Continued Strong Momentum with ELAHERE Launch in US;
Presented Positive Results for ELAHERE from Phase 3 MIRASOL Trial During Late-Breaking Oral Presentation at ASCO; First Therapy to Demonstrate an Overall Survival Benefit Compared to Chemotherapy in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer
Submission of ELAHERE MAA to Support Expansion into
Presented Interim Analysis from Phase 2 CADENZA Trial at EHA Congress Showing Encouraging Anti-Tumor Activity and Durable Responses for Pivekimab Sunirine in BPDCN; Pivotal Frontline Cohort Now Fully Enrolled
Generated
Conference Call to be Held at
“This quarter we achieved a significant milestone for patients and our organization. With positive data from our confirmatory MIRASOL trial, ELAHERE is the first therapy to demonstrate an overall survival benefit versus chemotherapy in a Phase 3 trial in platinum-resistant ovarian cancer. These data further support the potential of ELAHERE to become the new standard of care for FRα-positive platinum-resistant disease,” said
Enyedy continued, “We also progressed our broader development program to move ELAHERE into platinum-sensitive disease and position it as the combination agent of choice in ovarian cancer. Turning to our second pivotal program, PVEK, we presented an interim analysis from our CADENZA trial showing encouraging anti-tumor activity and durable responses in BPDCN and are pleased to share that we enrolled our last patient in the pivotal de novo frontline cohort at the end of the second quarter. We also advanced development with IMGC936 and IMGN151, our second-generation ADC targeting FRα. Looking ahead, we see continued momentum through the second half of the year with multiple data readouts and regulatory milestones, including efficacy results from PICCOLO with ELAHERE monotherapy in platinum-sensitive ovarian cancer and from the expansion cohorts with the PVEK/VEN/AZA triplet in frontline AML as well as the submissions of the MAA and sBLA for ELAHERE.”
RECENT PROGRESS
ANTICIPATED UPCOMING EVENTS
FINANCIAL RESULTS
Total revenues were
Research and development expenses were
Selling, general and administrative expenses were
Net loss for the second quarter of 2023 was
In
ImmunoGen had
FINANCIAL GUIDANCE
ImmunoGen has updated its financial guidance for 2023 and now expects operating expenses of between
The Company expects that its existing cash and cash equivalents, together with anticipated future product and collaboration revenues, will fund operations for more than two years.
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at
ABOUT ELAHERE
ELAHERE® (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.
ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Eye problems are common with ELAHERE and can be severe. ELAHERE also can cause severe or life-threatening inflammation of the lungs that may lead to death and patients may develop nerve problems called peripheral neuropathy during treatment. Please see full Prescribing Information, including Boxed Warning, and Medication Guide for ELAHERE.
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.
Vidaza® and Venclexta® are registered trademarks of their respective owners. ELAHERE® is a registered trademark of
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These statements include, but are not limited to, the Company’s expectations related to its revenues, operating expenses, and cash forecast; the potential of ELAHERE to become the standard of care and combination agent of choice in FRα-positive ovarian cancer; the potential full approval of ELAHERE in the US and regulatory approval of ELAHERE in
IMMUNOGEN, INC. | |||||||||||||||||
SELECTED FINANCIAL INFORMATION | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
2023 |
2022 |
||||||||||||||||
ASSETS | |||||||||||||||||
Cash and cash equivalents | $ |
571,987 |
$ |
275,138 |
|||||||||||||
Other assets |
142,340 |
73,798 |
|||||||||||||||
Total assets | $ |
714,327 |
$ |
348,936 |
|||||||||||||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||||||||||||
Current portion of deferred revenue | $ |
14,389 |
$ |
13,856 |
|||||||||||||
Other current liabilities |
79,313 |
108,002 |
|||||||||||||||
Term loan, net |
71,957 |
- |
|||||||||||||||
Long-term portion of deferred revenue |
30,217 |
36,355 |
|||||||||||||||
Other long-term liabilities |
27,609 |
34,897 |
|||||||||||||||
Shareholders' equity |
490,842 |
155,826 |
|||||||||||||||
Total liabilities and shareholders' equity | $ |
714,327 |
$ |
348,936 |
|||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||
2023 |
2022 |
2023 |
2022 |
||||||||||||||
Revenues: | |||||||||||||||||
Product revenue, net | $ |
77,371 |
$ |
- |
$ |
106,915 |
$ |
- |
|||||||||
License and milestone fees |
40 |
6,973 |
15,071 |
37,865 |
|||||||||||||
Non-cash royalty revenue |
5,742 |
7,116 |
10,581 |
13,544 |
|||||||||||||
Research and development support |
- |
73 |
455 |
831 |
|||||||||||||
Total revenues |
83,153 |
14,162 |
133,022 |
52,240 |
|||||||||||||
Cost and operating expenses: | |||||||||||||||||
Cost of sales |
909 |
- |
1,535 |
- |
|||||||||||||
Research and development |
50,077 |
51,422 |
101,697 |
95,704 |
|||||||||||||
Selling, general and administrative |
36,356 |
23,793 |
76,372 |
40,441 |
|||||||||||||
Total cost and operating expenses |
87,342 |
75,215 |
179,604 |
136,145 |
|||||||||||||
Loss from operations |
(4,189) |
(61,053) |
(46,582) |
(83,905) |
|||||||||||||
Interest income (expense), net |
1,905 |
590 |
4,074 |
644 |
|||||||||||||
Non-cash interest expense on liability related to sale of future royalty & term loan |
(1,079) |
(1,078) |
(1,932) |
(2,327) |
|||||||||||||
Other (loss) income, net |
(8) |
(480) |
55 |
(578) |
|||||||||||||
Loss before income taxes | $ |
(3,371) |
$ |
(62,021) |
$ |
(44,385) |
$ |
(86,166) |
|||||||||
Income tax expense |
877 |
- |
877 |
- |
|||||||||||||
Net loss |
(4,248) |
(62,021) |
(45,262) |
(86,166) |
|||||||||||||
Basic and diluted net loss per common share | $ |
(0.02) |
$ |
(0.24) |
$ |
(0.17) |
$ |
(0.34) |
|||||||||
Basic and diluted weighted average common shares outstanding |
263,446 |
253,336 |
261,160 |
253,263 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230731119395/en/
INVESTOR RELATIONS:
ImmunoGen
781-895-0600
anabel.chan@immunogen.com
MEDIA:
ImmunoGen
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com
Source:
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