. Because the holders of
our common stock do not have cumulative voting rights and directors are generally to be elected by a majority of the votes casts
with respect to the directors at any meeting of our stockholders for the election of directors, holders of more than fifty percent,
and in some cases less than 50%, of the issued and outstanding shares of our common stock can elect all of our directors.
Dividend
Rights
The
holders of our common stock are entitled to receive such dividends as may be declared by our board of directors out of funds legally
available for dividends. Our board of directors is not obligated to declare a dividend. Any future dividends will be subject to
the discretion of our board of directors and will depend upon, among other things, future earnings, the operating and financial
condition of our company, its capital requirements, general business conditions and other pertinent factors. We do not anticipate
that dividends will be paid in the foreseeable future.
Miscellaneous
Rights and Provisions
In
the event of our liquidation or dissolution, whether voluntary or involuntary, each share of our common stock is entitled to share
ratably in any assets available for distribution to holders of our common stock after satisfaction of all liabilities.
Our
common stock is not convertible or redeemable and has no preemptive, subscription or conversion rights. There are no conversions,
redemption, sinking fund or similar provisions regarding our common stock.
Our
common stock, after the fixed consideration thereof has been paid or performed, are not subject to assessment, and the holders
of our common stock are not individually liable for the debts and liabilities of our company.
Our
bylaws provide that our board of directors may amend our bylaws by a majority vote of our board of directors including any bylaws
adopted by our stockholders, but our stockholders may from time to time specify particular provisions of these bylaws, which must
not be amended by our board of directors. Our current bylaws were adopted by our board of directors. Therefore, our board of directors
can amend our bylaws to make changes to the provisions relating to the quorum requirement and votes requirements to the extent
permitted by the Nevada Revised Statutes.
Anti-Takeover
Provisions
Some
features of the Nevada Revised Statutes, which are further described below, may have the effect of deterring third parties from
making takeover bids for control of our company or may be used to hinder or delay a takeover bid. This would decrease the chance
that our stockholders would realize a premium over market price for their shares of common stock as a result of a takeover bid.
Acquisition
of Controlling Interest
The
Nevada Revised Statutes contain provisions governing the acquisition of a controlling interest of certain Nevada corporations.
These provisions provide generally that any person or entity that acquires in excess of a specified percentage of the outstanding
voting shares of a Nevada corporation may be denied voting rights with respect to the acquired shares, unless the holders of a
majority of the voting power of the corporation, excluding shares of which such acquiring person or entity, an officer or a director
of the corporation, and an employee of the corporation exercises voting rights, elect to restore such voting rights in whole or
in part. These provisions apply whenever a person or entity acquires shares that, but for the operation of these provisions, would
bring voting power of such person or entity in the election of directors within any of the following three ranges:
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1.
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20%
or more but less than 33 1/3%;
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2.
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33
1/3% or more but less than or equal to 50%; or
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The
stockholders or board of directors of a corporation may elect to exempt the stock of the corporation from these provisions through
adoption of a provision to that effect in the articles of incorporation or bylaws of the corporation. Our articles of incorporation
and bylaws do not exempt our common stock from these provisions.
These
provisions are applicable only to a Nevada corporation, which:
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1.
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has
200 or more stockholders of record, at least 100 of whom have addresses in Nevada appearing
on the stock ledger of the corporation; and
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2.
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does
business in Nevada directly or through an affiliated corporation.
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At
this time, we do not have 100 stockholders of record who have addresses in Nevada appearing on the stock ledger of our company
nor do we conduct any business in Nevada, either directly or through an affiliated corporation. Therefore, we believe that these
provisions do not apply to acquisitions of our shares and will not until such time as these requirements have been met. At such
time as they may apply to us, these provisions may discourage companies or persons interested in acquiring a significant interest
in or control of our company, regardless of whether such acquisition may be in the interest of our stockholders.
Combination
with Interested Stockholder
The
Nevada Revised Statutes contain provisions governing the combination of any Nevada corporation that has 200 or more stockholders
of record with an interested stockholder. As of March 26, 2021, we had approximately 206 stockholders of record. Therefore, we
believe that these provisions do not apply to us and will not until such time as these requirements have been met. At such time
as they may apply to us, these provisions may also have the effect of delaying or making it more difficult to effect a change
in control of our company.
