ENGLEWOOD, Colo., Aug. 4,
2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (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 results for the second quarter period ended
June 30, 2021, and provided a
corporate overview and business update.
Mr. Michael Macaluso, President
and Chief Executive Officer, commented, "This was an exciting
quarter for Ampio, and I am proud of our accomplishments over the
past three months. We completed our Phase I trial utilizing inhaled
Ampion for COVID-19 patients with respiratory distress, which
showed that Ampion reduced all-cause mortality by 78% over the
Standard of Care. On the basis of those results, during the current
quarter we worked with the Federal Drug Administration (FDA) to
initiate Phase II trials utilizing inhaled Ampion and intravenous
(IV) Ampion for COVID-19 patients with respiratory distress that
may support an Emergency Use Authorization (EUA). We have commenced
enrollment, which we expect to see incrementally increase in the
near term as a result of expanding the inhaled Ampion Phase II
study to India, which had, and is
continuing to experience, a significant wave of serious COVID-19
infections. Additionally, we are exploring the first at-home
inhalation treatment for long COVID patients in a Phase I study
utilizing inhaled Ampion. The study is currently enrolling and
could represent a significant breakthrough in patient care."
"Ampio Pharmaceuticals has joined the Russell 2000® and Russell
3000® Indexes," continued Macaluso, "which I take as a sign that
the market now understands the broad potential of Ampion as a
platform anti-inflammatory treatment for patients with unmet
medical needs."
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 during the call will be as follows:
- Osteoarthritis of the Knee (OAK) Clinical Trial 2021
Timeline / Update
- COVID-19 Platform / Pipeline Overview and Update
- Update on Other Pre-Clinical Research Programs
JUNE 30, 2021, FINANCIAL
RESULTS
Cash and cash equivalents totaled $20.5
million as of June 30, 2021,
compared to $17.3 million on
December 31, 2020. The increase of
$3.2 million, or 18%, is primarily
attributable to net proceeds received from the utilization of our
at-the-market (ATM) equity offering and stock option / warrant
exercises of $9.5 million and
$0.2 million, respectively; partially
offset by cash required to fund the operating activities of
$6.5 million.
|
QTD
|
YTD
|
Description
|
2021
|
2020
|
% Change
|
2021
|
2020
|
% Change
|
Operating
Expenses
|
$
3,673,000
|
$
2,600,000
|
41%
|
$
7,491,000
|
$
8,622,000
|
-13%
|
Net Loss
|
$
(3,556,000)
|
$
(2,731,000)
|
30%
|
$
(7,222,000)
|
$
(7,910,000)
|
-9%
|
Net Loss per share
(diluted)
|
$
(0.02)
|
$
(0.02)
|
0%
|
$
(0.04)
|
$
(0.05)
|
-20%
|
Operating Expenses: Operating expenses consist of
research and development ("R&D") expenses and general and
administrative ("G&A") expenses, both of which are further
explained below.
|
QTD
|
YTD
|
Description
|
2021
|
2020
|
% Change
|
2021
|
2020
|
% Change
|
R&D
|
$
2,273,000
|
$
1,118,000
|
103%
|
$
4,568,000
|
$
5,373,000
|
-15%
|
G&A
|
$
1,400,000
|
$
1,482,000
|
-6%
|
$
2,923,000
|
$
3,249,000
|
-10%
|
Total Operating
Expenses
|
$
3,673,000
|
$
2,600,000
|
41%
|
$
7,491,000
|
$
8,622,000
|
-13%
|
Research and Development Expenses: R&D expenses for
the three months ended June 30, 2021
increased by approximately $1.2
million, or 103%, from R&D expenses for the three months
ended June 30, 2020. The increase was
primarily attributable to costs incurred related to the AP-013
study database contract whereby outsourced efforts were utilized to
ensure the validity and accuracy of the study database prior to
submission to the FDA. The AP-013 study was paused in April 2020. In addition, the Company incurred
costs during the current period related to start-up / launch
related costs for three incremental clinical trials (i.e., AP-017,
AP-018 and AP-019) to study the effects of inhaled / intravenous
Ampion on patients suffering from COVID-19 related issues.
R&D expenses for the six months ended June 30, 2021 decreased by approximately
$0.8 million, or 15%, from R&D
expenses for the six months ended June 30,
2020. The decrease was primarily attributable to an overall
decrease in clinical trial and sponsored research expenses in the
current period of $1.4 million,
attributable to the pause of the AP-013 study in April 2020, which was partially offset by the
incremental costs associated with the AP-013 database costs and
incremental COVID-19 and other research studies in the current
period.
