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Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) is a pre-revenue stage biotechnology company based in Greenwood Village, Colorado. The company is focused on developing innovative treatments for osteoarthritis through its OA-201 program. This program aims to develop a unique and proprietary small molecule formulation designed to alleviate pain and protect cartilage in patients suffering from osteoarthritis of the knee (OAK) and potentially other joints.
Recently, Ampio faced significant developments, including a 20-to-1 reverse stock split approved by its Board of Directors to address its stock price and meet NYSE American's listing requirements. The reverse stock split took effect in September 2023. Despite these efforts, Ampio decided to voluntarily delist its common stock from NYSE American and deregister its shares to reduce regulatory costs and conserve cash for future operations.
In the clinical field, Ampio has partnered with Ascendia Pharmaceuticals, Inc. to support the development of OA-201. Ascendia will provide comprehensive services ranging from formulation to cGMP manufacturing. Despite promising initial results, recent non-clinical studies failed to demonstrate significant pain reduction benefits, leading to the termination of the OA-201 program in February 2024.
Ampio has also been involved in legal proceedings, including securities fraud class actions and derivative actions, all of which reached settlements in early 2024. The company anticipates that the settlements will be covered by its D&O insurance policy.
The company recently announced that it will delist its common stock and terminate its reporting obligations under the Securities and Exchange Act of 1934, effective April 2024. This decision aims to preserve cash and facilitate an orderly wind down of operations.
For more information, visit the company's website or contact Ampio Pharmaceuticals directly via email at mmartino@ampiopharma.com.
Ampio Pharmaceuticals, Inc. (AMPE) announced a registered direct offering of 25 million shares and 15 million warrants at $0.90 per share, expected to close on December 15, 2021. The offering, led by A.G.P./Alliance Global Partners, aims to raise approximately $22.5 million, intended for general corporate purposes, including working capital and conducting clinical trials. The warrants will have an exercise price of $1.10 and are exercisable immediately, expiring in five years. The shares will be offered under a previously filed shelf registration statement with the SEC.
Ampio Pharmaceuticals (NYSE American: AMPE) will host a business update call with its chairman and CEO, Mike Martino, on December 1, 2021, at 4:30 p.m. EST. Interested investors and analysts can access the call via the provided webcast link. The call will be in listen-only mode, and questions will be addressed through the webcast. Ampio focuses on immunology-based therapies for inflammatory conditions, aiming to advance its lead drug, Ampion™, which has a patent portfolio extending to 2037 and possible FDA market exclusivity.
Ampio Pharmaceuticals (NYSE American: AMPE) announced a conference call with CEO Michael Martino on December 1, 2021, at 4:30 pm EDT to discuss corporate updates. The session will be listen-only, with no questions entertained. Ampio focuses on immunology-based therapies for inflammatory conditions, primarily through its lead drug, Ampion™, which has extensive patent protection until 2037 and may qualify for 12-year FDA market exclusivity. The call can be accessed via their website or provided dial-in numbers.
Ampio Pharmaceuticals (AMPE) announced that Mike Macaluso is on a one-year medical leave as Chairman and CEO, effective immediately. Board member Michael Martino has been appointed Interim Chairman and CEO. Macaluso's leave follows medical treatment he disclosed in October 2021. Martino, who has extensive experience in the pharmaceutical industry, expressed confidence in leading the company as it nears FDA submission for its osteoarthritis treatment and continues its Phase II trial for COVID-19 complications. Ampio focuses on immunomodulatory therapies and holds a promising patent portfolio.
Ampio Pharmaceuticals (AMPE) reported its financial results for Q3 and YTD 2021 on November 10, showing a net loss of $3.6 million for Q3, an 8% increase from the previous year, with diluted net loss per share remaining unchanged at $0.02. Operating expenses rose by 17% to $3.85 million, driven mainly by a 57% increase in R&D expenditures. Cash and cash equivalents decreased slightly to $17.1 million, with guidance indicating sufficient funds to operate through Q1 2023. The company is advancing its Ampion therapy in both clinical and preclinical studies, including a Phase 2 COVID-19 trial in India.
Ampio Pharmaceuticals (NYSE American: AMPE) will host a conference call on November 10, 2021, at 4:30 pm EDT to discuss their financial results for Q3 2021 and share a corporate update. The call will provide insights into the company's operations and future plans, focusing on their lead drug, Ampion™, which targets inflammatory conditions with potential FDA market exclusivity. Interested participants can access the call and webcast via their website, and questions can be submitted online.
Ampio Pharmaceuticals (NYSE American: AMPE) announced the appointment of Howard Levy as Chief Medical Officer and the addition of Kevin Buchi and Michael Martino to its Board of Directors. These executives bring extensive experience in the biopharmaceutical industry. Ampio also promoted Holli Cherevka to President and COO, effective immediately. CEO Mike Macaluso emphasized the need for a strengthened leadership team to support the company’s strategic initiatives, especially in light of positive clinical trial results and upcoming licensing agreements.
Ampio Pharmaceuticals (AMPE) has received regulatory approval from India's Drugs Controller General (DCGI) for its Phase II clinical trial (AP-019) utilizing inhaled Ampion™ to treat respiratory distress in COVID-19 patients. This comes after the successful Phase I trial, which demonstrated a 78% reduction in all-cause mortality compared to standard care. India continues to face health challenges with over 33 million infections, making the approval timely. Ampion aims to target inflammation directly in the lungs, addressing a critical medical need as COVID-19 remains a health threat.
Ampio Pharmaceuticals (AMPE) reported positive top-line results from its Phase III study (AP-013) of Ampion for severe osteoarthritis of the knee. The study showed a statistically significant reduction in pain and improved function after 12 weeks. This study is critical as it confirms Ampion's efficacy as the second Phase III trial required for FDA approval, addressing an unmet medical need. The safety profile of Ampion remains robust, with no serious adverse events reported. The company plans to consolidate this data for a Biologic License Application (BLA) submission.
Ampio Pharmaceuticals (NYSE American: AMPE) announced the preprint release of a manuscript titled "LMWF5A Demonstrates an Anti-Inflammatory Mode of Action and Similar Drug Targets to Dexamethasone in Activated PBMC." The research highlights Ampion™, a novel anti-inflammatory biologic, showing potential to treat conditions with fewer side effects compared to dexamethasone. Currently, two Phase II clinical trials are ongoing for COVID-19 treatment using Ampion. The study supports existing knowledge while providing new hypotheses for future investigations.
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