ImmunoGen Reports Second Quarter Fiscal Year 2016 Financial Results and Provides Corporate Update
− Conference Call Today at
- Both ImmunoGen's FORWARD I and FORWARD II clinical trials are open for patient enrollment. FORWARD I is designed to support an Accelerated Approval pathway for lead program mirvetuximab soravtansine and FORWARD II assesses this first-in-class folate receptor α (FRα)-targeting antibody-drug conjugate (ADC) in multiple combination regimens.
- Bayer has initiated a Phase 2 study designed to support registration of anetumab ravtansine, its mesothelin-targeting ADC. Anetumab ravtansine is the second partner ADC - after Roche's Kadcyla® - with ImmunoGen technology to advance into potential registration testing. Roche expects findings from its KRISTINE neoadjuvant trial in 2016, a potential new use for Kadcyla.
"ImmunoGen is off to a strong start for 2016, with multiple clinical
trial initiations underway," commented
Update on Wholly Owned Product Programs
Mirvetuximab soravtansine - First FRα-targeting ADC is a potential new treatment for ovarian cancer and other FRα-positive solid tumors.
Assessments as single-agent therapy for pretreated FRα-positive
- Updated Phase 1 findings were presented at the AACR-NCI-EORTC meeting in November for the dataset reported at ASCO in May (abstracts #C47 and #5518, respectively). These included that 35% (7/20) of patients with FRα-positive platinum-resistant disease treated had a confirmed objective response, with most (6/7) responders on mirvetuximab soravtansine for 6 months or longer. This compares with ImmunoGen's target response rate of 30% or more to advance the ADC as monotherapy. Most of the patients and all of the responders had high or medium FRα levels on their tumors.
Patient enrollment is open for the Company's FORWARD I Phase 2
trial, which is designed to support an Accelerated Approval
pathway for mirvetuximab soravtansine. FORWARD I is being
conducted in partnership with the
GOG Foundation, Inc.To qualify for enrollment, patients must have ovarian cancer with high or medium FRα expression that was previously treated with 3 or 4 regimens.
- Patient enrollment was completed in 4Q2015 in the 20-patient Phase 1 expansion cohort requiring biopsies. The Company intends to present initial biomarker data from this assessment at a medical meeting in 2Q2016 in addition to reporting mature data from the 40-patient Phase 1 cohort in this disease at the meeting.
Assessments as combination therapy for FRα-positive ovarian cancer:
- Encouraging preclinical data with a range of combination regimens were presented at the AACR-NCI-EORTC meeting (abstract C170).
- In December, patient dosing began in the Phase 1b/2 trial, FORWARD II, assessing mirvetuximab soravtansine in combination with approved anticancer agents.
Assessments for the treatment of other FRα-positive cancers:
- In 4Q2015, patient enrollment was completed in the 20-patient Phase 1 expansion cohort assessing the ADC for FRα-positive relapsed/refractory endometrial cancer. The Company expects to report findings from this assessment in 2H2016.
- Additional cancer types are being evaluated for FRα expression preclinically.
IMGN529 and coltuximab ravtansine - CD37- and CD19-targeting, respectively, ADCs for diffuse large B-cell lymphoma (DLBCL) and potentially other B-cell malignancies.
- Preclinical findings of strong synergy for IMGN529 used in combination with rituximab were reported at ASH (abstract #1548) in December.
- Patient enrollment in a Phase 2 trial assessing IMGN529 in combination with rituximab is expected to begin early this year. Enrollment in a Phase 2 trial assessing coltuximab ravtansine in a different combination regimen is expected to begin in 2H2016.
IMGN779 - First CD33-targeting ADC utilizing an IGN cancer-killing agent. IGNs are a new class of DNA-acting agents invented by ImmunoGen.
- Mechanism of action data were reported at ASH (abstract #1366).
- ImmunoGen is preparing to initiate Phase 1 testing of IMGN779 for the treatment of acute myeloid leukemia in 1H2016.
Update on Partner Programs
Nine companies are advancing ADCs with ImmunoGen technology. Recent highlights include:
- Patient dosing has begun in Bayer's global Phase 2 clinical trial designed to support registration of its mesothelin-targeting ADC, anetumab ravtansine. This event triggers a milestone payment to ImmunoGen that will be reflected in the Company's 3QFY2016 financial results.
- Roche expects data from its KRISTINE trial assessing Kadcyla in the neoadjuvant setting for early HER2-positive breast cancer to be reported this year and, if positive, to bring these to regulatory authorities for potential filing in 2016.
- In December, Takeda took its first license for the exclusive right to develop ADCs to an undisclosed target using ImmunoGen technology.
- Also in December, CytomX announced it is advancing a novel anticancer agent targeting CD166 using its ProbodyTM technology and ImmunoGen's ADC technology under a strategic collaboration established between the companies in early 2014.
For the Company's quarter ended
Revenues for 2QFY2016 were
Operating expenses in 2QFY2016 were
ImmunoGen had approximately
Financial Guidance for Fiscal Year 2016
ImmunoGen's financial guidance remains unchanged from that issued in
Conference Call Information
ImmunoGen is holding a conference call today at
ImmunoGen is a clinical-stage biotechnology company that develops targeted anticancer therapeutics with its proprietary ADC technology. The Company's lead product candidate, mirvetuximab soravtansine, is a potential treatment for folate receptor α-positive ovarian cancers and other solid tumors. A number of major healthcare companies have licensed rights to use ImmunoGen's ADC technology to develop novel anticancer therapies; it is used in Roche's marketed product, Kadcyla®. More information about the Company can be found at www.immunogen.com.
Kadcyla® is a registered trademark of
ProbodyTM is a trademark of CytomX Therapeutics, Inc.
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 2016 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||212,283||$||278,109|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||224,366||242,909|
|Total liabilities and shareholders' equity||$||251,580||$||313,823|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Six Months Ended|
|License and milestone fees||$||10,692||$||41,417||$||16,762||$||47,651|
|Non-cash royalty revenue||6,291||-||11,975||-|
|Research and development support||848||832||1,620||1,608|
|Clinical materials revenue||3||1,426||2,328||3,453|
|Research and development||38,199||27,647||73,331||55,665|
|General and administrative||8,054||6,872||16,383||13,967|
|Total operating expenses||46,253||34,519||89,714||69,632|
|(Loss) income from operations||(28,224||)||13,781||(56,834||)||(8,129||)|
|Non-cash interest expense on liability related to sale of future royalty||(5,059||)||-||(10,202||)||-|
|Other income (loss), net||56||(146||)||69||(518||)|
|Net (loss) income||$||(33,227||)||$||13,635||$||(66,967||)||$||(8,647||)|
|Net (loss) income per common share, basic and diluted||$||(0.38||)||$||0.16||$||(0.77||)||$||(0.10||)|
|Weighted average common shares outstanding, diluted||86,970||86,665||86,904||85,904|
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