UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________________
FORM 8-K
__________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 5, 2024
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2seventy bio, Inc.
(Exact name of Registrant as Specified in Its Charter)
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| Delaware | 001-40791 | 86-3658454 |
(State or Other Jurisdiction
of Incorporation) | (Commission File Number) | (IRS Employer
Identification No.) |
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| 60 Binney Street, | | 02142 |
| Cambridge, MA | | |
| (Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: (339) 499-9300
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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 Instructions A.2. below):
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading
Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.0001 par value per share | TSVT | The NASDAQ Stock Market LLC |
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 x
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. o
Item 2.02 Results of Operations and Financial Condition.
On February 5, 2024, 2seventy bio, Inc. (the “Company”) announced that Abecma (idecabtagene vicleucel, or ide-cel) generated approximately $56 million in U.S. revenue during the fourth quarter of 2023. The Company and Bristol Myers Squibb (“BMS”) share equally in all profits and losses related to development, manufacture and commercialization of Abecma in the U.S. This announcement is based on information provided to the Company by BMS and is unaudited and does not present all information necessary for an understanding of the Company’s financial condition as of December 31, 2023 and its results of operations for the quarter and year then ended. The Company expects to announce its full results for the quarter and year ended December 31, 2023 on or before April 1, 2024.
Item 8.01 Other Events.
On February 5, 2024, the Company and BMS issued a press release announcing that the U.S. Food and Drug Administration will convene a virtual meeting of the Oncologic Drugs Advisory Committee (“ODAC”) on March 15, 2024, to review data supporting the supplemental Biologics License Application (sBLA) for Abecma for triple-class exposed relapsed or refractory multiple myeloma based results from the pivotal Phase 3 KarMMa-3 study. The companies anticipate that the ODAC will review data related to the secondary endpoint of overall survival from the study. A copy of the press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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Exhibit
No. | | Description |
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| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document and incorporated as Exhibit 101) |
Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including the Company’s anticipated revenue for the quarter ended December 31, 2023. The use of words such as “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” or the negative of such words or other similar expressions can be used to identify forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. These and other risks and uncertainties are described in additional detail in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed March 16, 2023, its Quarterly Reports on Form 10-Q filed on May 10, 2023, August 14, 2023 and November 14, 2023, and its other filings made with the SEC from time to time. Although the Company’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by the Company. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this Current Report on Form 8-K speaks only as of the date on which it is made. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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.
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| Dated: February 5, 2024 | | 2seventy bio, Inc. |
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| | By: | /s/ Chip Baird |
| | | Chip Baird |
| | | Chief Operating Officer |
| | | (Principal Financial and Accounting Officer) |
