Filed Pursuant
to General Instruction II.L of Form F-10
File No.
333-259994
This prospectus supplement
(the "Prospectus Supplement"), together with the short form base
shelf prospectus dated July 5, 2021 to which it relates, as amended
or supplemented (the "Base Shelf Prospectus"), and each document
deemed to be incorporated by reference into this Prospectus
Supplement and the Base Shelf Prospectus, as amended or
supplemented (collectively, the "Prospectus"), constitutes a public
offering of these securities only in those jurisdictions where they
may be lawfully offered for sale and only by persons permitted to
sell such securities. No securities regulatory authority has
expressed an opinion about these securities and it is an offence to
claim otherwise.
Information has been
incorporated by reference in the Prospectus from documents filed
with securities commissions or similar authorities in Canada.
Copies of the documents incorporated herein by reference may be
obtained on request without charge from the Secretary of Cybin Inc.
at 100 King Street West, Suite 5600, Toronto, Ontario M5X 1C9,
telephone 1-866-292-4601, and are also available electronically at
www.sedar.com and www.sec.gov/edgar.
PROSPECTUS
SUPPLEMENT
(To the Short
Form Base Shelf Prospectus dated July 5, 2021)

CYBIN INC.
U.S.$35,000,000
Common Shares
Cybin Inc. ("Cybin" or the
"Corporation") is hereby qualifying the distribution (the
"Offering") of common shares in the capital of the
Corporation (the "Common Shares"), having an aggregate sale
price of up to U.S.$35,000,000 (or the equivalent in United States
dollars determined using the daily exchange rate posted by the Bank
of Canada on the date the Common Shares are sold), see "Plan of
Distribution" and "Description of the Common
Shares".
The issued and outstanding Common
Shares are listed in Canada on the Neo Exchange Inc. ("NEO")
and in the United States on the NYSE American LLC ("NYSE
American"), in each case under the trading symbol "CYBN". On
August 5, 2022, the last trading day prior to the filing of this
Prospectus Supplement, the closing prices of the Common Shares
listed on the NEO and NYSE American were $0.95 and U.S.$0.73,
respectively.
The Corporation has entered into an
"at-the-market equity" distribution agreement dated August 8, 2022
(the "Distribution Agreement") with Cantor Fitzgerald Canada
Corporation (the "Canadian Agent") and Cantor Fitzgerald
& Co. (the "US Agent", together with the Canadian Agent,
the "Agents") pursuant to which the Corporation may
distribute Common Shares from time to time through the Agents, as
agents, in accordance with the terms of the Distribution Agreement,
see "Plan of Distribution". Sales of Common Shares, if any,
under the Prospectus are anticipated to be made in transactions
that are deemed to be "at-the-market distributions" as defined in
National Instrument 44-102 - Shelf Distributions ("NI
44-102") and an "at-the-market offering" as defined in Rule
415(a)(4) under the United States Securities Act of 1933, as
amended (the "U.S. Securities Act"), in privately negotiated
transactions and/or any other method permitted by applicable law
including sales made directly on the NEO by the Canadian Agent, and
on NYSE American by the US Agent, or any other recognized
marketplace upon which the Common Shares are listed or quoted or
where the Common Shares are traded in Canada or the United States.
The Common Shares will be distributed at the market prices
prevailing at the time of the sale. As a result, prices at which
Common Shares are sold may vary as between purchasers and during
the period of any distribution. There is no minimum amount of
funds that must be raised under the Offering. This means that the
Offering may terminate after raising only a portion of the Offering
amount set out above, or none at all. The Canadian Agent is not
registered as a broker-dealer in the United States and,
accordingly, will only sell Common Shares on marketplaces in
Canada. The US Agent is not registered as an investment dealer in
any Canadian jurisdiction and, accordingly, will only sell Common
Shares on marketplaces in the United States. See "Plan of
Distribution".
The Offering is being made
concurrently in Canada under the terms of the Prospectus and in the
United States under the Corporation's Registration Statement on
Form F-10 (File No. 333-259994) (the "Registration
Statement"), filed with the United States Securities and
Exchange Commission (the "SEC"), of which this Prospectus
Supplement forms a part.
The Corporation will pay the Agents
compensation for their services in acting as agent in connection
with the sale of Common Shares pursuant to the Distribution
Agreement equal to 3% of the gross sale price per Common Share sold
(the "Commission").
The Corporation has applied to list
the Common Shares distributed hereunder on the NEO and NYSE
American has authorized the listing of the Common Shares to be
offered in the Offering. Listing will be subject to the Corporation
fulfilling all listing requirements of the NEO and NYSE
American.
An investment in the Common
Shares is highly speculative and involves significant risks that
you should consider before purchasing Common Shares. See the
"Risk Factors" section in this Prospectus
Supplement, including in the documents incorporated by
reference.
The net proceeds that the
Corporation will receive from sales of the Common Shares will vary
depending on the number of shares actually sold and the offering
price for such shares, but will not exceed U.S.$33,950,000 in the
aggregate. See "Use of Proceeds" for how the net proceeds,
if any, from sales under this Prospectus Supplement will be
used.
The Corporation is permitted,
under the multi-jurisdictional disclosure system adopted by the
United States and Canada ("MJDS"), to prepare this Prospectus
Supplement and the accompanying Base Shelf Prospectus in accordance
with Canadian disclosure requirements. Purchasers of Common Shares
should be aware that such requirements are different from those of
the United States. Financial statements included or incorporated by
reference herein have been prepared in accordance with
International Financial Reporting Standards, as issued by the
International Accounting Standards Board, and may not be comparable
to financial statements of United States companies, which are
prepared under United States generally accepted accounting
principles, or "US GAAP". Such financial statements are subject to
the standards of the Public Company Accounting Oversight Board
(United States) and the SEC independence standards.
This Prospectus Supplement and
the Base Shelf Prospectus do not contain all of the information set
forth in the Registration Statement, certain parts of which are
omitted in accordance with the rules and regulations of the SEC, or
the schedules or exhibits that are part of the Registration
Statement. Investors in the United States should refer to the
Registration Statement and the exhibits thereto for further
information with respect to the Corporation and the Common
Shares.
Purchasers of Common Shares
should be aware that the acquisition of Common Shares may have tax
consequences both in the United States and in Canada. Such
consequences for purchasers who are resident in, or citizens of,
the United States or who are resident in Canada may not be
described fully herein. Purchasers of Common Shares should read the
tax discussion contained in this Prospectus Supplement and consult
their own tax advisors. See "Certain Canadian Income Tax
Considerations" and "Certain United States
Federal Income Tax Considerations".
The enforcement by investors of
civil liabilities under United States federal securities laws may
be affected adversely by the fact that the Corporation is
incorporated under the laws of Canada, certain of the officers and
directors are not residents of the United States, that some or all
of the Agents or experts named in this Prospectus Supplement and in
the accompanying Base Shelf Prospectus are not residents of the
United States, and that a substantial portion of the assets of the
Corporation and such persons are located outside the United States.
See "Enforcement of Civil
Liabilities".
NEITHER THE SEC NOR ANY STATE
SECURITIES COMMISSION OR REGULATOR HAS APPROVED OR DISAPPROVED THE
COMMON SHARES NOR PASSED UPON THE ACCURACY OR ADEQUACY OF THE
PROSPECTUS AND THIS PROSPECTUS SUPPLEMENT. ANY REPRESENTATION TO
THE CONTRARY IS A CRIMINAL OFFENCE.
In connection with the sale of
the Common Shares on the Corporation's behalf, the Agents may be
deemed to be an "underwriter" within the meaning of Section
2(a)(11) of the U.S. Securities Act, and the compensation of the
Agents may be deemed to be underwriting commissions or discounts.
The Corporation has agreed to provide indemnification and
contribution to the Agents against certain liabilities, including
liabilities under the U.S. Securities Act.
As sales agents, the Agents will
not engage in any prohibited transactions to stabilize or maintain
the price of the Common Shares. Neither the Agents nor any person
or company acting jointly or in concert with either of the Agents
may, in connection with the distribution, enter into any
transaction that is intended to stabilize or maintain the market
price of the Common Shares distributed under this Prospectus
Supplement, including selling an aggregate number or principal
amount of Common Shares that would result in the Agents creating an
over-allocation position in the Common Shares.
Each of Douglas Drysdale, Michael
Palfreyman, Alex Nivorozhkin and Brett Greene, officers of
the Corporation, resides outside of Canada. They have each
appointed Maxims CS Inc., Suite 1800, 181 Bay Street, Toronto,
Ontario, M5J 2T9, as agent for service of process in Ontario.
Prospective purchasers are advised that it may not be possible for
investors to enforce judgments obtained in Canada against any
person or company that is incorporated, continued or otherwise
organized under the laws of a foreign jurisdiction or resides
outside of Canada, even if the party has appointed an agent for
service of process.
Except as otherwise indicated,
references to "Canadian dollars" or "$" are to the currency of
Canada. Certain totals, subtotals and percentages may not precisely
reconcile due to rounding.
The Corporation's head and
registered office is located at 100 King Street West, Suite 5600,
Toronto, ON M5X 1C9.
Cantor
TABLE OF CONTENTS
Prospectus Supplement
Base Shelf Prospectus
ABOUT THIS PROSPECTUS
SUPPLEMENT
This document consists of two
parts. The first part is this Prospectus Supplement, which
describes certain terms of the Common Shares that the Corporation
is offering and also adds to and updates certain information
contained in the Base Shelf Prospectus and the documents
incorporated by reference therein. The second part, the Base Shelf
Prospectus, gives more general information, some of which may not
apply to the Common Shares offered hereunder. Defined terms or
abbreviations used in this Prospectus Supplement that are not
defined herein have the meanings ascribed thereto in the Base Shelf
Prospectus. Investors should rely only on the information contained
or incorporated by reference in this Prospectus Supplement and the
Base Shelf Prospectus. The Corporation has not, and the Agents have
not, authorized anyone to provide investors with different or
additional information. The Corporation is not, and the Agents are
not, making an offer to sell Common Shares in any jurisdiction
where the offer or sale is not permitted. Investors should not
assume that the information appearing in this Prospectus
Supplement, the Base Shelf Prospectus or any documents incorporated
by reference herein or therein, is accurate as of any date other
than the date indicated in those documents, as the Corporation's
business, operating results, financial condition and prospects may
have changed since such date. Before you invest, you should
carefully read this Prospectus Supplement, the accompanying Base
Shelf Prospectus and all information incorporated by reference
herein and therein. These documents contain information you should
consider when making your investment decision.
The Corporation filed the Base
Shelf Prospectus with the securities commissions in all Canadian
provinces and territories (the "Canadian Qualifying
Jurisdictions") in order to qualify the offering of the
securities described in the Base Shelf Prospectus in accordance
with National Instrument 44-102 Shelf Distributions. The
Ontario Securities Commission issued a receipt dated July 5, 2021
in respect of the final Base Shelf Prospectus as the principal
regulatory authority under Multilateral Instrument 11-102
Passport System, and each of the other commissions in the
Canadian Qualifying Jurisdictions is deemed to have issued a
receipt under National Policy 11-202 Process for Prospectus
Review in Multiple Jurisdictions.
The Base Shelf Prospectus also
forms part of the Registration Statement that the Corporation filed
with the SEC on October 1, 2021 under the U.S. Securities Act
utilizing the MJDS. The Registration Statement became effective
under the U.S. Securities Act on October 8, 2021. The Registration
Statement includes the Base Shelf Prospectus with certain
modifications and deletions permitted by Form F-10 and the rules
and regulations of the SEC. This Prospectus Supplement is being
filed by the Corporation with the SEC in accordance with General
Instruction II.L of Form F-10.
Unless otherwise indicated or the
context otherwise requires, all references in this Prospectus
Supplement to "Cybin" or the "Corporation", except as
otherwise indicated or as the context otherwise indicates, mean
Cybin Inc. and its subsidiaries and associated
corporations.
This Prospectus Supplement is
deemed to be incorporated by reference in the Base Shelf Prospectus
solely for the purposes of the Offering. Other documents are also
incorporated or deemed to be incorporated by reference in this
Prospectus Supplement and in the Base Shelf Prospectus. See
"Documents Incorporated by Reference".
CAUTIONARY STATEMENT REGARDING
FORWARD-LOOKING INFORMATION
Certain statements contained in
this Prospectus Supplement, and in certain documents incorporated
by reference herein, constitute "forward-looking information" and
"forward-looking statements," within the meaning of applicable
securities laws. All statements other than statements of historical
fact, including, without limitation, those regarding the
Corporation's future financial position and results of operations,
strategy, plans, objectives, goals and targets, future developments
in the markets where the Corporation participates or is seeking to
participate, and any statements preceded by, followed by or that
include the words "believe", "expect", "aim", "intend", "plan",
"continue", "will", "may", "would", "anticipate", "estimate",
"forecast", "predict", "project", "seek", "should", "objective",
"assumes" or similar expressions or the negative thereof, are
forward-looking statements.
These statements are not historical
facts but instead represent only the Corporation's expectations,
estimates and projections regarding future events. These statements
are not guarantees of future performance and involve assumptions,
risks and uncertainties that are difficult to predict. Therefore,
actual results may differ materially from what is expressed,
implied or forecasted in such forward-looking statements.
Additional factors that could cause actual results, performance or
achievements to differ materially include, but are not limited to,
those discussed under "Risk Factors" in the Annual
Information Form (as defined herein) and in this Prospectus
Supplement and in other documents incorporated by reference herein.
Management provides forward-looking statements because it believes
they provide useful information to readers when considering their
investment objectives and cautions readers that the information may
not be appropriate for other purposes. Consequently, all of the
forward-looking statements made in this Prospectus Supplement and
in documents incorporated by reference herein are qualified by
these cautionary statements and other cautionary statements or
factors contained herein, and there can be no assurance that the
actual results or developments will be realized or, even if
substantially realized, that they will have the expected
consequences to, or effects on, the Corporation. These
forward-looking statements are made as of the date of this
Prospectus Supplement and the Corporation assumes no obligation to
update or revise them to reflect subsequent information, events or
circumstances or otherwise, except as required by law.
The forward-looking statements in
this Prospectus Supplement and in documents incorporated by
reference herein are based on numerous assumptions regarding the
Corporation's present and future business strategies and the
environment in which the Corporation will operate in the future,
including assumptions regarding business and operating strategies,
and the Corporation's ability to operate on a profitable basis.
Some of the risks which could
affect future results and could cause results to differ materially
from those expressed in the forward-looking statements contained
herein include: the net proceeds, if any, from sales under this
Prospectus Supplement; the Corporation's use of proceeds and
business objectives and milestones and the anticipated timing of
execution, see "Use of Proceeds"; novel coronavirus
"COVID-19"; limited operating history; achieving publicly announced
milestones; speculative nature of investment risk; early stage of
the industry and product development; regulatory risks and
uncertainties; plans for growth; limited products; limited
marketing and sales capabilities; no assurance of commercial
success; no profits or significant revenues; reliance on third
parties for clinical development activities; risks related to third
party relationships; reliance on contract manufacturers; safety and
efficacy of products; clinical testing and commercializing
products; completion of clinical trials; commercial grade product
manufacturing; nature of regulatory approvals; unfavourable
publicity or consumer perception; social media; biotechnology and
pharmaceutical market competition; reliance on key executives and
scientists; employee misconduct; business expansion and growth;
negative results of external clinical trials or studies; product
liability; enforcing contracts; product recalls; distribution and
supply chain interruption; difficulty to forecast; promoting the
brand; product viability; success of quality control systems;
reliance on key inputs; liability arising from fraudulent or
illegal activity; operating risk and insurance coverage; costs of
operating as public company; management of growth; conflicts of
interest; foreign operations; cybersecurity and privacy risk;
environmental regulation and risks; decriminalisation of
psychedelics; forward-looking statements may prove to be
inaccurate; effects of inflation; political and economic
conditions; application and interpretation of tax laws; enforcement
of civil liabilities; Risks Related to Intellectual Property:
trademark protection; trade secrets; patent law reform; patent
litigation and intellectual property; protection of intellectual
property; third-party licences; Financial and Accounting Risks:
substantial number of authorized but unissued Common Shares;
dilution; negative cash flow from operating activities; additional
capital requirements; lack of significant product revenue;
estimates or judgments relating to critical accounting policies;
inadequate internal controls; Risks related to the Common Shares:
market for the Common Shares; significant sales of Common Shares;
volatile market price for the Common Shares; tax issues; no
dividends; Risks related to the Offering: an investment in the
Common Shares is highly speculative; completion of the Offering;
negative operating cash flow and going concern; discretion in the
use of proceeds; potential dilution; trading market; significant
sales of Common Shares; positive return not guaranteed.
Although the forward-looking
statements are based upon what management currently believes to be
reasonable assumptions, the Corporation cannot assure prospective
investors that actual results, performance or achievements will be
consistent with these forward-looking statements. In particular,
the Corporation has made assumptions regarding, among other
things:
• substantial
fluctuation of losses from quarter to quarter and year to year due
to numerous external risk factors, and anticipation that the
Corporation will continue to incur significant losses in the
future;
• uncertainty as
to the Corporation's ability to raise additional funding to support
operations;
• the
Corporation's ability to access additional funding;
• the
fluctuation of foreign exchange rates;
• the duration
of COVID-19 and the extent of its economic and social impact;
• the risks
associated with the development of the Corporation's product
candidates which are at early stages of development;
• reliance upon
industry publications as the Corporation's primary sources for
third-party industry data and forecasts;
• reliance on
third parties to plan, conduct and monitor the Corporation's
preclinical studies and clinical trials;
• reliance on
third party contract manufacturers to deliver quality clinical and
preclinical materials;
• the
Corporation's product candidates may fail to demonstrate safety and
efficacy to the satisfaction of regulatory authorities or may not
otherwise produce positive results;
• risks related
to filing investigational new drug applications to commence
clinical trials and to continue clinical trials if approved;
• the risks of
delays and inability to complete clinical trials due to
difficulties enrolling patients;
• competition
from other biotechnology and pharmaceutical companies;
• the
Corporation's reliance on the capabilities and experience of the
Corporation's key executives and scientists and the resulting loss
of any of these individuals;
• the
Corporation's ability to fully realize the benefits of
acquisitions;
• the
Corporation's ability to adequately protect the Corporation's
intellectual property and trade secrets;
• the risk of
patent-related or other litigation; and
• the risk of
unforeseen changes to the laws or regulations in the United States,
Canada, the United Kingdom, Ireland and other jurisdictions in
which the Corporation operates.
Drug development involves long lead
times, is very expensive and involves many variables of
uncertainty. Anticipated timelines regarding drug development are
based on reasonable assumptions informed by current knowledge and
information available to the Corporation. Every patient treated on
future studies can change those assumptions either positively (to
indicate a faster timeline to new drug applications and other
approvals) or negatively (to indicate a slower timeline to new drug
applications and other approvals). This Prospectus Supplement and
the documents incorporated by reference herein contain certain
forward-looking statements regarding anticipated or possible drug
development timelines. Such statements are informed by, among other
things, regulatory guidelines for developing a drug with safety
studies, proof of concept studies, and pivotal studies for new drug
application submission and approval, and assumes the success of
implementation and results of such studies on timelines indicated
as possible by such guidelines, other industry examples, and the
Corporation's development efforts to date.
In addition to the factors set out
above and those identified under the heading "Risk Factors"
in the Annual Information Form and in this Prospectus Supplement,
other factors not currently viewed as material could cause actual
results to differ materially from those described in the
forward-looking statements. Although the Corporation has attempted
to identify important risks and factors that could cause actual
actions, events or results to differ materially from those
described in forward-looking statements, there may be other factors
and risks that cause actions, events or results not to be
anticipated, estimated or intended. Accordingly, readers should not
place any undue reliance on forward-looking statements.
Many of these factors are beyond
the Corporation's ability to control or predict. These
factors are not intended to represent a complete list of the
general or specific factors that may affect the Corporation. The
Corporation may note additional factors elsewhere in this
Prospectus Supplement and in any documents incorporated by
reference herein. All forward-looking statements speak only as of
the date made. All subsequent written and oral forward-looking
statements attributable to the Corporation, or persons acting on
the Corporation's behalf, are expressly qualified in their
entirety by the cautionary statements. Except as required by law,
the Corporation undertakes no obligation to update any
forward-looking statement.
The forward-looking statements
contained in this Prospectus Supplement and the documents
incorporated by reference herein are expressly qualified in their
entirety by the foregoing cautionary statement. Investors
should read this entire Prospectus, including the Annual
Information Form, the documents incorporated by reference herein,
and each applicable Prospectus Supplement, and consult their own
professional advisers to ascertain and assess the income tax and
legal risks and other aspects associated with holding securities of
the Corporation.
DOCUMENTS INCORPORATED BY
REFERENCE
This Prospectus Supplement is
deemed to be incorporated by reference in the Base Shelf Prospectus
solely for the purpose of the Offering.
As at the date hereof, the
following documents of the Corporation filed with the securities
commissions or similar authorities in Canada, and filed with, or
furnished to, the SEC, are specifically incorporated by reference
into, and form an integral part of, this Prospectus Supplement:
1. annual
information form of the Corporation dated June 20, 2022 (the
"Annual Information Form") for the year ended March 31,
2022;
2. the
audited consolidated financial statements of the Corporation and
the notes thereto as at and for the fiscal year ended March 31,
2022, together with the auditor's report thereon;
3. management's
discussion and analysis of the Corporation for the year ended March
31, 2022;
4. the
Corporation's unaudited interim condensed consolidated financial
statements for the three months ended June 30, 2022, and related
notes thereto (the "Interim Financial Statements");
5. the
management's discussion and analysis for the three ended June 30,
2022 (the "Interim MD&A"); and
6. management
information circular of the Corporation dated July 13, 2022
relating to an annual meeting of shareholders of the Corporation to
be held on August 15, 2022.
Any document of the type referred
to in Section 11.1 of Form 44-101F1 - Short Form Prospectus
Distributions filed by the Corporation with a securities commission
or similar regulatory authority in Canada subsequent to the date of
this Prospectus Supplement and prior to the termination of this
distribution shall be deemed to be incorporated by reference in the
Prospectus Supplement for the purposes of the Offering. In
addition, if the Corporation disseminates a news release in respect
of previously undisclosed information that, in the Corporation's
determination, constitutes a "material fact" (as such term is
defined under applicable Canadian securities laws), the Corporation
will identify such news release as a "designated news release" for
the purposes of the Prospectus in writing on the face page of the
version of such news release that the Corporation files on SEDAR
(any such news release, a "Designated News Release"), and
any such Designated News Release shall be deemed to be incorporated
by reference into the Prospectus only for the purposes of the
Offering. These documents will be available through the internet on
the Corporation's SEDAR profile, which can be accessed at
www.sedar.com. In addition, any other report on Form 6-K or 40-F or
the exhibits thereto filed or furnished, as applicable, by the
Corporation with the SEC, under the United States Securities
Exchange Act of 1934, as amended (the "Exchange Act"), from
the date of this Prospectus Supplement and prior to the termination
or completion of the Offering shall be deemed to be incorporated by
reference as exhibits to the Registration Statement of which this
Prospectus Supplement and accompanying Base Shelf Prospectus forms
a part, but in the case of any report on Form 6-K, only if and to
the extent expressly so provided in any such report. The
Corporation's current reports on Form 6-K and annual reports on
Form 40-F are available on EDGAR at www.sec.gov.
Any statement contained in this
Prospectus Supplement or in a document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or
superseded for the purposes of the Offering to the extent that a
statement contained herein or in any subsequently filed document
which also is or is deemed to be incorporated by reference in this
Prospectus Supplement or Base Shelf Prospectus modifies or
supersedes that statement. Any statement so modified or superseded
shall not constitute a part of this Prospectus Supplement except as
so modified or superseded. The modifying or superseding statement
need not state that it has modified or superseded a prior statement
or include any information set forth in the document that it
modifies or supersedes. The making of a modifying or superseding
statement shall not be deemed an admission for any purposes that
the modified or superseded statement, when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be stated or
that is necessary to make a statement not misleading in light of
the circumstances in which it was made.
References to the Corporation's
website in any documents that are incorporated by reference into
this Prospectus Supplement and the Base Shelf Prospectus do not
incorporate by reference the information on such website into this
Prospectus Supplement and the Base Shelf Prospectus and the
Corporation disclaims any such incorporation by reference. Neither
the Corporation nor the Agents have provided or otherwise
authorized any other person to provide investors with information
other than that contained or incorporated by reference in this
Prospectus Supplement or accompanying Base Shelf Prospectus, and
neither the Corporation nor the Agents take any responsibility for
other information that others may give you. If an investor is
provided with different or inconsistent information, he or she
should not rely on it.
DOCUMENTS FILED AS PART OF THE
REGISTRATION STATEMENT
In addition to the documents
specified in this Prospectus Supplement and in the accompanying
Base Shelf Prospectus under "Documents Incorporated by
Reference", the following documents have been or will be filed
with the SEC as part of the Registration Statement: (i) the
Distribution Agreement; (ii) powers of attorney from certain of the
Corporation's directors and officers (included on the signature
page of the Registration Statement); (iii) the consent of Zeifmans
LLP; and (iv) the consent of the Corporation's Canadian counsel,
Aird & Berlis LLP.
ADDITIONAL INFORMATION
The Corporation has filed with the
SEC the Registration Statement under the U.S. Securities Act with
respect to the Common Shares offered under this Prospectus
Supplement. This Prospectus Supplement, the accompanying Base Shelf
Prospectus and the documents incorporated by reference herein and
therein, which form a part of the Registration Statement, do not
contain all of the information set forth in the Registration
Statement, certain parts of which are contained in the exhibits to
the Registration Statement as permitted by the rules and
regulations of the SEC. Information omitted from this Prospectus
Supplement or the Base Shelf Prospectus but contained in the
Registration Statement is available on EDGAR under the
Corporation's profile at www.sec.gov. Reference is also made to the
Registration Statement and the exhibits thereto for further
information with respect to the Corporation, the Offering and the
Common Shares. Statements contained in this Prospectus Supplement
as to the contents of certain documents are not necessarily
complete and, in each instance, reference is made to the copy of
the document filed as an exhibit to the Registration Statement.
Each such statement is qualified in its entirety by such
reference.
The Corporation is required to file
with the various securities commissions or similar authorities in
all of the provinces and territories of Canada, annual and
quarterly reports, material change reports and other information.
The Corporation is also an SEC registrant subject to the
informational requirements of the Exchange Act and, accordingly,
files with, or furnishes to, the SEC certain reports and other
information. Under MJDS, these reports and other information
(including financial information) may be prepared in accordance
with the disclosure requirements of Canada, which differ from those
of the United States. As a foreign private issuer, the Corporation
is exempt from the rules under the Exchange Act prescribing the
furnishing and content of proxy statements, and the Corporation's
officers, directors and principal shareholders are exempt from the
reporting and short-swing profit recovery provisions contained in
Section 16 of the Exchange Act.
THE CORPORATION
This summary does not contain
all the information that may be important to you in deciding
whether to invest in the Common Shares. You should read the entire
Prospectus, including the section entitled "Risk Factors", the
applicable Prospectus Supplement, and the documents incorporated by
reference herein, including the Annual Information Form, before
making such decision.
Summary of the Business
The Corporation is a biotechnology
company focused on advancing pharmaceutical therapies, delivery
mechanisms, novel compounds and protocols as potential therapies
for various psychiatric and neurological conditions. The
Corporation is developing technologies and delivery systems aiming
to improve the pharmacokinetics of its psychedelic molecules while
retaining the therapeutics benefit. The new molecules and delivery
systems are expected to be studied through clinical trials to
confirm safety and efficacy.
The Corporation has historically
had two business segments: (a) Serenity Life Sciences Inc. and
Cybin US Holdings Inc. ("Cybin U.S.") that focus on the
research and development of psychedelic pharmaceutical products;
and (b) Natures Journey Inc. ("Natures Journey") that
focused on consumer mental wellness, including non-psychedelic
nutraceutical products (the "Product Line") and consumer
mental wellness. In November 2021, the Corporation decided to not
proceed with the Natures Journey business segment in order to
prioritize its research and development of psychedelic
pharmaceutical products.
Psychedelics
The Corporation is conducting
research and development of psychedelic therapeutics that aim to
address unmet mental health conditions by leveraging proprietary
drug discovery platforms, novel formulation approaches, innovative
drug delivery systems, and optimized treatment regimens. This
comprehensive strategy is predicated on structural modifications of
known and well understood tryptamine derivatives to improve their
pharmacokinetic properties without altering their respective
pharmacology.
Across the various research and
development programs, the Corporation is researching and developing
a wide array of novel, synthetic psychedelic API intended to be
delivered through innovative drug delivery systems including
sublingual films,1 orally disintegrating
tablets ("ODT")2 and via
inhalation.
The Corporation intends to apply
for regulatory approval for products targeting major depressive
disorder ("MDD"), alcohol use disorder ("AUD") and
various anxiety disorders.3 The Corporation is also
developing products that may have the potential to address
neuroinflammation.4
Non-Psychedelics
In November 2021, the Corporation
decided to not proceed with the Natures Journey business segment,
including the Product Line in order to prioritize its progression
of its research and development of psychedelic pharmaceutical
products. As of the date hereof, the Corporation has not begun
operations nor generated any revenue from the sale of the Product
Line and it does not expect any revenues from the Product Line
going forward.
For additional information in
respect of the Corporation and its operation, please see the
Corporation's Annual Information Form incorporated by reference
into this Prospectus Supplement.
Recent Developments
There have been no material
developments in the business of the Corporation since August 7,
2022, the date of the Corporation's most recently issued Interim
Financial Statements and Interim MD&A.
___________________________________________
Intercorporate
Relationships
As at the date of this Prospectus
Supplement, the Corporation's corporate structure includes the
following material wholly-owned subsidiaries:

Note:
(1) The
shareholders of Adelia Therapeutics Inc. ("Adelia")
hold certain non-voting securities of Cybin U.S. issued in
connection with the acquisition of Adelia on December 14, 2020 (the
"Adelia Transaction"). For additional information in respect
of the Adelia Transaction, please see the Corporation's Annual
Information Form incorporated by reference in this Prospectus
Supplement.
DESCRIPTION OF THE COMMON
SHARES
The Corporation is authorized to
issue an unlimited number of Common Shares and an unlimited number
of preferred shares. As at August 8, 2022, the Corporation had
166,120,171 Common Shares and nil preferred shares issued and
outstanding. For a summary of certain material attributes and
characteristics of the Common Shares, see "Description of the
Securities Being Distributed - Common Shares" in the Base Shelf
Prospectus.
CONSOLIDATED
CAPITALIZATION
There have been
no material changes in the Corporation's share or loan
capitalization on a consolidated basis since the date of the
Interim Financial Statements. As a result of the Offering, the
shareholder's equity of the Corporation will increase by the amount
of the net proceeds of the Offering and the number of issued and
outstanding Common Shares will increase by the number of Common
Shares actually distributed under the Offering.
