ENGLEWOOD, Colo., May 5, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions for which there are limited
treatment options, today reported quarterly financial results for
the first quarter period ended March 31,
2021, and provided a corporate overview and business
update.
Mr. Michael Macaluso, President
and Chief Executive Officer, commented, "This has been an important
quarter for Ampio, with noted progress across our therapeutic
platform. For example, the FDA has recently responded to our plans
for the AP-013 Phase III trial for the intra-articular injection of
Ampion for patients suffering from severe osteoarthritis of the
knee (OAK). The response not only provides us with flexibility for
maintaining the Special Protocol Assessment (SPA) but, in addition,
allows us to consider several alternative paths forward to an
optimal solution that may include strategic discussions with
potential partners for the commercialization, and expansion of
osteoarthritis indications, of Ampion."
"We were also encouraged with the results of the AP-014 Phase I
clinical trial of inhaled Ampion for COVID-19 patients. The study
met its primary endpoint of safety and tolerability, and a 78%
reduction in all-cause mortality was observed for patients treated
with Ampion compared to Standard of Care (SOC). Approximately 24%
of the patients receiving SOC alone died during the study, compared
with 5% treated with Ampion."
"Our results from the AP-014 trial are strong and compelling,"
continued Macaluso, "and we look forward to promptly enrolling
patients in a set of double-blind, placebo-controlled Phase II
trials utilizing Ampion in COVID-19 patients with inhalation and
intravenous routes of drug delivery. We will be looking for
confirmation of the efficacy results seen in our Phase I trial in
order to move quickly in applying for Emergency Use
Authorization."
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) Phase I clinical trial of Ampion met its
primary endpoint, and demonstrated improvement in all-cause
mortality
- Double-blind, placebo-controlled Phase II trials utilizing (i)
inhaled Ampion for patients impacted from COVID-19 induced
respiratory distress and (ii) intravenously delivered Ampion for
COVID-19 patients, will begin enrollment in the U.S. during the
second quarter of 2021
OAK Clinical Trial 2021 Timeline / Update
- Positive FDA response provides guidance on multiple pathways
forward on paused AP-013 Phase III trial in osteoarthritis of the
knee (OAK)
Long-COVID and Other Clinical Trial 2021 Timeline /
Update
- Phase I Long-COVID trial is expected to commence enrolling
patients in the U.S. during the second quarter of 2021
Update on Other Pre-Clinical Research Programs
- Results of pre-clinical study demonstrated that Ampion inhibits
pro-inflammatory pathway in types of immune cells implicated in
COVID-19 and Lupus Nephritis
- Ampion shown to suppress TRL7
signaling, and thereby, reducing the pro-inflammatory chemokine,
CXCL10
Financial Results for the First Quarter Period Ended
March 31, 2021
Cash and cash equivalents totaled $15.8
million at March 31, 2021,
compared to $17.3 million at
December 31, 2020. The decrease of
$1.5 million is primarily
attributable cash used to fund the operating activities for the
period of $4.1 million; partially
offset by net proceeds received from the utilization of our
at-the-market (ATM) equity offering and warrant exercises totaling
$2.6 million and $0.1 million, respectively.
Research and development expenditures for the first quarter
period ended March 31, 2021 were
$2.3 million, compared to
$4.3 million for the same period in
2020. The decrease in research and development expenses of
$2.0 million, or 46%, for the first quarter period ended
March 31, 2021 compared to the
amounts for the same period in 2020 was primarily due to the
overall decrease in clinical trial and sponsor research related
expenses related to the AP-013 study being temporarily paused in
April 2020 and continuing through
current as a result of the COVID-19 pandemic. The pause of
this study resulted in a reduction of expenses totaling
$2.4 million which was partially
offset by $0.2 million of expenses
associated with the AP-014 (inhaled Ampion) and AP-017 (intravenous
Ampion) Phase I studies; both of which were initiated in periods
subsequent to March 31, 2020.
General and administrative expenses for the first quarter period
ended March 31, 2021 were
$1.5 million, compared to
$1.8 million for the same period in
2020. The decrease in general and administrative expenses for the
first quarter period ended March 31,
2021 compared with the same period for 2020 is primarily due
to the decrease in professional fees as a result of the decrease in
legal costs which is primarily attributable to both the securities
class action and derivative cases being closed in the third quarter
of 2020.
Other income was $0.2 million for
the first quarter period ended March 31,
2021 compared to other income of $0.8
million for the same period in 2020. For the first quarter
period ended March 31, 2021 the other
income relates directly to the warrant derivative gain recorded for
the investor warrants as a result of the warrant exercises during
the period which reduced the liability and was partially offset by
the increase in stock price of 6.3% during the period. The
derivative gain of $0.8 million
recorded for the 2020 period related to the reduction of the
derivative liability resulting from the 28.2% reduction of stock
price during the period.