A
corporation affected by these provisions may not engage in a combination within three years after the interested stockholder acquires
his, her or its shares unless the combination or purchase is approved by the board of directors before the interested stockholder
acquired such shares. Generally, if approval is not obtained, then after the expiration of the three-year period, the business
combination may be consummated with the approval of the board of directors before the person became an interested stockholder
or a majority of the voting power held by disinterested stockholders, or if the consideration to be received per share by disinterested
stockholders is at least equal to the highest of:
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1.
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the
highest price per share paid by the interested stockholder within the three years immediately
preceding the date of the announcement of the combination or within three years immediately
before, or in, the transaction in which he, she or it became an interested stockholder,
whichever is higher; or
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2.
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the
market value per share on the date of announcement of the combination or the date the
person became an interested stockholder, whichever is higher.
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Generally,
these provisions define an interested stockholder as a person who is the beneficial owner, directly or indirectly of 10% or more
of the voting power of the outstanding voting shares of a corporation. Generally, these provisions define combination to include
any merger or consolidation with an interested stockholder, or any sale, lease, exchange, mortgage, pledge, transfer or other
disposition, in one transaction or a series of transactions with an interested stockholder of assets of the corporation having:
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1.
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an
aggregate market value equal to 5% or more of the aggregate market value of the assets
of the corporation;
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2.
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an
aggregate market value equal to 5% or more of the aggregate market value of all outstanding
shares of the corporation; or
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3.
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representing
10% or more of the earning power or net income of the corporation.
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Transfer
Agent and Registrar
The
transfer agent and registrar for our common stock is Securities Transfer Corporation located at 2591 Dallas Parkway, Suite 102,
Frisco, TX 75034.
DESCRIPTION
OF DEBT SECURITIES
The
following description, together with the additional information we include in any applicable prospectus supplements, summarizes
the material terms and provisions of the debt securities that we may offer under this prospectus. While the terms we have summarized
below will apply generally to any future debt securities we may offer pursuant to this prospectus, we will describe the particular
terms of any debt securities that we may offer in more detail in the applicable prospectus supplement. If we so indicate in a
prospectus supplement, the terms of any debt securities offered under such prospectus supplement may differ from the terms we
describe below, and to the extent the terms set forth in a prospectus supplement differ from the terms described below, the terms
set forth in the prospectus supplement shall control.
We
may sell from time to time, in one or more offerings under this prospectus, debt securities, which may be senior or subordinated.
We will issue any such senior debt securities under a senior indenture that we will enter into with a trustee to be named in the
senior indenture. We will issue any such subordinated debt securities under a subordinated indenture, which we will enter into
with a trustee to be named in the subordinated indenture. We use the term “indentures” to refer to either the senior
indenture or the subordinated indenture, as applicable. The indentures will be qualified under the Trust Indenture Act of 1939,
as in effect on the date of the indenture. We use the term “debenture trustee” to refer to either the trustee under
the senior indenture or the trustee under the subordinated indenture, as applicable.
The
following summaries of material provisions of the senior debt securities, the subordinated debt securities and the indentures
are subject to, and qualified in their entirety by reference to, all the provisions of the indenture applicable to a particular
series of debt securities.
General
Each
indenture will provide that debt securities may be issued from time to time in one or more series and may be denominated and payable
in foreign currencies or units based on or relating to foreign currencies. Neither indenture will limit the amount of debt securities
that may be issued thereunder, and each indenture will provide that the specific terms of any series of debt securities shall
be set forth in, or determined pursuant to, an authorizing resolution and/or a supplemental indenture, if any, relating to such
series.
We
will describe in each prospectus supplement the following terms relating to a series of debt securities:
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the
title or designation;
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the
aggregate principal amount and any limit on the amount that may be issued;
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the
currency or units based on or relating to currencies in which debt securities of such series are denominated and the currency
or units in which principal or interest or both will or may be payable;
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whether
we will issue the series of debt securities in global form, the terms of any global securities and who the depositary will
be;
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the
maturity date and the date or dates on which principal will be payable;
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the
interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin to
accrue, the date or dates interest will be payable and the record dates for interest payment dates or the method for determining
such dates;
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whether
or not the debt securities will be secured or unsecured, and the terms of any secured debt;
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the
terms of the subordination of any series of subordinated debt;
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the
place or places where payments will be payable;
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our
right, if any, to defer payment of interest and the maximum length of any such deferral period;
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the
date, if any, after which, and the price at which, we may, at our option, redeem the series of debt securities pursuant to
any optional redemption provisions;
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the
date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund provisions or otherwise,
to redeem, or at the holder’s option to purchase, the series of debt securities;
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whether
the indenture will restrict our ability to pay dividends, or will require us to maintain any asset ratios or reserves;
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whether
we will be restricted from incurring any additional indebtedness;
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a
discussion on any material or special U.S. federal income tax considerations applicable to a series of debt securities;
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the
denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral
multiple thereof; and
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any
other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities.
