Filed pursuant to Rule 424(b)(3)
Registration No. 333-227448
and Registration No. 333-227794
PROSPECTUS SUPPLEMENT NO. 9
(To
Prospectus dated October 12, 2018)
INTELLIPHARMACEUTICS INTERNATIONAL INC.
Common Shares
This
Prospectus Supplement No. 9 (this "Prospectus Supplement") amends
and supplements our Prospectus dated October 12, 2018, as
previously supplemented (the "Prospectus"), which form a part of
our Registration Statement (our "Registration Statement") on Form
F-1 (Registration Nos. 333-227448 and 333-227794). This Prospectus
Supplement is being filed to update, amend and supplement the
information included or incorporated by reference in the Prospectus
with the information contained in this Prospectus Supplement. The
Prospectus and this Prospectus Supplement relate to the public
offering of common shares issuable upon the exercise of warrants,
pre-funded warrants and underwriter’s warrants issued in the public
offering of securities which closed on October 16,
2018.
This
Prospectus Supplement includes information from our Report on Form
6-K, which was filed with the Securities and Exchange Commission on
November 27, 2018. The Report, as filed, is set forth
below.
This
Prospectus Supplement should be read in conjunction with the
Prospectus, except to the extent that the information in this
Prospectus Supplement updates and supersedes the information
contained in the Prospectus.
NEITHER THE U.S. SECURITIES AND EXCHANGE COMMISSION (THE "SEC") NOR
ANY STATE SECURITIES COMMISSION OR CANADIAN SECURITIES REGULATOR
HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF
THIS PROSPECTUS SUPPLEMENT IS TRUTHFUL OR COMPLETE. ANY
REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
_______________
The
date of this Prospectus Supplement is November 27,
2018
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November 2018.
Commission File
Number: 000-53805
Intellipharmaceutics International Inc.
(Translation of
registrant's name into English)
30 WORCESTER ROAD TORONTO, ONTARIO M9W 5X2
(Address of
principal executive office)
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F. Form 20-F [ x ] Form 40-F [ ]
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): ___
Note: Regulation S-T
Rule 101(b)(1) only permits the submission in paper of a Form 6-K
if submitted solely to provide an attached annual report to
security holders.
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ___
Note: Regulation S-T
Rule 101(b)(7) only permits the submission in paper of a Form 6-K
if submitted to furnish a report or other document that the
registrant foreign private issuer must furnish and make public
under the laws of the jurisdiction in which the registrant is
incorporated, domiciled or legally organized (the registrant's
“home country”), or under the rules of the home
country exchange on which the registrant's securities are traded,
as long as the report or other document is not a press release, is
not required to be and has not been distributed to the registrant's
security holders, and, if discussing a material event, has already
been the subject of a Form 6-K submission or other Commission
filing on EDGAR.
This Report of
Foreign Private Issuer on Form 6-K and the attached exhibit 99.1
shall be incorporated by reference into the Company's effective
Registration Statements on Form F-3, as amended and supplemented
(Registration Statement Nos. 333-172796 and 333-218297), filed with
the Securities and Exchange Commission, from the date on which this
Report is filed, to the extent not superseded by documents or
reports subsequently filed or furnished by Intellipharmaceutics
International Inc. under the Securities Act of 1933 or the
Securities Exchange Act of 1934.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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Intellipharmaceutics International Inc.
(Registrant)
/s/ Andrew Patient
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Date: November 27,
2018
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Andrew
Patient
Chief Financial Officer
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EXHIBIT LIST
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Exhibit
|
Description
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99.1
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News
release dated November 27, 2018 - Intellipharmaceutics Submits
Investigational New Drug Application to the U.S. FDA for IPCI006
(oxycodone hydrochloride immediate release) Tablets Incorporating
its Abuse Deterrent and Overdose Resistant Technology
|
EXHIBIT
99.1
Intellipharmaceutics Submits
Investigational New Drug Application to the U.S. FDA for IPCI006
(oxycodone hydrochloride immediate release) Tablets Incorporating
its Abuse Deterrent and Overdose Resistant
Technology
Toronto, Ontario, November 27, 2018 Intellipharmaceutics
International Inc. (NASDAQ and TSX:IPCI)
("Intellipharmaceutics" or the "Company"), a pharmaceutical company
specializing in the research, development and manufacture of novel
and generic controlled-release and targeted-release oral solid
dosage drugs, today announced that it has submitted an
investigational new drug (“IND”) application to the
U.S. Food and Drug Administration (“FDA”) for its
oxycodone hydrochloride immediate release (“IPCI006”)
tablets in the 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
strengths.
Oxycodone
hydrochloride is indicated for the management of moderate to severe
pain where the use of an opioid analgesic is
appropriate.
This
novel drug formulation incorporates the Company’s Paradoxical
OverDose Resistance Activating System (“PODRAS™”)
delivery technology and its novel Point Of Divergence Drug Delivery
System (“nPODDDS™”) technology.
IPCI006
is designed to prevent, delay or limit the release of oxycodone
hydrochloride when more intact tablets than prescribed are
ingested, thus delaying or preventing overdose and allowing for
sufficient time for a rescue or medical intervention to take place.
