>>AUSTIN, Texas, Feb. 5 /PRNewswire-FirstCall/ -- Introgen Therapeutics, Inc. (Nasdaq: INGN - news) announced today that its results for the quarter ended December 31, 2001, were consistent with its expectations, during which time Introgen reported progress in its clinical development program, clinical and regulatory infrastructure and manufacturing experience.
In September 2001 Introgen changed its fiscal year end from June 30 to December 31. Introgen reported a net loss of $6.2 million, or $0.29 per share, for the quarter ended December 31, 2001, and a net loss of $12.3 million or $0.58 per share, for the six months ended December 31, 2001. These results compare to a net loss of $2.4 million, or $0.13 per share, for the quarter December 31, 2000, and a net loss of $4.4 million or $0.39 per share for the six months ended December 31, 2000.
The Company had revenue of $283,000 for the quarter ended December 31, 2001, compared to revenue of $3.3 million for the quarter ended December 31, 2000, and revenue of $298,000 for the six months ended December 31, 2001, compared to revenue of $4.9 million for the six months ended December 31, 2000. Total costs of goods sold and operating expenses were $6.9 million for the quarter ended December 31, 2001, compared to $6.1 million for the quarter ended December 31, 2000, and were $13.6 million for the six months ended December 31, 2001, compared to $9.7 million for the six months ended December 31, 2000. At December 31, 2001, the Company had cash, cash equivalents, and short-term investments of $48.8 million.
Introgen's president and CEO, David G. Nance, said, ``Introgen experienced a productive quarter as we continued to move forward clinically with multiple programs, including the enrollment in our Phase 3 program. Although Introgen's primary attention is on its Phase 3 clinical studies, I am pleased that our robust research programs for pipeline products such as INGN 241 and INGN 251 are receiving attention in scientific journals and meetings.''
Clinical Program Update
Enrollment is progressing in Introgen's Phase 3 program. Two controlled and randomized clinical studies for the treatment of head and neck cancer with Introgen's p53 gene drug, INGN 201, are being conducted in the North America, Western and Eastern Europe. Introgen is also conducting Phase 1 and 2 clinical studies with INGN 201 in indications including lung, prostate and esophageal cancer in the United States and Japan. INGN 201 continues to be developed in both late stage and early stage cancer in combination with conventional treatments such as chemotherapy, radiotherapy and surgery. Introgen's Phase 1 study with INGN 241, the mda-7 gene drug, is also active and enrolling patients with solid tumors.
Research Program Update
Introgen's research efforts are yielding exciting results in a number of important oncology targets as well as cardiovascular disease. Introgen's research team, along with its collaborators, plan to present in either poster or oral presentations, data from thirteen abstracts on INGN 201, 241 and 251 at the upcoming American Association of Cancer Research conference being held April 6-10 in San Francisco, Calif. The majority of presentations focus on Introgen's mda-7 product, INGN 241. Additionally, Dr. James Merritt, Introgen's chief medical officer has been asked to present in a workshop entitled ``Cancer - How to Design Cancer Gene Therapy Clinical Trials'' at the American Society of Gene Therapy meeting being held June 5-9 in Boston, Mass. An abstract for mda-7 has also been submitted to the 2002 annual meeting of the American Society of Clinical Oncology (ASCO).
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 randomized, controlled 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 manufacturing program for third parties. Introgen's 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, without limitation, Introgen's stage of product development and its limited experience in the development of gene- based drugs in general, uncertainties related to clinical trials, Introgen's dependence upon proprietary technology and patent protection, Introgen's history of operating losses and accumulated deficits, Introgen's reliance on collaborative relationships, Introgen's ability to obtain appropriate regulatory approvals, and market acceptance of Introgen's product candidates, as well as other risks detailed 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 on September 19, 2001 and its quarterly report of Form 10-Q filed with the Securities and Exchange Commission on November 14, 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.
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 www.companyboardroom.com . For those unable to listen to the broadcast the call will be archived at the same address or at www.introgen.com in the Investor Relations section.
Editor's Note: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's Website at: www.introgen.com or call Introgen's toll-free Investor Relations hotline at 1-877-776-GENE (4363).
Contact:
Introgen Therapeutics, Inc.
C. Channing Burke
(512) 708 9310 Ext. 322
Email: c.burke@introgen.com
INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED SIX MONTHS ENDED
DECEMBER 31, DECEMBER 31,
2001 2000 2001 2000
COLLABORATIVE
RESEARCH AND
DEVELOPMENT
REVENUES FROM
AFFILIATE --- $1,509,210 --- $3,015,655
PRODUCT SALES TO
AFFILIATE --- 1,500,000 --- 1,500,000
COST OF SALES --- (2,372,204) --- (2,487,783)
GROSS MARGIN FROM
PRODUCT SALES --- (872,204) --- (987,783)
OTHER REVENUE 283,070 252,898 297,697 391,031
OPERATING EXPENSES:
RESEARCH AND
DEVELOPMENT 5,017,766 2,820,769 10,062,421 5,152,785
GENERAL AND
ADMINISTRATIVE 1,841,620 928,769 3,526,244 2,040,090
LOSS FROM
OPERATIONS (6,576,316) (2,859,634) (13,290,968) (4,773,972)
INTEREST AND OTHER
INCOME, NET 351,306 431,073 962,535 402,827
NET LOSS $(6,225,010) $(2,428,561) $(12,328,433) $(4,371,145)
NET LOSS PER SHARE,
BASIC AND DILUTED $(0.29) $(0.13) $(0.58) $(0.39)
SHARES USED IN
COMPUTING BASIC AND
DILUTED NET LOSS
PER SHARE 21,445,212 18,092,257 21,440,380 11,120,670
INTROGEN THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
2001 2001
CASH AND SHORT TERM INVESTMENTS $34,976,529 $48,824,542
RECEIVABLE FROM SALE OF PREFERRED STOCK 25,000,000 ---
ACCOUNTS RECEIVABLE --- 137,014
OTHER CURRENT ASSETS 511,640 674,407
PROPERTY AND EQUIPMENT, NET 11,507,385 10,443,017
OTHER ASSETS 351,719 345,477
TOTAL ASSETS 72,347,273 60,424,457
ACCOUNTS PAYABLE AND OTHER CURRENT
LIABILITIES 6,191,943 6,460,579
NOTES PAYABLE AND CAPITAL LEASE
OBLIGATIONS, NET OF CURRENT PORTION 9,798,121 9,036,588
OTHER LONG TERM LIABILITIES 288,000 361,467
TOTAL LIABILITIES 16,278,064 15,858,634
TOTAL STOCKHOLDERS' EQUITY 56,069,209 44,565,823
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $72,347,273 $60,424,457<<
Cheers, Tuck |
