1. ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, will present at the upcoming 39th Annual J.P. Morgan Virtual Healthcare Conference. The presentation is scheduled for 10:50am ET on January 13, 2021.

    Following the presentation, Mr. Enyedy will be joined by other members of ImmunoGen's management team for a question-and-answer session at 11:10am ET.

    A webcast of the presentation and question-and-answer session will be accessible live through the "Investors & Media" section of the Company's website, www.immunogen.com; a replay will be available in the same location.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next…

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, will present at the upcoming 39th Annual J.P. Morgan Virtual Healthcare Conference. The presentation is scheduled for 10:50am ET on January 13, 2021.

    Following the presentation, Mr. Enyedy will be joined by other members of ImmunoGen's management team for a question-and-answer session at 11:10am ET.

    A webcast of the presentation and question-and-answer session will be accessible live through the "Investors & Media" section of the Company's website, www.immunogen.com; a replay will be available in 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.

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  2.  Updated Data Demonstrating Favorable Safety Profile and Encouraging Monotherapy Activity in BPDCN Presented During Oral Session

    Preclinical Combination Data in Relapsed/Refractory AML Support Further Evaluation of Triplet; Trial in Progress Poster for Phase 1b/2 Study Presented

    Conference Call to be Held on Monday, December 7 at 8:00 a.m. ET

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that new safety and efficacy findings from the expansion phase of the Phase 1/2 study of IMGN632 in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented during an oral session at the 62nd American Society of Hematology…

     Updated Data Demonstrating Favorable Safety Profile and Encouraging Monotherapy Activity in BPDCN Presented During Oral Session

    Preclinical Combination Data in Relapsed/Refractory AML Support Further Evaluation of Triplet; Trial in Progress Poster for Phase 1b/2 Study Presented

    Conference Call to be Held on Monday, December 7 at 8:00 a.m. ET

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that new safety and efficacy findings from the expansion phase of the Phase 1/2 study of IMGN632 in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented during an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting.

    "Comprising the largest prospective study with a single agent in patients with relapsed/refractory BPDCN, the results presented at ASH build on the previous data reported for IMGN632 and reinforce the potential of this CD123-targeting ADC as a best-in-class treatment option for BPDCN," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "Given IMGN632's favorable safety profile, demonstrated anti-tumor activity, and ease of administration via short infusion in an outpatient setting, we continue to enroll both frontline and relapsed/refractory BPDCN patients in this trial. In addition, the preclinical data presented by our partners at MD Anderson Cancer Center in relapsed/refractory AML further support the combination of IMGN632 with azacitidine and venetoclax, which we are actively enrolling in a Phase 1b/2 clinical trial."

    "BPDCN is a rare, aggressive hematologic malignancy that is characterized by historically low overall survival rates," said Naveen Pemmaraju, MD, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center. "Despite currently available therapies, outcomes for relapsed/refractory patients remain poor and there is an urgent need to develop better-tolerated treatment options in the frontline setting. These updated safety and efficacy findings for IMGN632 in patients with relapsed/refractory BPDCN are encouraging, and I look forward to advancing IMGN632 into pivotal development."

    IMGN632 MONOTHERAPY DATA IN BPDCN

    Title: "Clinical Profile of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm" (Abstract #167)

    Oral Presentation Session: 616

    Date: Saturday, December 5, 2020

    Time: 12:30pm PT/3:30pm ET

    Updated key findings include:

    Safety

    • IMGN632 demonstrated a favorable safety profile in 29 patients who received 0.045 mg/kg once every 3 weeks via a short (under 30 minutes) intravenous infusion, with limited grade ≥3 treatment-related adverse events (AEs) and no treatment-related deaths.
    • The most common grade ≥3 AEs were febrile neutropenia, hyperglycemia, and thrombocytopenia (10% each).
    • Grade ≥3 liver function test elevations were seen in one patient (3%).
    • No capillary leak syndrome was reported.

    Efficacy

    • In all relapsed/refractory BPDCN patients, the overall response rate (ORR) was 29% (8/28) with a composite complete remission (CCR) rate of 18% (5/28).
    • In patients with prior SL-401 exposure (tagraxofusp-erzs), the ORR was 31% (4/13) with a CCR of 15% (2/13).
    • Among patients with bone marrow response assessment, 60% (9/15) achieved a bone marrow complete response (blasts <5%).
    • Durable responses were seen in multiple patients, up to 9.2 months without hematopoietic stem cell transplant.
    • Two patients have been successfully bridged to hematopoietic stem cell transplant.

    TRIAL IN PROGRESS POSTER

    Title: "A Phase 1b/2 Study of IMGN632, a CD123-Targeting Antibody-Drug Conjugate, As Monotherapy or in Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia" (Abstract 1047)

    Poster Session: 616

    Date: Saturday, December 5, 2020

    Time: 7:00am – 3:30pm PT/10:00am – 6:30pm ET

    PRECLINICAL POSTER

    In addition, our partners at MD Anderson Cancer Center will present preclinical data from their study combining IMGN632, venetoclax, and azacitidine in in vitro and in vivo AML models.

    Title: "Combining IMGN632, a Novel CD123-Targeting Antibody Drug Conjugate with Azacitidine and Venetoclax Facilitates Apoptosis in Vitro and Prolongs Survival In Vivo in AML Models" (Abstract 2886)

    Poster Session: 617

    Date: Monday, December 7, 2020

    Time: 7:00am – 3:30pm PT/10:00am – 6:30pm ET

    Additional information can be found at www.hematology.org, including abstracts.

    CONFERENCE CALL INFORMATION

    ImmunoGen will hold a conference call on Monday, December 7 at 8:00 a.m. ET to discuss the data presented at ASH, the pathway to FDA approval in BPDCN, and an AML program progress update; Dr. Naveen Pemmaraju, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, will join the call to review the BPDCN data presented at ASH. To access the live call by phone, dial (877) 621-5803; the conference ID is 1795760. The call, along with associated slides, 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 IMGN632

    IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 is currently being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy and in combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) for patients with relapsed/refractory AML. IMGN632 uses one of ImmunoGen's novel indolinobenzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against tumor cells, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads. FDA has granted IMGN632 Breakthrough Therapy Designation in relapsed/refractory BPDCN.

    ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)

    BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the approval of a CD123-targeting therapy, the unmet need remains high for patients, both in the frontline and in the relapsed/refractory setting.

    ABOUT ACUTE MYELOID LEUKEMIA (AML)

    AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, 21,380 patients will be diagnosed with AML this year and 10,590 patients will die from the disease.

    ABOUT CD123

    CD123, the interleukin-3 alpha chain, is expressed on multiple myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative neoplasms. With limited expression on normal hematopoietic cells, rapid internalization, and expression on AML leukemia stem cells, CD123 is a validated therapeutic target, with the approval of a CD123-targeting therapy for BPDCN.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to "target a better now."

    Learn more about who we are, what we do, and how we do it at www.immunogen.com.

    Vidaza® and Venclexta® are registered trademarks of their respective owners.

    This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen'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 ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  3. 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 8:00am ET on Monday, December 7, 2020 to discuss updated findings from the first-in-human trial of IMGN632, an antibody-drug conjugate targeting CD123, in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) to be presented in an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting on December 5, 2020. During the call, Dr. Naveen Pemmaraju, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, will summarize the data presented during the oral session and management will provide…

    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 8:00am ET on Monday, December 7, 2020 to discuss updated findings from the first-in-human trial of IMGN632, an antibody-drug conjugate targeting CD123, in patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN) to be presented in an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting on December 5, 2020. During the call, Dr. Naveen Pemmaraju, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center, will summarize the data presented during the oral session and management will provide an update on the pathway to FDA approval for IMGN632 in BPDCN as well as recent progress in the acute myeloid leukemia (AML) program.

    CONFERENCE CALL INFORMATION

    To access the live call by phone, dial (877) 621-5803; the conference ID is 1795760. The call, along with associated slides, 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.

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  4. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the following presentations by Company management at upcoming investor conferences will be webcast:

    • Piper Sandler 32nd Annual Virtual Healthcare Conference
      November 23 at 10:00am ET
    • Evercore ISI Annual HealthCONx Conference
      December 1 at 12:10pm ET

    A webcast of each 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…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the following presentations by Company management at upcoming investor conferences will be webcast:

    • Piper Sandler 32nd Annual Virtual Healthcare Conference

      November 23 at 10:00am ET
    • Evercore ISI Annual HealthCONx Conference

      December 1 at 12:10pm ET

    A webcast of each 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.

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  5. Partnership with Huadong Medicine Accelerates Development and Commercialization of Mirvetuximab Soravtansine in Greater China

    Encouraging Anti-Tumor Activity and Tolerability Data from FORWARD II Triplet Cohort Evaluating Mirvetuximab in Combination with Carboplatin and Avastin® in Platinum-Sensitive Ovarian Cancer Presented at ESMO

    FDA Breakthrough Therapy Designation Received for IMGN632 in Relapsed or Refractory BPDCN

    First Patient Enrolled in Phase 1 Trial Evaluating ADAM9-Targeting ADC, IMGC936, in Solid Tumors

    Strengthened Balance Sheet Expected to Fund 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…

    Partnership with Huadong Medicine Accelerates Development and Commercialization of Mirvetuximab Soravtansine in Greater China

    Encouraging Anti-Tumor Activity and Tolerability Data from FORWARD II Triplet Cohort Evaluating Mirvetuximab in Combination with Carboplatin and Avastin® in Platinum-Sensitive Ovarian Cancer Presented at ESMO

    FDA Breakthrough Therapy Designation Received for IMGN632 in Relapsed or Refractory BPDCN

    First Patient Enrolled in Phase 1 Trial Evaluating ADAM9-Targeting ADC, IMGC936, in Solid Tumors

    Strengthened Balance Sheet Expected to Fund 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 ended September 30, 2020.

    "We have generated significant momentum over the last several months, achieving a number of important milestones across the business," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Our collaboration with Huadong Medicine accelerates access to mirvetuximab for ovarian cancer patients in Greater China with an ideal partner who brings extensive regional and oncology development and commercialization experience and capabilities. Beyond Greater China, we continue to prioritize enrollment in our pivotal trials and remain on track to report top-line data in the third quarter of 2021 for SORAYA and the first half of 2022 for MIRASOL."

    Enyedy continued, "At ESMO in September, we shared final data from our FORWARD II triplet cohort, which demonstrated the encouraging efficacy and favorable tolerability of mirvetuximab in combination with carboplatin and Avastin® in FRα-positive recurrent, platinum-sensitive ovarian cancer. We are working to define the best path to label expansion for our combination regimens to benefit patients in earlier lines of therapy and establish mirvetuximab as the agent of choice to pair with other agents in ovarian cancer. On the regulatory front, we were pleased to receive FDA Breakthrough Therapy designation for IMGN632 in relapsed or refractory BPDCN, confirming the high unmet need for safe and effective therapies for this rare, aggressive cancer. We continue to advance multiple cohorts with IMGN632 and look forward to presenting updated monotherapy BPDCN expansion data in an oral presentation at ASH. Furthermore, we were pleased to enroll the first patient in our Phase 1 trial evaluating IMGC936, our ADAM9-targeting ADC in co-development with MacroGenics. Finally, we have further strengthened our balance sheet via our At-the-Market facility and business development activities and now expect to fund operations into the second half of 2022."

    RECENT PROGRESS

    • Entered into an exclusive collaboration to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan (Greater China) for an upfront payment of $40 million, with the potential to receive additional milestone payments of up to $265 million as certain development, regulatory, and commercial objectives are achieved, as well as low double-digit to high teen royalties as a percentage of mirvetuximab commercial sales. Lazard acted as financial advisor and Ropes & Gray LLP acted as legal advisor to ImmunoGen in support of this transaction.
    • Continued site activation and patient enrollment in the pivotal SORAYA and confirmatory MIRASOL trials.
    • Presented mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin® (bevacizumab) at the European Society for Medical Oncology (ESMO) Congress.
    • Received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for IMGN632 in relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
    • Continued to advance multiple cohorts with IMGN632, including monotherapy expansion in BPDCN and minimal residual disease positive (MRD+) acute myeloid leukemia (AML) following frontline induction therapy and combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) in relapsed or refractory AML patients.
    • Enrolled first patient in a Phase 1 trial evaluating IMGC936, a novel ADAM9-targeting ADC being co-developed with MacroGenics, in solid tumors including non-small cell lung, colorectal, pancreatic, gastric, and triple negative breast cancers.
    • Entered into an exclusive license with Viridian Therapeutics, Inc. to develop and commercialize an insulin-like growth factor-1 receptor (IGF-1R) antibody for all non-oncology indications that do not use radiopharmaceuticals in exchange for an upfront payment, with the potential to receive additional development milestone payments of approximately $50 million and up to $95 million in sales milestone payments plus mid-single-digit royalties on the commercial sales of any resulting product.

    ANTICIPATED UPCOMING EVENTS

    • Present updated data from the IMGN632 monotherapy BPDCN expansion cohort in an oral presentation at the American Society of Hematology (ASH) Annual Meeting in December, which will build upon the abstract data recently released showing an overall response rate of 30% in 23 heavily pretreated, relapsed/refractory patients, along with a favorable safety and tolerability profile, without capillary leak syndrome or need for hospitalization for administration. A trial-in-progress poster on the AML monotherapy and combination cohorts will also be presented.
    • Support initiation of an investigator sponsored, randomized trial comparing mirvetuximab plus carboplatin versus standard platinum-based therapy in recurrent platinum-sensitive ovarian cancer.

    FINANCIAL RESULTS

    Revenues for the quarter ended September 30, 2020 were $18.2 million, compared with $13.3 million for the quarter ended September 30, 2019, which consisted primarily of non-cash royalty revenues.

    Operating expenses for the third quarter of 2020 were $34.9 million, compared with $31.2 million for the same quarter in 2019. The increase was largely driven by R&D expenses, which were $24.7 million in the third quarter of 2020, compared with $21.0 million for the third quarter of 2019. This increase was primarily due to greater clinical trial expenses driven by costs related to the Company's MIRASOL, SORAYA, and IMGN632 studies and lower partner cost-sharing reimbursements. General and administrative expenses for the third quarter of 2020 increased to $10.2 million compared to $9.2 million for the third quarter of 2019, primarily due to increased professional fees. Operating expenses for the prior quarter included a $1.0 million restructuring charge related to retention costs.

    Net loss for the third quarter of 2020 was $22.4 million, or $0.13 per basic and diluted share, compared to a net loss of $21.8 million, or $0.15 per basic and diluted share, for the third quarter of 2019. Weighted average shares outstanding increased to 174.5 million from 148.5 million in the prior year.

    ImmunoGen had $188.2 million in cash and cash equivalents as of September 30, 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 $87.2 million for the first nine months of 2020, compared with cash used in operations of $55.8 million for the same period in 2019. The prior year period benefited from $65.2 million of net proceeds generated from the sale of the Company's residual rights to Kadcyla® (ado-trastuzumab emtansine) royalties in January 2019. Net proceeds from the sale of equipment were $0.6 million for the first nine months of 2020 compared with capital expenditures of $(2.8) million for the same period in 2019.

    In October 2020, the Company sold 12.9 million shares of its common stock through its At-the-Market ("ATM") facility, generating net proceeds to the Company of approximately $54 million, after deducting underwriting discounts and estimated offering expenses. Additionally, pursuant to a collaboration agreement executed with Huadong Medicine in October 2020, the Company received a $40 million upfront payment.

    FINANCIAL GUIDANCE

    ImmunoGen has updated its financial guidance for 2020 as follows:

    • revenues between $60 million and $65 million;
    • operating expenses between $160 million and $165 million; and
    • cash and cash equivalents at December 31, 2020 to be between $245 million and $250 million.

