ENGLEWOOD, Colo., March 3, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions, today reported annual financial
results for the year ended December 31,
2020 and provided a corporate overview / business
update.
Mr. Michael Macaluso, President
and CEO, noted, "The FDA has recently responded to our requests to
expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by
recommending we conduct a randomized, double-blinded,
placebo-controlled Phase II trial in each. They also
indicated that their recommended trial design for both will allow
for an effective and efficient review of data results, determine
the safety and statistical significance and effectiveness of Ampion
in comparison to Standard of Care, all of which are necessary for
the FDA to objectively determine that the known and potential
benefits of Ampion outweigh the known and potential risks and,
consequently, Ampion may be considered for emergency use
authorization (EUA).
In addition, we have provided a detailed proposal to the FDA in
response to their recent guidance regarding the status of our
Osteoarthritis of the Knee (OAK) Phase III clinical trial, which is
paused as a result of the COVID pandemic. In summary, our
response proposes analysis of the existing data in a reduced level
of patients who had completed the 12-week study regimen for
submission. It is important to note that this response is
part of an ongoing active dialog with the FDA and until the
FDA renders a final decision, this trial data will continue to
remain paused and blinded to ensure clinical trial integrity.
Ampion is a platform biologic and, as such, is agnostic to
whether it is treating a COVID patient or an osteoarthritis auto-
immune condition. Simplified, Ampion directly and effectively
addresses inflammation. Consequently, our ongoing and
continued research and clinical trials may be applicable to a
significant number of additional disease complications, not just
COVID."
Mr. Michael Macaluso, President
and Chief Executive Officer, Dr. David Bar-Or, Director and
Founder, Ms. Holli Cherevka, Chief
Operating Officer and Mr. Daniel
Stokely, Chief Financial Officer will be hosting a
Conference Call for the Investment Community this afternoon
beginning at 4:30 PM ET (see details
below).
The key areas of focus will be as follows:
COVID-19 Platform / Pipeline Overview and Update
- AP-014 (inhaled) and AP-016 (intravenous) clinical trial
update
- Possibility of obtaining an Emergency Use Authorization (EUA)
from the FDA for inhaled and intravenous Ampion
OAK Clinical Trial 2021 Timeline / Update
- Ampio's Osteoarthritis of the Knee (OAK) Phase III trial being
conducted under a Special Protocol Assessment (SPA) with the
FDA
- Ampio harmonizes steps for OAK Phase III trial with the FDA
guidance during the COVID-19 health emergency and submitted an SPA
amendment to the FDA
PASC/Long Hauler and Other Clinical Trial 2021 Timelines /
Updates
- Status of PASC/Long Hauler Study
- Kidney Disease
- Pediatric diseases
Financial Results for Year Ended December 31, 2020
Cash and cash equivalents totaled $17.3
million at December 31, 2020,
compared to $6.5 million at
December 31, 2019. The increase is
attributable to net proceeds received from the utilization of our
at-the-market (ATM) equity offering and warrant exercises totaling
$25.6 million, partially offset by
cash used to fund operating activities of $14.7 million.
Research and development expenditures for the year ended
December 31, 2020 were $9.2 million, compared to $12.6 million for the same period in 2019. The
decrease in research and development expenses for the year ended
December 31, 2020 compared to the
amounts for the same period in 2019 was primarily due to the AP-013
study being temporarily paused in April
2020 as a result of the stay-at-home mandates issued by
state and federal governments in response to the COVID-19 pandemic
and travel restrictions implemented by the Company's contracted
Clinical Research Organization (CRO), partially offset by expenses
associated with the inhaled Ampion safety study, the AP-014
(inhaled Ampion) Phase I study and the AP-016 (intravenous Ampion)
Phase I study, which were all initiated during the 2020 period.
General and administrative expenses for the year ended
December 31, 2020 were $6.7 million, compared to $6.0 million for the same period in 2019. The
increase in general and administrative expenses for the year ended
December 31, 2020 compared with the
same period for 2019 is primarily due to the increase in directors
and officer's insurance premiums, which was consistent with the
overall market for coverage, and an increase in stock-based
compensation expense as a result of the issuance and repricing of
stock options.
Other expense was negligible for the year ended December 31, 2020 compared to other income of
$5.0 million for the same period in
2019. In fiscal 2019, a derivative gain was recorded from
previously issued investor warrants as a result of (i) the current
year exercise of investor warrants and (ii) the overall increase in
the price of the Company's stock at December
31, 2020. This was partially offset by the income recognized
in the current year from the Payroll Protection Funding Program,
whereby the Company believes it is probable that the loan will be
forgiven by the Small Business Administration as the loan has
already been forgiven by the Company's lending institution.
Net loss for the year ended December 31,
2020 was $15.9 million, or
$0.09 on a fully diluted per share
basis, compared to a net loss of $13.6
million, or $0.14 on a fully
diluted per share basis, for the same period in 2019. The higher
net loss reported for the year ended December 31, 2020 compared to the same period for
2019 is primarily attributable to a reduction in other income as a
result of the recognition of a derivative loss on previously issued
investor warrants, partially offset by a reduction in clinical
trial and related costs as a result of pausing the AP-013 study in
early 2020 due to the COVID-19 pandemic.
The total shares of common stock outstanding were 193,378,996 at
December 31, 2020, compared to
158,644,757 at December 31, 2019.
