Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted
molecular therapies for cancer, today announced that on September 29,
2008, it received a letter from The Nasdaq Stock Market ("Nasdaq”)
indicating that during the preceding 30 consecutive trading days, the
closing bid price of Introgen’s common stock
has been below the $1.00 minimum bid price per share required for
continued listing on the Nasdaq Global Market under Nasdaq Marketplace
Rule 4450(a)(5). This letter has no immediate effect on the listing of
Introgen’s common stock.
COMPLIANCE PROCESS
The letter stated that, in accordance with Nasdaq Marketplace Rule
4450(e)(2), Introgen will be provided 180 calendar days, or until March
30, 2009, to regain compliance with the minimum bid price requirement by
maintaining a closing bid price of $1.00 per share or higher for a
minimum of 10 consecutive trading days. If Introgen is unsuccessful in
meeting the minimum bid requirement during this initial 180-day period,
Nasdaq will provide notice to Introgen that the company’s
common stock will be delisted from the Nasdaq Global Market. If Introgen
receives such a notice, Introgen may appeal Nasdaq’s
determination to delist its common stock, or alternatively, it may apply
to transfer its common stock to the Nasdaq Capital Market providing
Introgen satisfies all criteria for initial listing on the Nasdaq
Capital Market, other than compliance with the minimum bid price
requirement. If such application to the Nasdaq Capital Market is
approved, then Introgen will have an additional 180-day compliance
period in order to regain compliance with the minimum bid price
requirement while listed on the Nasdaq Capital Market.
BACKGROUND
As announced on September 5, 2008, Introgen also received a letter from
Nasdaq indicating that it was not in compliance with Marketplace Rule
4450(b)(1)(A), requiring a minimum $50 million market value of listed
securities for continued inclusion on The Nasdaq Global Market. Introgen
is appealing such determination. The company’s
shares will continue to be listed on The Nasdaq Global Market pending
the outcome of the appeal. Alternatively, Introgen may apply to have its
listing transferred to The Nasdaq Capital Market, provided that it
satisfies the requirements for continued listing on that market at the
time of transfer.
ABOUT INTROGEN
Introgen Therapeutics, Inc. is a biopharmaceutical company focused on
the discovery, development and commercialization of targeted molecular
therapies for the treatment of cancer and other diseases. Introgen is
developing molecular therapeutics, immunotherapies, vaccines and
nano-particle tumor suppressor therapies to treat a wide range of
cancers using tumor suppressors, cytokines and genes. Introgen maintains
integrated research, development, manufacturing, clinical and regulatory
departments and operates multiple manufacturing facilities including a
commercial scale cGMP manufacturing facility. In June 2008, Introgen
submitted a BLA to the FDA requesting marketing approval for ADVEXIN p53
therapy to treat recurrent, refractory head and neck cancer.
Simultaneously, Gendux Molecular Limited, an Introgen subsidiary,
submitted a MAA to the EMEA for the same indication. The EMEA accepted
Introgen’s MAA for review. The FDA has
declined to file Introgen’s BLA at this time,
and Introgen plans to appeal such refusal. ADVEXIN represents the first
of a new class of tumor suppressor cancer therapy and is the first of
its kind to be submitted for regulatory approval in the United States
and Europe.
FORWARD-LOOKING STATEMENTS
Statements in this release that are not strictly historical may be "forward-looking”
statements, including those relating to Introgen’s
ability to maintain its listing on the Nasdaq Global Market or to
transfer its listing to the Nasdaq Capital Market, and the success of
any appeal to Nasdaq. The actual results may differ from those described
in this release due to uncertainties in the Nasdaq delisting process and
the discretionary nature of the Panel’s
decisions; as well as to the risks and uncertainties that exist in
Introgen’s operations and business
environment, including Introgen’s stage of
product development and the limited experience in the development of
gene-based drugs in general, dependence upon proprietary technology and
the current competitive environment, history of operating losses and
accumulated deficits, reliance on collaborative relationships, and
uncertainties related to clinical trials, the safety and efficacy of
Introgen’s product candidates, the ability to
obtain the appropriate regulatory approvals, Introgen’s
patent protection and market acceptance, as well as other risks detailed
from time to time in Introgen’s filings with
the Securities and Exchange Commission including its filings on Form
10-K and Form 10-Q. Introgen undertakes no obligation to publicly
release the results of any revisions to any forward-looking statements
that reflect events or circumstances arising after the date hereof.