ENGLEWOOD, Colo., April 18,
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 Ampio Stockholders:
On March 28, 2023, we filed our
2022 Annual Report on Form 10-K. In this letter we would like to
elaborate on two key operational points which were included in that
Annual Report.
Firstly, we want to elaborate on progress with the development
of what we have previously called, "AR-300." We gained a
considerable amount of knowledge about osteoarthritis (OA) from the
company's previous clinical and in vitro studies with Ampion. In
January 2022, we began work on
"AR-300," a series of synthetic formulations of what we believed to
be the three active pharmaceutical ingredients (APIs) that were
present at low levels in Ampion.
Our development efforts in the first quarter 2023 have focused
on rigorously testing different formulations of these APIs at an
independent, well-respected research organization, using two
validated, well-published rodent models of OA, which we will
highlight here. The first model, called the medial meniscal tear
(MMT) model, results in pathology that highly resembles the
pathology that occurs with OA in humans, and is the most common
preclinical model used by industry to identify potential therapies
that may inhibit cartilage degeneration associated with OA. The
second model, the mono-iodoacetate (MIA) model, measures the
effects of potential therapies on the pain associated with
progressive stages of OA, and is also the most common preclinical
model used by industry to identify potential therapies to treat the
pain associated with OA.
To-date, we have shown cartilage protection in the MMT model
with multiple combinations of the prospective APIs, with one
formulation generating especially encouraging results.
Additionally, in the MIA model, several alternative formulations
have demonstrated immediate and early pain reduction in the
inflammatory pain phase of the model. The combination of pain
reduction and prevention of cartilage degeneration provides
optimism that we have a drug candidate to treat OA of the knee
(OAK). Of course, we will have to demonstrate these benefits in
clinical trials acceptable to regulators and payers, but we are
encouraged by these results. Additionally, we want to emphasize
that these are results that were never observed with Ampion,
nor with the original formulations of AR-300. These results show
that we are now in possession of new and unique formulations,
separate and distinct from both Ampion and AR-300, that demonstrate
their own therapeutic potential. Because of that, we have already
taken steps to protect this new intellectual property,
worldwide.
Based on this progress, we have focused our ongoing efforts
toward optimizing two potential formulations to take forward into
development. In the third quarter of 2023, we intend to select one
of these optimized formulations to move towards clinical
development. Given that these formulations are unique, proprietary,
and are neither Ampion nor AR-300 (or derivatives thereof), we will
now refer to development of these new formulations as OA-20X
program. With the data from these additional studies, we will be in
position later this year to seek scientific advice meetings with
the FDA, UK, and EU regulatory authorities.
Secondly, we want to elaborate on our progress in implementing a
hybrid, virtual organizational model. From the outset, our intent
was (and remains) to retain the organizational capabilities to
govern a publicly traded company, comply with related reporting
requirements, lead strategy development and program selection, and
identify, retain, and manage third-party contractors with specific
and proven expertise in the different, related activities required
to develop a drug (e.g., drug candidate selection,
formulation development, GMP manufacturing, preclinical
development, clinical development, regulatory, etc.) on a
just-in-time, as needed basis. We believe this model positions us
to drive strategic development in the most expeditious and
cost-effective way.
We communicated, and began implementing, this organizational
strategy at the end of 2022 with a planned reduction in force,
which continued into the first quarter 2023. In addition, we
entered into a sublease agreement effective March 1, 2023, whereby we have subleased the
entire Ampio facility in Colorado.
As a result of implementing this organizational strategy, Ampio now
has five full-time employees, numerous engaged consultants with
industry leading expertise in osteoarthritis (OA) drug development
(as outlined above) and independent labs and contract manufacturing
partners, all collaborating to further the development of the
OA-20x program. We expect to remain a Colorado-based company for the foreseeable
future and for the time being have retained our current mailing
address. We estimate that this strategy will result in annualized
cost savings of approximately $4.6
million, allowing us to focus our cash investment on OA-20x
development for 2023 in addition to our ongoing governance and
reporting obligations as a publicly traded company and other
necessary expenses.
Again, this update elaborates on just two points from our
recently filed Annual Report, and we encourage you to read the full
Annual Report in its entirety because it contains important
information. We look forward to updating you following conclusion
of the third quarter 2023.
Best regards,
J. Kevin Buchi, Chair of the
Board of Directors
Michael A. Martino, Chief Executive
Officer
Caution Regarding Forward-Looking Statements
All statements other than statements of historical facts
contained in this letter, including statements regarding our
anticipated future clinical developments, future financial
position, and plans and objectives of management for future
operations, are forward-looking statements. Words such as "may",
"will", "should", "forecast", "could", "expect", "suggest",
"believe", "estimate", "continue", "anticipate", "intend",
"ongoing", "opportunity", "potential", "predicts", "seek", "plan,"
or similar words, or the negatives of such terms or other
variations on such terms or comparable terminology, typically
identify forward-looking statements.
Forward-looking statements are based on certain assumptions and
expectations of future events and trends that are subject to risks
and uncertainties including: we are dependent on the success of our
OA-20X program and we cannot be certain that any preclinical data
will support its further development; there can be no assurance
that we will be successful in identifying or completing any
strategic alternative or that any such strategic alternative will
yield value for our stockholders; we may not be able to manage
third parties to provide timely, high quality, and cost-effective
services to us; our history of losses and our cash resources
available to execute our business plan over the next twelve months
raise substantial doubt about our ability to continue as a going
concern; we are involved in legal proceedings that likely will
adversely affect our financial position and our pursuit of
strategic alternatives; we may need additional capital to fund our
future operations, the development of the OA-20X program and any
strategic transaction; we are dependent on adequate protection of
our patent and proprietary rights; the price of our stock has been
and may continue to be extremely volatile; if we cannot continue to
satisfy the NYSE American continued listing requirements and rules,
our securities may be delisted, which could negatively impact the
price of our securities; and other risks described in "Risk
Factors" and elsewhere in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2022
and subsequent periodic reports filed with the SEC.
We undertake no obligation to update or revise publicly any
forward-looking statements to reflect events or circumstances after
the date of such statements for any reason, except as otherwise
required by law.
For more information, contact:
Ampio Pharmaceuticals, Inc.
Michael Martino
Chief Executive Officer
mmartino@ampiopharma.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ampio-pharmaceuticals-issues-letter-to-stockholders-301799782.html
SOURCE Ampio Pharmaceuticals, Inc.