IMGN ImmunoGen Inc.

6.71
-0.04  -1%
Previous Close 6.75
Open 6.66
52 Week Low 3.38
52 Week High 10.88
Market Cap $1,341,611,840
Shares 199,942,152
Float 177,047,878
Enterprise Value $1,089,580,526
Volume 563,824
Av. Daily Volume 1,667,657
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Upcoming Catalysts

Drug Stage Catalyst Date
Mirvetuximab soravtansine - FORWARD II
Ovarian cancer and relapsed endometrial cancer
Phase 1/2
Phase 1/2
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IMGN632
Relapse/Refractory AML, ALL, BPDCN
Phase 1/2
Phase 1/2
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Mirvetuximab - SORAYA
Ovarian cancer
Phase 3
Phase 3
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IMGC936
Solid Tumors
Phase 1
Phase 1
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Mirvetuximab - MIRASOL
Cancer - ovarian cancer and relapsed endometrial cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Trastuzumab emtansine ( T-DM1, trastuzumab-DM1) - Kadcyla - MARIANNE trial
Cancer - 1st-line HER2+ Metastatic Breast Cancer
Phase 3
Phase 3
Phase 3 data released Dec 18 2014. Met non-inferiority endpoint but did NOT significantly improve PFS compared to Herceptin and chemotherapy
Kadcyla KRISTINE trial
HER2-positive breast cancer - neo-adjuvant setting
Phase 3
Phase 3
Phase 3 trial did not meet endpoints.
Kadcyla GATSBY trial
Cancer - metastatic HER2+ gastric cancer
Phase 3
Phase 3
Endpoint not met - October 2015
Kadcyla
2nd-line HER2+ Metastatic Breast Cancer
Approved
Approved
Approved Feb 22 2013 - under priority review

Latest News

  1. Top-Line Data from Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer Expected in the Fourth Quarter of 2021

    FORWARD II Mirvetuximab Plus Avastin® Doublet Cohort in Recurrent Ovarian Cancer, Regardless of Platinum Status, Selected for Oral Presentation at ASCO

    Preclinical Data Demonstrating Anti-Tumor Activity of First-in-Class ADAM9-Targeting ADC, IMGC936, Presented at AACR

    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 financial results for the quarter ended March 31, 2021.

    "During the first quarter, we advanced our portfolio of innovative…

    Top-Line Data from Pivotal SORAYA Trial of Mirvetuximab Soravtansine in Ovarian Cancer Expected in the Fourth Quarter of 2021

    FORWARD II Mirvetuximab Plus Avastin® Doublet Cohort in Recurrent Ovarian Cancer, Regardless of Platinum Status, Selected for Oral Presentation at ASCO

    Preclinical Data Demonstrating Anti-Tumor Activity of First-in-Class ADAM9-Targeting ADC, IMGC936, Presented at AACR

    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 financial results for the quarter ended March 31, 2021.

    "During the first quarter, we advanced our portfolio of innovative ADCs and accelerated preparations for two potential product launches next year," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "We saw a limited delay in patient enrollment in the pivotal SORAYA trial for our lead program, mirvetuximab soravtansine, which has shifted the anticipated timing of top-line data from the third into the fourth quarter of this year and the projected submission of the BLA into the first quarter of 2022. We have also experienced some COVID-related impact on accrual to our confirmatory MIRASOL trial and now expect the read-out on the primary endpoint to move from the second into the third quarter of 2022. Beyond SORAYA and MIRASOL, we are commencing several studies to move mirvetuximab into earlier lines of ovarian cancer therapy, including an investigator-sponsored trial of mirvetuximab in combination with carboplatin in the neoadjuvant setting that initiated this quarter. We are also supporting a randomized study comparing mirvetuximab combined with carboplatin to standard of care in patients with recurrent platinum-sensitive disease and have submitted a protocol to FDA for a single-arm study of mirvetuximab monotherapy in later-line platinum-sensitive patients, with both studies anticipated to begin enrollment in the second half of this year. Finally, we were pleased to receive notice that mature data from our mirvetuximab plus Avastin® doublet cohort in recurrent ovarian cancer, regardless of platinum status, have been selected for an oral presentation at ASCO in June."

