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Share Name | Share Symbol | Market | Type |
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ImmunoGen Inc | NASDAQ:IMGN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 31.235 | 32.80 | 29.67 | 0 | 01:00:00 |
Initial Data from FORWARD II Expansion Cohort of Mirvetuximab Soravtansine with KEYTRUDA® Reported at ESMO
Phase 1 Data for IMGN779 and IMGN632 to be Presented in Oral Sessions at ASH
Conference Call to be Held at 8:00 a.m. ET Today
ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today reviewed recent progress in the business and reported operating results for the quarter ended September 30, 2018.
“With the completion of enrollment in FORWARD I, we have initiated the activities required to support a BLA filing and launch mirvetuximab soravtansine in ovarian cancer. Over the last three months, we have completed the product validation runs for drug substance, put in place operational metrics and resources to ensure timely assessment of the primary endpoint for the study, and moved ahead with pre-launch commercial planning,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “In parallel, we continued to execute across the remainder of the business, including presentation of initial data from the FORWARD II KEYTRUDA combination at ESMO, accelerating accrual in the FORWARD II triplet cohort, and advancing our next ADC into preclinical development in collaboration with MacroGenics. Looking ahead to the fourth quarter and the coming year, with a strong cash runway, we are well-positioned to deliver on our strategic priorities and look forward to oral presentations for our novel IGN assets, IMGN779 and IMGN632, at ASH in December and to announcing top-line results from FORWARD I during the first half of 2019.”
PIPELINE PROGRESS AND PARTNER-RELATED UPDATES
ANTICIPATED UPCOMING EVENTS
FINANCIAL RESULTSRevenues for the quarter ended September 30, 2018 were $10.9 million, compared with $8.5 million for the quarter ended September 30, 2017. License and milestone fees of $0.7 million for the third quarter of 2018 included recognition of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals. Revenues in the third quarter of 2018 included $8.4 million in non-cash royalty revenues, compared with $6.5 million for the same quarter in 2017. Revenues for the third quarter of 2018 also included $0.4 million of research and development (R&D) support fees and $1.4 million of clinical materials revenue, compared with $0.7 million and $1.2 million, respectively, for the same quarter in 2017.
Operating expenses for the third quarter of 2018 were $56.5 million, compared with $39.6 million for the same quarter in 2017. The increase was driven by R&D expenses, which were $47.2 million in the third quarter of 2018, compared with $31.7 million for the third quarter of 2017. This increase was primarily due to higher antibody and cytotoxic manufacturing costs in support of commercial validation runs for mirvetuximab soravtansine, along with higher clinical trial costs related to the FORWARD II combination assessments and, to a lesser extent, expenses resulting from stock-based compensation. General and administrative expenses in the third quarter of 2018 were $8.3 million, compared to $7.9 million in the same quarter of 2017. Operating expenses for the third quarter of 2018 also included a $0.9 million restructuring charge due to the workforce reduction related to the previously announced decommissioning of the Company’s Norwood facility.
ImmunoGen reported a net loss of $46.8 million, or $0.32 per basic and diluted share, for the third quarter of 2018, compared with a net loss of $56.7 million, or $0.61 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 147.2 million from 93 million in those quarters.
ImmunoGen had $303.2 million in cash and cash equivalents as of September 30, 2018, compared with $267.1 million as of December 31, 2017, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $125.1 million for the first nine months of 2018, compared with cash provided from operations of $37.1 million for the same period in 2017. The prior period benefited from a $30 million paid-up license fee received from Sanofi, a $75 million upfront payment received from Jazz Pharmaceuticals, and a $25 million upfront payment received from Debiopharm. Capital expenditures were $4.2 million and $0.8 million for the nine months ended September 30, 2018 and 2017, respectively.
FINANCIAL GUIDANCEImmunoGen has updated its cash and revenue guidance for 2018. ImmunoGen now expects:
Guidance for operating expenses remains unchanged:
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations at least a year beyond the top-line results from the Phase 3 FORWARD I trial, which are expected in the first half of 2019.
CONFERENCE CALL INFORMATIONImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 323-794-2423; the conference ID is 8582527. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through November 16, 2018.
ABOUT IMMUNOGENImmunoGen 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.” Our lead product candidate, mirvetuximab soravtansine, is in a Phase 3 study for folate receptor alpha (FRα)-positive platinum resistant ovarian cancer, and in Phase 1b/2 testing in combination regimens. Our novel IGN candidates for hematologic malignancies, IMGN779 and IMGN632, are in Phase 1 studies.
Learn more about who we are, what we do, and how we do it at www.immunogen.com.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. KADCYLA®, HERCEPTIN®, and AVASTIN® are registered trademarks of Genentech, a member of the Roche Group. PROBODY™ is a trademark of CytomX Therapeutics, Inc.
FORWARD-LOOKING STATEMENTSThis 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 December 31, 2018; its cash and marketable securities as of December 31, 2018; 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 December 31, 2017 and other reports filed with the Securities and Exchange Commission.
ImmunoGen, Inc. Reports Financial Results for Quarter and Nine Months Ended September 30, 2018 IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in thousands, except per share amounts) CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) September 30, December 31, 2018 2017 ASSETS Cash and cash equivalents $ 303,205 $ 267,107 Other assets 36,659 27,569 Total assets $ 339,864 $ 294,676 LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) Current portion of deferred revenue $ 1,713 $ 1,405 Other current liabilities 68,657 54,365 Long-term portion of deferred revenue 80,592 93,752 Other long-term liabilities 142,014 163,049 Shareholders' equity (deficit) 46,888 (17,895 ) Total liabilities and shareholders' equity (deficit) $ 339,864 $ 294,676 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Revenues: License and milestone fees $ 672 $ 79 $ 13,533 $ 49,889 Non-cash royalty revenue 8,441 6,503 22,873 20,555 Research and development support 388 650 1,159 3,030 Clinical materials revenue 1,427 1,248 2,465 2,525 Total revenues 10,928 8,480 40,030 75,999 Expenses: Research and development 47,243 31,689 130,775 99,896 General and administrative 8,347 7,908 26,994 24,863 Restructuring charge 870 - 3,287 386 Total operating expenses 56,460 39,597 161,056 125,145 Loss from operations (45,532 ) (31,117 ) (121,026 ) (49,146 ) Non-cash debt conversion expense - (22,191 ) - (22,191 ) Non-cash interest expense on liability related to sale of future royalty & convertible bonds (2,546 ) (3,385 ) (8,203 ) (10,461 ) Interest expense on convertible bonds (23 ) (762 ) (70 ) (3,012 ) Other income (loss), net 1,294 773 2,255 1,916 Net loss $ (46,807 ) $ (56,682 ) $ (127,044 ) $ (82,894 ) Net loss per common share, basic and diluted $ (0.32 ) $ (0.61 ) $ (0.92 ) $ (0.93 ) Weighted average common shares outstanding, diluted 147,220 93,001 137,472 89,133
View source version on businesswire.com: https://www.businesswire.com/news/home/20181102005091/en/
INVESTOR RELATIONS CONTACTImmunoGen, Inc.Sarah Kiely, 781-895-0600sarah.kiely@immunogen.comorMEDIA CONTACTCourtney O’Konek, 781-895-0600courtney.okonek@immunogen.comorTHRUST Strategic CommunicationsChelcie Lister, 910-777-3049chelcie@thrustsc.comorFTI ConsultingRobert Stanislaro, 212-850-5657robert.stanislaro@fticonsulting.com
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