ImmunoGen Reports Recent Progress and Operating Results for Six-Month Period and Quarter Ended December 31, 2016
First Patient Enrolled in Phase 3 FORWARD I Trial of Mirvetuximab Soravtansine
Continued Momentum in 2017 with Data Expected from Pipeline Programs
Conference Call to be Held at
"In 2016, we strengthened ImmunoGen operationally and financially with a
focused strategy and disciplined execution," said
Recent highlights include:
Proprietary Portfolio
-
First patient dosed in the Phase 3 FORWARD I registration trial of
mirvetuximab soravtansine in platinum-resistant ovarian cancer
(
January 2017 ); -
Publication of results of the mirvetuximab soravtansine Phase 1
expansion cohort in the
Journal of Clinical Oncology (December 2016 ); -
Oral and poster presentations highlighting preclinical data for
IMGN632 at the
American Society of Hematology (ASH) Annual Meeting (December 2016 ), demonstrating exceptional activity in acute myeloid leukemia (AML) models, including those resistant to standard of care therapies, as well as reduced toxicity to human marrow progenitor cells, compared to a DNA-crosslinking payload while maintaining similar potency; -
Presentation of preclinical data at
Society for Immunotherapy of Cancer's (SITC) 2016 conference demonstrating the potential for enhanced activity when combining mirvetuximab soravtansine with immune checkpoint inhibition (November 2016 ).
Partner Programs
-
Sanofi advancing isatuximab (
SAR650984 ), a CD38-targeting antibody, in combination with pom-dex to a Phase 3 clinical trial in multiple myeloma (Q4 2016); and -
Novartis dosing the first patient with HKT288, a CDH6-targeting ADC,
in a Phase 1 clinical trial in ovarian cancer and renal cell carcinoma
(
December 2016 ).
Upcoming anticipated events include:
-
Activation of more than 100 sites in
North America andWestern Europe to enable the rapid enrollment of patients to the mirvetuximab soravtansine Phase 3 FORWARD I trial; -
Presentation of:
-
Expanded Phase 1 data from the biopsy cohort for mirvetuximab
soravtansine at the
Society of Gynecologic Oncology (SGO) annual meeting (March 2017 ); -
Nine posters highlighting ImmunoGen's technology and innovation in
ADCs at the
American Association for Cancer Research (AACR) annual meeting (April 2017 ); - Initial data from the Company's Phase 1b/2 FORWARD II trial evaluating mirvetuximab soravtansine in combination with Avastin®, carboplatin, Doxil® or Keytruda® (Q2 2017);
- Pooled data from over 100 ovarian cancer patients treated in multiple mirvetuximab soravtansine Phase 1 cohorts and data from the Phase 1 steroid eye drop expansion cohort (Q2 2017);
- Initial Phase 1 data for IMGN779, a CD33-targeting ADC, for the treatment of AML (mid-2017), which will be the first clinical data reported with an ADC using ImmunoGen's DNA-alkylating payload;
-
Expanded Phase 1 data from the biopsy cohort for mirvetuximab
soravtansine at the
- Filing of an IND to initiate clinical testing with IMGN632, a CD123-targeting ADC integrating a more potent DNA-alkylating payload (Q3 2017).
Financial Results
As previously disclosed, effective
Operating expenses for the six month transition period ended
ImmunoGen reported a net loss of
ImmunoGen had approximately
Financial Guidance
For 2017, ImmunoGen expects:
-
revenues between $70 million and
$75 million , which includes$28 million of expected upfront and milestone fees from our partners; - operating expenses between $175 million and $180 million; and
-
cash and marketable securities at
December 31, 2017 between $35 million and $40 million.
ImmunoGen expects that its current cash plus expected cash revenues from partners and collaborators will enable the Company to fund operations into the second quarter of 2018.
Conference Call Information
ImmunoGen is holding a conference call today at
About
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen's lead product candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.
Avastin®, Doxil®, Keytruda® 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 for the twelve months ending
-Financials Follow-
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SELECTED FINANCIAL INFORMATION | ||||||||||||||||||||||||||
(in thousands, except per share amounts) | ||||||||||||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||||
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2016 | 2016 | |||||||||||||||||||||||||
ASSETS | ||||||||||||||||||||||||||
Cash and cash equivalents | $ | 159,964 | $ | 245,026 | ||||||||||||||||||||||
Other assets | 38,900 | 34,214 | ||||||||||||||||||||||||
Total assets | $ | 198,864 | $ | 279,240 | ||||||||||||||||||||||
LIABILITIES AND SHAREHOLDERS' DEFICIT | ||||||||||||||||||||||||||
Current liabilities | $ | 55,776 | $ | 60,439 | ||||||||||||||||||||||
Long-term portion of deferred revenue and other long-term liabilities | 295,938 | 301,105 | ||||||||||||||||||||||||
Shareholders' deficit | (152,850) | (82,304) | ||||||||||||||||||||||||
Total liabilities and shareholders' deficit | $ | 198,864 | $ | 279,240 | ||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
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2016 | 2015 | 2016 | 2015 | |||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||
License and milestone fees | $ | 5,076 | $ | 10,692 | $ | 5,152 | $ | 16,762 | ||||||||||||||||||
Royalty revenue | - | 195 | - | 195 | ||||||||||||||||||||||
Non-cash royalty revenue | 6,710 | 6,291 | 12,894 | 11,975 | ||||||||||||||||||||||
Research and development support | 1,427 | 848 | 2,781 | 1,620 | ||||||||||||||||||||||
Clinical materials revenue | 633 | 3 | 679 | 2,328 | ||||||||||||||||||||||
Total revenues | 13,846 | 18,029 | 21,506 | 32,880 | ||||||||||||||||||||||
Expenses: | ||||||||||||||||||||||||||
Research and development | 33,657 | 38,199 | 66,566 | 73,331 | ||||||||||||||||||||||
General and administrative | 8,536 | 8,054 | 17,995 | 16,383 | ||||||||||||||||||||||
Restructuring charge | 301 | - | 4,431 | - | ||||||||||||||||||||||
Total operating expenses | 42,494 | 46,253 | 88,992 | 89,714 | ||||||||||||||||||||||
Loss from operations | (28,648) | (28,224) | (67,486) | (56,834) | ||||||||||||||||||||||
Non-cash interest expense on liability related to sale of future royalty & convertible bonds | (3,647) | (5,059) | (8,665) | (10,202) | ||||||||||||||||||||||
Interest expense on convertible bonds | (1,099) | - | (2,249) | - | ||||||||||||||||||||||
Other (loss) income, net | (758) | 56 | (483) | 69 | ||||||||||||||||||||||
Net loss | $ | (34,152) | $ | (33,227) | $ | (78,883) | $ | (66,967) | ||||||||||||||||||
Net loss per common share, basic and diluted | $ | (0.39) | $ | (0.38) | $ | (0.91) | $ | (0.77) | ||||||||||||||||||
Weighted average common shares outstanding, diluted | 87,102 | 86,970 | 87,102 | 86,904 |
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