Item 8.01 Other Events
On June 15, 2020, Phathom Pharmaceuticals, Inc. (the "Company") announced that
it has randomized the first new patients in each of its two Phase 3 clinical
trials since temporarily pausing new patient randomization in response to the
COVID-19 pandemic.
In March 2020, the Company temporarily paused new patient randomization in its
PHALCON-EE and PHALCON-HP clinical trials. The decision was not based on any
study-related COVID-19 infections or other safety events but rather was in
support of global efforts to combat the spread of the SARS-CoV-2coronavirus.
During the temporary pause, the Company worked closely with sites to ensure
patients who were already enrolled and randomized in the PHALCON-EE and
PHALCON-HP studies could remain safely in the trial with as little disruption as
possible. The Company has not experienced any interruptions to clinical trial
supply, including manufacturing and the overall supply chain.
The Company continues to closely monitor the COVID-19 situation and, at this
time, continues to expect to provide top-line data from the PHALCON-EE and
PHALCON-HP trials in 2021.
Forward Looking Statements
The Company cautions you that statements contained in this report regarding
matters that are not historical facts are forward-looking statements. These
statements are based on the Company's current beliefs and expectations. Such
forward-looking statements include, but are not limited to, statements regarding
the expected availability of vonoprazan to be delivered to clinical trial sites;
and when the Company expects to provide topline data for the Phase 3 clinical
trials of vonoprazan. The inclusion of forward-looking statements should not be
regarded as a representation by the Company that any of its plans will be
achieved. Actual results may differ from those set forth in this report due to
the risks and uncertainties inherent in the Company's business, including,
without limitation: the rate of patient enrollment in PHALCON-EE and PHALCON-HP
which, due to the COVID-19 pandemic, is highly uncertain due to factors outside
the Company's control; potential additional delays in the commencement,
enrollment and completion of clinical trials; patients already enrolled in
PHALCON-EE and PHALCON-HP may not complete the clinical trials or public health
conditions and governmental restrictions may lead the Company to stopping such
trials all together, which may adversely impact its trial results and
development plans; the Company's dependence on third parties in connection with
product manufacturing, research and preclinical and clinical testing; regulatory
developments in the United States and foreign countries; unexpected adverse side
effects or inadequate efficacy of vonoprazan that may limit its development,
regulatory approval and/or commercialization, or may result in recalls or
product liability claims; the Company's ability to obtain and maintain
intellectual property protection for vonoprazan; the Company's ability to comply
with its license agreement with Takeda; the Company's ability to maintain
undisrupted business operations due to the recent spread of the COVID-19
coronavirus, including delaying or otherwise disrupting the Company's clinical
trials, manufacturing and supply chain, and other risks described in the
Company's filings with the Securities and Exchange Commission ("SEC"), including
under the heading "Risk Factors" in the Company's Annual Report on Form 10-K and
any subsequent filings with the SEC. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
hereof, and the Company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date hereof. All
forward-looking statements are qualified in their entirety by this cautionary
statement, which is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
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