Introgen Therapeutics, Inc. (NASDAQ:INGN), a developer of targeted
molecular therapies for cancer, today announced that on September 4,
2008, it received a letter from The Nasdaq Stock Market ("Nasdaq")
indicating that it had not regained 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
intends to request a hearing before the Nasdaq Listing
Qualifications Panel (the "Panel”).
The company expects the hearing to take place within four to eight
weeks, and 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.
APPEAL PROCESS
Pursuant to The Nasdaq Marketplace Rules, the Panel has discretion to
grant an exception not to exceed 180 days from September 4, 2008, the
date of receipt of the Staff delisting notification, allowing the
Company to implement and adhere to a plan of compliance. There can be no
assurance that the Panel will grant the company's request for continued
listing on The Nasdaq Global Market. In the event of an unfavorable
determination by the Panel, the Company would alternatively apply to
have its common stock transferred to The Nasdaq Capital Market, as long
as it satisfies the requirements for continued inclusion set forth in
the Marketplace Rules. There can be no assurance that the Company's
shares will be approved for listing on The Nasdaq Capital Market.
BACKGROUND
As announced on August 1, 2008, Introgen received a letter from Nasdaq
indicating that it was not in compliance with the minimum $50 million
market value of listed securities nor the alternative requirement of a
minimum $50 million in total assets and total revenue required for
continued listing on The Nasdaq Global Market set forth in Marketplace
Rules 4450(b)(1)(A) and 4450(b)(1)(B), respectively. In accordance with
the Nasdaq Marketplace Rule 4450(e)(4), the company was provided a
period of 30 calendar days to regain compliance with the Marketplace
Rule.
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.