CARISMA THERAPEUTICS, INC. Item 7.01 - Regulation FD Disclosure.
On
The Type C Meeting has been scheduled for
The information furnished in this Item 7.01 shall not be deemed to be "filed" for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of such section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding the Company's plans to conduct an
additional Phase 3 clinical trial for potential resubmission of its BLA for
Vicineum and the Company's plans to provide additional information at the time
of the Type C Meeting. The Company's actual results and the timing of events
could differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, including the risk that
the Type C Meeting may not occur within the anticipated timing, or at all, the
risk that the Type C Meeting may not enable the Company align with the FDA on
the protocol for an additional Phase 3 clinical trial of Vicineum for the
treatment of BCG-unresponsive NMIBC, the risk that the Company may not resume
its plans to pursue regulatory approval for Vicineum for the treatment of
BCG-unresponsive NMIBC in the US, the risk that the additional Phase 3 clinical
trial of Vicineum for the treatment of BCG-unresponsive NMIBC may fail to
demonstrate safety and efficacy to the satisfaction of the FDA, or otherwise
produce favorable results, the risk that the FDA may not approve the BLA for
Vicineum for the treatment of BCG-unresponsive NMIBC if the Company resubmits
the BLA at a future time and the risk that Vicineum for the treatment of
BCG-unresponsive NMIBC may cause undesirable side effects, serious adverse
events or have other properties that could delay or halt clinical trials, delay
or prevent its regulatory approval by the FDA, limit the commercial profile of
its labeling, if approved, or result in significant negative consequences
following any marketing approval, among other risks and uncertainties. A further
description of the risks and uncertainties relating to the business of the
Company is contained in the Company's most recent annual report on Form 10-K and
the Company's quarterly reports on Form 10-Q, as well as any amendments thereto
reflected in subsequent filings with the
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