    Revenue guidance does not include any potential impact from the agreement with Huadong Medicine. ImmunoGen expects that its current cash, inclusive of the $40 million upfront payment received from the collaboration agreement with Huadong Medicine and $54 million of net proceeds generated from the recent ATM facility, as well as anticipated future cash receipts from partners, 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 9864218. 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®, Venclexta®, and Kadcyla® 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 occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen'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 ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 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)
     

    September 30,

     

    December 31,

    2020

     

    2019

    ASSETS
     
    Cash and cash equivalents

    $

    188,217

     

    $

    176,225

     

    Other assets

     

    59,735

     

     

    59,037

     

     
    Total assets

    $

    247,952

     

    $

    235,262

     

     
    LIABILITIES AND SHAREHOLDERS' DEFICIT
     
    Current portion of deferred revenue

    $

    3,985

     

    $

    309

     

    Other current liabilities

     

    95,836

     

     

    77,101

     

    Long-term portion of deferred revenue

     

    126,541

     

     

    127,123

     

    Other long-term liabilities

     

    64,481

     

     

    106,850

     

    Shareholders' deficit

     

    (42,891

    )

     

    (76,121

    )

     
    Total liabilities and shareholders' deficit

    $

    247,952

     

    $

    235,262

     

     
     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)

    Three Months Ended

     

    Nine Months Ended

    September 30,

     

    September 30,

    2020

     

    2019

     

    2020

     

    2019

     
    Revenues:
    Non-cash royalty revenue

    $

    18,087

     

    $

    13,202

     

    $

    45,159

     

    $

    32,102

     

    License and milestone fees

     

    97

     

     

    79

     

     

    1,325

     

     

    5,237

     

    Research and development support

     

    5

     

     

    -

     

     

    17

     

     

    68

     

     
    Total revenues

     

    18,189

     

     

    13,281

     

     

    46,501

     

     

    37,407

     

     
    Expenses:
    Research and development

     

    24,685

     

     

    21,015

     

     

    75,014

     

     

    88,467

     

    General and administrative

     

    10,231

     

     

    9,208

     

     

    28,862

     

     

    28,686

     

    Restructuring charge

     

    -

     

     

    1,020

     

     

    1,524

     

     

    20,921

     

     
    Total operating expenses

     

    34,916

     

     

    31,243

     

     

    105,400

     

     

    138,074

     

     
    Loss from operations

     

    (16,727

    )

     

    (17,962

    )

     

    (58,899

    )

     

    (100,667

    )

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

     

    (5,645

    )

     

    (4,275

    )

     

    (17,428

    )

     

    (11,525

    )

    Interest expense on convertible bonds

     

    (24

    )

     

    (24

    )

     

    (71

    )

     

    (71

    )

    Other income, net

     

    22

     

     

    511

     

     

    638

     

     

    3,316

     

     
    Net loss

    $

    (22,374

    )

    $

    (21,750

    )

    $

    (75,760

    )

    $

    (108,947

    )

     
    Basic and diluted net loss per common share

    $

    (0.13

    )

    $

    (0.15

    )

    $

    (0.44

    )

    $

    (0.74

    )

     
    Basic and diluted weighted average common shares outstanding

     

    174,508

     

     

    148,479

     

     

    172,215

     

     

    148,143

     

     

     

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  6. 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 Jefferies Virtual London Healthcare Conference. The presentation is scheduled for November 18, 2020 at 12:00pm 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…

    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 Jefferies Virtual London Healthcare Conference. The presentation is scheduled for November 18, 2020 at 12:00pm 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.

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  7. 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 Friday, November 6, 2020 to discuss its third 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 9864218. 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 Friday, November 6, 2020 to discuss its third 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 9864218. 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.

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  8. Partnership Accelerates Development Path for Mirvetuximab in Greater China and Expands Huadong Medicine's Oncology Portfolio with Innovative ADC

    Combines ImmunoGen's Lead Clinical Program with Huadong's Regional Oncology Expertise

    ImmunoGen to Receive $40 Million Upfront Payment and is Eligible to Receive Up to $265 Million in Potential Development, Regulatory, and Commercial Milestone Payments

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd., today announced that the companies have entered into an exclusive collaboration to develop and commercialize…

    Partnership Accelerates Development Path for Mirvetuximab in Greater China and Expands Huadong Medicine's Oncology Portfolio with Innovative ADC

    Combines ImmunoGen's Lead Clinical Program with Huadong's Regional Oncology Expertise

    ImmunoGen to Receive $40 Million Upfront Payment and is Eligible to Receive Up to $265 Million in Potential Development, Regulatory, and Commercial Milestone Payments

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, and Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Huadong Medicine Co., Ltd., today announced that the companies have entered into an exclusive collaboration to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan (Greater China). ImmunoGen will retain all rights to mirvetuximab in the rest of the world.

    This collaboration provides ImmunoGen with access to the second largest pharmaceutical market in the world via Huadong Medicine's development, regulatory, and commercial capabilities, while supporting Huadong Medicine's growth strategy to build a deep portfolio of oncology, endocrinology, and autoimmunology candidates. Mirvetuximab adds a compelling late-stage oncology asset to Huadong Medicine's portfolio.

    "With extensive regional experience, the right development and regulatory capabilities, and access to a deep local network of hospitals and clinics across Greater China, Huadong Medicine is an ideal partner for us," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "This collaboration reflects mirvetuximab's potential to deliver meaningful value to ovarian cancer patients as well as our ability to translate our work in ADCs into long-term relationships that create sustainable value for ImmunoGen and our partners. We look forward to working closely with Huadong Medicine to develop and commercialize mirvetuximab in Greater China as we advance the mirvetuximab program and prepare for the first potential commercial launch in the United States in 2022."

    "ImmunoGen is a leader in the development of ADCs for the treatment of cancer and this partnership provides us with a late-stage asset that will enable us to further expand our pipeline of innovative oncology programs," said Liang Lu, Chairman of Huadong Medicine. "The compelling clinical data generated to date highlights mirvetuximab's potential to be a promising therapy for an extremely difficult to treat disease and we look forward to beginning its development as we seek to meet the growing needs of ovarian cancer patients in Greater China."

    Under the terms of the agreement, ImmunoGen will receive an upfront payment of $40 million and is eligible to receive additional milestone payments of up to $265 million as certain development, regulatory, and commercial objectives are achieved. ImmunoGen is also eligible to receive low double digit to high teen royalties as a percentage of mirvetuximab commercial sales by Huadong Medicine in Greater China.

    Huadong Medicine will be responsible for the development as well as potential regulatory submissions and commercialization of mirvetuximab in Greater China pursuant to input from a joint steering committee comprised of individuals from both companies. Huadong Medicine will also have the opportunity to participate in global clinical studies of mirvetuximab conducted by ImmunoGen. ImmunoGen will continue to be responsible for the development and commercialization of mirvetuximab in the United States and other geographies.

    ABOUT MIRVETUXIMAB SORAVTANSINE

    Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

    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.

    ABOUT HUADONG MEDICINE

    Huadong Medicine Co., Ltd. (SZ.000963) is a leading Chinese pharmaceutical company based in Hangzhou, China. Founded in 1993, Huadong Medicine has fully integrated R&D, manufacturing, distribution, sales and marketing capabilities. Huadong Medicine's product portfolio and pipeline are specialized in oncology, immunology, nephrology and diabetes. The Company's annual revenue in 2019 exceeded 5 billion USD. Huadong Medicine has 12,000 employees among which 1,000 are dedicated to R&D. Huadong Medicine possesses one of the most extensive commercial coverage and marketing capabilities in China. ‘Patient Centered, Science Driven' is Huadong's value. For additional information, please visit www.eastchinapharm.com/en.

    FORWARD-LOOKING STATEMENTS

    This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen'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 successful execution of the collaboration with Huadong and their development and commercialization efforts; the timing and outcome of ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  9. ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that it has raised gross proceeds of approximately $54.8 million through its At-the-Market ("ATM") facility pursuant to its Open Market Sale AgreementSM dated as of September 25, 2020 with Jefferies LLC, as sales agent (the "Sale Agreement"), with participation based on interest received from multiple institutional investors. On October 9, 2020, the Company sold approximately 12.7 million shares of the Company's common stock at a per share purchase price of $4.33, the market price at the time of sale.

    The additional funds raised through the ATM strengthen the Company's balance sheet and will be used…

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that it has raised gross proceeds of approximately $54.8 million through its At-the-Market ("ATM") facility pursuant to its Open Market Sale AgreementSM dated as of September 25, 2020 with Jefferies LLC, as sales agent (the "Sale Agreement"), with participation based on interest received from multiple institutional investors. On October 9, 2020, the Company sold approximately 12.7 million shares of the Company's common stock at a per share purchase price of $4.33, the market price at the time of sale.

    The additional funds raised through the ATM strengthen the Company's balance sheet and will be used to fund the Company's operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization and commercialization activities, capital expenditures, and working capital.

    The shares of common stock described above were sold pursuant to the Company's shelf registration statement on Form S-3 (File No. 333-223507), previously filed with the Securities and Exchange Commission ("SEC") on March 7, 2018, which became effective upon filing, and a prospectus supplement dated September 25, 2020 and the accompanying prospectus the Company filed with the SEC in connection with the offer and sale of the Company's common stock pursuant to the Sale Agreement. Copies of the prospectus supplement and the accompanying prospectus may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at or by telephone at (877) 821-7388. Electronic copies of the prospectus supplement and the accompanying prospectus are also available on the SEC's website at http://www.sec.gov.

    This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    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."

    FORWARD-LOOKING STATEMENTS

    This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; the presentation of pre-clinical and clinical data on ImmunoGen's product candidates; and the expected uses of the proceeds from the sales of the Company's common stock described in this press release. 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 pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  10. ImmunoGen, Inc., (NASDAQ:IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).

    "We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "We look forward to continuing to work with FDA to further define the development…

    ImmunoGen, Inc., (NASDAQ:IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).

    "We are pleased FDA has granted Breakthrough Therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies."

    According to FDA guidelines, Breakthrough Therapy designation is designed to expedite the development and review of drugs that are intended to treat a serious condition and have generated preliminary clinical evidence that the drug may demonstrate substantial improvement over available therapy. Breakthrough Therapy designation was granted for IMGN632 based on the findings from the BPDCN cohort of the first-in-human study of IMGN632, for which initial data were presented in an oral session at the American Society of Hematology (ASH) Annual Meeting in 2019. Updated data from the IMGN632 monotherapy BPDCN dose expansion cohort will be presented at ASH this December.

    ABOUT IMGN632

    IMGN632 is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), and acute lymphocytic leukemia (ALL). IMGN632 is currently being evaluated in multiple cohorts, including monotherapy for patients with BPDCN and minimal residual disease positive (MRD+) AML following frontline induction therapy and in combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) for patients with relapsed/refractory AML. IMGN632 uses one of ImmunoGen's novel indolino-benzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against AML blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

    ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM

    BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the recent approval of a CD123-targeting therapy, the unmet need remains high for patients, particularly in the relapsed/refractory setting.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to "target a better now."

    Learn more about who we are, what we do, and how we do it at www.immunogen.com.

    Vidaza® and Venclexta® are registered trademarks of their respective owners.

    FORWARD-LOOKING STATEMENTS

    This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen'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 ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  11. Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for people with central nervous system (CNS) disorders, today announced that it has expanded its leadership team as it works to advance its clinical and preclinical-stage portfolio of novel programs for both rare and prevalent conditions. The leadership appointments include Dean J. Mitchell as chairman of the board of directors, Nicole Sweeny as chief commercial officer and Alyssa Wyant as senior vice president, regulatory and quality. Mr. Mitchell replaces former chairman Nicholas Galakatos, Ph.D., global head of Blackstone Life Sciences, who will continue to serve as a director of Praxis.

    "We are thrilled…

    Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for people with central nervous system (CNS) disorders, today announced that it has expanded its leadership team as it works to advance its clinical and preclinical-stage portfolio of novel programs for both rare and prevalent conditions. The leadership appointments include Dean J. Mitchell as chairman of the board of directors, Nicole Sweeny as chief commercial officer and Alyssa Wyant as senior vice president, regulatory and quality. Mr. Mitchell replaces former chairman Nicholas Galakatos, Ph.D., global head of Blackstone Life Sciences, who will continue to serve as a director of Praxis.

    "We are thrilled to welcome this esteemed group of leaders to the team, each of whom brings significant expertise in their respective functions," said Marcio Souza, president and chief executive officer of Praxis. "Praxis is at an exciting stage in its evolution following our recent financing, with multiple potential value creating milestones expected over the next year. Dean's extensive industry track record and wealth of strategy and development insights will be invaluable as we enter the next phase of growth for our company. Nicole's background leading portfolio and product strategy and Alyssa's experience leading regulatory functions will be critical as we navigate the clinical development and potential registration paths for our programs in depression, movement disorders, pain and epilepsy."

    Dean J. Mitchell is a pharmaceutical industry veteran, with extensive expertise building and leading biopharmaceutical companies as chairman or chief executive officer across all stages of growth and product development. Mr. Mitchell is the former chairman of Covid Pharma Holdings and PaxVax Corporation, prior to their respective sales, and currently serves as chairman of the board of directors of Kinnate Biopharma Inc., and as a member of the board of directors at Theravance Biopharma, Inc. (NASDAQ:TBPH), ImmunoGen Inc. (NASDAQ:IMGN) and Precigen Inc. (formerly Intrexon Inc.).

    Nicole Sweeny has nearly 20 years of commercial experience from product strategy to multiple specialty and rare disease launches across more than a dozen approved products. Ms. Sweeny previously served as franchise head/U.S. general manager at Takeda, and earlier, held U.S. and global roles of increasing responsibility at Shire and Genzyme.

    Alyssa Wyant brings more than 20 years of regulatory affairs experience to Praxis, including having led the creation and implementation of global strategies for the development, registration and post-approval activities for numerous approved products across both CNS and rare diseases. Most recently, Ms. Wyant served as senior vice president, regulatory affairs at EryDel S.p.A, and earlier, held senior leadership roles at Edge Therapeutics, Inc. and PTC Therapeutics, Inc.

    "Praxis is making swift progress in the advancement of their portfolio of therapies for the treatment of a range of CNS disorders, and I am pleased to join the board at such a pivotal time in its evolution," said Mr. Mitchell. "The company's approach to restoring excitatory and inhibitory balance to neuronal circuits in the brain has the potential to address prevalent psychiatric diseases and neurologic disorders, as well as severe pediatric epilepsies, and I look forward to working closely with Marcio and the team to advance this exciting and potentially high-impact pipeline."

    About Praxis

    Praxis is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. We are applying insights into genetic mutations that drive excitation-inhibition imbalance to enable us to develop a pipeline addressing prevalent psychiatric and neurologic conditions and rare diseases. We have established a broad portfolio, including five disclosed programs across multiple CNS disorders, including depression, epilepsy, movement disorders and pain syndromes. For more information, please visit www.praxismedicines.com.

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  12. Triplet Combination Demonstrates Encouraging Anti-Tumor Activity and Tolerability in Recurrent Platinum-Sensitive Ovarian Cancer

    ImmunoGen, Inc., (NASDAQ:IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced final data from the FORWARD II triplet cohort evaluating mirvetuximab soravtansine in combination with carboplatin and Avastin® (bevacizumab) in patients with folate receptor alpha (FRα)-positive recurrent, platinum-sensitive ovarian cancer at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress.

    "Although there have been advances in the treatment of platinum-sensitive disease with targeted and maintenance therapies, there remains a significant need for…

    Triplet Combination Demonstrates Encouraging Anti-Tumor Activity and Tolerability in Recurrent Platinum-Sensitive Ovarian Cancer

    ImmunoGen, Inc., (NASDAQ:IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced final data from the FORWARD II triplet cohort evaluating mirvetuximab soravtansine in combination with carboplatin and Avastin® (bevacizumab) in patients with folate receptor alpha (FRα)-positive recurrent, platinum-sensitive ovarian cancer at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress.