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We
may issue debt securities that provide for an amount less than their stated principal amount to be due and payable upon declaration
of acceleration of their maturity pursuant to the terms of the indenture. We will provide you with information on the federal
income tax considerations and other special considerations applicable to any of these debt securities in the applicable prospectus
supplement.
Conversion
or Exchange Rights
We
will set forth in the prospectus supplement the terms, if any, on which a series of debt securities may be convertible into or
exchangeable for our common stock or our other securities. We will include provisions as to whether conversion or exchange is
mandatory, at the option of the holder or at our option. We may include provisions pursuant to which the number of shares of our
common stock or our other securities that the holders of the series of debt securities receive would be subject to adjustment.
Information
Concerning the Debenture Trustee
The
debenture trustee, other than during the occurrence and continuance of an event of default under the applicable indenture, undertakes
to perform only those duties as are specifically set forth in the applicable indenture. Upon an event of default under an indenture,
the debenture trustee under such indenture must use the same degree of care as a prudent person would exercise or use in the conduct
of his or her own affairs. Subject to this provision, the debenture trustee is under no obligation to exercise any of the powers
given it by the indentures at the request of any holder of debt securities unless it is offered reasonable security and indemnity
against the costs, expenses and liabilities that it might incur.
Payment
and Paying Agents
Unless
we otherwise indicate in the applicable prospectus supplement, we will make payment of the interest on any debt securities on
any interest payment date to the person in whose name the debt securities, or one or more predecessor securities, are registered
at the close of business on the regular record date for the interest.
We
will pay principal of and any premium and interest on the debt securities of a particular series at the office of the paying agents
designated by us, except that unless we otherwise indicate in the applicable prospectus supplement, we will make interest payments
by check which we will mail to the holder. Unless we otherwise indicate in a prospectus supplement, we will designate the corporate
trust office of the debenture trustee in the City of New York as our sole paying agent for payments with respect to debt securities
of each series. We will name in the applicable prospectus supplement any other paying agents that we initially designate for the
debt securities of a particular series. We will maintain a paying agent in each place of payment for the debt securities of a
particular series.
All
money we pay to a paying agent or the debenture trustee for the payment of the principal of or any premium or interest on any
debt securities which remains unclaimed at the end of two years after such principal, premium or interest has become due and payable
will be repaid to us, and the holder of the security thereafter may look only to us for payment thereof.
Governing
Law
The
indentures and the debt securities will be governed by and construed in accordance with the laws of the State of Nevada, except
to the extent that the Trust Indenture Act is applicable.
Subordination
of Subordinated Debt Securities
Our
obligations pursuant to any subordinated debt securities will be unsecured and will be subordinate and junior in priority of payment
to certain of our other indebtedness to the extent described in a prospectus supplement. The subordinated indenture does not limit
the amount of senior indebtedness we may incur. It also does not limit us from issuing any other secured or unsecured debt.
DESCRIPTION
OF WARRANTS
General
We
may issue warrants to our stockholders to purchase shares of our common stock. We may offer warrants separately or together with
one or more debt securities, common stock or rights, or any combination of those securities in the form of units, as described
in the applicable prospectus supplement. Each series of warrants will be issued under a separate warrant agreement to be entered
into between us and a bank or trust company, as warrant agent. The warrant agent will act solely as our agent in connection with
the certificates relating to the rights of the series of certificates and will not assume any obligation or relationship of agency
or trust for or with any holders of rights certificates or beneficial owners of rights. The following description sets forth certain
general terms and provisions of the rights to which any prospectus supplement may relate. The particular terms of the warrant
to which any prospectus supplement may relate and the extent, if any, to which the general provisions may apply to the rights
so offered will be described in the applicable prospectus supplement. To the extent that any particular terms of the warrant,
warrant agreement or warrant certificates described in a prospectus supplement differ from any of the terms described below, then
the terms described below will be deemed to have been superseded by that prospectus supplement. We encourage you to read the applicable
warrant agreement and warrant certificate for additional information before you decide whether to purchase any of our rights.
