News

February 06, 2003
ImmunoGen, Inc. Reports Second Quarter 2003 Results; Company Provides Business Update

  CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 6, 2003--ImmunoGen, Inc. (Nasdaq: IMGN):

  • Conference call and webcast is scheduled for February 6, 2003 at 4:30 p.m. EST.
  • Conference call dial-in number: (913) 981-5507. No passcode is required. Playback of the call will be available from approximately 7:30 p.m. EST on February 6 through 11:59 p.m. EST on February 13, 2003. To listen to the playback, please call (719) 457-0820 and refer to passcode #686084.
  • A live webcast of the call may be accessed by going to the "Investor Relations" section on ImmunoGen's website, http://www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location until February 13, 2003.

ImmunoGen, Inc. (Nasdaq: IMGN) today announced financial results for the three and six months ended December 31, 2002. For the three-month period, the Company reported a net loss of $5.3 million, or $0.12 per basic and diluted share, compared to a net loss of $1.7 million, or $0.04 per basic and diluted share, in the same quarter last year. For the six-month period ended December 31, 2002, the Company reported a net loss of $8.5 million, or $0.20 per basic and diluted share, compared to a net loss of $3.3 million, or $0.08 per basic and diluted share, in the same period last year.

Revenue for the three months ended December 31, 2002 was $2.5 million as compared to revenue of $1.5 million for the same period last year. Revenue for the second quarter included a milestone payment of $1.0 million from Millennium Pharmaceuticals to ImmunoGen related to the commencement of clinical trials of MLN2704. Also included in revenue for the three-month period ended December 31, 2002 was $0.9 million of clinical material reimbursements related to the manufacture of clinical material under certain collaborative agreements and $0.5 million of previously deferred revenue related to payments made pursuant to existing collaborative agreements.

Total operating expenses for the three-month period ended December 31, 2002 were $8.7 million as compared to $5.1 million for the same period last year. Included in total operating expenses for the three-month period ended December 31, 2002 was research and development expense totaling $6.6 million, as compared to research and development expense of $3.0 million last year. The increase in research and development expense in the quarter ended December 31, 2002 is related to continued advancement of our Tumor-Activated Prodrug (TAP) technology, support of our collaborators and the strengthening of our research and development infrastructure. Included in research and development expense for the three months ended December 31, 2002 is $1.9 million related to the cost of antibody that the Company has purchased in anticipation of potential future clinical trials.

As of December 31, 2002, ImmunoGen had approximately $120.9 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 December 31, 2002, the Company had repurchased 2,053,445 shares of its common stock at a total cost of $6.7 million, and through February 4, 2003, the Company had repurchased 2,603,605 shares of its common stock at a total cost of $8.4 million.

Mitchel Sayare, Ph.D., ImmunoGen Chairman and CEO, commented, "The Phase I program for cantuzumab mertansine is complete, and the findings support expansion of the clinical program for this important product candidate to broad Phase II evaluation. We are excited about the prospects of licensing cantuzumab mertansine to a marketing partner that will successfully carry it forward."

Dr. Sayare continued, "In the past quarter, a number of important achievements were made with other TAP product candidates. Significant progress was made in the huN901-DM1/ BB-10901 Phase I/II study underway in the United States: the Phase I portion was completed, the findings presented, and the Phase II portion begun. In November, Millennium announced the initiation of clinical trials with its TAP product candidate, MLN2704, in patients with metastatic, androgen-independent prostate cancer. In addition to triggering a milestone payment to ImmunoGen, this achievement also increases the number of TAP product candidates that have begun clinical evaluation."

Update on Cantuzumab Mertansine

Three Phase I clinical trials, each exploring a different dosing regimen, now have been completed with cantuzumab mertansine (huC242-DM1). In its Phase I program, cantuzumab mertansine was found to be well tolerated and evidence of biological activity was reported. It was found that the greatest amount of drug can be administered when doses are administered at least one week apart. More frequent dosing provides no apparent advantage to compensate for the reduced convenience. The key results from the three studies have been presented at national oncology medical conferences.

