ImmunoGen Reports Recent Progress and Second Quarter 2021 Financial Results
Compelling Final Data from FORWARD II Study Combining Mirvetuximab Soravtansine with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status, Presented at ASCO
Top-line Data from Pivotal SORAYA Trial on Track for Q4 Release
Continued Progress in Ongoing MIRASOL, IMGN632, and IMGC936 Studies
Conference Call to be Held at
"With top-line data from our pivotal SORAYA trial on track for release in Q4, we have accelerated preparations for the BLA submission and commercial launch of mirvetuximab. In parallel, we continue to generate data that support mirvetuximab as the combination agent of choice for ovarian cancer patients," said
Enyedy added, "Beyond mirvetuximab, our IMGN632, IMGC936, and IMGN151 programs are progressing as anticipated. Patient accrual continues in our IMGN632 trials in BPDCN and AML, with data from our AML cohort expected at ASH next quarter. Our dose-escalation study of IMGC936 is enrolling in multiple solid tumor types and we are on track to file the IND for IMGN151 by year-end. With a focus on execution towards key inflection points, we look forward to transforming ImmunoGen into a fully integrated oncology company with the potential for two innovative ADCs on the market in 2022."
RECENT PROGRESS
-
Presented final data from the FORWARD II study evaluating mirvetuximab in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate at the 2021
American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. - Completed accrual in the pivotal SORAYA study and further enrolled patients in the confirmatory MIRASOL study for mirvetuximab.
- Supported enrollment of investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and in a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
- Advanced accrual in the pivotal 801 Phase 2 study of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
- Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza® (azacitidine) and Venclexta® (venetoclax) in R/R acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
- Escalated dosing in the Phase 1 study of IMGC936 in multiple solid tumor types.
- Progressed activities to support an investigational new drug (IND) application for IMGN151.
ANTICIPATED UPCOMING EVENTS
- Release top-line data from the pivotal SORAYA study in the fourth quarter of 2021 and submit the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022.
- Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022.
- Enroll the first patient in PICCOLO, a single-arm study of mirvetuximab monotherapy in high FRα recurrent platinum-sensitive ovarian cancer, in the third quarter of 2021, designed to support potential label expansion.
-
Present initial AML combination data for IMGN632 at the 2021
American Society of Hematology (ASH) Annual Meeting inDecember 2021 . - Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in early 2022.
- Submit the IND application for IMGN151 by the end of 2021.
FINANCIAL RESULTS
Revenues for the quarter ended
Operating expenses for the second quarter of 2021 were
Net loss for the second quarter of 2021 was
ImmunoGen had
FINANCIAL GUIDANCE
ImmunoGen's financial guidance for 2021 remains unchanged:
-
revenues between
$65 million and$75 million ; -
operating expenses between
$200 million and$210 million ; and -
cash and cash equivalents at
December 31, 2021 to be between$140 million and$150 million .
ImmunoGen expects that its current cash will fund operations into the second half of 2022.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at
ABOUT IMMUNOGEN
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
Avastin®, Vidaza®, and Venclexta® are registered trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
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 and operating expenses for the twelve months ending
SELECTED FINANCIAL INFORMATION | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
2021 |
2020 |
||||||||||||||||
ASSETS | |||||||||||||||||
Cash and cash equivalents | $ |
239,538 |
$ |
293,856 |
|||||||||||||
Other assets |
61,908 |
61,216 |
|||||||||||||||
Total assets | $ |
301,446 |
$ |
355,072 |
|||||||||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||||||||
Current portion of deferred revenue | $ |
53,792 |
$ |
29,249 |
|||||||||||||
Other current liabilities |
66,527 |
93,074 |
|||||||||||||||
Long-term portion of deferred revenue |
55,480 |
80,860 |
|||||||||||||||
Other long-term liabilities |
57,182 |
62,319 |
|||||||||||||||
Shareholders' equity |
68,465 |
89,570 |
|||||||||||||||
Total liabilities and shareholders' equity | $ |
301,446 |
$ |
355,072 |
|||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
||||||||
Revenues: | |||||||||||||||||
Non-cash royalty revenue | $ |
16,690 |
$ |
14,075 |
$ |
32,235 |
$ |
27,072 |
|||||||||
License and milestone fees |
252 |
945 |
409 |
1,228 |
|||||||||||||
Research and development support |
6 |
5 |
10 |
12 |
|||||||||||||
Total revenues |
16,948 |
15,025 |
32,654 |
28,312 |
|||||||||||||
Expenses: | |||||||||||||||||
Research and development |
34,589 |
22,921 |
69,002 |
50,329 |
|||||||||||||
General and administrative |
9,728 |
9,767 |
19,937 |
18,631 |
|||||||||||||
Restructuring charge |
- |
699 |
- |
1,524 |
|||||||||||||
Total operating expenses |
44,317 |
33,387 |
88,939 |
70,484 |
|||||||||||||
Loss from operations |
(27,369) |
(18,362) |
(56,285) |
(42,172) |
|||||||||||||
Non-cash interest expense on liability related to sale of future royalty & convertible bonds |
(3,557) |
(6,081) |
(8,201) |
(11,783) |
|||||||||||||
Interest expense on convertible bonds |
(23) |
(23) |
(47) |
(47) |
|||||||||||||
Other income (loss), net |
208 |
168 |
(259) |
616 |
|||||||||||||
Net loss | $ |
(30,741) |
$ |
(24,298) |
$ |
(64,792) |
$ |
(53,386) |
|||||||||
Basic and diluted net loss per common share | $ |
(0.15) |
$ |
(0.14) |
$ |
(0.32) |
$ |
(0.31) |
|||||||||
Basic and diluted weighted average common shares outstanding |
199,890 |
174,354 |
199,365 |
171,055 |
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INVESTOR RELATIONS AND MEDIA CONTACTS
ImmunoGen
781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com
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