USE OF PROCEEDS
The net proceeds from the Offering
are not determinable in light of the nature of the distribution.
The net proceeds of any given distribution of Common Shares through
the Agents in an "at-the-market distribution" or "at-the-market
offering" will represent the gross proceeds after deducting the
applicable compensation payable to the Agents under the
Distribution Agreement and the expenses of the distribution. The
proceeds actually received by the Corporation will depend on the
number of Common Shares actually sold and the offering price of
such Common Shares. See "Plan of Distribution".
Assuming net proceeds of the
maximum of U.S.$33,950,000 on or before the expiry of the
Prospectus on August 5, 2023, the Corporation intends to use the
net proceeds of the Offering for: (i) growth opportunities, and
(ii) working capital initiatives. The Corporation believes it is
prudent, particularly at the Corporation's stage of development and
the competitive industry landscape, to secure capital for general
corporate and working capital purposes to ensure that the
Corporation maintains sufficient liquidity and capital resources in
the near to medium term.
At any given time, the Corporation
may be engaged in discussions and activities in respect of
potential growth initiatives and other strategic opportunities that
are complementary or accretive to the Corporation's business, which
may include acquisitions or other investments. As of the date of
this Prospectus Supplement, the Corporation has not identified any
specific investments or projects, nor any probable or significant
acquisitions it wishes to undertake; however, it is important for
the Corporation to have funds available to quickly and
opportunistically pursue such opportunities as they arise. To the
extent the Corporation requires additional capital, it may raise
funds through debt and equity financing in the future.
The use of the net proceeds of the
Offering to fund potential growth initiatives and other strategic
opportunities is subject to change due to the influence of many
evolving variables, including those as described under "Stage of
Development" in the Interim MD&A and in the Annual
Information Form, any changes in legislation and regulations,
applications for licenses and the receipt of required licenses,
renewals and other regulatory approvals. As a result, the
Corporation cannot provide definitive details with respect to
timing or specific uses of the net proceeds of the Offering. Such
decisions will depend on market and competitive factors, as
described herein, as they evolve over time. See "Cautionary
Statement Regarding Forward-Looking Statements" and "Risk
Factors".
There may be circumstances where
for sound business reasons, the Corporation reallocates the use of
proceeds depending on the amount of proceeds raised, the time
periods in which the proceeds are raised, developments in relation
to potential growth initiatives and other strategic opportunities
or unforeseen events, see "Risk Factors - Risks Related to the
Offering - Discretion in the Use of Proceeds".
Since inception, the Corporation
has financed its operations primarily from the issuance of equity
and interest income on funds available for investment. To date, the
Corporation has raised approximately $120,000,000 in gross proceeds
through private placement and prospectus offerings. The Corporation
has experienced operating losses and cash outflows from operations
since incorporation and will require ongoing financing to continue
its research and development activities. As the Corporation has not
yet achieved profitability, there are uncertainties regarding its
ability to continue as a going concern. The Corporation has not
earned any revenue or reached successful commercialization of any
products. The Corporation's success is dependent upon the ability
to finance its cash requirements to continue its activities. There
is no assurance that additional capital or other types of financing
will be available if needed or that these financings will be on
terms at least as favourable to the Corporation as those previously
obtained, or at all. To the extent that the Corporation has
negative operating cash flows in future periods, it may need to
deploy a portion of its existing working capital to fund such
negative cash flows. The Corporation will be required to raise
additional funds through the issuance of additional equity
securities, through loan financing, or other means, such as through
partnerships with other companies and research and development
reimbursements. There is no assurance that additional capital or
other types of financing will be available if needed or that these
financings will be on terms at least as favourable to the
Corporation as those previously obtained. See "Risk Factors -
Risks Related to an Offering - Negative Operating Cash Flow and
Going Concern".
Until applied, the net proceeds
will be held as cash balances in the Corporation's bank account or
invested in certificates of deposit and other instruments issued by
banks or obligations of or guaranteed by the Government of Canada
or any province thereof in accordance with the Corporation's
investment policies.
For detailed information in
respect of the Corporation's business objectives and milestones,
sources and use of capital, and the application of proceeds from
prior offerings by the Corporation, prospective purchasers should
carefully consider the information described in the Base Shelf
Prospectus, Annual Information Form and the Interim MD&A, to
which there has been no material changes since the date of the
applicable document.
PLAN OF DISTRIBUTION
The Corporation has entered into
the Distribution Agreement with the Agents under which the
Corporation may issue and sell from time to time Common Shares
having an aggregate sale price of up to U.S.$35,000,000 (or the
equivalent in United States dollars determined using the daily
exchange rate posted by the Bank of Canada on the date the Common
Shares are sold) in each of the provinces and territories of Canada
and in the United States pursuant to placement notices delivered by
the Corporation to the Agents from time to time in accordance with
the terms of the Distribution Agreement. Sales of Common Shares, if
any, will be made in transactions that are deemed to be
"at-the-market distributions" as defined in NI 44-102 and an
"at-the-market offering" as defined in Rule 415(a)(4) under the
U.S. Securities Act, in privately negotiated transactions and/or
any other method permitted by applicable law including sales made
by the Agents directly on the NEO, NYSE American or any other
trading market for the Common Shares in Canada or the United
States. Subject to the pricing parameters in a placement notice,
the Common Shares will be distributed at the market prices
prevailing at the time of the sale. As a result, prices may vary as
between purchasers and during the period of distribution. The
Corporation cannot predict the number of Common Shares that the
Corporation may sell under the Distribution Agreement on the NEO,
NYSE American or any other trading market for the Common Shares in
Canada, or if any Common Shares will be sold.
The Agents are not required to sell
any specific number or dollar amount of Common Shares, but will use
its commercially reasonable efforts to sell the Common Shares
pursuant to the terms and conditions of the Distribution Agreement.
There is no minimum amount of funds that must be raised under
the Offering. This means that the Offering may terminate after only
raising a small portion of the offering amount set out above, or
none at all.
The Agents will offer the Common
Shares subject to the terms and conditions of the Distribution
Agreement from time to time or as otherwise agreed upon by the
Corporation and the Agents. Subject to the terms and conditions of
the Distribution Agreement, the Agents will use their commercially
reasonable efforts to sell, on the Corporation's behalf, all of the
Common Shares requested to be sold by the Corporation. The
Corporation may instruct the Agents not to sell Common Shares if
the sales cannot be achieved at or above the price designated by
the Corporation in a particular placement notice.
Neither the Corporation nor the
Agents may suspend the Offering upon proper notice to the other
party. The Corporation and the Agents each have the right, by
giving written notice as specified in the Distribution Agreement,
to terminate the Distribution Agreement in each party's sole
discretion at any time. Pursuant to the Distribution Agreement, the
Offering will terminate upon the earliest of (i) the termination of
the Distribution Agreement as provided for therein, (ii) the date
on which the aggregate gross proceeds from sales of Common Shares
pursuant to the Distributions Agreement equal U.S.$35,000,000 and
(iii) August 5, 2023.
The Corporation will pay the Agents
the Commission for their services in acting as agent in connection
with the sale of Common Shares pursuant to the Distribution
Agreement in an amount equal to 3% of the gross sale price per
Common Share sold (the "Commission"). Provided, however,
that the Corporation shall not be obligated to pay the Agents any
Commission on any sale of Common Shares that it is not possible to
settle due to (i) a suspension or material limitation in trading in
securities generally on the NEO or NYSE American, (ii) a material
disruption in securities settlement or clearance services in Canada
or the United States, (iii) failure by the applicable Agent to
comply with its obligations under the terms of the Distribution
Agreement; or (iv) if the Corporation and the Agents agree,
pursuant to the terms of the Distribution Agreement, that no sale
of Common shares will take place. The sales proceeds remaining
after payment of the Commission and after deducting any expenses
payable by the Corporation and any transaction or filing fees
imposed by any governmental, regulatory, or self-regulatory
organization in connection with the sales, will equal the net
proceeds to the Corporation from the sale of such Common
Shares.
The applicable Agent or Agents will
provide written confirmation to the Corporation no later than the
opening of the trading day immediately following the trading day on
which it has made sales of the Common Shares under the Distribution
Agreement. Each confirmation will include the number of Common
Shares sold on such day (including the number of Common Shares sold
on the NEO and or NYSE American, or on any other marketplace in
Canada or the United States), the average price of the Common
Shares sold on such day (including the average price of Common
Shares sold on NEO, NYSE American or on any other marketplace in
Canada or the United States), the gross proceeds, the Commission
payable by the Corporation to the Agents with respect to such sales
and the net proceeds payable to the Corporation. The Agents will
also assist the Corporation with such other periodic reporting as
may be reasonably requested by the Corporation with respect to the
sales of Common Shares.
The Corporation will disclose the
number and average price of the Common Shares sold under this
Prospectus Supplement, as well as the gross proceeds, Commission
and net proceeds from sales hereunder in the Corporation's annual
and interim financial statements and related management discussion
& analysis, annual information forms and annual reports on Form
40-F, filed on SEDAR and filed or furnished, as applicable, with
the SEC on EDGAR, for any quarters or annual periods in which sales
of Common Shares occur.
Settlement for sales of Common
Shares will occur, unless otherwise specified in an applicable
placement notice, on the second trading day on the applicable
exchange following the date on which any sales were made in return
for payment of the net proceeds to the Corporation. There is no
arrangement for funds to be received in an escrow, trust or similar
arrangement. Sales of Common Shares in the United States will be
settled through the facilities of The Depository Trust Corporation
or by such other means as the Corporation and the Agents may agree
upon and sales of Common Shares in Canada will be settled through
the facilities of The Canadian Depository for Securities or by such
other means as the Corporation and the Agents may agree.
The Canadian Agent is not
registered as a broker-dealer in the United States and,
accordingly, will only sell Common Shares on marketplaces in
Canada. The US Agent is not registered as an investment dealer in
any Canadian jurisdiction and, accordingly, will only sell Common
Shares on marketplaces in the United States.
The Offering is being made in
Canada under the terms of this Prospectus Supplement and
concurrently in the United States under the terms of the
Corporation's Registration Statement filed with the SEC of which
this Prospectus Supplement forms a part. In connection with the
sale of the Common Shares on the Corporation's behalf, the Agents
may be deemed to be an "underwriter" within the meaning of Section
2(a)(11) of the U.S. Securities Act, and the compensation of the
Agents may be deemed to be underwriting commissions or discounts.
The Corporation has agreed to provide indemnification and
contribution to the Agents against certain liabilities, including
liabilities under the U.S. Securities Act.
The Corporation has agreed to pay
the reasonable fees, disbursements and expenses of counsel to the
Agents in connection with the Offering, subject to the terms of the
Distribution Agreement and any other agreement in writing between
the Corporation and the Agents. No agent, underwriter or
dealer involved in the distribution of Common Shares under the
Offering, no affiliate of such an agent, underwriter or dealer and
no person or company acting jointly or in concert with such an
agent, underwriter or dealer has over-allotted, or will over-allot,
securities in connection with such distribution or effected, or
will affect any other transactions that are intended to stabilize
or maintain the market price of the Common Shares.
The total expenses related to the
commencement of the Offering to be paid by the Corporation,
excluding the Commission payable to the Agents under the
Distribution Agreement, are estimated to be approximately up to
U.S.$300,000.
Each of the Agents and its
affiliates have in the past provided and may in the future provide
various investment banking, commercial banking and other financial
services for the Corporation and its affiliates, for which services
they have received and may in the future receive customary fees. To
the extent required by Regulation M, the Agents will not engage in
any market making activities involving the Common Shares while the
Offering is ongoing under this Prospectus Supplement.
The Corporation has applied to list
the Common Shares offered by this Prospectus Supplement on the NEO
and NYSE American has authorized the listing of the Common Shares
to be offered in the Offering. Listing will be subject to the
Corporation fulfilling all of the listing requirements of the NEO
and NYSE American.
TRADING PRICE AND VOLUME
The Common Shares are listed for
trading on the NEO and NYSE American under the symbol "CYBN". The
following table sets forth the reported monthly range of high and
low prices per Common Share and total monthly volumes traded on the
NEO and NYSE American for each of the months indicated during the
12-month period prior to the date of this Prospectus
Supplement.
NEO Price Range
|
|
Month |
|
High ($)(1) |
|
Low ($)(1) |
|
Volume(1) |
|
|
|
|
|
|
|
August 2021 |
|
3.99 |
|
2.15 |
|
11,652,282 |
|
|
|
|
|
|
|
September 2021 |
|
3.55 |
|
2.54 |
|
9,933,259 |
|
|
|
|
|
|
|
October 2021 |
|
2.79 |
|
2.24 |
|
5,973,696 |
|
|
|
|
|
|
|
November 2021 |
|
2.94 |
|
1.65 |
|
14,160,868 |
|
|
|
|
|
|
|
December 2021 |
|
1.94 |
|
1.35 |
|
6,191,101 |
|
|
|
|
|
|
|
January 2022 |
|
1.54 |
|
1.21 |
|
3,636,976 |
|
|
|
|
|
|
|
February 2022 |
|
1.46 |
|
1.11 |
|
2,935,312 |
|
|
|
|
|
|
|
March 2022 |
|
1.20 |
|
0.95 |
|
3,883,026 |
|
|
|
|
|
|
|
April 2022 |
|
1.12 |
|
0.68 |
|
1,784,193 |
|
|
|
|
|
|
|
May 2022 |
|
0.54 |
|
0.50 |
|
3,017,959 |
|
|
|
|
|
|
|
June 2022 |
|
1.06 |
|
0.67 |
|
2,662,940 |
|
|
|
|
|
|
|
July 2022 |
|
0.79 |
|
0.69 |
|
1,697,807 |
|
|
|
|
|
|
|
August (1 - 5), 2022 |
|
0.95 |
|
0.78 |
|
744,487 |
Note:
(1) Source:
TMX Money as of the date of this Prospectus Supplement.
On August 5, 2022, being the last
day on which the Common Shares traded prior to the date of this
Prospectus Supplement, the closing price of the Common Shares as
reported on the NEO was $0.95.
NYSE American Price Range |
|
Month |
|
High (U.S.$)(1) |
|
Low (U.S.$)(1) |
|
Volume(1) |
|
|
|
|
|
|
|
August 2021(2) |
|
3.38 |
|
1.68 |
|
27,050,719 |
|
|
|
|
|
|
|
September 2021 |
|
2.86 |
|
1.98 |
|
23,267,531 |
|
|
|
|
|
|
|
October 2021 |
|
2.29 |
|
1.81 |
|
26,186,831 |
|
|
|
|
|
|
|
November 2021 |
|
2.355 |
|
1.29 |
|
57,337,568 |
|
|
|
|
|
|
|
December 2021 |
|
1.54 |
|
1.05 |
|
32,155,939 |
|
|
|
|
|
|
|
January 2022 |
|
1.22 |
|
0.82 |
|
19,882,525 |
|
|
|
|
|
|
|
February 2022 |
|
1.16 |
|
0.862 |
|
13,843,580 |
|
|
|
|
|
|
|
March 2022 |
|
0.95 |
|
0.70 |
|
14,441,487 |
|
|
|
|
|
|
|
April 2022 |
|
0.88 |
|
0.42 |
|
15,659,793 |
|
|
|
|
|
|
|
May 2022 |
|
0.71 |
|
0.3903 |
|
14,762,190 |
|
|
|
|
|
|
|
June 2022 |
|
0.86 |
|
0.5301 |
|
12,694,019 |
|
|
|
|
|
|
|
July 2022 |
|
0.65 |
|
0.50 |
|
11,863,781 |
|
|
|
|
|
|
|
August (1 - 5), 2022 |
|
0.73 |
|
0.58 |
|
5,173,572 |
Notes:
(1) Source:
NYSE American as of the date of this Prospectus Supplement.
(2) Prior
to August 5, 2021, the Common Shares were quoted on the OTCQB®
Venture Market under the symbol "CLXPF" (the
"OTCQB"). The OTCQB quotation ceased when the Common
Shares were listed on NYSE American on August 5, 2021.
On August 5, 2022, being the last
day on which the Common Shares traded prior to the date of this
Prospectus Supplement, the closing price of the Common Shares as
reported on NYSE American was U.S.$0.73.
PRIOR SALES
The following table sets forth the
details regarding all issuances of Common Shares, including
issuances of all securities convertible or exchangeable into Common
Shares, during the 12-month period before the date of this
Prospectus Supplement:
Date of Issuance |
|
Number of
Securities Issued |
|
Type |
|
Issuance / Exercise
Price Per Security |
August 12, 2021(1) |
|
100,000 |
|
Common Shares |
|
$0.75 |
August 12, 2021(1) |
|
255,887 |
|
Common Shares |
|
$0.64 |
August 16, 2021 |
|
215,000 |
|
Options |
|
$2.48 |
August 17, 2021(2) |
|
18,788.5 |
|
Exchangeable Securities |
|
$33.70(4) |
August 18, 2021 |
|
300,000 |
|
Options |
|
$2.48 |
August 31, 2021(2) |
|
9,392.6 |
|
Exchangeable Securities |
|
$33.80(5) |
September 10, 2021(1) |
|
191,540 |
|
Common Shares |
|
$0.75 |
September 16, 2021(3) |
|
125,000 |
|
Common Shares |
|
$0.64 |
September 16, 2021(1) |
|
370,000 |
|
Common Shares |
|
$0.75 |
September 27, 2021 |
|
585,000 |
|
Options |
|
$3.15 |
September 27, 2021 |
|
195,000(6) |
|
Options |
|
$2.87 |
September 30, 2021 |
|
450,000 |
|
Options |
|
$3.15 |
September 30, 2021 |
|
740,000(7) |
|
Options |
|
$2.78 |
October 13, 2021(1) |
|
18,000 |
|
Common Shares |
|
$0.25 |
October 21, 2021(3) |
|
325,000 |
|
Common Shares |
|
$0.25 |
October 29, 2021(3) |
|
150,000 |
|
Common Shares |
|
$1.36 |
October 29, 2021(1) |
|
5,500 |
|
Common Shares |
|
$0.25 |
November 16, 2021(3) |
|
175,000 |
|
Common Shares |
|
$1.39 |
November 16, 2021(1) |
|
1,000,000 |
|
Common Shares |
|
$0.25 |
November 18, 2021(2) |
|
28,903 |
|
Exchangeable Securities |
|
$24.40(8) |
November 23, 2021(3) |
|
88,300 |
|
Common Shares |
|
$1.39 |
November 29, 2021(2) |
|
31,721.5 |
|
Exchangeable Securities |
|
$19.80(9) |
November 30, 2021(3) |
|
300,000 |
|
Common Shares |
|
$1.39 |
December 16, 2021(1) |
|
150,000 |
|
Common Shares |
|
$0.25 |
December 16, 2021(3) |
|
62,500 |
|
Common Shares |
|
$0.64 |
December 31, 2021 |
|
40,000 |
|
Options |
|
$3.15 |
December 31, 2021 |
|
1,250,000 |
|
Options |
|
$1.50 |
January 6, 2022(2) |
|
15,611.4 |
|
Exchangeable Securities |
|
$15.10(10) |
January 21, 2022(11) |
|
586,800 |
|
Common Shares |
|
$1.25 |
February 14, 2022(2) |
|
41,028.2 |
|
Exchangeable Securities |
|
$13.43(12) |
February 15, 2022(1) |
|
27,585 |
|
Common Shares |
|
$0.64 |
February 18, 2022(2) |
|
17,239.5 |
|
Exchangeable Securities |
|
$13.50(13) |
February 28, 2022(3) |
|
37,500 |
|
Common Shares |
|
$0.64 |
March 4, 2022(11) |
|
1,254,360 |
|
Common Shares |
|
$1.13 |
March 4, 2022 |
|
1,075,600 |
|
Options |
|
$1.13 |
March 4, 2022 |
|
60,000 |
|
Options |
|
$3.15 |
March 8, 2022 |
|
400,000 |
|
Options |
|
$1.02 |
March 18, 2022(1) |
|
100,000 |
|
Common Shares |
|
$0.25 |
March 25, 2022(2) |
|
90,546 |
|
Exchangeable Securities |
|
$10.00(14) |
April 1, 2022(2) |
|
22,428.3 |
|
Exchangeable Securities |
|
$10.20(15) |
May 5, 2022(15) |
|
380,230 |
|
Common Shares |
|
$0.68 |
May 24, 2022(1) |
|
500,000 |
|
Common Shares |
|
$0.25 |
June 14, 2022(1) |
|
500,000 |
|
Common Shares |
|
$0.25 |
June 22, 2022(1) |
|
99,638 |
|
Common Shares |
|
$0.64 |
June 22, 2022(2) |
|
456.50 |
|
Exchangeable Securities |
|
$10.20(16) |
June 24, 2022(2) |
|
266,933.1 |
|
Exchangeable Securities |
|
$7.62(17) |
June 27, 2022(2) |
|
37,366.2 |
|
Exchangeable Securities |
|
$7.50(18) |
June 30, 2022 |
|
65,000 |
|
Options |
|
$1.00 |
June 30, 2022 |
|
500,000 |
|
Options |
|
$0.90 |
Notes:
(1) Common
Shares issued on exercise of warrants to purchase Common Shares
(each, a "Warrant").
(2) Represents
Class B common shares in the capital of Cybin U.S. ("Class B
Shares") issued in connection with the Adelia Transaction to
Adelia shareholders. The Class B Shares are exchangeable at the
holder's option for Common Shares on the basis of 10 Common Shares
for 1 Class B Share, subject to customary adjustments.
(3) Common
Shares issued on exercise of options to purchase Common Shares
granted pursuant to the Corporation's equity incentive plan (each,
an "Option").
(4) Price
per Class B Share of Cybin U.S., which are exchangeable for 187,886
Common Shares, resulting in an effective issue price of $3.37 per
Common Share.
(5) Price
per Class B Share of Cybin U.S., which are exchangeable for 93,926
Common Shares, resulting in an effective issue price of $3.38 per
Common Share.
(6) As
the result of the termination of an employee of the Corporation,
20,000 options expired on October 21, 2021.
(7) On
March 4, 2022, 20,000 options were cancelled pursuant to an
acknowledgement agreement.
(8) Price
per Class B Share of Cybin U.S., which are exchangeable for 289,030
Common Shares, resulting in an effective issue price of $2.44 per
Common Share.
(9) Price
per Class B Share of Cybin U.S., which are exchangeable for 317,215
Common Shares, resulting in an effective issue price of $1.98 per
Common Share.
(10) Price
per Class B Share of Cybin U.S., which are exchangeable for 156,114
Common Shares, resulting in an effective issue price of $1.51 per
Common Share.
(11) Common
Shares issued in exchange for Class B Shares.
(12) Price
per Class B Share of Cybin U.S., which are exchangeable for 410,282
Common Shares, resulting in an effective issue price of $1.34 per
Common Share.
(13) Price
per Class B Share of Cybin U.S., which are exchangeable for 172,395
Common Shares, resulting in an effective issue price of $1.35 per
Common Share.
(14) Price
per Class B Share of Cybin U.S., which are exchangeable for 905,460
Common Shares, resulting in an effective issue price of $1.00 per
Common Share.
(15) Price
per Class B Share of Cybin U.S., which are exchangeable for 224,283
Common Shares, resulting in an effective issue price of $1.02 per
Common Share.
(16) Price
per Class B Share of Cybin U.S., which are exchangeable for 4,560
Common Shares, resulting in an effective issue price of $1.02 per
Common Share.
(17) Price
per Class B Share of Cybin U.S., which are exchangeable for
2,669,331 Common Shares, resulting in an effective issue price of
$0.762 per Common Share.
(18) Price
per Class B Share of Cybin U.S., which are exchangeable for 373,662
Common Shares, resulting in an effective issue price of $0.75 per
Common Share.
CERTAIN CANADIAN INCOME TAX
CONSIDERATIONS
The following is, as at the date of
this short form prospectus, a summary of the principal Canadian
federal income tax considerations under the Tax Act generally
applicable to an investor who acquires Common Shares as beneficial
owner pursuant to the Offering and who, for the purposes of the Tax
Act and at all relevant times, deals at arm's length with the
Corporation and the Agents, is not affiliated with the Corporation
or the Agents, and who acquires and holds the Common Shares as
capital property (a "Holder"). Generally, the Common Shares
will be considered to be capital property to a Holder thereof
provided that the Holder does not use the Common Shares in the
course of carrying on a business of trading or dealing in
securities and such Holder has not acquired them in one or more
transactions considered to be an adventure or concern in the nature
of trade.
This summary does not apply to a
Holder (i) that is a "financial institution" for the purposes of
the mark-to-market rules contained in the Tax Act; (ii) that is a
"specified financial institution" as defined in the Tax Act; (iii),
an interest in which would be a "tax shelter investment" as defined
in the Tax Act; (iv) that has made a functional currency reporting
election under section 261 of the Tax Act; (v) that has entered
into or will enter into a "derivative forward agreement" or
"synthetic disposition arrangement", as those terms are defined in
the Tax Act, with respect to the Common Shares; or (vi) that
receives dividends on the Common Shares under or as part of a
"dividend rental arrangement", as defined in the Tax Act. Such
Holders should consult their own tax advisors with respect to an
investment in Common Shares.
Additional considerations, not
discussed herein, may be applicable to a Holder that is a
corporation resident in Canada, and is, or becomes, or does not
deal at arm's length for purposes of the Tax Act with a corporation
resident in Canada that is or becomes, as part of a transaction or
event or series of transactions or events that includes the
acquisition of Common Shares, controlled by a non-resident person,
or group of non-resident persons not dealing with each other at
arm's length, for purposes of the foreign affiliate dumping rules
in section 212.3 of the Tax Act. Such Holders should consult their
own tax advisors.
This summary is based upon the
current provisions of the Tax Act and the regulations thereunder in
force as of the date hereof and counsel's understanding of the
current published administrative policies and assessing practices
of the Canada Revenue Agency (the "CRA"). This summary takes
into account all specific proposals to amend the Tax Act and the
regulations thereunder publicly announced by or on behalf of the
Minister of Finance (Canada) prior to the date hereof (the "Tax
Proposals") and assumes that the Tax Proposals will be enacted
in the form proposed, although no assurance can be given that the
Tax Proposals will be enacted in their current form or at all. This
summary does not otherwise take into account any changes in law or
in the administrative policies or assessing practices of the CRA,
whether by legislative, governmental or judicial decision or
action, nor does it take into account or consider other federal or
any provincial, territorial or foreign income tax considerations,
which considerations may differ significantly from the Canadian
federal income tax considerations discussed in this summary.
This summary is not exhaustive
of all possible Canadian federal income tax considerations
applicable to a Holder in respect of the transactions described
herein. The income or other tax consequences will vary depending on
the particular circumstances of the Holder, including the province
or provinces in which the Holder resides or carries on business.
Accordingly, this summary is of a general nature only and is not
intended to be, nor should it be construed to be, legal or tax
advice or representations to any particular Holder. Moreover, no
advance income tax ruling has been applied for or obtained from the
CRA to confirm the tax consequences of any of the transactions
described herein. Holders should consult their own legal and tax
advisors for advice with respect to the tax consequences of an
investment in the Common Shares based on their particular
circumstances.
Currency Conversion
Subject to certain exceptions that
are not discussed herein, for the purposes of the Tax Act, all
amounts relating to the acquisition, holding or disposition of
Common Shares (including dividends, adjusted cost base and proceeds
of disposition) must be expressed in Canadian dollars. Amounts
denominated in U.S. dollars must generally be converted into
Canadian dollars based on the single daily exchange rate as quoted
by the Bank of Canada on the date such amounts arise or such other
rate of exchange as is acceptable to the CRA.
Holders Resident in
Canada
The following portion of this
summary is generally applicable to a Holder who at all relevant
times, for purposes of the Tax Act, is or is deemed to be resident
in Canada (a "Resident Holder").
Certain Resident Holders whose
Common Shares might not constitute capital property may make, in
certain circumstances, an irrevocable election permitted by
subsection 39(4) of the Tax Act to deem the Common Shares, and
every other "Canadian security" as defined in the Tax Act, held by
such persons in the taxation year of the election and each
subsequent taxation year to be capital property. Resident Holders
should consult their own tax advisors regarding this election.
Dividends
Dividends received or deemed to be
received on the Common Shares will be included in computing a
Resident Holder's income. In the case of an individual (other than
certain trusts), such dividends will be subject to the gross-up and
dividend tax credit rules normally applicable in respect of
"taxable dividends" received from "taxable Canadian corporations"
(each as defined in the Tax Act). An enhanced gross-up and dividend
tax credit will be available to individuals in respect of "eligible
dividends" designated by the Corporation to the Resident Holder in
accordance with the provisions of the Tax Act. There may be
limitations on the ability of the Corporation to designate
dividends as eligible dividends.
Dividends received or deemed to be
received on a Common Share by a Resident Holder that is a
corporation will be included in computing the corporation's income
and will generally be deductible in computing its taxable income.
In certain circumstances, subsection 55(2) of the Tax Act will
treat a taxable dividend received (or deemed to be received) by a
Resident Holder that is a corporation as proceeds of disposition or
a capital gain. Resident Holders that are corporations should
consult their own tax advisors in this regard.
A Resident Holder that is a
"private corporation" (as defined in the Tax Act) or a "subject
corporation" (as defined in subsection 186(3) of the Tax Act) may
be liable to pay an additional tax (refundable in certain
circumstances) under Part IV of the Tax Act on dividends received
or deemed to be received on the Common Shares to the extent such
dividends are deductible in computing the Resident Holder's taxable
income. Resident Holders that are corporations should consult their
own tax advisors regarding their particular circumstances.
Dispositions of Common
Shares
Upon a disposition (or a deemed
disposition) of a Common Share (other than a disposition to the
Corporation that is not a sale in the open market in the manner in
which shares would normally be purchased by any member of the
public in an open market), a Resident Holder generally will realize
a capital gain (or a capital loss) equal to the amount by which the
proceeds of disposition of such share, net of any reasonable costs
of disposition, are greater (or are less) than the adjusted cost
base of such share to the Resident Holder immediately before the
disposition or deemed disposition. The adjusted cost base to a
Resident Holder of a Common Share will be determined by averaging
the cost of that Common Share with the adjusted cost base
(determined immediately before the acquisition of the Common Share)
of all other Common Shares held as capital property at that time by
the Resident Holder. For a description of the treatment of capital
gains and capital losses, see "Certain Canadian Income Tax
Considerations -Holders Resident in Canada - Capital Gain /
Loss" below.
