Item 2.02 Results of Operations and Financial Condition
On
The estimated cash and investments figure is preliminary and unaudited,
represents management's estimate as of the date of this report is subject to
completion of the Company's financial closing procedures for the fourth quarter
and fiscal year ended
The information provided under Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) 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 a filing.
Item 8.01 Other Events
On
SGT-001
Following implementation of its updated risk mitigation strategy, the Company
dosed a ninth patient in its ongoing IGNITE DMD Phase I/II clinical trial for
SGT-001 in
SGT-003
At the conference, the Company will present additional preclinical data on SGT-003, the Company's next-generation Duchenne gene therapy program, demonstrating increased protein expression and more targeted biodistribution compared to AAV9. The Company intends to initiate IND-enabling studies for SGT-003 in 2022 to support a planned IND submission in early 2023.
Platform Technologies
At the conference, the Company will introduce and present data on development programs for two of its Platform Technologies, Novel Capsids and Dual Gene Expression. These programs are part of the Company's ongoing research efforts to develop innovative technologies that it believes may hold potential to translate into meaningful treatments and drive the Company's future pipeline expansion.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits:
99.1 Press Release, datedJanuary 10, 2022 104 Cover Page Interactive Data File (formatted as Inline XBRL)
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 ability of the Company to continue dosing patients in the IGNITE DMD trial, the Company's plans to present data from IGNITE DMD, and the Company's SGT-003 program, including the Company's expectation for filing an IND. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions
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are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such statements are
subject to numerous important factors, risks and uncertainties that may cause
actual events or results to differ materially from current expectations and
beliefs, including but not limited to: risks associated with the Company's
ability to continue IGNITE DMD on the timeline expected or at all, obtain and
maintain necessary approvals from the
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