    "Although there have been advances in the treatment of platinum-sensitive disease with targeted and maintenance therapies, there remains a significant need for additional active, well-tolerated combinations in the platinum-sensitive setting," said David O'Malley, MD, Professor, Director of Gynecologic Oncology and Co-Director, Gynecologic Oncology Phase 1 Program at The Ohio State University and the James Cancer Center, and FORWARD II Principal Investigator. "The efficacy outcomes demonstrated by combining full dose mirvetuximab with bevacizumab and carboplatin in more heavily pretreated platinum-sensitive ovarian cancer patients is encouraging relative to current standard of care triplet regimens."

    In the FORWARD II triplet cohort Phase 1b trial, 41 patients with a median age of 63 years received the combination of full dose mirvetuximab with carboplatin and bevacizumab. Eligibility criteria included patients with recurrent platinum-sensitive ovarian cancer that expressed medium or high levels of FRα, who had been treated with up to two prior lines of therapy. 73% of patients had one prior line of therapy and 27% had two prior lines of therapy, while 42% of patients had received prior PARP inhibitors, and 24% had received prior treatment with bevacizumab.

    Key Findings from FORWARD II Triplet Cohort

    • In 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of FRα who have received up to two prior lines of therapy, the confirmed overall response rate (ORR) for the triplet was 83%, with a median duration of response (DOR) of 10.9 months and median progression free survival (PFS) of 12.8 months.
    • These efficacy outcomes are encouraging relative to those reported in less heavily pretreated patient populations for other carboplatin and bevacizumab-based triplets.
    • Mirvetuximab was readily combined and well tolerated with standard dosing of carboplatin and bevacizumab, with a manageable adverse event (AE) profile as anticipated for this triplet based on the side effect profiles of each agent. Thrombocytopenia, a common adverse event with carboplatin treatment, was the most common cause of drug-related discontinuations.
    • Post-carboplatin (median 6 cycles), mirvetuximab soravtansine and bevacizumab continuation/maintenance was well tolerated.

    "Having generated a wealth of data demonstrating encouraging efficacy and favorable tolerability, mirvetuximab continues to show promise in combination – not only as a triplet but also when combined with bevacizumab or carboplatin as a doublet. In the future, we look forward to defining a formal path to registration for mirvetuximab in combination with approved agents with the goal of expanding use into earlier lines of therapy and becoming the combination agent of choice in ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen.

    ESMO Poster Details

    In addition, the City of Hope will present data from their study of mirvetuximab in combination with gemcitabine in patients with recurrent FRα-positive ovarian cancer, endometrial cancer, and triple negative breast cancer.

    • Title: "A Phase I Study of Mirvetuximab Soravtansine (MIRV) and Gemcitabine (G) in Patients (Pts) with Selected FRα-positive Solid Tumors: Results in the Endometrial Cancer (EC) Cohort" (Presentation #863P)
    • Date: Thursday, September 17, 2020
    • Time: 9:00 a.m. CEST/3:00 a.m. ET
    • Lead Author: Mihaela C. Cristea, MD, Associate Clinical Professor, Department of Medical Oncology and Therapeutics Research, Gynecologic Oncology Peritoneal Malignancy Program, City of Hope Comprehensive Cancer Care Center

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

    ABOUT FORWARD II

    FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin® (bevacizumab), carboplatin, or Keytruda® (pembrolizumab) in patients with folate receptor alpha (FRα)-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

    ABOUT MIRVETUXIMAB SORAVTANSINE

    Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

    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® and Keytruda® are registered trademark 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 occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen'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 ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  13. 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 present at the upcoming H.C. Wainwright Virtual Global Investment Conference. The presentation is scheduled for September 14, 2020 at 11am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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…

    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 present at the upcoming H.C. Wainwright Virtual Global Investment Conference. The presentation is scheduled for September 14, 2020 at 11am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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.

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  14. Encouraging Data from FORWARD II Study of Mirvetuximab in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status, Presented at ASCO

    Preclinical Data on Next Generation Anti-FRα ADC, IMGN151, Demonstrating Enhanced Anti-Tumor Activity, Presented at AACR

    Positive Opinion on Orphan Drug Designation for IMGN632 for Treatment of BPDCN Adopted by EMA's COMP

    IND Application for Novel ADAM9-Targeting ADC, IMGC936, Accepted by FDA

    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 June 30…

    Encouraging Data from FORWARD II Study of Mirvetuximab in Combination with Avastin® in Recurrent Ovarian Cancer, Regardless of Platinum Status, Presented at ASCO

    Preclinical Data on Next Generation Anti-FRα ADC, IMGN151, Demonstrating Enhanced Anti-Tumor Activity, Presented at AACR

    Positive Opinion on Orphan Drug Designation for IMGN632 for Treatment of BPDCN Adopted by EMA's COMP

    IND Application for Novel ADAM9-Targeting ADC, IMGC936, Accepted by FDA

    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 June 30, 2020.

    "Despite the challenges of operating in a fully remote environment due to the pandemic, our performance in the second quarter was marked by sound execution and important data presentations and regulatory milestones," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "In an oral presentation at ASCO, we shared data demonstrating the potential of mirvetuximab to serve as the combination agent of choice with Avastin in recurrent ovarian cancer, with an overall response rate in the platinum-resistant subset more than twice the response rate observed with Avastin plus chemotherapy combinations in this population and, in the platinum-sensitive subset, an overall response rate higher than previously seen with platinum-based doublets. We also presented preclinical data at AACR for IMGN151 that support development of this next generation ADC in a wide array of FRα-positive tumor types. On the regulatory front, we were pleased that EMA's Committee for Orphan Medicinal Products adopted a positive opinion to grant IMGN632 orphan drug designation for the treatment of BPDCN and that FDA accepted the IND application for IMGC936. Further, we strengthened our management team by welcoming Stacy Coen as our Chief Business Officer and Susan Altschuller, PhD as our Chief Financial Officer."

    Enyedy continued, "While we have maintained a high level of productivity over the last quarter, the impact of COVID-19 has slowed site activation and patient enrollment for SORAYA, which we believe will result in a limited delay of six- to eight-weeks in the readout of topline data. With conditions improving in Europe, we expect to accelerate both SORAYA and MIRASOL over the remainder of 2020 and continue to anticipate the BLA for mirvetuximab in the second half of 2021. We also look forward to advancing our monotherapy and combination cohorts for IMGN632 and initiating the Phase 1 study of IMGC936 in partnership with MacroGenics. Finally, we will provide mature data from our triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin in patients with recurrent, platinum-sensitive ovarian cancer at ESMO in September and an update on our progress with IMGN632 at ASH in December."

    RECENT PROGRESS

    • Presented data from the FORWARD II study evaluating mirvetuximab in combination with Avastin (bevacizumab) in recurrent ovarian cancer, regardless of platinum status, in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) Annual Meeting.
    • Continued site activation and patient enrollment in the pivotal SORAYA and confirmatory MIRASOL trials, with sites opening in multiple countries in Europe during the quarter.
    • Received positive opinion from the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) to grant IMGN632 orphan drug designation for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
    • Advanced multiple cohorts with IMGN632, including monotherapy expansion in BPDCN and minimal residual disease positive (MRD+) acute myeloid leukemia (AML) following frontline induction therapy and combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) in relapsed/refractory AML patients.
    • Received acceptance for an investigational new drug (IND) application for IMGC936, a novel ADAM9-targeting ADC being co-developed with MacroGenics, from the US Food and Drug Administration (FDA).
    • Presented compelling preclinical data evaluating our next generation anti-folate receptor alpha (FRα) ADC, IMGN151, in ovarian cancer and other tumor types in a poster at the virtual American Association for Cancer Research (AACR) Annual Meeting.
    • Transitioned IMGN151 into preclinical development.
    • Appointed Stacy Coen as Chief Business Officer and Susan Altschuller, PhD as Chief Financial Officer.

    ANTICIPATED UPCOMING EVENTS

    • Present mature data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab at the European Society for Medical Oncology (ESMO) Congress in September.
    • Support initiation of an investigator sponsored, randomized trial comparing mirvetuximab plus carboplatin versus standard platinum-based therapy in recurrent platinum-sensitive ovarian cancer in the fourth quarter.
    • Present updated data from the IMGN632 monotherapy BPDCN expansion and progress on the AML monotherapy and combination cohorts at the American Society of Hematology (ASH) Annual Meeting in December.
    • Initiate Phase 1 trial for IMGC936 in ADAM-9 positive solid tumors including non-small cell lung, pancreatic, gastric, and triple negative breast cancer in the fourth quarter.

    FINANCIAL RESULTS

    Revenues for the quarter ended June 30, 2020 were $15.0 million, compared with $15.5 million for the quarter ended June 30, 2019. Revenues in the second quarter of 2020 included $14.1 million in non-cash royalty revenues, compared with $10.4 million for the second quarter of 2019. License and milestone fees of $5.1 million for the second quarter of 2019 included recognition and receipt of a $5 million partner milestone, compared to $0.9 million of upfront license fees recognized in the second quarter of 2020.

    Operating expenses for the second quarter of 2020 were $33.4 million, compared with $56.6 million for the same quarter in 2019. The decrease was primarily driven by a $19.3 million restructuring charge recorded in the prior period. Operating expenses for the current period included a $0.7 million restructuring charge related to retention costs. R&D expenses were $22.9 million in the second quarter of 2020, compared with $28.6 million for the second quarter of 2019. This decrease was primarily due to lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, including decreases in personnel, facility, and third-party research expenses. Partially offsetting these decreases, clinical trial expenses increased in the current quarter driven by costs related to the Company's MIRASOL, SORAYA, and IMGN632 combination therapy studies. General and administrative expenses for the second quarter of 2020 increased to $9.8 million compared to $8.7 million for the second quarter of 2019, primarily due to increased professional fees and a higher allocation of facility-related expenses for excess laboratory and office space, partially offset by lower personnel expenses.

    Net loss for the second quarter of 2020 was $24.3 million, or $0.14 per basic and diluted share, compared to a net loss of $43.4 million, or $0.29 per basic and diluted share, for the second quarter of 2019. Weighted average shares outstanding increased to 174.4 million from 148.1 million in the prior year.

    ImmunoGen had $219.5 million in cash and cash equivalents as of June 30, 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 $56.5 million for the first six months of 2020, compared with cash used in operations of $20.8 million for the same period in 2019. The prior year period benefited from $65.2 million of net proceeds generated from the sale of the Company's residual rights to Kadcyla® (ado-trastuzumab emtansine) royalties in January 2019. Net proceeds from the sale of equipment were $1.4 million for the first six months of 2020 compared with capital expenditures of $(2.4) million for the same period in 2019.

    FINANCIAL GUIDANCE

    ImmunoGen's financial guidance for 2020 remains unchanged:

    • revenues between $60 million and $65 million;
    • operating expenses between $165 million and $170 million; and
    • cash and cash equivalents at December 31, 2020 to be between $170 million and $175 million.

    ImmunoGen is preparing for potential accelerated approval for mirvetuximab in platinum-resistant ovarian cancer and is planning for increased investment in 2021 related to manufacturing in support of commercial launch. With the addition of these investments, the Company expects that its current cash and anticipated cash receipts from partners will fund operations into the second quarter 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 4388395. 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®, Venclexta®, and Kadcyla® 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: ImmunoGen's revenues and operating expenses for the twelve months ending December 31, 2020; ImmunoGen's cash and marketable securities as of December 31, 2020; the length of time that ImmunoGen's cash and anticipated cash receipts from partners will fund operations; the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical 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 ImmunoGen's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical 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 resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 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)
     

    June 30,

     

    December 31,

    2020

     

    2019

    ASSETS
     
    Cash and cash equivalents $

    219,506

     

    $

    176,225

     

    Other assets

    50,222

     

    59,037

     

     
    Total assets $

    269,728

     

    $

    235,262

     

     
    LIABILITIES AND SHAREHOLDERS' DEFICIT
     
    Current portion of deferred revenue $

    80

     

    $

    309

     

    Other current liabilities

    90,799

     

    77,101

     

    Long-term portion of deferred revenue

    126,535

     

    127,123

     

    Other long-term liabilities

    76,837

     

    106,850

     

    Shareholders' deficit

    (24,523

    )

    (76,121

    )

     
    Total liabilities and shareholders' deficit $

    269,728

     

    $

    235,262

     

     
     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)

    Three Months Ended

    Six Months Ended

    June 30,

    June 30,

    2020

     

    2019

     

    2020

     

    2019

     
    Revenues:
    Non-cash royalty revenue $

    14,075

     

    $

    10,412

     

    $

    27,072

     

    $

    18,900

     

    License and milestone fees

    945

     

    5,079

     

    1,228

     

    5,158

     

    Research and development support

    5

     

    51

     

    12

     

    68

     

     
    Total revenues

    15,025

     

    15,542

     

    28,312

     

    24,126

     

     
    Expenses:
    Research and development

    22,921

     

    28,559

     

    50,329

     

    67,452

     

    General and administrative

    9,767

     

    8,700

     

    18,631

     

    19,478

     

    Restructuring charge

    699

     

    19,342

     

    1,524

     

    19,901

     

     
    Total operating expenses

    33,387

     

    56,601

     

    70,484

     

    106,831

     

     
    Loss from operations

    (18,362

    )

    (41,059

    )

    (42,172

    )

    (82,705

    )

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

    (6,081

    )

    (3,818

    )

    (11,783

    )

    (7,250

    )

    Interest expense on convertible bonds

    (23

    )

    (23

    )

    (47

    )

    (47

    )

    Other income, net

    168

     

    1,454

     

    616

     

    2,805

     

     
    Net loss $

    (24,298

    )

    $

    (43,446

    )

    $

    (53,386

    )

    $

    (87,197

    )

     
    Basic and diluted net loss per common share $

    (0.14

    )

    $

    (0.29

    )

    $

    (0.31

    )

    $

    (0.59

    )

     
    Basic and diluted weighted average common shares outstanding

    174,354

     

    148,129

     

    171,055

     

    147,972

     

     

     

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  15. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming 40th Annual Canaccord Genuity Virtual Growth Conference. The presentation is scheduled for August 12, 2020 at 9:00am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming 40th Annual Canaccord Genuity Virtual Growth Conference. The presentation is scheduled for August 12, 2020 at 9:00am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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
  16. ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that in connection with the appointment of Susan Altschuller, PhD as ImmunoGen's Senior Vice President and Chief Financial Officer, the compensation committee of ImmunoGen's Board of Directors granted to Dr. Altschuller non-qualified stock option awards under the ImmunoGen, Inc. Inducement Equity Incentive Plan (the "Inducement Plan") to purchase (i) 300,000 shares of common stock, which options vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary…

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that in connection with the appointment of Susan Altschuller, PhD as ImmunoGen's Senior Vice President and Chief Financial Officer, the compensation committee of ImmunoGen's Board of Directors granted to Dr. Altschuller non-qualified stock option awards under the ImmunoGen, Inc. Inducement Equity Incentive Plan (the "Inducement Plan") to purchase (i) 300,000 shares of common stock, which options vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, and (ii) 165,500 shares of common stock, which options will vest in accordance with certain performance milestones as set forth in the form of performance-based stock option agreement authorized by the compensation committee of ImmunoGen's Board of Directors as of February 7, 2020 and previously filed by ImmunoGen with the Securities and Exchange Commission; with vesting of the options subject to Dr. Altschuller's continued employment with ImmunoGen on the applicable vesting date. The options have an exercise price of $4.74 per share, which is equal to the closing price of ImmunoGen's common stock on the Nasdaq Global Select Market on July 20, 2020.

    The options were granted as an inducement material to Dr. Altschuller becoming an employee of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the Inducement Plan and the stock option agreement covering the applicable grant.

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individuals' entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    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.

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  17. 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, PhD has been appointed Senior Vice President and Chief Financial Officer.

    "Susan is an outstanding addition to our management team and we are pleased to welcome her at this pivotal moment for ImmunoGen, with the registration studies for our lead program enrolling, our earlier-stage portfolio advancing, and a strong balance sheet," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Her energy and extensive experience in investor relations, business planning, and corporate finance will be invaluable as we enter the next stage of ImmunoGen's evolution and look…

    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, PhD has been appointed Senior Vice President and Chief Financial Officer.

