Item 7.01 Regulation FD Disclosure
On
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. Such
forward-looking statements include, but are not limited to, those regarding the
plans for presentation of data from IGNITE DMD and other statements containing
the words "anticipate," "believe," "continue," "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "predict," "project," "should," "target,"
"would," "working," and similar expressions. 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. These risks and uncertainties include, but are not
limited to, risks associated with the Company's ability to resume and/or
continue IGNITE DMD on the timeline expected or at all, obtain and maintain
necessary approvals from the FDA and other regulatory authorities, obtain and
maintain the necessary approvals from investigational review boards at IGNITE
DMD clinical trial sites and the IGNITE DMD data safety monitoring board, enroll
patients in IGNITE DMD, continue to advance SGT-001 in clinical trials,
replicate in clinical trials positive results found in preclinical studies and
earlier stages of clinical development, advance the development of its product
candidates under the timelines it anticipates in current and future clinical
trials, successfully optimize and scale its manufacturing process, obtain,
maintain or protect intellectual property rights related to its product
candidates, compete successfully with other companies that are seeking to
develop Duchenne treatments and gene therapies, manage expenses, and raise the
substantial additional capital needed, on the timeline necessary, to continue
development of SGT-001, achieve its other business objectives and continue as a
going concern. For a discussion of other risks and uncertainties, and other
important factors, any of which could cause the Company's actual results to
differ from those contained in the forward-looking statements, see the "Risk
Factors" section, as well as discussions of potential risks, uncertainties and
other important factors, in the Company's most recent filings with the
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