Item 8.01 Other Events.
As previously announced, Beam Therapeutics Inc. (Beam) was informed on July 29,
2022, via e-mail communication from the U.S. Food and Drug Administration (FDA),
that the BEAM-201 Investigational New Drug (IND) application for the treatment
of relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic
lymphoma had been placed on clinical hold. Beam has now received a formal
clinical hold letter from the FDA dated August 25, 2022 in which the FDA
requested: (i) additional control data from genomic rearrangement assessments;
(ii) further analyses of certain off-target editing experiments; (iii)
additional control data for a cytokine independent growth assay; and (iv) an
updated investigator brochure that includes information regarding any new
nonclinical studies. Beam intends to complete the required studies and submit a
Complete Response in the fourth quarter of 2022.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Investors are
cautioned not to place undue reliance on these forward-looking statements,
including, but not limited to, statements related to Beam's expectations
regarding its ability to respond to the FDA's clinical hold letter on the
BEAM-201 IND and its intentions regarding timing to complete the required
studies and submit a response to the FDA. Each forward-looking statement is
subject to important risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such statement, including,
without limitation, risks and uncertainties related to: Beam's ability to timely
generate data in response to the FDA's clinical hold letter that the FDA finds
to be fully responsive; the outcomes of Beam's discussions with the FDA
regarding the clinical hold; and the other risks and uncertainties identified
under the headings "Risk Factors Summary" and "Risk Factors" in Beam's Annual
Report on Form 10-K for the year ended December 31, 2021, under the heading
"Risk Factors" in Beam's Quarterly Report on Form 10-Q for the quarter ended
June 30, 2022, and in any subsequent filings with the Securities and Exchange
Commission. These forward-looking statements speak only as of the date of this
report. Factors or events that could cause Beam's actual results to differ may
emerge from time to time, and it is not possible for Beam to predict all of
them. Beam undertakes 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.
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