General and Administrative Expenses: G&A expenses for
the three months ended June 30, 2021,
decreased by approximately $0.1
million, or 6%, from G&A expenses for the three months
ended June 30, 2020. G&A expenses
for the six months ended June 30,
2021, decreased by approximately $0.3
million, or 10%, from G&A expenses for the six months
ended June 30, 2020. The decrease for
both periods was primarily attributable to a decrease in
litigation-related legal costs as a result of the dismissal of the
securities class action and derivative cases during the third
quarter 2020.
The total shares of common stock outstanding were 200,070,419 on
June 30, 2021, compared to
193,378,996 on 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 fourth quarter of 2022.
Conference Call and Webcast
Ampio will host a conference call today at 4:30 pm EDT (1:30 pm
PDT) to discuss these second quarter 2021 results and
provide a corporate business update.
The live call / webcast may be accessed as follows:
Domestic: 888-506-0062
Conference ID # 469825
International:
973-528-0011 Conference ID # 469825
Webcast
Link: https://www.webcaster4.com/Webcast/Page/2569/42087
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 biopharmaceutical company
primarily focused on the advancement of immunology-based therapies
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 2037 and will be eligible for 12-year FDA market
exclusivity upon approval as a novel biologic under the Biologics
Price Competition and Innovation Act (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 access equity financing and fund research and
development programs and operations through the fourth quarter of
2022, expectations with respect to Ampion, including its ability to
treat prevalent inflammatory conditions for which there are limited
treatment options (including COVID-19) and its ability to offer the
benefits of steroids without the side effects, 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-19 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 Ampion'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)
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
20,549,000
|
|
$
|
17,346,000
|
Prepaid expenses and
other
|
|
|
2,358,000
|
|
|
1,147,000
|
Total current
assets
|
|
|
22,907,000
|
|
|
18,493,000
|
|
|
|
|
|
|
|
Fixed assets,
net
|
|
|
3,074,000
|
|
|
3,561,000
|
Right-of-use
asset
|
|
|
728,000
|
|
|
824,000
|
Total
assets
|
|
$
|
26,709,000
|
|
$
|
22,878,000
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
|
$
|
2,937,000
|
|
$
|
1,550,000
|
Lease liability-current
portion
|
|
|
298,000
|
|
|
284,000
|
Total current
liabilities
|
|
|
3,235,000
|
|
|
1,834,000
|
|
|
|
|
|
|
|
Lease
liability-long-term
|
|
|
773,000
|
|
|
925,000
|
Warrant derivative
liability
|
|
|
2,340,000
|
|
|
2,607,000
|
Total
liabilities
|
|
|
6,348,000
|
|
|
5,366,000
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note 7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 - 200,070,419 as of June 30, 2021
and 193,378,996 as
of December 31, 2020
|
|
|
20,000
|
|
|
19,000
|
Additional paid-in
capital
|
|
|
228,091,000
|
|
|
218,020,000
|
Accumulated
deficit
|
|
|
(207,750,000)
|
|
|
(200,527,000)
|
Total stockholders'
equity
|
|
|
20,361,000
|
|
|
17,512,000
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
26,709,000
|
|
$
|
22,878,000
|
AMPIO
PHARMACEUTICALS, INC.
Condensed
Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,273,000
|
|
$
|
1,118,000
|
|
$
|
4,568,000
|
|
$
|
5,373,000
|
|
General and
administrative
|
|
|
1,400,000
|
|
|
1,482,000
|
|
|
2,923,000
|
|
|
3,249,000
|
|
Total operating
expenses
|
|
|
3,673,000
|
|
|
2,600,000
|
|
|
7,491,000
|
|
|
8,622,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,000
|
|
|
—
|
|
|
2,000
|
|
|
12,000
|
|
Paycheck Protection
Program loan forgiveness
|
|
|
—
|
|
|
544,000
|
|
|
—
|
|
|
544,000
|
|
Derivative gain
(loss)
|
|
|
116,000
|
|
|
(675,000)
|
|
|
267,000
|
|
|
156,000
|
|
Total other income
(expense)
|
|
|
117,000
|
|
|
(131,000)
|
|
|
269,000
|
|
|
712,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,556,000)
|
|
$
|
(2,731,000)
|
|
$
|
(7,222,000)
|
|
$
|
(7,910,000)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.02)
|
|
$
|
(0.02)
|
|
$
|
(0.04)
|
|
$
|
(0.05)
|
|
Diluted
|
|
$
|
(0.02)
|
|
$
|
(0.02)
|
|
$
|
(0.04)
|
|
$
|
(0.05)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
196,179,371
|
|
|
166,392,893
|
|
|
195,785,398
|
|
|
162,723,309
|
|
Diluted
|
|
|
201,448,038
|
|
|
166,392,893
|
|
|
200,985,349
|
|
|
163,906,257
|
|
Company Contacts
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.