AUSTIN, Texas, May 10 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. announced today its results for the quarter ended March 31, 2006, reporting progress during the period in its research and development and clinical trial programs.
During the quarter ended March 31, 2006 Introgen used cash, cash equivalents and short-term investments of $5.7 million to conduct its operations. Introgen’s cash, cash equivalents, marketable securities and short-term investments were $30.1 million at March 31, 2006.
Revenue was $225,000 for the quarter ended March 31, 2006, compared to revenue of $624,000 for the quarter ended December 31, 2005 and $509,000 for the quarter ended March 31, 2005. Operating expense was $8.8 million for the quarter ended March 31, 2006, which includes $2.2 million of expense related to stock options 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 December 31, 2005, including $527,000 of expense related to stock options and $7.0 million for the quarter ended March 31, 2005, including $88,000 of expense related to stock options.
Introgen reported a net loss of $8.2 million, or $0.22 per share, for the quarter ended March 31, 2006. These results compare to a net loss of $6.7 million, or $0.19 per share, for the previous quarter ended December 31, 2005 and a net loss of $6.2 million, or $0.20 per share, for the comparable quarter ended March 31, 2005.
New ADVEXIN Data
During the conference call Introgen will present new data from its ADVEXIN clinical trials in recurrent head and neck cancer showing that ADVEXIN therapy was correlated with statistically significant increased durable tumor growth control and survival in this poor prognostic group of patients. In recurrent head and neck cancer, an abnormal p53 pathway detected by high p53 levels in tumor tissue is associated with a poor prognosis to standard therapy. In ADVEXIN Phase 2 clinical trials, this biomarker of abnormal p53 function identified patients most likely to benefit from ADVEXIN treatment that restores p53 pathway activity.
New Developments Discussed
Introgen will discuss other recent developments and announcements, including its decision to make ADVEXIN therapy available on a compassionate use basis for patients with Li-Fraumeni Syndrome cancers. Li-Fraumeni Syndrome (LFS) is an inherited genetic disorder that greatly increases the risk of developing several types of cancer typically with initial occurrence at a young age. The majority of LFS families have inherited mutations in the p53 tumor suppressor gene. The treatment of Li-Fraumeni tumors with ADVEXIN p53 represents therapy targeted to the molecular defect underlying the cause and progression of these malignancies. Cancers resulting from this syndrome are due to abnormal p53 function that is directly addressed by ADVEXIN’s mechanisms of action.
FDA News Release
During the conference call reference will be made to an FDA announcement made during the reporting quarter. The referenced FDA document can be accessed online at:
http://www.fda.gov/bbs/topics/news/2006/NEW01316.html
The company will also discuss filings for European registration of ADVEXIN under European Medicines Evaluation Agency (EMEA) Exceptional Approval provisions. These submissions are being made by Gendux, AB, Introgen’s wholly owned subsidiary based in Stockholm, Sweden.
Quarterly Conference Call
Introgen has scheduled a conference call to discuss its financial results at 4:30 p.m. Eastern Standard Time today. Introgen invites interested investors to listen to the call and view the accompanying slide presentation, descriptive of portions of the clinical data discussion, which will be carried live on its Web site at http://www.introgen.com . Those who wish to participate should log on several minutes before the discussion begins. After clicking on the presentation icon, investors should follow the instructions to ensure their systems are set up to hear the event and view the presentation slides, or download the correct applications at no charge. 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 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 MARCH 31, DECEMBER 31, 2006 2005 (Unaudited) (Thousands) CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS 27,378 33,122 MARKETABLE SECURITIES 2,764 2,892 OTHER CURRENT ASSETS 282 297 PROPERTY AND EQUIPMENT, NET 5,859 6,181 GRANT RIGHTS ACQUIRED 0 163 OTHER ASSETS 321 326 TOTAL ASSETS $36,604 $42,981 ACCOUNTS PAYABLE, ACCRUALS AND OTHER CURRENT LIABILITIES $6,662 $6,782 NOTES PAYABLE, NET OF CURRENT PORTION 7,683 7,784 OTHER LONG TERM LIABILITIES 1,358 1,404 TOTAL LIABILITIES 15,703 15,970 TOTAL STOCKHOLDERS’ EQUITY 20,901 27,011 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $36,604 $42,981 INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENT OF OPERATIONS (Unaudited) THREE MONTHS ENDED MARCH 31, 2006 2005 (Thousands except per share information.) CONTRACT SERVICES, GRANT AND OTHER REVENUE $225 $509 OPERATING EXPENSES: RESEARCH AND DEVELOPMENT 5,046 5,239 GENERAL AND ADMINISTRATIVE 3,796 1,810 TOTAL OPERATING EXPENSES 8,842 7,049 LOSS FROM OPERATIONS (8,617) (6,540) INTEREST INCOME, INTEREST EXPENSE AND OTHER INCOME, NET 398 309 NET (LOSS) ($8,219) ($6,231) NET LOSS PER SHARE, BASIC AND DILUTED ($0.22) ($0.20) SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER SHARE 37,180 30,741
Introgen Therapeutics, Inc.
CONTACT: C. Channing Burke of Introgen Therapeutics, Inc.,+1-512-708-9310, ext. 322, or c.burke@introgen.com