Financial Guidance
Based on its current operating plans and expected access to
equity financing, Ampio expects to have cash and access to external
sources of liquidity sufficient to fund research and development
programs and operations through the first quarter of 2022.
Conference Call and Webcast
Ampio will host a conference call today at 4:30pm EST (1:30 pm
PST) to discuss these 2020 annual results and provide a
corporate business update.
The live call / webcast may be accessed as follows:
Domestic:
|
888-506-0062 Conference ID # 441054
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|
International:
|
973-528-0011 Conference ID # 441054
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Webcast
Link:
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https://www.webcaster4.com/Webcast/Page/2569/39961
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The conference call will also be available from the Investors
Relations section of the Company's website at www.ampiopharma.com
and will be archived there shortly after the live event.
Receipt of Audit Opinion with Going Concern
Qualification
Pursuant to the disclosure requirements of the NYSE American
Company Guidelines Sections 401(h) and 610(b), Ampio is reporting
that its audited financial statements for the fiscal year ended
December 31, 2020, included in
Ampio's Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 3, 2021,
contains an audit opinion from its independent registered public
accounting firm that includes an explanatory paragraph related to
Ampio's ability to continue as a going concern. 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,
2020.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage
biopharmaceutical company primarily focused on the development of
Ampion, our product candidate, to treat prevalent inflammatory
conditions for which there are limited treatment options. Ampio's
lead drug, Ampion, is backed by an extensive patent portfolio with
intellectual property protection extending through 2035 and will be
eligible for 12-year FDA market exclusivity upon approval as a
novel biologic under the Biologics Price Competition and Innovation
Act of 2009 (BPCIA).
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
ability to fund research and development programs and operations
into 2022, expectations with respect to Ampion, including its
ability to treat prevalent inflammatory conditions for which there
are limited treatment options, the term of Ampio's patent
protection and the timing and likelihood of Ampion's approval as a
novel biologic under the BPCIA, including the availability of
12-year FDA market exclusivity in connection with such approval.
These forward-looking statements are made on the basis of the
current beliefs, expectations, and assumptions of the management of
Ampio and are subject to significant risks and uncertainties that
could cause actual results to differ materially from what may be
expressed or implied in these forward-looking statements. 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, in 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.
Ampio
Pharmaceuticals, Inc.
|
Balance
Sheets
|
|
|
December 31,
|
|
December 31,
|
|
2020
|
|
2019
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
17,346,000
|
|
$
|
6,532,000
|
Prepaid expenses and
other
|
|
1,147,000
|
|
|
1,718,000
|
Total current
assets
|
|
18,493,000
|
|
|
8,250,000
|
|
|
|
|
|
|
Fixed assets,
net
|
|
3,561,000
|
|
|
4,748,000
|
Right-of-use
asset
|
|
824,000
|
|
|
1,003,000
|
Total
assets
|
$
|
22,878,000
|
|
$
|
14,001,000
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
$
|
1,550,000
|
|
$
|
4,025,000
|
Lease liability-current
portion
|
|
284,000
|
|
|
259,000
|
Total current
liabilities
|
|
1,834,000
|
|
|
4,284,000
|
|
|
|
|
|
|
Lease
liability-long-term
|
|
925,000
|
|
|
1,210,000
|
Warrant derivative
liability
|
|
2,607,000
|
|
|
2,064,000
|
Total
liabilities
|
|
5,366,000
|
|
|
7,558,000
|
|
|
|
|
|
|
Commitments and
contingencies (Note 8)
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Preferred Stock, par
value $0.0001; 10,000,000 shares authorized; none issued
|
|
—
|
|
|
—
|
Common Stock, par value
$0.0001; 300,000,000 shares authorized; shares issued and
outstanding - 193,378,996 as of December 31, 2020 and
158,644,757 as of December 31, 2019
|
|
19,000
|
|
|
16,000
|
Additional paid-in
capital
|
|
218,020,000
|
|
|
191,060,000
|
Accumulated
deficit
|
|
(200,527,000)
|
|
|
(184,633,000)
|
Total stockholders'
equity
|
|
17,512,000
|
|
|
6,443,000
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
22,878,000
|
|
$
|
14,001,000
|
Ampio
Pharmaceuticals, Inc.
|
Statements of
Operations
|
|
|
|
Year Ended
December 31,
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
Research and
development
|
|
$
|
9,172,000
|
|
$
|
12,622,000
|
General and
administrative
|
|
|
6,662,000
|
|
|
5,954,000
|
Total operating
expenses
|
|
|
15,834,000
|
|
|
18,576,000
|
|
|
|
|
|
|
|
Other (expense)
income
|
|
|
|
|
|
|
Interest
income
|
|
|
12,000
|
|
|
77,000
|
Paycheck Protection
Program funding
|
|
|
544,000
|
|
|
—
|
Derivative (loss)
gain
|
|
|
(543,000)
|
|
|
4,869,000
|
Loss on disposal of
fixed asset
|
|
|
(73,000)
|
|
|
—
|
Total other (expense)
income
|
|
|
(60,000)
|
|
|
4,946,000
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(15,894,000)
|
|
$
|
(13,630,000)
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.09)
|
|
$
|
(0.10)
|
Diluted
|
|
$
|
(0.09)
|
|
$
|
(0.14)
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding:
|
|
|
|
|
|
|
Basic
|
|
|
172,846,773
|
|
|
130,601,500
|
Diluted
|
|
|
172,846,773
|
|
|
131,135,178
|
Company Contacts
Investor Relations
Joe
Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.