Intellipharmaceutics International Inc. (Nasdaq:IPCI) (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, in order to replace its
existing expiring shelf registration statement, it has filed
a new shelf registration statement on Form F-3 with the U.S.
Securities and Exchange Commission ("SEC”). The new
registration statement is subject to review by the SEC. The Company
has also filed a preliminary short form base shelf prospectus with
securities regulatory authorities in each of the provinces and
territories of Canada, except Quebec. The Company has no immediate
plans to sell securities under the shelf prospectus and new
registration statement, except as it may deem appropriate through
the sale of additional common shares under its existing
at-the-market equity program or otherwise. The filing is intended
to restore the original capacity which was available under its
previous base shelf prospectus and expiring shelf registration
statement, thereby maintaining flexibility to capitalize on future
financing opportunities, if necessary.
Once the shelf prospectus is cleared and the new shelf
registration statement is declared effective by the SEC, these
filings would, subject to securities regulatory requirements and
limitations, provide for the potential offering of up to an
aggregate of US$100 million of the Company's common shares,
preference shares, warrants, subscription receipts and units, or
any combination thereof, from time to time in one or more
offerings. The Company's existing universal shelf registration
statement expires on June 4, 2017, but, in accordance with SEC
rules, the Company may make securities offerings under the existing
shelf registration statement until the new registration statement
is declared effective, subject to a maximum extension of 180 days.
The specific terms of such future offerings, if any, would be
subject to market conditions and established, subject to the
approval of the Company's Board of Directors, at the time of such
offering and will be described in detail in a prospectus supplement
filed at the time of any such offering.
A registration statement relating to these securities has been
filed with the U.S. Securities and Exchange Commission, but has not
yet become effective. These securities may not be sold, nor
may offers to buy be accepted prior to the time the registration
statement becomes effective. This news release shall not constitute
an offer to sell or the solicitation of an offer to buy these
securities in any jurisdiction, nor shall there be any sale of
these securities in any jurisdiction in which an offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such
jurisdiction.
When available, copies of the prospectus and any prospectus
supplement relating to a particular offering may be obtained by
contacting Domenic Della Penna, Chief Financial Officer at
Intellipharmaceutics International Inc., 30 Worcester Road,
Toronto, ON Canada M9W 5X2.
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 the efficient development of a wide range of
existing and new pharmaceuticals. Based on this technology
platform, Intellipharmaceutics has developed several drug delivery
systems and a pipeline of products (some of which have received
U.S. Food and Drug Administration ("FDA”) approval) and product
candidates in various stages of development, including Abbreviated
New Drug Applications ("ANDAs") filed with the FDA (and
one Abbreviated New Drug Submission filed with Health Canada) in
therapeutic areas that include neurology, cardiovascular,
gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application ("NDA")
505(b)(2) specialty drug product candidates in its development
pipeline. These include Rexista™, an abuse deterrent oxycodone
based on its proprietary nPODDDS™ novel Point Of Divergence Drug
Delivery System (for which an NDA has been filed with the FDA), and
Regabatin™ XR (pregabalin extended-release capsules). Our current
development effort is increasingly directed towards improved
difficult-to-develop controlled-release drugs which follow an NDA
505(b)(2) regulatory pathway. The Company has increased its
research and development emphasis towards new product development,
facilitated by the 505(b)(2) regulatory pathway, by advancing the
product development program for both Rexista™ and Regabatin™. The
505(b)(2) pathway (which relies in part upon the approving agency's
findings for a previously approved drug) both accelerates
development timelines and reduces costs in comparison to NDAs for
new chemical entities. An advantage of our strategy for development
of NDA 505(b)(2) drugs is that our product candidates can, if
approved for sale by the FDA, potentially enjoy an exclusivity
period which may provide for greater commercial opportunity
relative to the generic ANDA route.