Capital Gain / Loss
Generally, a Resident Holder is
required to include in computing its income for a taxation year
one-half of the amount of any capital gain (a "taxable capital
gain") realized in the year. Subject to and in accordance with
the provisions of the Tax Act, a Resident Holder is required to
deduct one-half of the amount of any capital loss (an "allowable
capital loss") realized in a taxation year from taxable capital
gains realized in the year by such Resident Holder. Allowable
capital losses in excess of taxable capital gains for the taxation
year of disposition may be carried back and deducted in any of the
three preceding taxation years or carried forward and deducted in
any following taxation year against net taxable capital gains
realized in such years to the extent and under the circumstances
described in the Tax Act.
The amount of any capital loss
realized on the disposition or deemed disposition of Common Shares
by a Resident Holder that is a corporation may be reduced by the
amount of dividends received or deemed to have been received by it
on such shares or shares substituted for such shares to the extent
and in the circumstances specified by the Tax Act. Similar rules
may apply where a Common Share is owned by a partnership or trust
of which a corporation, trust or partnership is a member or
beneficiary. Resident Holders to whom these rules may be relevant
should consult their own tax advisors.
A Resident Holder that is,
throughout the relevant taxation year, a "Canadian-controlled
private corporation" or "CCPC" (as defined in the Tax Act) will be
subject to an additional tax (refundable in certain circumstances)
in respect of its "aggregate investment income" (as defined in the
Tax Act) for the year, which will include taxable capital gains.
Draft legislation released in the 2022 Canadian federal budget
extends liability for the additional tax payable by a
"Canadian-controlled private corporation" to a "substantive CCPC"
(as defined in a draft amendment to the Tax Act). Resident Holders
that are "Canadian-controlled private corporations" or "substantive
CCPCs" should consult their own tax advisors regarding their
particular circumstances.
Minimum Tax
Capital gains realized and
dividends received (or deemed to be received) by a Resident Holder
that is an individual or a trust, other than certain specified
trusts, may give rise to minimum tax under the Tax Act. Resident
Holders that are individuals should consult their own tax advisors
in this regard.
Holders Not Resident in
Canada
The following portion of this
summary is generally applicable to a Holder who at all relevant
times, for purposes of the Tax Act, (i) is not, and is not deemed
to be, resident in Canada; and (ii) does not use or hold and is not
deemed to use or hold its Common Shares in, or in the course of
carrying on, a business in Canada (a "Non-Resident Holder").
Special rules, which are not discussed in this summary, may apply
to a Non-Resident Holder that is an insurer carrying on business in
Canada and elsewhere or that is an "authorized foreign bank" (as
defined in the Tax Act). Such Non-Resident Holders should consult
their own tax advisors.
The term "US Holder," for
the purposes of this summary, means a Non-Resident Holder who, for
purposes of the Canada-United States Tax Convention (1980),
as amended (the "Canada-US Tax Treaty"), is at all relevant
times a resident of the United States and is a "qualifying person"
within the meaning of the Canada-US Tax Treaty eligible for the
full benefits of the Canada-US Tax Treaty. In some circumstances,
persons deriving amounts through fiscally transparent entities
(including limited liability companies) may be entitled to benefits
under the Canada-US Tax Treaty. Non-Resident Holders are urged to
consult their own tax advisors to determine their entitlement to
benefits under the Canada-US Tax Treaty and related compliance
requirements based on their particular circumstances.
Dividends
Dividends paid or credited or
deemed under the Tax Act to be paid or credited by the Corporation
to a Non-Resident Holder on the Common Shares will generally be
subject to Canadian withholding tax at the rate of 25% on the gross
amount of the dividend, unless such rate is reduced by the terms of
an applicable income tax treaty or convention. Under the Canada-US
Tax Treaty, the withholding rate on any such dividend beneficially
owned by a Non-Resident Holder that is a US Holder or otherwise
entitled to the relevant benefits of such treaty is generally
reduced to 15%, and to 5% if such Non-Resident Holder is a company
that beneficially owns at least 10% of the voting stock of the
Corporation. Non-Resident Holders should consult their own tax
advisors to determine their entitlement to benefits under any
applicable tax treaty or convention based on their particular
circumstances.
Dispositions of Common
Shares
A Non-Resident Holder generally
will not be subject to tax under the Tax Act in respect of a
capital gain realized on the disposition or deemed disposition of a
Common Share unless the Common Share constitutes (or is deemed to
constitute) "taxable Canadian property" to the Non-Resident Holder
thereof for purposes of the Tax Act at the time of disposition, and
is not "treaty-protected property" (as defined in the Tax Act) of
the Non-Resident Holder at the time of the disposition.
Provided the Common Shares are
listed on a "designated stock exchange", as defined in the Tax Act
(which currently includes the NEO), at the time of disposition, the
Common Shares generally will not constitute taxable Canadian
property of a Non-Resident Holder at that time, unless at any time
during the 60 month period immediately preceding the disposition
the following two conditions are met concurrently: (i) the
Non-Resident Holder, persons with whom the Non-Resident Holder did
not deal at arm's length, partnerships in which the Non-Resident
Holder or any such non-arm's length person holds a membership
interest (either directly or indirectly through one or more
partnerships), or the Non-Resident Holder together with all such
persons and partnerships, owned 25% or more of the issued shares of
any class or series of shares of the Corporation; and (ii) more
than 50% of the fair market value of the Common Shares was derived
directly or indirectly from one or any combination of real or
immovable property situated in Canada, Canadian resource properties
(as defined in the Tax Act), timber resource properties (as defined
in the Tax Act) or options, interests or for civil law rights in
such property, whether or not such property exists. Notwithstanding
the foregoing, a Common Share may be deemed to be "taxable Canadian
property" in certain other circumstances.
The Common Shares of a US Holder
will generally constitute "treaty-protected property" for purposes
of the Tax Act at any given time unless the value of the Common
Shares is derived principally from real property situated in Canada
at that time. For this purpose, "real property" has the meaning
that term has under the laws of Canada and includes any option or
similar right in respect thereof and in any case, includes usufruct
of real property, rights to explore for or to exploit mineral
deposits, sources and other natural resources and rights to amounts
computed by reference to the amount or value of production from
such resources.
Non-Resident Holders should
consult their own tax advisors as to whether their Common Shares
constitute "taxable Canadian property".
If the Common Shares are "taxable
Canadian property" to a Non-Resident Holder and such Non-Resident
Holder is not exempt from tax under the Tax Act in respect of the
disposition of such Common Shares pursuant to an applicable income
tax treaty or convention, the tax consequences as described above
under the headings "Certain Canadian Income Tax Considerations -
Holders Resident in Canada - Dispositions of Common Shares" and
"Certain Canadian Income Tax Considerations - Holders Resident
in Canada - Capital Gain / Loss" will generally apply. Such
Non-Resident Holders should consult their own tax advisors.
CERTAIN UNITED STATES FEDERAL
INCOME TAX CONSIDERATIONS
The following is a general summary
of certain material U.S. federal income tax considerations
applicable to a U.S. Holder (as defined below) arising from and
relating to the acquisition, ownership and disposition of Common
Shares acquired pursuant to this Offering. This summary is for
general information purposes only and does not purport to be a
complete analysis or listing of all potential U.S. federal income
tax considerations that may apply to a U.S. Holder arising from or
relating to the acquisition, ownership and disposition of Common
Shares. In addition, this summary does not take into account the
individual facts and circumstances of any particular U.S. Holder
that may affect the U.S. federal income tax consequences to such
U.S. Holder, including, without limitation, specific tax
consequences to a U.S. Holder under an applicable income tax
treaty. Accordingly, this summary is not intended to be, and should
not be construed as, legal or U.S. federal income tax advice with
respect to any U.S. Holder. This summary does not address the U.S.
federal alternative minimum, U.S. federal net investment income,
U.S. federal estate and gift, U.S. state and local, and non-U.S.
tax consequences to U.S. Holders of the acquisition, ownership and
disposition of Common Shares. In addition, except as specifically
set forth below, this summary does not discuss applicable income
tax reporting requirements. Each prospective U.S. Holder should
consult its own tax advisors regarding the U.S. federal, U.S.
federal alternative minimum, U.S. federal net investment income,
U.S. federal estate and gift, U.S. state and local, and non-U.S.
tax consequences relating to the acquisition, ownership and
disposition of Common Shares.
No ruling from the Internal Revenue
Service (the "IRS") has been requested, or will be obtained,
regarding the U.S. federal income tax consequences of the
acquisition, ownership and disposition of Common Shares. This
summary is not binding on the IRS, and the IRS is not precluded
from taking a position that is different from, or contrary to, the
positions taken in this summary. In addition, because the
authorities on which this summary is based are subject to various
interpretations, the IRS and the U.S. courts could disagree with
one or more of the conclusions described in this summary.
Scope of this Summary
Authorities
This summary is based on the U.S.
Internal Revenue Code of 1986, as amended (the "Code"),
Treasury Regulations (whether final, temporary, or proposed),
published rulings of the IRS, published administrative positions of
the IRS, the current provisions of the Canada-United States Tax
Convention (1980) (the "Canada-U.S. Tax Convention"), and
U.S. court decisions that are applicable, and, in each case, as in
effect and available, as of the date of this document. Any of the
authorities on which this summary is based could be changed in a
material and adverse manner at any time, and any such change could
be applied on a retroactive or prospective basis, which could
affect the U.S. federal income tax considerations described in this
summary. Except as provided herein, this summary does not discuss
the potential effects, whether adverse or beneficial, of any
proposed legislation that, if enacted, could be applied on a
retroactive or prospective basis.
U.S. Holders
For purposes of this summary, the
term "U.S. Holder" means a beneficial owner of Common Shares
acquired pursuant to this Offering that is for U.S. federal income
tax purposes:
-
An individual who is a citizen or resident of the United
States;
-
a corporation (or other entity treated as a corporation for U.S.
federal income tax purposes) organized under the laws of the United
States, any state thereof or the District of Columbia;
-
an estate whose income is subject to U.S. federal income
taxation regardless of its source; or
- a
trust that (1) is subject to the primary supervision of a court
within the U.S. and the control of one or more U.S. persons for all
substantial decisions or (2) has a valid election in effect under
applicable Treasury Regulations to be treated as a U.S.
person.
Non-U.S. Holders
For purposes of this summary, a
"non-U.S. Holder" is a beneficial owner of Common Shares that is
not a U.S. Holder or an entity classified as a partnership for U.S.
federal income tax purposes. This summary does not address the U.S.
federal, state or local tax consequences to non-U.S. Holders
arising from or relating to the acquisition, ownership and
disposition of Common Shares. Accordingly, a non-U.S. Holder should
consult its own tax advisors regarding the U.S. federal, state or
local and non-U.S. tax consequences (including the potential
application of and operation of any income tax treaties) relating
to the acquisition, ownership and disposition of Common Shares.
U.S. Holders Subject to Special
U.S. Federal Income Tax Rules Not Addressed
This summary does not address the
U.S. federal income tax considerations applicable to U.S. Holders
that are subject to special provisions under the Code, including,
but not limited to U.S. Holders that: (a) are tax-exempt
organizations, qualified retirement plans, individual retirement
accounts, or other tax-deferred accounts; (b) are financial
institutions, underwriters, insurance companies, real estate
investment trusts, or regulated investment companies; (c) are
broker-dealers, dealers, or traders in securities or currencies
that elect to apply a mark-to-market accounting method; (d) have a
"functional currency" other than the U.S. dollar; (e) own Common
Shares as part of a straddle, hedging transaction, conversion
transaction, constructive sale, or other integrated transaction;
(f) acquire Common Shares in connection with the exercise of
employee stock options or otherwise as compensation for services;
(g) hold Common Shares other than as a capital asset within the
meaning of Section 1221 of the Code (generally, property held for
investment purposes); (h) are subject to the alternative minimum
tax; (i) are subject to special tax accounting rules with respect
to Common Shares; (j) are partnerships or other "pass-through"
entities (and partners or other owners thereof); (k) are S
corporations (and shareholders thereof); (l) are U.S. expatriates
or former long-term residents of the United States subject to
Section 877 or 877A of the Code; (m) hold Common Shares in
connection with a trade or business, permanent establishment, or
fixed base outside the United States; or (n) own or have owned or
will own (directly, indirectly, or by attribution) 10% or more of
the total combined voting power or value of the outstanding shares
of the Corporation. U.S. Holders that are subject to special
provisions under the Code, including, but not limited to, U.S.
Holders described immediately above, should consult their own tax
advisors regarding the U.S. federal, U.S. federal alternative
minimum, U.S. federal net investment income, U.S. federal estate
and gift, U.S. state and local, and non-U.S. tax consequences
relating to the acquisition, ownership and disposition of Common
Shares.
If an entity or arrangement that is
classified as a partnership (or other "pass-through" entity) for
U.S. federal income tax purposes holds Common Shares, the U.S.
federal income tax consequences to such entity or arrangement and
the partners (or other owners or participants) of such entity or
arrangement generally will depend on the activities of the entity
or arrangement and the status of such partners (or owners or
participants). This summary does not address the tax consequences
to any such partner (or owner or participant). Partners (or other
owners or participants) of entities or arrangements that are
classified as partnerships or as "pass-through" entities for U.S.
federal income tax purposes should consult their own tax advisors
regarding the U.S. federal income tax consequences arising from and
relating to the acquisition, ownership and disposition of Common
Shares.
Passive Foreign Investment
Company Rules
PFIC Status
If the Corporation was to
constitute a "passive foreign investment company" under the meaning
of Section 1297 of the Code (a "PFIC", as defined below) for
any year during a U.S. Holder's holding period, then certain
potentially adverse rules would affect the U.S. federal income tax
consequences to a U.S. Holder as a result of the acquisition,
ownership and disposition of Common Shares. Based on current
business plans and financial expectations, the Corporation expects
to be a PFIC for its current tax year and may be a PFIC in future
tax years. No opinion of legal counsel or ruling from the IRS
concerning the status of the Corporation as a PFIC has been
obtained or is currently planned to be requested. The determination
of whether any corporation was, or will be, a PFIC for a tax year
depends, in part, on the application of complex U.S. federal income
tax rules, which are subject to differing interpretations. In
addition, whether any corporation will be a PFIC for any tax year
depends on the assets and income of such corporation over the
course of each such tax year and, as a result, cannot be predicted
with certainty as of the date of this document. Accordingly, there
can be no assurance that the IRS will not challenge any
determination made by the Corporation (or any subsidiary of the
Corporation) concerning its PFIC status. Each U.S. Holder should
consult its own tax advisors regarding the PFIC status of the
Corporation and each subsidiary of the Corporation.
In any year in which the
Corporation is classified as a PFIC, a U.S. Holder will be required
to file an annual report with the IRS containing such information
as Treasury Regulations and/or other IRS guidance may require. In
addition to penalties, a failure to satisfy such reporting
requirements may result in an extension of the time period during
which the IRS can assess a tax. U.S. Holders should consult their
own tax advisors regarding the requirements of filing such
information returns under these rules, including the requirement to
file an IRS Form 8621 annually.
The Corporation generally will be a
PFIC if, for a tax year, (a) 75% or more of the gross income of the
Corporation is passive income (the "PFIC income test") or
(b) 50% or more of the value of the Corporation's assets either
produce passive income or are held for the production of passive
income, based on the quarterly average of the fair market value of
such assets (the "PFIC asset test"). "Gross income"
generally includes all sales revenues less the cost of goods sold,
plus income from investments and from incidental or outside
operations or sources, and "passive income" generally includes, for
example, dividends, interest, certain rents and royalties, certain
gains from the sale of stock and securities, and certain gains from
commodities transactions. Active business gains arising from the
sale of commodities generally are excluded from passive income if
substantially all of a foreign corporation's commodities are stock
in trade or inventory, depreciable property used in a trade or
business, or supplies regularly used or consumed in the ordinary
course of its trade or business, and certain other requirements are
satisfied.
For purposes of the PFIC income
test and PFIC asset test described above, if the Corporation owns,
directly or indirectly, 25% or more of the total value of the
outstanding shares of another corporation, the Corporation will be
treated as if the Corporation (a) held a proportionate share of the
assets of such other corporation and (b) received directly a
proportionate share of the income of such other corporation. In
addition, for purposes of the PFIC income test and PFIC asset test
described above, and assuming certain other requirements are met,
"passive income" does not include certain interest, dividends,
rents, or royalties that are received or accrued by the Corporation
from certain "related persons" (as defined in Section 954(d)(3) of
the Code) also organized in Canada, to the extent such items are
properly allocable to the income of such related person that is not
passive income.
Under certain attribution rules, if
the Corporation is a PFIC, U.S. Holders will generally be deemed to
own their proportionate share of the Corporation's direct or
indirect equity interest in any company that is also a PFIC (a
"Subsidiary PFIC"), and will generally be subject to U.S.
federal income tax on their proportionate share of (a) any "excess
distributions," as described below, on the stock of a Subsidiary
PFIC and (b) a disposition or deemed disposition of the stock of a
Subsidiary PFIC by the Corporation or another Subsidiary PFIC, both
as if such U.S. Holders directly held the shares of such Subsidiary
PFIC. In addition, U.S. Holders may be subject to U.S. federal
income tax on any indirect gain realized on the stock of a
Subsidiary PFIC on the sale or disposition of Common Shares.
Accordingly, U.S. Holders should be aware that they could be
subject to tax under the PFIC rules even if no distributions are
received and no redemptions or other dispositions of Common Shares
are made.
Default PFIC Rules Under Section
1291 of the Code
If the Corporation is a PFIC for
any tax year during which a U.S. Holder owns Common Shares, the
U.S. federal income tax consequences to such U.S. Holder of the
acquisition, ownership, and disposition of Common Shares will
depend on whether and when such U.S. Holder makes an election to
treat the Corporation and each Subsidiary PFIC, if any, as a
"qualified electing fund" or "QEF" under Section 1295 of the Code
(a "QEF Election") or makes a mark-to-market election under
Section 1296 of the Code (a "Mark-to-Market Election"). A
U.S. Holder that does not make either a QEF Election or a
Mark-to-Market Election will be referred to in this summary as a
"Non-Electing U.S. Holder".
A Non-Electing U.S. Holder will be
subject to the rules of Section 1291 of the Code (described below)
with respect to: (a) any gain recognized on the sale or other
taxable disposition of Common Shares; and (b) any "excess
distribution" received on the Common Shares. A distribution
generally will be an "excess distribution" to the extent that such
distribution (together with all other distributions received in the
current tax year) exceeds 125% of the average distributions
received during the three preceding tax years (or during a U.S.
Holder's holding period for the Common Shares, if shorter).
Under Section 1291 of the Code, any
gain recognized on the sale or other taxable disposition of Common
Shares (including an indirect disposition of the stock of any
Subsidiary PFIC), and any "excess distribution" received on Common
Shares or with respect to the stock of a Subsidiary PFIC, must be
ratably allocated to each day in a Non-Electing U.S. Holder's
holding period for the respective Common Shares. The amount of any
such gain or excess distribution allocated to the tax year of
disposition or distribution of the excess distribution and to years
before the entity became a PFIC, if any, would be taxed as ordinary
income (and not eligible for certain preferred rates). The amounts
allocated to any other tax year would be subject to U.S. federal
income tax at the highest tax rate applicable to ordinary income in
each such year, and an interest charge would be imposed on the tax
liability for each such year, calculated as if such tax liability
had been due in each such year. A Non-Electing U.S. Holder that is
not a corporation must treat any such interest paid as "personal
interest," which is not deductible.
If the Corporation is a PFIC for
any tax year during which a Non-Electing U.S. Holder holds Common
Shares, the Corporation will continue to be treated as a PFIC with
respect to such Non-Electing U.S. Holder, regardless of whether the
Corporation ceases to be a PFIC in one or more subsequent tax
years. A Non-Electing U.S. Holder may terminate this deemed PFIC
status by electing to recognize gain (which will be taxed under the
rules of Section 1291 of the Code discussed above), but not loss,
as if such Common Shares were sold on the last day of the last tax
year for which the Corporation was a PFIC.
QEF Election
A U.S. Holder that makes a timely
and effective QEF Election for the first tax year in which the
holding period of its Common Shares begins generally will not be
subject to the rules of Section 1291 of the Code discussed above
with respect to its Common Shares. A U.S. Holder that makes a
timely and effective QEF Election will be subject to U.S. federal
income tax on such U.S. Holder's pro rata share of (a) the net
capital gain of the Corporation, which will be taxed as long-term
capital gain to such U.S. Holder, and (b) the ordinary earnings of
the Corporation, which will be taxed as ordinary income to such
U.S. Holder. Generally, "net capital gain" is the excess of (a) net
long-term capital gain over (b) net short-term capital loss, and
"ordinary earnings" are the excess of (a) "earnings and profits"
over (b) net capital gain. A U.S. Holder that makes a QEF Election
will be subject to U.S. federal income tax on such amounts for each
tax year in which the Corporation is a PFIC, regardless of whether
such amounts are actually distributed to such U.S. Holder by the
Corporation. However, for any tax year in which the Corporation is
a PFIC and has no net income or gain, U.S. Holders that have made a
QEF Election would not have any income inclusions as a result of
the QEF Election. If a U.S. Holder that made a QEF Election has an
income inclusion, such a U.S. Holder may, subject to certain
limitations, elect to defer payment of current U.S. federal income
tax on such amounts, subject to an interest charge. If such U.S.
Holder is not a corporation, any such interest paid will be treated
as "personal interest," which is not deductible.
A U.S. Holder that makes a timely
and effective QEF Election with respect to the Corporation
generally (a) may receive a tax-free distribution from the
Corporation to the extent that such distribution represents
"earnings and profits" of the Corporation that were previously
included in income by the U.S. Holder because of such QEF Election
and (b) will adjust such U.S. Holder's tax basis in the Common
Shares to reflect the amount included in income or allowed as a
tax-free distribution because of such QEF Election. In addition, a
U.S. Holder that makes a QEF Election generally will recognize
capital gain or loss on the sale or other taxable disposition of
Common Shares.
The procedure for making a QEF
Election, and the U.S. federal income tax consequences of making a
QEF Election, will depend on whether such QEF Election is timely. A
QEF Election will be treated as "timely" if such QEF Election is
made for the first year in the U.S. Holder's holding period for the
Common Shares in which the Corporation was a PFIC. A U.S. Holder
may make a timely QEF Election by filing the appropriate QEF
Election documents at the time such U.S. Holder files a U.S.
federal income tax return for such year. If a U.S. Holder does not
make a timely and effective QEF Election for the first year in the
U.S. Holder's holding period for the Common Shares, the U.S. Holder
may still be able to make a timely and effective QEF Election in a
subsequent year if such U.S. Holder meets certain requirements and
makes a "purging" election to recognize gain (which will be taxed
under the rules of Section 1291 of the Code discussed above) as if
such Common Shares were sold for their fair market value on the day
the QEF Election is effective. If a U.S. Holder makes a QEF
Election but does not make a "purging" election to recognize gain
as discussed in the preceding sentence, then such U.S. Holder shall
be subject to the QEF Election rules and shall continue to be
subject to tax under the rules of Section 1291 discussed above with
respect to its Common Shares. If a U.S. Holder owns PFIC stock
indirectly through another PFIC, separate QEF Elections must be
made for the PFIC in which the U.S. Holder is a direct shareholder
and the Subsidiary PFIC for the QEF rules to apply to both
PFICs.
A QEF Election will apply to the
tax year for which such QEF Election is timely made and to all
subsequent tax years, unless such QEF Election is invalidated or
terminated or the IRS consents to revocation of such QEF Election.
If a U.S. Holder makes a QEF Election and, in a subsequent tax
year, the Corporation ceases to be a PFIC, the QEF Election will
remain in effect (although it will not be applicable) during those
tax years in which the Corporation is not a PFIC. Accordingly, if
the Corporation becomes a PFIC in another subsequent tax year, the
QEF Election will be effective and the U.S. Holder will be subject
to the QEF rules described above during any subsequent tax year in
which the Corporation qualifies as a PFIC.
For each tax year that the
Corporation qualifies as a PFIC, the Corporation: (a) intends to
make publicly available to U.S. Holders, upon their written
request, a "PFIC Annual Information Statement" for the Corporation
as described in Treasury Regulation Section 1.1295-1(g) (or any
successor Treasury Regulation) and (b) upon written request,
intends to use commercially reasonable efforts to provide such
additional information that such U.S. Holder is reasonably required
to obtain in connection with maintaining such QEF Election with
regard to the Corporation. The Corporation may elect to provide
such information on the Corporation's website. However, U.S.
Holders should be aware that the Corporation can provide no
assurances that the Corporation will provide any such information
relating to any Subsidiary PFIC and as a result, a QEF Election may
not be available with respect to any Subsidiary PFIC. Because the
Corporation may own shares in one or more Subsidiary PFICs at any
time, U.S. Holders will continue to be subject to the rules
discussed above with respect to the taxation of gains and excess
distributions with respect to any Subsidiary PFIC for which the
U.S. Holders do not obtain such required information. Each U.S.
Holder should consult its own tax advisors regarding the
availability of, and procedure for making, a QEF Election with
respect to the Corporation and any Subsidiary PFIC.
A U.S. Holder makes a QEF Election
by attaching a completed IRS Form 8621, including a PFIC Annual
Information Statement, to a timely filed United States federal
income tax return. However, if the Corporation does not provide the
required information with regard to the Corporation or any of its
Subsidiary PFICs, U.S. Holders will not be able to make a QEF
Election for such entity and will continue to be subject to the
rules of Section 1291 of the Code discussed above that apply to
Non-Electing U.S. Holders with respect to the taxation of gains and
excess distributions.
Mark-to-Market Election
A U.S. Holder may make a
Mark-to-Market Election only if the Common Shares are marketable
stock. The Common Shares generally will be "marketable stock" if
the Common Shares are regularly traded on (a) a national securities
exchange that is registered with the SEC, (b) the national market
system established pursuant to section 11A of the Exchange Act, or
(c) a foreign securities exchange that is regulated or supervised
by a governmental authority of the country in which the market is
located, provided that (i) such foreign exchange has trading
volume, listing, financial disclosure, and surveillance
requirements, and meets other requirements and the laws of the
country in which such foreign exchange is located, together with
the rules of such foreign exchange, ensure that such requirements
are actually enforced and (ii) the rules of such foreign exchange
effectively promote active trading of listed stocks. If such stock
is traded on such a qualified exchange or other market, such stock
generally will be "regularly traded" for any calendar year during
which such stock is traded, other than in de minimis quantities, on
at least 15 days during each calendar quarter. Each U.S. Holder
should consult its own tax advisor in this matter.
A U.S. Holder that makes a
Mark-to-Market Election with respect to its Common Shares generally
will not be subject to the rules of Section 1291 of the Code
discussed above with respect to such Common Shares. However, if a
U.S. Holder does not make a Mark-to-Market Election beginning in
the first tax year of such U.S. Holder's holding period for the
Common Shares for which the Corporation is a PFIC and such U.S.
Holder has not made a timely QEF Election, the rules of Section
1291 of the Code discussed above will apply to certain dispositions
of, and distributions on, the Common Shares.
A U.S. Holder that makes a
Mark-to-Market Election will include in ordinary income, for each
tax year in which the Corporation is a PFIC, an amount equal to the
excess, if any, of (a) the fair market value of the Common Shares,
as of the close of such tax year over (b) such U.S. Holder's
adjusted tax basis in such Common Shares. A U.S. Holder that makes
a Mark-to-Market Election will be allowed a deduction in an amount
equal to the excess, if any, of (a) such U.S. Holder's adjusted tax
basis in the Common Shares, over (b) the fair market value of such
Common Shares (but only to the extent of the net amount of
previously included income as a result of the Mark-to-Market
Election for prior tax years).
A U.S. Holder that makes a
Mark-to-Market Election generally also will adjust such U.S.
Holder's tax basis in the Common Shares to reflect the amount
included in gross income or allowed as a deduction because of such
Mark-to-Market Election. In addition, upon a sale or other taxable
disposition of Common Shares, a U.S. Holder that makes a
Mark-to-Market Election will recognize ordinary income or ordinary
loss (not to exceed the excess, if any, of (a) the amount included
in ordinary income because of such Mark-to-Market Election for
prior tax years over (b) the amount allowed as a deduction because
of such Mark-to-Market Election for prior tax years). Losses that
exceed this limitation are subject to the rules generally
applicable to losses provided in the Code and Treasury
Regulations.
A U.S. Holder makes a
Mark-to-Market Election by attaching a completed IRS Form 8621 to a
timely filed United States federal income tax return. A
Mark-to-Market Election applies to the tax year in which such
Mark-to-Market Election is made and to each subsequent tax year,
unless the Common Shares cease to be "marketable stock" or the IRS
consents to revocation of such election. Each U.S. Holder should
consult its own tax advisors regarding the availability of, and
procedure for making, a Mark-to-Market Election.
Although a U.S. Holder may be
eligible to make a Mark-to-Market Election with respect to the
Common Shares, no such election may be made with respect to the
stock of any Subsidiary PFIC that a U.S. Holder is treated as
owning, because such stock is not marketable. Hence, the
Mark-to-Market Election will not be effective to avoid the
application of the default rules of Section 1291 of the Code
described above with respect to deemed dispositions of Subsidiary
PFIC stock or excess distributions from a Subsidiary PFIC to its
shareholder.
Other PFIC Rules
Under Section 1291(f) of the Code,
the IRS has issued proposed Treasury Regulations that, subject to
certain exceptions, would cause a U.S. Holder that had not made a
timely QEF Election to recognize gain (but not loss) upon certain
transfers of Common Shares that would otherwise be tax-deferred
(e.g., gifts and exchanges pursuant to corporate reorganizations).
However, the specific U.S. federal income tax consequences to a
U.S. Holder may vary based on the manner in which Common Shares are
transferred.
Certain additional adverse rules
may apply with respect to a U.S. Holder if the Corporation is a
PFIC, regardless of whether such U.S. Holder makes a QEF Election.
For example, under Section 1298(b)(6) of the Code, a U.S. Holder
that uses Common Shares as security for a loan will, except as may
be provided in Treasury Regulations, be treated as having made a
taxable disposition of such Common Shares.
In addition, a U.S. Holder who
acquires Common Shares from a decedent will not receive a "step up"
in tax basis of such Common Shares to fair market value unless such
decedent had a timely and effective QEF Election in place.
Special rules also apply to the
amount of foreign tax credit that a U.S. Holder may claim on a
distribution from a PFIC. Subject to such special rules, foreign
taxes paid with respect to any distribution in respect of stock in
a PFIC are generally eligible for the foreign tax credit. The rules
relating to distributions by a PFIC and their eligibility for the
foreign tax credit are complicated, and a U.S. Holder should
consult with its own tax advisors regarding the availability of the
foreign tax credit with respect to distributions by a PFIC.
The PFIC rules are complex, and
each U.S. Holder should consult its own tax advisors regarding the
PFIC rules and how the PFIC rules may affect the U.S. federal
income tax consequences of the acquisition, ownership, and
disposition of Common Shares.
