Item 8.01 Other Events.
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The Phase 1 dose escalation portion of the Company's ongoing Phase 1/2 clinical trials of INZ-701 for the treatment of ENPP1 Deficiency and for the treatment of ABCC6 Deficiency has each been fully enrolled. The Phase 2 extension portion of each trial is also ongoing.
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The Company plans to report topline data from both of the ongoing Phase 1/2 clinical trials in ENPP1 Deficiency and ABCC6 Deficiency in the first quarter of 2023.
Forward-Looking Statements
Statements in this Current Report on Form 8-K about future expectations, plans,
and prospects, as well as any other statements regarding matters that are not
historical facts, may constitute "forward-looking statements" within the meaning
of The Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements regarding the availability of
clinical trial data. The words "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "plan," "potential," "predict,"
"project," "should," "target," "will," "would" and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. 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 conduct its
ongoing Phase 1/2 clinical trials of INZ-701 for ENPP1 Deficiency and ABCC6
Deficiency; obtain and maintain necessary approvals from the FDA and other
regulatory authorities; continue to advance its product candidates in
preclinical studies and clinical trials; replicate in later clinical trials
positive results found in preclinical studies and early-stage clinical trials of
its product candidates; advance the development of its product candidates under
the timelines it anticipates in planned and future clinical trials; obtain,
maintain and protect intellectual property rights related to its product
candidates; manage expenses; and raise the substantial additional capital needed
to achieve its business objectives. 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 in the Company's most recent Annual
Report on Form 10-K filed with the
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