− Conference Call Today at 8:00 am ET−
The Company is investing in its wholly owned product programs,
including expanding its mirvetuximab soravtansine (IMGN853) and
IMGN529 clinical programs and developing plans for recently reacquired
coltuximab ravtansine (
SAR3419). Initial clinical data with mirvetuximab soravtansine in the treatment of platinum-resistant ovarian cancer are to be reported at ASCO annual meeting.
ImmunoGen continues to expand its antibody-drug conjugate (ADC)
technology portfolio, had multiple presentations at the AACR annual
meeting, and recently announced access to its technology has been
The Company expects to end its fiscal year on
June 30, 2015with between $265 million and $275 millionin cash and cash equivalents, reflecting its recent royalty transaction.
"We are executing against our product development plan and recently
strengthened our financial resources to support these programs,"
Mirvetuximab soravtansine, a potential new therapy for many cases of ovarian cancer as well as for endometrial cancer and other solid tumors that highly express folate receptor α (FRα); wholly owned by ImmunoGen.
- This ADC now has received orphan designation in ovarian cancer in the EU as well as in the US.
- Initial findings with mirvetuximab soravtansine - used as a single agent - to treat FRα-positive platinum-resistant ovarian cancer will be presented at the 2015 ASCO Annual Meeting. The data are from a disease-specific Phase 1 cohort. ImmunoGen plans to initiate a Phase 2 trial in this indication by the end of 2015 that could potentially support an accelerated registration pathway.
- ImmunoGen also plans to initiate in 2H2015 assessment of mirvetuximab soravtansine used in combination regimens for ovarian cancer.
- Assessment of mirvetuximab soravtansine for the treatment of FRα-positive relapsed/ refractory (R/R) endometrial cancer is ongoing. ImmunoGen is preparing to also assess it for FRα-positive R/R non-small cell lung cancer.
- In addition to the every three week dosing schedule being used in the disease-specific testing underway, dose-finding with a weekly dosing regimen is advancing. The findings to date also have been accepted for presentation at ASCO.
IMGN529, a potential new treatment for B-cell malignancies; wholly owned by ImmunoGen.
- Once the recommended Phase 2 dose is established, ImmunoGen plans to evaluate it specifically for the treatment of R/R diffuse large B-cell lymphomas (DLBCL) and chronic lymphocytic leukemia.
Preclinical findings with IMGN529 used with rituximab (Rituxan®)
will be reported at the
International Conference on Malignant Lymphomain Luganoin June 2015. ImmunoGen is planning to initiate a clinical trial to assess the combination.
- The next IMGN529 clinical data presentation(s) are targeted for the ASH annual meeting in December.
Indatuximab ravtansine (BT-062), a CD138-targeting ADC for multiple myeloma and certain solid tumors; wholly owned by Biotest; ImmunoGen holds rights to opt-in with Biotest on joint US development and commercialization.
- Phase 2 trial ongoing in multiple myeloma; Phase 1 trial ongoing in triple-negative breast cancer and metastatic urinary bladder cancer.
Coltuximab ravtansine (
- ImmunoGen recently regained the rights to this promising ADC from Sanofi.
IMGN779, CD33-targeting ADC utilizing one of ImmunoGen's DNA-acting payload agents; a potential treatment for acute myeloid leukemia and myelodysplastic syndrome; wholly owned by ImmunoGen.
- Remains on track for IND submission in 2H2015.
IMGN289, EGFR-targeting ADC, wholly owned by ImmunoGen.
- The Company has stopped Phase 1 testing and returned the program to research.
Approved in the US,
Europe, and other geographies based on the results from the EMILIA Phase 3 trial; in development by Roche for a number of indications, with data from the MARIANNE Phase 3 trial to be presented at ASCO.
- ImmunoGen recently reported a monetization transaction pertaining to the royalties earned on Kadcyla sales.
For the Company's quarter ended
Revenues for 3QFY2015 were
Operating expenses in 3QFY2015 were
ImmunoGen had approximately
Financial Guidance for Fiscal Year 2015
ImmunoGen has updated its guidance for its fiscal year ending
ImmunoGen now projects cash and cash equivalents at
Conference Call Information
ImmunoGen is holding a conference call today at
Rituxan® and Kadcyla® are registered trademarks of their respective owners.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2015 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||111,827||$||142,261|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||51,320||68,365|
|Total liabilities and shareholders' equity||$||133,802||$||165,318|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|License and milestone fees||$||5,078||$||305||$||52,729||$||39,150|
|Research and development support||532||1,948||2,140||5,860|
|Clinical materials revenue||718||2,064||4,171||2,197|
|Research and development||25,666||38,280||81,331||81,171|
|General and administrative||7,000||6,040||20,967||18,013|
|Total operating expenses||32,666||44,320||102,298||99,184|
|Loss from operations||(21,239||)||(37,445||)||(29,368||)||(45,031||)|
|Other (expense) income, net||(379||)||(7||)||(897||)||166|
|Net loss per common share, basic and diluted||$||(0.25||)||$||(0.44||)||$||(0.35||)||$||(0.53||)|
|Weighted average common shares outstanding, diluted||86,080||85,684||85,962||85,375|
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