    "Susan is an outstanding addition to our management team and we are pleased to welcome her at this pivotal moment for ImmunoGen, with the registration studies for our lead program enrolling, our earlier-stage portfolio advancing, and a strong balance sheet," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Her energy and extensive experience in investor relations, business planning, and corporate finance will be invaluable as we enter the next stage of ImmunoGen's evolution and look to allocate our capital in the most effective and efficient manner possible."

    Dr. Altschuller has 20 years of financial management, investor relations, and business planning experience with leading pharmaceutical and biotechnology companies. She joins ImmunoGen from Alexion Pharmaceuticals where she started as Head of Investor Relations before moving to Head of Enterprise Finance, where she led global financial reporting and provided counsel on investment prioritization to support the Company's strategic imperatives. Prior to joining Alexion, Dr. Altschuller was Head of Investor Relations at Bioverativ, where she served as the primary interface with Wall Street and led all investor-related activities for the launch of the Biogen spin-off. Early in her career, Dr. Altschuller held positions at Biogen in various functions of increasing responsibility, including investor relations, corporate finance, and commercial finance. She received a BSE in Biomedical Engineering with Honors from Tulane University, a PhD in Biomedical Engineering from the Illinois Institute of Technology, and an MBA from the MIT Sloan School of Management.

    "I am excited to be joining the ImmunoGen team and look forward to playing a key role in the meaningful work the Company does to deliver more good days for people living with cancer," said Dr. Altschuller. "The prospects and potential of its novel portfolio of next generation antibody-drug conjugates is exciting, particularly as the organization transitions from clinical-stage to a fully-integrated commercial biotech."

    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.

    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 advancement of ImmunoGen's research and development programs and Dr. Altschuller's potential contributions to ImmunoGen. 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 pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  18. 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 Friday, July 31, 2020 to discuss its second 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 4388395. 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 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 Friday, July 31, 2020 to discuss its second 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 4388395. 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 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
  19. Next Generation FRα-Targeting ADC Engineered to Maximize Potential Clinical Benefit for Patients with Lower FRα Expression

    Potent Anti-Tumor Activity Exhibited in Ovarian Cancer and Other Tumor Types Regardless of FRα Expression Level

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced preclinical data for its next generation anti-folate receptor alpha (FRα) ADC, IMGN151, which is being investigated in tumors with a broad range of FRα expression. The findings were shared via poster presentation at the virtual American Association for Cancer Research (AACR) Annual Meeting II.

    "Engineered to include multiple antibody and linker-payload innovations…

    Next Generation FRα-Targeting ADC Engineered to Maximize Potential Clinical Benefit for Patients with Lower FRα Expression

    Potent Anti-Tumor Activity Exhibited in Ovarian Cancer and Other Tumor Types Regardless of FRα Expression Level

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced preclinical data for its next generation anti-folate receptor alpha (FRα) ADC, IMGN151, which is being investigated in tumors with a broad range of FRα expression. The findings were shared via poster presentation at the virtual American Association for Cancer Research (AACR) Annual Meeting II.

    "Engineered to include multiple antibody and linker-payload innovations, IMGN151 targets tumors with a broad range of FRα expression," said Eric Westin, MD, Vice President of Clinical Development and Translational Sciences at ImmunoGen. "IMGN151 demonstrated enhanced anti-tumor activity in both in vitro and in vivo preclinical models, with complete regression of human tumor xenograft models induced in those with high, medium, and low levels of FRα expression. Based on these data, we look forward to exploring IMGN151 in the clinic in multiple FRα-positive epithelial malignancies, including ovarian, endometrial, triple negative breast, and non-small cell lung cancer."

    IMGN151 PRECLINICAL DATA

    Poster Presentation, Abstract 2890

    IMGN151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a highly potent maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life, and increased bystander activity. The average drug per antibody ratio is 3.5. IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FRα expression and compared to mirvetuximab soravtansine (IMGN853). Cell lines and xenograft models originated from ovarian, endometrial, breast, and cervical cancer.

    Key findings include:

    • The protease-cleavable linker deployed in IMGN151 improves stability and ADC exposure; as compared to IMGN853, pharmacokinetic studies in cynomolgus monkeys showed increased ADC half-life by 60 hours and conjugate exposure in vivo by 40%.
    • The IMGN151 biparatopic format boosted antibody binding events and DM21 payload delivery in tumor cell lines; the increased payload delivery and greater membrane permeability of DM21 enhanced bystander killing activity.
    • In vitro, IMGN151 was more active against FRα-positive cell lines, with the most pronounced effect in cells with low to medium levels of FRα.
    • In vivo, IMGN151 demonstrated better activity over IMGN853 against low and medium levels of FRα, and equivalent activity to IMGN853 against FRα high tumors with lower effective dose; all tested doses were well tolerated.

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

    ABOUT IMGN151

    IMGN151 is a next-generation ADC, designed to address the unmet needs of cancer patients with tumor types expressing lower levels of folate receptor alpha (FRα). IMGN151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a highly potent maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life, and increased bystander activity.

    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 pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen'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 ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  20. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that the 2020 Annual Meeting of Shareholders (the "Annual Meeting") will be held virtually due to the public health impact of the coronavirus outbreak (COVID-19) and to support the health and well-being of the Company's management, shareholders, and other meeting participants.

    The Annual Meeting will be held on Wednesday, June 17, 2020 at 9:00 a.m. Eastern in a virtual format only. As described in the proxy materials for the Annual Meeting previously distributed, shareholders as of the close of business on April 13, 2020, the record date, are entitled to participate in the Annual Meeting. Shareholders…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, announced today that the 2020 Annual Meeting of Shareholders (the "Annual Meeting") will be held virtually due to the public health impact of the coronavirus outbreak (COVID-19) and to support the health and well-being of the Company's management, shareholders, and other meeting participants.

    The Annual Meeting will be held on Wednesday, June 17, 2020 at 9:00 a.m. Eastern in a virtual format only. As described in the proxy materials for the Annual Meeting previously distributed, shareholders as of the close of business on April 13, 2020, the record date, are entitled to participate in the Annual Meeting. Shareholders who attend the virtual Annual Meeting by following the instructions below will have an opportunity to vote and to submit questions electronically during the meeting.

    Shareholders will not be able to attend the Annual Meeting in person. Instead, shareholders can attend the Annual Meeting by accessing the meeting center at www.virtualshareholdermeeting.com/IMGN2020.

    • Shareholders of Record: Shareholders of record at the close of business on April 13, 2020 (i.e., shares are held in the shareholder's own name in the records of the Company's transfer agent, Broadridge Corporate Issuer Solutions, Inc. ("Broadridge")) can attend the virtual Annual Meeting by accessing the meeting center at www.virtualshareholdermeeting.com/IMGN2020 and entering the 16-digit control number on the proxy card or Notice Regarding the Availability of Proxy Materials previously received. Shareholders of record that have misplaced their control number can call Broadridge at (855) 697-4961.
    • Beneficial Owners: Beneficial owners of the Company's common stock at the close of business on April 13, 2020 (i.e., shares are held by the shareholder's broker in "street name") can attend the Annual Meeting by accessing the meeting center at www.virtualshareholdermeeting.com/IMGN2020 and entering the 16-digit control number found on the notice and instructions received from their broker or other nominee.

    If a shareholder does not have their 16-digit control number, the shareholder will be able to access and listen to the Annual Meeting as a guest, but the shareholder will not be able to vote their shares or submit questions during the Annual Meeting.

    Instructions on how to connect to the Annual Meeting and participate via the Internet, including how to demonstrate proof of stock ownership, ask questions, and vote, are posted at www.virtualshareholdermeeting.com/IMGN2020.

    Shareholders will also be able to submit questions through the platform being used for the Annual Meeting. Shareholders may ask questions that are confined to matters properly presented at the Annual Meeting and of general concern to the Company.

    The Annual Meeting will begin promptly at 9:00 a.m. Eastern on June 17, 2020. Shareholders are encouraged to access the Annual Meeting prior to the start time. Online access will open approximately at 8:45 a.m. Eastern, and shareholders should allow ample time to log in to the Annual Meeting and test their computer audio system. The Company recommends that shareholders carefully review in advance the procedures needed to gain admission to the Annual Meeting.

    Whether or not a shareholder plans to attend the Annual Meeting, the Company urges shareholders to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.

    A notice regarding this change to a virtual meeting format (the "Notice") is being filed with the Securities and Exchange Commission together with this press release. Additional information regarding the Annual Meeting, shareholder participation and voting is provided in the Notice, which all shareholders are urged to read.

    Technical Difficulties

    If shareholders encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number that will be posted on the virtual Annual Meeting log in page.

    The virtual Annual Meeting platform is fully supported across browsers (Internet Explorer, Firefox, Chrome, and Safari) and devices (desktops, laptops, tablets, and cell phones) running the most updated version of applicable software and plugins. Shareholders should ensure that they have a strong internet connection wherever they intend to participate in the Annual Meeting. Shareholders should also give themselves plenty of time to log in and ensure that they can hear streaming audio prior to the start of the Annual Meeting.

    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.

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  21. ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on May 29, 2020 the compensation committee of the Company's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 98,000 shares of its common stock to three new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan (the "Inducement Plan"), which options vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, with vesting of each option subject to such employee's continued employment…

    ImmunoGen Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on May 29, 2020 the compensation committee of the Company's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 98,000 shares of its common stock to three new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan (the "Inducement Plan"), which options vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, with vesting of each option subject to such employee's continued employment with ImmunoGen on such vesting date (such options, the "Employee Options"). The Employee Options have an exercise price of $4.68 per share, which is equal to the closing price of ImmunoGen's common stock on the Nasdaq Global Select Market on May 29, 2020.

    In addition, ImmunoGen announced that in connection with the previously announced appointment of Stacy A. Coen as ImmunoGen's Senior Vice President and Chief Business Officer, the compensation committee of ImmunoGen's Board of Directors granted to Ms. Coen non-qualified stock option awards under the Inducement Plan to purchase (i) 260,000 shares of common stock, which options vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, and (ii) 120,000 shares of common stock, which options will vest in accordance with certain performance milestones as set forth in the form of performance-based stock option agreement authorized by the compensation committee of the Company's Board of Directors as of February 7, 2020 previously filed by ImmunoGen with the Securities and Exchange Commission (such options, the "Coen Options"); with vesting of the Coen Options subject to Ms. Coen's continued employment with ImmunoGen on the applicable vesting date. The Coen Options have an exercise price of $4.92 per share, which is equal to the closing price of ImmunoGen's common stock on the Nasdaq Global Select Market on June 1, 2020.

    The Employee Options and the Coen Options were granted as an inducement material to the new employees and Ms. Coen becoming employees of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms and conditions of the Inducement Plan and the stock option agreement covering the applicable grant.

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individuals' entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    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.

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  22. ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Stacy A. Coen has been appointed Senior Vice President and Chief Business Officer.

    "We are excited to welcome Stacy to the ImmunoGen leadership team as mirvetuximab soravtansine moves through registration studies and our early-stage pipeline continues to advance," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Stacy is a proven business leader with broad corporate strategy and business development expertise, and will play an important role in our organization as we continue to execute against our strategy, explore new opportunities for our pipeline, and seek to bring mirvetuximab…

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Stacy A. Coen has been appointed Senior Vice President and Chief Business Officer.

    "We are excited to welcome Stacy to the ImmunoGen leadership team as mirvetuximab soravtansine moves through registration studies and our early-stage pipeline continues to advance," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Stacy is a proven business leader with broad corporate strategy and business development expertise, and will play an important role in our organization as we continue to execute against our strategy, explore new opportunities for our pipeline, and seek to bring mirvetuximab to patients as quickly as possible."

    Ms. Coen brings over 20 years of business and corporate development experience from leading oncology and rare disease companies. She joins ImmunoGen from Editas Medicine, where she served as Vice President, Business Development and was responsible for business development, strategy, transactions, and alliance management. Prior to joining Editas, Ms. Coen served in multiple roles of increasing responsibility at Genzyme Corporation (now known as Sanofi Genzyme), including Vice President, Head of Rare Disease Business Development and Licensing, and Vice President, Global Head of Strategy and Business Development, Multiple Sclerosis, among others. She currently serves on the Board of Trustees of Huntington's Disease Society of America and is a member of MassBio and the Alliance for Regenerative Medicine (ARM). Ms. Coen received a BS in Finance and Economics from the University of Massachusetts and an MBA from the Darden Graduate School of Business at the University of Virginia.

    "I am delighted to join ImmunoGen as the Company works to bring its first product to market and advance a portfolio of novel ADCs," said Ms. Coen. "I look forward to working with the talented team at ImmunoGen and contributing to the goal of delivering more good days to people living with cancer."

    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.

    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 advancement of ImmunoGen's research and development programs and Ms. Coen's potential contributions to ImmunoGen. 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 pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  23. With a Confirmed Overall Response Rate of 64% and Favorable Tolerability in Patients with High FRα Expression, Combination Demonstrates Encouraging Outcomes Relative to Available Regimens

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings were presented in an oral presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program…

    With a Confirmed Overall Response Rate of 64% and Favorable Tolerability in Patients with High FRα Expression, Combination Demonstrates Encouraging Outcomes Relative to Available Regimens

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings were presented in an oral presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program.

    "The data presented at ASCO demonstrate the potential of mirvetuximab to serve as the combination agent of choice for both platinum-sensitive and platinum-resistant recurrent ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We are particularly encouraged by the overall response rate of 64% observed in patients with high FRα expression, regardless of platinum status. We look forward to the continued evaluation of mirvetuximab with bevacizumab in this increasing population of recurrent ovarian cancer patients for whom a non-platinum based regimen would be appropriate.

    "Despite the advances with PARP inhibitors and anti-angiogenic agents in newly diagnosed ovarian cancer, active, well-tolerated therapies for women with recurrent disease regardless of platinum status are still needed," said Lucy Gilbert, MD, Professor, and Director of the Gynecologic Oncology Division at McGill University Health Center in Montreal, Canada. "With this combination, the overall response rate in the platinum-resistant subset is more than twice the usual response rate for this population and similarly, in the platinum-sensitive subset, the overall response rate is higher than previously seen with platinum-based doublets. Given these responses and the favorable tolerability profile of this combination, these data are exciting and demonstrate the potential of mirvetuximab to address the growing unmet need in this patient population."

    UPDATED DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB

    Oral Presentation, Abstract 6004

    The cohort enrolled 60 patients with a median age of 60 and a median number of 2 prior lines of therapy (range 1-4). Thirty-two patients (53%) had platinum-resistant disease with a platinum-free interval (PFI) of less than or equal to 6 months; 28 patients (47%) had platinum-sensitive disease – of which 20 patients (33%) had a PFI greater than 6 months and less than or equal to 12 months and 8 patients (13%) had a PFI greater than 12 months. The combination of mirvetuximab with bevacizumab in this cohort demonstrates promising anti-tumor activity with a favorable tolerability profile, particularly among patients with high levels of FRα expression, and is encouraging relative to outcomes with available therapies reported in similar populations. In today's oral presentation, key updated data include:

    • In the overall patient population, objective responses were seen in 28 patients and the confirmed overall response rate (ORR) was 47% (95% CI, 34, 60).
    • In patients with high FRα expression (n=33), the confirmed ORR was 64% (95% CI, 45, 80), with an ORR of 59% (95% CI, 33, 82) in the platinum-resistant subgroup (n=17), and 69% (95% CI, 41, 89) in the platinum-sensitive subgroup (n=16).
    • With a median follow-up of 8.5 months and nearly half of patients with high FRα expression remaining on study, the duration of response and progression-free survival data are immature.
    • The adverse events (AEs) observed with the doublet were manageable and consistent with the side effect profiles of each agent. The most common treatment-related AEs were low-grade, including diarrhea, blurred vision, fatigue, and nausea; grade 3+ AEs were infrequent.

