PARP x Tubulin

- The full approval of ELAHERE is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) - Data show that ELAHERE treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35% - ELAHERE represents AbbVie's first approved solid tumor treatment following the recent acquisition of ImmunoGen NORTH CHICAGO, Ill., March 22, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE. "The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE to investigator's choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumors express high levels of FRα and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS). "As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and ELAHERE changes that," said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator. ABOUT THE PHASE 3 MIRASOL TRIAL MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor. Based on current results: OS hazard ratio (HR) was 0.67 (95% confidence interval [CI]: 0.50, 0.88; p=0.0046), representing a 33% reduction in risk of death in the ELAHERE arm compared to the IC chemotherapy arm. PFS HR was 0.65 (95% CI: 0.52, 0.81; p<0.0001), representing a 35% reduction in the risk of tumor or cancer progression in the ELAHERE arm compared to IC chemotherapy. ELAHERE showed overall fewer Grade 3+ adverse events and a lower rate of discontinuations due to adverse events when compared to the IC chemotherapy control group. The most common (≥20%) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils. ABOUT OVARIAN CANCER Ovarian cancer is the leading cause of death from gynecological cancers in the United States. Each year, approximately 20,000 patients are diagnosed. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities. 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. Patients requiring access support may call 1-833-ELAHERE or visit . The Marketing Authorization Application (MAA) for ELAHERE in Europe has been accepted by the European Medicines Agency (EMA). Regulatory submissions for ELAHERE are also under review in multiple other countries. INDICATION 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. IMPORTANT SAFETY INFORMATION WARNING: OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities. WARNINGS and PRECAUTIONS Ocular Disorders ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis. Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%). The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients. Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider. Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms. Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions. Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE. Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology. Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients. Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring. Peripheral Neuropathy (PN) Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%). Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN. Embryo-Fetal Toxicity Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose. ADVERSE REACTIONS The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils. DRUG INTERACTIONS DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors. USE IN SPECIAL POPULATIONS Lactation Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose. Hepatic Impairment Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN). Please see full Prescribing Information, including BOXED WARNING About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Company Codes: NYSE:ABBV

Continued Strong Demand for ELAHERE; US Net Sales of $105.2 Million in Q3 ELAHERE MAA in FRα-Positive Platinum-Resistant Ovarian Cancer Accepted by EMA; sBLA to Support Full Approval in US Submitted to FDA PICCOLO Trial of ELAHERE in Platinum-Sensitive Ovarian Cancer Meets Primary Endpoint of Objective Response Rate; Full Data Anticipated in Mid-2024 Advanced Geographic Market Expansion Through Collaboration with Takeda to Develop and Commercialize ELAHERE in Japan and Acceptance of NDA by the NMPA in China Expanded Leadership Team with Appointments of Lauren White, Chief Financial Officer, and Heather Adkins Huet, Chief Scientific Officer Conference Call to be Held at 8:00 a.m. ET Today WALTHAM, Mass.