UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event
reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including
area code: (
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol |
Name of Each Exchange on Which Registered |
||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On October 26, 2022, Ms. Kristen Harrington-Smith, Senior Vice President of ImmunoGen, Inc. (the “Company”), resigned from her position as Chief Commercial Officer, effective November 16, 2022, for personal reasons and intends to pursue a new opportunity closer to her residence and family. Her departure is unrelated to the Company’s business performance, including expectations relating to the potential U.S. Food and Drug Administration approval of mirvetuximab soravtansine.
Mr. Todd Talarico, Vice President of Market Access, will assume the responsibilities of Chief Commercial Officer on an interim basis while the Company engages in a search for a permanent replacement for Ms. Harrington-Smith.
Item 7.01 Regulation FD Disclosure.
On November 1, 2022, the Company issued a press release regarding Ms. Harrington-Smith’s departure. A copy of this press release is attached as Exhibit 99.1.
The information contained in this item, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release of ImmunoGen, Inc. dated November 1, 2022 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL (eXtensible Business Reporting Language) document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ImmunoGen, Inc. | |
| Date: November 1, 2022 | /s/ Mark Enyedy |
| Mark Enyedy | |
| President and Chief Executive Officer |
Exhibit 99.1
ImmunoGen Announces Departure of Chief Commercial Officer
Waltham, MA – November 1, 2022 – ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Kristen Harrington-Smith, Senior Vice President and Chief Commercial Officer (CCO), will be departing the Company. Ms. Harrington-Smith is leaving for personal reasons to pursue a new opportunity closer to her home and her departure is unrelated to the Company’s business performance, including expectations relating to the potential approval of mirvetuximab soravtansine (mirvetuximab). She will continue with the Company until November 16, 2022 to support the transition of her responsibilities. Todd Talarico, Vice President of Market Access, will serve as interim leader of the commercial organization pending a search to identify a new permanent CCO.
“We thank Kristen for her significant contributions to the business, particularly her efforts to build a best-in-class commercial organization and to prepare us for the expected launch of mirvetuximab, ” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “We are highly confident that accelerated approval for mirvetuximab will be granted on or before the November 28, 2022 PDUFA date. Our deep and experienced commercial team is ready to support a successful launch, with our field organization fully staffed, our distribution, market access, and patient support infrastructure in place, and vials of commercial-ready drug product in inventory. We look forward to the opportunity to bring this important product candidate to ovarian cancer patients within the month.”
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. These statements include, but are not limited to, ImmunoGen’s expectations related to: the occurrence, timing, and outcome of potential preclinical, clinical, and regulatory events related to, and the potential benefits of, the Company’s product candidates, including, but not limited to, the outcome of the FDA’s review of the Company’s BLA for mirvetuximab and the commercial launch of mirvetuximab. Various factors could cause ImmunoGen’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of the Company’s preclinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of preclinical studies, clinical trials, and regulatory processes; the timing and outcome of the Company’s anticipated interactions with regulatory authorities, including that the FDA may determine that our BLA for mirvetuximab does not meet the conditions for accelerated approval; the risk that we may not be able to obtain adequate prices and reimbursement for any approved products, including the potential for delays or additional difficulties for mirvetuximab; the risk that the results of the ongoing MIRASOL trial may fail to support full approval of mirvetuximab and, if so, that additional studies may be required; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and the resulting impact on ImmunoGen’s industry and business; and other factors as set forth in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022, Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2022 and August 1, 2022, and other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future developments, or otherwise, except as may be required by applicable law.
INVESTOR RELATIONS CONTACT
ImmunoGen
Anabel Chan
781-895-0600
anabel.chan@immunogen.com
MEDIA CONTACTS
ImmunoGen
Courtney O’Konek
781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting
Robert Stanislaro
212-850-5657
robert.stanislaro@fticonsulting.com