General Rules Applicable to the
Ownership and Disposition of Common Shares
The following discussion is
subject, in its entirety, to the rules described above under the
heading "Passive Foreign Investment Company Rules".
Distributions on Common
Shares
A U.S. Holder that receives a
distribution, including a constructive distribution, with respect
to an Common Share will be required to include the amount of such
distribution in gross income as a dividend (without reduction for
any Canadian income tax withheld from such distribution) to the
extent of the current or accumulated "earnings and profits" of the
Corporation, as computed for U.S. federal income tax purposes. A
dividend generally will be taxed to a U.S. Holder at ordinary
income tax rates if the Corporation is a PFIC for the tax year of
such distribution or the preceding tax year. To the extent that a
distribution exceeds the current and accumulated "earnings and
profits" of the Corporation, such distribution will be treated
first as a tax-free return of capital to the extent of a U.S.
Holder's tax basis in the Common Shares and thereafter as gain from
the sale or exchange of such Common Shares. (See "Sale or Other
Taxable Disposition of Common Shares" below). However, the
Corporation does not intend to maintain the calculations of its
earnings and profits in accordance with U.S. federal income tax
principles, and each U.S. Holder therefore should assume that any
distribution by the Corporation with respect to the Common Shares
will constitute ordinary dividend income. Dividends received on
Common Shares by corporate U.S. Holders generally will not be
eligible for the "dividends received deduction". Subject to
applicable limitations and provided the Corporation is eligible for
the benefits of the Canada-U.S. Tax Convention or the Common Shares
are readily tradable on a United States securities market,
dividends paid by the Corporation to non-corporate U.S. Holders,
including individuals, generally will be eligible for the
preferential tax rates applicable to long-term capital gains for
dividends, provided certain holding period and other conditions are
satisfied, including that the Corporation not be classified as a
PFIC in the tax year of distribution or in the preceding tax year.
The dividend rules are complex, and each U.S. Holder should consult
its own tax advisors regarding the application of such rules.
Sale or Other Taxable
Disposition of Common Shares
Upon the sale or other taxable
disposition of Common Shares, a U.S. Holder generally will
recognize capital gain or loss in an amount equal to the difference
between the U.S. dollar value of cash received plus the fair market
value of any property received and such U.S. Holder's tax basis in
such Common Shares sold or otherwise disposed of. A U.S. Holder's
tax basis in Common Shares generally will be such U.S. Holder's
U.S. dollar cost for such Common Shares. Gain or loss recognized on
such sale or other disposition generally will be long-term capital
gain or loss if, at the time of the sale or other disposition, the
Common Shares have been held for more than one year.
Preferential tax rates currently
apply to long-term capital gain of a U.S. Holder that is an
individual, estate, or trust. There are currently no preferential
tax rates for long-term capital gain of a U.S. Holder that is a
corporation. Deductions for capital losses are subject to
significant limitations under the Code.
Additional
Considerations
Receipt of Foreign
Currency
The amount of any distribution paid
to a U.S. Holder in foreign currency, or on the sale, exchange or
other taxable disposition of Common Shares, generally will be equal
to the U.S. dollar value of such foreign currency based on the
exchange rate applicable on the date of receipt (regardless of
whether such foreign currency is converted into U.S. dollars at
that time). A U.S. Holder will have a tax basis in the foreign
currency equal to its U.S. dollar value on the date of receipt. Any
U.S. Holder who converts or otherwise disposes of the foreign
currency after the date of receipt may have a foreign currency
exchange gain or loss that would be treated as ordinary income or
loss, and generally will be U.S. source income or loss for foreign
tax credit purposes. Different rules apply to U.S. Holders who use
the accrual method of tax accounting. Each U.S. Holder should
consult its own U.S. tax advisors regarding the U.S. federal income
tax consequences of receiving, owning, and disposing of foreign
currency.
Foreign Tax Credit
Subject to the PFIC rules discussed
above, a U.S. Holder that pays (whether directly or through
withholding) Canadian income tax with respect to dividends paid on
Common Shares generally will be entitled, at the election of such
U.S. Holder, to receive either a deduction or a credit for such
Canadian income tax. Generally, a credit will reduce a U.S.
Holder's U.S. federal income tax liability on a dollar-for-dollar
basis, whereas a deduction will reduce a U.S. Holder's income that
is subject to U.S. federal income tax. This election is made on a
year-by-year basis and applies to all foreign taxes paid (whether
directly or through withholding) by a U.S. Holder during a year.
The foreign tax credit rules are complex, and involve the
application of rules that depend on a U.S. Holder's particular
circumstances. Accordingly, each U.S. Holder should consult its own
U.S. tax advisors regarding the foreign tax credit rules.
Backup Withholding and
Information Reporting
Under U.S. federal income tax law
and Treasury Regulations, certain categories of U.S. Holders must
file information returns with respect to their investment in, or
involvement in, a foreign corporation. For example, U.S. return
disclosure obligations (and related penalties) are imposed on
individuals who are U.S. Holders that hold certain specified
foreign financial assets in excess of certain threshold amounts.
The definition of specified foreign financial assets includes not
only financial accounts maintained in foreign financial
institutions, but also, unless held in accounts maintained by a
financial institution, any stock or security issued by a non-U.S.
person, any financial instrument or contract held for investment
that has an issuer or counterparty other than a U.S. person and any
interest in a non-U.S. entity. U.S. Holders may be subject to these
reporting requirements unless their Common Shares are held in an
account at certain financial institutions. Penalties for failure to
file certain of these information returns are substantial. U.S.
Holders should consult their own tax advisors regarding the
requirements of filing information returns, including the
requirement to file an IRS Form 8938.
Payments made within the U.S. or by
a U.S. payor or U.S. middleman, of dividends on, and proceeds
arising from the sale or other taxable disposition of, Common
Shares will generally be subject to information reporting and
backup withholding tax if a U.S. Holder (a) fails to furnish such
U.S. Holder's correct U.S. taxpayer identification number
(generally on IRS Form W-9), (b) furnishes an incorrect U.S.
taxpayer identification number, (c) is notified by the IRS that
such U.S. Holder has previously failed to properly report items
subject to backup withholding tax, or (d) fails to certify, under
penalty of perjury, that such U.S. Holder has furnished its correct
U.S. taxpayer identification number and that the IRS has not
notified such U.S. Holder that it is subject to backup withholding
tax. However, certain exempt persons generally are excluded from
these information reporting and backup withholding rules. Backup
withholding is not an additional tax. Any amounts withheld under
the U.S. backup withholding tax rules will be allowed as a credit
against a U.S. Holder's U.S. federal income tax liability, if any,
or will be refunded, if such U.S. Holder furnishes required
information to the IRS in a timely manner.
The discussion of reporting
requirements set forth above is not intended to constitute a
complete description of all reporting requirements that may apply
to a U.S. Holder. A failure to satisfy certain reporting
requirements may result in an extension of the time period during
which the IRS can assess a tax, and under certain circumstances,
such an extension may apply to assessments of amounts unrelated to
any unsatisfied reporting requirement. Each U.S. Holder should
consult its own tax advisors regarding the information reporting
and backup withholding rules.
THE ABOVE SUMMARY IS NOT
INTENDED TO CONSTITUTE A COMPLETE ANALYSIS OF ALL TAX
CONSIDERATIONS APPLICABLE TO U.S. HOLDERS WITH RESPECT TO THE
ACQUISITION, OWNERSHIP AND DISPOSITION OF COMMON SHARES. U.S.
HOLDERS SHOULD CONSULT THEIR OWN TAX ADVISORS AS TO THE TAX
CONSIDERATIONS APPLICABLE TO THEM IN LIGHT OF THEIR OWN PARTICULAR
CIRCUMSTANCES.
RISK FACTORS
An investment in the Common
Shares is highly speculative and subject to a number of risks.
Before deciding whether to invest, investors should consider
carefully the risks factors set forth below and in the documents
incorporated by reference in the Base Shelf Prospectus and this
Prospectus Supplement (including those discussed under the heading
"Risk Factors" in the Base Shelf Prospectus and the Corporation's
most recent annual information form, annual management discussion
& analysis and interim management discussion & analysis)
and all of the other information in the Prospectus Supplement
(including, without limitation, the documents incorporated by
reference). The risks described in this Prospectus Supplement are
not the only risks that affect the Corporation. Additional risks
and uncertainties that the Corporation is unaware of, or that the
Corporation currently deems not to be material, may also become
important factors that affect the Corporation. If any such risks
actually occur, the Corporation's business, financial condition or
results of operations could be materially adversely affected, with
the result that the trading price of the Common Shares could
decline and investors could lose all or part of their
investment.
Risk Factors Related to the
Offering
"At-the-Market"
Offerings
Investors who purchase Common
Shares in this Offering at different times will likely pay
different prices, and so may experience different outcomes in their
investment results. The Corporation will have discretion, subject
to market demand, to vary the timing, prices, and numbers of Common
Shares sold, and there is no minimum or maximum sales price.
Investors may experience a decline in the value of their Common
Shares as a result of sales made at prices lower than the prices
they paid.
An Investment in the Common
Shares is Highly Speculative
An investment in the Common Shares
and the Corporation's prospects generally are speculative due to
the risky nature of its business and the present stage of its
development. Investors may lose their entire investment. There is
no assurance that risk management steps taken will avoid future
loss due to the occurrence of the risks described or incorporated
by reference herein, or other unforeseen risks. If any of such
risks actually occur, then the Corporation's business, financial
condition and operating results could be adversely affected.
Investors should carefully consider all risks and consult with
their professional advisors to assess any investment in the
Corporation.
Negative Operating Cash Flow
and Going Concern
The Corporation has had negative
cash flow from operating activities since inception. Drug
development involves long lead times, is very expensive and
involves many variables of uncertainty. As such, significant
capital investment will be required to achieve the Corporation's
existing plans. The Corporation's net losses have had and will
continue to have an adverse effect on, among other things,
shareholder equity, total assets and working capital. The
Corporation expects that losses may fluctuate from quarter to
quarter and year to year, and that such fluctuations may be
substantial based on the stage of development of its principal
programs. The Corporation cannot predict when it will become
profitable, if at all. Accordingly, the Corporation may be required
to obtain additional financing in order to meet its future cash
commitments.
The threat of the Corporation's
ability to continue as a going concern will be removed only when,
in the opinion of the Corporation's auditor, the Corporation's
revenues have reached a level that is able to sustain its business
operations. If the Corporation is unable to obtain additional
financing from outside sources and eventually generate enough
revenues, the Corporation may be forced to sell a portion or all of
the Corporation's assets, or curtail or discontinue the
Corporation's operations. If any of these events happen,
shareholders could lose all or part of their investment. The
Corporation's financial statements do not include any adjustments
to the Corporation's recorded assets or liabilities that might be
necessary if the Corporation becomes unable to continue as a going
concern. See "Risk Factors - Risks Related to the Offering -
Potential Need for Additional Financing".
Discretion in the Use of
Proceeds
The Corporation will have
discretion concerning the use of the net proceeds of the Offering
as well as the timing of their expenditures, and may apply the net
proceeds of the Offering in ways other than as described under
"Use of Proceeds". As a result, an investor will be relying
on the judgment of management for the application of the net
proceeds of the Offering. Management may use the net proceeds of
the Offering in ways that an investor may not consider desirable.
The results and the effectiveness of the application of the net
proceeds are uncertain. If the net proceeds are not applied
effectively, the Corporation's business, prospects, financial
position, financial condition or results of operations may
suffer.
Potential Need for Additional
Financing
The continued development of the
Corporation will require additional financing. The Corporation's
activities do have scope for flexibility in terms of the amount and
timing of expenditures, and expenditures may be adjusted
accordingly. However, further operations will require additional
capital and will depend on the Corporation's ability to obtain
financing through debt, equity or other means. The Corporation's
ability to meet its obligations and maintain operations may be
contingent upon successful completion of additional financing
arrangements. There is no assurance that the Corporation will be
successful in obtaining the required financing in the future or
that such financing will be available on terms acceptable to the
Corporation. In addition, any future financing may also be dilutive
to existing shareholders of the Corporation. See "Risk Factors -
Risks Related to the Offering - Negative Operating Cash Flow and
Going Concern" and "Risk Factors - Risks Related to the
Offering - Potential Dilution".
No Certainty of Net Proceeds
from the Offering
There is no certainty that
U.S.$35,000,000, or any amount, will be raised under the Offering.
The Agents have agreed to use commercially reasonable efforts to
sell the Common Shares when and to the extent requested by the
Corporation, but the Corporation is not required to request the
sale of the maximum amount offered or any amount and, if the
Corporation requests a sale, the Corporation and the Agents are not
obligated to purchase any Common Shares that are not sold. As a
result of the Offering being made on a commercially reasonable
efforts basis with no minimum, and only as requested by the
Corporation, the Corporation may raise substantially less than the
maximum total offering amount or nothing at all.
Potential
Dilution
The Corporation's articles of
incorporation and by-laws allow it to issue an unlimited number of
Common Shares for such consideration and on such terms and
conditions as established by the board of directors of the
Corporation, in many cases, without the approval of the
Corporation's shareholders. With any additional issuance of Common
Shares, investors will suffer dilution to their voting power and
the Corporation may experience dilution in its earnings per share.
"Risk Factors - Risks Related to an Offering - Potential Need
for Additional Financing".
Trading Market
The Corporation cannot assure that
a market will continue to develop or be sustained for the Common
Shares. If a market does not continue to develop or is not
sustained, it may be difficult for purchasers to sell Common Shares
at an attractive price or at all. The Corporation cannot predict
the prices at which the Common Shares will trade.
Significant Sales of Common
Shares
Significant sales of Common Shares,
or the availability of such securities for sale, could adversely
affect the prevailing market prices for the Common Shares. A
decline in the market prices of the Common Shares could impair the
Corporation's ability to raise additional capital through the sale
of securities should it desire to do so.
Positive Return Not
Guaranteed
There is no guarantee that the
Common Shares will earn any positive return in the short term or
long term. A holding of Common Shares is highly speculative and
involves a high degree of risk and should be undertaken only by
holders whose financial resources are sufficient to enable them to
assume such risks and who have no need for immediate liquidity in
their investment. A holding of Common Shares is appropriate only
for holders who have the capacity to absorb a loss of some or all
of their holdings.
Application and
Interpretation of Tax Laws
The Corporation is subject to
direct and indirect taxes in various foreign jurisdictions. The
amount of tax that the Corporation pays, directly or indirectly, is
subject to the interpretation of applicable tax laws in the
jurisdictions of operations in which the Corporation has interests.
The Corporation has taken and will continue to take tax positions
based on the application and interpretation of tax laws, but tax
accounting often involves complex matters and judgment is required
in determining the Corporation's foreign provisions for taxes and
other tax liabilities. There can be no assurance that a taxing
authority will not have a different interpretation of the law and
assess the Corporation, or the operations in which the Corporation
has interests, with additional taxes. Further, the Corporation's
future effective tax rates could be impacted by changes in tax laws
or regulations, and changing interpretation of existing laws or
regulations. Both domestic and international tax laws, and
interpretation of the tax laws, are subject to change as a result
of changes in fiscal policy, changes in legislation, evolution of
regulation and court rulings. The application of these tax laws and
related regulations is subject to legal and factual interpretation,
judgment and uncertainty.
Enforcement of Civil
Liabilities
Certain of the Corporation's
subsidiaries and assets are located outside of Canada. Accordingly,
it may be difficult for investors to enforce within Canada any
judgments obtained against the Corporation, including judgments
predicated upon the civil liability provisions of applicable
Canadian securities laws or otherwise. Consequently, investors may
be effectively prevented from pursuing remedies against the
Corporation under Canadian securities laws or otherwise.
The Corporation has subsidiaries
incorporated in the United States and Ireland. It may not be
possible for shareholders to effect service of process outside of
Canada against the directors and officers of the Corporation who
are not resident in Canada. In the event a judgment is obtained in
a Canadian court against one or more of such persons for violations
of Canadian securities laws or otherwise, it may not be possible to
enforce such judgment against persons not resident in Canada.
Additionally, it may be difficult for an investor, or any other
person or entity, to assert Canadian securities law or other claims
in original actions instituted in the United States and Ireland.
Courts in such jurisdictions may refuse to hear a claim based on a
violation of Canadian securities laws or otherwise on the grounds
that such jurisdiction is not the most appropriate forum to bring
such a claim. Even if a foreign court agrees to hear a claim, it
may determine that the local law, and not Canadian law, is
applicable to the claim. If Canadian law is found to be applicable,
the content of applicable Canadian law must be proven as a fact,
which can be a time consuming and costly process. Certain matters
of procedure will also be governed by foreign law. See the section
entitled "Enforcement of Civil Liabilities."
The Corporation expects to be
a "passive foreign investment company", which may have adverse U.S.
federal income tax consequences for U.S. investors
Based on current business plans and
financial expectations, the Corporation expects to be a PFIC for
its current tax year and may be a PFIC in future tax years. If the
Corporation is a PFIC for any year during a U.S. taxpayer's holding
period of Common Shares, then such U.S. taxpayer generally will be
required to treat any gain realized upon a disposition of the
Common Shares or any so-called excess "distribution" received on
its Common Shares as ordinary income, and to pay an interest charge
on a portion of such gain or distribution. In certain
circumstances, the sum of the tax and the interest charge may
exceed the total amount of proceeds realized on the disposition, or
the amount of excess distribution received, by the U.S. taxpayer.
Subject to certain limitations, these tax consequences may be
mitigated if a U.S. taxpayer makes a timely and effective QEF
Election (as defined below) or a Mark-to-Market Election (as
defined below). Subject to certain limitations, such elections may
be made with respect to the Common Shares. A U.S. taxpayer who
makes a timely and effective QEF Election generally must report on
a current basis its share of the Corporation's net capital gain and
ordinary earnings for any year in which the Corporation is a PFIC,
whether or not the Corporation distributes any amounts to its
shareholders. A U.S. taxpayer who makes the Mark-to-Market Election
generally must include as ordinary income each year the excess of
the fair market value of the Common Shares over the taxpayer's
basis therein. This paragraph is qualified in its entirety by the
discussion above under the heading "Certain United States
Federal Income Tax Considerations - Passive Foreign Investment
Company Rules." Each potential investor who is a U.S. taxpayer
should consult its own tax advisor regarding the tax consequences
of the PFIC rules and the acquisition, ownership, and disposition
of the Common Shares.
EXPERTS
The matters referred to under
"Certain Canadian Income Tax Considerations" and "Certain
United States Federal Income Tax Considerations", as well as
certain other legal matters relating to the issue and sale of the
Common Shares, will be passed upon on behalf of the Corporation by
Aird & Berlis LLP, with respect to Canadian legal matters, and
by Dorsey & Whitney LLP, with respect to United States legal
matters, and certain legal matters on behalf of the Agents by
Bennett Jones LLP, with respect to Canadian legal matters, and
Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, P.C., with respect
to United States legal matters.
As of the date of this Prospectus
Supplement, the partners and associates of Aird & Berlis LLP
and Bennett Jones LLP, beneficially owned, directly or indirectly,
less than 1% of the outstanding securities of the Corporation.
AUDITORS, TRANSFER AGENT AND
REGISTRAR
Zeifmans LLP, Chartered
Professional Accountants, are the auditors of the Corporation and
have confirmed that they are independent of the Corporation within
the meaning of the relevant rules and related interpretations
prescribed by the relevant professional bodies in Canada and any
applicable legislation or regulation. Neither Zeifmans LLP nor any
designated professional thereof, had any registered or beneficial
interest in any securities or other property of the Corporation at
the time they audited the relevant financial statements
incorporated by reference in this Prospectus Supplement or at any
time thereafter.
The registrar and transfer agent of
the Common Shares is Odyssey Trust Company at its principal office
in Calgary, Alberta.
EXEMPTIONS
Pursuant to a decision of the
Autorité des marchés financiers dated June 10, 2021, the
Corporation was granted a permanent exemption from the requirement
to translate into French this Prospectus Supplement, the Base Shelf
Prospectus as well as the documents incorporated by reference
herein and therein. The exemption was granted on the condition that
the Base Shelf Prospectus and any Prospectus Supplement (other than
in relation to an "at-the-market distribution") be translated into
French if the Corporation offers securities to Québec purchasers in
connection with an offering other than in relation to an
"at-the-market distribution".
ENFORCEMENT OF CIVIL
LIABILITIES
The Corporation is a corporation
existing under the Business Corporations Act (Ontario).
Other than Douglas Drysdale, Michael Palfreyman, Alex Nivorozhkin
and Brett Greene, all of the directors and officers, and all of the
experts named in this Prospectus Supplement or the accompanying
Base Shelf Prospectus, are residents of Canada or otherwise reside
outside the United States, and all or a substantial portion of
their assets, and a majority of the Corporation's assets, are
located outside the United States. The Corporation has appointed an
agent for service of process in the United States, but it may be
difficult for holders of the Common Shares who reside in the United
States to effect service within the United States upon those
directors, officers and experts who are not residents of the United
States. It may also be difficult for holders of the Common Shares
who reside in the United States to realize upon judgments of courts
of the United States predicated upon the Corporation's civil
liability and the civil liability of its directors, officers and
experts under the United States federal securities laws or the
securities or "Blue Sky" laws of any state within the United
States.
The Corporation has been advised by
its Canadian counsel, Aird & Berlis LLP, that there is doubt as
to the enforceability in Canada by a court in original actions, or
in actions to enforce judgments of United States courts, of civil
liabilities predicated solely upon United States federal securities
laws or any such state securities or "Blue Sky" laws of any state
within the United States.
The Corporation filed with the SEC,
concurrently with the Registration Statement, an appointment of
agent for service of process on Form F-X. Under the Form F-X, the
Corporation appointed C T Corporation System as the agent for
service of process in the United States in connection with any
investigation or administrative proceeding conducted by the SEC,
and any civil suit or action brought against or involving the
Corporation in a United States court arising out of, related to, or
concerning the offering of Common Shares under this Prospectus
Supplement and the accompanying Base Shelf Prospectus.
SHORT FORM BASE SHELF PROSPECTUS

CYBIN INC.
$125,000,000
Common Shares
Warrants
Units
Debt Securities
Subscription Receipts
This short form base shelf prospectus (“Prospectus”) relates
to the offering for sale from time to time (each, an
“Offering”) by Cybin Inc. (the “Corporation” or
“Cybin”) during the 25-month period that this Prospectus,
including any of amendments thereto, remains valid, of up to
$125,000,000 in the aggregate of: (i) common shares
(“Common Shares”) of the Corporation; (ii) warrants
(“Warrants”) to purchase other Securities (as defined below)
of the Corporation; (iii) units (“Units”) comprising of
one or more of the other Securities, (iv) senior and
subordinated unsecured debt securities (collectively, “Debt
Securities”), including debt securities convertible or
exchangeable into other securities of the Corporation, and
(v) subscription receipts (“Subscription Receipts” and
together with the Common Shares, Warrants, Units and Debt
Securities, collectively referred to herein as the
“Securities”). The Securities may be offered separately or
together, in amounts, at prices and on terms determined based on
market conditions at the time of the sale and as set forth in an
accompanying prospectus supplement (“Prospectus
Supplement”).
All shelf information permitted under applicable laws to be omitted
from this Prospectus will be contained in one or more Prospectus
Supplements that will be delivered to purchasers together with this
Prospectus, except in cases where an exemption from such delivery
requirements is available. Each Prospectus Supplement containing
the specific terms of any Securities will be incorporated by
reference into this Prospectus for the purposes of securities
legislation as of the date of the Prospectus Supplement and only
for the purposes of the distribution of the Securities to which the
Prospectus Supplement pertains.
The specific terms of any Securities offered will be described in a
Prospectus Supplement, including: (i) in the case of Common
Shares, the number of Common Shares offered, the offering price (in
the event the offering is a fixed price distribution), the manner
of determining the offering price(s) (in the event the offering is
a non-fixed price
distribution) and any other specific terms; (ii) in the case
of Warrants, the number of Warrants being offered, the offering
price (in the event the offering is a fixed price distribution),
the manner of determining the offering price(s) (in the event the
offering is a non-fixed
price distribution), the designation, number and terms of the other
Securities purchasable upon exercise of the Warrants, and any
procedures that will result in the adjustment of those numbers, the
exercise price, the dates and periods of exercise and any other
specific terms; (iii) in the case of Units, the number of
Units offered, the offering price, the designation, number and
terms of the other Securities comprising the Units, and any other
specific terms; (iv) in the case of Debt Securities, the
specific designation of the Debt Securities, whether such Debt
Securities are senior or subordinate, the aggregate principal
amount of the Debt Securities being offered, the currency or
currency unit in which the Debt Securities may be purchased,
authorized denominations, any limit on the aggregate principal
amount of the Debt Securities of the series being offered, the
issue and delivery date, the maturity date, the offering price (at
par, at a discount or at a premium), the interest rate or method of
determining the interest rate, the interest payment date(s), any
conversion or exchange rights that are attached to the Debt
Securities, any redemption provisions, any repayment provisions and
any other specific terms; and (v) in the case of Subscription
Receipts, the number of Subscription Receipts being offered, the
offering price (in the event the offering is a fixed price
distribution), the manner of determining the offering price(s) (in
the event the offering is a non-fixed price distribution), the
terms, conditions and procedures for the conversion of the
Subscription Receipts into other Securities, the designation,
number and terms of such other Securities, and any other specific
terms. A Prospectus Supplement relating to a particular Offering of
Securities may include terms pertaining to the Securities being
offered thereunder that are not within the terms and parameters
described in this Prospectus.
The Securities may be sold through underwriters or dealers,
directly by us pursuant to applicable statutory exemptions, or
through designated agents from time to time. See “Plan of
Distribution”. The Prospectus Supplement relating to a
particular Offering of Securities will identify each underwriter,
dealer or agent, as the case may be, engaged by the Corporation in
connection with the offering and sale of the Securities, and will
set forth the terms of the Offering of such Securities, including,
to the extent applicable, any fees, discounts or any other
compensation payable to underwriters, dealers or agents in
connection with the Offering, the method of distribution of the
Securities, the initial issue price (in the event that the offering
is a fixed price distribution), the net proceeds to us and any
other material terms of the plan of distribution.
The Securities may be sold from time to time in one or more
transactions at a fixed price or prices or at non-fixed prices. This Prospectus may
qualify an “at-the-market distribution”,
as defined in National Instrument 44-102 – Shelf Distributions
(“NI 44-102”). If
offered on a non-fixed
price basis, the Securities may be offered at market prices
prevailing at the time of sale, at prices determined by reference
to the prevailing price of a specified security in a specified
market or at prices to be negotiated with purchasers including
sales in transactions that are deemed to be “at-the-market distributions”,
including sales made directly on the Neo Exchange Inc. (the
“NEO”) or other existing trading markets for the Securities,
and as set forth in an accompanying Prospectus Supplement, in which
case the compensation payable to an underwriter, dealer or agent in
connection with any such sale will be decreased by the
amount, if any, by which the aggregate price paid for the
Securities by the purchasers is less than the gross proceeds paid
by the underwriter, dealer or agent to the Corporation. The price
at which the Securities will be offered and sold may vary from
purchaser to purchaser and during the period of distribution. See
“Plan of Distribution”.
This Prospectus does not qualify the issuance of Debt Securities in
respect of which the payment of principal and/or interest may be
determined, in whole or in part, by reference to one or more
underlying interests including, for example, an equity or debt
security, a statistical measure of economic or financial
performance including, but not limited to, any currency, consumer
price or mortgage index, or the price or value of one or more
commodities, indices or other items, or any other item or formula,
or any combination or basket of the foregoing items. For greater
certainty, this Prospectus may qualify for issuance Debt Securities
in respect of which the payment of principal and/or interest may be
determined, in whole or in part, by reference to published rates of
a central banking authority or one or more financial institutions,
such as a prime rate or bankers’ acceptance rate, or to recognized
market benchmark interest rates such as the London Inter-Bank
Offered Rate (LIBOR), Euro Inter-Bank Offered Rate (EURIBOR) or a
United States federal funds rate.
No underwriter or dealer involved in an “at-the-market distribution”
under this Prospectus, no affiliate of such an underwriter or
dealer and no person or company acting jointly or in concert with
such an underwriter or dealer will over-allot securities in
connection with such distribution or effect any other transactions
that are intended to stabilize or maintain the market price of the
offered Securities or securities of the same class as the
Securities distributed under the “at-the-market distribution”,
including selling an aggregate number or principal amount of
Securities that would result in the underwriter creating an
over-allocation position in the Securities.
In connection with any Offering of the Securities, subject to
applicable laws and other than an “at-the-market distribution”,
the underwriters or agents may over-allot or effect transactions
that stabilize or maintain the market price of the offered
Securities at a level above that which might otherwise prevail on
the open market. Such transactions, if commenced, may be
interrupted or discontinued at any time. See “Plan of
Distribution”.
The Common Shares are listed on the NEO under the trading symbol
“CYBN”, and in the United States on the OTCQB under the trading
symbol “CLXPF”. On July 2, 2021, the last trading day prior to
the filing of this Prospectus, the closing prices of the Common
Shares listed on the NEO and the OTCQB were $2.60 and US$2.12,
respectively.
Unless specified in the applicable Prospectus Supplement, there
is no market through which the Subscription Receipts, Warrants,
Units and Debt Securities may be sold and purchasers may not be
able to resell the Subscription Receipts, Warrants, Units and Debt
Securities purchased under this Prospectus and the Prospectus
Supplement. This may affect the pricing of the Subscription
Receipts, Warrants, Units and Debt Securities in the secondary
market, the transparency and availability of trading prices, the
liquidity of the Subscription Receipts, Warrants, Units and Debt
Securities and the extent of issuer regulation. See “Risk
Factors”.
Prospective investors should be aware that the purchase of
Securities may have tax consequences that may not be fully
described in this Prospectus or in any Prospectus Supplement, and
should carefully review the tax discussion, if any, in the
applicable Prospectus Supplement and in any event consult with a
tax advisor.
An investment in the Securities is subject to a number of risks,
including those risks described in this Prospectus and documents
incorporated by reference into this Prospectus. See “Risk
Factors” in this Prospectus and in the Corporation’s
Annual Information Form and Annual MD&A (each as defined
herein) incorporated by reference herein.
No person is authorized by the Corporation to provide any
information or to make any representation other than as contained
in this Prospectus in connection with the issue and sale of the
Securities offered hereunder.
No underwriter has been involved in the preparation of this
Prospectus or performed any review of the contents hereof.