--(BUSINESS WIRE)-- 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 financial results for the quarter ended September 30, 2023. “Building on the momentum generated in the first half of 2023, we delivered a strong third quarter highlighted by significant ELAHERE revenue growth and the achievement of key operational milestones,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “With a 36% increase in sequential quarterly net sales and over $210 million in product revenue through the first nine months of the year, ELAHERE is tracking towards one of the most successful first product launches in oncology in a decade. We also made important progress in our effort to bring ELAHERE to eligible patients around the world with the acceptance of the MAA by the EMA and the NDA by the NMPA, and the establishment of a collaboration with Takeda to deliver ELAHERE in Japan.” Enyedy continued, “In addition, we advanced the ELAHERE development program and are pleased to report that our PICCOLO trial in platinum-sensitive ovarian cancer has met the primary endpoint of objective response rate based on an interim efficacy assessment. With a number of patients remaining on treatment and longer follow-up required to establish mature response durability of ELAHERE in this patient population, we anticipate an ORR of at least 48% when we report full data in mid-2024. Turning to our second pivotal program, PVEK, we continue to advance our 802 study and look forward to reporting data from our PVEK/VEN/AZA triplet in frontline AML at ASH in December. We also continued to monitor the NSCLC cohort with IMGC936 and advanced dose escalation with IMGN151, our second-generation ADC targeting FRα. We look forward to a strong finish to the year and a productive 2024 with the continued growth of ELAHERE, important new data for our programs, and geographic expansion in Europe and China.” RECENT PROGRESS ELAHERE (mirvetuximab soravtansine-gynx) Generated $105.2 million in ELAHERE net sales for the quarter ended September 30, 2023. Obtained acceptance of the Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for ELAHERE in folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) to support approval and launch in Europe. Submitted the supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) to support conversion to full approval. Our partner, Huadong Medicine, obtained acceptance of the New Drug Application (NDA) to the National Medical Products Administration (NMPA) of China for ELAHERE in FRα-positive PROC to support approval and launch. Announced collaboration with Takeda Pharmaceutical Company Limited (Takeda) granting Takeda an exclusive license to develop and commercialize ELAHERE in Japan. The Company received an upfront payment of $23.21 million and is eligible to receive up to approximately $1352 million in regulatory and commercial milestone payments in addition to tiered royalties in the low double-digits to mid-twenties. Clinical Pipeline and Research Presented additional subset analyses in prior lines of therapy and prior exposure to PARP inhibitor (PARPi) therapy from MIRASOL in an oral session at the 24th Congress of the European Society of Gynaecological Oncology (ESGO) demonstrating clinical outcomes of safety and efficacy consistent with the overall MIRASOL study population. Reported that PICCOLO, the ongoing single-arm Phase 2 trial of mirvetuximab in FRα-high, platinum-sensitive ovarian cancer (PSOC) has met the primary endpoint of objective response rate (ORR) based upon an interim assessment with no new safety signals identified. An ORR of at least 48% is expected when full data are reported in mid-2024. Established a multi-target license and option agreement with ImmunoBiochem Corporation to develop next-generation ADCs. Corporate Appointed Lauren White as Senior Vice President and Chief Financial Officer, and Heather Adkins Huet, PhD, as Senior Vice President and Chief Scientific Officer. ANTICIPATED UPCOMING EVENTS Potential FDA approval of ELAHERE’s sBLA in H1 2024. Report full data from the single-arm Phase 2 PICCOLO trial of mirvetuximab in FRα-high PSOC in mid-2024. Potential EMA approval of ELAHERE in late 2024 to support launch in Europe. Our partner, Huadong Medicine, is planning for NMPA approval of ELAHERE by the end of 2024 to support launch in China. Report data from the 802 trial, evaluating the pivekimab sunirine (pivekimab) triplet with Venclexta® (venetoclax) and Vidaza® (azacitidine) in frontline acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting in December 2023. Report top-line data from the pivotal frontline de novo cohort in the Phase 2 CADENZA trial of pivekimab in blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 2024. Provide an update on the IMGC936 non-small cell lung cancer (NSCLC) cohort following a prespecified interim analysis. FINANCIAL RESULTS Total revenues were $113.4 million for the quarter ended September 30, 2023, including $105.2 million of net product revenues from sales of ELAHERE, compared to $15.4 million in total revenues for the quarter ended September 30, 2022. The increase was driven by