AUSTIN, Texas, Aug. 9 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. announced today that the Company and the FDA have reached agreement to incorporate the use of Introgen’s biomarkers in the analysis of ADVEXIN clinical data in support of FDA approval of ADVEXIN p53 cancer therapy. Introgen recently presented prognostic biomarker data identifying patients with statistically significant increased survival and disease control following ADVEXIN therapy.
Max Talbott, Introgen’s senior vice president of Worldwide Commercial Development and Regulatory Affairs stated, “The use of Introgen’s prognostic biomarkers for clinical data analysis is a key regulatory element in positioning ADVEXIN therapy for FDA approval. We now plan to use the biomarkers to analyze our phase 3 patient data. The FDA has previously told the company that its Phase 3 trial data may be used for interim efficacy analyses.”
During the quarter Introgen also advanced its research and development and clinical trial programs. Introgen reported its financial results were in line with expectations and guidance for the quarter ended June 30, 2006. During the quarter, Introgen used cash, cash equivalents and short-term investments of $5.9 million to conduct its operations. Introgen’s cash, cash equivalents, marketable securities and short-term investments were $23.4 million at June 30, 2006.
Revenue was $98,000 for the quarter ended June 30, 2006, compared to revenue of $225,000 for the quarter ended March 31, 2006 and $336,000 for the quarter ended June 30, 2005. Operating expense was $8.2 million for the quarter ended June 30, 2006 and $8.8 million for the quarter ended March 31, 2006, which includes $1.6 million and $2.2 million, respectively, of expense related to stock options primarily resulting from the implementation of Statement of Financial Accounting Standard No. 123R, “Share-Based Payments.” Operating expense was $7.7 million for the quarter ended June 30, 2005, including $711,000 of expense related to stock options.
Introgen reported a net loss of $7.7 million, or $0.21 per share, for the quarter ended June 30, 2006. These results compare to a net loss of $8.2 million, or $0.22 per share, for the previous quarter ended March 31, 2006 and a net loss of $7.1 million, or $0.23 per share, for the comparable quarter ended June 30, 2005.
Introgen reported a net loss of $15.9 million, or $0.43 per share, for the six months ended June 30, 2006. These results compare to a net loss of $13.3 million, or $0.43 per share, for the six months ended June 30, 2005. Revenue was $323,000 for the six months ended June 30, 2006, compared to revenue of $845,000 for the six months ended June 30, 2005. Operating expense was $17.0 million for the six months ended June 30, 2006, which includes $3.8 million of expense related to stock options primarily resulting from the implementation of Statement of Financial Accounting Standard No. 123R, “Share- Based Payments.” Operating expense was $14.8 million for the six months ended June 30, 2005, including $799,000 of expense related to stock options.
Quarterly Conference Call
Introgen has scheduled a conference call to discuss regulatory developments and financial results at 4:30 p.m. Eastern Time today. Introgen invites interested investors to listen to the call which will be carried live on its Web site at http://www.introgen.com . The call may also be accessed by dialing 1-877-616-4476 or 1-706-679-7372. For those unable to listen to the broadcast the call will be archived on Introgen’s website.
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.
Statements in this release that are not strictly historical may be “forward-looking” statements, including those relating to Introgen’s future success with its research programs and clinical development program for treatment of cancer or other diseases and Introgen’s financial performance. The actual results may differ from those described in this release due to 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.
Editor’s Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen’s website at http://www.introgen.com
Contact: Introgen Therapeutics, Inc. C. Channing Burke (512) 708 9310 Ext. 322 Email: c.burke@introgen.com INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEET JUNE 30, DECEMBER 31, 2006 2005 (Unaudited) (Thousands) CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS 21,476 33,122 MARKETABLE SECURITIES 1,901 2,892 OTHER CURRENT ASSETS 347 297 PROPERTY AND EQUIPMENT, NET 5,741 6,181 GRANT RIGHTS ACQUIRED 0 163 OTHER ASSETS 303 326 TOTAL ASSETS $29,768 $42,981 ACCOUNTS PAYABLE, ACCRUALS AND OTHER CURRENT LIABILITIES $6,743 $6,782 NOTES PAYABLE, NET OF CURRENT PORTION 7,709 7,784 OTHER LONG TERM LIABILITIES 1,425 1,404 TOTAL LIABILITIES 15,877 15,970 TOTAL STOCKHOLDERS’ EQUITY 13,891 27,011 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $29,768 $42,981 INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited) THREE MONTHS ENDED SIX MONTHS ENDED JUNE 30, JUNE 30, 2006 2005 2006 2005 (Thousands except per share information.) CONTRACT SERVICES, GRANT AND OTHER REVENUE $98 $336 $323 $845 OPERATING EXPENSES: RESEARCH AND DEVELOPMENT 4,896 5,700 9,942 10,939 GENERAL AND ADMINISTRATIVE 3,273 2,006 7,069 3,816 TOTAL OPERATING EXPENSES 8,169 7,706 17,011 14,755 LOSS FROM OPERATIONS (8,071) (7,370) (16,688) (13,910) INTEREST INCOME, INTEREST EXPENSE AND OTHER INCOME, NET 380 309 778 618 NET (LOSS) ($7,691) ($7,061) ($15,910) ($13,292) NET LOSS PER SHARE, BASIC AND DILUTED ($0.21) ($0.23) ($0.43) ($0.43) SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER SHARE 37,214 31,182 37,197 30,963
Introgen Therapeutics, Inc.
CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,+1-512-708-9310, ext. 322, or c.burke@introgen.com
Web site: http://www.introgen.com/