It is also intended to present a significant barrier to abuse by
snorting, “parachuting”, injecting or smoking finely
crushed oxycodone hydrochloride immediate release
tablets.
The
data generated from the studies conducted under this IND is
expected to form part of a new drug application (“NDA”)
seeking FDA approval for IPCI006 tablets.
If
approved, IPCI006 may be the first immediate release formulation of
oxycodone hydrochloride intended to simultaneously prevent or delay
overdose and prevent abuse by intranasal or intravenous
routes.
The CEO
of Intellipharmaceutics, Dr. Isa Odidi, said, “We believe
IPCI006 not only will demonstrate the strength of our
abuse-deterrent technologies, but also the value of our portfolio
of oxycodone hydrochloride product candidates. We are particularly
excited at the potential of having the first immediate release
formulation of oxycodone hydrochloride tablets focused on
presenting a barrier to abuse through overdose by taking multiple
tablets, abuse through intranasal inhalation and abuse through
intravenous injection – in one
formulation.”
According
to Symphony Health Solutions Corporation, U.S. sales of oxycodone
hydrochloride immediate release for the 12 months ended October 31,
2018 were approximately $710 Million (in TRx MBS Dollars, which
represents projected new and refilled prescriptions representing a
standardized dollar metric based on manufacturer's published
catalog or list prices to wholesalers and does not represent actual
transaction prices and does not include prompt pay or other
discounts, rebates or reductions in price).
There can be no assurance that we will be successful in
submitting any NDA with the FDA, that the FDA will approve the
Company’s IPCI006 product candidate for sale in the U.S.
market or any related abuse-deterrent label claims, or that it will
ever be successfully commercialized and produce significant revenue
for us.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a
pharmaceutical company specializing in the research, development
and manufacture of novel and generic controlled-release and
targeted-release oral solid dosage drugs. The Company's patented
Hypermatrix™ technology
is a multidimensional controlled-release drug delivery platform
that can be applied to a wide range of existing and new
pharmaceuticals. Intellipharmaceutics has developed several drug
delivery systems based on this technology platform, with a pipeline
of products (some of which have received FDA approval) in various
stages of development. The Company has abbreviated new drug
application (“ANDA”) and NDA 505(b)(2) drug product
candidates in its development pipeline. These include the
Company’s abuse-deterrent
oxycodone hydrochloride extended release formulation
(“Oxycodone ER”) based on its proprietary
nPODDDS™ drug delivery
system (for which an NDA has been filed with the FDA), and
Regabatin™ XR (pregabalin
extended-release capsules).
Cautionary Statement Regarding Forward-Looking
Information
Certain statements in this document constitute
“forward-looking statements” within the meaning of the
United States Private Securities Litigation Reform Act of 1995
and/or “forward-looking information” under the
Securities Act (Ontario). These statements include, without
limitation, statements expressed or implied regarding our
expectations regarding our plans, goals and milestones, status of
developments or expenditures relating to our business, plans to
fund our current activities, and statements concerning our
partnering activities, health regulatory submissions, strategy,
future operations, future financial position, future sales,
revenues and profitability, projected costs and market penetration
and risks or uncertainties related to our ability to realize any
benefits from our recent reverse stock split and our ability to
comply with the Nasdaq and TSX continued listing standards. In some
cases, you can identify forward-looking statements by terminology
such as “appear”, “unlikely”,
“target”, "may", "will", "should", "expects", "plans",
"plans to", "anticipates", "believes", "estimates", "predicts",
"confident", "prospects", "potential", "continue", "intends", "look
forward", "could", “would”, “projected”,
“goals”, “set to”, “seeking” or
the negative of such terms or other comparable terminology. We made
a number of assumptions in the preparation of our forward-looking
statements. You should not place undue reliance on our
forward-looking statements, which are subject to a multitude of
known and unknown risks and uncertainties that could cause actual
results, future circumstances or events to differ materially from
those stated in or implied by the forward-looking statements. Risks
and uncertainties relating to us and our business can be found in
the "Risk Factors" section of our latest annual information form,
our latest Form 20-F, and our latest Form F-1 and Form F-3
(including any documents forming a part thereof or incorporated by
reference therein), as amended, as well as in our reports, public
disclosure documents and other filings with the securities
commissions and other regulatory bodies in Canada and the U.S.,
which are available on www.sedar.com and www.sec.gov. The
forward-looking statements reflect our current views with respect
to future events and are based on what we believe are reasonable
assumptions as of the date of this document and we disclaim any
intention and have no obligation or responsibility, except as
required by law, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Trademarks used herein are the property of their respective
holders.
Unless the context otherwise requires, all references to "we,"
"us," "our," "Intellipharmaceutics," and the "Company" refer to
Intellipharmaceutics International Inc. and its
subsidiaries.
The information attributed to Symphony Health Solutions Corporation
herein is provided as is, and Symphony makes no representation
and/or warranty of any kind, including but not limited to, the
accuracy and/or completeness of such information.
CONTACT INFORMATION
Company
Contact:
Intellipharmaceutics
International Inc.
Andrew
Patient
Chief
Financial Officer
416.798.3001
ext. 106
investors@intellipharmaceutics.com
Investor
Contact:
ProActive
Capital
Kirin
Smith
646.863.6519
ksmith@pcgadvisors.com