On March 29, 2022 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, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2021 (Press release, Ampio, MAR 29, 2022, View Source [SID1234611147]).

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"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.