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Entry into a Material Definitive
Agreement.
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Item 7.01.
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Regulation FD Disclosure.
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On April 28, 2022, Ampio
Pharmaceuticals, Inc. (the “Company”) held a conference call at
8:00 a.m. Eastern Time discussing the update from the Food and Drug
Administration with respect to its AP-013 study. The information
provided in that conference call is attached as Exhibit 99.1 hereto
and incorporated herein by reference.
The information in this Form 8-K is furnished under “Item 7.01
Regulation FD Disclosure” and Exhibit 99.1, attached hereto, and
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. It may be
incorporated by reference in a filing under the Exchange Act or the
Securities Act of 1933, as amended, only if such subsequent filing
specifically references such disclosure in this Form 8-K.
Cautionary Note Regarding Forward
Looking Statements
The Company's statements in
this Form 8-K that are not historical fact, and including, but not
limited to, statements that relate to future plans or events or are
conditional in nature, are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by the use of words
such as "believe,"" may", "will", "should", "forecast", "could",
"expect", "suggest", "plan," "believe", "estimate", "continue",
"anticipate"," and "intend", "ongoing", "opportunity", "potential",
"predicts", "seek", "plan,", or similar expressions words. These
forward-looking statements include statements regarding the
Company's expectations and plans with respect to Ampion and its
classification, as well as those associated with regulatory
approvals and other FDA decisions, clinical trials (and FDA's
decisions regarding such trials), results of safety profiles, and
decisions and changes in business conditions and capital
requirements and similar events and the likelihood and timing of
Ampion's approval as a novel biologic under the BPCIA, all of which
are inherently subject to various risks and uncertainties. The
risks and uncertainties involved include those detailed from time
to time in the Company's filings with the Securities and Exchange
Commission, including without limitation, under the Company's
Annual Report on Form 10-K and other documents filed with the
Securities and Exchange Commission. Such risks include, but are not
limited to: our ability to fund our operations, including our
ability to access funding through our "at-the-market" equity
offering or through other equity or debt offerings; our ability to
retain key employees, consultants, and advisors and to attract,
retain and motivate qualified personnel; the progress and results
of clinical trials for Ampion and additional costs or delays
associated such trials, including with respect to AP-013; the
significant competition in the search for a successful treatment
for the novel Coronavirus Disease 2019 ("COVID-19"); our ability to
enroll hospitalized patients in our Phase 1 and 2 trials of Ampion
for the treatment of COVID-19 given the unplanned variability of
the virus, vaccine rates and mutations in the virus in certain
geographies; our ability to receive regulatory approval for and
sell the products that we are developing for the treatment of
COVID-19; our reliance on third parties to conduct our clinical
trials resulting in costs or delays that prevent us from
successfully commercializing Ampion; competition for patients in
conducting clinical trials, delaying product development and
straining our limited financial resources; the risk and costs
associated with our decision to terminate enrollment in the Phase 3
clinical trial for treatment of severe Osteoarthritis of the Knee
due to considerations relating to the COVID-19 pandemic, and the
risk that the data is not accepted by the FDA; our ability to
navigate the regulatory approval process in the U.S. and other
countries, and our success in obtaining required regulatory
approvals for Ampion on a timely basis; commercial developments for
products that compete with Ampion; the actual and perceived
effectiveness of Ampion, and how Ampion compares to competitive
products; adverse effects and the unpredictable nature of the
ongoing COVID-19 pandemic; adverse developments in our research and
development activities; potential liability if any of our product
candidates cause illness, injury or death, or adverse publicity
from any such events; our ability to operate our business
efficiently, manage capital expenditures and costs (including
general and administrative expenses) and obtain financing when
required; and our expectations with respect to future licensing,
partnering or other strategic activities. The Company undertakes no
obligation to revise or update these forward-looking statements,
whether as a result of new information, future events or
otherwise.