    Enyedy added, "We continued enrollment for our second pivotal program, IMGN632, in patients with frontline and relapsed/refractory BPDCN, with top-line data expected in the first half of 2022. IMGN632 is also in ongoing development in AML, both as a monotherapy and in combinations. Moving to our earlier-stage portfolio, we presented preclinical data at AACR last month on IMGC936, our first-in-class ADAM9-targeting ADC, demonstrating anti-tumor activity in multiple solid tumor models, and we advanced dose escalation in the Phase 1 study for this program. IND-enabling activities for our next-generation anti-FRα ADC, IMGN151, are on track to submit an application to the FDA by the end of 2021. With pre-commercial activities underway, we look forward to a meaningful year ahead with a number of important milestones across the business as we work towards bringing our first two therapies to market next year."

    RECENT PROGRESS

    • Further enrolled patients in the pivotal SORAYA and confirmatory MIRASOL trials.
    • Supported initiation of an investigator-sponsored trial of mirvetuximab plus carboplatin in the neoadjuvant setting.
    • Submitted to the US Food and Drug Administration (FDA) a single-arm study protocol for mirvetuximab monotherapy in later-line platinum-sensitive ovarian cancer patients.
    • Advanced accrual of the pivotal 801 Phase 1/2 study of IMGN632 in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.
    • Continued patient enrollment in the 802 Phase 1b/2 study of IMGN632 in combination with Vidaza® (azacitidine) and Venclexta® (venetoclax) in R/R and frontline acute myeloid leukemia (AML) patients and as a monotherapy in minimal residual disease positive (MRD+) AML.
    • Presented preclinical data on IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics, in a poster at the virtual American Association for Cancer Research (AACR) Annual Meeting.
    • Moved through dose-escalation cohorts 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

    • Generate top-line pivotal SORAYA data 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.
    • Complete patient enrollment in MIRASOL and generate top-line data in the third quarter of 2022.
    • Present mature data from the Phase 1b FORWARD II cohort evaluating mirvetuximab in combination with Avastin® (bevacizumab) in recurrent ovarian cancer in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting in June.
    • Initiate a single-arm study of mirvetuximab monotherapy in recurrent platinum-sensitive ovarian cancer in the second half of 2021 to support potential label expansion.
    • Support the start of a randomized Phase 2 investigator-sponsored study of mirvetuximab plus carboplatin in recurrent platinum-sensitive ovarian cancer in the second half of 2021.
    • Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) Annual Meeting in December.
    • 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 March 31, 2021 were $15.7 million, compared with $13.3 million for the quarter ended March 31, 2020, which consisted primarily of non-cash royalty revenues.

    Operating expenses for the first quarter of 2021 were $44.6 million, compared with $37.1 million for the same quarter in 2020. The increase was largely driven by research and development expenses, which were $34.4 million in the first quarter of 2021, compared with $27.4 million for the first quarter of 2020. This increase was primarily due to greater clinical trial expenses driven by costs related to the MIRASOL, SORAYA, and IMGC936 studies, greater external manufacturing costs, and greater personnel and temporary staffing costs. General and administrative expenses for the first quarter of 2021 increased to $10.2 million, compared to $8.9 million for the first quarter of 2020, primarily due to increased professional fees and personnel costs, including greater stock-based compensation. Operating expenses for the first quarter of 2020 included a $0.8 million restructuring charge related to retention costs.

    Net loss for the first quarter of 2021 was $34.1 million, or $0.17 per basic and diluted share, compared to a net loss of $29.1 million, or $0.17 per basic and diluted share, for the first quarter of 2020. Weighted average shares outstanding increased to 198.8 million for the 2021 period from 166.9 million in the prior year.

    ImmunoGen had $283.1 million in cash and cash equivalents as of March 31, 2021, compared with $293.9 million as of December 31, 2020, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $44.6 million for the first three months of 2021, compared with cash used in operations of $28.3 million for the same period in 2020. Capital expenditures were $(0.9) million for the first quarter of 2021, compared with net proceeds from the sale of equipment of $1.4 million for the first quarter of 2020.