ELAHERE net sales, partially offset by $7.4 million of license fees recorded as revenue in the prior year period pursuant to the Company’s collaboration agreements with Eli Lilly and Company and Novartis Institutes for BioMedical Research, Inc. Research and development expenses were $47.6 million for the quarter ended September 30, 2023 compared to $59.2 million for the quarter ended September 30, 2022. The decrease was primarily driven by ELAHERE supply costs expensed in the prior quarter versus capitalized in the current period and lower hiring expenses. Partially offsetting these decreases, salaries and benefits increased driven largely by the expansion of our medical affairs organization. Selling, general and administrative expenses were $37.7 million for the quarter ended September 30, 2023 compared to $33.6 million for the quarter ended September 30, 2022. The increase was due primarily to greater expenses in support of the US launch of ELAHERE, including costs related to the addition of our commercial organization and sales and marketing activities. Net income for the third quarter of 2023 was $30.7 million, or $0.10 per basic and diluted share, compared to a net loss of $77.8 million, or $0.31 per basic and diluted share, for the third quarter of 2022. ImmunoGen had $605.5 million in cash and cash equivalents and $130.7 million in accounts receivable as of September 30, 2023, compared with $275.1 million in cash and cash equivalents and $12.6 million in accounts receivable as of December 31, 2022. Cash used in operations was $137.7 million for the first nine months of 2023 compared with cash used in operations of $169.6 million for the same period in 2022. Capital expenditures were $1.6 million and $1.1 million for the first nine months of 2023 and 2022, respectively. FINANCIAL GUIDANCE ImmunoGen’s full year financial guidance for 2023 remains unchanged; the Company continues to expect: revenues, excluding product revenue from ELAHERE, between $45 million and $50 million; and operating expenses between $350 million and $365 million. The Company continues to expect 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 8:00 a.m. ET to discuss these results. To access the live call by phone, please register here. A dial-in and unique PIN will be provided to join the call. The call may also be accessed through the Investors and Media section of the Company’s website, . Following the call, a replay will be available at the same location. 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 pro 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 . Vidaza® and Venclexta® are registered trademarks of their respective owners. ELAHERE® is a registered trademark of ImmunoGen, Inc. 1 ¥3.4 billion (0.0068 exchange rate as of September 5, 2023); 2 ¥19.9 billion (0.0068 exchange rate as of August 25, 2023) FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. These statements include, but are not limited to, the timing and outcome of the submissions of a Marketing Authorization Application in Europe, a supplemental Biologics License Application in the US, and a New Drug Application in China; the potential development and commercialization of ELAHERE in Japan; the timing and presentation of clinical data on the Company’s products and product candidates, including data from the PICCOLO trial, the pivekimab triplet, top-line data from the Phase 2 CADENZA trial, and IMGC936; the Company’s revenues and operating expenses for 2023; the Company’s anticipated cash runway; and the Company’s future product and collaboration revenues. 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 successful execution of the collaboration with Takeda and their development and commercialization efforts; the timing and outcome of the Company's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of clinical trials and regulatory processes; the timing and outcome of anticipated interactions with regulatory authorities; the risk that the Company may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for ELAHERE in light of the FDA granting accelerated approval; and other factors as set forth in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023, the Company's Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission on April 28, 2023 and July 31, 2023, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. ImmunoGen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law. IMMUNOGEN, INC. SELECTED FINANCIAL INFORMATION (in thousands, except per share amounts) CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) September 30, December 31, 2023 2022 ASSETS Cash and cash equivalents $ 605,535 $ 275,138 Accounts