ENGLEWOOD, Colo., Nov. 10, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunomodulatory therapies
for common inflammatory conditions, today reported results for the
three- and nine-month periods ended September 30, 2021 and provided a corporate
overview and business update.
Ms. Holli Cherevka, President and
Chief Operating Officer, commented, "This quarter marked an
exciting period of growth for drug development in the Ampion
platform therapy, both in clinical and preclinical development.
We have locked the osteoarthritis Phase 3 pivotal trial
database, and are currently analyzing the data, which may provide a
significant treatment option for an unmet medical need in severely
disabled patients.
We have commenced the enrollment and treatment of COVID-19
patients in India for the Phase 2
AP-019 study utilizing inhaled Ampion therapy compared to
control.
Furthermore, we continue to investigate Ampion's potential in
new indications within the preclinical space, most recently
publishing data supportive of application in acute kidney injury,
and in the autoimmune space relating to lupus nephritis. This early
data suggests we may still be just scratching the surface of
Ampion's potential."
Ms. Holli Cherevka, President and
Chief Operating Officer, Howard
Levy, M.B.B.Ch., Ph.D., M.M.M., Chief Medical Officer, David
Bar-Or, MD, Director and Founder, 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 clinical and
preclinical updates, as well as the financial results for the three
and nine-month period ended September 30,
2021.
SEPTEMBER 30, 2021 FINANCIAL
RESULTS
Cash and cash equivalents totaled $17.1
million as of September 30,
2021, compared to $17.3
million on December 31, 2020.
The decrease of $0.2 million, or 1%,
is primarily attributable to cash required to fund the operating
activities of $10.4 million;
partially offset by net proceeds received from the utilization of
the at-the-market equity offering program and stock option /
warrant exercises of $10.0 million
and $0.2 million, respectively.
|
QTD
|
YTD
|
Description
|
2021
|
2020
|
% Change
|
2021
|
2020
|
% Change
|
Operating
Expenses
|
$
3,851,000
|
$
3,302,000
|
17%
|
$
11,343,000
|
$
11,923,000
|
-5%
|
Net Loss
|
$
3,628,000
|
$
3,368,000
|
8%
|
$
10,851,000
|
$
11,277,000
|
-4%
|
Net Loss per
share
(diluted)
|
$
0.02
|
$
0.02
|
0%
|
$
0.06
|
$
0.07
|
-0.14%
|
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
|
$
2,594,000
|
$
1,655,000
|
57%
|
$
7,163,000
|
$
7,027,000
|
2%
|
G&A
|
$
1,257,000
|
$
1,647,000
|
-24%
|
$
4,180,000
|
$
4,896,000
|
-15%
|
Total Operating
Expenses
|
$
3,851,000
|
$
3,302,000
|
17%
|
$
11,343,000
|
$
11,923,000
|
-5%
|
Research and Development Expenses: R&D expenses for
the three months ended September 30,
2021 increased by $0.9
million, or 57%, from R&D expenses for the three months
ended September 30, 2020. The
increase was primarily attributable to costs associated with the
continuation of the Phase I / II COVID studies and outsourced CRO
efforts focused on finalizing the validation and quality review of
the AP-013 study database.
R&D expenses for the nine months ended September 30, 2021 increased by $0.1 million, or 2%, from R&D expenses for
the nine months ended September 30,
2020. The net increase was primarily attributable to an
overall increase in pre-clinical research and production of
clinical trial product totaling $ 0.8
million. These increases were partially offset by a decrease
in clinical trial and sponsored research expenses during the
current period of $0.5 million,
attributable to the pause of the AP-013 study in April 2020, which was partially offset by the
incremental costs associated with the validation and quality review
of AP-013 database and incremental costs associated with the Phase
I / II COVID-19 studies conducted during the current period.
General and Administrative Expenses: G&A expenses for
the three months ended September 30,
2021, decreased by approximately $0.4
million, or 24%, from G&A expenses for the three months
ended September 30, 2020. G&A
expenses for the nine months ended September
30, 2021, decreased by approximately $0.7 million, or 15%, from G&A expenses for
the nine months ended September 30,
2020. The decrease for both periods was primarily
attributable to a decrease in litigation-related legal costs and
commercial insurance costs.
The total shares of common stock outstanding were 200,458,263 on
September 30, 2021, compared to
193,378,996 on December 31, 2020.