    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 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 9982696. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

    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 December 31, 2021; its cash and cash equivalents as of December 31, 2021; the occurrence, timing, and outcome of potential preclinical, clinical, and regulatory events related to the Company's product candidates; and the presentation of preclinical and clinical data on the Company's 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 the Company's preclinical 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; the Company's ability to financially support its product programs; 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, 2021, and other reports filed with the Securities and Exchange Commission.

    IMMUNOGEN, INC.
    SELECTED FINANCIAL INFORMATION
    (in thousands, except per share amounts)
     
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)
     

    March 31,

     

    December 31,

    2021

     

    2020

    ASSETS

     

     

     

     

     

     

    Cash and cash equivalents

    $

    283,120

     

     

    $

    293,856

     

    Other assets

     

    62,842

     

     

     

    61,216

     

     

     

     

    Total assets

    $

    345,962

     

     

    $

    355,072

     

     

     

     

    LIABILITIES AND SHAREHOLDERS' EQUITY

     

     

     

     

     

     

    Current portion of deferred revenue

    $

    51,515

     

     

    $

    29,249

     

    Other current liabilities

     

    82,838

     

     

     

    93,074

     

    Long-term portion of deferred revenue

     

    58,522

     

     

     

    80,860

     

    Other long-term liabilities

     

    58,967

     

     

     

    62,319

     

    Shareholders' equity

     

    94,120

     

     

     

    89,570

     

     

     

     

    Total liabilities and shareholders' equity

    $

    345,962

     

     

    $

    355,072

     

     

     

     

     

     

     

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

     

     

     

    (Unaudited)

     

     

     

    Three Months Ended

    March 31,

    2021

     

    2020

     

     

     

    Revenues:

     

     

     

    Non-cash royalty revenue

    $

    15,545

     

     

    $

    12,997

     

    License and milestone fees

     

    157

     

     

     

    283

     

    Research and development support

     

    4

     

     

     

    7

     

     

     

     

    Total revenues

     

    15,706

     

     

     

    13,287

     

     

     

     

    Expenses:

     

     

     

    Research and development

     

    34,413

     

     

     

    27,408

     

    General and administrative

     

    10,209

     

     

     

    8,864

     

    Restructuring charge

     

    -

     

     

     

    825

     

     

     

     

    Total operating expenses

     

    44,622

     

     

     

    37,097

     

     

     

     

    Loss from operations

     

    (28,916

    )

     

     

    (23,810

    )

     

     

     

    Non-cash interest expense on liability related to sale of future royalty & convertible bonds

     

    (4,644

    )

     

     

    (5,702

    )

    Interest expense on convertible bonds

     

    (24

    )

     

     

    (24

    )

    Other (loss) income, net

     

    (467

    )

     

     

    448

     

     

     

     

    Net loss

    $

    (34,051

    )

     

    $

    (29,088

    )

     

     

     

    Basic and diluted net loss per common share

    $

    (0.17

    )

     

    $

    (0.17

    )

     

     

     

    Basic and diluted weighted average common shares outstanding

     

    198,835

     

     

     

    166,947

     

     

    View Full Article Hide Full Article
  2. ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the Company will host a conference call at 8:00 a.m. ET on Monday, May 10, 2021 to discuss its first quarter operating results. Management will also provide a brief update on the business.

    Conference Call Information

    To access the live call by phone, dial (877) 621-5803; the conference ID is 9982696. The call may also be accessed through the Investors and Media section of the Company's website, www.immunogen.com. Following the call, a replay will be available at the same location.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes…

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the Company will host a conference call at 8:00 a.m. ET on Monday, May 10, 2021 to discuss its first quarter operating results. Management will also provide a brief update on the business.

    Conference Call Information

    To access the live call by phone, dial (877) 621-5803; the conference ID is 9982696. The call may also be accessed through the Investors and Media section of the Company's website, www.immunogen.com. Following the call, a replay will be available at the same location.

    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.

