ENGLEWOOD, Colo., March 15, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced their 2017
financial results during a conference call hosted on Wednesday, March 7th at 5:00 pm EST. Included below are highlighted
disclosures from the corporate update and filed Annual report on
Form 10K.
Year End and Fourth Quarter 2017 Highlights
- Pivotal trial, AP-003-C, demonstrated positive results for both
primary and secondary endpoints with Ampion™ treatment in severe
osteoarthritis of the knee (OAK)
-
- Primary endpoint achieved statistical significance when 71% of
Ampion-treated patients met the OARSI responder criteria, which
exceeded the historically based standard control for a meaningful
treatment in severe OAK (p < 0.001).
- Ampion was statistically superior to the historic saline
control group in a composite endpoint of pain and function at 12
weeks (p < 0.001).
- Quality of life measures demonstrated statistically significant
improvement at 12 weeks with Ampion treatment compared to the
historically based standard (p < 0.001).
- Ampion was safe and well tolerated with no drug-related serious
treatment-emergent adverse events (TEAEs).
- The Open Label Extension (OLE) study to support the long-term
continuous use of Ampion with up to five injections a year began
following the completion of pivotal trial AP-003-C.
- Peer-reviewed publication of severely diseased osteoarthritis
of the knee (OAK) patients in Ampion clinical trials, the largest
report of severely diseased patients to date, was published as a
feature article in Orthopedics.
https://doi.org/10.3928/01477447-20171114-05
Management Comments
Michael
Macaluso, Ampio's CEO and chairman of the board, commented,
"We are excited about the positive pivotal trial read-out at the
end of 2017 and look forward to continuing to advance the Ampion
program. The improvements patients recognize in both pain and
function were supported by the safety and tolerability of the
product. With a serious and chronic condition like OAK, safety and
continuous long-term use are critical. We are pleased to report the
continued safety and tolerability of the product following three
injections of Ampion with no drug-related TEAEs or serious TEAEs
reported in the OLE study."
Michael continued, "As a novel biologic, Ampion will be
identified as a 'reference product' upon FDA approval.
Reference products are granted twelve years of exclusivity under
the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not
permitted to approve an application for a biosimilar or
interchangeable product until 12 years after the date of the first
licensure of the reference product. Ampion is also supported by
global patent coverage in all major jurisdictions for
pharmaceutical compositions and methods of treating a range of
conditions. The portfolio includes 125 issued patents and 85
pending patent applications throughout seven primary patent
families having expiration dates that extend to 2035. This patent
coverage and 12 years market exclusivity provide a strong runway
for commercial market entry."
Receipt of Audit Opinion with Going Concern
Qualification
The Company is required under the NYSE MKT
Company Guide Sections 401(h) and 610(b) to publish certain
disclosures. As previously disclosed in its Annual Report on Form
10-K for the fiscal year ended December 31,
2017, which was filed with the Securities and Exchange
Commission on March 6, 2018, the
Company's audited financial statements contained a going concern
explanatory paragraph in the audit opinion from its independent
registered public accounting firm. This announcement does not
represent any change or amendment to the Company's financial
statements or to its Annual Report on Form 10-K for the fiscal year
ended December 31, 2017.
As announced during the March 7,
2018, conference call, the company received an additional
$2.8M in the first two months of 2018
from the exercise of options and warrants. This increased cash on
the balance sheet without any further dilution to our shareholders.
The company has reduced the warrant position from 17.5M outstanding warrants at December 1, 2017, to 7.8M warrants outstanding as of February 28, 2018.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a development stage biopharmaceutical company primarily
focused on the development of therapies to treat prevalent
inflammatory conditions for which there are limited treatment
options. We are developing compounds that decrease inflammation by
(i) inhibiting specific pro-inflammatory compounds by affecting
specific pathways at the protein expression and at the
transcription level; (ii) activating specific phosphatase or
depletion of the available phosphate needed for the inflammation
process; and (iii) decreasing vascular permeability.
Forward-Looking Statements
Ampio's
statements in this press release that are not historical fact, and
that relate to future plans or events, 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," "expect," "plan," "anticipate,"
and similar expressions. These forward-looking statements include
statements regarding Ampio's expectations with respect to Ampion™,
as well as those associated with clinical trials, regulatory
approvals, the ability of Ampio to enter into partnering
arrangements, the Biological License Application (BLA) and
decisions and changes in business conditions and similar events,
all of which are inherently subject to various risks and
uncertainties. The risks and uncertainties involved include
those detailed from time to time in Ampio's filings with the
Securities and Exchange Commission, including without limitation,
under Ampio's Annual Report on Form 10-K and other documents filed
with the Securities and Exchange Commission. Ampio undertakes no
obligation to revise or update these forward-looking statements,
whether as a result of new information, future events or
otherwise.
Company Contact
Tom Chilcott
Chief Financial Officer
Phone: (720) 437-6500
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SOURCE Ampio Pharmaceuticals, Inc.