IMGN ImmunoGen Inc

Item 8.01 - Other Events.

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On December 5, 2020, the Company issued a press release relating to safety and efficacy findings from the expansion phase of the Company’s Phase 1/2 clinical trial of IMGN632 in patients with relapsed/refractory BPDCN that were presented during an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting on December 5, 2020. A copy of the press release is being filed with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

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In addition, the U.S. Food and Drug Administration (FDA) advised the Company to add a pivotal cohort of up to 20 newly-diagnosed patients to the Company’s ongoing Phase 1/2 clinical trial of IMGN632 in relapsed/refractory BPDCN to support a potential label that could cover all BPDCN patients, both frontline and relapsed or refractory. With the benefit of this guidance from FDA, the Company has moved forward with this pivotal cohort and expects to complete enrollment and generate topline data from the study within the next 12 to 18 months, with a biologics license application (BLA) submission expected in 2022.

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Forward-Looking Statements

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This Current Report on Form 8-K includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, the Company’s expectations related to: the occurrence, timing, and outcome of potential pre-clinical, clinical, and regulatory events related to the Company’s product candidates, in particular with respect to IMGN632; and the presentation of pre-clinical and clinical data on the Company’s product candidates, in particular with respect to IMGN632. For these statements, the Company 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 the Company’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 Current Report on Form 8-K. 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 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; 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 the Company’s industry and business; and other factors more fully described in the Company’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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