    View Full Article Hide Full Article
  3. First-in-Class ADAM9-Targeting ADC Demonstrates Anti-Tumor Activity in Multiple Solid Tumor Models

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that a poster highlighting preclinical data for its novel ADAM9-targeting ADC, IMGC936, which is being investigated in multiple solid tumor types, is being presented at the American Association of Cancer Research (AACR) Virtual Annual Meeting April 10-15, 2021.

    "ADAM9 is overexpressed in a wide range of solid tumors and minimally expressed on normal tissue, which makes it an ideal ADC target," said Eric Westin, MD, Vice President, Clinical Development and Translational Sciences at ImmunoGen. "IMGC936 showed…

    First-in-Class ADAM9-Targeting ADC Demonstrates Anti-Tumor Activity in Multiple Solid Tumor Models

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that a poster highlighting preclinical data for its novel ADAM9-targeting ADC, IMGC936, which is being investigated in multiple solid tumor types, is being presented at the American Association of Cancer Research (AACR) Virtual Annual Meeting April 10-15, 2021.

    "ADAM9 is overexpressed in a wide range of solid tumors and minimally expressed on normal tissue, which makes it an ideal ADC target," said Eric Westin, MD, Vice President, Clinical Development and Translational Sciences at ImmunoGen. "IMGC936 showed compelling anti-tumor activity against multiple patient-derived xenograft models with clinically relevant levels of ADAM9 and was well-tolerated across all models tested. We continue to enroll patients in our Phase 1 dose-escalation study of IMGC936 in multiple tumor types and look forward to sharing initial data by the end of 2021 or early 2022."

    POSTER PRESENTATION

    • Title: "IMGC936, an investigational ADAM9-targeting antibody-drug conjugate, is active against patient-derived ADAM9-expressing xenograft models"
    • Day/Time: Saturday, April 10, 2021 at 8:30 AM ET
    • Session Category: Immunology
    • Session Title: PO.IM02.10 - Therapeutic Antibodies, Including Engineered Antibodies
    • Abstract: 1841

    Additional information can be found at www.aacr.org.

    ABOUT IMGC936

    IMGC936 is a first-in-class ADAM9-targeting antibody-drug conjugate (ADC) that is comprised of a humanized antibody engineered to include a YTE mutation for enhanced exposure through improved recycling, a tri-peptide cleavable linker stable in circulation, and a next-generation DM21 maytansinoid payload, which is more potent and hydrophobic, resulting in increased bystander activity.

    ADAM9 is a cell surface protein that belongs to the ADAM (a disintegrin and metalloproteinase) family of proteases, which have been implicated in cytokine and growth factor shedding and cell migration. Dysregulation of ADAM9 has been involved in tumor progression and metastasis, as well as pathological neovascularization. ADAM9 is overexpressed in multiple solid tumor types (e.g., non-small cell lung, gastric, pancreatic, triple-negative breast, and colorectal cancers) and minimally expressed on normal tissue, making ADAM9 an attractive target for ADC development.

    IMGC936 is being co-developed with MacroGenics and is currently in a Phase 1 study enrolling patients with solid tumors that express ADAM9.

    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.

    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 preclinical, clinical, and regulatory events related to the Company's product candidates; and the presentation of preclinical and clinical data on the Company's 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 the Company's preclinical 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; the Company's ability to financially support its product programs; 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, 2021, and other reports filed with the Securities and Exchange Commission.

    View Full Article Hide Full Article
  4. ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming H.C. Wainwright Virtual Global Life Sciences Conference. The presentation will be available on-demand on March 9, 2021 at 7:00 a.m. ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer…

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Susan Altschuller, Chief Financial Officer, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming H.C. Wainwright Virtual Global Life Sciences Conference. The presentation will be available on-demand on March 9, 2021 at 7:00 a.m. ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates 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.

    View Full Article Hide Full Article
  5. Top-Line Data from Pivotal SORAYA Trial for Mirvetuximab Soravtansine in Ovarian Cancer Expected in Q3 2021; BLA to be Submitted by Year-End

    Full Approval Pathway for IMGN632 in BPDCN Aligned with FDA; Updated Phase 1/2 Data in BPDCN Presented at ASH

    Balance Sheet Funds Operations into the Second Half of 2022

    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 financial results for the quarter and year ended December 31, 2020.

