Item 8.01 Other Events.
On
The Company believes that in the
The Company is in active conversations with regulators and anticipates enrolling a global, placebo-controlled Phase 2 clinical trial in vaccinated or unvaccinated participants with mild-to-moderate COVID-19 later this year. As has been stated by other companies in this space, the COVID-19 environment is nuanced and fluid. Consistent with this, the regulatory pathways for authorization and/or approval are anticipated to continue to evolve.
Pending ongoing regulatory discussions and study feasibility, the Company
anticipates generating data from Phase 3 registrational trials in 2023. Should
study results support, the Company expects to file for an emergency use
authorization, if available, while also seeking to generate data to support a
NDA filing in the
The Company announces material information to its investors using filings with
the
About PBI-0451
PBI-0451 is an orally administered direct-acting antiviral that inhibits the coronavirus (CoV) main protease (Mpro), including SARS-CoV-2 that causes COVID-19. Inhibition of Mpro prevents the liberation and assembly of the viral replication complex within infected cells that is required to produce more viral RNA and virions. Safety and pharmacokinetic data from the first-in-human study (Study PBI-0451-0001, NCT 05011812) support that PBI-0451, administered twice daily as a stand-alone agent, has the potential for antiviral activity against SARS-CoV-2.
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Forward Looking Statement
This Current Report on Form 8-K (Current Report) contains statements that relate
to future events and expectations and, as such, constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. When or if used in this Current Report, the words "anticipate," "believe,"
"could," "estimate," "expect," "intend," "may," "ongoing," "outlook," "plan,"
"predict," "should," "will," and similar expressions and their variants, as they
relate to the Company, may identify forward-looking statements. All statements
that reflect the Company's expectations, assumptions or projections about the
future, other than statements of historical fact, are forward-looking
statements, including, without limitation, statements regarding the company's
future financial or business performance, conditions, plans, prospects, trends
or strategies and other financial and business matters; and the planned timing
and conduct of the company's clinical trial programs for its product candidate,
timing for reporting on interim data and preliminary conclusions from on-going
assessments. Forward-looking statements reflect the Company's current beliefs,
expectations, and assumptions regarding the future of its business, its future
plans and strategies, its development plans, its preclinical and clinical
results, future conditions and other factors the Company believes are
appropriate in the circumstances. Although the Company believes the expectations
and assumptions reflected in such forward-looking statements are reasonable, the
Company can give no assurance that they will prove to be correct.
Forward-looking statements are not guarantees of future performance and are
subject to risks, uncertainties and changes in circumstances that are difficult
to predict, which could cause the Company's actual activities and results to
differ materially from those expressed in any forward-looking statement. Such
risks and uncertainties include, but are not limited to: (i) risks and
uncertainties related to the Company's ability to advance, obtain regulatory
approval of and ultimately commercialize its product candidates; (ii) the timing
and results of preclinical studies and clinical trials; (iii) the Company's
ability to maintain financial resources necessary to continue its clinical
trials, fund development goals and fund business operations; (iv) the impact of
the COVID-19 pandemic on the Company's business, clinical trials, financial
condition, liquidity and results of operations; (v) the Company's ability to
protect its intellectual property and (vi) other risks and uncertainties
described under the heading "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended
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