Item 7.01 Regulation FD Disclosure.
On
The information under this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished herewith 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 8.01 Other Events.
The Company from time to time presents and/or distributes to the investment
community slide presentations to provide updates and summaries of its business.
On
Statements contained under this Item 8.01, including Exhibit 99.2, regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to: express or implied statements regarding TCR2's expectations for the Phase 1/2 clinical trial of gavo-cel; TCR2's expectations for the safety and efficacy of its product candidates and enhancements, including gavo-cel, TC-510 and TC-520, compared to current T-cell therapy approaches; TCR2'sexpectations regarding the timing of determining an RP2D for gavo-cel, TCR2's expectations regarding the timing of INDs, TCR2's expectations regarding the estimated patient populations and related market opportunities in gavo-cel's, TC-510's and TC-520's targeted indications; TCR2's expectations regarding manufacturing of its product candidates, and TCR2's expectations regarding its product candidate pipeline and business development opportunities.
Any forward-looking statements are based on management's current expectations of
future events and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. Risks that contribute to the
uncertain nature of the forward-looking statements include, without limitation:
uncertainties inherent in clinical studies and in the availability and timing of
data from ongoing clinical studies; whether interim results from a clinical
trial will be predictive of the final results of a trial; the possibility that
positive results from preclinical studies and correlative studies may not
necessarily be predictive of the results of TCR2's planned clinical trials,
including the Phase 1/2 clinical trial of gavo-cel; the risk that the results
from the Phase 1/2 clinical trial of gavo-cel will not support further
development and marketing approval; the risk that TCR2 may be unable to gain
approval of gavo-cel and its other product candidates on a timely basis, if at
all; the risk that TCR2 has over-estimated the potential patient population for
its product candidates, if approved; the risk that the current COVID-19 pandemic
will impact TCR2's clinical trials and other operations; and other risks set
forth under the caption "Risk Factors" in TCR2's most recent Annual Report on
Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with
the
Item 9.01 Financial Statements and Exhibits.
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(d) Exhibits Exhibit No. Description 99.1 Press release issued byTCR2 Therapeutics Inc. onOctober 20, 2021 99.2 Copy ofTCR2 Therapeutics Inc. slide presentation datedOctober 20, 2021 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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