Cash and Cash Equivalents of $34 Million Expected to Fund Current Operations
into 2H 2023
Company to host Conference Call
Tuesday, March 29, 2022, at
4:30pm EDT
ENGLEWOOD, Colo., March 29,
2022 /PRNewswire/ -- Ampio Pharmaceuticals,
Inc. (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunomodulatory therapies for the
treatment of pain resulting from osteoarthritis in the knee and
potentially other articular joints, today reported financial
results and operational highlights for the fourth quarter and year
ended December 31, 2021.
"We have made significant progress on core objectives, including
the release of positive Phase 3 data and the submission of a Type C
meeting request to the FDA," said Mike Martino, Chairman and
CEO of Ampio. "Additionally, we have secured incremental liquidity
that improves financial strength and is expected to fund current
operations into the second half of 2023. This provides strategic
options as we continue discussions with the FDA and potential
partners. Further, we have strengthened our corporate governance,
compliance, and clinical development expertise through the
expansion of our Board of Directors and appointments of key
leadership positions."
Ampio is pleased to provide recent operational highlights that
are summarized below.
OAK Clinical
Development
- Phase 3 Study, AP-013: The AP-013 study, a Phase 3 trial
designed to evaluate pain and function in patients with the target
condition of severe osteoarthritis of the knee (OAK), was designed
to confirm the efficacy observed in the first pivotal study,
AP-003-A, and support an Ampion Biologics Licensing Application
(BLA). The AP-013 study was found to have been impacted by COVID-19
using a blinded sensitivity analysis. To mitigate this impact, a
modified-intent-to-treat (mITT) population is proposed to evaluate
efficacy in AP-013.
- Analysis of AP-013 Data: AP-013 analysis of the three efficacy
analysis populations demonstrated:
-
- In the mITT population, Ampion demonstrated a statistically
significant reduction in pain (p=0.042) and trended toward
improvement in function versus saline control.
- In the Per Protocol population of AP-013, Ampion demonstrated
statistically significant reduction in pain (p = 0.020) and a
statistically significant improvement in function (p = 0.027)
versus saline control.
- The Intent to Treat population was impacted by a large amount
of missing data and mandated imputation due to COVID-19 and did not
demonstrate statistically significant reduction in pain or
statistically significant improvement in function.
- Type C Meeting with FDA: The FDA has agreed to a written
response to our Type C Meeting request regarding the AP-013 study.
By the end of the first half of this year, the Company expects to
have FDA clarity on whether the AP-013 trial together with AP-003-A
will support an Ampio BLA for the treatment of pain associated with
severe OAK.
COVID-19 Clinical
Development
- AP-017 Intravenous (IV) Treatment for Severe COVID: Study
AP-017 was designed to evaluate IV Ampion treatment in severe
COVID-19 patients in up to 200 patients with an interim analysis at
30 patients for sample size re-estimation. The interim enrollment
and analysis for sample size re-estimation is complete. The
observed safety profile of IV Ampion treatment has been excellent
to date and there will be no sample size adjustment in the study.
However, enrollment has been slow, and the COVID-19 treatment and
regulatory approval landscape has evolved. Therefore, the Company
has stopped further enrollment and will analyze the data completely
to determine next steps for the use of IV Ampion.
- AP-018 Inhaled Treatment for Long-COVID: Study AP-018 was
designed to evaluate inhaled Ampion treatment in 30 patients with
Long-COVID. Enrollment was completed in December 2021, and the Day 60 post-treatment
safety and efficacy measures are currently underway. Once complete,
the data will be prepared for analysis, and the Company will
determine next steps for the program when the analysis has been
completed. Ampio is on track to complete the data analysis by the
end of the second quarter of 2022.
- AP-019 Inhaled Treatment for Severe COVID: Study AP-019 was
designed to evaluate inhaled Ampion treatment in up to 200 severe
COVID-19 patients with an interim analysis for sample size
re-estimation. The interim enrollment was completed with 129
patients in the first quarter of 2022. Ampio is on track to
complete the data analysis by the end of the second quarter of
2022, at which time the Company will determine next steps for the
study.
Expansion of Leadership
- Expansion of Board of Directors: Ampio announced the
appointment of J. Kevin Buchi,
Michael Martino, and Elizabeth Varki Jobes, Esq. to the Ampio
Pharmaceuticals Board of Directors. These appointments expand the
Company's Board of Directors to eight members and prepares the
Company for its next phase.