receivable 130,694 12,596 Inventory 33,768 16,196 Other assets 52,104 45,006 Total assets $ 822,101 $ 348,936 LIABILITIES AND SHAREHOLDERS' EQUITY Current portion of deferred revenue $ 37,186 $ 13,856 Other current liabilities 97,474 108,002 Term loan, net 72,113 - Long-term portion of deferred revenue 26,718 36,355 Other long-term liabilities 27,014 34,897 Shareholders' equity 561,596 155,826 Total liabilities and shareholders' equity $ 822,101 $ 348,936 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Revenues: Product revenue, net $ 105,164 $ - $ 212,079 $ - License and milestone fees 51 7,382 15,122 45,247 Non-cash royalty revenue 7,355 7,993 17,936 21,537 Research and development support 855 - 1,310 831 Total revenues 113,425 15,375 246,447 67,615 Cost and operating expenses: Cost of sales 2,155 - 3,690 - Research and development 47,570 59,181 149,267 154,885 Selling, general and administrative 37,744 33,623 114,116 74,064 Total cost and operating expenses 87,469 92,804 267,073 228,949 Income (loss) from operations 25,956 (77,429) (20,626) (161,334) Interest income (expense), net 4,844 1,539 8,918 2,183 Non-cash interest expense on liability related to sale of future royalty and term loan (1,054) (867) (2,986) (3,194) Other loss, net (164) (998) (109) (1,576) Income (loss) before income taxes $ 29,582 $ (77,755) $ (14,803) $ (163,921) Income tax benefit 1,166 - 289 - Net income (loss) 30,748 (77,755) (14,514) (163,921) Net income (loss) per common share - basic $ 0.10 $ (0.31) $ (0.05) $ (0.65) Net income (loss) per common share - diluted $ 0.10 $ (0.31) $ (0.05) $ (0.65) Weighted-average common shares outstanding - basic 273,341 253,511 265,265 253,371 Weighted-average common shares outstanding - diluted 287,590 253,511 265,265 253,371 View source version on businesswire.com: Contacts INVESTOR RELATIONS ImmunoGen Anabel Chan 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: ImmunoGen Inc. 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Data Further Position ELAHERE to Become the New Standard of Care for Patients with FRα-Positive Platinum-Resistant Ovarian Cancer Findings to be Highlighted in Oral Presentation at ESGO Annual Congress WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced findings from two subset analyses of the Phase 3 confirmatory MIRASOL trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC). The findings will be presented by Dr. Toon Van Gorp in an oral presentation today at the 24th Congress of the European Society of Gynaecological Oncology (ESGO) in Istanbul, Turkey. “Consistent with the strong topline MIRASOL data where superiority was seen across all efficacy endpoints, these subset analyses show that the improvements in progression-free survival, objective response rates, and overall survival demonstrated in the overall study population are also observed regardless of the number of prior lines of therapy,” said Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven. “Importantly, the benefit seen with ELAHERE in patients treated with a prior PARP inhibitor is particularly encouraging, as it has been shown that PARP inhibitors have a potential negative impact on the efficacy of subsequent chemotherapies. These new data being presented at ESGO, including a consistent safety and tolerability profile, provide valuable insights for physicians into ELAHERE’s broad and meaningful benefit compared to chemotherapy and further position ELAHERE to become the new standard of care for patients with FRα-positive PROC.” MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator's choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan). MIRASOL enrolled 453 patients with PROC, whose tumors express high levels of FRα using what is now the Ventana FOLR1-2.1 assay, and who have been treated with one to three prior regimens. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 40% had two prior lines of therapy, and 46% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR), overall survival (OS), and patient-reported outcomes (PROs). EFFICACY OF MIRVETUXIMAB SORAVTANSINE IN FOLATE RECEPTOR ALPHA HIGH, PLATINUM-RESISTANT OVARIAN CANCER BY TYPE AND NUMBER OF PRIOR TREATMENT REGIMENS: AN EXPLORATORY ANALYSIS Lead Author: Toon Van Gorp, MD Date/Time: Thursday, September 28, 2023, 2:00-2:35pm TRT / 7:00-7:35am ET Abstract: #1015 and #1056 In addition to the top-line MIRASOL data previously disclosed and subsequently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, the following new data are being presented at ESGO: ELAHERE demonstrated clinically meaningful improvement in PFS and ORR by investigator assessment and in OS compared to IC chemotherapy, regardless of