Encouraging Efficacy Signal Observed in Pre-Specified Subset of Patients in Phase 3 FORWARD I Study; Company to Meet with Regulators this Quarter to Discuss Potential Path Forward for Mirvetuximab Soravtansine Monotherapy
FORWARD II Trial with Mirvetuximab Combinations Continues to Enroll, with Mature Data from Avastin® Expansion Cohort to be Presented at
Operational Review Underway with Goal of Extending Cash Position
Conference Call to be Held at
“Following the readout of the top-line results from FORWARD I, we have undertaken a comprehensive analysis of the data and see a consistent efficacy signal across a range of parameters in the pre-specified subset of ovarian cancer patients with high folate receptor alpha (FRα) expression. Specifically, in comparison to chemotherapy, we have observed higher response rates, more durable responses, and longer progression-free and overall survival in patients with high FRα expression treated with mirvetuximab,” said
Enyedy continued, “In parallel, our FORWARD II combination trial continues to enroll patients and we look forward to presenting mature data for mirvetuximab in combination with Avastin in platinum-resistant ovarian cancer patients at
RECENT
Mirvetuximab Soravtansine
IGN Programs, Early-Stage Pipeline, and Research
Operational Updates
ANTICIPATED UPCOMING EVENTS
FINANCIAL RESULTS
Revenues for the quarter ended
Operating expenses for the first quarter of 2019 were
ImmunoGen reported a net loss of
ImmunoGen had
FINANCIAL GUIDANCE
ImmunoGen will provide an update on the Company’s 2019 financial guidance following the completion of the operational review.
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.” The Company has built a productive platform generating a broad pipeline of ADCs targeting solid tumors and hematologic malignancies.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
Kadcyla® and Avastin® are registered trademarks of Genentech, a member of the
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 occurrence, timing and outcome of potential pre-clinical, clinical and regulatory events related to the Company's and its collaboration partners' product programs; and the presentation of preclinical and clinical data on the Company’s and collaboration partners’ product candidates. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGen's actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGen's and the Company's collaboration partners' research and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense and results of preclinical studies, clinical trials and regulatory processes; ImmunoGen's ability to financially support its product programs; ImmunoGen's dependence on collaborative partners; industry merger and acquisition activity; and other factors more fully described in ImmunoGen’s Annual Report on Form 10-K for the year ended
IMMUNOGEN, INC. | ||||||||||
SELECTED FINANCIAL INFORMATION (in thousands, except per share amounts) |
||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
(Unaudited) | ||||||||||
March 31, 2019 |
December 31, 2018 |
|||||||||
ASSETS | ||||||||||
Cash and cash equivalents | $ | 270,396 | $ | 262,252 | ||||||
Other assets | 53,529 | 33,129 | ||||||||
Total assets | $ | 323,925 | $ | 295,381 | ||||||
LIABILITIES AND SHAREHOLDERS' (DEFICIT) EQUITY | ||||||||||
Current portion of deferred revenue | $ | 317 | $ | 317 | ||||||
Other current liabilities | 61,109 | 70,343 | ||||||||
Long-term portion of deferred revenue | 145,693 | 80,485 | ||||||||
Other long-term liabilities | 144,410 | 133,264 | ||||||||
Shareholders' (deficit) equity | (27,604 | ) | 10,972 | |||||||
Total liabilities and shareholders' (deficit) equity | $ | 323,925 | $ | 295,381 | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(Unaudited) | ||||||||||
Three Months Ended March 31, |
||||||||||
2019 | 2018 | |||||||||
Revenues: | ||||||||||
Non-cash royalty revenue | $ | 8,488 | $ | 7,190 | ||||||
License and milestone fees | 79 | 11,540 | ||||||||
Research and development support | 17 | 383 | ||||||||
Clinical materials revenue | - | 702 | ||||||||
Total revenues | 8,584 | 19,815 | ||||||||
Expenses: | ||||||||||
Research and development | 38,893 | 44,831 | ||||||||
General and administrative | 10,778 | 9,995 | ||||||||
Restructuring charge | 559 | 1,731 | ||||||||
Total operating expenses | 50,230 | 56,557 | ||||||||
Loss from operations | (41,646 | ) | (36,742 | ) | ||||||
Non-cash interest expense on liability related to sale of future royalty & convertible bonds | (3,432 | ) | (3,046 | ) | ||||||
Interest expense on convertible bonds | (24 | ) | (24 | ) | ||||||
Other income, net | 1,351 | 1,199 | ||||||||
Net loss | $ | (43,751 | ) | $ | (38,613 | ) | ||||
Net loss per common share, basic and diluted | $ | (0.30 | ) | $ | (0.30 | ) | ||||
Weighted average common shares outstanding, basic and diluted | 147,813 | 130,619 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190503005035/en/
Source:
INVESTOR RELATIONS CONTACT
Sarah Kiely
781-895-0600
sarah.kiely@immunogen.com
MEDIA CONTACT
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com
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