Net loss for the first quarter period ended March 31, 2021 was $3.7
million, or $0.02 on a fully
diluted per share basis, compared to a net loss of $5.2 million, or $0.04 on a fully diluted per share basis, for the
same period in 2020. The lower net loss reported for the first
quarter period ended March 31, 2021
compared to the same period for 2020 is primarily attributable to a
reduction in clinical trial and sponsor related research expenses
of $2.4 million as a result of
pausing the AP-013 study in early 2020 due to the COVID-19
pandemic; partially offset by the higher reported derivative gain
resulting from the reduction of the derivative liability associated
with the unexercised investor warrants.
The total shares of common stock outstanding were 195,689,128 at
March 31, 2021, compared to
193,378,996 at December 31, 2020.
Financial Guidance
Based on its current operating plans and expected access to
equity financing, Ampio expects to have cash and cash equivalents
along with access to external sources of liquidity sufficient to
fund research and development programs and business operations
through the second 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 first quarter 2021 results and provide
a corporate business update.
The live call /
webcast may be accessed as follows:
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Domestic:
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888-506-0062
Conference ID # 268913
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International:
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973-528-0011
Conference ID # 268913
|
Webcast
Link:
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https://www.webcaster4.com/Webcast/Page/2569/40836
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A replay of 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.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage
biopharmaceutical company primarily focused on the advancement of
immunology-based therapies for 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 "could,"
"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 significance of
reported results in early clinical trials, the timing of patient
enrollment for the Phase I Long-COVID trial and the Phase II COVID
trials, the timing and outcome of the Company's application for
Emergency Use Authorization of Ampion in COVID-19 patients with
inhalation and intravenous routes of drug delivery, 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. Condensed Balance
Sheets (unaudited)
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|
|
|
|
|
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March
31,
|
|
December 31,
|
|
|
2021
|
|
2020
|
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|
|
|
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Assets
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|
|
|
|
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Current
assets
|
|
|
|
|
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Cash and cash
equivalents
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$
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15,804,000
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|
$
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17,346,000
|
Prepaid expenses and
other
|
|
|
1,798,000
|
|
|
1,147,000
|
Total current
assets
|
|
|
17,602,000
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|
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18,493,000
|
|
|
|
|
|
|
|
Fixed assets,
net
|
|
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3,348,000
|
|
|
3,561,000
|
Right-of-use
asset
|
|
|
776,000
|
|
|
824,000
|
Total
assets
|
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$
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21,726,000
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|
$
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22,878,000
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|
|
|
|
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Liabilities and
Stockholders' Equity
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|
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Current
liabilities
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|
|
|
|
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Accounts payable and
accrued expenses
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|
$
|
1,351,000
|
|
$
|
1,550,000
|
Lease liability-current
portion
|
|
|
291,000
|
|
|
284,000
|
Total current
liabilities
|
|
|
1,642,000
|
|
|
1,834,000
|
|
|
|
|
|
|
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Lease
liability-long-term
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|
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851,000
|
|
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925,000
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Warrant derivative
liability
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|
|
2,456,000
|
|
|
2,607,000
|
Total
liabilities
|
|
|
4,949,000
|
|
|
5,366,000
|
|
|
|
|
|
|
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Commitments and
contingencies (Note 7)
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Stockholders'
equity
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Preferred Stock, par
value $0.0001; 10,000,000 shares authorized; none issued
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—
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—
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Common Stock, par value
$0.0001; 300,000,000 shares authorized; shares issued and
outstanding – 195,689,128 as of March 31, 2021 and 193,378,996 as
of December 31, 2020
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19,000
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|
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19,000
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Additional paid-in
capital
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|
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220,952,000
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|
218,020,000
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Accumulated
deficit
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(204,194,000)
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(200,527,000)
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Total stockholders'
equity
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|
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16,777,000
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|
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17,512,000
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|
|
|
|
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Total liabilities and
stockholders' equity
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$
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21,726,000
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$
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22,878,000
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Ampio
Pharmaceuticals, Inc. Condensed Statements of
Operations (unaudited)
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Three Months Ended
March 31,
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2021
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2020
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Operating
expenses
|
|
|
|
|
|
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Research and
development
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$
|
2,296,000
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|
$
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4,254,000
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General and
administrative
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1,523,000
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|
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1,767,000
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|
Total operating
expenses
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|
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3,819,000
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|
|
6,021,000
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|
|
|
|
|
|
|
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Other
income
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|
|
|
|
|
|
|
Interest
income
|
|
|
1,000
|
|
|
11,000
|
|
Derivative
gain
|
|
|
151,000
|
|
|
831,000
|
|
Total other
income
|
|
|
152,000
|
|
|
842,000
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|
|
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Net loss
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$
|
(3,667,000)
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|
$
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(5,179,000)
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Net loss per common
share:
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Basic
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$
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(0.02)
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$
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(0.03)
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Diluted
|
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$
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(0.02)
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|
$
|
(0.04)
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|
|
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Weighted average
number of common shares outstanding:
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|
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Basic
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|
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195,387,047
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|
|
159,053,722
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Diluted
|
|
|
200,752,267
|
|
|
160,557,777
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|
Company Contact
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.