We
will provide in a prospectus supplement the following terms of the warrants being issued:
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the
specific designation and aggregate number of, and the price at which we will issue, the warrants;
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the
currency or currency units in which the offering price, if any, and the exercise price are payable;
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the
designation, amount and terms of the securities purchasable upon exercise of the warrants;
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if
applicable, the exercise price for shares of our common stock and the number of shares of common stock to be received upon
exercise of the warrants;
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if
applicable, the exercise price for our debt securities, the amount of debt securities to be received upon exercise, and a
description of that series of debt securities;
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the
date on which the right to exercise the warrants will begin and the date on which that right will expire or, if you may not
continuously exercise the warrants throughout that period, the specific date or dates on which you may exercise the warrants;
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whether
the warrants will be issued in fully registered form or bearer form, in definitive or global form or in any combination of
these forms, although, in any case, the form of a warrant included in a unit will correspond to the form of the unit and of
any security included in that unit;
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any
applicable material U.S. federal income tax consequences;
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the
identity of the warrant agent for the warrants and of any other depositaries, execution or paying agents, transfer agents,
registrars or other agents;
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the
proposed listing, if any, of the warrants or any securities purchasable upon exercise of the warrants on any securities exchange;
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if
applicable, the date from and after which the warrants and the common stock and/or debt securities will be separately transferable;
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if
applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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information
with respect to book-entry procedures, if any;
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the
anti-dilution provisions of the warrants, if any;
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any
redemption or call provisions;
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whether
the warrants may be sold separately or with other securities as parts of units; and
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any
additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the
warrants.
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Each
warrant will entitle the holder of rights to purchase for cash the principal amount of shares of common stock or other securities
at the exercise price provided in the applicable prospectus supplement. Warrants may be exercised at any time up to the close
of business on the expiration date for the rights provided in the applicable prospectus supplement.
Holders
may exercise warrants as described in the applicable prospectus supplement. Upon receipt of payment and the warrant certificate
properly completed and duly executed at the corporate trust office of the rights agent or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the shares of common stock or other securities, as applicable, purchasable
upon exercise of the rights. If less than all of the warrants issued in any rights offering are exercised, we may offer any unsubscribed
securities directly to persons other than stockholders, to or through agents, underwriters or dealers or through a combination
of such methods, including pursuant to standby arrangements, as described in the applicable prospectus supplement.
Warrant
Agent
The
warrant agent for any warrants we offer will be set forth in the applicable prospectus supplement.
Outstanding
Warrants and Options
As
of March 26, 2021, we had outstanding warrants to purchase an aggregate of 5,165,510 shares of our common stock having a per share
exercise price ranging between $3.14 and $11.19 These warrants have a [three-year term], the latest expiring on [February 1, 2023].
In addition, as of such date we also had outstanding options issued to employees and other service providers for an aggregate
of 3,434,858 shares of our common stock having a share exercise price ranging between $0.0012 and $16.8.
DESCRIPTION
OF RIGHTS
General
We
may issue rights to our stockholders to purchase shares of our common stock or the other securities described in this prospectus.
We may offer rights separately or together with one or more additional rights, debt securities, common stock or warrants, or any
combination of those securities in the form of units, as described in the applicable prospectus supplement. Each series of rights
will be issued under a separate rights agreement to be entered into between us and a bank or trust company, as rights agent. The
rights agent will act solely as our agent in connection with the certificates relating to the rights of the series of certificates
and will not assume any obligation or relationship of agency or trust for or with any holders of rights certificates or beneficial
owners of rights. The following description sets forth certain general terms and provisions of the rights to which any prospectus
supplement may relate. The particular terms of the rights to which any prospectus supplement may relate and the extent, if any,
to which the general provisions may apply to the rights so offered will be described in the applicable prospectus supplement.
To the extent that any particular terms of the rights, rights agreement or rights certificates described in a prospectus supplement
differ from any of the terms described below, then the terms described below will be deemed to have been superseded by that prospectus
supplement. We encourage you to read the applicable rights agreement and rights certificate for additional information before
you decide whether to purchase any of our rights.