- Strengthening of Management: Ampio announced the appointment of
Michael Martino as Chairman of the
Board of Directors and Chief Executive Officer. Additionally,
Howard Levy, M.B.B.Ch., Ph.D.,
M.M.M., was appointed as Chief Medical Officer, and Holli Cherevka was promoted to the position of
President and Chief Operating Officer.
Fourth Quarter and Full-Year 2021
Financial Results
- Net Loss: Net loss was $6.2
million for the fourth quarter compared to net loss of
$4.6 million for the fourth quarter
of 2020, and $17.1 million for the
year compared to a loss of $15.9
million for the year ended December
31, 2020. Further details on these variances are below.
- R&D Expenses: Research and development expenses were
$4.7 million for the fourth quarter
compared to $2.1 million for the
fourth quarter of 2020, and $11.9
million for the year compared to $9.2
million for the year ended December
31, 2020. The primary drivers of the year-over-year increase
were incremental costs associated with the COVID-19 Phase 1 and 2
studies which were initiated late in 2020 and during the 2021
period. These costs were partially offset by (i) reduction in costs
associated with the AP-013 study which was paused in the 2020
period.
- G&A Expenses: General and administrative expenses were
$4.5 million for the fourth quarter
compared to $1.8 million for the
fourth quarter of 2020, and $8.7
million for the year compared to $6.7
million for the year ended December
31, 2020. The increase was primarily attributable to (i)
increase in share-based compensation and professional fees for
legal and other advisory services
- Cash position: Cash and cash equivalents on December 31, 2021, totaled $33.9 million, compared to $17.3 million as of December 31, 2020, driven primarily by (i) net
proceeds from the closing of a registered direct offering in
December totaling $20.7 million, and
(ii) net proceeds of $10.0 million
from the sale of common stock with the "at-the-market" equity
offering program throughout the year; partially offset by cash used
in operating activities totaling $14.1
million. Ampio projects its cash position will fund current
operations into 2H 2023.
Further details on Fourth Quarter and Full-Year 2021 Financial
and key variances are included below.
AMPIO
PHARMACEUTICALS, INC.
|
|
|
Balance
Sheets
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
33,892,000
|
|
$
|
17,346,000
|
Prepaid expenses
and other
|
|
|
1,740,000
|
|
|
1,147,000
|
Total
current assets
|
|
|
35,632,000
|
|
|
18,493,000
|
|
|
|
|
|
|
|
Fixed assets,
net
|
|
|
2,564,000
|
|
|
3,561,000
|
Right-of-use
asset, net
|
|
|
629,000
|
|
|
824,000
|
Total assets
|
|
$
|
38,825,000
|
|
$
|
22,878,000
|
|
|
|
|
|
|
|
Liabilities and Stockholders'
Equity
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts payable
and accrued expenses
|
|
$
|
4,811,000
|
|
$
|
1,550,000
|
Lease
liability-current portion
|
|
|
311,000
|
|
|
284,000
|
Total
current liabilities
|
|
|
5,122,000
|
|
|
1,834,000
|
|
|
|
|
|
|
|
Lease
liability-long-term
|
|
|
614,000
|
|
|
925,000
|
Warrant
derivative liability
|
|
|
5,805,000
|
|
|
2,607,000
|
Total
liabilities
|
|
|
11,541,000
|
|
|
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 - 227,325,381 as of December 31, 2021 and
193,378,996 as of
December 31, 2020
|
|
|
23,000
|
|
|
19,000
|
Additional
paid-in capital
|
|
|
244,863,000
|
|
|
218,020,000
|
Accumulated
deficit
|
|
|
(217,602,000)
|
|
|
(200,527,000)
|
Total
stockholders' equity
|
|
|
27,284,000
|
|
|
17,512,000
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
38,825,000
|
|
$
|
22,878,000
|
AMPIO
PHARMACEUTICALS, INC.