    "Effective, tolerable treatment options for patients with recurrent ovarian cancer unfortunately remain limited," explained David O'Malley, MD, Professor, Division Director of Gynecology Oncology and Co-Director of the Gyn Onc Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Principal Investigator. "These promising results confirm previously reported mirvetuximab plus bevacizumab data demonstrating a deeper and more durable tumor burden reduction in women whose tumors express high levels of FRα. These results add to the body of evidence that mirvetuximab can potentially be used to treat a broader patient population. I look forward to further evaluating these data as they mature."

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

    ABOUT FORWARD II

    FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin® (bevacizumab), carboplatin, or Keytruda® (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

    ABOUT MIRVETUXIMAB SORAVTANSINE

    Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By delivering 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® and Keytruda® 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 occurrence, timing, and outcome of potential clinical and regulatory events related to ImmunoGen's product candidates; and the presentation of clinical data on ImmunoGen'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 ImmunoGen's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  24. ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming Jefferies Virtual Healthcare Conference. The presentation is scheduled for June 3, 2020 at 9:30am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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…

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming Jefferies Virtual Healthcare Conference. The presentation is scheduled for June 3, 2020 at 9:30am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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.

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  25. Next Generation Anti-FRα ADC Demonstrates Potent Anti-Tumor Activity in Ovarian Cancer Models and Other FRα-positive Tumor Types in Preclinical Studies

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced preclinical data for its next generation anti-folate receptor alpha (FRα) ADC, IMGN151, which is being investigated in tumors with a broad range of FRα expression. The data will be shared via poster presentation at the virtual American Association for Cancer Research (AACR) Annual Meeting II being held June 22-24, 2020.

    "To address the unmet needs of additional patient populations, we sought to develop a FRα-targeting ADC active against ovarian cancer…

    Next Generation Anti-FRα ADC Demonstrates Potent Anti-Tumor Activity in Ovarian Cancer Models and Other FRα-positive Tumor Types in Preclinical Studies

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced preclinical data for its next generation anti-folate receptor alpha (FRα) ADC, IMGN151, which is being investigated in tumors with a broad range of FRα expression. The data will be shared via poster presentation at the virtual American Association for Cancer Research (AACR) Annual Meeting II being held June 22-24, 2020.

    "To address the unmet needs of additional patient populations, we sought to develop a FRα-targeting ADC active against ovarian cancer and other tumor types with a broad range of FRα expression. IMGN151 demonstrates our continued innovation in the field of ADCs, incorporating several key design elements including a novel biparatopic antibody that enhances binding with FRα and payload delivery as well as DM21, our most advanced maytansinoid derivative that, together with a peptide linker, provides improved stability and increased bystander anti-tumor activity," said Eric Westin, MD, Vice President, Clinical Development and Translational Sciences for ImmunoGen. "In preclinical models, IMGN151 showed activity not only in high FRα-expressing tumors, but also improved activity in medium and low FRα-expressing tumors, suggesting promising potential in a broad set of patients with an array of tumor types. As we continue to analyze these data, we look forward to advancing IMGN151 into preclinical development."

    PRECLINICAL DATA ON IMGN151

    IMGN151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a highly potent maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life, and increased bystander activity. The average drug per antibody ratio is 3.5.

    Key findings include:

    • IMGN151 activity was characterized against cell lines and xenograft models with a wide range of FRα expression and compared to mirvetuximab soravtansine (IMGN853). Cell lines and xenograft models originated from ovarian, endometrial, breast, and cervical cancer.
    • In tumor cells with medium and high FRα expression, IMGN151 boosted antibody binding events and payload delivery by 100% and 170%, respectively.
    • IMGN151 increased ADC half-life by 60 hours and conjugate exposure in vivo by 40%, as compared to IMGN853.
    • In vitro, IMGN151 was up to 200 times more active against four FRα-medium cell lines. IMGN151 also had better bystander killing activity in a mixed culture of target-positive and negative cells.
    • In vivo, IMGN151 induced complete tumor regressions of human tumor xenograft models with high, medium, and low FRα expression. All tested doses were well tolerated.

    POSTER PRESENTATION

    • Title: "IMGN151: A Next Generation Folate Receptor Alpha Targeting Antibody Drug Conjugate Active Against Tumors with Low, Medium, and High Receptor Expression"
    • Day/Time: Monday, June 22, 2020 at 9:00 AM ET
    • Session Category: Experimental and Molecular Therapeutics
    • Session Title: Antibody Drug Conjugates
    • Abstract: 2890

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

    ABOUT IMGN151

    IMGN151 is a next-generation ADC, designed to address the unmet needs of cancer patients with tumor types expressing lower levels of folate receptor alpha (FRα). IMGN151 comprises an asymmetric, bivalent, biparatopic antibody targeting two independent epitopes of FRα, linked to a highly potent maytansinoid derivative, DM21, via a cleavable peptide linker with enhanced stability, longer half-life, and increased bystander activity.

    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 pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical and clinical data on ImmunoGen'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 ImmunoGen's pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  26. Combination Demonstrates Promising Anti-Tumor Activity and Favorable Tolerability, with a Confirmed Overall Response Rate of &gt;60% in Patients with High FRα Expression

    Results to be Presented in an Oral Session at ASCO 2020 Virtual Scientific Program

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at the American…

    Combination Demonstrates Promising Anti-Tumor Activity and Favorable Tolerability, with a Confirmed Overall Response Rate of >60% in Patients with High FRα Expression

    Results to be Presented in an Oral Session at ASCO 2020 Virtual Scientific Program

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program on May 29, 2020. Three "trial in progress" posters will also be presented during the meeting.

    "With the benefit of the clinical profile demonstrated by mirvetuximab monotherapy, we have pursued a development strategy to establish mirvetuximab as the agent of choice in combination regimens to treat expanded populations of patients with recurrent ovarian cancer. To this end, we are encouraged by the compelling anti-tumor activity and favorable tolerability observed with the combination of mirvetuximab plus bevacizumab in patients for whom a non-platinum based regimen is appropriate," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These findings show greater depth and duration of tumor reduction in women whose tumors express high levels of FRα, regardless of platinum status, reinforcing the potential of this doublet in these patients. As these data mature, we look forward to further evaluating this combination in the recurrent ovarian cancer setting."

    INITIAL DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB

    This cohort enrolled 60 patients with FRα-positive recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate, with a median age of 60 years and a median number of 2 prior lines of therapy (range 1-4). The combination of mirvetuximab soravtansine with bevacizumab in this cohort demonstrates encouraging anti-tumor activity with a favorable tolerability profile, particularly among the subset of patients with high levels of FRα expression.

    Key findings include:

    • In the overall patient population, objective responses were seen in 26 patients and the confirmed overall response rate (ORR) was 43% (95% CI, 31, 57).
    • In patients with high FRα expression (n=33), the confirmed ORR was 61% (95% CI, 42, 77), with an ORR of at least 50% in each of the platinum-resistant and platinum-sensitive subgroups.
    • With many patients remaining on study, the duration of response and progression free survival data are immature.
    • The adverse events (AEs) observed with the doublet were as expected based on the side effect profiles of each agent. The most common treatment-related low grade AEs were diarrhea, blurred vision, nausea, and fatigue; grade 3+ AEs were infrequent, with the most common being hypertension and neutropenia.

    "With the increasing need for non-platinum regimens in recurrent ovarian cancer, we are excited to further advance mirvetuximab in combination with bevacizumab, building on the prior data for this combination in women with platinum resistant disease," stated Lucy Gilbert, MD, Professor, and Director of the Gynecologic Oncology Division at McGill University Health Center in Montreal, Canada. "These initial data demonstrate meaningful clinical benefit in women with recurrent disease, regardless of platinum status, and I look forward to reporting longer-term follow up and further evaluating the doublet in this expanded patient population."

    ORAL PRESENTATION SESSION

    • Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer"
    • Day/Time: Friday, May 29 at 8:00 AM ET
    • Lead Author: Lucy Gilbert, MD, McGill University Health Center, Montreal, Canada
    • Abstract: 6004

    TRIAL IN PROGRESS POSTERS

    The following posters will be available on Friday, May 29 at 8:00 AM ET in the ASCO Meeting Library:

    • Title: "MIRASOL (GOG 3045/ENGOT OV-55): A Randomized, Open-label, Phase 3 study of Mirvetuximab Soravtansine versus Investigator's Choice of Chemotherapy in Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor Alpha (FRα) Expression"
    • Lead Author: Kathleen Moore, MD, University of Oklahoma Health Sciences Center
    • Abstract: TPS6103 (Poster 274)
    • Title: "A Phase 1/2 Study of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, and Other CD123-Positive Hematologic Malignancies"
    • Lead Author: Naval Daver, MD, MD Anderson Cancer Center
    • Abstract: TPS7563 (Poster 336)
    • Title: "A Phase 1b/2 Study of the CD123-Targeting Antibody-Drug Conjugate IMGN632 as Monotherapy or in Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia"
    • Lead Author: Naval Daver, MD, MD Anderson Cancer Center
    • Abstract: TPS7564 (Poster 337)

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

    ABOUT FORWARD II

    FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

    ABOUT MIRVETUXIMAB SORAVTANSINE

    Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate (ADC) comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By delivering 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®, Venclexta®, and Keytruda® 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 occurrence, timing, and outcome of potential clinical and regulatory events related to ImmunoGen's product candidates; and the presentation of clinical data on ImmunoGen'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 ImmunoGen's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGen's ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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  27. ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming RBC Capital Markets Global Healthcare Virtual Conference. The presentation is scheduled for May 19, 2020 at 10:20am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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…

    ImmunoGen, Inc. (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming RBC Capital Markets Global Healthcare Virtual Conference. The presentation is scheduled for May 19, 2020 at 10:20am ET.

    A webcast of the presentation will be accessible through the Investors and Media section of the Company's website on 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.

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  28. ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on April 30, 2020 the compensation committee of the Company's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 38,300 shares of its common stock to two new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan, or the Inducement Plan. The stock options were granted as an inducement material to the new employees' becoming employees of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a…

    ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on April 30, 2020 the compensation committee of the Company's Board of Directors granted non-qualified stock option awards to purchase an aggregate of 38,300 shares of its common stock to two new employees under the ImmunoGen, Inc. Inducement Equity Incentive Plan, or the Inducement Plan. The stock options were granted as an inducement material to the new employees' becoming employees of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individuals' entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    The options have an exercise price of $4.08 per share, which is equal to the closing price of ImmunoGen's common stock on the Nasdaq Global Select Market on April 30, 2020. Each option will vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, subject to such employee's continued employment with ImmunoGen on such vesting dates. Each option is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement covering the grant.

    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.

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  29. Pivotal SORAYA Trial Initiated for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer

    Data from FORWARD II Avastin® Expansion Cohort in Platinum-Agnostic Ovarian Cancer Selected for Oral Presentation at ASCO

    Pre-Clinical Data on Next Generation Anti-FRα ADC to be Presented at AACR

    Operational Plans Remain on Track amid COVID-19 Pandemic

    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, 2020.

    "During the last quarter, we moved forward with our registration studies for mirvetuximab and…

    Pivotal SORAYA Trial Initiated for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer

    Data from FORWARD II Avastin® Expansion Cohort in Platinum-Agnostic Ovarian Cancer Selected for Oral Presentation at ASCO

    Pre-Clinical Data on Next Generation Anti-FRα ADC to be Presented at AACR

    Operational Plans Remain on Track amid COVID-19 Pandemic

    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, 2020.

    "During the last quarter, we moved forward with our registration studies for mirvetuximab and advanced our portfolio of earlier-stage candidates, while adapting to meet the evolving challenges of the COVID-19 pandemic," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Our lead program remains on track with the initiation of our pivotal SORAYA trial and patient enrollment in our confirmatory MIRASOL trial progressing as anticipated. In parallel, we continue to follow our FORWARD II combination cohorts and we are pleased to have initial data from our Avastin expansion cohort in platinum-agnostic ovarian cancer selected for a virtual oral presentation at ASCO in May. IND-enabling activities for IMGC936, our novel ADAM9-targeting ADC, continue on plan with an IND submission anticipated by the end of this quarter and we look forward to presenting pre-clinical data on IMGN151, our next generation anti-FRα ADC being investigated in tumors with a broad range of FRα expression, at the virtual AACR Annual Meeting in June."

    Enyedy added, "Having generated approximately $98M in net proceeds through a follow-on offering in January, we are in a strong financial position with our anticipated cash runway extended well into 2022. Drawing on the organizational resilience built over the last year, our team has risen to the challenge of COVID-19 to ensure that we can meet the needs of our patients around the globe. We have put in place business continuity plans to allow us to operate effectively in a virtual working environment, actively monitor our progress in our key studies, and rapidly adapt in response to new developments. Through these efforts, we seek to maintain the momentum we have generated in the business throughout 2020."

    RECENT PROGRESS

    • Initiated SORAYA, a new single-arm study in platinum-resistant ovarian cancer for women previously treated with Avastin® (bevacizumab), which is designed to support accelerated approval for mirvetuximab.
    • Continued to open sites and enroll patients in confirmatory Phase 3 MIRASOL trial.
    • Advanced multiple cohorts with IMGN632, including monotherapy expansion in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and minimal residual disease positive (MRD+) acute myeloid leukemeia (AML) following frontline induction therapy and combinations with Vidaza® (azacitidine) and Venclexta® (venetoclax) in relapsed/refractory AML patients.
    • Progressed investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
    • Raised $97.7 million in net proceeds in a follow-on offering in January.
    • Activated business continuity plans in the context of COVID-19.

    ANTICIPATED UPCOMING EVENTS

    • Continue patient enrollment in pivotal SORAYA and confirmatory MIRASOL trials.
    • Support initiation of an additional platinum-sensitive investigator sponsored trial evaluating mirvetuximab in combination with carboplatin in over 100 patients.
    • Present initial data from the FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with bevacizumab in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) Annual Meeting in May.
    • Present pre-clinical data evaluating our next generation anti-folate receptor alpha (FRα) ADC, IMGN151, in ovarian cancer and other tumor types in a poster at the virtual American Association for Cancer Research (AACR) Annual Meeting in June.
    • Present updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall.
    • Continue enrollment in IMGN632 monotherapy and combination cohorts.
    • File IND for IMGC936 at the end of Q2.
    • Transition IMGN151 into pre-clinical development.

    FINANCIAL RESULTS

    Revenues for the quarter ended March 31, 2020 were $13.3 million, compared with $8.6 million for the quarter ended March 31, 2019, which consisted primarily of non-cash royalty revenues.

    Operating expenses for the first quarter of 2020 were $37.1 million, compared with $50.2 million for the same quarter in 2019. The decrease was driven by R&D expenses, which were $27.4 million for the first quarter of 2020 compared with $38.9 million for the first quarter of 2019. This decrease was primarily due to lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, including decreases in personnel, facility, and third-party research expenses. Partially offsetting these decreases, clinical trial expenses increased in the current quarter driven by costs related to the Company's MIRASOL, SORAYA, and IMGN632 combination therapy studies. General and administrative expenses for the first quarter of 2020 decreased to $8.9 million compared to $10.8 million for the first quarter of 2019 primarily due to lower personnel expenses resulting from the restructuring, partially offset by a higher allocation of facility-related expenses for excess laboratory and office space. Operating expenses for the first quarter of 2020 also included a $0.8 million restructuring charge related to retention costs, compared to a $0.6 million charge recorded in the first quarter of 2019 related to a loss recorded on leased office space.

    Net loss for the first quarter of 2020 was $29.1 million, or $0.17 per basic and diluted share, compared to a net loss of $43.8 million, or $0.30 per basic and diluted share, for the first quarter of 2019. Weighted average shares outstanding increased to 166.9 million from 147.8 million in the prior year.

    In January 2020, pursuant to a public offering, the Company sold an aggregate of 24.5 million shares of its common stock, with net proceeds to the Company of $97.7 million, after deducting underwriting discounts and offering expenses.