In January, the findings from the first Phase I study were published in the Journal of Clinical Oncology. In "Cantuzumab Mertansine, a Maytansinoid Immunoconjugate Directed to the CanAg Antigen: A Phase I, Pharmacokinetic and Biologic Correlative Study" by Anthony W. Tolcher et al., the study investigators conclude that "the absence of severe hematologic toxic effects, preliminary evidence of cantuzumab mertansine tumor localization, and encouraging biologic activity in chemotherapy-refractory patients warrant further broad clinical development of this immunoconjugate in CanAg-expressing tumors." Evidence of drug localization at the tumor site was obtained by testing for the presence of cantuzumab mertansine in biopsy tissue taken from a colon cancer patient (who had accessible metastases) twenty-four hours after drug administration.

Cantuzumab mertansine is a TAP product created by conjugating the cytotoxic agent DM1 with the humanized monoclonal antibody huC242. 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. ImmunoGen has the development and commercialization rights for cantuzumab mertansine.

Update on huN901-DM1/BB-10901

Two clinical trials are currently underway with huN901-DM1/BB-10901: a Phase I/II study in the U.S. that examines dosing the agent once weekly for four weeks followed by two no-treatment weeks, and a Phase I study in the United Kingdom that examines dosing the agent once daily for three days followed by eighteen no-treatment days.

The Phase I portion of the U.S. Phase I/II study is complete and the Phase II portion has started. The Phase I findings were presented in November at the "Molecular Targets and Cancer Therapeutics" international symposium that was organized by the European Organization for Research and Treatment of Cancer, the National Cancer Institute, and the American Association for Cancer Research. In their conclusions, the clinical investigators noted that huN901-DM1/BB-10901 can be safely administered for repetitive courses at doses comparable to those that produced antitumor activity in preclinical models. They found that the maximum tolerated dose is 60 mg/m2 with the dosing regimen studied, and they noted that at this dose level and below, toxicities were modest (in particular, no hematological toxicity was observed) and preliminary evidence of anti-tumor activity was seen.

huN901-DM1/BB-10901 is a TAP product candidate in development for the treatment of small-cell lung cancer and other CD56-expressing tumors. 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.

Other Programs

ImmunoGen continues to make progress with other programs in the Company's pipeline, including huMy9-6-DM1 and the IGF-1 receptor program. The Company also continues its collaborations with Boehringer Ingelheim, Millennium, Genentech, and Abgenix related to the use of the Company's TAP technology with antibodies developed by these companies. In November 2002, Millennium announced the initiation of clinical trials with MLN2704 (formerly MLN591DM1). This TAP product candidate is composed of ImmunoGen's DM1 effector molecule and Millennium's MLN591 antibody. The MLN591 antibody targets the prostate-specific membrane antigen (PSMA) expressed by virtually all prostate tumors.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer biopharmaceuticals. The Company's TAP technology uses tumor-targeting antibodies to deliver a highly potent, cell-killing agent specifically to cancer cells. Two ImmunoGen-developed TAP products have begun clinical evaluation: cantuzumab mertansine and huN901-DM1/BB-10901; the latter 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 anticancer products that use ImmunoGen's TAP technology with the partner's antibody: Boehringer Ingelheim (bivatuzumab mertansine), Millennium (MLN2704), 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, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause the Company's 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 the Company's 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; the Company's dependence upon existing and potential collaborative partners; uncertainty as to whether the Company's potential products or those of the Company's collaborators will succeed in entering human clinical trials and uncertainty as to the results of such trials; the risk that the Company and/or its collaborators may not be able to obtain regulatory approvals necessary to commercialize their product candidates; the potential development by competitors of competing products and technologies; uncertainty whether the Company's 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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