Each of Douglas Drysdale, Michael Palfreyman, Alex Nivorozhkin and
Brett Green, officers of the Corporation, resides outside of
Canada. They have each appointed Maxims CS Inc., Suite 1800, 181
Bay Street, Toronto, Ontario, M5J 2T9, as agent for service of
process in Ontario. Prospective purchasers are advised that it may
not be possible for investors to enforce judgments obtained in
Canada against any person or company that is incorporated,
continued or otherwise organized under the laws of a foreign
jurisdiction or resides outside of Canada, even if the party has
appointed an agent for service of process, see “Risk
Factors – Risks Related to an Offering – Enforcement of Civil
Liabilities”.
In this Prospectus, references to the “Corporation”,
“Cybin”, “we”, “us” and “our” refer to
Cybin Inc. and/or, as applicable, one or more of its subsidiaries.
The Corporation’s registered and head office is located at 100 King
Street West, Suite 5600, Toronto, Ontario M5X 1C9.
The Corporation currently has two business segments:
(a) Serenity Life Sciences Inc. (“Serenity Life”) and Cybin US
Holdings Inc. (“Cybin U.S.”) that focus on the research,
development and commercialization of psychedelic-inspired regulated
medicines; and (b) Natures Journey Inc. (“Natures Journey”)
that focuses on consumer mental wellness, including, but not
limited to, non-psychedelic mushroom
nutraceutical products. Like most life sciences and pharmaceutical
companies, Serenity Life’s and Cybin U.S.’s (psychedelic) business
is focused on research and development, see “Use of
Proceeds”. Currently the Corporation plans to conduct
research and development on synthesized API from pharmaceutical
manufacturers in Jamaica. No product will be commercialized prior
to applicable legal or regulatory approval.
The Canadian and United States federal governments regulate
drugs through the Controlled Drugs and Substances
Act (Canada) (the “CDSA”) and the Controlled
Substances Act (21 U.S.C. § 811) (the “CSA”),
respectively, which place controlled substances in a schedule.
Under the CDSA, psilocybin is currently a Schedule III drug. Under
the CSA, psilocybin is currently a Schedule I drug.
Unlike in Canada and the United States, psilocybin mushrooms are
not an illegal drug under Jamaica’s Dangerous Drugs Act,
1948. The Corporation’s activity in relation to the
sponsored research of psilocybin mushrooms, botanicals and other
related fungi is limited to the jurisdiction of Jamaica. The
Corporation’s future business activities in Jamaica involve the
import of psychedelic and pharmaceutical based medicines (derived
from mushrooms) for the purposes of research and development and
clinical trials in Jamaica.
ii
In both Canada and the United States, the applicable federal
government is responsible for regulating, among other things, the
approval, import, sale and marketing of drugs, including any
psychedelic substances, whether natural or novel. Health Canada,
and the Food and Drug Administration (“FDA”) in the United States,
have not approved psilocybin as a drug for any indication. It is
illegal to possess such substances without a prescription. The
Corporation does not directly engage in any activities that would
trigger the need to comply with any federal laws related to
psychedelic substances. See “Regulatory Overview –
Research and Development”.
The Corporation does not deal with psychedelic substances except
in jurisdictions where such activity is not illegal and then only
within laboratory and clinical trial settings conducted within
approved regulatory frameworks. The Corporation initially intends
to sponsor and work with licensed third parties in Jamaica to
conduct any clinical trials and research relating to psychedelics
and currently does not handle controlled or restricted substances
under the CDSA or CSA. If the Corporation were to conduct this work
without reliance on third parties, it would need to obtain the
required licenses, approvals and authorizations from Health Canada,
the FDA or other applicable regulatory bodies. The Corporation does
not have any direct or indirect involvement with illegal selling,
production or distribution of any substances in jurisdictions in
which it operates.
Natural health products (“NHPs”), prescription drugs, and
non-prescription drugs
are all classified and regulated under the federal Food
and Drugs Act (Canada) (the “Canadian FDA”). Labelling,
marketing and selling of any NHPs must comply with the Canadian
FDA, including by ensuring that the Corporation’s products are not
packaged or marketed in a manner that is misleading or deceptive to
a consumer. In the United States, foods, drugs and dietary
supplements are subject to extensive regulation. The
Federal Food, Drug, and Cosmetic Act and the
Dietary Supplement Health and Education Act of 1994
generally govern, among other things, the research, development,
testing, manufacturing, storage, recordkeeping, approval, labeling,
promotion and marketing, distribution, post-approval monitoring and
reporting, sampling, and import and export of foods, drugs and
dietary supplements. See “Regulatory Overview – United
States”.
The Corporation’s operations are conducted in strict compliance
with local laws where such activities are permissible and do not
require any specific legal or regulatory approvals.
Given the early stage of its prescription drug product
development, the Corporation can make no assurance that its
research and development program will result in regulatory approval
or commercially viable products. To achieve profitable operations,
the Corporation, alone or with others, must successfully develop,
gain regulatory approval for, and market its future products. The
Corporation currently has no products that have been approved by
Health Canada, the Ministry of Health (Jamaica), the FDA, or any
similar regulatory authority. To obtain regulatory approvals for
its prescription drug product candidates being developed and to
achieve commercial success, clinical trials must demonstrate that
the prescription drug product candidate are safe for human use and
that they demonstrate efficacy. See “Risk
Factors” herein and “Risk Factors”
in the Annual Information Form.
Certain statements throughout this Prospectus regarding
psilocybin, psychedelic tryptamine, tryptamine derivatives or other
psychedelic compounds, nutraceutical products or functional
mushrooms have not been evaluated by Health Canada, the FDA or
other similar regulatory authorities, nor has the efficacy of
psilocybin, psychedelic tryptamine, tryptamine derivatives or other
psychedelic compounds, nutraceutical products or functional
mushrooms been confirmed by approved research. There is no
assurance that psilocybin, psychedelic tryptamine, tryptamine
derivatives or other psychedelic compounds, nutraceutical products
or functional mushrooms can be used to diagnose, treat, cure or
prevent any disease or condition and robust scientific research and
clinical trials are needed. There are multiple risk factors
regarding the ability to successfully commercially scale a
chemically synthesized process to obtain psilocybin and other
analogues, including, but not limited to, regulatory changes or
other changes in law, and risks related to drug development.
See “Risk Factors” herein and “Risk
Factors” in the Annual Information Form.
The Corporation oversees and monitors compliance with applicable
laws in each jurisdiction in which it operates. In addition to the
Corporation’s senior executives and the employees responsible for
overseeing compliance, the Corporation has local
regulatory/compliance counsel engaged in every jurisdiction in
which it operates. See “Compliance Program”.
Additionally, the Corporation has received legal opinions or advice
in each jurisdiction where it currently operates regarding
(a) compliance with applicable regulatory frameworks and
(b) potential exposure and implications arising from
applicable laws in jurisdictions where the Corporation has
operations or intends to operate.
For these reasons, the Corporation may be (a) subject to
heightened scrutiny by regulators, stock exchanges, clearing
agencies and other authorities, (b) susceptible to regulatory
changes or other changes in law, and (c) subject to risks
related to drug development, among other things. There are a number
of risks associated with the business of the Corporation. See
“Risk Factors” herein and “Risk
Factors” in the Annual Information Form.
An investment in the Securities is highly speculative and
involves a high degree of risk that should be considered by
potential purchasers. An investment in the Securities is suitable
only for those purchasers who are willing to risk a loss of some or
all of their investment and who can afford to lose some or all of
their investment. A prospective purchaser should therefore review
this Prospectus and the documents incorporated by reference herein
in their entirety, including the Annual Information Form, and
carefully consider the risk factors described under the section
“Risk Factors” in this Prospectus, prior to
investing in the Securities. See “Cautionary Note
Regarding Forward-Looking Information” and
“Risk Factors”.
iii
GENERAL MATTERS
Investors should rely only on the information contained in or
incorporated by reference into this Prospectus or any applicable
Prospectus Supplement. The Corporation has not authorized anyone to
provide investors with different information. Information
contained on the Corporation’s website shall not be deemed to be a
part of this Prospectus or incorporated by reference herein or in
any applicable Prospectus Supplement and may not be relied upon by
prospective investors for the purpose of determining whether to
invest in the Securities qualified for distribution under this
Prospectus. The Corporation is not making an offer of these
Securities in any jurisdiction where the offer is not permitted.
Investors should not assume that the information contained in this
Prospectus is accurate as of any date other than the date on the
front of this Prospectus or the date of the relevant document
incorporated by reference. The Corporation’s business, operating
results, financial condition and prospects may have changed since
that date.
The information contained on www.cybin.com is not intended to be
included in or incorporated by reference herein, and prospective
purchasers should not rely on such information when deciding
whether or not to invest in any Securities.
In this Prospectus, unless stated otherwise or the context requires
otherwise, all dollar amounts are expressed in Canadian
dollars.
CAUTIONARY NOTE
REGARDING FORWARD-LOOKING INFORMATION
Certain statements contained in this Prospectus, and in certain
documents incorporated by reference in this Prospectus, constitute
“forward-looking information” and “forward-looking statements”. All
statements other than statements of historical fact contained in
this Prospectus and in documents incorporated by reference in this
Prospectus, including, without limitation, those regarding the
Corporation’s future financial position and results of operations,
strategy, plans, objectives, goals and targets, future developments
in the markets where the Corporation participates or is seeking to
participate, and any statements preceded by, followed by or that
include the words “believe”, “expect”, “aim”, “intend”, “plan”,
“continue”, “will”, “may”, “would”, “anticipate”, “estimate”,
“forecast”, “predict”, “project”, “seek”, “should”, “objective”,
“assumes” or similar expressions or the negative thereof, are
forward-looking statements.
These statements are not historical facts but instead represent
only the Corporation’s expectations, estimates and projections
regarding future events. These statements are not guarantees of
future performance and involve assumptions, risks and uncertainties
that are difficult to predict. Therefore, actual results may differ
materially from what is expressed, implied or forecasted in such
forward-looking statements. Additional factors that could cause
actual results, performance or achievements to differ materially
include, but are not limited to, those discussed under “Risk
Factors” in the Annual Information Form and in this Prospectus
and in other documents incorporated by reference in this
Prospectus. Management provides forward-looking statements because
it believes they provide useful information to readers when
considering their investment objectives and cautions readers that
the information may not be appropriate for other purposes.
Consequently, all of the forward-looking statements made in this
Prospectus and in documents incorporated by reference in this
Prospectus are qualified by these cautionary statements and other
cautionary statements or factors contained herein, and there can be
no assurance that the actual results or developments will be
realized or, even if substantially realized, that they will have
the expected consequences to, or effects on, the Corporation. These
forward-looking statements are made as of the date of this
Prospectus and the Corporation assumes no obligation to update or
revise them to reflect subsequent information, events or
circumstances or otherwise, except as required by law.
The forward-looking statements in this Prospectus and in documents
incorporated by reference in this Prospectus are based on numerous
assumptions regarding the Corporation’s present and future business
strategies and the environment in which the Corporation will
operate in the future, including assumptions regarding business and
operating strategies, and the Corporation’s ability to operate on a
profitable basis.
1
Some of the risks which could affect future results and could cause
results to differ materially from those expressed in the
forward-looking statements contained herein include: novel
coronavirus “COVID-19”;
limited operating history; achieving publicly announced milestones;
speculative nature of investment risk; early stage of the industry
and product development; regulatory risks and uncertainties;
Jamaican operations; emerging market risk; plans for growth;
limited products; limited marketing and sales capabilities; no
assurance of commercial success; no profits or significant
revenues; reliance on third parties for clinical development
activities; risks related to third party relationships; reliance on
contract manufacturers; safety and efficacy of products; clinical
testing and commercializing products; completion of clinical
trials; commercial grade product manufacturing; nature of
regulatory approvals; unfavourable publicity or consumer
perception; social media; biotechnology and pharmaceutical market
competition; reliance on key executives and scientists; employee
misconduct; business expansion and growth; negative results of
external clinical trials or studies; product liability; enforcing
contracts; product recalls; distribution and supply chain
interruption; difficulty to forecast; promoting the brand; product
viability; success of quality control systems; reliance on key
inputs; liability arising from fraudulent or illegal activity;
operating risk and insurance coverage; costs of operating as public
company; management of growth; conflicts of interest; foreign
operations; cybersecurity and privacy risk; environmental
regulation and risks; Risks Related to Intellectual Property:
trademark protection; trade secrets; patent law reform; patent
litigation and intellectual property; protection of intellectual
property; third-party licences; Financial and Accounting Risks:
substantial number of authorized but unissued common shares;
dilution; negative cash flow from operating activities; additional
capital requirements; lack of significant product revenue;
estimates or judgments relating to critical accounting policies;
Risks related to the Common Shares: market for the Common Shares;
significant sales of Common Shares; volatile market price for the
Common Shares; tax issues; no dividends; Risks related to an
Offering and the Corporation: an investment in the Securities is
speculative; completion of an Offering; receipt of all regulatory
and stock exchange approvals in respect of an Offering;
forward-looking statements may prove to be inaccurate; potential
dilution; potential need for additional financing; negative
operating cash flow and going concern; discretion over the use of
proceeds; management of growth; the Common Shares are subject to
market price volatility; no history of payment of cash dividends;
limited operating history as a public company; and risks relating
to research and development objectives and milestones.
Although the forward-looking statements contained in this
Prospectus are based upon what management currently believes to be
reasonable assumptions, the Corporation cannot assure prospective
investors that actual results, performance or achievements will be
consistent with these forward-looking statements. In particular,
the Corporation has made assumptions regarding, among other
things:
|
• |
|
substantial fluctuation of losses from quarter to quarter and year
to year due to numerous external risk factors, and anticipation
that we will continue to incur significant losses in the
future;
|
|
• |
|
uncertainty as to the Corporation’s ability to raise additional
funding to support operations;
|
|
• |
|
the Corporation’s ability to access additional funding;
|
|
• |
|
the fluctuation of foreign exchange rates;
|
|
• |
|
the duration of COVID-19
and the extent of its economic and social impact;
|
|
• |
|
the risks associated with the development of the Corporation’s
product candidates which are at early stages of development;
|
|
• |
|
reliance upon industry publications as the Corporation’s primary
sources for third-party industry data and forecasts;
|
|
• |
|
reliance on third parties to plan, conduct and monitor the
Corporation’s preclinical studies and clinical trials;
|
|
• |
|
reliance on third party contract manufacturers to deliver quality
clinical and preclinical materials;
|
|
• |
|
the Corporation’s product candidates may fail to demonstrate safety
and efficacy to the satisfaction of regulatory authorities or may
not otherwise produce positive results;
|
2
|
• |
|
risks related to filing investigational new drug applications to
commence clinical trials and to continue clinical trials if
approved;
|
|
• |
|
the risks of delays and inability to complete clinical trials due
to difficulties enrolling patients;
|
|
• |
|
competition from other biotechnology and pharmaceutical
companies;
|
|
• |
|
the Corporation’s reliance on the capabilities and experience of
the Corporation’s key executives and scientists and the resulting
loss of any of these individuals;
|
|
• |
|
the Corporation’s ability to fully realize the benefits of
acquisitions;
|
|
• |
|
the Corporation’s ability to adequately protect the Corporation’s
intellectual property and trade secrets;
|
|
• |
|
the risk of patent-related or other litigation; and
|
|
• |
|
the risk of unforeseen changes to the laws or regulations in the
United States, Jamaica and Canada and other jurisdictions in which
the Corporation operates.
|
Drug development involves long lead times, is very expensive and
involves many variables of uncertainty. Anticipated timelines
regarding drug development are based on reasonable assumptions
informed by current knowledge and information available to the
Corporation. Every patient treated on future studies can change
those assumptions either positively (to indicate a faster timeline
to new drug applications and other approvals) or negatively (to
indicate a slower timeline to new drug applications and other
approvals). This Prospectus and the documents incorporated by
reference herein contain certain forward-looking statements
regarding anticipated or possible drug development timelines. Such
statements are informed by, among other things, regulatory
guidelines for developing a drug with safety studies, proof of
concept studies, and pivotal studies for new drug application
submission and approval, and assumes the success of implementation
and results of such studies on timelines indicated as possible by
such guidelines, other industry examples, and the Corporation’s
development efforts to date.
In addition to the factors set out above and those identified under
the heading “Risk Factors” in the Annual Information Form
and in this Prospectus, other factors not currently viewed as
material could cause actual results to differ materially from those
described in the forward-looking statements. Although the
Corporation has attempted to identify important risks and factors
that could cause actual actions, events or results to differ
materially from those described in forward-looking statements,
there may be other factors and risks that cause actions, events or
results not to be anticipated, estimated or intended. Accordingly,
readers should not place any undue reliance on forward-looking
statements.
Many of these factors are beyond the Corporation’s
ability to control or predict. These factors are not intended to
represent a complete list of the general or specific factors that
may affect the Corporation. The Corporation may note additional
factors elsewhere in this Prospectus and in any documents
incorporated by reference into this Prospectus. All forward-looking
statements speak only as of the date made. All subsequent written
and oral forward-looking statements attributable to the
Corporation, or persons acting on the Corporation’s behalf,
are expressly qualified in their entirety by the cautionary
statements. Except as required by law, the Corporation undertakes
no obligation to update any forward-looking statement.
The forward-looking statements contained in this Prospectus and
the documents incorporated by reference herein are expressly
qualified in their entirety by the foregoing cautionary
statement. Investors should read this entire Prospectus,
including the Annual Information Form, the documents incorporated
by reference herein, and each applicable Prospectus Supplement, and
consult their own professional advisers to ascertain and assess the
income tax and legal risks and other aspects associated with
holding Securities.
3
EXEMPTION
Pursuant to a decision of the Autorité des marchés financiers dated
June 10, 2021, the Corporation was granted a permanent
exemption from the requirement to translate into French this
Prospectus as well as the documents incorporated by reference
therein and any Prospectus Supplement to be filed in relation to an
“at-the-market distribution”.
This exemption is granted on the condition that this Prospectus and
any Prospectus Supplement (other than in relation to an
“at-the-market distribution”)
be translated into French if the Corporation offers Securities to
Québec purchasers in connection with an Offering of Securities
other than in relation to an “at-the-market
distribution”.
TRADEMARKS AND SERVICE
MARKS
This prospectus includes trademarks, trade names and service marks
which are protected under applicable intellectual property laws for
use in connection with the operation of our business, and which are
the property of the Corporation. All other trade names, trademarks
or service marks appearing in this prospectus that are not
identified as marks owned by us are the property of their
respective owners. Solely for convenience, trademarks, service
marks and trade names referred to in this prospectus may be listed
without the ®, (TM) and (sm)
symbols, however, we will assert, to the fullest extent under
applicable law, our applicable rights in these trademarks, service
marks and trade names.
MARKETING
MATERIALS
Any template version of marketing materials (as such terms are
defined in National Instrument 41-101 – General Prospectus
Requirements) that are utilized in connection with the
distribution of Securities will be filed under the Corporation’s
profile on www.sedar.com (SEDAR). In the event that such marketing
materials are filed after the date of the applicable Prospectus
Supplement for the offering and before termination of the
distribution of such Securities, such filed versions of the
marketing materials will be deemed to be incorporated by reference
into the applicable Prospectus Supplement for the purposes of the
distribution of the Securities to which the Prospectus Supplement
pertains.
MARKET AND INDUSTRY
DATA
Market and industry data contained and incorporated by reference in
this Prospectus or any applicable Prospectus Supplement concerning
economic and industry trends is based upon good faith estimates of
our management or derived from information provided by industry
sources. The Corporation believes that such market and industry
data is accurate and that the sources from which it has been
obtained are reliable. However, we cannot guarantee the accuracy of
such information and we have not independently verified the
assumptions upon which projections of future trends are based.
While the Corporation is not aware of any misstatements regarding
the industry data presented herein, the Corporation’s estimates
involve risks and uncertainties and are subject to change based on
various factors, including those discussed under “Cautionary
Note Regarding Forward-Looking Information” and “Risk
Factors” in this Prospectus.
4
DOCUMENTS INCORPORATED
BY REFERENCE
Information has been incorporated by reference in this
Prospectus from documents filed with securities commissions or
similar authorities in Canada. Copies of the documents
incorporated herein by reference may be obtained on request without
charge from the Secretary of the Corporation at 100 King Street
West, Suite 5600, Toronto, Ontario M5X 1C9, telephone (908)
764-8385, and are also
available electronically on SEDAR.
The following documents of the Corporation filed with the
securities commissions or similar authorities in Canada are
incorporated by reference in this Prospectus:
Any document of the type referred to in Section 11.1 of Form
44-101F1 – Short Form
Prospectus Distributions filed by the Corporation with a
securities commission or similar regulatory authority in Canada
after the date of this Prospectus and prior to 25 months from the
date hereof shall be deemed to be incorporated by reference in this
Prospectus.
Any statement contained in this Prospectus or in a document
incorporated or deemed to be incorporated by reference in this
Prospectus shall be deemed to be modified or superseded for the
purposes of this Prospectus to the extent that a statement
contained herein or in any subsequently filed document which also
is or is deemed to be incorporated by reference in this Prospectus
modifies or supersedes that statement. Any statement so modified or
superseded shall not constitute a part of this Prospectus except as
so modified or superseded. The modifying or superseding statement
need not state that it has modified or superseded a prior statement
or include any information set forth in the document that it
modifies or supersedes. The making of a modifying or superseding
statement shall not be deemed an admission for any purposes that
the modified or superseded statement, when made, constituted a
misrepresentation, an untrue statement of a material fact or an
omission to state a material fact that is required to be stated or
that is necessary to make a statement not misleading in light of
the circumstances in which it was made.
Upon filing of a new annual information form and related annual
financial statements with, and where required, accepted by, the
applicable securities regulatory authorities during the currency of
this Prospectus, the previous annual information form, including
all amendments thereto, the previous annual financial statements
and all interim financial statements (including any interim period
management’s discussion and analysis related thereto), material
change reports and management information circulars filed prior to
the commencement of the fiscal year in which the new annual
information form is filed, shall be deemed no longer to be
incorporated into this Prospectus for purposes of future offers and
sales of Securities hereunder.
A Prospectus Supplement containing the specific terms of any
Securities offered thereunder will be delivered to purchasers of
such Securities together with this Prospectus to the extent
required under applicable securities laws and will be deemed to be
incorporated by reference into this Prospectus as of the date of
such Prospectus Supplement solely for the purposes of the
Securities offered hereunder and thereunder.
5
THE CORPORATION
This summary does not contain all the information that may be
important to you in deciding whether to invest in the Securities.
You should read the entire Prospectus, including the section
entitled “Risk Factors”, the applicable Prospectus Supplement, and
the documents incorporated by reference herein, including the
Annual Information Form, before making such decision.
Summary of the Business
The Corporation is a biotechnology company focused on advancing
pharmaceutical therapies, delivery mechanisms, novel compounds and
protocols as potential therapies for various psychiatric and
neurological conditions. The Corporation is developing technologies
and delivery systems aiming to improve the pharmacokinetics of its
psychedelic molecules while retaining the therapeutics benefit. The
new molecules and delivery systems are expected to be studied
through clinical trials to confirm safety and efficacy.
The Corporation believes that there is presently a sizeable legal
market for psychedelic pharmaceutical and nutraceutical products
and, further, believes that there is a promising prospect for a
strong, legal psychedelic pharmaceutical and nutraceutical industry
to emerge globally. In particular, although the legal market for
psychedelic pharmaceutical products is presently limited, globally,
and in some jurisdictions it is still in its early stages, the
Corporation believes that , in time, owing to generally increased
acceptance and regulation of psychedelic-based treatments, this
will give way to the emergence of numerous and sizable
opportunities for market participants, including the
Corporation.
Psychedelics are progressively emerging as potential alternative
candidates for conventional therapies for individuals suffering
from elusive maladies like post-traumatic stress disorder
(“PTSD”), addiction, anxiety, and depression.1 For example, in
August of 2020, as a result of the efforts of TheraPsil, a
non-profit coalition that
advocates for a legal, Special Access Programme access to
psilocybin therapy for palliative care of Canadians, four Canadians
with incurable cancer were approved by the Canadian federal
Minister of Health, to use psilocybin therapy in the treatment of
their end-of-life
distress.2
As of the date of this Prospectus, certain synthetic psychoactive
tryptamines and phenthylamines are being researched as candidates
for the treatment of several psychiatric conditions, such as PTSD
and depression.3 In 2018 and 2019,
for example, the FDA granted breakthrough therapy designation for
psilocybin for use as a candidate in the treatment of Major
Depressive Disorder (“MDD”).4 At present,
treatments for such conditions are limited in effectiveness, with
some traditional treatment methods posing a heightened risk of
complications. By contrast, the Corporation expects that
psychoactive compounds, such as psilocybin, may in time also emerge
as a safer and healthier medical treatment alternative for various
ailments.
1 |
https://www.baystreet.ca/stockstowatch/7145/Magic-Mushroom-Market-Set-to-Grow-10-Feet-Tall.
|
2 |
https://www.forbes.com/sites/davidcarpenter/2020/08/08/four-terminally-ill-canadians-gain-legal-right-to-use-magic-mushrooms-for-end-of-life-distress/#3194f50a2bdf.
|
3 |
https://www.healtheuropa.eu/worlds-first-magic-mushroom-nasal-spray-for-ptsd-and-depression/95434/.
|
4 |
https://www.biopharmaglobal.com/2019/11/26/usona-institute-receives-fda-breakthrough-therapy-designation-for-psilocybin-for-the-treatment-of-major-depressive-disorder/.
|
6
The Corporation’s target market is focused on psychedelic
pharmaceutical and non-psychedelic products. The
Corporation views its synthetic psychedelic substances as boosters
for the brain that can potentially rebuild pathways and break
negative patterns all while looking at non-psychedelic medical extracts as
the next wave of nutraceuticals that can potentially optimize
overall health.5
The Corporation currently has two business segments:
(a) Serenity Life and Cybin U.S. that focus on the research
and development of psychedelic pharmaceutical products; and
(b) Natures Journey that focuses on consumer mental wellness,
including non-psychedelic
nutraceutical products.
For additional information in respect of the Corporation and its
operation, please see the Corporation’s Annual Information Form
incorporated by reference into this Prospectus.
Inter-Corporate Relationships
As at the date of this Prospectus, the Corporation’s corporate
structure includes the following material wholly-owned
subsidiaries:

Note: (1) The Adelia Shareholders (defined below) hold certain
non-voting securities of
Cybin US, see “Select Recent Developments” below.
5 |
Certain statements regarding psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds,
nutraceutical products or functional mushrooms have not been
evaluated by Health Canada, the FDA or other similar regulatory
authorities, nor has the efficacy of psilocybin, psychedelic
tryptamine, tryptamine derivatives or other psychedelic compounds,
nutraceutical products or functional mushrooms been confirmed by
approved research. There is no assurance that psilocybin,
psychedelic tryptamine, tryptamine derivatives or other psychedelic
compounds, nutraceutical products or functional mushrooms can be
used to diagnose, treat, cure or prevent any disease or condition
and robust scientific research and clinical trials are needed.
There are multiple risk factors regarding the ability to
successfully commercially scale a chemically synthesized process to
obtain psilocybin and other analogues.
|
7
COVID-19
Pandemic
On March 11, 2020, the World Health Organization declared the
outbreak of COVID-19 a
pandemic. Since the outbreak of COVID-19, the Corporation has focused
its efforts on safeguarding the health and well-being of its
employees, consultants and community members. To help slow the
spread of COVID-19, the
Corporation’s employees have been working remotely, where possible,
and abiding by local and national guidance put in place in Canada,
the United States, and Jamaica related to social distancing and
restrictions on travel outside of the home. The Corporation has and
will continue to abide by the protocols within Canada, the United
States, and Jamaica regarding the performance of work activities.
The duration and the immediate and eventual impact of the
COVID-19 pandemic remains
unknown. In particular, it is not possible to reliably estimate the
length and severity of these developments and the impact on the
financial results and condition of the Corporation. To date, a
number of businesses have suspended or scaled back their operations
and development as cases of COVID-19 have been confirmed, for
precautionary purposes or as governments have declared a state of
emergency or taken other actions. In the event that the operations
or development of the Corporation are suspended or scaled back, or
if the Corporation’s supply chains are disrupted, such events may
have a material adverse effect on the Corporation. The breadth of
the impact of the COVID-19 pandemic on investors,
businesses, the global economy and financial and commodity markets
may also have a material adverse effect on the Corporation.
For additional information see “Risk Factors – Risks Related to
the Business of the Corporation – Novel Coronavirus COVID-19”.
Select Recent Developments
On December 4, 2020, the Corporation entered into a
contribution agreement (the “Contribution Agreement”) with
Cybin Corp., Cybin U.S. and all of the shareholders (the “Adelia
Shareholders”) of Adelia Therapeutics Inc. (“Adelia”)
whereby Cybin U.S. agreed to purchase from the Adelia Shareholders
all of the issued and outstanding Adelia shares in exchange for the
Class B Shares. The Adelia Transaction closed on
December 14, 2020.
Pursuant to the Contribution Agreement and the support agreement
entered into among Cybin U.S. and the Adelia Shareholders (the
“Support Agreement”), the Adelia Shareholders received
non-voting Class B
common shares in the capital of Cybin U.S. (each a
“Class B Share”), which are exchangeable for
Common Shares, on a 10 Common Shares for 1 Class B Share
basis, at the option of the holder thereof, subject to customary
adjustments. The Class B Shares issued to the Adelia
Shareholders on the closing of the Adelia Transaction are
exchangeable for a total of 8,688,330 Common Shares. The aggregate
value of the Class B Shares to be issued to the Adelia
Shareholders on the closing of the Adelia Transaction was
$10,773,529.50.
Under the Contribution Agreement, the Adelia Shareholders are also
entitled to Class B Shares upon the occurrence of certain
milestones as set out in the Contribution Agreement, which are also
exchangeable for Common Shares on a 10 Common Shares for 1
Class B Share basis. The total value of the Class B
Shares issuable pursuant to the milestones is up to $9,388,045.50
assuming all milestones are met prior to the applicable deadlines.
In March, 2021, pursuant to the terms of the Contribution
Agreement, an aggregate of 42,247.3 Class B Shares were issued
to the Adelia Shareholders in satisfaction of $686,306.31 due to
them upon meeting the certain relevant milestone.
No Class B Shares are exchangeable prior to the first
anniversary of closing of the Adelia Transaction, and not more
than: (i) 33 1/3% of the Class B Shares will be exchangeable
prior to the second anniversary of the Adelia Transaction; (ii) 66
2/3% of the Class B Shares will be exchangeable prior to the
third anniversary of the Adelia Transaction; and
(iii) thereafter, 100% of the Class B Shares will be
exchangeable. The Class B Shares issued to the Adelia
Shareholders are exchangeable for a total of 511,631 Common Shares,
resulting in an effective issue price of $1.99 per Common
Share.