    ImmunoGen had $247.3 million in cash and cash equivalents as of March 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 $(28.3) million for the quarter ended March 31, 2020, compared with cash provided by operations of $10.2 million for the quarter ended March 31, 2019. The prior year period benefited from $65.2 million of net proceeds generated from the sale of the Company's residual rights to Kadcyla® (ado-trastuzumab emtasine) royalties in January 2019. Net proceeds from the sale of equipment were $1.4 million for the first quarter of 2020 compared with capital expenditures of $(2.1) million for the first quarter of 2019.

    FINANCIAL GUIDANCE

    ImmunoGen's financial guidance for 2020 remains unchanged:

    • revenues between $60 million and $65 million;
    • operating expenses between $165 million and $170 million; and
    • cash and cash equivalents at December 31, 2020 to be between $170 million and $175 million.

    ImmunoGen expects that its current cash and anticipated cash receipts from partners 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 7796220. 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®, Venclexta®, and Kadcyla® 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: ImmunoGen's revenues and operating expenses for the twelve months ending December 31, 2020; ImmunoGen's cash and marketable securities as of December 31, 2020; how long ImmunoGen's cash and anticipated cash receipts from partners will fund operations; the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to ImmunoGen's product candidates; and the presentation of pre-clinical 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 ImmunoGen's clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical 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 resulting impact on ImmunoGen's industry and business; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2019 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,

     

    2020

     

     

    2019

     

    ASSETS
     
    Cash and cash equivalents 

    $

     

    247,299

     

    $

     

    176,225

     

    Other assets  

    51,510

     

     

    59,037

     

     
    Total assets

    $

     

    298,809

     

    $

     

    235,262

     

     
    LIABILITIES AND SHAREHOLDERS' DEFICIT
     
    Current portion of deferred revenue

    $

     

    123

     

    $

     

    309

     

    Other current liabilities

    85,383

     

    77,101

     

    Long-term portion of deferred revenue

    127,387

     

    127,123

     

    Other long-term liabilities

    90,019

     

    106,850

     

    Shareholders' deficit  

    (4,103

    )

     

    (76,121

    )

     
    Total liabilities and shareholders' deficit

    $

     

    298,809

     

    $

     

    235,262

     

     
     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
    Three Months Ended
    March 31,
     

    2020

     

       

    2019

     

     
    Revenues:
    Non-cash royalty revenue

                                   12,997

     

                                        8,488

     

    License and milestone fees

    $

     

                                        283

     

    $

     

                                             79

     

    Research and development support  

                                             7

     

     

                                             17

     

     
    Total revenues  

                                   13,287

     

     

                                        8,584

     

     
    Expenses:
    Research and development 

                                   27,408

     

                                      38,893

     

    General and administrative 

                                     8,864

     

                                      10,778

     

    Restructuring charge  

                                        825

     

     

                                           559

     

     
    Total operating expenses  

                                   37,097

     

     

                                      50,230

     

     
     Loss from operations

                                 (23,810

    )

                                    (41,646

    )

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

                                    (5,702

    )

                                      (3,432

    )

    Interest expense on convertible bonds

                                         (24

    )

                                            (24

    )

    Other income, net  

                                        448

     

     

                                        1,351

     

     
    Net loss

    $

     

                                 (29,088

    )

    $

     

                                    (43,751

    )

     
    Basic and diluted net loss per common share

    $

     

                                      (0.17

    )

    $

     

                                         (0.30

    )

     
     
    Basic and diluted weighted average common shares outstanding  

                                 166,947

     

     

                                   147,813

     

     

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  30. 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 Friday, May 1, 2020 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 7796220. 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 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 Friday, May 1, 2020 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 7796220. 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 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
  31. Accelerated Approval Pathway Defined for Mirvetuximab Soravtansine in Ovarian Cancer; Pivotal SORAYA Trial Expected to Enroll First Patient in Q1 2020

    Phase 3 Confirmatory MIRASOL Trial for Mirvetuximab Enrolling Patients

    Updated IMGN632 AML and BPDCN Monotherapy Data Presented at ASH

    $97.6 Million Net Proceeds from Public Offering Extends Cash Runway to 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, 2019.

    "Following the results of FORWARD I, we moved decisively…

    Accelerated Approval Pathway Defined for Mirvetuximab Soravtansine in Ovarian Cancer; Pivotal SORAYA Trial Expected to Enroll First Patient in Q1 2020

    Phase 3 Confirmatory MIRASOL Trial for Mirvetuximab Enrolling Patients

    Updated IMGN632 AML and BPDCN Monotherapy Data Presented at ASH

    $97.6 Million Net Proceeds from Public Offering Extends Cash Runway to 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, 2019.

    "Following the results of FORWARD I, we moved decisively to restructure the business to reduce our costs, prioritized our portfolio to focus on our most promising programs, and worked constructively with FDA to define an accelerated path to approval for mirvetuximab," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "With the benefit of these steps, we have emerged from a challenging year with significant momentum driven by the start of our registration program for mirvetuximab in platinum-resistant ovarian cancer and continued progress with our portfolio of early-stage products. In particular, we have enrolled the first patient in the confirmatory MIRASOL Phase 3 trial for mirvetuximab, presented clinical data at ASH in December demonstrating IMGN632's encouraging anti-tumor activity and favorable tolerability in patients with AML and BPDCN, and, most recently, raised roughly $98 million in a follow-on offering to strengthen our balance sheet."

    Enyedy added, "We enter 2020 with a number of important upcoming milestones to drive value in the business. For mirvetuximab, these include opening our pivotal SORAYA trial in the first quarter, continuing to enroll MIRASOL, initiating an additional combination study in platinum-sensitive disease, and presenting data from our platinum-agnostic and platinum-sensitive combination studies. Building upon the encouraging data we reported in 2019, we will continue to advance IMGN632 in the clinic and look forward to presenting BPDCN and MRD+ monotherapy and AML combination data this year. In addition, we expect the IND for IMGC936, our novel ADAM9-targeting ADC, to be filed during the first half of the year. With these catalysts ahead, we look forward to a productive next twelve months."

    RECENT PROGRESS

    • Received guidance from the U.S. Food and Drug Administration (FDA) that SORAYA, a new single-arm study in platinum-resistant ovarian cancer, could support accelerated approval for mirvetuximab.
    • Enrolled the first patient in our confirmatory Phase 3 MIRASOL trial.
    • Presented preclinical combination data and updated clinical monotherapy data for IMGN632 with additional patients enrolled in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) expansion cohorts at the American Society of Hematology (ASH) Annual Meeting in December.
    • Continued enrollment for IMGN632 monotherapy in Phase 1 expansion cohorts in patients with AML, BPDCN, relapsed acute lymphocytic leukemia (ALL), and minimal residual disease positive (MRD+) AML patients following frontline induction therapy.
    • Advanced IMGN632 combination therapy studies with Vidaza® (azacitidine) and Venclexta® (venetoclax) in relapsed/refractory unfit AML patients.
    • Progressed investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
    • Outlicensed our epithelial cell adhesion molecule (EpCAM)-targeting Probody-drug conjugate to CytomX in exchange for an upfront fee and milestone and royalty payments.
    • Raised $97.6 million in a follow-on offering completed in January.

    ANTICIPATED 2020 EVENTS

    • Initiate pivotal SORAYA trial in the first quarter of 2020 and continue enrollment in the confirmatory Phase 3 MIRASOL trial.
    • Open an additional platinum-sensitive investigator sponsored trial evaluating mirvetuximab in combination with carboplatin.
    • Present initial data from the Phase 1b FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with Avastin® (bevacizumab) in mid-2020 and updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall of 2020.
    • Continue enrollment with IMGN632 monotherapy in relapsed AML, ALL, BPDCN, and MRD+ AML expansion cohorts and in combinations in AML.
    • Present IMGN632 BPDCN and AML combination and MRD+ monotherapy data at ASH in December.
    • File IND for IMGC936 in the first half of 2020.
    • Transition next generation anti-folate receptor alpha (FRα) ADC, IMGN151, to pre-clinical development in mid-2020.

    FINANCIAL RESULTS

    Total revenues in the fourth quarter and year ended December 31, 2019 increased to $44.9 million and $82.3 million, respectively, compared to $13.4 million and $53.4 million for the same periods in 2018. Revenues are comprised of the following components:

    • License and milestone fees: License and milestone fees of $34.8 million for the year ended 2019, of which $29.6 million was recorded in the fourth quarter, included $14.5 million in amortization of a $75 million upfront fee previously received under the Company's collaboration agreement with Jazz, $7.3 million of a $7.5 million fee recognized pursuant to a license agreement executed with CytomX in December 2019, and $12.7 million in partner milestones. Of these amounts noted, $15.2 million of related cash will be received in 2020. License and milestone fees of $15.3 million for 2018 included $13.8 million of recognized upfront fees previously received from partners and $1.5 million in partner milestone payments.
    • Non-cash royalty revenue: Non-cash royalty revenue in the fourth quarter and year ended December 31, 2019 increased to $15.3 million and $47.4 million, respectively, compared to $9.3 million and $32.2 million for the same periods in 2018.

    Research and development expenses were $26.1 million for the quarter ended December 31, 2019 compared to $43.7 million for the quarter ended December 31, 2018, and $114.5 million for the year ended December 31, 2019 compared to $174.5 million for the year ended December 31, 2018. The decreases in both periods are primarily due to: (i) lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019 and the closing of our manufacturing facility at the end of 2018, including decreases in personnel, facility, and third-party research expenses; (ii) lower external manufacturing costs driven by activity to support commercial validation of mirvetuximab in the prior year periods; and, (iii) decreased clinical trial expenses for the year ended December 31, 2019 driven by lower activity in the FORWARD I Phase 3 clinical trial; however, clinical trial expenses for the fourth quarter of 2019 increased compared to the fourth quarter of 2018 driven by expenses incurred to initiate the MIRASOL and IMGN632 combination studies.

    General and administrative expenses were flat at $9.8 million for the fourth quarter of 2019 and 2018, and $38.5 million for the year ended December 31, 2019 compared to $36.7 million for the year ended December 31, 2018. The increase year over year is primarily due to a higher allocation of facility-related expenses for excess laboratory and office space, partially offset by lower personnel expenses resulting from the restructuring of the business. Similar variances occurred quarter over quarter, but were further offset by lower stock compensation expense driven largely by stock options forfeited in the fourth quarter of 2019.

    Restructuring charge of $0.5 million and $21.4 million recorded in the fourth quarter and year ended December 31, 2019, respectively, related to the restructuring of the business at the end of the second quarter of 2019, compared to $0.4 million and $3.7 million recorded in the same periods in 2018 related to the decommissioning of the Norwood facility.

    Net income for the fourth quarter of 2019 was $4.8 million, or $0.03 per basic and diluted share, compared to a net loss of $(41.8) million, or $(0.28) per basic and diluted share, for the fourth quarter of 2018. Net loss for the year ended December 31, 2019 was $(104.1) million, or $(0.70) per basic and diluted share, compared to a net loss of $(168.8) million, or $(1.21) per basic and diluted share.

    ImmunoGen had $176.2 million in cash and cash equivalents as of December 31, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $88.4 million for the year ended December 31, 2019, compared with cash used in operations of $166.4 million for the year ended December 31, 2018. The current year benefited from $65.2 million of net proceeds generated from the sale of the Company's residual rights to Kadcyla® (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures, net of proceeds from the sale of equipment, were $0.5 million and $5.2 million for 2019 and 2018, respectively.

    In January 2020, pursuant to a public offering, the Company sold an aggregate of 24,523,750 shares of its common stock, with net proceeds to the Company of $97.6 million, after deducting underwriting discounts and estimated offering expenses.

    FINANCIAL GUIDANCE

    For 2020, ImmunoGen expects:

    • revenues between $60 million and $65 million;
    • operating expenses between $165 million and $170 million; and
    • cash and cash equivalents at December 31, 2020 to be between $170 million and $175 million.

    ImmunoGen expects that its current cash, inclusive of the proceeds generated from the recent public offering and anticipated cash receipts from partners, 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 3989656. 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®, Venclexta® , and Kadcyla®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, 2020; its cash and marketable securities as of December 31, 2020 the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to the Company's product candidates; and the presentation of pre-clinical 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 clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; the Company's ability to financially support its product programs; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2018 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,

    2019

    December 31,

    2018

    ASSETS
     
    Cash and cash equivalents

    $

    176,225

    $

    262,252

    Other assets

    59,437

    33,129

     
    Total assets

    $

    235,662

    $

    295,381

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

    $

    309

    $

    317

    Other current liabilities

    77,101

    70,343

    Long-term portion of deferred revenue

    127,123

    80,485

    Other long-term liabilities

    107,250

    133,264

    Shareholders' (deficit) equity

    (76,121)

    10,972

     
    Total liabilities and shareholders' (deficit) equity

    $

    235,662

    $

    295,381

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
     

    Three Months Ended

    December 31,

    Year Ended

    December 31,

    2019

    2018

    2019

    2018

     
    Revenues:
    License and milestone fees

    $

    29,551

    $

    1,747

    $

    34,788

    $

    15,280

    Non-cash royalty revenue

    15,313

    9,281

    47,415

    32,154

    Research and development support

    -

    218

    68

    1,377

    Clinical materials revenue

    -

    2,170

    -

    4,635

     
    Total revenues

    44,864

    13,416

    82,271

    53,446

     
    Expenses:
    Research and development

    26,055

    43,681

    114,522

    174,456

    General and administrative

    9,803

    9,752

    38,489

    36,746

    Restructuring charge

    512

    406

    21,433

    3,693

     
    Total operating expenses

    36,370

    53,839

    174,444

    214,895

     
    Income (loss) from operations

    8,494

    (40,423)

    (92,173)

    (161,449)

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

    (5,354)

    (2,428)

    (16,879)

    (10,631)

    Interest expense on convertible bonds

    (24)

    (25)

    (95)

    (95)

    Other income, net

    1,698

    1,077

    5,014

    3,332

     
    Net income (loss)

    $

    4,814

    $

    (41,799)

    $

    (104,133)

    $

    (168,843)

     
    Basic and diluted net income (loss) per common share

    $

    0.03

    $

    (0.28)

    $

    (0.70)

    $

    (1.21)

     
    Basic and diluted weighted average common shares outstanding

    148,809

    147,287

    148,311

    139,946

     

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  32. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the following presentations by Company management at upcoming investor conferences will be webcast:

    • Guggenheim Healthcare Talks Oncology Day

      February 13th at 3:00 pm Eastern
    • SVB Leerink 9th Annual Global Healthcare Conference

      February 26th at 10:30 am Eastern
    • Cowen 40th Annual Healthcare Conference

      March 2nd at 11:20 am Eastern

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

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the following presentations by Company management at upcoming investor conferences will be webcast:

    • Guggenheim Healthcare Talks Oncology Day

      February 13th at 3:00 pm Eastern
    • SVB Leerink 9th Annual Global Healthcare Conference

      February 26th at 10:30 am Eastern
    • Cowen 40th Annual Healthcare Conference

      March 2nd at 11:20 am Eastern

    A webcast of each presentation will be accessible through the Investors and Media section of the Company's website on 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.

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  33. ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on January 31, 2020 the compensation committee of the Company's board of directors granted a non-qualified stock option award to purchase an aggregate of 6,600 shares of its common stock to a new employee under the ImmunoGen, Inc. Inducement Equity Incentive Plan, or the Inducement Plan. The stock option was granted as an inducement material to the new employee's becoming an employee of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a…

    ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on January 31, 2020 the compensation committee of the Company's board of directors granted a non-qualified stock option award to purchase an aggregate of 6,600 shares of its common stock to a new employee under the ImmunoGen, Inc. Inducement Equity Incentive Plan, or the Inducement Plan. The stock option was granted as an inducement material to the new employee's becoming an employee of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    The option has an exercise price of $4.725 per share, which is equal to the closing price of ImmunoGen's common stock on The Nasdaq Global Select Market on January 31, 2020. The option will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, subject to such employee's continued employment with ImmunoGen on such vesting dates. The option is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement covering the grant.