We
will provide in a prospectus supplement the following terms of the rights being issued:
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●
|
the
date of determining the stockholders entitled to the rights distribution;
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●
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the
aggregate number of shares of common stock or other securities purchasable upon exercise of the rights;
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●
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the
aggregate number of rights issued;
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●
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whether
the rights are transferrable and the date, if any, on and after which the rights may be separately transferred;
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●
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the
date on which the right to exercise the rights will commence, and the date on which the right to exercise the rights will
expire;
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●
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the
method by which holders of rights will be entitled to exercise;
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●
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the
conditions to the completion of the offering, if any;
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●
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the
withdrawal, termination and cancellation rights, if any;
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●
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whether
there are any backstop or standby purchaser or purchasers and the terms of their commitment, if any;
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●
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whether
stockholders are entitled to oversubscription rights, if any;
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●
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any
applicable U.S. federal income tax considerations; and
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●
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any
other terms of the rights, including terms, procedures and limitations relating to the distribution, exchange and exercise
of the rights, as applicable.
|
Each
right will entitle the holder of rights to purchase for cash the principal amount of shares of common stock or other securities
at the exercise price provided in the applicable prospectus supplement. Rights may be exercised at any time up to the close of
business on the expiration date for the rights provided in the applicable prospectus supplement.
Holders
may exercise rights as described in the applicable prospectus supplement. Upon receipt of payment and the rights certificate properly
completed and duly executed at the corporate trust office of the rights agent or any other office indicated in the prospectus
supplement, we will, as soon as practicable, forward the shares of common stock or other securities, as applicable, purchasable
upon exercise of the rights. If less than all of the rights issued in any rights offering are exercised, we may offer any unsubscribed
securities directly to persons other than stockholders, to or through agents, underwriters or dealers or through a combination
of such methods, including pursuant to standby arrangements, as described in the applicable prospectus supplement.
Rights
Agent
The
rights agent for any rights we offer will be set forth in the applicable prospectus supplement.
DESCRIPTION
OF UNITS
The
following description, together with the additional information that we include in any applicable prospectus supplements summarizes
the material terms and provisions of the units that we may offer under this prospectus. While the terms we have summarized below
will apply generally to any units that we may offer under this prospectus, we will describe the particular terms of any series
of units in more detail in the applicable prospectus supplement. The terms of any units offered under a prospectus supplement
may differ from the terms described below.
We
will incorporate by reference from reports that we file with the SEC, the form of unit agreement that describes the terms of the
series of units we are offering, and any supplemental agreements, before the issuance of the related series of units. The following
summaries of material terms and provisions of the units are subject to, and qualified in their entirety by reference to, all the
provisions of the unit agreement and any supplemental agreements applicable to a particular series of units. We urge you to read
the applicable prospectus supplements related to the particular series of units that we may offer under this prospectus, as well
as any related free writing prospectuses and the complete unit agreement and any supplemental agreements that contain the terms
of the units.
General
We
may issue units consisting of common stock, one or more debt securities, warrants or rights for the purchase of common stock and/or
debt securities in one or more series, in any combination. Each unit will be issued so that the holder of the unit is also the
holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each
security included in the unit. The unit agreement under which a unit is issued may provide that the securities included in the
unit may not be held or transferred separately, at any time or at any time before a specified date.
We
will describe in the applicable prospectus supplement the terms of the series of units being offered, including:
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●
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the
designation and terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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|
●
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any
provisions of the governing unit agreement that differ from those described below; and
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●
|
any
provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units.
|
The
provisions described in this section, as well as those set forth in any prospectus supplement or as described under “Description
of Capital Stock,” “Description of Debt Securities,” “Description of Warrants” and “Description
of Rights” will apply to each unit, as applicable, and to any common stock, debt security, warrant or right included in
each unit, as applicable.
Unit
Agent
The
name and address of the unit agent for any units we offer will be set forth in the applicable prospectus supplement.
Issuance
in Series
We
may issue units in such amounts and in such numerous distinct series as we determine.
Enforceability
of Rights by Holders of Units
Each
unit agent will act solely as our agent under the applicable unit agreement and will not assume any obligation or relationship
of agency or trust with any holder of any unit. A single bank or trust company may act as unit agent for more than one series
of units. A unit agent will have no duty or responsibility in case of any default by us under the applicable unit agreement or
unit, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any
holder of a unit may, without the consent of the related unit agent or the holder of any other unit, enforce by appropriate legal
action its rights as holder under any security included in the unit.
