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Introgen Therapeutics Announces Third Quarter 2001 Results (PR Newswire) ... trials for INGN 201 in additional cancer indications including prostate, ovarian, bladder, brain, and breast cancer.......Introgen`s second product candidate, INGN 241 (Adenoviral-mda7) for the treatment of solid tumors, is in Phase I clinical development.... - Oct 30 4:04 PM ET

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Posted on: 10/30/2001

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Tuesday October 30, 4:04 pm Eastern Time

Press Release

SOURCE: Introgen Therapeutics, Inc.

Introgen Therapeutics Announces Third Quarter 2001 Results

AUSTIN, Texas, Oct. 30 /PRNewswire/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) announced today that its results for the quarter ended September 30, 2001, were consistent with its expectations, during which time Introgen reported progress in its clinical development program, patent portfolio and manufacturing experience.

In September 2001 Introgen changed its fiscal year end from June 30 to December 31. Introgen reported a net loss of $6.1 million, or $0.28 per share, for the quarter ended September 30, 2001. These results compare to a net loss of $1.9 million, or $0.47 per share, for the corresponding quarter of 2000. Introgen had nominal revenue for the third quarter of 2001 compared to revenue of $1.6 million for the corresponding quarter of 2000. Total operating expenses were $6.7 million for the third quarter of 2001 compared to $3.6 million for the corresponding quarter of 2000. Introgen had cash, cash equivalents, short-term investments and long-term investments of $54.1 million at September 30, 2001.

Introgen's president and CEO, David G. Nance, said, "Introgen experienced a productive quarter as we continued to move forward clinically with multiple programs. Introgen is aggressively prosecuting its clinical development programs for INGN 201 and INGN 241. A number of clinical trials are enrolling patients including two Phase III registration trials. Our clinical and regulatory teams have expanded to meet the demand of our growing clinical study operations. We now have three medical doctors and approximately a dozen Ph.D.s on staff. On the manufacturing front, Introgen received two awards to produce the worldwide adenoviral reference material to be used by companies and academic institutions developing adenovirus based products, which we believe validates our manufacturing expertise and infrastructure and distinguishes us among our peers."

"Significant progress for our patent portfolio was attained by the issuance of three U.S. patents, including a patent that covers the use of any gene in combination with DNA damaging agents such as chemotherapy and radiation therapy," said David L. Parker, J.D., Ph.D., vice president of intellectual property for Introgen. "Two patents covering the PTEN and p16 genes strengthen the position of those product candidates. The combination therapy patent further solidifies and expands Introgen's leading position in combination therapy. Introgen's previous combination therapy patents concern p53 gene therapy, where this patent is based on the finding that chemotherapy or radiation actually enhances the expression of any gene therapy, regardless of the therapeutic gene that is used, and regardless of how the gene is administered."

"We look forward to presenting interim data for INGN 241, Adenoviral-mda7, at the upcoming 10th International Conference on Gene Therapy of Cancer in San Diego where we, and our collaborators, have numerous presentations for various products in Introgen's pipeline," said Tom Finnegan, vice president of corporate development and finance. "Introgen will continue to increase its exposure to the financial community by making several presentations at key conferences in Europe and hosting private meetings during November."

Quarterly Conference Call

Introgen has scheduled a conference call to discuss the financial results at 4:30 p.m. ET today. Interested parties can access a live Internet broadcast at . For those unable to listen to the broadcast the call will be archived at the same address or at in the Investor Relations section.

Introgen is a leader in the development and production of gene-based drugs for the treatment of cancer and other diseases. Introgen's product candidates engage precise molecular targets to produce a highly specific therapeutic effect. By selectively killing cancer cells and harnessing natural protection mechanisms, Introgen's product candidates may be less toxic than conventional treatments. Introgen specializes in combining appropriate gene delivery systems and therapeutic genes to make its gene-based drugs. Introgen is currently conducting two Phase III clinical trials with its lead product, INGN 201, for the treatment of head and neck cancer. Introgen's gene therapeutics have been used in approximately twenty clinical trials worldwide either alone or in combination with conventional treatments such as chemotherapy, surgery and radiotherapy. Introgen is also conducting a Phase II clinical trial for INGN 201 in lung cancer and Phase I trials for INGN 201 in additional cancer indications including prostate, ovarian, bladder, brain, and breast cancer. New applications using the human immune system with INGN 201 are being explored. Introgen's second product candidate, INGN 241 (Adenoviral-mda7) for the treatment of solid tumors, is in Phase I clinical development.

Certain statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties. Such forward-looking statements include, but are not limited to, those relating to the success of Introgen's clinical development program, the strength of Introgen's intellectual property portfolio and Introgen's manufacturing expertise. There can be no assurance that Introgen will be able to commercially develop gene-based drugs, that necessary regulatory approvals will be obtained or that any clinical trials or studies undertaken will be successful or that the proposed treatments will prove to be safe and/or effective. The actual results may differ from those described in this press release due to risks and uncertainties that exist in Introgen's operations and business environment, including, but without limitation, Introgen's stage of product development and the limited experience in the development of gene- based drugs in general, its dependence upon proprietary technology and current competition, history of operating losses and accumulated deficits, Introgen's reliance on collaborative relationships, and uncertainties related to clinical trials, safety, efficacy, the ability to obtain the appropriate regulatory approvals, 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 annual report of Form 10-K filed with the Securities and Exchange Commission and the 10-K filed with the Securities and Exchange Commission on September 19, 2001. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising from the date hereof.

Editor's Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's Website at: or call Introgen's toll-free Investor Relations hotline at 1-877-776-GENE (4363).


                                              SEPTEMBER 30,    SEPTEMBER 30,
                                                  2001              2000

      REVENUES FROM AFFILIATE                         ---        $1,506,445

    OTHER REVENUE                                  14,627           138,133

      RESEARCH AND DEVELOPMENT                  5,044,655         2,447,593
      GENERAL AND ADMINISTRATIVE                1,684,624         1,111,320

        LOSS FROM OPERATIONS                   (6,714,652)       (1,914,335)

    INTEREST AND OTHER INCOME (EXPENSE), NET      611,230           (28,248)

        NET LOSS                              ($6,103,422)      ($1,942,583)

    NET LOSS PER SHARE, BASIC AND DILUTED          ($0.28)           ($0.47)
      NET LOSS PER SHARE                       21,435,044         4,165,985


                                              SEPTEMBER 30,       JUNE 30,
                                                  2001              2001

    CASH AND SHORT TERM INVESTMENTS           $54,065,593       $34,976,529
    RECEIVABLE FROM SALE OF PREFERRED STOCK           ---        25,000,000
    ACCOUNTS RECEIVABLE                           194,224               ---
    OTHER CURRENT ASSETS                           55,999           511,640
    PROPERTY AND EQUIPMENT, NET                10,973,366        11,507,385
    OTHER ASSETS                                  348,846           351,719
      TOTAL ASSETS                            $65,638,028       $72,347,273

     LIABILITIES                               $5,473,430        $6,191,943
     OBLIGATIONS, NET OF CURRENT PORTION        9,421,980         9,798,121
    OTHER LONG-TERM LIABILITIES                   352,535           288,000
      TOTAL LIABILITIES                        15,247,945        16,278,064
      TOTAL STOCKHOLDERS' EQUITY               50,390,083        56,069,209
       EQUITY                                 $65,638,028       $72,347,273

     Introgen Therapeutics, Inc.
     C. Channing Burke
     (512) 708 9310 Ext. 322

SOURCE: Introgen Therapeutics, Inc.

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