CARISMA THERAPEUTICS, INC. Item 7.01 - Regulation FD Disclosure.
On
This meeting has been requested as a follow up to the Type C meeting that the
Company held with the FDA on
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 an additional Phase 3 clinical trial
that the Company is evaluating for potential resubmission of a BLA for Vicineum
for the treatment of NMIBC and the Company's plans to continue the process to
review strategic alternatives with the goal of maximizing shareholder value,
which are based on the Company's current expectations and inherently involve
significant risks and uncertainties. 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 request for a Type A meeting may not be granted or that such Type A meeting
may not occur within the anticipated timing, or at all, the risk that the Type A
meeting may not enable the Company to align with the FDA on the remaining
outstanding items related to an additional Phase 3 clinical trial of Vicineum
for the treatment of NMIBC, the risk that the Company may not continue its plans
to conduct an additional Phase 3 clinical trial and pursue regulatory approval
for Vicineum for the treatment of NMIBC in the US, the risk that an additional
Phase 3 clinical trial of Vicineum for the treatment of 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 NMIBC if the Company resubmits the BLA at a future
time, the risk that Vicineum for the treatment of 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, the risk
that the Company may pursue one or more strategic alternatives instead of
pursuing an additional Phase 3 clinical trial and the risk that the Company may
not be successful in identifying one or more strategic alternatives or
ultimately pursuing a strategic alternative that delivers the anticipated
benefits or enhances shareholder value, 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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