ImmunoGen Reports Recent Progress and First Quarter 2018 Operating Results
Patient Enrollment in FORWARD I Phase 3 Trial of Mirvetuximab Soravtansine Completed Ahead of Schedule; On Track for Top-Line Results in the First Half of 2019
Encouraging Data Reported from FORWARD II Assessment of Mirvetuximab
with Keytruda®; Additional Combination Data to
be Presented in 2018, including Mirvetuximab in Combination with Avastin®
IMGN779 and IMGN632 Advancing Through Dose-Finding Evaluations with
Data Expected in the Fourth Quarter;
Conference Call to be Held at
“We have achieved a number of important milestones to start the year,
led by the advancement of mirvetuximab soravtansine,” said
- In April, ImmunoGen announced the completion of patient enrollment two months ahead of schedule in its Phase 3 FORWARD I trial. FORWARD I is designed to support full approval of mirvetuximab as a single-agent therapy for platinum-resistant ovarian cancer.
- In April, ImmunoGen successfully completed a pre-specified interim analysis for futility after 80 progression-free survival (PFS) events in FORWARD I. The study will continue as planned based on the recommendation of the Independent Data Monitoring Committee and the Company is on-track to report top-line results in first half of 2019.
- In March, ImmunoGen presented data from the dose-escalation FORWARD II cohort evaluating mirvetuximab in combination with Keytruda (pembrolizumab) at the Society of Gynecologic Oncology (SGO) Annual Meeting, demonstrating encouraging efficacy and favorable tolerability in patients with platinum-resistant ovarian cancer. Notably, in the subset of eight patients with medium or high levels of folate receptor alpha (FRα) expression, the confirmed overall response rate (ORR) was 63 percent (95% CI 25, 92), with a median PFS of 8.6 months (95% CI 1.6, upper bound not yet reached), and duration of response of 36.1 weeks. Based on these data, ImmunoGen is enrolling an additional 35 patients with medium or high FRα expression levels in an expansion cohort in the FORWARD II study and expects to present data from this cohort later this year.
Early-Stage Pipeline – Novel IGN Compounds
IMGN779 is a CD33-targeting ADC in a Phase 1 dose-finding study in
relapsed/refractory acute myeloid leukemia (AML). Dose escalation is
continuing with both biweekly and weekly dosing schedules.
The Food and Drug Administration( FDA) has granted orphan-drug designation to IMGN779 for the treatment of AML.
- IMGN632 is a CD123-targeting ADC in a Phase 1 dose-finding study for AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Research and Innovation
In April, ImmunoGen presented three posters at the
American Association for Cancer Research(AACR) Annual Meeting highlighting the Company’s ongoing innovation in ADCs, including advancements to payloads and targets for enhanced anti-tumor activity as well as insights into factors that determine the clinical efficacy of ADCs.
Anticipated Upcoming Events
Report updated data from the FORWARD II mirvetuximab plus Avastin
(bevacizumab) combination expansion cohort in approximately 50
patients at the American Society of Clinical Oncology (
ASCO) Annual Meeting;
- Anticipate partner Takeda to begin clinical testing of TAK-164 in 2Q 2018;
- Report initial findings from the FORWARD II mirvetuximab plus pembrolizumab combination expansion cohort in 35 patients in the second half of the year;
- Report additional data from IMGN779 Phase 1 dose finding study in 4Q 2018 and identify the recommended Phase 2 dose before the end of the year;
- Report initial data from IMGN632 Phase 1 dose finding study in 4Q 2018; and
- Advance ADAM9 program into IND-enabling activities before year-end.
Revenues for the quarter ended
Operating expenses, including R&D and G&A expenses, for the first
quarter of 2018 were
ImmunoGen reported a net loss of
ImmunoGen has updated its operating expenses guidance for 2018. ImmunoGen now expects:
- operating expenses between $200 million and $205 million.
Guidance for revenues and cash remains unchanged:
revenues between $60 million and
$65 million; and
cash and cash equivalents at
December 31, 2018between $115 million and $120 million.
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations into the fourth quarter of 2019.
Conference Call Information
ImmunoGen will hold a conference call today at
ImmunoGen is a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. The Company’s lead product candidate, mirvetuximab soravtansine, is in the Phase 3 FORWARD I trial for FRα-positive platinum-resistant ovarian cancer, and is in the Phase 1b/2 FORWARD II trial in combination regimens for earlier-stage disease. ImmunoGen has three additional clinical-stage product candidates, two of which are being developed in collaboration with
Keytruda®, Avastin®, and Kadcyla® are registered trademarks of their respective owners.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures for the twelve months ending
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||218,383||$||267,107|
|LIABILITIES AND SHAREHOLDERS' DEFICIT|
|Current portion of deferred revenue||$||611||$||1,405|
|Other current liabilities||65,616||54,365|
|Long-term portion of deferred revenue||81,522||93,752|
|Other long-term liabilities||153,527||163,049|
|Total liabilities and shareholders' deficit||$||264,965||$||294,676|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended|
|License and milestone fees||$||11,540||$||18,730|
|Non-cash royalty revenue||7,190||7,613|
|Research and development support||383||1,478|
|Clinical materials revenue||702||678|
|Research and development||44,831||32,888|
|General and administrative||9,995||8,119|
|Total operating expenses||56,557||41,393|
|Loss from operations||(36,742||)||(12,894||)|
|Non-cash interest expense on liability related to sale of future royalty & convertible bonds||(3,046||)||(3,575||)|
|Interest expense on convertible bonds||(24||)||(1,125||)|
|Other income, net||1,199||249|
|Net loss per common share, basic and diluted||$||(0.30||)||$||(0.20||)|
|Weighted average common shares outstanding, basic and diluted||130,619||87,160|
Sarah Kiely, 781-895-0600
Courtney O’Konek, 781-895-0158
FTI Consulting, Inc.
Robert Stanislaro, 212-850-5657