    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.

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  34. 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 Friday, February 14, 2020 to discuss its 2019 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 3989656. The call may also be accessed through the Investors and Media section of the Company's website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates 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 Friday, February 14, 2020 to discuss its 2019 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 3989656. The call may also be accessed through the Investors and Media section of the Company's website, www.immunogen.com. Following the webcast, a replay of the call 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.

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  35. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced the closing of its previously announced underwritten public offering of 24,523,750 shares of its common stock at a price of $4.25 per share, which included the exercise in full by the underwriters of their option to purchase up to 3,198,750 additional shares of common stock. ImmunoGen received total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) of $104.2 million.

    ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced the closing of its previously announced underwritten public offering of 24,523,750 shares of its common stock at a price of $4.25 per share, which included the exercise in full by the underwriters of their option to purchase up to 3,198,750 additional shares of common stock. ImmunoGen received total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) of $104.2 million.

    ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

    Jefferies, Cowen and William Blair acted as joint book-running managers for the offering.

    The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at or by telephone at (833) 297-2926; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at or by telephone at (800) 621-0687.

    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."

    This press release includes forward-looking statements, including statements related to the public offering of securities by ImmunoGen, including statements about intended use of the net proceeds of the offering and existing capital. 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 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: uncertainties inherent in the initiation of future clinical trials and such other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2018 and other filings with the Securities and Exchange Commission.

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  36. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced the pricing of an underwritten public offering of 21,325,000 shares of its common stock at a price of $4.25 per share, before underwriting discounts. ImmunoGen also granted the underwriters a 30-day option to purchase up to an additional 3,198,750 shares of its common stock at the public offering price, less the underwriting discounts. All of the shares of common stock in the offering are to be sold by ImmunoGen.

    ImmunoGen anticipates the total gross proceeds from the offering (before deducting the underwriting discounts and estimated offering expenses) will be $90.6 million, excluding any exercise…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced the pricing of an underwritten public offering of 21,325,000 shares of its common stock at a price of $4.25 per share, before underwriting discounts. ImmunoGen also granted the underwriters a 30-day option to purchase up to an additional 3,198,750 shares of its common stock at the public offering price, less the underwriting discounts. All of the shares of common stock in the offering are to be sold by ImmunoGen.

    ImmunoGen anticipates the total gross proceeds from the offering (before deducting the underwriting discounts and estimated offering expenses) will be $90.6 million, excluding any exercise of the underwriters' option to purchase additional shares.

    ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

    Jefferies, Cowen and William Blair are acting as joint book-running managers for the proposed offering.

    The offering is expected to close on or about January 27, 2020, subject to satisfaction of customary closing conditions.

    The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at or by telephone at (833) 297-2926; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at or by telephone at (800) 621-0687.

    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."

    This press release includes forward-looking statements, including statements related to the public offering of securities by ImmunoGen, including statements about the completion and timing of the public offering, the anticipated total gross proceeds from the offering and the intended use of the net proceeds of the offering and existing capital. 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 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: uncertainties inherent in the initiation of future clinical trials and such other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

    95046004v.4

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  37. ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen.

    ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply…

    ImmunoGen, Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen.

    ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

    Jefferies, Cowen and William Blair are acting as joint book-running managers for the proposed offering.

    The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at or by telephone at (877) 821-7388; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at or by telephone at (800) 621-0687.

    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."

    This press release includes forward-looking statements, including statements related to the proposed public offering of securities by ImmunoGen, including the intended use of the net proceeds of the offering and existing capital. 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 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 uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, uncertainties inherent in the initiation of future clinical trials and such other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

    91592487v.6

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  38. ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, will present at the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. The presentation is scheduled for 9:30am PT (12:30pm ET) on January 16, 2019.

    Following the presentation, Mr. Enyedy will be joined by other members of ImmunoGen's management team for a question-and-answer session at 10:00am PT (1:00pm ET).

    A webcast of the presentation and question-and-answer session will be accessible live through the "Investors & Media" section of the Company's website, www.immunogen.com; a replay will be available in the same location.

    ABOUT

    ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Mark Enyedy, President and CEO, will present at the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. The presentation is scheduled for 9:30am PT (12:30pm ET) on January 16, 2019.

    Following the presentation, Mr. Enyedy will be joined by other members of ImmunoGen's management team for a question-and-answer session at 10:00am PT (1:00pm ET).

    A webcast of the presentation and question-and-answer session will be accessible live through the "Investors & Media" section of the Company's website, www.immunogen.com; a replay will be available in 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.

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  39. ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on December 23, 2019 the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase an aggregate of 16,900 shares of its common stock to a new employee under the ImmunoGen, Inc. Inducement Equity Incentive Plan, or the Inducement Plan. The stock option was granted as an inducement material to the new employee's becoming an employee of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following…

    ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that on December 23, 2019 the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase an aggregate of 16,900 shares of its common stock to a new employee under the ImmunoGen, Inc. Inducement Equity Incentive Plan, or the Inducement Plan. The stock option was granted as an inducement material to the new employee's becoming an employee of ImmunoGen in accordance with Nasdaq Listing Rule 5635(c)(4).

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of ImmunoGen (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with ImmunoGen, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    The option has an exercise price of $5.46 per share, which is equal to the closing price of ImmunoGen's common stock on the Nasdaq Global Select Market on December 23, 2019. The option will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the date of grant, and thereafter an additional 6.25% of the shares vesting on each succeeding quarterly anniversary of the date of grant, subject to such employee's continued employment with ImmunoGen on such vesting dates. The option is subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option agreement covering the grant.

    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.

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  40. Top-Line Data from New Pivotal Single-Arm Trial, SORAYA, Expected in First Half of 2021

    Confirmatory MIRASOL Trial for Mirvetuximab on Track to Start by Year-End

    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 announced that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who…

    Top-Line Data from New Pivotal Single-Arm Trial, SORAYA, Expected in First Half of 2021

    Confirmatory MIRASOL Trial for Mirvetuximab on Track to Start by Year-End

    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 announced that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab).

    "We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "Having aligned with the agency that women with FRα-high platinum-resistant ovarian cancer that has progressed after prior treatment with bevacizumab require better therapeutic options, we are pleased to advance mirvetuximab in this patient population with SORAYA, which, if successful, would enable us to submit an application for accelerated approval during the second half of 2021. We anticipate enrolling the first patient in SORAYA next quarter and expect top-line data from the study in mid-2021."

    ImmunoGen's mirvetuximab program now includes two new trials, SORAYA and MIRASOL, which will enroll concurrently.

    SORAYA: Pivotal Trial

    SORAYA is a single-arm trial with mirvetuximab that will enroll approximately 100 patients. Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens – at least one of which included bevacizumab. The primary endpoint of this study is overall response rate by investigator assessment and the key secondary endpoint is duration of response.

    MIRASOL: Confirmatory Trial

    MIRASOL is a randomized Phase 3 trial in which 430 patients will be randomized 1:1 to receive either mirvetuximab or investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens. The primary endpoint of this study is progression free survival by investigator assessment. The key secondary endpoints include: overall response rate, overall survival, and patient-reported outcomes.

    "We have reviewed the data generated from our Phase 1 and FORWARD I studies using the PS2+ scoring method and have identified 70 patients who would meet the key eligibility criteria for SORAYA. The overall response rate in these patients was 31.4% with 95% CI (20.9%, 43.6%) and a median duration of response of 7.8 months with 95% CI (3.98, -)," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These data compare quite favorably to the response rate seen with single agent chemotherapy in platinum resistant disease, which was 12% in the AURELIA and CORAIL trials, and included patients naïve to and previously treated with bevacizumab."

    Berkenblit continued, "Replicating these data in SORAYA would support an application for accelerated approval in advance of the completion of MIRASOL, which would thereafter provide the randomized data needed for conversion to full approval. We are delighted to advance both studies as soon as possible."

    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 7190603. 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 MIRVETUXIMAB SORAVTANSINE

    Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

    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.

    AVASTIN® is a registered trademark of Genentech, Inc.

    This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGen's expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to the Company's 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 Company's ability to control future spending to enable it to fund its remaining operations through the release of top-line results from the SORAYA and MIRASOL trials, as well as the risks and uncertainties inherent in the Company's development programs, including clinical studies and regulatory processes, their timings and results. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

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  41. Data Demonstrating Potential in AML and BPDCN Presented During Oral Presentation; Dose and Schedule Selected for Further Development

    Preclinical Combination Data Also Presented; Support Further Evaluation of IMGN632 Doublets and Triplet in AML

    ImmunoGen, Inc., (NASDAQ:IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that new safety and efficacy findings from the dose escalation and expansion of the first-in-human trial of IMGN632 in patients with relapsed/refractory acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented in an oral session at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. Preclinical…

    Data Demonstrating Potential in AML and BPDCN Presented During Oral Presentation; Dose and Schedule Selected for Further Development

    Preclinical Combination Data Also Presented; Support Further Evaluation of IMGN632 Doublets and Triplet in AML

    ImmunoGen, Inc., (NASDAQ:IMGN) a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that new safety and efficacy findings from the dose escalation and expansion of the first-in-human trial of IMGN632 in patients with relapsed/refractory acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented in an oral session at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. Preclinical data related to IMGN632 in combination with Vidaza® (azacitidine) and Venclexta® (venetoclax), and two "trial in progress" posters were also presented at the conference.

    "The data presented at ASH demonstrate the potential of IMGN632 to offer a new treatment option for patients with AML and BPDCN," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With the benefit of a comprehensive assessment of IMGN632's safety and efficacy across a wide range of doses and two schedules, we have selected a dose and schedule that demonstrate significant anti-tumor activity, favorable tolerability, and the convenience of a short infusion that can be administered in an outpatient setting. Together with the preclinical data on combining IMGN632 with azacitidine and venetoclax presented by our collaborators from MD Anderson, these updated clinical results provide a strong foundation for our ongoing expansion of IMGN632 monotherapy studies in BPDCN, AML, and ALL, and the recent initiation of our trial to evaluate IMGN632 combinations with azacitidine and venetoclax in relapsed and frontline AML, as well as IMGN632 as a monotherapy in minimal residual disease positive AML patients."

    "We are particularly encouraged by the activity and tolerability of IMGN632 in heavily pre-treated patients, including a 40% ORR in relapsed and refractory de novo AML patients treated at the recommended phase 2 dose, and the responses in relapsed or refractory BPDCN patients previously treated with Elzonris® (tagraxofusp-erzs) and intensive chemotherapy," said Naval Daver, MD, Associate Professor in the Department of Leukemia at MD Anderson Cancer Center. "We look forward to continuing to evaluate IMGN632 as a monotherapy and in combination with azacitidine and venetoclax in doublet and triplet regimens in relapsed/refractory AML and frontline older AML."

    PHASE 1 DATA ON IMGN632 AS A MONOTHERAPY IN AML AND BPDCN

    Oral Presentation, Abstract #734

    Updated key findings from the Phase 1 study of IMGN632 include the following:

    Safety

    • IMGN632 was administered to 95 patients over dose levels ranging from 0.015 to 0.45 mg/kg intravenously on the every 3 week schedule and 0.015 to 0.06 mg/kg on the fractionated day 1, 4, and 8 schedule every 3 weeks.
    • IMGN632 displays a well tolerated safety profile and activity at doses up to and including 0.09 mg/kg per cycle.
    • The most common treatment-related adverse event was infusion-related reactions (24% all grades, 8% grade 3); none required IMGN632 discontinuation.
    • Single dose-limiting toxicities were seen at the highest dose levels tested (0.18-0.45 mg/kg): three reversible cases of veno-occlusive disease and one prolonged neutropenia; no patterns of hepatotoxicity or cytopenias occurred with doses below 0.18 mg/kg.
    • Although no maximum tolerated dose was determined on either schedule, based on the efficacy, safety, and pharmacokinetic data generated, the dose and schedule of 0.045 mg/kg given on day 1 every 3 weeks has been selected as the monotherapy recommended Phase 2 dose.

    AML Efficacy

    • Across all dose levels and both schedules, of the patients assessable for efficacy (n=71), 38 (54%) had a reduction in bone marrow blasts and 13 (18%) achieved an objective response, including 2 complete remissions (CR) and 10 with incomplete recovery (CRi) and one morphologic leukemia free state (MLFS) in heavily pretreated patients. The vast majority of these responders (92%) had failed prior intensive therapies, including 3 with prior transplant, 69% had failed 2-3 prior lines of therapy, and 54% had an adverse risk classification.
    • At the dose and schedule selected as the recommended Phase 2 dose (0.045 mg/kg Q3W), a 40% response rate was seen in relapsed and refractory patients with de novo AML, including 1 CR, 4 CRi, and 1 MLFS (with subsequent conversion to CRi).

    BPDCN Efficacy

    • 3 of 9 (33%) evaluable relapsed/refractory BPDCN patients achieved a response after a 1-2 doses of 0.045 mg/kg IMGN632 (1 CR, 1 CRi, and 1 partial remission); all three patients had received prior SL-401 (tagraxofusp-erzs), two had received intense multi-agent chemotherapy, and one had prior stem cell transplant.

    PRECLINICAL DATA ON IMGN632 IN COMBINATION WITH AZACITIDINE AND VENETOCLAX

    Poster Presentation, Abstract 1375

    IMGN632 was evaluated in combination with azacitidine, and as a triplet with azacitidine and venetoclax in AML models, including patient derived xenografts (PDX). The addition of IMGN632 to azacitidine alone or to azacitidine plus venetoclax consistently led to reductions in tumor burden and to improved survival in these murine models. These data support clinical testing of the addition of IMGN632 to standard of care therapy including azacitidine, and azacitidine plus venetoclax in AML patients.

    Additional information, including abstracts, can be found at www.hematology.org.

    ABOUT IMGN632

    IMGN632 is a CD123-targeting ADC in Phase I testing for hematological malignancies, including acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), and acute lymphocytic leukemia (ALL). IMGN632 uses one of ImmunoGen's novel indolino-benzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against AML blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

    ABOUT ACUTE MYELOID LEUKEMIA (AML)

    AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, 21,380 patients will be diagnosed with AML this year and 10,590 patients will die from the disease.

    ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)

    BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the recent approval of a CD123-targeting therapy, the unmet need remains high in the relapsed/refractory setting.

    ABOUT CD123

    CD123, the interleukin-3 alpha chain, is expressed on multiple myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative neoplasms. With limited expression on normal hematopoietic cells, rapid internalization, and expression on AML leukemia stem cells, CD123 is a validated therapeutic target, with the recent approval of a CD123-targeting therapy for BPDCN.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to "target a better now."

    Learn more about who we are, what we do, and how we do it at www.immunogen.com.

    Vidaza®, Venclexta® and Elzonris® are registered trademarks of their respective owners.

    FORWARD-LOOKING STATEMENTS

    This press release includes forward-looking statements based on management's current expectations. 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. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including risks related to preclinical and clinical studies, their timings and results, and the potential that earlier clinical studies may not be predictive of future results. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

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  42. 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 participate in a fireside chat at the upcoming Piper Jaffray Healthcare Conference. The fireside chat is scheduled for 12:30 p.m. ET on December 3, 2019.

    A webcast of the fireside chat will be accessible live through the "Investors & Media" section of the Company's website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.

    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…

    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 participate in a fireside chat at the upcoming Piper Jaffray Healthcare Conference. The fireside chat is scheduled for 12:30 p.m. ET on December 3, 2019.

    A webcast of the fireside chat will be accessible live through the "Investors & Media" section of the Company's website, www.immunogen.com; a replay will be available in the same location for approximately two weeks.

    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.