|
|
|
Statements of
Operations
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
11,900,000
|
|
$
|
9,172,000
|
|
General and
administrative
|
|
|
8,671,000
|
|
|
6,662,000
|
|
Total operating
expenses
|
|
|
20,571,000
|
|
|
15,834,000
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
Interest
income
|
|
|
4,000
|
|
|
12,000
|
|
Paycheck
Protection Program loan forgiveness
|
|
|
—
|
|
|
544,000
|
|
Derivative gain
(loss)
|
|
|
3,492,000
|
|
|
(543,000)
|
|
Loss on disposal
of fixed asset
|
|
|
—
|
|
|
(73,000)
|
|
Total other income
(expense)
|
|
|
3,496,000
|
|
|
(60,000)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,075,000)
|
|
$
|
(15,894,000)
|
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.09)
|
|
$
|
(0.09)
|
|
Diluted
|
|
$
|
(0.10)
|
|
$
|
(0.09)
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares outstanding:
|
|
|
|
|
|
|
|
Basic
|
|
|
199,299,072
|
|
|
172,846,773
|
|
Diluted
|
|
|
204,963,019
|
|
|
172,846,773
|
|
Conference Call Details
Date/Time: March 29, 2022,
at 4:30 pm EDT
Conferencing Link:
https://event.on24.com/wcc/r/3683372/9CD2C8B658E56541C487F44C34E897BB
Access Code: 66744
Canada dial-in number (Toll
Free): 1 833 950 0062
Canada dial-in number (Local):
1 226 828 7575
US dial-in number (Toll Free): 1
844 200 6205
US dial-in number (Local):
1 646 904 5544
Access code:
931547
*Participants will need to enter the participant access code
before being met by an operator
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.
About Ampio
Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the advancement of immunomodulatory therapies for the
treatment of pain resulting from osteoarthritis in the knee and
potentially other articular joints. Ampio's lead drug, Ampion™, is
backed by an extensive patent portfolio with intellectual property
protection extending through 2037 and may 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 including, but not limited to, statements that relate to
future plans or events or are conditional in nature, 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,"" may", "will", "should", "forecast", "could", "expect",
"suggest", "plan," "believe", "estimate", "continue",
"anticipate"," and "intend", "ongoing", "opportunity", "potential",
"predicts", "seek", "plan,", or similar expressions words. These
forward-looking statements include statements regarding Ampio's
expectations with respect to Ampion and its classification, as
well as those associated with regulatory approvals and other FDA
decisions, clinical trials (and FDA's decisions regarding such
trials), results of safety profiles, and decisions and changes in
business conditions and similar events and the likelihood and
timing of Ampion's approval as a novel biologic under the BPCIA,
the ability of liquidity to support future operations, 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. Such risks include, but are not limited
to: our ability to fund our operations, including our ability to
access funding through our "at-the-market" equity offering or
through other equity or debt offerings; our ability to retain key
employees, consultants, and advisors and to attract, retain and
motivate qualified personnel; the progress and results of clinical
trials for Ampion and additional costs or delays associated
therewith; the significant competition in the search for a
successful treatment for the novel Coronavirus Disease 2019
("COVID-19"); our ability to enroll hospitalized patients in our
Phase 1 and 2 trials of Ampion for the treatment of COVID-19 given
the unplanned variability of the virus, vaccine rates and mutations
in the virus in certain geographies; our ability to receive
regulatory approval for and sell the products that we are
developing for the treatment of COVID-19; our reliance on third
parties to conduct our clinical trials resulting in costs or delays
that prevent us from successfully commercializing Ampion;
competition for patients in conducting clinical trials, delaying
product development and straining our limited financial resources;
the risk and costs associated with our decision to suspend
enrollment in the Phase 3 clinical trial for treatment of severe
Osteoarthritis of the Knee due to considerations relating to the
COVID-19 pandemic, and the possibility that the data generated by
that clinical trial may have been adversely impacted by the
COVID-19 pandemic; our ability to navigate the regulatory approval
process in the U.S. and other countries, and our success in
obtaining required regulatory approvals for Ampion on a timely
basis; commercial developments for products that compete with
Ampion; the actual and perceived effectiveness of Ampion, and how
Ampion compares to competitive products; adverse effects and the
unpredictable nature of the ongoing COVID-19 pandemic; adverse
developments in our research and development activities; potential
liability if any of our product candidates cause illness, injury or
death, or adverse publicity from any such events; our ability to
operate our business efficiently, manage capital expenditures and
costs (including general and administrative expenses) and obtain
financing when required; and our expectations with respect to
future licensing, partnering or other strategic activities. Ampio
undertakes no obligation to revise or update these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor and Media Contacts:
Russo Partners
Tony Russo or Nic Johnson
info@ampiopharma.com
tony.russo@russopartnersllc.com
nic.johnson@russopartnersllc.com
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SOURCE Ampio Pharmaceuticals, Inc.