CARISMA THERAPEUTICS, INC. Item 7.01 - Regulation FD Disclosure.
On
As previously disclosed, the Company entered into the Roche License Agreement in
The milestone payment from Roche will further strengthen the Company's balance sheet as it works toward an additional clinical trial for Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC"), followed by a potential resubmission of a Biologics License Application ("BLA").
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS:
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding any future payments to the Company
pursuant to the Roche License Agreement including any future milestone payments
and royalty payments, the Company's expectation that the payment from Roche will
further strengthen the Company's balance sheet, the Company's expectation that
with the payment from Roche the Company's cash and cash equivalents will be
sufficient to fund its current operating plan into 2024 and the Company's plans
to conduct an additional clinical trial for Vicineum for the treatment of
BCG-unresponsive NMIBC prior to potential resubmission of a BLA for Vicineum,
which are based on the Company's current expectations and inherently involve
significant risks and uncertainties. The Company's actual results could differ
materially from those indicated by such forward-looking statements as a result
of various important factors, including the occurrence of any event, change or
other circumstances that could give rise to the termination of the Roche License
Agreement, the uncertainties inherent in the initiation and conduct of clinical
trials, availability and timing of data from clinical trials, whether results of
early clinical trials or preclinical studies will be indicative of the results
of future trials, the adequacy of any clinical models, uncertainties associated
with regulatory review of clinical trials and applications for marketing
approvals, the risk that the Company may not resume its plans to pursue
regulatory approval for Vicineum, the risk that clinical trials of Vicineum for
the treatment of BCG-unresponsive NMIBC, including the additional clinical trial
required for potential resubmission of the BLA, 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, 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,
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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