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  43. Updated Phase 1 Data to be Highlighted in Oral Presentation Demonstrate Tolerable Safety Profile and Encouraging Activity in AML and BPDCN

    Preclinical Data for IMGN632 in Combination with Azacitidine and Venetoclax Support Clinical Evaluation of Doublets and Triplet in AML

    ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that abstracts highlighting the Company's investigational ADC therapy, IMGN632, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting to be held December 7-10 in Orlando, FL.

    IMGN632 is a CD123-targeting ADC in Phase I testing for hematological malignancies, including acute myeloid…

    Updated Phase 1 Data to be Highlighted in Oral Presentation Demonstrate Tolerable Safety Profile and Encouraging Activity in AML and BPDCN

    Preclinical Data for IMGN632 in Combination with Azacitidine and Venetoclax Support Clinical Evaluation of Doublets and Triplet in AML

    ImmunoGen Inc., (NASDAQ:IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that abstracts highlighting the Company's investigational ADC therapy, IMGN632, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting to be held December 7-10 in Orlando, FL.

    IMGN632 is a CD123-targeting ADC in Phase I testing for hematological malignancies, including acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), and acute lymphocytic leukemia (ALL). IMGN632 uses one of ImmunoGen's novel indolino-benzodiazepine (IGN) payloads, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against AML blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.

    Updated safety and efficacy findings from the dose escalation and expansion of the first-in-human trial of IMGN632 in patients with relapsed/refractory AML and BPDCN will be reported in an oral presentation. Preclinical data related to IMGN632 in combination with Vidaza® (azacitidine) and Venclexta® (venetoclax) and two "trial in progress" posters will also be presented in poster sessions.

    "Building on initial data shared at ASH last year, we continue to be encouraged by the anti-leukemia activity and tolerability of IMGN632 in AML and BPCDN," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These data support the continued development of IMGN632 as a monotherapy for BPDCN and MRD+ AML, and in combinations for AML. Despite recent advances, including the first drug approved for BPDCN and approvals of targeted therapies for molecularly-defined subsets of AML, the need remains for well-tolerated, effective, and convenient therapies in these diseases."

    ORAL PRESENTATION DETAILS

    Oral Session 613: Monday, December 9, 2019, 3:00pm EST

    Title (Abstract #734): "Clinical Profile of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm"

    Initial key findings include:

    Safety

    • IMGN632 was administered to 74 patients over dose levels ranging from 0.015 to 0.45 mg/kg intravenously on the every 3 week schedule and 0.015-0.06 mg/kg on the fractionated day 1, 4, and 8 schedule every 3 weeks.
    • IMGN632 displays a tolerable safety profile and activity at doses up to 0.3 mg/kg.
    • The most common treatment-related adverse event was infusion-related reactions (16%; four grade 3); none required treatment discontinuation.
    • Single dose-limiting toxicities were seen at the three highest dose levels tested: one prolonged neutropenia and two reversible cases of veno-occlusive disease; no patterns of hepatotoxicity or cytopenias occurred with doses below 0.18 mg/kg.
    • Although no maximum tolerated dose was determined on either schedule, based on the efficacy, safety, and pharmacokinetic data generated, the dose and schedule of 0.045 mg/kg given on day 1 every 3 weeks has been selected for Phase 2 development.

    AML Efficacy

    • In the assessable AML population (n=66), 37 (55%) had a reduction in bone marrow blasts and 13 (20%) achieved an objective response across all dose levels and both schedules achieved an objective response, including three complete remissions (CR) and eight CRs with incomplete recovery (CRi) in heavily pretreated patients. The majority of responders (77%) had failed prior intensive therapies, including three with prior transplant, 62% had an adverse risk classification, and 23% were primary refractory.
    • A 32% response rate (6/19 patients; two CR, three CRi, and one morphologic leukemia free state) was seen in primary AML patients treated with dose and schedule selected for Phase 2 development.

    BPDCN Efficacy

    • Three of seven evaluable BPDCN patients (43%) achieved a response after a single dose of IMGN632, one CR, one CRi, and one partial remission; all three patients had received prior SL-401 (tagraxofusp-erzs; Elzonris®).

    POSTER SESSION

    Poster Session 616: Saturday, December 7, 2019, 5:30-7:30pm EST

    Title (Abstract #1375): "IMGN632, a CD123-Targeting ADC Bearing a DNA-Alkylating IGN Payload, Combines Effectively with Azacitidine and Venetoclax In Vivo, Prolonging Survival in Preclinical Models of Human Acute Myeloid Leukemia (AML)"

    TRIALS IN PROGRESS POSTER SESSIONS

    Poster Session 613: Saturday, December 7, 2019, 5:30-7:30pm EST

    Title (Abstract #1334): "A Phase I Study of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, and Other CD123-Positive Hematologic Malignancies"

    Poster Session 613: Sunday, December 8, 2019, 6:00-8:00pm EST

    Title (Abstract #2601): "A Phase 1b/2 Study of the CD123-Targeting Antibody-Drug Conjugate IMGN632 as Monotherapy or in Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia"

    Additional information can be found at www.hematology.org, including abstracts.

    ABOUT ACUTE MYELOID LEUKEMIA (AML)

    AML is a cancer of the bone marrow cells that produce white blood cells. It causes the marrow to increasingly generate abnormal, immature white blood cells (blasts) that do not mature into effective infection-fighting cells. The blasts quickly fill the bone marrow, impacting the production of normal platelets and red blood cells. The resulting deficiencies in normal blood cells leave the patient vulnerable to infections, bleeding problems, and anemia. It is estimated that, in the U.S. alone, 21,380 patients will be diagnosed with AML this year and 10,590 patients will die from the disease.

    ABOUT BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (BPDCN)

    BPDCN is a rare form of blood cancer that has features of both leukemia and lymphoma, with characteristic skin lesions, lymph node involvement, and frequent spread to the bone marrow. This aggressive cancer requires intense treatment often followed by stem cell transplant. Despite the recent approval of a CD123-targeting therapy, the unmet need remains high in the relapsed/refractory setting.

    ABOUT CD123

    CD123, the interleukin-3 alpha chain, is expressed on multiple myeloid and lymphoid cancers including AML, BPDCN, ALL, chronic myeloid leukemia, and myeloproliferative neoplasms. With limited expression on normal hematopoietic cells, rapid internalization, and expression on AML leukemia stem cells, CD123 is a validated therapeutic target, with the recent approval of a CD123-targeting therapy for BPDCN.

    ABOUT IMMUNOGEN

    ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to "target a better now."

    Learn more about who we are, what we do, and how we do it at www.immunogen.com.

    Vidaza®, Venclexta®, and Elzonris® are registered trademarks of their respective owners.

    FORWARD-LOOKING STATEMENTS

    This press release includes forward-looking statements based on management's current expectations. 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. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including risks related to preclinical and clinical studies, their timings and results, and the potential that earlier clinical studies may not be predictive of future results. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and other reports filed with the Securities and Exchange Commission.

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  44. Full Mirvetuximab Soravtansine Phase 3 FORWARD I and Initial Phase 1b FORWARD II Triplet Data Presented at ESMO

    Phase 3 MIRASOL Trial for Mirvetuximab in Ovarian Cancer on Track to Start by Year-End

    Updated IMGN632 AML and BPDCN Monotherapy Data Accepted as Oral Presentation 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 financial results for the quarter ended September 30, 2019.

    "The FORWARD I analyses presented at ESMO have provided us with valuable insights into the patients who benefit most from mirvetuximab," said Mark Enyedy, ImmunoGen's…

    Full Mirvetuximab Soravtansine Phase 3 FORWARD I and Initial Phase 1b FORWARD II Triplet Data Presented at ESMO

    Phase 3 MIRASOL Trial for Mirvetuximab in Ovarian Cancer on Track to Start by Year-End

    Updated IMGN632 AML and BPDCN Monotherapy Data Accepted as Oral Presentation 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 financial results for the quarter ended September 30, 2019.

    "The FORWARD I analyses presented at ESMO have provided us with valuable insights into the patients who benefit most from mirvetuximab," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer. "We have since met with FDA to review these data and the design of MIRASOL, the Phase 3 study of mirvetuximab for platinum-resistant ovarian cancer patients whose tumors express high levels of folate receptor alpha. We anticipate enrolling our first patient before year-end and, on the strength of the data we have generated in the program, believe we have increased the likelihood of a positive outcome with this next study."

    Enyedy added, "IMGN632 continues to make encouraging progress in the clinic, with the initiation of combination studies in relapsed/refractory AML patients and monotherapy expansion into relapsed ALL and MRD+ AML patients following frontline induction therapy. We exit the year with significant momentum across our portfolio with an oral presentation for IMGN632 at ASH, ongoing studies for mirvetuximab combination regimens, advances in our early-stage pipeline, and a strong financial position to execute against our strategic priorities."

    RECENT PROGRESS

    • Presented full data and additional exploratory analyses from the Phase 3 FORWARD I study evaluating mirvetuximab compared to chemotherapy in women with folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) Congress.
    • Presented initial safety and overall response data from the Phase 1b FORWARD II triplet cohort evaluating mirvetuximab in combination with carboplatin and Avastin® (bevacizumab) in patients with recurrent, platinum-sensitive ovarian cancer at ESMO.
    • Met with the United States Food and Drug Administration (FDA) to review the design of MIRASOL, the Phase 3 study evaluating mirvetuximab as monotherapy for women with FRα-high, platinum-resistant ovarian cancer.
    • Completed enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in "platinum agnostic" ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy.
    • For IMGN632 monotherapy, continued enrollment in the Phase 1 expansion cohorts in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), opened an expansion cohort now enrolling patients with relapsed acute lymphocytic leukemia (ALL), and initiated a study in minimal residual disease positive (MRD+) AML patients following frontline induction therapy.
    • For IMGN632 combination therapy, initiated studies with Vidaza® (azacitidine) and Venclexta® (venetoclax) in relapsed/refractory unfit AML patients.
    • Advanced investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.

    ANTICIPATED UPCOMING EVENTS

    • Initiate MIRASOL by year-end.
    • Present preclinical combination data (poster presentation) and updated clinical monotherapy data (oral presentation) for IMGN632 with additional patients enrolled in AML and BPDCN expansion cohorts at the American Society of Hematology (ASH) Annual Meeting in December.
    • Continue enrollment in IMGN632 combination and single-agent BPDCN, relapsed AML, MRD+ AML, and relapsed ALL expansion cohorts.
    • IND filing for IMGC936 in the first half of 2020.
    • Present initial data from FORWARD II platinum agnostic and updated triplet combination studies in mid-2020.
    • Transition next generation anti-FRα ADC, IMGN151, to pre-clinical development in mid-2020.

    FINANCIAL RESULTS

    Revenues for the quarter ended September 30, 2019 were $13.3 million, compared with $10.9 million for the quarter ended September 30, 2018. Revenues in the third quarter of 2019 included $13.2 million in non-cash royalty revenues, compared with $8.4 million for the third quarter of 2018. Revenues for the prior year period also included $0.7 million of license and milestone fees, inclusive of a $0.5 million milestone pursuant to a license agreement with Fusion Pharmaceuticals, $0.4 million of research and development (R&D) support fees, and $1.4 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

    Operating expenses for the third quarter of 2019 were $31.2 million, compared with $56.5 million for the same quarter in 2018. The decrease was driven by R&D expenses, which were $21.0 million in the third quarter of 2019 compared with $47.2 million for the third quarter of 2018. This decrease was primarily due to: lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, including decreases in personnel and third-party research expenses and lower facility-related allocations; a decrease in clinical trial expenses in the current period driven by greater activity in the FORWARD I Phase 3 clinical trial during the prior year period; and lower external manufacturing costs driven by activity to support commercial validation of mirvetuximab in the prior year period. General and administrative expenses in the third quarter of 2019 were $9.2 million, compared to $8.3 million in the third quarter of 2018, primarily due to a higher allocation of facility-related expenses for excess laboratory and office space resulting from the recent restructuring. Operating expenses for the third quarter of 2019 also included a $1.0 million charge related primarily to retention costs resulting from the restructuring, compared to a $0.9 million charge recorded in the third quarter of 2018 related to the decommissioning of the Company's Norwood facility.

    ImmunoGen reported a net loss of $21.8 million, or $0.15 per basic and diluted share, for the third quarter of 2019, compared with a net loss of $46.8 million, or $0.32 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 148.5 million from 147.2 million in those quarters.

    ImmunoGen had $204.5 million in cash and cash equivalents as of September 30, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $55.8 million for the first nine months of 2019, compared with cash used in operations of $125.1 million for the same period in 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company's residual rights to Kadcyla® (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures were $2.8 million and $4.2 million for the first nine months of 2019 and 2018, respectively.

    FINANCIAL GUIDANCE

    ImmunoGen has updated its financial guidance for 2019 as follows:

    • revenues between $65 million and $70 million;
    • operating expenses between $170 million and $175 million; and
    • cash and cash equivalents at December 31, 2019, between $170 million and $175 million.

    Revenue guidance has been updated to reflect recognition of deferred revenue under our Jazz Pharmaceuticals collaboration related to IMGN779, which was discontinued as part of ImmunoGen's portfolio prioritization exercise in June of this year. ImmunoGen expects that its current cash, together with expense reductions resulting from the operational changes previously announced and anticipated cash receipts from partners, will fund operations through the release of top-line results from MIRASOL, which are expected in the first 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 8865657. 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®, Venclexta®, and Kadcyla® 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, 2019; its cash and marketable securities as of December 31, 2019; the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to the Company's product candidates; and the presentation of pre-clinical 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 clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; the Company's ability to financially support its product programs; and other factors more fully described in ImmunoGen's Annual Report on Form 10-K for the year ended December 31, 2018 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)
     
    September 30, December 31,

     

    2019

     

     

    2018

     

    ASSETS
     
    Cash and cash equivalents

    $

     

    204,491

     

    $

     

    262,252

     

    Other assets

    49,645

     

    33,129

     

     
    Total assets

    $

     

    254,136

     

    $

     

    295,381

     

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

    $

     

    14,817

     

    $

     

    317

     

    Other current liabilities

    73,357

     

    70,343

     

    Long-term portion of deferred revenue

    131,035

     

    80,485

     

    Other long-term liabilities

    121,152

     

    133,264

     

    Shareholders' (deficit) equity

    (86,225

    )

    10,972

     

     
    Total liabilities and shareholders' (deficit) equity

    $

     

    254,136

     

    $

     

    295,381

     

     
     
     
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
    Three Months Ended Nine Months Ended
    September 30, September 30,

    2019

     

    2018

     

    2019

     

    2018

     

     
    Revenues:
    Non-cash royalty revenue

    $

     

    13,202

     

    $

     

    8,441

     

    $

     

    32,102

     

    $

     

    22,873

     

    License and milestone fees

    79

     

    672

     

    5,237

     

    13,533

     

    Research and development support

    -

     

    388

     

    68

     

    1,159

     

    Clinical materials revenue

    -

     

    1,427

     

    -

     

    2,465

     

     
    Total revenues

    13,281

     

    10,928

     

    37,407

     

    40,030

     

     
    Expenses:
    Research and development

    21,015

     

    47,243

     

    88,467

     

    130,775

     

    General and administrative

    9,208

     

    8,347

     

    28,686

     

    26,994

     

    Restructuring charge

    1,020

     

    870

     

    20,921

     

    3,287

     

     
    Total operating expenses

    31,243

     

    56,460

     

    138,074

     

    161,056

     

     
    Loss from operations

    (17,962

    )

    (45,532

    )

    (100,667

    )

    (121,026

    )

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

    (4,275

    )

    (2,546

    )

    (11,525

    )

    (8,203

    )

    Interest expense on convertible bonds

    (24

    )

    (23

    )

    (71

    )

    (70

    )

    Other income (loss), net

    511

     

    1,294

     

    3,316

     

    2,255

     

     
    Net loss

    $

     

    (21,750

    )

    $

     

    (46,807

    )

    $

     

    (108,947

    )

    $

     

    (127,044

    )

     
    Basic and diluted net loss per common share

    $

     

    (0.15

    )

    $

     

    (0.32

    )

    $

     

    (0.74

    )

    $