Financial Guidance
Based on its current projection 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 its
business operations through the first quarter of 2023.
Conference Call & Webcast:
Wednesday, November 10, 2021,
4:30 pm EDT / 2:30 pm MT
Webcast
Link: https://event.on24.com/wcc/r/3499388/60A0DA16A47D6B146B1AA111CA73357E
Conference Call (listen only):
Canada dial-in number
(Toll Free): 1 833 950 0062
Canada
dial-in number (Local): 1 226 828 7575
United
States: 1 844 200 6205
United
States (Local): 1 646 904 5544
All
other locations: +1 929 526 1599
Access
code: 385971
In order to submit questions, participants must have internet
connectivity, as questions will only be addressed via the
webcast. The conference call line will be in listen only
mode.
The conference call and webcast can also be accessed from the
Investor 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 common 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 common 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 from 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)
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
17,118,000
|
|
$
|
17,346,000
|
Prepaid expenses and
other
|
|
|
1,850,000
|
|
|
1,147,000
|
Total current
assets
|
|
|
18,968,000
|
|
|
18,493,000
|
|
|
|
|
|
|
|
Fixed assets,
net
|
|
|
2,827,000
|
|
|
3,561,000
|
Right-of-use
asset
|
|
|
679,000
|
|
|
824,000
|
Total
assets
|
|
$
|
22,474,000
|
|
$
|
22,878,000
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts payable and
accrued expenses
|
|
$
|
2,083,000
|
|
$
|
1,550,000
|
Lease liability-current
portion
|
|
|
304,000
|
|
|
284,000
|
Total current
liabilities
|
|
|
2,387,000
|
|
|
1,834,000
|
|
|
|
|
|
|
|
Lease
liability-long-term
|
|
|
694,000
|
|
|
925,000
|
Warrant derivative
liability
|
|
|
2,118,000
|
|
|
2,607,000
|
Total
liabilities
|
|
|
5,199,000
|
|
|
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 - 200,458,263 as of September 30, 2021 and
193,378,996 as of December 31, 2020
|
|
|
20,000
|
|
|
19,000
|
Additional paid-in
capital
|
|
|
228,633,000
|
|
|
218,020,000
|
Accumulated
deficit
|
|
|
(211,378,000)
|
|
|
(200,527,000)
|
Total stockholders'
equity
|
|
|
17,275,000
|
|
|
17,512,000
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
22,474,000
|
|
$
|
22,878,000
|
AMPIO
PHARMACEUTICALS, INC.
Condensed
Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
2,594,000
|
|
$
|
1,655,000
|
|
$
|
7,163,000
|
|
$
|
7,027,000
|
|
General and
administrative
|
|
|
1,257,000
|
|
|
1,647,000
|
|
|
4,180,000
|
|
|
4,896,000
|
|
Total operating
expenses
|
|
|
3,851,000
|
|
|
3,302,000
|
|
|
11,343,000
|
|
|
11,923,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
1,000
|
|
|
—
|
|
|
3,000
|
|
|
12,000
|
|
Paycheck Protection
Program loan forgiveness
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
544,000
|
|
Derivative
gain
|
|
|
222,000
|
|
|
7,000
|
|
|
489,000
|
|
|
163,000
|
|
Loss on disposal of
fixed asset
|
|
|
—
|
|
|
(73,000)
|
|
|
—
|
|
|
(73,000)
|
|
Total other income
(expense)
|
|
|
223,000
|
|
|
(66,000)
|
|
|
492,000
|
|
|
646,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,628,000)
|
|
$
|
(3,368,000)
|
|
$
|
(10,851,000)
|
|
$
|
(11,277,000)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.02)
|
|
$
|
(0.02)
|
|
$
|
(0.05)
|
|
$
|
(0.07)
|
|
Diluted
|
|
$
|
(0.02)
|
|
$
|
(0.02)
|
|
$
|
(0.06)
|
|
$
|
(0.07)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
200,419,371
|
|
|
178,622,349
|
|
|
197,347,030
|
|
|
168,061,672
|
|
Diluted
|
|
|
201,563,122
|
|
|
178,622,349
|
|
|
198,576,052
|
|
|
168,551,972
|
|
Company Contacts
Investor Relations
Daniel G Stokely, CPA
dstokely@ampiopharma.com
(720) 437-6500
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SOURCE Ampio Pharmaceuticals, Inc.