8
REGULATORY
OVERVIEW
A summary of the applicable regulatory framework for the
Corporation’s various business segments and proposed business
activity are set forth below.
|
|
|
|
|
Business Segment
|
|
Current/Proposed
Location of Operation
|
|
Summary of Applicable Regulatory Frameworks
|
Serenity Life & Cybin
U.S.(1) |
|
Canada, United
Kingdom, United States & Jamaica |
|
The Canadian and United States federal governments regulate drugs
through the CDSA and the CSA, respectively, which place controlled
substances in a schedule.(2)
Under the CDSA, psilocybin is currently a Schedule III
drug.(3)
Under the CSA, psilocybin is currently a Schedule I
drug.(4)
Misuse of Drugs Regulations 2001 and the Misuse of Drugs
Regulations 2001
|
|
|
|
Natures Journey(5) |
|
Canada and the
United States |
|
Food and Drugs Act (Canada)
Dietary Supplement Health and Education Act of 1994
The Federal Food, Drug, and Cosmetic Act
|
|
|
|
Jamaica Research &
Development |
|
Jamaica |
|
Psilocybin mushrooms are not an illegal drug under Jamaica’s
Dangerous Drugs Act, 1948.(6)
The Corporation’s activity in relation to the sponsored research of
psilocybin mushrooms, botanicals and other related fungi is limited
to the jurisdiction of Jamaica.
|
Notes:
(1) |
Business segment focuses on the research, development and
commercialization of psychedelic-inspired regulation medicines.
|
(2) |
In both Canada and the United States, the applicable federal
government is responsible for regulating, among other things, the
approval, import, sale and marketing of drugs, including any
psychedelic substances, whether natural or novel. Health Canada and
the FDA have not approved psilocybin as a drug for any indication.
It is illegal to possess such substances without a prescription.
The Corporation does not directly engage in any activities that
would trigger the need to comply with any federal laws related to
psychedelic substances. See “Regulatory Overview – Research and
Development”.
|
(3) |
For further information on the Canadian regulatory framework, see
“Regulatory Overview – Canada – Psychedelics.”
|
(4) |
For further information on the United States regulatory framework,
see “Regulatory Overview – United States.”
|
(5) |
Business segment focuses on consumer mental wellness, including
non-psychedelic mushroom
nutraceutical products.
|
(6) |
Psilocybin mushrooms do not fall within the definition of a
dangerous drug under the Dangerous Drugs Act, 1948 in
Jamaica. For further information on the Jamaica regulatory
framework, see “Regulatory Overview – Jamaica.”
|
9
Canada
Psychedelics
In Canada, oversight of healthcare is divided between the federal
and provincial governments. The federal government is responsible
for regulating, among other things, the approval, import, sale, and
marketing of drugs such as psilocybin and other psychedelic
substances, whether natural or novel. The provincial/territorial
level of government has authority over the delivery of health care
services, including regulating health facilities, administering
health insurance plans such as the Ontario Health Insurance Plan,
distributing prescription drugs within the province, and regulating
health professionals such as doctors, psychologists,
psychotherapists and nurse practitioners. Regulation is generally
overseen by various colleges formed for that purpose, such as the
College of Physicians and Surgeons of Ontario.
Certain psychoactive compounds, such as psilocybin, are considered
controlled substances under Schedule III of the CDSA. In order to
conduct any scientific research, including pre-clinical and clinical trials,
using psychoactive compounds listed as controlled substances under
the CDSA, an exemption under Section 56 of the CDSA
(“Section 56 Exemption”) is required.
This exemption allows the holder to possess and use the controlled
substance without being subject to the restrictions set out in the
CDSA. The Corporation has not applied for a Section 56
Exemption from Health Canada.
The possession, sale or distribution of controlled substances is
prohibited unless specifically permitted by the government. A party
may seek government approval for a Section 56 Exemption to
allow for the possession, transport or production of a controlled
substance for medical or scientific purposes. Products that contain
a controlled substance such as psilocybin cannot be made,
transported or sold without proper authorization from the
government. A party can apply for a Dealer’s Licence under the Food
and Drug Regulations (Part J). In order to qualify as a licensed
dealer, a party must meet all regulatory requirements mandated by
the regulations including having compliant facilities, compliant
materials and staff that meet the qualifications under the
regulations of a senior person in charge and a qualified person in
charge. Assuming compliance with all relevant laws (Controlled
Drugs and Substances Act, Food and Drugs Regulations)
and subject to any restrictions placed on the licence by Health
Canada, an entity with a Dealer’s Licence may produce, assemble,
sell, provide, transport, send, deliver, import or export a
restricted drug (as listed in Part J in the Food and Drugs
Regulations – which includes psilocybin and psilocin) (see s.
J.01.009 (1) of the Food and Drug Regulations).
The Corporation intends to sponsor and work with licensed third
parties to conduct any clinical trials and research and does not
handle controlled substances. If the Corporation were to conduct
this work without the reliance on third parties, it would need to
obtain additional licences and approvals described above.
Non-Psychedelics
NHPs, prescription drugs, and non-prescription drugs are all
classified and regulated under the Canadian FDA.
The product safety, quality, manufacturing, packaging, labeling,
storage, importation, advertising, distribution, sale and clinical
trials of NHPs, drugs, cosmetics and foods are subject to
regulation primarily under the Canadian FDA and associated
regulations, including the Food and Drug Regulations, Cosmetic
Regulations and the Natural Health Products Regulations, and
related Health Canada guidance documents and policies
(collectively, the “Canadian Regulations”). In addition,
drugs and NHPs are regulated under the federal Controlled Drugs
and Substances Act if the product is considered a “controlled
substance” or a “precursor,” as defined in that statute or in
related regulatory provisions.
Health Canada is primarily responsible for administering the
Canadian Regulations.
Health Canada and the Canadian Regulations also set out
requirements for establishment and site licences, market
authorization for drugs and NHP licences. Each NHP must have a
product licence or a Homeopathic
10
Medicine Number (“DIN-HM”) issued by Health Canada
before it can be sold in Canada. Health Canada assigns a natural
health product number (“NPN”) to each NHP once Health Canada
issues the licence for that NHP. The Canadian Regulations require
that all drugs and NHPs be manufactured, packaged, labeled,
imported, distributed and stored under Canadian Good Manufacturing
Practices (“GMP”) or the equivalent thereto, and that all
premises used for manufacturing, packaging, labeling and importing
drugs and NHPs have a site licence (NHPs) or establishment licence
(drugs), which requires GMP compliance. The Canadian Regulations
also set out requirements for labeling, packaging, clinical trials
and adverse reaction reporting.
Health Canada and the Canadian Regulations, among other things,
govern the manufacture, formulation, packaging, labeling,
advertising and sale of NHPs and drugs, and regulate what may be
represented on labels and in promotional materials regarding the
claimed properties of products. The Canadian Regulations also
require NHPs and drugs sold in Canada to affix a label showing
specified information, such as the proper and common name of the
medicinal and non-
medicinal ingredients and their source, the name and address of the
manufacturer/product licence holder, its lot number, adequate
directions for use, a quantitative list of its medical ingredients
and its expiration date. In addition, the Canadian Regulations
require labeling to bear evidence of the marketing authorization as
evidenced by the designation drug identification number,
DIN-HM or NPN, followed
by an eight-digit number assigned to the product and issued by
Health Canada.
The Corporation’s expected nutraceutical products will be
considered “food” and, as such, will be principally regulated under
the Canadian FDA and the Canadian Regulations. The Corporation must
ensure that the labelling, marketing and selling of any of its
products comply with the Canadian FDA, including by ensuring that
the Corporation’s products are not packaged or marketed in a manner
that is misleading or deceptive to a consumer.
See “Description of the Business—Research and Development”
in the Corporation’s Annual Information Form for additional
information concerning the regulation applicable to the process
required before prescription drug product candidates may be
marketed in Canada.
United States
The FDA and other federal, state, local and foreign regulatory
agencies impose substantial requirements upon the clinical
development, approval, labeling, manufacture, marketing and
distribution of drug products. These agencies regulate, among other
things, research and development activities and the testing,
approval, manufacture, quality control, safety, effectiveness,
labeling, storage, record keeping, advertising and promotion of any
prescription drug product candidates or commercial products. The
regulatory approval process is generally lengthy and expensive,
with no guarantee of a positive result. Moreover, failure to comply
with applicable FDA or other requirements may result in civil or
criminal penalties, recall or seizure of products, injunctive
relief including partial or total suspension of production, or
withdrawal of a product from the market. The Corporation intends to
file an investigational new drug application (“IND”) with
the FDA in the first half of 2021.6
Psilocybin, psilocin, dimethyltryptamine, and 5-Methoxy-N-N-dimethyltryptamine
are strictly controlled under the CSA as Schedule I substances.
Schedule I substances by definition have no currently accepted
medical use in the United States, a lack of accepted safety for use
under medical supervision, and a high potential for
abuse. Schedule I and II drugs are subject to the strictest
controls under the CSA, including manufacturing and procurement
quotas, security requirements and criteria for importation. Anyone
wishing to conduct research on
6 |
The Corporation has not yet held a pre-IND meeting with the FDA, in
preparation for the filing of an IND application for the Sublingual
Film. The Corporation has assumed that the FDA will grant such a
Pre-IND meeting and that
it will be able to complete the IND approval process; however,
there is no guarantee that any such IND application will be
accepted or granted by FDA. The Corporation has contracted with
IntelgenX to develop a sublingual film formulation of psilocybin.
IntelgenX has produced multiple formulation types but the final
formulation has not been selected. Successful completion of
formulation is necessary before clinical trials supplies can be
provided to investigators.
|
11
substances listed in Schedule I under the CSA must register with
the U.S. Drug Enforcement Administration (“DEA”), and obtain
DEA approval of the research proposal.
See “Description of the Business – Research and Development”
in the Corporation’s Annual Information Form for additional
information concerning the regulation applicable to the process
required before prescription drug product candidates may be
marketed in the United States.
The FDA also regulates the formulation, manufacturing, preparation,
packaging, labeling, holding, and distribution of foods, drugs and
dietary supplements under the Federal Food, Drug and Cosmetic
Act (“FFDCA”) and the Dietary Supplement Health and
Education Act of 1994 (“DSHEA”). “Dietary supplements”
are defined as vitamins, minerals, herbs, other botanicals, amino
acids and other dietary substances for human use to supplement the
diet, as well as concentrates, metabolites, constituents, extracts
or combinations of such dietary ingredients. Generally, under
DSHEA, dietary ingredients that were on the market prior to
October 15, 1994 may be used in dietary supplements without
notifying the FDA. New dietary ingredients (i.e., not marketed in
the U.S. prior to October 15, 1994) must be the subject of a
new dietary ingredient notification submitted to the FDA unless the
ingredient has been “present in the food supply as an article used
for food” without being “chemically altered.” A new dietary
ingredient notification must provide the FDA with evidence of a
“history of use or other evidence of safety” establishing that use
of the dietary ingredient, when used under the conditions
recommended or suggested in the labeling of the dietary supplement,
“will reasonably be expected to be safe.” A new dietary ingredient
notification must be submitted to the FDA at least 75 days before
the initial marketing of the new dietary ingredient. There can be
no assurance that the FDA will accept the evidence of safety for
any new dietary ingredients that the Corporation may want to
market, and the FDA’s refusal to accept such evidence could prevent
the marketing of such dietary ingredients.
The DSHEA revised the provisions of the FFDCA concerning the
composition and labeling of dietary supplement ingredients and
products. Under the DSHEA, dietary supplement labeling must include
the statement of identity (name of the dietary supplement), the net
quantity of contents statement (amount of the dietary supplement),
the nutrition labeling, the ingredient list, and the name and place
of business of the manufacturer, packer, or distributor. The DSHEA
also states that dietary supplements may display “statements of
nutritional support,” provided certain requirements are met. Such
statements must be submitted to the FDA within 30 days of first use
in marketing and must be accompanied by a label disclosure that
“This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.” Such statements may describe how a
particular dietary ingredient affects the structure, function or
general well-being of the body, or the mechanism of action by which
a dietary ingredient may affect body structure, function or
well-being, but may not expressly or implicitly represent that a
dietary supplement will diagnose, cure, mitigate, treat, or prevent
a disease. Any statement of nutritional support the Corporation
makes in labeling must possess scientific evidence substantiating
that the statement is truthful and not misleading. If the FDA were
to determine that a particular statement of nutritional support was
an unacceptable drug claim or an unauthorized version of a health
claim about disease risk reduction for a food product, or if the
FDA were to determine that a particular claim was not adequately
supported by existing scientific data or was false or misleading,
the Corporation would be prevented from using that claim. In
addition, the FDA deems promotional and internet materials as
labeling; therefore, the Corporation’s promotional and internet
materials must comply with FDA requirements and could be the
subject of regulatory action by the FDA, or by the Federal Trade
Commission (the “FTC”) if that agency or other governmental
authorities, reviewing the materials as advertising, considers the
materials false and misleading.
U.S. laws also require recordkeeping and reporting to the FDA of
all serious adverse events involving dietary supplements products.
The Corporation will need to comply with such recordkeeping and
reporting requirements, and implement procedures governing adverse
event identification, investigation and reporting. As a result of
reported adverse events, health and safety risks or violations of
applicable laws and regulations, the Corporation may from time to
time elect, or be required, to recall, withdraw or remove a product
from a market, either temporarily or permanently.
12
The Corporation’s expected nutraceutical products will be
considered “food” and must be labeled as such. Within the U.S.,
this category of products is subject to the federal Nutrition,
Labeling and Education Act (“NLEA”), and regulations
promulgated under the NLEA. The NLEA regulates health claims,
ingredient labeling and nutrient content claims characterizing the
level of a nutrient in the product. The ingredients in conventional
foods must either be generally recognized as safe by experts for
the purposes to which they are put in foods, or be approved as food
additives under FDA regulations. If the Corporation’s expected
nutraceutical products were regulated as foods, it would be
required to comply with the Federal Food
Safety & Modernization Act and applicable
regulations. The Corporation would be required to provide foreign
supplier certifications evidencing the Corporation’s compliance
with FDA requirements.
The FDA has broad authority to enforce the provisions of the FFDCA
applicable to foods, drugs, dietary supplements, and cosmetics,
including powers to issue a public warning letter to a company, to
publicize information about illegal or harmful products, to request
a recall of products from the market, and to request the United
States Department of Justice to initiate a seizure action, an
injunction action, or a criminal prosecution in the U. S. courts.
The Corporation could be subject to fines and penalties, including
under administrative, civil and criminal laws for violating U.S.
laws and regulations, and the Corporation’s expected nutraceutical
products could be banned or subject to recall from the marketplace.
The Corporation could also be subject to possible business and
consumer claims under applicable statutory, product liability and
common laws.
The FTC will exercise jurisdiction over the advertising of the
Corporation’s expected nutraceutical products in the United States.
The FTC has in the past instituted enforcement actions against
several dietary supplement and food companies and against
manufacturers of dietary supplement products, including for false
and misleading advertising, label claims or product promotional
claims. In addition, the FTC has increased its scrutiny of the use
of testimonials, which the Corporation may utilize, as well as the
role of endorsements and product clinical studies. The Corporation
cannot be sure that the FTC, or comparable foreign agencies, will
not question the Corporation’s advertising, product claims,
promotional materials or other operations in the future. The FTC
has broad authority to enforce its laws and regulations, including
the ability to institute enforcement actions that could result in
recall actions, consent decrees, injunctions, and civil and
criminal penalties by the companies involved. Failure to comply
with the FTC’s laws and regulations could impair the Corporation’s
ability to market the Corporation’s expected nutraceutical
products.
The Corporation will also be subject to regulation under various
state and local laws, ordinances and regulations that include
provisions governing, among other things, the registration,
formulation, manufacturing, packaging, labeling, advertising, sale
and distribution of foods and dietary supplements. In addition, in
the future, the Corporation may become subject to additional laws
or regulations administered by the FDA or by other federal, state,
local or foreign governmental authorities, to the repeal of laws or
regulations that the Corporation considers favorable, or to more
stringent interpretations of current laws or regulations. In the
future, the Corporation believes that the dietary supplement
industry will likely face increased scrutiny from federal, state
and local governmental authorities. It is difficult to predict the
effect future laws, regulations, repeals or interpretations will
have on the Corporation’s business. However, such changes could
require the reformulation of products, recalls or discontinuance of
products, additional administrative requirements, revised or
additional labeling, increased scientific substantiation or other
requirements. Any such changes could have a material adverse effect
on the Corporation’s business or financial performance.
Jamaica
Psilocybin mushrooms do not fall within the definition of a
dangerous drug under the Dangerous Drugs Act (the
“DDA”) in Jamaica. The Corporation’s future business
activities in Jamaica involve the import of psychedelic and
pharmaceutical based medicines (derived from mushrooms) for the
purposes of conducting research and development as well as testing
on human subjects i.e., clinical trials in Jamaica. It is intended
that the clinical trials will be conducted by the University of
West Indies (“UWI”) and the Corporation will act as a
sponsor (the “Clinical Trials”).
13
The process of conducting clinical trials in Jamaica is governed by
the Ministry of Health, Jamaica Guidelines for the Conduct of
Research on Human Subjects (the “Guidelines”). The
Corporation and the UWI would be required to ensure that the
clinical trials are being conducted in accordance with these
Guidelines. The Guidelines provide that prior to conducting
research on human subjects, all researchers (i.e., academics,
scientists, students, and investigators) are required to prepare a
research protocol/proposal.
Research protocols should be submitted to the Medical Officer of
Health in the parish where the proposed research is to be
conducted, for evaluation of the ethical and scientific merits.
Where the site of the proposed research includes a hospital, the
Senior Medical Officer of the facility should also receive a copy
of the research protocol, and his/her approval to conduct the study
should be obtained.
The regulation of the sale, manufacturing, importation and
distribution of drugs in Jamaica is largely governed by the
Food & Drugs Act, 1964 (the “Jamaica
FDA”) and the Food and Drugs Regulations, 1975
(the “Regulations”). Section 4 of the Jamaica FDA
prohibits the importation of any drug into Jamaica unless it
conforms to the law of the country in which it was manufactured or
produced and is accompanied by a certificate declaring that the
drug does not contravene any known laws of that country and that
its sale therein for consumption or use by or for man or animal, as
the case may be, would not constitute a violation of the laws of
that country.
Regulation 40 stipulates that, a person shall not sell,
manufacture, import or distribute a drug unless that drug has been
registered with the MOH. The Regulations further state that a
permit must be obtained from the Ministry of Health Jamaica
(“MOH”) for the sale, manufacturing, importation and
distribution of drugs into Jamaica. Additionally, Regulation 65
states that a person shall not import, sell, advertise for sale, or
manufacture a new drug in Jamaica unless that person has obtained a
licence from the MOH.
Failure to comply with section 4 of the Jamaica FDA shall result in
such person being guilty of an offence and liable to a fine not
exceeding J$1,000,000 (approximately US$6,711) or to imprisonment
with or without hard labour for a term not exceeding twelve months.
Where a person committing an offence under the Jamaica FDA is a
corporation, the chairman, president, the officers and every
director thereof concerned in the management of such corporation,
shall also be guilty of the same offence unless he/she proves that
the act or omission constituting the offence took place without
his/her knowledge or that he/she exercised all due diligence to
prevent the commission thereof.
Regulation 87 provides that any person who fails to comply with the
Regulations shall be guilty of an offence and shall be liable to a
fine not exceeding J$2,000 (approximately US$13) or to imprisonment
for a term not exceeding twelve months.
In the event that the Clinical Trials include the preparation and
manufacture of precursor chemicals, then the Precursor Chemicals
Act (the “PCA”) may be applicable to the Clinical
Trials. As per section 6 of the PCA, any person who proposes to
engage in any prescribed activity shall apply to the
Pharmaceutical & Regulatory Affairs Department of the MOH
for a licence to engage in such prescribed activity.
Section 23 under the PCA stipulates that any person who
engages in any prescribed activity without obtaining the requisite
licence shall be guilty of an offence and liable to a fine not
exceeding J$3,000,000 (approximately US$20,134) or to imprisonment
for a term not exceeding three years or to both such fine and
imprisonment.
As of the date of this Prospectus, the Corporation’s sponsorship of
the Clinical Trials has not commenced. The Corporation has
submitted its application to the Institutional Review Board and
Ethics Committee of the Ministry of Health Jamaica (“Jamaica
IRB”) and is awaiting comments. Once such comments are settled,
if any, the Corporation will begin its sponsorship of the Clinical
Trials subject to applicable laws. The Corporation is unable to
apply for an import licence for its sponsored Clinical Trial
materials until it receives final Jamaica IRB approval. Once
received, the Corporation will apply to obtain an import licence
and any other required licences.
14
United Kingdom
In the UK, there are two main “layers” of regulation with which
products containing controlled substances must comply. These are:
(i) controlled drugs legislation, which applies to all
products irrespective of the type of product, and (ii) the
regulatory framework applicable to a specific category of products,
in this case, pharmaceuticals and food/food supplements.
The main UK controlled drugs legislation is the Misuse of Drugs Act
1971 (“MDA”) and the Misuse of Drugs Regulations 2001
(“MDR”), each as amended. The MDA sets out the penalties for
unlawful production, possession and supply of controlled drugs
based on three classes of risk (A, B and C). The MDR sets out the
permitted uses of controlled drugs based on which Schedule (1 to 5)
they fall within.
In the United Kingdom, “Fungus (of any kind) which contains
psilocin or an ester of psilocin” is controlled as a Class A
drug under the MDA and Schedule 1 drug under the MDR. As psilocybin
is a phosphate ester of psilocin, even if it were isolated from
psilocin, it would still fulfil this definition.
In the United Kingdom, Class A drugs are deemed to be the most
dangerous, and so carry the harshest punishments for unlawful
manufacture, production, possession and supply. Schedule 1 drugs
can only be lawfully manufactured, produced, possessed and supplied
under a Home Office licence. Whilst exemptions do exist, none are
applicable to the API.
Licensing Requirements
The Corporation obtains acceptable psychedelic agent psilocybin
(“API”) from the pharmaceutical ingredient provider who is
based in the United States. The API itself is expected to be
manufactured and packaged in FDA-registered facilities in the
United Kingdom. The API is expected to be sent directly to the
Corporation’s partners for research and development purposes in the
United States, Canada and Jamaica.
Although the facilities in the UK are currently FDA-registered, this would not be
sufficient to ensure the existence of valid marketing activities at
this site. As mentioned above, in order to produce, possess and
supply the API, the UK-based facility must also hold a
domestic licence issued by the Home Office covering the
manufacture, production, possession and supply of a controlled
substance, as well as an export licence for each API shipment. The
export application must include details of the importer and any
import licence required by the local authorities in the United
States.
All premises that are licensed in connection with the possession,
supply, manufacture and/or production of controlled drugs are
required to adhere to detailed security standards.7
Typically, when controlled drugs are being transported between
licensees, responsibility for their security remains with the owner
and does not transfer to either the courier or the customer until
the drugs arrive at their destination and are signed for. However,
where a third party is involved in the transit and/or storage of
controlled drugs, even if they are not the legal owners, this party
also carries responsibility for their security by virtue of being
‘in possession’ of them. Under the Home Office guidance, each
organisation involved in the movement of controlled drugs should
have a standard operating procedure covering their
responsibilities, record keeping, reconciliation and reporting of
thefts/losses.8
7 |
Home Office guidance; Security guidance for all existing or
prospective Home Office Controlled Drug Licensees and/or Precursor
Chemical Licensees or Registrants; 2020;
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/
857591/Security_Guidance_for_all_Businesses_and_Other_Organisations_v1.4_Jan_2020.pdf.
|
8 |
Home Office guidance; Guidelines for Standard Operating Procedures
(SOPs);
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/480572/StandardOpProcedure.pdf.
|
15
Pharmaceutical Products
Products are regulated as “medicinal products” under UK legislation
(the Human Medicines Regulations 2012) if (i) they are
presented as a substance or combination of substances having
properties for treating or preventing disease in human beings
having a medicinal effect (e.g., in marketing claims) or
(ii) have a medicinal effect (i.e., even if no claims are made
about the product).
A product has a “medicinal effect” if it has a pharmacological,
immunological or metabolic effect on the body that restores,
corrects or modifies a physiological function. Whether this is the
case for a specific product will depend on factors such as the
concentration of the psilocybin/psilocin and the mode of action of
any psilocybin/psilocin absorbed in the body.
If a product is a medicinal product, a marketing authorisation for
the product is required before the product can be placed on the
market in the UK. The process for obtaining a marketing
authorisation involves submitting pre-clinical and clinical data as
well as quality and manufacturing information in the form of a
common technical document. In addition to a marketing authorisation
for the product itself, companies carrying out activities involving
medicinal products, such as manufacturing, distribution and
wholesaling, need to meet defined standards (GMP) and/or Good
Distribution Practice (GDP) and to hold a related licence from the
UK Medicines and Healthcare products Regulatory Agency
(“MHRA”).
As mentioned above, once the API has been made in the UK, it is
expected to be sent directly to the Corporation’s partners for
research and development purposes in the United States, Canada or
Jamaica. How the API is subsequently processed will determine the
licences that the UK-based facility must hold. In
particular:
|
• |
|
If the API is just one ‘ingredient’ of the investigational
medicinal product (“IMP”) which is used in the clinical
trial then the UK-based
facility must register with the MHRA and provide the MHRA with 60
days’ notice of the intended start of manufacture/distribution, and
comply with GMP and Good Distribution Practice for active
substances.
|
|
• |
|
Conversely, if the API will itself constitute the IMP, the
manufacturer must hold a Manufacturer’s Authorisations for IMPs
licence (“MIA(IMP)”). In this scenario, an MIA(IMP) would be
required regardless of whether the IMP is for use in the UK,
another EEA Member State or a third country (such as the United
States, Canada or Jamaica).
|
Some products fall on the borderline between medicines and another
category such as medical devices, cosmetics or food supplements.
The regulatory status of the product will be determined by i) the
actual effect of the product on the body and ii) any claims made
about the effect of the product. Where a product is
potentially both a medicinal product and another category of
product, the legal position in the UK (and EU) is that it will be
regulated as a medicinal product.
Food/Food Supplements
|
• |
|
Functional foods and nutraceuticals must comply with general UK
food laws.
|
|
• |
|
Ordinarily, food and food ingredients do not need to be
pre-authorised before
they can be placed on the market. However, “novel foods”, which are
foods that have not been consumed to a significant degree by humans
in the UK or EU before 15 May 1997 do require pre-authorisation under the EU Novel
Foods Regulation (EU) 2015/2283, which has been retained in UK law
post-Brexit. Whilst psychedelic mushrooms may have been consumed in
the past, the same cannot be said for isolated psilocybin or
psilocin. For this reason, it is likely that any food item
containing isolated psilocybin and/or psilocin that is not
considered to be a medicinal product would fulfil the definition of
a ‘novel food’.
|
|
• |
|
To place a novel food on the market in the UK, it must be
authorised in advance (either under an EU authorisation if granted
pre-1 January 2021, or
after this date under a Great Britain authorisation for
|
16
|
England, Scotland and Wales and under an EU authorisation for
Northern Ireland). Under the updated EU Novel Foods Regulation,
novel foods authorisations are now generic and not
applicant-specific as they were under the previous novel foods
legislation. As such, in principle, once authorised, anyone can
place the authorised novel food on the UK market provided that it
complies with the terms of the authorisation which include
conditions of use, specifications and labelling requirements.
|
|
• |
|
Since novel food applications are a material investment, companies
are using two routes to try to protect their assets: drafting the
application narrowly and as specific as possible to their own
product, making it more challenging for other companies to produce
an ingredient that meets the conditions of the authorisation; and
if the application relies on newly developed scientific evidence
which is designated by the applicant as proprietary in the
application, and accepted as such in the application process, that
proprietary evidence will be protected by a 5-year period of exclusivity for the
applicant for that novel ingredient.
|
|
• |
|
In broad terms, the information required in the application dossier
includes: a description of the production process; the detailed
composition of the novel food; scientific evidence demonstrating
that the novel food does not pose a safety risk to human health;
and the proposed conditions of intended use and labelling
requirements. The responsibility to obtain a novel foods
authorisation would be that of the person who intended to
commercialise the product, and not the manufacturer of the
psilocybin/psilocin itself.
|
In addition to novel foods legislation, the person who intends to
commercialise the product in the UK would also have to comply with
the full body of food legislation, which includes food labelling
and food hygiene requirements.
Research and Development
The Corporation is focused on development of psychedelic medicines
and other products, through research and development of novel
chemical compounds and delivery mechanisms and study of such
compounds in clinical environments around the world including, but
not limited to research and studies to be conducted with the UWI
and, its affiliate, the Caribbean Institute for Health Research.
The Corporation anticipates growing its pipeline of psychedelic
pharmaceutical products inspired medicines through its internal
research, development, proprietary discovery programs, mergers and
acquisitions, joint ventures and collaborative development
agreements. For the time being, the Corporation maintains
intellectual property generated by its R&D programs through
patent filings and as trade secrets. The Corporation anticipates
that as these programs mature more patent applications will be
filed and more details about these programs will be disclosed at
such time.
As a result of COVID-19,
UWI has implemented certain facility procedures and is utilizing
technology in an effort to mitigate the effects of the pandemic,
specifically by moving patient interactions to remote status
wherever possible. The Corporation cannot guarantee that the
continued effects of COVID-19 will not impact patient
recruiting for clinical trials and institutional processes at UWI
or other institutions involved in pharmaceutical product
development.
Psychedelics are a class of drug whose primary action is to trigger
psychedelic experiences via serotonin receptor agonism, causing
thought, visual and auditory changes, and altered state of
consciousness. Major psychedelic drugs include mescaline, LSD,
psilocybin, and dimethyl tryptamine (“DMT”). Psilocybin is a
naturally occurring psychedelic prodrug compound produced by more
than 200 species of mushrooms, collectively known as psilocybin
mushrooms. The most potent are members of the genus
Psilocybe, such as P. azurescens,
P. semilanceata, and P.
cyanescens, but psilocybin has also been isolated from about
a dozen other genera. As a prodrug, psilocybin is quickly converted
by the body to psilocin, which has mind-altering effects.
The pharmacokinetics, pharmacology and human metabolism of
psilocybin are well known and well characterized. In conjunction
with psychotherapy, psilocybin has been utilized broadly in phase
II clinical trials.
17
Psilocybin found in certain species of mushrooms is a non-habit forming naturally occurring
psychedelic compound. Once ingested, psilocybin is rapidly
metabolized to psilocin, which then acts on serotonin receptors in
the brain. The Corporation intends to research and sponsor clinical
trials on the efficacy of chemically synthesized psilocybin as it
relates to the following indications9:
|
• |
|
mental health (depression, PTSD, anxiety and attention deficit
hyperactivity disorder); and
|
|
• |
|
addiction (alcohol, drugs and cigarettes).
|
In late 2019, management of Cybin Corp. commenced research and
development on the delivery of synthetic psilocybin and other
psychedelics through mechanisms such as sublingual film delivery.
