ImmunoGen Reports Fourth Quarter and Fiscal Year 2016 Financial Results and Provides Quarterly Business Update
− Conference call at
Following positive meeting with
FDA, Phase 3 FORWARD I study of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer on track to begin before year end.
- Mirvetuximab soravtansine plus Avastin® combination regimen advanced to Phase 2 in FORWARD II trial.
- Phase 1 testing of IMGN779 - the first ADC deploying an ImmunoGen DNA-alkylating payload - initiated in patients with acute myeloid leukemia (AML).
Recent appointment of
Mark Enyedyas President and CEO brings proven leadership and deep experience building oncology businesses.
Company ended fiscal year with approximately
$245 millionin cash and is moving to reporting on calendar-year basis.
"With our lead candidate poised to enter Phase 3 and a portfolio of
well-differentiated programs advancing behind it, I am excited to have
joined the strong team managing ImmunoGen's transition to a
fully-integrated biotech company," stated
Mirvetuximab soravtansine is a well-differentiated experimental therapy for the treatment of ovarian cancer and potentially other tumor types that express its target, folate receptor alpha (FRα). This ADC is being evaluated in clinical trials as a single-agent therapy for platinum-resistant ovarian cancer and in combination regimens for both platinum-resistant and platinum-sensitive disease.
Held Type B meeting with the
U.S. Food and Drug Administration(FDA) to review the path to registration for mirvetuximab soravtansine and the proposed FORWARD I study protocol. With the benefit of the agency's guidance, ImmunoGen is moving forward with initiating this Phase 3 trial as previously outlined, including with the primary endpoint of progression-free survival (PFS).
Reported data from 46 patients with FRα-positive platinum-resistant
ovarian cancer at the
American Society of Clinical Oncology(ASCO) meeting in June. Mirvetuximab soravtansine demonstrated robust single-agent activity in these patients, with the greatest response rates and PFS reported in patients with high or medium levels of FRα expression on their tumors and who had received up to three prior regimens, the patient population eligible for enrollment in FORWARD I.
Strategic Combination Regimens
- Initiated the 35-patient Phase 2 assessment in FORWARD II of mirvetuximab soravtansine in combination with Avastin following successful completion of dose finding.
- Continued enrollment in the FORWARD II cohorts assessing the ADC used with pegylated liposomal doxorubicin (PLD) and, separately, with carboplatin, with the cohort assessing the combination with Keytruda® on track to open this summer.
Exploring Additional Opportunities
- Through ImmunoGen's collaboration with the National Comprehensive Cancer Network (NCCN), grants were awarded for clinical assessment of mirvetuximab soravtansine in combination with gemcitabine and as a treatment of triple negative breast cancer as well as for preclinical studies on mechanisms of resistance, sensitivity, and biomarkers.
IMGN779 / IMGN632
IMGN779 and IMGN632 deploy ImmunoGen's new ultra-potent, DNA-acting payload agents that alkylate DNA without crosslinking it. In preclinical studies, these agents have been found to avoid the sustained toxicity seen with DNA-crosslinking agents.
- Initiated Phase 1 clinical testing of IMGN779, a CD33-targeting ADC, for the treatment of AML. Initial clinical data from this trial are expected to be presented in 2017.
Advanced CD123-targeting IMGN632 into IND-enabling testing. The first
preclinical findings with this novel ADC were presented at the
European Hematology Associationannual meeting, with additional data on its distinctive activity and tolerability expected to be presented in late 2016.
IMGN529 deploys ImmunoGen's validated maytansinoid payload technology and recently gained orphan drug status in diffuse large B-cell lymphoma (DLBCL).
- Initiated Phase 2 clinical testing of IMGN529 used in combination with Rituxan® for patients with B-cell malignancies including DLBCL based on marked synergy in preclinical testing.
Fiscal Year 2016 Financial Results
ImmunoGen's fiscal year 2016 ended
For the Company's fiscal year ended
Revenues in FY2016 were
Operating expenses in FY2016 were
ImmunoGen had approximately
ImmunoGen is transitioning to a fiscal year ending
Conference Call Information
ImmunoGen is holding a conference call today at
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 being advanced to 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.
Avastin®, Kadcyla®, Keytruda®, and Rituxan® 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 six months ending
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||245,026||$||278,109|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||307,950||242,909|
|Total liabilities and shareholders' equity||$||287,085||$||313,823|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Fiscal Year Ended|
|License and milestone fees||$||76||$||5,086||$||26,915||$||57,815|
|Non-cash royalty revenue||5,944||5,461||25,299||5,461|
|Research and development support||1,335||708||4,014||2,848|
|Clinical materials revenue||53||1,356||3,579||5,527|
|Research and development||37,490||30,437||146,915||111,768|
|General and administrative||9,298||7,261||36,916||28,228|
|Total operating expenses||46,788||37,698||183,831||139,996|
|Loss from operations||(39,380||)||(25,087||)||(123,829||)||(54,455||)|
|Non-cash interest expense on liability related to sale of future royalty & convertible bonds||(4,956||)||(5,436||)||(20,130||)||(5,436||)|
|Other (expense) income, net||(424||)||49||304||(848||)|
|Net loss per common share, basic and diluted||$||(0.51||)||$||(0.35||)||$||(1.65||)||$||(0.71||)|
|Weighted average common shares outstanding, diluted||87,062||86,269||86,976||86,038|
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