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 plans, goals and milestones, status of developments
or expenditures relating to our business, plans to fund our current
activities, statements concerning our partnering activities, health
regulatory submissions, strategy, future operations, future
financial position, future sales, revenues and profitability,
projected costs, and market penetration. In some cases, you can
identify forward-looking statements by terminology such as "may,"
"will," "should," "expects," "plans," "plans to," "anticipates,"
"believes," "estimates," "predicts," "confident", "prospects,"
"potential," "continue," "intends," "look forward," "could," 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, uncertainties and other factors that could affect our actual
results include, but are not limited to, the effects of general
economic conditions, securing and maintaining corporate alliances,
our estimates regarding our capital requirements, and the effect of
capital market conditions and other factors, including the current
status of our product development programs, on capital
availability, the potential dilutive effects of any future
financing and the expected use of any proceeds from any offering of
our securities, our ability to maintain compliance with the
continued listing requirements of the principal markets on which
our securities are traded, our programs regarding research,
development and commercialization of our product candidates, the
timing of such programs, the timing, costs and uncertainties
regarding obtaining regulatory approvals to market our product
candidates and the difficulty in predicting the timing and results
of any product launches, the timing and amount of profit-share
payments from our commercial partners, and the timing and amount of
any available investment tax credits, the actual or perceived
benefits to users of our drug delivery technologies, products and
product candidates as compared to others, our ability to establish
and maintain valid and enforceable intellectual property rights in
our drug delivery technologies, products and product candidates,
the scope of protection provided by intellectual property for our
drug delivery technologies, products and product candidates, the
actual size of the potential markets for any of our products and
product candidates compared to our market estimates, our selection
and licensing of products and product candidates, our ability to
attract distributors and collaborators with the ability to fund
patent litigation and with acceptable product development,
regulatory and commercialization expertise and the benefits to be
derived from such collaborative efforts, sources of revenues and
anticipated revenues, including contributions from distributors and
collaborators, product sales, license agreements and other
collaborative efforts for the development and commercialization of
product candidates, our ability to create an effective direct sales
and marketing infrastructure for products we elect to market and
sell directly, the rate and degree of market acceptance of our
products, delays that may be caused by changing regulatory
requirements, the difficulty in predicting the timing of regulatory
approval and launch of competitive products, the difficulty in
predicting the impact of competitive products on volume, pricing,
rebates and other allowances, the inability to forecast wholesaler
demand and/or wholesaler buying patterns, the seasonal fluctuation
in the numbers of prescriptions written for our Focalin XR®
(dexmethylphenidate hydrochloride extended-release) capsules which
may produce substantial fluctuations in revenues, the timing and
amount of insurance reimbursement regarding our products, changes
in laws and regulations affecting the conditions required by the
FDA for approval, testing and labeling of drugs including abuse or
overdose deterrent properties, and changes affecting how opioids
are regulated and prescribed by physicians, changes in laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical products,
changes in U.S. federal income tax laws currently being considered,
including, but not limited to, the U.S. changing the method by
which foreign income is taxed and resulting changes to the passive
foreign investment company laws and regulations which may impact
our shareholders, the success and pricing of other competing
therapies that may become available, our ability to retain and hire
qualified employees, the availability and pricing of third party
sourced products and materials, challenges related to the
development, commercialization, technology transfer, scale-up,
and/or process validation of manufacturing processes for our
products or product candidates, the manufacturing capacity of
third-party manufacturers that we may use for our products,
potential product liability risks, the recoverability of the cost
of any pre-launch inventory should a planned product launch
encounter a denial or delay of approval by regulatory bodies,
a delay in commercialization, or other potential issues, the
successful compliance with FDA, Health Canada and other
governmental regulations applicable to us and our third party
manufacturers' facilities, products and/or businesses,
difficulties, delays or changes in the FDA approval process or test
criteria for ANDAs and NDAs, challenges in securing final FDA
approval for our product candidates, including RexistaTM in
particular, if a patent infringement suit is filed against us with
respect to any particular product candidates (such as in the case
of RexistaTM), which could delay the FDA's final approval of such
product candidates, healthcare reform measures that could hinder or
prevent the commercial success of our products and product
candidates, the FDA may not approve requested product labeling for
our product candidate(s) having abuse-deterrent properties,
targeting common forms of abuse (oral, intra-nasal and
intravenous), risks associated with cyber-security and the
potential for vulnerability of our digital information or the
digital information of a current and/or future drug
development or commercialization partner of ours, and risks arising
from the ability and willingness of our third-party
commercialization partners to provide documentation that may be
required to support information on revenues earned by us from those
commercialization partners. Additional 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-3 (including any documents forming a
part thereof or incorporated by reference therein), 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.
Company
Contact: |
Intellipharmaceutics
International Inc. |
Domenic Della
Penna |
Chief Financial
Officer |
416-798-3001 ext. 106
investors@intellipharmaceutics.com |
|
Investor
Contact: |
ProActive Capital |
Kirin Smith |
646-863-6519ksmith@proactivecapital.com |
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