LEGAL
MATTERS
Mintz,
Levin, Cohn, Ferris, Glovsky and Popeo, P.C., New York, New York, will pass upon the validity of the issuance of the securities
to be offered by this prospectus.
EXPERTS
The
financial statements incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December
31, 2020 have been so incorporated in reliance on the report of Kesselman & Kesselman, Certified Public Accountants (Isr.),
a member firm of PricewaterhouseCoopers International Limited, an independent registered public accounting firm, given on the
authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
are subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, and file annual, quarterly and current
reports, proxy statements and other information with the SEC. You may read and copy these reports, proxy statements and other
information at the SEC’s public reference facilities at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. You can request
copies of these documents by writing to the SEC and paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for
more information about the operation of the public reference facilities. SEC filings are also available at the SEC’s web
site at http://www.sec.gov.
This
prospectus is only part of a registration statement on Form S-3 that we have filed with the SEC under the Securities Act and therefore
omits certain information contained in the registration statement. We have also filed exhibits and schedules with the registration
statement that are excluded from this prospectus, and you should refer to the applicable exhibit or schedule for a complete description
of any statement referring to any contract or other document. You may inspect a copy of the registration statement, including
the exhibits and schedules, without charge, at the public reference room or obtain a copy from the SEC upon payment of the fees
prescribed by the SEC.
We
also maintain a website at www.orgenesis.com, through which you can access our SEC filings. The information set forth on,
or accessible from, our website is not part of this prospectus.
INCORPORATION
OF INFORMATION BY REFERENCE
The
SEC allows us to “incorporate by reference” information that we file with them. Incorporation by reference allows
us to disclose important information to you by referring you to those other documents. The information incorporated by reference
is an important part of this prospectus, and information that we file later with the SEC will automatically update and supersede
this information. This prospectus omits certain information contained in the registration statement, as permitted by the SEC.
You should refer to the registration statement and any prospectus supplement filed hereafter, including the exhibits, for further
information about us and the securities we may offer pursuant to this prospectus. Statements in this prospectus regarding the
provisions of certain documents filed with, or incorporated by reference in, the registration statement are not necessarily complete
and each statement is qualified in all respects by that reference. Copies of all or any part of the registration statement, including
the documents incorporated by reference or the exhibits, may be obtained upon payment of the prescribed rates at the offices of
the SEC listed above in “Where You Can Find More Information.” The documents we are incorporating by reference are:
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●
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our
Annual Report on Form 10-K for the year ended December 31, 2020, filed on March 9, 2021;
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|
●
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the
description of our Common Stock which is filed as Exhibit 4.1 to our Annual Report on Form 10-K for the year ended
December 31, 2020, including all amendments or reports filed for the purpose of updating such description; and
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●
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all
reports and other documents subsequently filed by us pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act after
the date of this prospectus and prior to the termination or completion of the offering of securities under this prospectus
shall be deemed to be incorporated by reference in this prospectus and to be a part hereof from the date of filing such reports
and other documents.
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Unless
otherwise noted, the SEC file number for each of the documents listed above is 001-38416.
Any
statement contained in this prospectus or in a document incorporated or deemed to be incorporated by reference into this prospectus
will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained in this prospectus
or any other subsequently filed document that is deemed to be incorporated by reference into this prospectus modifies or supersedes
the statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute
a part of this prospectus.
You
may request, orally or in writing, a copy of any or all of the documents incorporated herein by reference. These documents will
be provided to you at no cost, by contacting: Orgenesis Inc., Attention: Corporate Secretary, 20271 Goldenrod Lane, Germantown
MD 20876 or call (480) 659-6404.
You
should rely only on information contained in, or incorporated by reference into, this prospectus and any prospectus supplement.
We have not authorized anyone to provide you with information different from that contained in this prospectus or incorporated
by reference in this prospectus. We are not making offers to sell the securities in any jurisdiction in which such an offer or
solicitation is not authorized or in which the person making such offer or solicitation is not qualified to do so or to anyone
to whom it is unlawful to make such offer or solicitation.
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution
The
following table sets forth an itemization of the various expenses, all of which we will pay, in connection with the issuance and
distribution of the securities being registered. All of the amounts shown are estimated except the SEC Registration Fee.