Cybin has filed a patent application for such delivery
mechanism.
In partnership with UWI, the Corporation plans to conduct research
and development of synthetic psilocybin. The Corporation’s activity
in relation to the intended research of psilocybin mushrooms,
botanicals and other related fungi is limited to the jurisdiction
of Jamaica and the Corporation does not deal with psychedelic
substances except within laboratory and clinical trial settings
conducted within approved regulatory frameworks in order to
identify and develop treatments for medical conditions and does not
have any direct or indirect involvement with illegal selling,
production or distribution of any substances in jurisdictions in
which it operates. The Corporation’s Jamaica team is composed of
business consultants, legal counsel and local post-doctoral
research students. As of the date of this Prospectus, the
Corporation’s sponsorship of the clinical trials has not commenced.
The Corporation has submitted its application to the Jamaica IRB
and has received conditional approval and is awaiting final
approval. Once such comments are settled, if any, the Corporation
will begin its sponsorship of the clinical trials subject to
applicable laws. The Corporation is unable to apply for an import
license for its sponsored clinical trial materials until it
receives final Jamaica IRB approval, once received, the Corporation
will apply to obtain an import license.
Research and development is led by the Corporation’s North American
Chief Research and Development Officer, Dr. Michael G.
Palfreyman. Dr. Palfreyman, who holds a PhD in Neuroscience
and Neuropharmacology from the University of Nottingham, United
Kingdom, is an accomplished pharmaceutical industry veteran
responsible for more than 30 successful clinical programs.
The Corporation has also retained Stosic and Associates, a leading
government relations firm, to work with high level pharmaceutical,
institutional and government relations individuals to progress the
acceptance of psychedelics in Canada for medical use.
The Corporation’s research and development must be conducted in
strict compliance with the regulations of federal, state, local and
regulatory agencies in Canada and the United States, and the
equivalent regulatory agencies in the other jurisdictions in which
the Corporation operates, including Jamaica. These regulatory
authorities regulate, among other things, the research,
manufacture, promotion and distribution of drugs in specific
jurisdictions under applicable laws and regulations. It is
important to note, that unlike in Canada and the United States,
psilocybin mushrooms are not an illegal drug under Jamaica’s DDA.
Accordingly, conducting
9 |
Certain statements regarding psilocybin, psychedelic tryptamine,
tryptamine derivatives or other psychedelic compounds,
nutraceutical products or functional mushrooms have not been
evaluated by Health Canada, the FDA or other similar regulatory
authorities, nor has the efficacy of psilocybin, psychedelic
tryptamine, tryptamine derivatives or other psychedelic compounds,
nutraceutical products or functional mushrooms been confirmed by
approved research. There is no assurance that psilocybin,
psychedelic tryptamine, tryptamine derivatives or other psychedelic
compounds, nutraceutical products or functional mushrooms can be
used to diagnose, treat, cure or prevent any disease or condition
and robust scientific research and clinical trials are needed.
There are multiple risk factors regarding the ability to
successfully commercially scale a chemically synthesized process to
obtain psilocybin and other analogues.
|
18
research on psilocybin mushrooms does not contravene the laws of
Jamaica and does not require any permit or authorization from
Jamaican regulatory authorities.
Canada
Psychedelics
The process required before a prescription drug product candidate
may be marketed in Canada generally involves:
|
• |
|
Chemical and Biological Research – Laboratory tests are
carried out on tissue cultures and with a variety of small animals
to determine the effects of the drug. If the results are promising,
the manufacturer will proceed to the next step of development.
|
|
• |
|
Pre-Clinical
Development – Animals are given the drug in varying amounts
over differing periods of time. If it can be shown that the drug
causes no serious or unexpected harm at the doses required to have
an effect, the manufacturer will proceed to clinical trials.
|
|
• |
|
Clinical Trials – Phase I – The first administration in
humans is to test if people can tolerate the drug. If this testing
is to take place in Canada, the manufacturer must prepare a
clinical trial application for the Therapeutic Products Directorate
of Health Canada (the “TPD”). This includes the results of
the first two steps and a proposal for testing in humans. If the
information is sufficient, the Health Products and Food Branch of
Health Canada (the “HPFB”) grants permission to start
testing the drug, generally first on healthy volunteers.
|
|
• |
|
Clinical Trials – Phase II – Phase II trials are carried out
on people with the target condition, who are usually otherwise
healthy, with no other medical condition. Trials carried out in
Canada must be approved by the TPD. In phase II, the objective of
the trials is to continue to gather information on the safety of
the drug and begin to determine its effectiveness.
|
|
• |
|
Clinical Trials – Phase III – If the results from phase II
show promise, the manufacturer provides an updated clinical trial
application to the TPD for phase III trials. The objectives of
phase III include determining whether the drug can be shown to be
effective, and have an acceptable side effect profile, in people
who better represent the general population. Further information
will also be obtained on how the drug should be used, the optimal
dosage regimen and the possible side effects.
|
|
• |
|
New Drug Submission – If the results from phase III continue
to be favourable, the drug manufacturer can submit a new drug
submission (“NDS”) to the TPD. A drug manufacturer can
submit an NDS regardless of whether the clinical trials were
carried out in Canada. The TPD reviews all the information gathered
during the development of the drug and assesses the risks and
benefits of the drug. If it is judged that, for a specific patient
population and specific conditions of use, the benefits of the drug
outweigh the known risks, the HPFB will approve the drug by issuing
a notice of compliance.
|
United States
The process required before a prescription drug product candidate
may be marketed in the United States generally involves:
|
• |
|
completion of extensive non-clinical laboratory tests, animal
studies and formulation studies, all performed in accordance with
the FDA’s Good Laboratory, Good Clinical and/or Manufacturing
Practice regulations;
|
|
• |
|
submission to the FDA of an IND, which must become effective before
human clinical trials may begin;
|
|
• |
|
approval by an institutional review board or independent ethics
committee at each clinical trial site before each trial may be
initiated;
|
19
|
• |
|
for some products, performance of adequate and well-controlled
human clinical trials in accordance with the FDA’s regulations,
including Good Clinical Practices, to establish the safety and
efficacy of the prescription drug product candidate for each
proposed indication;
|
|
• |
|
submission to the FDA of a New Drug Application (“NDA”);
and
|
|
• |
|
FDA review and approval of the NDA prior to any commercial
marketing, sale or shipment of the drug.
|
The testing and approval process requires substantial time, effort
and financial resources, and the Corporation cannot be certain that
any approvals for its prescription drug product candidates will be
granted on a timely basis, if at all.
Non-clinical tests
include laboratory evaluations of product chemistry, formulation
and stability, as well as studies to evaluate toxicity in animals
and other animal studies. The results of non-clinical tests, together with
manufacturing information and analytical data, are submitted as
part of an IND to the FDA. Some non-clinical testing may continue
even after an IND is submitted. The IND also includes one or more
protocols for the initial clinical trial or trials and an
investigator’s brochure. An IND automatically becomes effective 30
days after receipt by the FDA, unless the FDA, within the
30-day time period,
raises concerns or questions relating to the proposed clinical
trials as outlined in the IND and places the clinical trial on a
clinical hold. In such cases, the IND sponsor and the FDA must
resolve any outstanding concerns or questions before any clinical
trials can begin. Clinical trial holds also may be imposed at any
time before or during studies due to safety concerns or
non-compliance with
regulatory requirements.
An independent institutional review board (“IRB”), at each
of the clinical centers proposing to conduct the clinical trial
must review and approve the plan for any clinical trial before it
commences at that center. An IRB considers, among other things,
whether the risks to individuals participating in the trials are
minimized and are reasonable in relation to anticipated benefits.
The IRB also approves the consent form signed by the trial
participants and must monitor the study until completed. The
FDA, the IRB, or the sponsor may suspend or discontinue a clinical
trial at any time on various grounds, including a finding that the
subjects are being exposed to an unacceptable health risk. There
also are requirements governing the reporting of ongoing clinical
trials and completed clinical trials to public registries.
The FDA offers a number of regulatory mechanisms that provide
expedited or accelerated approval procedures for selected drugs and
indications which are designed to address unmet medical needs in
the treatment of serious or life-threatening diseases or
conditions. These include programs such as Breakthrough Therapy
designations, Fast Track designations, Priority Review and
Accelerated Approval, which the Corporation may need to rely upon
in order to receive timely approval or to be competitive.
The Corporation may plan to seek orphan drug designation for
certain indications qualified for such designation. The U.S., E.U.
and other jurisdictions may grant orphan drug designation to drugs
intended to treat a “rare disease or condition,” which, in the
U.S., is generally a disease or condition that affects fewer than
200,000 individuals in the United States, or 200,000 or more
individuals in the United States and for which there is no
reasonable expectation that the cost of developing and making a
drug available in the United States for this type of disease or
condition will be recovered from sales of the product. In the
E.U., orphan drug designation can be granted if: the disease is
life threatening or chronically debilitating and affects no more
than 50 in 100,000 persons in the E.U.; without incentive it is
unlikely that the drug would generate sufficient return to justify
the necessary investment; and no satisfactory method of treatment
for the condition exists or, if it does, the new drug will provide
a significant benefit to those affected by the condition. Orphan
drug designation must be requested before submitting an NDA. If a
product that has an orphan drug designation subsequently receives
the first regulatory approval for the indication for which it has
such designation, the product is entitled to orphan exclusivity,
meaning that the applicable regulatory authority may not approve
any other applications to market the same drug for the same
indication, except in very limited circumstances, for a period of
seven years in the U.S. and 10 years in the E.U. Orphan drug
designation does not prevent competitors from developing or
20
marketing different drugs for the same indication or the same drug
for different indications. After orphan drug designation is
granted, the identity of the therapeutic agent and its potential
orphan use are publicly disclosed. Orphan drug designation does not
convey an advantage in, or shorten the duration of, the
development, review and approval process. However, this designation
provides an exemption from marketing and authorization (NDA)
fees.
Drugs manufactured or distributed pursuant to FDA approvals are
subject to continuing regulation by the FDA, including, among other
things, requirements relating to recordkeeping, periodic reporting,
product sampling and distribution, reporting of adverse experiences
with the product, and complying with promotion and advertising
requirements. The FDA may impose a number of post-approval
requirements as a condition of approval of an NDA. For example, the
FDA may require post-market testing, including phase IV clinical
trials, and surveillance to further assess and monitor the
product’s safety and effectiveness after commercialization. In
addition, drug manufacturers and their subcontractors involved in
the manufacture and distribution of approved drugs are required to
register their establishments with the FDA and certain state
agencies and are subject to periodic unannounced inspections by the
FDA and certain state agencies for compliance with ongoing
regulatory requirements, including current Good Manufacturing
Practices, which impose certain procedural and documentation
requirements. Failure to comply with statutory and regulatory
requirements may subject a manufacturer to legal or regulatory
action, such as warning letters, suspension of manufacturing,
product seizures, injunctions, civil penalties or criminal
prosecution. There is also a continuing, annual prescription drug
product program user fee.
The FDA may withdraw approval if compliance with regulatory
requirements and standards is not maintained or if problems occur
after the product reaches the market. Later discovery of previously
unknown problems with a product, including adverse events of
unanticipated severity or frequency, or with manufacturing
processes, or failure to comply with regulatory requirements, may
result in revisions to the approved labeling to add new safety
information, requirements for post-market studies or clinical
trials to assess new safety risks, or imposition of distribution or
other restrictions under a risk evaluation and mitigation
strategy.
Controlled Substances
The CSA and its implementing regulations establish a “closed
system” of regulations for controlled substances. The CSA imposes
registration, security, recordkeeping and reporting, storage,
manufacturing, distribution, importation and other requirements
under the oversight of the DEA. The DEA is responsible for
regulating controlled substances, and requires those individuals or
entities that manufacture, import, export, distribute, research, or
dispense controlled substances to comply with the regulatory
requirements in order to prevent the diversion of controlled
substances to illicit channels of commerce.
Facilities that manufacture, distribute, import or export any
controlled substance must register annually with the DEA. The DEA
registration is specific to the particular location, activity(ies)
and controlled substance schedule(s). For example, separate
registrations are needed for import and manufacturing, and each
registration will specify which schedules of controlled substances
are authorized.
The DEA inspects all manufacturing facilities to review security,
recordkeeping, reporting and handling prior to issuing a controlled
substance registration. The specific security requirements vary by
the type of business activity and the schedule and quantity of
controlled substances handled. The most stringent requirements
apply to manufacturers of Schedule I and Schedule II substances.
Required security measures commonly include background checks on
employees and physical control of controlled substances through
storage in approved vaults, safes and cages, and through use of
alarm systems and surveillance cameras. Once registered,
manufacturing facilities must maintain records documenting the
manufacture, receipt and distribution of all controlled substances.
Manufacturers must submit periodic reports to the DEA of the
distribution of Schedule I and II controlled substances, Schedule
III narcotic substances, and other designated substances.
Registrants must also report any controlled substance thefts or
significant losses, and must obtain authorization to destroy or
dispose of controlled substances. Imports of Schedule I and II
controlled substances for commercial purposes are
21
generally restricted to substances not already available from a
domestic supplier or where there is not adequate competition among
domestic suppliers. In addition to an importer or exporter
registration, importers and exporters must obtain a permit for
every import or export of a Schedule I and II substance or Schedule
III, IV and V narcotic, and submit import or export declarations
for Schedule III, IV and V non-narcotics.
For drugs manufactured in the United States, the DEA establishes
annually an aggregate quota for the amount of substances within
Schedules I and II that may be manufactured or produced in the
United States based on the DEA’s estimate of the quantity needed to
meet legitimate medical, scientific, research and industrial needs.
The quotas apply equally to the manufacturing of the active
pharmaceutical ingredient and production of dosage forms. The DEA
may adjust aggregate production quotas a few times per year, and
individual manufacturing or procurement quotas from time to time
during the year, although the DEA has substantial discretion in
whether or not to make such adjustments for individual
companies.
Individual U.S. states also establish and maintain separate
controlled substance laws and regulations, including licensing,
recordkeeping, security, distribution, and dispensing requirements.
State authorities, including boards of pharmacy, regulate use of
controlled substances in each state. Failure to maintain compliance
with applicable requirements, particularly as manifested in the
loss or diversion of controlled substances, can result in
enforcement action that could have a material adverse effect on the
Corporation’s business, operations and financial condition. The DEA
may seek civil penalties, refuse to renew necessary registrations,
or initiate proceedings to revoke those registrations. In certain
circumstances, violations could lead to criminal prosecution.
Patent Cooperation Treaty
The Patent Cooperation Treaty (the “PCT”) facilitates filing
for patent recognition in multiple jurisdictions simultaneously
using a single uniform patent application. 193 countries, including
Canada and the United States have ratified the PCT.
Ultimately, patents are still granted in each country individually.
As such, the PCT procedure consists of two phases: filing of an
international application, and national evaluation under the patent
laws in force in each country where a patent is sought.
Within 12 months of filing a provisional patent application at the
United States Patent and Trademark Office, the Corporation may
elect to file a regular utility patent application in the United
States in tandem with filing a PCT application with the World
Intellectual Property Office, in each case claiming priority to the
provisional patent application. Within 30 months of the provisional
filing date, deadlines begin for a PCT application to enter the
national phase in desired jurisdictions globally, such as Canada
(30 months) and Europe (31 months), in each case claiming priority
to the provisional patent application.
While the Corporation is focused on programs using
psychedelic-inspired compounds, the Corporation does not have any
direct or indirect involvement with the illegal selling, production
or distribution of any substances in the jurisdictions in which it
operates. The Corporation is exploring drug development within
approved laboratory clinical trial settings conducted within
approved regulatory frameworks. Though highly speculative, should
any prescription drug product be developed by the Corporation
(which, if it does occur, would not be for several years), such
drug product will not be commercialized prior to receipt of
applicable regulatory approval, which will only be granted if
clinical evidence of safety and efficacy for the intended use(s) is
successfully developed. The Corporation may also employ
non-prescription drugs,
where appropriate.
22
COMPLIANCE
PROGRAM
The Corporation oversees and monitors compliance with applicable
laws in each jurisdiction in which it operates. In addition to the
Corporation’s senior executives and the employees responsible for
overseeing compliance, the Corporation has local counsel engaged in
every jurisdiction in which it operates and has received legal
opinions or advice in each of these jurisdictions regarding
(a) compliance with applicable regulatory frameworks, and
(b) potential exposure to, and implications arising from,
applicable laws in jurisdictions in which the Corporation has
operations or intends to operate.
The Corporation works with third parties who require regulatory
licensing to handle scheduled drugs. The Corporation continuously
updates its compliance and channel programs to maintain regulatory
standards set for drug development. The Corporation also works with
clinical research organizations who maintain batch records and data
storage for the Corporation’s clinical programs.
Additionally, the Corporation has established a Medical &
Clinical Advisory Team, a Research, Clinical and Regulatory Team
and a Government Relations and Communications Team with
cross-functional expertise in business, neuroscience,
pharmaceuticals, mental health and psychedelics to advise
management.
In conjunction with the Corporation’s human resources and
operations departments, the Corporation oversees and implements
training on the Corporation’s protocols. The Corporation will
continue to work closely with external counsel and other compliance
experts, and is evaluating the engagement of one or more
independent third party providers to further develop, enhance and
improve its compliance and risk management and mitigation processes
and procedures in furtherance of continued compliance with the laws
of the jurisdictions in which the Corporation operates.
The programs currently in place include monitoring by executives of
the Corporation to ensure that operations conform to and comply
with required laws, regulations and operating procedures. The
Corporation is currently in compliance with the laws and
regulations in all jurisdictions and the related licencing
framework applicable to its business activities.
The Corporation and, to its knowledge, each of its third-party
researchers, suppliers and manufacturers have not received any
non-compliance, citations
or notices of violation which may have an impact on the
Corporation’s licences, business activities or operations.
The Corporation conducts due diligence on third-party researchers,
medical professionals, clinics, cultivators, processors and others
as applicable, with whom it engages. Such due diligence includes
but is not limited to the review of necessary licenses and the
regulatory framework enacted in the jurisdiction of operation.
Further, the Corporation generally obtains, under its contractual
arrangements, representations and warranties from such third
parties pertaining to compliance with applicable licensing
requirements and the regulatory framework enacted in the
jurisdiction of operation.
CONSOLIDATED
CAPITALIZATION
Since the date of the Annual Financial Statements, there has been
no material change to the share and loan capital of the
Corporation.
The applicable Prospectus Supplement will describe any material
changes, and the effect of such material changes, on the share and
loan capitalization of the Corporation that will result from the
issuance of Securities pursuant to each Prospectus Supplement.
23
USE OF PROCEEDS
The net proceeds from any Offering of Securities and the proposed
use of those proceeds will be set forth in the applicable
Prospectus Supplement relating to that Offering of Securities.
Notwithstanding, the Corporation’s management has broad discretion
in the application of proceeds of an Offering of Securities. On the
basis of results obtained or for other sound business reasons, the
Corporation may re-allocate funds as required.
Accordingly, the Corporation’s actual use of proceeds may vary
significantly from any proposed use of proceeds disclosed in any
applicable Prospectus Supplement. See “Risk Factors – Risks
Related to an Offering – Discretion over the Use of
Proceeds”.
Sources and Uses of Capital
The Corporation had cash and cash equivalents on hand as at
May 31, 2021 of approximately $58,409,485 including the
remaining net proceeds from the Corporation’s bought deal short
form prospectus offering for aggregate gross proceeds of
$34,303,500 (the “February Offering”) that was completed on
February 4, 2021. The Corporation’s current financial
resources are sufficient to meet its short-term liquidity
requirements and to fund its operations for at least the coming 12
months, exclusive of any additional proceeds to be raised through
an Offering of Securities. The Corporation’s expectation is based
on significant assumptions and is subject to significant risk, see
“Cautionary Note Regarding Forward Looking
Information” and “Risk Factors”. As
at May 31, 2021, the Corporation anticipates that it will
require approximately $39,417,732 to continue operations over the
next 12 months, including funding for the Corporations business
objectives and milestones.
|
|
|
|
|
|
|
|
|
|
|
|
|
Program(1)
|
|
Anticipated
12 Month Use
of Funds(2) |
|
|
Use of Proceeds
Disclosure in
February 2021
Prospectus(3) |
|
|
Amounts
Remaining to be
Applied From
Proceeds(4) |
|
Psilocybin Program
|
|
$ |
3,791,727 |
|
|
$ |
3,837,600 |
|
|
$ |
2,841,727 |
|
Deuterated Tryptamines Preclinical Programs
|
|
$ |
5,662,888 |
|
|
$ |
11,920,000 |
|
|
$ |
10,862,888 |
|
Phenethylamine Preclinical Development Program
|
|
$ |
2,375,141 |
|
|
$ |
2,600,000 |
|
|
$ |
2,375,141 |
|
Nutraceutical Products
|
|
$ |
500,000 |
|
|
$ |
500,000 |
|
|
$ |
500,000 |
|
Technology
|
|
$ |
4,187,704 |
|
|
$ |
6,425,000 |
|
|
$ |
6,187,764 |
|
Other, including General and Administrative
|
|
$ |
22,900,272 |
|
|
$ |
10,778,000 |
|
|
($ |
69,709 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
39,417,732 |
|
|
$ |
36,060,600 |
|
|
$ |
22,697,751 |
|
Notes:
(1) |
Please see the Corporation’s Annual MD&A for a description of
the Corporation’s Programs. All milestones are subject to receipt
of all necessary approvals, including the academic and scientific
organizations with which the Corporation is working.
|
(2) |
Certain amounts have been converted from USD to CAD at an exchange
rate of 1.2575:1.
|
(3) |
Represent proceeds from private placements previously disclosed in
the Listing Statement, as well proceeds disclosed in the February
Offering prospectus.
|
For detailed information in respect of the Corporation’s
business objectives and milestones, and the application of proceeds
from prior offerings by the Corporation, prospective purchasers of
Securities should carefully consider the information described in
the interim and annual management’s discussion and analysis of the
Corporation, and the documents incorporated by reference herein,
including the applicable Prospectus Supplement.
The expected uses of capital represents the Corporation’s current
intentions based upon its present plans and business condition,
which could change in the future as its plans and business
conditions evolve. The amounts and timing of the actual use of
available capital will depend on multiple factors and there may be
circumstances where, for sound business reasons, a reallocation of
capital, or termination of a program objective, may be necessary in
order for the Corporation to achieve its program objectives. The
Corporation may also require
24
additional funds in order to fulfill its expenditure requirements
to meet existing and any new business objectives, and the
Corporation expects to either issue additional securities or incur
debt to do so. The material factors or assumptions used to develop
the estimated amounts for the 12 months period disclosed above are
included in the “Cautionary Note Regarding Forward-Looking
Information” section above. The actual amount that the
Corporation spends in connection with each of the identified uses
and programs will depend on a number of factors, including those
listed under “Risk Factors” in, or incorporated by reference
in, this Prospectus.
Certain COVID-19 related
risks could delay or slow the implementation of the certain of the
Corporation’s planned programs resulting in additional costs for
the Corporation. The extent to which COVID-19 may impact the Corporation’s
business activities will depend on future developments, such as the
ultimate geographic spread of the disease, the duration of the
outbreak, travel restrictions, business disruptions, and the
effectiveness of actions taken in Canada, the United States,
Jamaica, and other countries to contain and treat the disease. As
these events are highly uncertain, the Corporation cannot determine
their potential impact on operations at this time. The COVID-19 pandemic may negatively
impact the Corporation’s business through disruption of supply and
manufacturing, which would influence the amount and timing of
planned expenditure. For example, prolonged disruptions in the
supply of goods and services relied on by the Corporation to
develop its products or restrictions resulting from government
regulations that impact the Corporation’s ability to conduct its
studies and clinic trials, may adversely impact the Corporation’s
business. See “The Corporation – COVID-19 Pandemic” and “Risk
Factors – Risks Related to the Business of the Corporation – Novel
Coronavirus COVID-19”.
Negative Cash Flow From Operations
Since inception, the Corporation has financed its operations
primarily from the issuance of equity and interest income on funds
available for investment. To date, the Corporation has raised
approximately $90,000,000 in gross proceeds through private
placement and prospectus offerings. The Corporation has experienced
operating losses and cash outflows from operations since
incorporation and will require ongoing financing to continue its
research and development activates. As the Corporation has not yet
achieved profitability, there are uncertainties regarding its
ability to continue as a going concern. The Corporation has not
earned any revenue or reached successful commercialization of any
products. The Corporation’s success is dependent upon the ability
to finance its cash requirements to continue its activities. There
is no assurance that additional capital or other types of financing
will be available if needed or that these financings will be on
terms at least as favourable to the Corporation as those previously
obtained, or at all. To the extent that the Corporation has
negative operating cash flows in future periods, it may need to
deploy a portion of its existing working capital to fund such
negative cash flows. The Corporation will be required to raise
additional funds through the issuance of additional equity
securities, through loan financing, or other means, such as through
partnerships with other companies and research and development
reimbursements. There is no assurance that additional capital or
other types of financing will be available if needed or that these
financings will be on terms at least as favourable to the
Corporation as those previously obtained. See “Risk Factors –
Risks Related to an Offering – Negative Operating Cash Flow
and Going Concern”.
DIVIDEND POLICY
The Corporation has never declared nor paid dividends on the Common
Shares. Currently, the Corporation intends to retain its future
earnings, if any, to fund the development and growth of its
business, and the Corporation does not anticipate declaring or
paying any dividends on the Common Shares in the near future,
although the Corporation reserves the right to pay dividends if and
when it is determined to be advisable by the board of directors of
the Corporation. As a result, shareholders will have to rely on
capital appreciation, if any, to earn a return on investment in the
Common Shares in the foreseeable future. See “Risk Factors –
Risks Related to an Offering – Speculative Nature of Investment
Risk”.
25
DESCRIPTION OF
SECURITIES BEING DISTRIBUTED
The following is a brief summary of certain general terms and
provisions of the Securities that may be offered pursuant to this
Prospectus. This summary does not purport to be complete. The
particular terms and provisions of the Securities as may be offered
pursuant to this Prospectus will be set forth in the applicable
Prospectus Supplement pertaining to such Offering of Securities,
and the extent to which the general terms and provisions described
below may apply to such Securities will be described in the
applicable Prospectus Supplement.
Common Shares
The Corporation is authorized to issue an unlimited number of
Common Shares and an unlimited number of preferred shares. As at
July 2, 2021, the Corporation had 148,413,013 Common Shares
and nil preferred shares issued and outstanding.
Each Common Share entitles the holder thereof to one vote at
meetings of shareholders of the Corporation other than meetings of
the holders of another class of shares. Each holder of Common
Shares is also entitled to receive dividends if, as and when
declared by the board of directors of the Corporation. Holders of
Common Shares are entitled to participate in any distribution of
the Corporation’s net assets upon liquidation, dissolution or
winding-up on an equal
basis per share. There are no pre-emptive, redemption, retraction,
purchase or conversion rights attaching to the Common Shares.
Common Shares may be sold separately or together with certain other
Securities under this Prospectus. Common Shares may also be
issuable on conversion, exchange, exercise or maturity of certain
other Securities qualified for issuance under this Prospectus.
Warrants
Warrants may be offered separately or together with other
Securities, as the case may be. Each series of Warrants may be
issued under a separate warrant indenture or warrant agency
agreement to be entered into between the Corporation and one or
more banks or trust companies acting as Warrant agent or may be
issued as stand-alone contracts. The applicable Prospectus
Supplement will include details of the Warrant agreements, if any,
governing the Warrants being offered. The Warrant agent, if any,
will be expected to act solely as the agent of the Corporation and
will not assume a relationship of agency with any holders of
Warrant certificates or beneficial owners of Warrants. The
following sets forth certain general terms and provisions of the
Warrants that may be offered under this Prospectus. The specific
terms of the Warrants, and the extent to which the general terms
described in this section apply to those Warrants, will be set
forth in the applicable Prospectus Supplement.
A copy of any warrant indenture or any warrant agency agreement
relating to an offering of Warrants will be filed by the
Corporation with the relevant securities regulatory authorities in
Canada after it has been entered into by the Corporation.
Each applicable Prospectus Supplement will set forth the terms and
other information with respect to the Warrants being offered
thereby, which may include, without limitation, the following
(where applicable):
|
• |
|
the designation of the Warrants;
|
|
• |
|
the aggregate number of Warrants offered and the offering
price;
|
|
• |
|
the designation, number and terms of the other Securities
purchasable upon exercise of the Warrants, and procedures that will
result in the adjustment of those numbers;
|
|
• |
|
the exercise price of the Warrants;
|
|
• |
|
the dates or periods during which the Warrants are exercisable;
|
|
• |
|
the designation and terms of any securities with which the Warrants
are issued;
|
26
|
• |
|
if the Warrants are issued as a unit with another Security, the
date on and after which the Warrants and the other Security will be
separately transferable;
|
|
• |
|
any minimum or maximum amount of Warrants that may be exercised at
any one time;
|
|
• |
|
whether such Warrants will be listed on any securities
exchange;
|
|
• |
|
any terms, procedures and limitations relating to the
transferability, exchange or exercise of the Warrants;
|
|
• |
|
certain material Canadian tax consequences of owning the Warrants;
and
|
|
• |
|
any other material terms and conditions of the Warrants.
|
Units
The Corporation may issue Units comprised of one or more of the
other Securities described herein in any combination. Each Unit may
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 may have
the rights and obligations of a holder of each included Security.
Any Unit agreement under which a Unit may be 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.
Each applicable Prospectus Supplement will set forth the terms and
other information with respect to the Units being offered thereby,
which may include, without limitation, the following (where
applicable):
|
• |
|
the designation, number 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;
|
|
• |
|
any provisions for the issuance, payment, settlement, transfer or
exchange of the Units or of the Securities comprising the
Units;
|
|
• |
|
certain material Canadian tax consequences of owning the Securities
comprising the Units; and
|
|
• |
|
any other material terms and conditions of the Units.
|
Debt Securities
Debt Securities will be senior or subordinated unsecured
indebtedness of the Corporation as described in the relevant
Prospectus Supplement. If the Debt Securities are senior
indebtedness, they will rank equally and rateably with all other
unsecured indebtedness of the Corporation, from time to time issued
and outstanding, which is not subordinated.
If the Debt Securities are subordinated indebtedness, they will
rank equally and rateably with all other subordinated Debt
Securities from time to time issued and outstanding. In the event
of the insolvency or winding-up of the Corporation, the
subordinated Debt Securities will be subordinated and postponed in
right of payment to the prior payment in full of all other
liabilities and indebtedness of the Corporation, other than
indebtedness that, by its terms, ranks equally with, or subordinate
to, such subordinated Debt Securities.
