ENGLEWOOD, Colo., Jan. 17,
2023 /PRNewswire/ -- Ampio Pharmaceuticals, Inc.
(NYSE American: AMPE) (the "Company") today released the following
letter to stockholders from its Chairman, Kevin Buchi and Chief Executive Officer,
Mike Martino.
Dear Fellow Ampio Stockholders:
2022 was a challenging year for our company. We continue to
receive update requests from individual stockholders. Rather than
responding to those individual requests, we are issuing this letter
to update all stockholders. Going forward, we will provide periodic
updates with our regular quarterly and annual filings with the
SEC.
The following are the relevant updates we can provide at this
time:
- Consistent with prior communications, we have completed
clinical trial reports for all legacy Ampion trials and submitted
those reports to the appropriate agencies for review and ultimate
publication on ClinicalTrials.gov. We have also informed the FDA
that we have discontinued development of Ampion and have withdrawn
the 3 Investigational New Drug (INDs) applications we held:
intra-articular injection for Osteoarthritis, intravenous and
nebulized COVID. These actions conclude all development efforts on
Ampion.
- Also consistent with prior communications, we have continued to
focus on reducing operating costs, including, but not limited to,
reducing personnel expense to correspond to the conclusion of the
development efforts relating to Ampion. We plan to provide an
update in our 2022 Form 10-K regarding our other efforts to reduce
our operating costs and cash burn.
- As communicated in our Form 10-Q for the third quarter 2022,
filed on November 14, 2022, the Ampio
board and management team are focused on a two-pronged approach to
increase stockholder value as part of our strategic alternatives
process, as follows:
- AR-300 is a novel, proprietary (patents pending), small
molecule formulation that has demonstrated promising
anti-inflammatory properties in vitro in preclinical animal studies
and protection of cartilage in preclinical rat meniscal tear
studies. We are currently conducting studies to evaluate the
efficacy of AR-300 in osteoarthritis pain.
If the preclinical data are compelling, we would plan to initially
target clinical development of AR-300 for the treatment of
osteoarthritis of the knee (OAK,) which we continue to believe
represents an attractive market opportunity. Clinical demonstration
of cartilage protection and pain management in the knee could
position AR-300 for administration early in the current OAK
treatment paradigm.
The development of AR-300 to date has been based, in part, on our
extensive drug discovery and clinical development experience during
the development of Ampion for the treatment of OAK. However, AR-300
is not Ampion, it is a new and unique formulation in preclinical
development. Given that, we cannot make assurances about the
success of the ongoing preclinical studies nor provide guidance on
the clinical development program until we have the data from the
studies underway. We expect to have preclinical pain and
chondroprotection results in the first half of 2023.
- Given the risks associated with preclinical drug development,
we continue to opportunistically identify and evaluate strategic
opportunities to acquire or license later stage assets and/or merge
with companies that have those assets. To-date, we have evaluated
more than a dozen such opportunities. However, finding attractive
and affordable assets and/or merger partners has been challenging
due to competition from the high number of companies with failed
clinical trials that are pursuing the same strategy, in addition to
our circumstances regarding our cash balance, the uncertainty
around our continued listing on a major exchange, and the potential
risks associated with ongoing legal and regulatory matters. Again,
we will provide updates in our future SEC filings to the extent
that there are any significant developments.
- In our last Form 10-Q, we disclosed stockholder litigation and
an SEC investigation. We will provide updates on these ongoing
matters in our SEC filings to the extent that there are material
developments. As noted above, the fact that these matters are
pending is an additional challenge to our strategic alternatives
process.
These are the updates we can provide at this time. We expect to
provide additional detail and further updates in our 2022 Form
10-K, which we expect to file at the end of Q1 2023. Until then,
while we know that patience is a difficult ask, we nonetheless do
appreciate any patience and support you can provide as we attempt
to navigate these difficult circumstances.
Best regards,
J. Kevin Buchi
Chairman of the Board
Michael A. Martino
Chief Executive Officer
Caution Regarding Forward-Looking Statements
This letter to Ampio stockholders contains forward-looking
statements concerning possible or anticipated future financial
performance, operations, business activities or plans. These
statements are typically preceded by the words "believes,"
"expects," "anticipates," "intends" or similar expressions. For
these forward-looking statements, we claim the protection of the
safe harbor for forward-looking statements contained in federal
securities laws. Shareholders and the investing public should
understand that these forward-looking statements are subject to
risks and uncertainties which could affect our actual results and
cause actual results to differ materially from those indicated in
the forward-looking statements.
We describe these risks and uncertainties in our Annual Report
on Form 10-K filed with the SEC and subsequently filed Quarterly
Reports on Form 10-Q and Current Reports on Form 8-K. They include,
but are not limited to: AR-300 is a pre-clinical stage formulation
and there is no assurance that AR-300 will demonstrate safety and
efficacy in preclinical studies to support continued development;
we may not be successful in securing a later stage asset or in
completing any transaction as part of our strategic alternatives
process; there can be no assurance that we will continue to meet
all of the requirements for continued listing on the NYSE American
or that our common stock will continue to trade on the NYSE
American; we may be unable to fund our operations and complete
transactions as part of our strategic alternatives process without
additional capital; and we are involved in legal proceedings that
have and likely will adversely affect our financial position and
our pursuit of strategic alternatives.
The forward-looking statements included in the letter to Ampio
stockholders speaks only as of the date hereof. Except as required
by law, we assume no obligation to update or revise these
forward-looking statements for any reason, even if new information
becomes available in the future.
For more information, contact:
Ampio Pharmaceuticals, Inc.
Michael Martino
Chief Executive Officer
mmartino@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.