SEC Registration Fee
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$
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12,980
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|
Legal Fees and Expenses
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*
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Accounting Fees and Expenses
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|
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*
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Miscellaneous
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|
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*
|
Total
|
$
|
|
*
|
*
Fees depend on number of issuances and amount of securities sold and accordingly cannot be estimated at this time.
Item
15. Indemnification of Directors and Officers
Nevada
Revised Statutes provide that:
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●
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a
corporation may indemnify any person who was or is a party or is threatened to be made
a party to any threatened, pending or completed action, suit or proceeding, whether civil,
criminal, administrative or investigative, except an action by or in the right of the
corporation, by reason of the fact that the person is or was a director, officer, employee
or agent of the corporation, or is or was serving at the request of the corporation as
a director, officer, employee or agent of another corporation, partnership, joint venture,
trust or other enterprise, against expenses, including attorneys’ fees, judgments,
fines and amounts paid in settlement actually and reasonably incurred by the person in
connection with the action, suit or proceeding if the person acted in good faith and
in a manner which he or she reasonably believed to be in or not opposed to the best interests
of the corporation, and, with respect to any criminal action or proceeding, had no reasonable
cause to believe his or her conduct was unlawful;
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●
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a
corporation may indemnify any person who was or is a party or is threatened to be made
a party to any threatened, pending or completed action or suit by or in the right of
the corporation to procure a judgment in its favor by reason of the fact that the person
is or was a director, officer, employee or agent of the corporation, or is or was serving
at the request of the corporation as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise against expenses,
including amounts paid in settlement and attorneys’ fees actually and reasonably
incurred by the person in connection with the defense or settlement of the action or
suit if the person acted in good faith and in a manner which the person reasonably believed
to be in or not opposed to the best interests of the corporation. Indemnification may
not be made for any claim, issue or matter as to which such a person has been adjudged
by a court of competent jurisdiction, after exhaustion of all appeals therefrom, to be
liable to the corporation or for amounts paid in settlement to the corporation, unless
and only to the extent that the court in which the action or suit was brought or other
court of competent jurisdiction determines upon application that in view of all the circumstances
of the case, the person is fairly and reasonably entitled to indemnity for such expenses
as the court deems proper; and
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●
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to
the extent that a director, officer, employee or agent of a corporation has been successful
on the merits or otherwise in defense of any threatened, pending or completed action,
suit or proceeding, or in defense of any claim, issue or matter therein, the corporation
must indemnify him or her against expenses, including attorneys’ fees, actually
and reasonably incurred by such person in connection with the defense.
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Nevada
Revised Statutes provide that we may make any discretionary indemnification only as authorized in the specific case upon a determination
that indemnification of the director, officer, employee or agent is proper in the circumstances. The determination must be made:
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●
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by
our board of directors by majority vote of a quorum consisting of directors who were
not parties to the action, suit or proceeding;
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●
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if
a majority vote of a quorum consisting of directors who were not parties to the action,
suit or proceeding so orders, by independent legal counsel in a written opinion;
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|
●
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if
a quorum consisting of directors who were not parties to the action, suit or proceeding
cannot be obtained, by independent legal counsel in a written opinion; or
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Nevada
Revised Statutes provide that a corporation may purchase and maintain insurance or make other financial arrangements on behalf
of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of
the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise
for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee
or agent, or arising out of his status as such, whether or not the corporation has the authority to indemnify him against such
liability and expenses.
Our
bylaws also require us to indemnify directors, officers and employees to the fullest extent allowed by law, provided, however,
that it will be within the discretion of our board of directors whether to advance any funds in advance of disposition of any
action, suit or proceeding.
Item
16. Exhibits
The
exhibits to this registration statement are listed in the Exhibit Index to this registration statement, which Exhibit Index is
hereby incorporated by reference.
Item
17. Undertakings
(a)
The undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i)
To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
(ii)
To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if
the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high
end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii)
To include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
provided,
however, that paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) do not apply if the information required to be included in
a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant
pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration
statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2)
That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall
be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at
that time shall be deemed to be the initial bona fide offering thereof.
(3)
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
(4)
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i)
Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as
of the date the filed prospectus was deemed part of and included in the registration statement; and
(ii)
Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement
as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale
of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and
any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement
relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement
made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or
deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will,
as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made
in the registration statement or prospectus that was part of the registration statement or made in any such document immediately
prior to such effective date.