prior PARPi exposure. In patients with prior PARPi (n=251), PFS hazard ratio (HR) was 0.58 (95% CI: 0.43, 0.78; p= 0.0002); in the PARPi-naïve subset (n=191), PFS HR was 0.74 (95% CI: 0.54, 1.03, p =0.0685). In patients with prior PARPi, ORR in the ELAHERE arm was 45% (95% CI: 36%, 54%), including 7 CRs, compared to 17% (95% CI: 11%, 25%), with no CRs, in the IC chemotherapy arm (p<0.0001); in the PARPi-naïve subset, ORR in the ELAHERE arm was 40% (95% CI: 30%, 51%), including 5 CRs, compared to 14% (95% CI: 8%, 23%), with no CRs, in the IC chemotherapy arm (p<0.0001). In patients with prior PARPi, OS HR was 0.48 (95% CI: 0.33, 0.71; p= 0.0002); in the PARPi-naïve subset, OS HR was 0.90 (95% CI: 0.590, 1.38, p =0.6319). ELAHERE demonstrated clinically meaningful improvements in PFS and ORR by investigator assessment and in OS compared to IC chemotherapy, regardless of prior lines of therapy (PLOT). In patients with 1 or 2 PLOT (n=245), the PFS HR was 0.61 (95% CI: 0.45, 0.81; p=0.0007); in patients with 3 PLOT (n=208), PFS HR was 0.71 (95% CI: 0.52, 0.98; p=0.0362). In patients with 1 or 2 PLOT, ORR in the ELAHERE arm was 46% (95% CI: 37%, 55%), including 10 complete responses (CRs), compared to 15% (95% CI: 9%, 22%), with no CRs, in the IC chemotherapy arm (p<0.0001); in patients with 3 PLOT, ORR in the ELAHERE arm was 38% (95% CI: 29%, 48%), including 2 CRs, compared to 18% (95% CI:11%, 26%), with no CRs, in the IC chemotherapy arm (p=0.0009). In patients with 1 or 2 PLOT, OS HR was 0.66 (95% CI: 0.45, 0.98; p=0.0375); in patients with 3 PLOT, OS HR was 0.65 (95% CI: 0.43, 0.96; p=0.0308). ELAHERE demonstrated a tolerable safety pro to IC chemotherapy consisting predominantly of low-grade ocular and gastrointestinal events. In all patients, the frequency of grade 3+ treatment-emergent adverse events (TEAEs) was 42% with ELAHERE and 54% with IC chemotherapy; the frequency of serious adverse events (SAEs) was 24% with ELAHERE and 33% with IC chemotherapy; and the frequency of discontinuations due to a TEAE was 9% with ELAHERE and 16% with IC chemotherapy. "Given ELAHERE is a potentially transformative option for those with platinum-resistant ovarian cancer, it will be important for clinicians to understand the consistency across these subset analyses from MIRASOL as they make treatment decisions with their patients," said Michael Vasconcelles, MD, ImmunoGen's Executive Vice President, Research, Development, and Medical Affairs. "Looking forward, we are excited to submit our MAA and sBLA to the EMA and FDA, respectively, before year end while continuing to advance our broader development program as we prioritize delivering ELAHERE to eligible patients in need." In November 2022, the US Food and Drug Administration (FDA) granted accelerated approval for ELAHERE for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens based on ORR and duration of response data from the pivotal SORAYA trial. Additional information can be found at . ABOUT OVARIAN CANCER Ovarian cancer is the leading cause of death from gynecological cancers in the US. Each year, roughly 20,000 patients are diagnosed, and 13,000 patients will die. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities. 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. Indication and Usage 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. Important Safety Information BOXED WARNING: OCULAR TOXICITY ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities. WARNINGS and PRECAUTIONS Ocular Disorders ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis. Ocular adverse reactions occurred in 61% of patients with ovarian cancer treated with ELAHERE. Nine percent (9%) of patients experienced Grade 3 ocular adverse reactions, including visual impairment, keratopathy/keratitis (corneal disorders), dry eye, photophobia, and eye pain; and one patient (0.2%) experienced Grade 4 keratopathy. The most common (≥5%) ocular adverse reactions were visual impairment (49%), keratopathy (36%), dry eye (26%), cataract (15%), photophobia (13%), and eye pain (12%). The median time to onset for first ocular adverse reaction was 1.2 months (range: 0.03 to 12.9). Of the patients who experienced ocular events, 49% had complete resolution and 39% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade) at last follow up. Ocular adverse reactions led to permanent discontinuation of ELAHERE in 0.6% of patients. Premedication and use of lubricating and ophthalmic topical steroids eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider. Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms. Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions. Pneumonitis Severe, life-threatening, or fatal interstitial lung disease, including pneumonitis, can occur in patients treated with ELAHERE. Pneumonitis occurred in 10% of patients treated with ELAHERE, including 0.8% with Grade 3 events, and 1 patient (0.2%) with a Grade 4 event. One patient (0.2%) died due to respiratory failure in the setting of pneumonitis and lung metastases. Monitor patients for pulmonary signs and symptoms of pneumonitis. Infectious, neoplastic, and other causes for symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring. Peripheral Neuropathy (PN) PN occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 2% of patients experienced Grade 3 PN. PN adverse reactions included peripheral neuropathy (19%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (2%), peripheral motor neuropathy (1%), neuralgia (0.4%), polyneuropathy (0.2%) and oral hypoesthesia (0.2%). Monitor patients for signs and symptoms of neuropathy. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN. Embryo-Fetal Toxicity Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose. ADVERSE REACTIONS Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%). Permanent discontinuation of ELAHERE due to adverse reactions occurred in 11% of patients. The most common (≥2%) adverse reactions leading to permanent discontinuation were intestinal obstruction (2%) and thrombocytopenia (2%). One patient (0.9%) permanently discontinued ELAHERE due to visual impairment (unilateral decrease to BCVA < 20/200 that resolved to baseline after discontinuation). Dosage delays of ELAHERE due to an adverse reaction occurred in 39% of patients. Adverse reactions which required dosage delays in ≥3% of patients included visual impairment (15%), keratopathy (11%), neutropenia (6%), dry eye (5%), cataracts (3%) and increased gamma-glutamyltransferase (3%). Dose reductions of ELAHERE due to an adverse reaction occurred in 20% of patients. Adverse reactions which required dose reductions in ≥3% of patients included visual impairment (9%) and keratopathy (7%). The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin. DRUG INTERACTIONS Strong CYP3A4 Inhibitors DM4 is a CYP3A4 substrate. Concomitant use of ELAHERE with strong CYP3A4 inhibitors may increase unconjugated DM4 exposure, which may increase the risk of ELAHERE adverse reactions. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors. USE IN SPECIAL POPULATIONS Lactation Advise women not to breastfeed during treatment with ELAHERE and for at least 1 month after the last dose. Pediatric Use Safety and effectiveness of ELAHERE have not been established in pediatric patients. Hepatic Impairment Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN). Please see full Prescribing Information, including Boxed Warning 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 pro 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 . ELAHERE® is a trademark of ImmunoGen, Inc. FORWARD-LOOKING STATEMENTS This press release includes forward-looking statements. These statements include, but are not limited to, ImmunoGen's expectations related to the potential of ELAHERE to become the new standard of care for patients with FRα-positive platinum-resistant ovarian cancer and to serve as a transformative option for platinum-resistant ovarian cancer patients; and the timing and outcome of the submissions of a Marketing Authorization Application in Europe and a supplemental Biologics License Application in the US. 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 successful execution of the collaboration with Takeda and their development and commercialization efforts; the timing and outcome of the Company's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of clinical trials and regulatory processes; the timing and outcome of anticipated interactions with regulatory authorities; the risk that the Company may not be able to obtain adequate price and reimbursement for any approved products, including the potential for delays or additional difficulties for ELAHERE in light of the FDA granting accelerated approval; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen's industry and business; and other factors as set forth in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2023, the Company's Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission on April 28, 2023 and July 31, 2023, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. ImmunoGen undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law. View source version on businesswire.com: Contacts INVESTOR RELATIONS ImmunoGen Anabel Chan 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: ImmunoGen Inc. View this news release online at: