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Ampio Pharmaceuticals, Inc. Announces Second Quarter 2021 Financial Results and Provides Corporate Update
Further details to be discussed on this afternoon’s conference call
ENGLEWOOD, CO, August 4, 2021 – 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 |
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Ampio Pharmaceuticals, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2021 10-K Annual Report includes:
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Our shelf registration statement, which was declared effective by the SEC in May 2020, provides us with the ability to sell up to an aggregate amount of $100.0 million of shares of common stock, preferred stock, debt securities, warrants and units, or any combination thereof, less any sales from the ATM equity offering program that occurred prior to May 6, 2020, which was the effective date of the shelf registration statement.
General and Administrative General and administrative expenses are summarized as follows: 2021 Quarter Compared to 2020 Quarter General and administrative costs decreased $0.4 million, or 24%, for the 2021 quarter compared to the 2020 quarter.
Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion and SOC, mortality was only 5%, representing an almost 80% improvement.
31 Insurance Insurance expense decreased $79,000, or 23%, for the 2021 quarter compared to the 2020 quarter due primarily to a decrease in our D&O insurance premiums as a result of favorable negotiations with the insurance carriers, which were influenced by the dismissal of the securities class action and derivative cases during the third quarter of 2020.
During the nine months ended September 30, 2021, we sold approximately 6.2 million shares of common stock pursuant to the ATM equity offering program, which yielded gross proceeds of approximately $10.5 million; offset by offering related costs of $0.5 million.
Due to its mode of...Read more
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As an immunomodulatory agent, we...Read more
The biopharmaceutical market, both domestic...Read more
This could lead to impairment...Read more
Elevated levels of inflammatory cytokines...Read more
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As an immunomodulatory agent, with...Read more
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32 During the nine months...Read more
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Stock-based Compensation Stock-based compensation expense...Read more
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2021 Period Compared to 2020...Read more
In May 2020, the shelf...Read more
In late 2020, we announced...Read more
Stock-based Compensation Stock-based compensation expense...Read more
However, during the nine months...Read more
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In March 2020, and most...Read more
Patients treated with Ampion were...Read more
Research and development costs with...Read more
30 Operations / manufacturing Operations...Read more
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Laboratory Laboratory expenses increased $402,000,...Read more
While we believe the studies...Read more
General and administrative costs with...Read more
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Laboratory Laboratory expenses increased $208,000,...Read more
Financial Statements, Disclosures and Schedules
Inside this 10-Q Quarterly Report
Material Contracts, Statements, Certifications & more
Ampio Pharmaceuticals, Inc. provided additional information to their SEC Filing as exhibits
Ticker: AMPE
CIK: 1411906
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-21-015493
Submitted to the SEC: Wed Nov 10 2021 4:13:36 PM EST
Accepted by the SEC: Wed Nov 10 2021
Period: Thursday, September 30, 2021
Industry: Pharmaceutical Preparations