Any convertible or exchangeable Debt Securities will be convertible
or exchangeable only for other securities of the Corporation.
In conformity with applicable laws of Canada, for all bonds and
notes of companies that are publicly offered, the Debt Securities
will be governed by a document called an “indenture”. There
will be a separate indenture for the senior Debt Securities and the
subordinated Debt Securities. An indenture is a contract between a
financial institution, acting on your behalf as trustee of the Debt
Securities offered, and us. The trustee has two main roles. First,
subject to some limitations on the extent to which the trustee can
act on your behalf, the trustee can enforce your rights against us
if we default on our obligations under the indenture. Second, the
trustee performs certain
27
administrative duties for us. The aggregate principal amount of
Debt Securities that may be issued under each indenture is
unlimited. A copy of the form of each indenture to be entered into
in connection with offerings of Debt Securities will be filed with
the applicable securities regulatory authorities in Canada when it
is entered into. A copy of any indenture or supplement thereto
entered into by us will be filed with securities regulatory
authorities and will be available on our profile on SEDAR.
This Prospectus does not qualify for issuance Debt Securities in
respect of which the payment of principal and/or interest may be
determined, in whole or in part, by reference to one or more
underlying interests including, for example, an equity or debt
security, a statistical measure of economic or financial
performance including, but not limited to, any currency, consumer
price or mortgage index, or the price or value of one or more
commodities, indices or other items, or any other item or formula,
or any combination or basket of the foregoing items. For greater
certainty, this Prospectus may qualify for issuance Debt Securities
in respect of which the payment of principal and/or interest may be
determined, in whole or in part, by reference to published rates of
a central banking authority or one or more financial institutions,
such as a prime rate or bankers’ acceptance rate, or to recognized
market benchmark interest rates such as LIBOR, EURIBOR or a United
States federal funds rate.
Selected provisions of the Debt Securities and the indenture(s)
under which such Debt Securities will be issued are summarized
below. This summary is not complete. The statements made in this
Prospectus relating to any indenture and Debt Securities to be
issued thereunder are summaries of certain anticipated provisions
thereof and are subject to, and are qualified in their entirety by
reference to, all provisions of the applicable indenture. The
indentures will not limit the amount of Debt Securities that we may
issue thereunder. We may issue Debt Securities from time to time
under an indenture in one or more series by entering into
supplemental indentures or by our board of directors or a duly
authorized committee authorizing the issuance. The Debt Securities
of a series need not be issued at the same time, bear interest at
the same rate or mature on the same date.
The Prospectus Supplement for a particular series of Debt
Securities will disclose the specific terms of such Debt
Securities, including the price or prices at which the Debt
Securities to be offered will be issued. The terms and provisions
of any Debt Securities offered under a Prospectus Supplement may
differ from the terms described below, and may not be subject to or
contain any or all of such terms. Those terms may include some or
all of the following:
|
• |
|
the designation, aggregate principal amount and authorized
denominations of such Debt Securities;
|
|
• |
|
the indenture under which such Debt Securities will be issued and
the trustee(s) thereunder;
|
|
• |
|
the currency or currency units for which the Debt Securities may be
purchased and the currency or currency unit in which the principal
and any interest is payable (in either case, if other than Canadian
dollars);
|
|
• |
|
whether such Debt Securities are senior or subordinated and, if
subordinated, the applicable subordination provisions;
|
|
• |
|
the percentage of the principal amount at which such Debt
Securities will be issued;
|
|
• |
|
the date or dates on which such Debt Securities will mature;
|
|
• |
|
the rate or rates per annum at which such Debt Securities will bear
interest (if any), or the method of determination of such rates (if
any);
|
|
• |
|
the dates on which any such interest will be payable and the record
dates for such payments;
|
|
• |
|
any redemption term or terms under which such Debt Securities may
be defeased;
|
|
• |
|
whether such Debt Securities are to be issued in registered form,
bearer form or in the form of temporary or permanent global
securities and the basis of exchange, transfer and ownership
thereof;
|
|
• |
|
the place or places where principal, premium and interest will be
payable;
|
28
|
• |
|
the designation and terms of any other Securities with which the
Debt Securities will be offered, if any, and the principal amount
of Debt Securities that will be offered with each Security;
|
|
• |
|
the securities exchange(s) on which such series of Debt Securities
will be listed, if any;
|
|
• |
|
any terms relating to the modification, amendment or waiver of any
terms of such Debt Securities or the applicable indenture;
|
|
• |
|
any change in the right of the trustee or the holders to declare
the principal, premium and interest with respect to such series of
debt securities to be due and payable;
|
|
• |
|
any limit upon the aggregate principal amount of the Debt
Securities of such series that may be authenticated and delivered
under the indenture;
|
|
• |
|
if other than the Corporation or the trustee, the identity of each
registrar and/or paying agent;
|
|
• |
|
if Debt Securities are issued as a Unit with another Security, the
date on and after which the Debt Securities and other Security will
be separately transferable;
|
|
• |
|
if Debt Securities are to be issued upon the exercise of Warrants,
the time, manner and place for such Securities to be authenticated
and delivered;
|
|
• |
|
if Debt Securities are to be convertible or exchangeable into other
securities of the Corporation, the terms and procedures for the
conversion or exchange of the Debt Securities into other
securities; and
|
|
• |
|
any other specific terms of the Debt Securities of such series,
including any events of default or covenants.
|
Subscription Receipts
Subscription Receipts may be offered separately or together with
other Securities, as the case may be. The Subscription Receipts may
be issued under a subscription receipt agreement.
The applicable Prospectus Supplement will include details of any
subscription receipt agreement covering the Subscription Receipts
being offered. A copy of any subscription receipt agreement
relating to an offering of Subscription Receipts will be filed by
the Corporation with the relevant securities regulatory authorities
in Canada after the Corporation has entered into it. The specific
terms of the Subscription Receipts, and the extent to which the
general terms described in this section apply to those Subscription
Receipts, will be set forth in the applicable Prospectus
Supplement. This description may include, without limitation, the
following (where applicable):
|
• |
|
the number of Subscription Receipts;
|
|
• |
|
the price at which the Subscription Receipts will be offered;
|
|
• |
|
the terms, conditions and procedures for the conversion of the
Subscription Receipts into other Securities;
|
|
• |
|
the designation, number and terms of the other Securities that may
be exchanged upon conversion of each Subscription Receipt;
|
|
• |
|
the designation, number and terms of other Securities with which
the Subscription Receipts will be offered, if any, and the number
of Subscription Receipts that will be offered with each
Security;
|
|
• |
|
terms applicable to the gross or net proceeds from the sale of the
Subscription Receipts plus any interest earned thereon;
|
|
• |
|
certain material Canadian tax consequences of owning the
Subscription Receipts; and
|
|
• |
|
any other material terms and conditions of the Subscription
Receipts.
|
29
PLAN OF
DISTRIBUTION
General
The Corporation may from time to time during the 25-month period that this Prospectus,
including any amendments and supplements hereto, remains valid,
offer for sale and sell up to an aggregate of $125,000,000 in
Securities hereunder.
The Securities may be sold by us (i) directly pursuant to
applicable statutory exemptions, (ii) to or through
underwriters or dealers, or (iii) through designated agents.
The Prospectus Supplement relating to a particular Offering of
Securities will identify any underwriter, dealer or agent engaged
in connection with the offering and sale of such Securities, and
will set forth the terms of the offering of such Securities,
including, to the extent applicable, any fees, discounts or any
other compensation payable to underwriters, dealers or agents in
connection with the offering, the method of distribution of the
Securities, the purchase price of the Securities (or the manner of
determination thereof if offered on a non-fixed price basis), the net
proceeds to us and any other material terms of the plan of
distribution (including sales in transactions that are deemed to be
“at-the-market distributions”
as defined in NI 44-102).
Any initial offering price and discounts, concessions or
commissions allowed or re-allowed or paid to underwriters,
dealers or agents may be changed from time to time. Only
underwriters named in the Prospectus Supplement are deemed to be
underwriters in connection with our Securities offered by that
Prospectus Supplement.
The Securities may be sold from time to time in one or more
transactions at a fixed price or prices or at non-fixed prices. If offered on a
non-fixed price basis,
the Securities may be offered at market prices prevailing at the
time of sale, at prices determined by reference to the prevailing
price of a specified security in a specified market or at prices to
be negotiated with purchasers including sales in transactions that
are deemed to be “at-the-market” distributions,
including sales made directly on the NEO or other existing trading
markets for the Securities, in which case the compensation payable
to an underwriter, dealer or agent in connection with any such sale
will be decreased by the amount, if any, by which the aggregate
price paid for the Securities by the purchasers is less than the
gross proceeds paid by the underwriter, dealer or agent to the
Corporation. The price at which the Securities will be offered and
sold may vary from purchaser to purchaser and during the period of
distribution.
Sales of Securities under an “at-the-market distribution”,
if any, will be made pursuant to an accompanying Prospectus
Supplement. Sales of Securities under any “at-the-market” program will
be made in transactions that are “at-the-market distributions”
as defined in NI 44-102.
The volume and timing of any “at-the-market distributions”
will be determined at the Corporation’s sole discretion.
No underwriter or dealer involved in an “at-the-market distribution”
under this Prospectus, no affiliate of such an underwriter or
dealer and no person or company acting jointly or in concert with
such an underwriter or dealer will over-allot securities in
connection with such distribution or effect any other transactions
that are intended to stabilize or maintain the market price of the
offered Securities or securities of the same class as the
Securities distributed under the “at-the-market distribution”,
including selling an aggregate number or principal amount of
Securities that would result in the underwriter creating an
over-allocation position in the Securities.
In connection with the sale of the Securities, underwriters,
dealers or agents may receive compensation from the Corporation
including in the form of underwriters’, dealers’ or agents’ fees,
commissions or concessions.
Underwriters, dealers and agents that participate in the
distribution of the Securities may be deemed to be underwriters for
the purposes of applicable Canadian securities legislation and any
such compensation that they receive from the Corporation and any
profit that they make on the resale of the Securities, may be
deemed to be underwriting commissions.
Underwriters, dealers or agents who participate in the distribution
of the Securities may be entitled, under agreements to be entered
into with the Corporation to indemnification by the Corporation
against certain
30
liabilities, including liabilities under Canadian securities
legislation, or to contribution with respect to payments, which
such underwriters, dealers or agents may be required to make in
respect thereof. Such underwriters, dealers and agents may be
customers of, engage in transactions with, or perform services for,
the Corporation in the ordinary course of business.
In connection with any Offering of Securities, subject to
applicable laws and other than an “at-the-market distribution”,
the underwriters, dealers or agents, as the case may be, may
over-allot or effect transactions which stabilize, maintain or
otherwise affect the market price of the offered Securities at a
level other than those which otherwise might prevail on the open
market. Such transactions may be commenced, interrupted or
discontinued at any time.
Unless specified in the applicable Prospectus Supplement, there is
no market through which the Subscription Receipts, Warrants, Units
and Debt Securities may be sold and purchasers may not be able to
resell the Subscription Receipts, Warrants, Units and Debt
Securities purchased under this Prospectus and the Prospectus
Supplement. This may affect the pricing of the Subscription
Receipts, Warrants, Units and Debt Securities in the secondary
market, the transparency and availability of trading prices, the
liquidity of the Subscription Receipts, Warrants, Units and Debt
Securities and the extent of issuer regulation. See “Risk
Factors”.
Offerings in the United States
The Securities have not been, and will not be, registered under the
U.S. Securities Act or any state securities laws and, subject to
certain exceptions, may not be offered or sold or otherwise
transferred or disposed of in the United States absent registration
or pursuant to an applicable exemption from registration under the
U.S. Securities Act and applicable state securities laws. In
addition, until 40 days after the commencement of an Offering of
Securities under any applicable Prospectus Supplement, an offer or
sale of Securities within the United States by any dealer (whether
or not participating in the Offering of Securities) may violate the
registration requirements of the U.S. Securities Act if such offer
is made otherwise than in reliance on an exemption from the
registration requirements of the U.S. Securities Act.
RISK FACTORS
An investment in the Securities involves a high degree of risk
and must be considered speculative due to the nature of the
Corporation’s business and present stage of development. Before
making an investment decision, prospective purchasers of Securities
should carefully consider the information described in this
Prospectus and the documents incorporated by reference herein,
including the applicable Prospectus Supplement. There are certain
risks inherent in an investment in the Securities, including the
factors described below and under the heading “Risk
Factors” in the Annual Information Form and under the
heading “Risks and Uncertainties” in the
Annual MD&A, and any other risk factors described herein or in
a document incorporated by reference herein, which investors should
carefully consider before investing. Additional risk factors
relating to a specific Offering of Securities will be described in
the applicable Prospectus Supplement. Some of the factors described
herein, in the documents incorporated by reference herein, and/or
the applicable Prospectus Supplement are interrelated and,
consequently, investors should treat such risk factors as a whole.
If any of the risk factors described herein, in the Annual
Information Form, in another document incorporated by reference
herein or in the applicable Prospectus Supplement occur, it could
have a material adverse effect on the business, financial condition
and results of operations of the Corporation. Additional risks and
uncertainties of which the Corporation currently is unaware or that
are unknown or that it currently deems to be immaterial could have
a material adverse effect on the Corporation’s business, financial
condition and results of operation. The Corporation cannot assure
purchasers that it will successfully address any or all of these
risks. There is no assurance that any risk management steps taken
will avoid future loss due to the occurrence of the risks described
herein, in the Annual Information Form, in the other documents
incorporated by reference herein or in the applicable Prospectus
Supplement or other unforeseen risks.
31
Risks Related to the Business of the Corporation
Novel Coronavirus “COVID-19”
The outbreak of the novel strain of coronavirus, specifically
identified as “COVID-19”,
has resulted in governments worldwide enacting emergency measures
to combat the spread of the virus. These measures, including the
implementation of travel bans, self-imposed quarantine periods and
social distancing, have caused material disruption to businesses
globally resulting in an economic slowdown. Global equity markets
have experienced significant volatility and weakness. Governments
and central banks have reacted with significant monetary and fiscal
interventions designed to stabilize economic conditions. The
duration and impact of the COVID-19 outbreak is unknown at this
time, as is the efficacy of the government and central bank
interventions. It is not possible to reliably estimate the length
and severity of these developments and the impact on the financial
results and condition of the Corporation and its operating
subsidiaries in future periods. However, depending on the length
and severity of the pandemic, COVID-19 could impact the
Corporation’s operations, could cause delays relating to approval
from Health Canada, the FDA and equivalent organizations in other
countries, could postpone research activities, and could impair the
Corporation’s ability to raise funds depending on COVID-19s effect on capital
markets.
The rapid development of the COVID-19 pandemic and the measures
being taken by governments and private parties to respond to it are
extremely fluid. While the Corporation has continuously sought to
assess the potential impact of the pandemic on its operations, any
assessment is subject to extreme uncertainty as to probability,
severity and duration. The Corporation has attempted to assess the
impact of the pandemic by identifying risks in the following
principle areas:
|
• |
|
Mandatory Closure. In response to the pandemic, many
provinces, states and localities have implemented mandatory
shut-downs of business to prevent the spread of COVID-19. In the locations where the
Corporation operates or conducts research activity, these
activities have been deemed an “essential service”, and thus not
subject to the mandatory closures applicable to nonessential
businesses. The Corporation’s ability to generate revenue and meet
its milestones could be materially impacted by any shut down of
operations or services.
|
|
• |
|
Research and Development Disruptions. The Corporation relies
on a third parties for its research and development activities. If
these third parties are unable to continue operating due to
mandatory closures or other effects of the pandemic, it may
negatively impact the Corporation’s ability to meet its milestones
and may significantly delay development. At this time, the
Corporation has not experienced any significant disruptions.
|
|
• |
|
Staffing Disruption. The Corporation is, for the time being,
implementing among its staff where feasible “social distancing”
measures recommended by local authorities. The Corporation has
cancelled nonessential travel by employees, implemented remote
meetings where possible, and permitted all staff who can work
remotely to do so. For those whose duties require them to work
on-site, measures have
been implemented to reduce infection risk, such as reducing contact
with patients, mandating additional cleaning and hand disinfection
and providing masks and gloves to certain personnel. Nevertheless,
despite such measures, the Corporation may find it difficult to
ensure that its operations remain staffed due to employees falling
ill with COVID-19,
becoming subject to quarantine, or deciding not to come to come to
work on their own volition to avoid infection.
|
The Corporation is actively addressing the risk to business
continuity represented by each of the above factors through the
implementation of a broad range of measures throughout its
structure and is re-assessing its response to the
COVID-19 pandemic on an
ongoing basis. The above risks individually or collectively may
have a material impact on the Corporation’s ability to generate
revenue.
The Corporation has sufficient cash on hand raised via equity
financings to fund its operations for the next 12-months and meet its working
capital requirements. It is anticipated that the long-term goals of
the Corporation
32
will require additional capital contributions via debt or equity
financings. In the event that the impact of COVID-19 worsens and negatively
affects capital markets generally, there is a risk that the
Corporation may not be able to secure funding for these long-term
objectives. See “The Corporation – COVID-19 Pandemic”.
Regulatory Risks and Uncertainties
In Canada, certain psychedelic drugs, including psilocybin, are
classified as Schedule III drugs under the CDSA and as such,
medical and recreational use is illegal under Canadian federal
laws. In the United States, certain psychedelic drugs, including
psilocybin, are classified as Schedule I drugs under the CSA and
the Controlled Substances Import and Export Act and as such,
medical and recreational use is illegal under the U.S. federal
laws. There is no guarantee that psychedelic drugs or psychedelic
inspired drugs will ever be approved as medicines in any
jurisdiction in which the Corporation operates. All activities
involving such substances by or on behalf of the Corporation are
conducted in accordance with applicable federal, provincial, state
and local laws. Further, all facilities engaged with such
substances by or on behalf of the Corporation do so under current
licences and permits issued by appropriate federal, provincial and
local governmental agencies. While the Corporation is focused on
programs using psychedelic inspired compounds, the Corporation does
not have any direct or indirect involvement with the illegal
selling, production or distribution of any substances in the
jurisdictions in which it operates and does not intend to have any
such involvement. However, the laws and regulations generally
applicable to the industry in which the Corporation is involved in
may change in ways currently unforeseen. Any amendment to or
replacement of existing laws or regulations, including the
classification or re-classification of the substances
the Corporation is developing or working with, which are matters
beyond the Corporation’s control, may cause the Corporation’s
business, financial condition, results of operations and prospects
to be adversely affected or may cause the Corporation to incur
significant costs in complying with such changes or it may be
unable to comply therewith. A violation of any applicable laws and
regulations of the jurisdictions in which the Corporation operates
could result in significant fines, penalties, administrative
sanctions, convictions or settlements arising from civil
proceedings initiated by either government entities in the
jurisdictions in which the Corporation operates, or private
citizens or criminal charges.
The loss of the necessary licences and permits for Schedule III
drugs could have an adverse effect on the Corporation’s
operations.
The psychedelic drug industry is a fairly new industry and the
Corporation cannot predict the impact of the ever-evolving
compliance regime in respect of this industry. Similarly, the
Corporation cannot predict the time required to secure all
appropriate regulatory approvals for future products, or the extent
of testing and documentation that may, from time to time, be
required by governmental authorities. The impact of compliance
regimes, any delays in obtaining, or failure to obtain regulatory
approvals may significantly delay or impact the development of
markets, its business and products, and sales initiatives and could
have a material adverse effect on the business, financial condition
and operating results of the Corporation.
The success of the Corporation’s business is dependent on the
reform of controlled substances laws pertaining to psilocybin. If
controlled substances laws are not favourably reformed in Canada,
the United States, and other global jurisdictions, including
Jamaica, the commercial opportunity that the Corporation is
pursuing may be highly limited.
The Corporation makes no medical, treatment or health benefit
claims about the Corporation’s proposed products. The FDA, Health
Canada or other similar regulatory authorities have not evaluated
claims regarding psilocybin, DMT, psilocybin analogues, or other
psychedelic compounds or nutraceutical products. The efficacy of
such products have not been confirmed by approved research. There
is no assurance that the use of psilocybin, DMT, psilocybin
analogues, or other psychedelic compounds or nutraceuticals can
diagnose, treat, cure or prevent any disease or condition. Vigorous
scientific research and clinical trials are needed. The Corporation
has not conducted clinical trials for the use of its proposed
products. Any references to quality, consistency, efficacy and
safety of potential products do not imply that the Corporation
verified such in clinical trials or that the
33
Corporation will complete such trials. If the Corporation cannot
obtain the approvals or research necessary to commercialize its
business, it may have a material adverse effect on the
Corporation’s performance and operations.
The FDA has broad authority to enforce the provisions of the FFDCA
applicable to foods, drugs, dietary supplements, and cosmetics,
including powers to issue a public warning letter to a company, to
publicize information about illegal or harmful products, to request
a recall of products from the market, and to request the United
States Department of Justice to initiate a seizure action, an
injunction action, or a criminal prosecution in the U. S. courts.
The Corporation could be subject to fines and penalties, including
under administrative, civil and criminal laws for violating U.S.
laws and regulations, and the Corporation’s products could be
banned or subject to recall from the marketplace. The Corporation
could also be subject to possible business and consumer claims
under applicable statutory, product liability and common laws.
Risks Related to an Offering
Speculative Nature of Investment Risk
An investment in the Securities carries a high degree of risk and
should be considered as a speculative investment. The Corporation
has no history of earnings, limited cash reserves, limited
operating history, has not paid dividends, and is unlikely to pay
dividends in the immediate or near future.
Negative Operating Cash Flow and Going Concern
The Corporation has negative cash flow from operating activities
and has historically incurred net losses. There is no assurance
that sufficient revenues will be generated in the near future. To
the extent that the Corporation has negative operating cash flows
in future periods, it may need to deploy a portion of its existing
working capital to fund such negative cash flows. The Corporation
will be required to raise additional funds through the issuance of
additional equity securities or through loan financing. There is no
assurance that additional capital or other types of financing will
be available if needed or that these financings will be on terms at
least as favourable to the Corporation as those previously
obtained, or at all. The Corporation’s ability to successfully
raise additional capital and maintain liquidity may by impaired by
factors outside of its control, such as a shift in consumer
attitudes towards certain therapeutic methods or a downturn in the
economy.
Any inclusion in the Corporation’s financial statements of a going
concern opinion may negatively impact the Corporation’s ability to
raise future financing and achieve future revenue. The threat of
the Corporation’s ability to continue as a going concern will be
removed only when, in the opinion of the Corporation’s auditor, the
Corporation’s revenues have reached a level that is able to sustain
its business operations. If the Corporation is unable to obtain
additional financing from outside sources and eventually generate
enough revenues, the Corporation may be forced to sell a portion or
all of the Corporation’s assets, or curtail or discontinue the
Corporation’s operations. If any of these events happen, you could
lose all or part of your investment. The Corporation’s financial
statements do not include any adjustments to the Corporation’s
recorded assets or liabilities that might be necessary if the
Corporation becomes unable to continue as a going concern. See
“Risk Factors – Risks Related to an Offering – Potential
Need for Additional Financing”.
Discretion over the Use of Proceeds
While detailed information regarding the use of proceeds from the
sale of the Securities will be described in the applicable
Prospectus Supplement, the Corporation will have broad discretion
over the use of net proceeds from an offering by the Corporation of
its Securities. There may be circumstances where, for sound
business reasons, a reallocation of funds may be deemed prudent or
necessary. In such circumstances, the net proceeds will be
reallocated at the Corporation’s sole discretion.
Management will have discretion concerning the use of proceeds
ascribed in the applicable Prospectus Supplement as well as the
timing of their expenditures. As a result, an investor will be
relying on the judgment of management for the application of the
proceeds. Management may use the net proceeds described in a
Prospectus
34
Supplement in ways that an investor may not consider desirable. The
results and the effectiveness of the application of the proceeds
are uncertain. If the proceeds are not applied effectively, the
Corporation’s results of operations may suffer. See “Use of
Proceeds”.
Potential Need for Additional Financing
The continued development of the Corporation will require
additional financing. The Corporation’s activities do have scope
for flexibility in terms of the amount and timing of expenditures,
and expenditures may be adjusted accordingly. However, further
operations will require additional capital and will depend on the
Corporation’s ability to obtain financing through debt, equity or
other means. The Corporation’s ability to meet its obligations and
maintain operations may be contingent upon successful completion of
additional financing arrangements. There is no assurance that the
Corporation will be successful in obtaining the required financing
in the future or that such financing will be available on terms
acceptable to the Corporation. In addition, any future financing
may also be dilutive to existing shareholders of the Corporation.
See “Risk Factors – Risks Related to an Offering – Negative
Operating Cash Flow and Going Concern” and “– Potential
Dilution”.
Volatile Market Price of Corporation’s Common Shares
The securities market in Canada has recently experienced a high
level of price and volume volatility, and the market prices of
securities of many companies have experienced wide fluctuations in
price which have not necessarily been related to the operating
performance, underlying asset values or prospects of such
companies. There can be no assurance that continual fluctuations in
price will not occur. It may be anticipated that any market for the
Common Shares will be subject to market trends generally,
notwithstanding any potential success of the Corporation. The value
of the Common Shares distributed hereunder will be affected by such
volatility.
The volatility of the Common Shares may affect the ability of
holders to sell the Common Shares at an advantageous price or at
all. Market price fluctuations in the Common Shares may be
adversely affected by a variety of factors relating to the
Corporation’s business, including fluctuations in the Corporation’s
operating and financial results, such results failing to meet the
expectations of securities analysts or investors and downward
revisions in securities analysis’ estimates in connection
therewith, sales of additional Common Shares, governmental
regulatory action, adverse change in general market conditions or
economic trends, acquisitions, dispositions or other material
public announcements by the Corporation or its competitors, along
with a variety of additional factors, including, without
limitation, those set forth under the heading “Cautionary Note
Regarding Forward-Looking Information”. In addition, the market
price for securities on stock markets, including the Neo is subject
to significant price and trading fluctuations. These fluctuations
have resulted in volatility in the market prices of securities that
often has been unrelated or disproportionate to changes in
operating performance. These broad market fluctuations may
materially adversely affect the market price of the
Corporation.
Additionally, the value of the Common Shares is subject to market
value fluctuations based upon factors that influence the
Corporation’s operations, such as legislative or regulatory
developments, competition, technological change and changes in
interest rates or foreign exchange rates. There can be no assurance
that the market price of the Common Shares will not experience
significant fluctuations in the future, including fluctuations that
are unrelated to the Corporation’s performance. As at the date of
this Prospectus, only the Common Shares are listed on a securities
exchange and may be purchased in the secondary market.
Potential Dilution
The Corporation’s articles of incorporation and by-laws allow it to issue an
unlimited number of Common Shares for such consideration and on
such terms and conditions as established by the board of directors
of the Corporation, in many cases, without the approval of the
Corporation’s shareholders. The Corporation cannot predict the size
of future issuances of Common Shares or other Securities or the
effect that future issuances and sales of Common Shares or other
Securities will have on the market price of our Securities.
Issuances of a
35
substantial number of additional Securities, or the perception that
such issuances could occur, may adversely affect prevailing market
prices for the Common Shares. With any additional issuance of
Common Shares, investors will suffer dilution to their voting power
and the Corporation may experience dilution in its earnings per
share. “Risk Factors – Risks Related to an Offering – Potential
Need for Additional Financing”.
Market for Securities
There is currently no market through which the Securities, other
than the Common Shares, may be sold and, unless otherwise specified
in the applicable Prospectus Supplement, such unlisted Securities
may not be listed on any securities or stock exchange or any
automated dealer quotation system. As a consequence, purchasers may
not be able to resell such unlisted Securities purchased under this
Prospectus. This may affect the pricing of our Securities, other
than our Common Shares, in the secondary market, the transparency
and availability of trading prices, the liquidity of these
Securities and the extent of issuer regulation. There can be no
assurance that an active trading market for our Securities, other
than our Common Shares, will develop or, if developed, that any
such market, including for our Common Shares, will be
sustained.
Enforcement of Civil Liabilities
Certain of our subsidiaries and assets are located outside of
Canada. Accordingly, it may be difficult for investors to enforce
within Canada any judgments obtained against the Corporation,
including judgments predicated upon the civil liability provisions
of applicable Canadian securities laws or otherwise. Consequently,
investors may be effectively prevented from pursuing remedies
against the Corporation under Canadian securities laws or
otherwise.
The Corporation has subsidiaries incorporated in the United States.
It may not be possible for shareholders to effect service of
process outside of Canada against the directors and officers of the
Corporation who are not resident in Canada. In the event a judgment
is obtained in a Canadian court against one or more of such persons
for violations of Canadian securities laws or otherwise, it may not
be possible to enforce such judgment against persons not resident
in Canada. Additionally, it may be difficult for an investor, or
any other person or entity, to assert Canadian securities law or
other claims in original actions instituted in the United States.
Courts in such jurisdiction may refuse to hear a claim based on a
violation of Canadian securities laws or otherwise on the grounds
that such jurisdiction is not the most appropriate forum to bring
such a claim. Even if a foreign court agrees to hear a claim, it
may determine that the local law, and not Canadian law, is
applicable to the claim. If Canadian law is found to be applicable,
the content of applicable Canadian law must be proven as a fact,
which can be a time-consuming and costly process. Certain matters
of procedure will also be governed by foreign law.
CERTAIN FEDERAL INCOME
TAX CONSIDERATIONS
The applicable Prospectus Supplement will include a general summary
of certain Canadian federal income tax consequences which may be
applicable to a purchaser of Securities offered thereunder.
Investors should read the tax discussion in any Prospectus
Supplement with respect to a particular offering and consult their
own tax advisors with respect to their own particular
circumstances.
LEGAL MATTERS
Certain legal matters in connection with the offering of the
Securities will be passed upon by Aird & Berlis LLP on
behalf of the Corporation. As at the date of this Prospectus, the
designated professionals of Aird & Berlis LLP, as a group,
beneficially own, directly or indirectly, less than one percent of
the securities of the Corporation.
36
AUDITORS, TRANSFER
AGENT AND REGISTRAR
Zeifmans LLP, Chartered Professional Accountants, are the auditors
of the Corporation and have confirmed that they are independent of
the Company within the meaning of the relevant rules and related
interpretations prescribed by the relevant professional bodies in
Canada and any applicable legislation or regulation. Neither
Zeifmans LLP nor any designated professional thereof, had any
registered or beneficial interest in any securities or other
property of the Corporation at the time they prepared the relevant
financial statements incorporated by reference in this Prospectus
or at any time thereafter
The registrar and transfer agent of the Common Shares is Odyssey
Trust Company at its principal office in Calgary, Alberta.
37
Cybin (AMEX:CYBN)
Historical Stock Chart
From May 2023 to Jun 2023
Cybin (AMEX:CYBN)
Historical Stock Chart
From Jun 2022 to Jun 2023