    "Despite the challenges of the pandemic, 2020 was a transformative year for ImmunoGen, as we adjusted to new ways of working, accelerated…

    Top-Line Data from Pivotal SORAYA Trial for Mirvetuximab Soravtansine in Ovarian Cancer Expected in Q3 2021; BLA to be Submitted by Year-End

    Full Approval Pathway for IMGN632 in BPDCN Aligned with FDA; Updated Phase 1/2 Data in BPDCN Presented at ASH

    Balance Sheet Funds Operations into the Second Half of 2022

    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 financial results for the quarter and year ended December 31, 2020.

    "Despite the challenges of the pandemic, 2020 was a transformative year for ImmunoGen, as we adjusted to new ways of working, accelerated our portfolio, strengthened our management team and balance sheet, and positioned the business for two potential product launches next year," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Within our portfolio, we advanced accrual in the pivotal SORAYA and confirmatory MIRASOL trials for mirvetuximab soravtansine in patients with ovarian cancer to support our projected timelines for top-line data and regulatory submissions. In addition, we established a second registration program with our CD123-targeting ADC, IMGN632, for which we received Breakthrough Therapy designation and aligned with FDA on a path to full approval in BPDCN. Furthermore, we began dosing patients in the Phase 1 study of IMGC936, our first-in-class ADAM9-targeting ADC for solid tumors, and transitioned IMGN151, our next-generation FRα-targeting ADC, into preclinical development. Finally, through a combination of business development and activity under our ATM facility, we added over $140 million to our balance sheet in the fourth quarter."

    Enyedy continued, "With the benefit of our progress in 2020, we enter this year with significant momentum and strong prospects for the business. For mirvetuximab, these include completing enrollment in SORAYA and reporting top-line pivotal data in the third quarter, followed by a planned BLA submission by the end of the year. With IMGN632, we expect top-line pivotal data in BPDCN in 12 to 18 months and anticipate sharing data from our Phase 1b/2 study of IMGN632 in combination with azacitidine and/or venetoclax in AML patients at ASH in December. We also anticipate completing dose escalation in the clinical study of IMGC936, with initial data late this year or early 2022. Finally, we expect to submit the IND for IMGN151 by year-end. Taken together, our pivotal programs, experienced management team, and strong balance sheet position us well to execute on our strategy and transition ImmunoGen to a fully-integrated oncology company with two products on the market in 2022."

    RECENT PROGRESS

    • Continued patient enrollment in the pivotal SORAYA and confirmatory MIRASOL trials.
    • Advanced our partnership with Huadong Medicine, having received acceptance of the investigational new drug (IND) application for mirvetuximab in China from the National Medical Products Administration (NMPA).
    • Aligned with the US Food and Drug Administration (FDA) on a path to full approval for IMGN632, amending our ongoing 801 Phase 1/2 study with a new pivotal cohort of up to 20 frontline blastic plasmacytoid dendritic cell neoplasm (BPDCN) patients.
    • Presented updated safety and efficacy findings from the Phase 1/2 expansion study of IMGN632 in patients with relapsed/refractory (R/R) BPDCN during an oral session at the American Society of Hematology (ASH) Annual Meeting in December. Our collaborators at MD Anderson Cancer Center also presented preclinical data at ASH in R/R acute myeloid leukemia (AML) that further support the combination of IMGN632 with Vidaza® (azacitidine) and Venclexta® (venetoclax).
    • Advanced patient accrual in the Phase 1 dose-escalation study evaluating IMGC936, our novel ADAM9-targeting ADC in co-development with MacroGenics.

