News

November 07, 2002
ImmunoGen, Inc. Reports First Quarter 2003 Results

CAMBRIDGE, Mass., Nov. 7 /PRNewswire-FirstCall/ -- ImmunoGen, Inc. (Nasdaq: IMGN) today announced financial results for the three months ended September 30, 2002. For the three-month period, the Company reported a net loss of $3.2 million, or $0.08 per basic and diluted share, compared to a net loss of $1.6 million, or $0.04 per basic and diluted share, in the same quarter last year.

Revenue for the three months ended September 30, 2002 was $2.3 million as compared to revenue of $1.4 million for the same period last year. Revenues for the first quarter included a milestone payment of $1.0 million from Boehringer Ingelheim to ImmunoGen related to the commencement of clinical trials of bivatuzumab mertansine, which is composed of ImmunoGen's DM1 Tumor- Activated Prodrug (TAP) effector molecule and Boehringer Ingelheim's anti- CD44v6 antibody.

Also included in revenues for the three-month period ended September 30, 2002 were $826,000 of clinical material reimbursements related to the manufacture of clinical material under certain collaborative agreements and $480,000 of previously deferred revenue related to payments made pursuant to existing collaborative agreements.

Total operating expenses for the three-month period ended September 30, 2002 were $6.6 million as compared to $4.6 million for the same period last year. Included in total operating expenses for the three-month period ended September 30, 2002 was research and development expense totaling $4.1 million, as compared to research and development expense of $2.5 million last year. The increase in research and development expense in the quarter ended September 30, 2002 is primarily related to continued advancement of the Company's TAP technology, support of the Company's collaborators, and growth in the Company's research and development infrastructure.

As of September 30, 2002, ImmunoGen had approximately $127.2 million in cash and marketable securities. The Company anticipates that its current capital resources and future collaborator payments, if any, will enable the Company to meet its operational expenses and capital expenditures for at least the next three fiscal years. On August 27, 2002, the Company announced that, effective immediately, its Board of Directors authorized the repurchase of up to 4.1 million shares of the Company's common stock. The repurchases are to be made at the discretion of management and as market conditions warrant. No time limit was set for the completion of the repurchase program. As of September 30, 2002, the Company had repurchased 952,800 shares of its common stock at a total cost of $3.1 million, and through November 4, 2002, the Company had repurchased 1,384,220 shares of its common stock at a total cost of $4.4 million.

Mitchel Sayare, Ph.D., Chairman and CEO, commented, "This quarter, the first TAP product to be developed by one of our licensing partners began clinical trials. There are now three TAP products in clinical trials, and a fourth -- Millennium's MLN591(DM1) -- currently is expected to begin clinical testing in 2002. As the number of TAP products in clinical trials increases, more data are gained on the performance of our technology in different types of cancers and with different antibodies."

Dr. Sayare continued, "We continue to be in negotiations with GlaxoSmithKline on our cantuzumab mertansine partnership. We recognize it is important to gain closure on these negotiations as quickly as possible. It is most important, however, that the resolution reached is the right one for ImmunoGen."

Update on Cantuzumab Mertansine

The final patient has been enrolled in the one Phase I study still underway with cantuzumab mertansine (huC242-DM1/SB-408075). The study will end when this last patient has completed treatment and evaluation as specified in the study protocol.

In its Phase I program, cantuzumab mertansine has been found to be well tolerated, evidence of biological activity has been reported, and its maximum tolerated dose has been identified under different dosing schedules. The key results from each of the three Phase I studies conducted were reported when each study was presented at a national oncology medical conference.

In June 2002, ImmunoGen announced that GlaxoSmithKline had elected not to advance cantuzumab mertansine into Phase II under the present terms of the license agreement. ImmunoGen and GlaxoSmithKline are currently in negotiations concerning this agreement. Should ImmunoGen determine that it is not in the Company's best interests to enter into a revised agreement with GlaxoSmithKline, rights to the product would be returned to ImmunoGen and the Company would be free to develop and relicense the product as the Company considers most appropriate. ImmunoGen owns the Investigational New Drug application (IND) for cantuzumab mertansine and has rights to the data from the clinical studies conducted.

Cantuzumab mertansine is a TAP product created by conjugating the cytotoxic agent DM1 with the humanized monoclonal antibody C242. The huC242 antibody targets the CanAg receptor found on the surface of a number of types of cancer cells, including colorectal, pancreatic, gastric, and certain non- small-cell lung cancers. In early 1999, the Company licensed development and commercialization rights for cantuzumab mertansine to SmithKline Beecham.

Update on huN901-DM1

The two Phase I studies of huN901-DM1 (BB-10901) are proceeding. The first study, which is being conducted in the United States, examines dosing huN901-DM1 once weekly for four weeks followed by two weeks off the agent. This study is nearing completion, and data from it are to be presented at the EORTC-NCI-AACR 2002 meeting to be held in Frankfurt, Germany, November 19-22. In August 2002, a Phase I study also was initiated in the United Kingdom. The U.K. study examines dosing huN901-DM1 once daily for three successive days followed by eighteen days off the agent.

huN901-DM1 is a TAP product candidate in development for the treatment of small-cell lung cancer. In May 2000, British Biotech acquired rights to develop the product candidate and to commercialize it in Europe and Japan. ImmunoGen retained commercialization rights for the U.S. and the rest of the world.

Update on Other ImmunoGen Programs

ImmunoGen continues to make progress with other programs in the Company's pipeline, such as huMy9-6-DM1 and its IGF-1 receptor program. The Company also continues its collaborations with Genentech, Abgenix, Millennium, and Boehringer Ingelheim related to the use of the Company's TAP technology with their antibodies.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer biopharmaceuticals. The Company's Tumor-Activated Prodrug (TAP) technology uses tumor-targeting antibodies to deliver a highly potent, cell-killing agent specifically to cancer cells. Two ImmunoGen-developed TAP products are in clinical trials: cantuzumab mertansine, which is licensed to GlaxoSmithKline, and huN901-DM1, which is licensed to British Biotech in certain territories. ImmunoGen helps fund its programs by licensing its TAP technology to other companies. Several companies are developing TAP products that use ImmunoGen's TAP technology with the partner's antibody: Boehringer Ingelheim (bivatuzumab mertansine), Millennium (MLN591(DM1)), and Genentech (Trastuzumab-DM1). ImmunoGen also has multitarget agreements with Genentech, Abgenix, and Millennium.

This press release includes forward-looking statements based on management's current expectations. For these statements, we claim the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause our actual results to differ materially from those discussed or implied in the forward-looking statements and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the success of our research and clinical development processes; the difficulties inherent in the development of pharmaceuticals, including uncertainties as to the timing, expense and results of preclinical studies and clinical trials; our dependence upon existing and potential collaborative partners; uncertainty as to whether our potential products or those of our collaborators will succeed in entering human clinical trials and uncertainty as to the results of such trials; the risk that we may not be able to obtain regulatory approvals necessary to commercialize our product candidates; the potential development by competitors of competing products and technologies; uncertainty whether our TAP technology will produce safe, effective and commercially viable products; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2002 and other current reports filed with the Securities and Exchange Commission.

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