(5)
That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities, in a primary offering of securities of the undersigned registrant pursuant to this registration
statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or
sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser
and will be considered to offer or sell such securities to such purchaser:
(i)
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
(ii)
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
(iii)
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
(iv)
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
(b)
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant, the registrant has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim
for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director,
officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the
opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final
adjudication of such issue.
(d)
The undersigned registrant hereby undertakes to file an application for the purpose of determining the eligibility of the trustee
to act under subsection (a) of Section 310 of the Trust Indenture Act (“Act”) in accordance with the rules and regulations
prescribed by the Commission under section 305(b)(2) of the Act.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of Germantown, State of Maryland, on March 26, 2021.
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ORGENESIS
INC.
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|
|
|
|
By
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/s/
Vered Caplan
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|
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Vered
Caplan
Chief
Executive Officer
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SIGNATURES
AND POWER OF ATTORNEY
We,
the undersigned officers and directors of Orgenesis Inc., hereby severally constitute and appoint each of Vered Caplan and Neil
Reithinger as our true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution for him or her
and in his or her name, place and stead, and in any and all capacities, to sign any and all amendments (including post-effective
amendments) to this registration statement (or any other registration statement for the same offering that is to be effective
upon filing pursuant to Rule 462(b) under the Securities Act of 1933), and to file the same, with all exhibits thereto and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent,
full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises,
as full to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement has been signed below by the following persons
in the capacities and on the dates indicated.
Signature
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Title
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Date
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/s/
Vered Caplan
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Chief
Executive Officer and Director (principal executive officer)
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|
March
26, 2021
|
Vered
Caplan
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|
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|
|
|
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|
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/s/
Neil Reithinger
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|
Chief
Financial Officer (principal financial officer and principal accounting officer)
|
|
March
26, 2021
|
Neil
Reithinger
|
|
|
|
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|
|
|
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/s/
David Sidransky
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|
Director
|
|
March
26, 2021
|
David
Sidransky
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|
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|
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|
|
|
|
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/s/
Guy Yachin
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|
Director
|
|
March
26, 2021
|
Guy
Yachin
|
|
|
|
|
|
|
|
|
|
/s/
Ashish Nanda
|
|
Director
|
|
March
26, 2021
|
Ashish
Nanda
|
|
|
|
|
|
|
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|
/s/
Yaron Adler
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|
Director
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|
March
26, 2021
|
Yaron
Adler
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/s/
Mario Philips
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Director
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March
26, 2021
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Mario
Philips
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EXHIBIT
INDEX
Exhibit
|
|
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Number
|
|
Description
|
|
|
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1.1*
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|
Form
of Underwriting Agreement.
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3.1
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Articles of Incorporation, as amended (incorporated by reference to an exhibit to our registration statement on Form S-8, filed on August 7, 2020).
|
3.2
|
|
Amended and Restated Bylaws (incorporated by reference to an exhibit to our current report on Form 8-K, filed on September 21, 2011).
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4.1*
|
|
Form
of Senior Debt Security.
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4.2*
|
|
Form
of Subordinated Debt Security.
|
4.3
|
|
Form of Senior Indenture.
|
4.4
|
|
Form of Subordinated Indenture.
|
4.5*
|
|
Form
of Warrant Agreement and Warrant Certificate.
|
4.6*
|
|
Form
of Rights Agreement and Right Certificate.
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4.7*
|
|
Form
of Unit Agreement and Unit.
|
5.1
|
|
Opinion of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. with respect to the legality of the securities being registered.
|
23.1
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|
Consent of Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited
|
23.2
|
|
Consent of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (included in the opinion filed as Exhibit 5.1).
|
24.1
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|
Powers of Attorney (included on the signature page of this registration statement).
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25.1*
|
|
The
Statement of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of the Trustee under the Senior Indenture
will be incorporated herein by reference from a subsequent filing in accordance with Section 305(b)(2) of the Trust Indenture
Act of 1939.
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25.2*
|
|
The
Statement of Eligibility on Form T-1 under the Trust Indenture Act of 1939, as amended, of the Trustee under the Subordinated
Indenture will be incorporated herein by reference from a subsequent filing in accordance with Section 305(b)(2) of the Trust
Indenture Act of 1939.
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*
To be filed by amendment or as an exhibit to a report pursuant to Section 13(a), 13(c) or 15(d) of the Exchange Act.
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