    UPCOMING EVENTS

    • Complete patient enrollment in SORAYA, with top-line pivotal data expected in the third quarter of 2021, and submit the biologics license application (BLA) by the end of 2021 to support potential accelerated approval in 2022.
    • Complete patient enrollment in MIRASOL, with top-line data expected in the first half of 2022.
    • Present mature data from the Phase 1b FORWARD II cohort evaluating mirvetuximab in combination with Avastin® (bevacizumab) in platinum agnostic, recurrent ovarian cancer at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
    • Support initiation of two investigator-sponsored trials of mirvetuximab plus carboplatin, including a randomized Phase 2 study in recurrent platinum-sensitive ovarian cancer and a neo-adjuvant study.
    • Enroll patients in the pivotal cohort of the 801 Phase 1/2 study of IMGN632 in frontline BPDCN patients and generate top-line data in 12 to 18 months.
    • Advance the 802 Phase 1b/2 study of IMGN632 in combination with azacitidine and venetoclax in R/R and frontline AML patients and as a monotherapy in minimal residual disease positive (MRD+) AML following frontline induction therapy.
    • Present updated R/R BPDCN and initial AML combination data for IMGN632 at ASH 2021.
    • Complete dose escalation and move to expansion cohorts in the Phase 1 study evaluating IMGC936, with initial data anticipated by the end of 2021 or early 2022.
    • Submit the investigational new drug (IND) application for IMGN151 by the end of 2021.

    FINANCIAL RESULTS

    Total revenues in the fourth quarter and year ended December 31, 2020 increased to $85.8 million and $132.3 million, respectively, compared to $44.9 million and $82.3 million for the same periods in 2019. Revenues are comprised of the following components:

    • License and milestone fees: License and milestone fees of $63.7 million for the year ended 2020, of which $62.4 million was recorded in the fourth quarter, included recognition of $60.5 million of the upfront fee previously received under the Company's collaboration agreement with Jazz Pharmaceuticals, and $3.2 million in upfront fees previously received from other partners. License and milestone fees of $34.8 million for 2019 included recognition of $22.1 million in upfront fees previously received from partners and $12.7 million in partner milestone payments.
    • Non-cash royalty revenue: Non-cash royalty revenue in the fourth quarter and year ended December 31, 2020 increased to $23.4 million and $68.5 million, respectively, compared to $15.3 million and $47.4 million for the same periods in 2019 due to rising global sales of Kadcyla® during both periods in 2020.

    Research and development expenses were $39.6 million for the quarter ended December 31, 2020 compared to $26.1 million for the quarter ended December 31, 2019, and $114.6 million for the year ended December 31, 2020 compared to $114.5 million for the year ended December 31, 2019. The increase in the current quarter was due to greater external manufacturing costs related to the potential commercial launch of mirvetuximab and clinical trials costs driven by advancement of the SORAYA and MIRASOL studies.

    General and administrative expenses were flat at $9.7 million and $9.8 million for the quarters ended December 31, 2020 and 2019, respectively, and $38.6 million and $38.5 million for the years ended December 31, 2020 and 2019, respectively.

    Restructuring charges of $1.5 million and $21.4 million were recorded in the years ended December 31, 2020 and 2019, respectively, related to the restructuring of the business at the end of the second quarter of 2019, with the current year charge comprised substantially of retention costs.

    Net income for the fourth quarter of 2020 was $31.4 million, or $0.16 per diluted share, compared to net income of $4.8 million, or $0.03 per diluted share, for the fourth quarter of 2019. Net loss for the year ended December 31, 2020 was $(44.4) million, or $(0.25) per diluted share, compared to a net loss of $(104.1) million, or $(0.70) per diluted share, for the year ended December 31, 2019.

    ImmunoGen had $293.9 million in cash and cash equivalents as of December 31, 2020, compared with $176.2 million as of December 31, 2019, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $78.6 million for the year ended December 31, 2020 compared with $88.4 million for the year ended December 31, 2019. Net proceeds from the sale of equipment were $0.5 million for 2020 compared with net capital expenditures of $(0.5) million for 2019.

    During the quarter ended December 31, 2020, the Company sold approximately 20 million shares of its common stock through its At-the-Market (ATM) facility, generating gross proceeds to the Company of approximately $100 million. In January 2021, the Company sold an additional 4.5 million shares of its common stock through its ATM facility, generating additional gross proceeds of approximately $35 million.

    FINANCIAL GUIDANCE

    For 2021, ImmunoGen expects:

    • 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, inclusive of the net proceeds generated from recent sales through its ATM facility, will fund operations into the second half of 2022.

    Revenue guidance includes the assumption that a portion of the upfront license fee from Huadong Medicine will be recognized in 2021 beginning with the delivery of the first clinical supply of mirvetuximab to support development in China.

    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, dial (877) 621-5803; the conference ID is 1666147. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

    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®, Kadcyla®, 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 December 31, 2021; its cash and cash equivalents as of December 31, 2021; the occurrence, timing, and outcome of potential preclinical, clinical, and regulatory events related to the Company's product candidates; and the presentation of preclinical and clinical data on the Company's 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 the Company's preclinical 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; the Company's ability to financially support its product programs; 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 more fully described under "Risk Factors" set forth on Exhibit 99.1 to ImmunoGen's Current Report on Form 8-K filed with the Securities and Exchange Commission on December 18, 2020 and other reports filed with the Securities and Exchange Commission.

    IMMUNOGEN, INC.
    SELECTED FINANCIAL INFORMATION
    (in thousands, except per share amounts)
     
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (Unaudited)
     

    December 31,

     

    December 31,

    2020

     

    2019

    ASSETS
     
    Cash and cash equivalents $

    293,856

     

    $

    176,225

     

    Other assets

    61,216

     

    59,037

     

     
    Total assets $

    355,072

     

    $

    235,262

     

     
    LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
     
    Current portion of deferred revenue $

    29,249

     

    $

    309

     

    Other current liabilities

    93,074

     

    77,101

     

    Long-term portion of deferred revenue

    80,860

     

    127,123

     

    Other long-term liabilities

    62,319

     

    106,850

     

    Shareholders' equity (deficit)

    89,570

     

    (76,121

    )

     
    Total liabilities and shareholders' equity (deficit) $

    355,072

     

    $

    235,262

     

     
     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)

    Three Months Ended

     

    Year Ended

    December 31,

     

    December 31,

    2020

     

    2019

     

    2020

     

    2019

     
    Revenues:
    License and milestone fees $

    62,417

     

    $

    29,551

     

    $

    63,742

     

    $

    34,788

     

    Non-cash royalty revenue

    23,370

     

    15,313

     

    68,529

     

    47,415

     

    Research and development support

    11

     

    -

     

    28

     

    68

     

     
    Total revenues

    85,798

     

    44,864

     

    132,299

     

    82,271

     

     
    Expenses:
    Research and development

    39,578

     

    26,055

     

    114,592

     

    114,522

     

    General and administrative

    9,738

     

    9,803

     

    38,600

     

    38,489

     

    Restructuring charge

    (37

    )

    512

     

    1,487

     

    21,433

     

     
    Total operating expenses

    49,279

     

    36,370

     

    154,679

     

    174,444

     

     
    Income (loss) from operations

    36,519

     

    8,494

     

    (22,380

    )

    (92,173

    )

     
    Non-cash interest expense on liability related to sale of future royalty & convertible bonds

    (5,679

    )

    (5,354

    )

    (23,107

    )

    (16,879

    )

    Interest expense on convertible bonds

    (24

    )

    (24

    )

    (95

    )

    (95

    )

    Other income, net

    572

     

    1,698

     

    1,210

     

    5,014

     

     
    Net income (loss) $

    31,388

     

    $

    4,814

     

    $

    (44,372

    )

    $

    (104,133

    )

     
    Net income (loss) per common share - basic $

    0.17

     

    $

    0.03

     

    $

    (0.25

    )

    $

    (0.70

    )

     
    Net income (loss) per common share - diluted $

    0.16

     

    $

    0.03

     

    $

    (0.25

    )

    $

    (0.70

    )

     
    Shares used in computation of per share amounts - basic

    188,681

     

    148,809

     

    176,153

     

    148,311

     

     
    Shares used in computation of per share amounts - diluted

    191,089

     

    150,605

     

    176,153

     

    148,311

     

     
     

     

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