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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 (AMPE) announced a pre-clinical study revealing that Ampion inhibits a critical pro-inflammatory pathway linked to COVID-19 and Lupus Nephritis. The study focused on Ampion's ability to suppress TLR7 signaling, significantly reducing CXCL10 release by up to 92% compared to saline (p<0.05). This research highlights Ampion's potential in treating inflammatory conditions, with a strong patent portfolio extending through 2035 and eligibility for 12-year market exclusivity upon FDA approval.
Ampio Pharmaceuticals (NYSE American: AMPE) announced its participation at the 23rd International Congress of the International Society for Aerosols in Medicine (ISAM) in Boise, Idaho, from May 22 to 26, 2021. The company will present a poster titled, "Regulatory decisions during COVID-19: Efficient nonclinical inhalation toxicology for a clinical program." Additionally, Ampio recently completed enrollment in its Phase I clinical trial using inhaled Ampion for respiratory distress caused by COVID-19. The company aims to showcase efficient development responsive to FDA requirements during the pandemic.
Ampio Pharmaceuticals (NYSE American: AMPE) will present at the virtual Benzinga Biotech Small Cap Conference on March 24 and 25, 2021. The presentation titled "Ampio – Business & Pipeline Update" is scheduled for March 24 from 2:00-2:20 PM EDT on Track 2. Ampio is focused on developing AmpionTM, an anti-inflammatory drug aimed at treating COVID-19 induced acute respiratory distress syndrome (ARDS) and severe osteoarthritis of the knee. With a strong patent portfolio valid until 2035, Ampion could receive 12-year FDA market exclusivity upon approval.
Ampio Pharmaceuticals (AMPE) has announced preliminary positive outcomes from its Phase I clinical trial of inhaled Ampion for treating respiratory distress due to COVID-19. The trial showed an 8% mortality rate in the Ampion group compared to 21% in standard care and reduced average hospital stay from 11 to 7 days. The company plans to initiate a Phase I trial for 'long hauler' COVID-19 patients and continues research on kidney and pediatric diseases. The FDA has advised moving directly to a randomized Phase II study, considering potential Emergency Use Authorization.
Ampio Pharmaceuticals (AMPE) will participate in the 33rd Annual ROTH Growth Conference from March 15-17, 2021. The virtual conference will include presentations from various companies and feature expert panels, including a discussion on therapeutics for SARS-CoV-2 led by Dr. David Bar-Or on March 15 at 12:00 PM EST. The Ampio management team will engage in one-on-one meetings with investors and analysts. This exclusive event is not open to the public, and interested participants should contact their ROTH representative for more details.
Ampio Pharmaceuticals (AMPE) reported its annual financial results for 2020, highlighting a net loss of $15.9 million, or $0.09 per diluted share, compared to a loss of $13.6 million in 2019. Cash and cash equivalents increased to $17.3 million from $6.5 million due to successful equity offerings. The company is engaged in clinical trials for COVID-19 treatments using Ampion, with plans for Phase II trials as recommended by the FDA. Additionally, the ongoing Osteoarthritis of the Knee (OAK) trial remains paused pending FDA guidance. The company received a going concern qualification in its audit opinion.
Ampio Pharmaceuticals, based in Englewood, Colo., announced its participation in the H.C. Wainwright Global Life Sciences Conference from March 9-10, 2021. The company will present a video webcast available on-demand starting at 7:00 am EST on March 9. This webcast will be accessible for registered attendees and archived for 90 days. Ampio focuses on immunology-based therapies for inflammatory conditions, with its lead product candidate, Ampion, having a strong patent portfolio and potential market exclusivity upon FDA approval.
Ampio Pharmaceuticals (NYSE American: AMPE) will hold a conference call on March 3, 2021, at 4:30pm EST to discuss its financial results for the year ended December 31, 2020 and provide a corporate update. The company is focused on developing its lead product candidate, Ampion, for treating inflammatory conditions. Ampion has a robust patent portfolio and could gain up to 12 years of FDA market exclusivity upon approval as a novel biologic.
The conference will be accessible via telephone and webcast.
Ampio Pharmaceuticals (AMPE) has expanded its Phase I clinical trial for the inhalation treatment of COVID-19 with Ampion by adding two new sites in Denver, CO, and Bozeman, MT. Led by experienced principal investigators, this expansion aims to accelerate patient enrollment. Preliminary data suggests Ampion may enhance clinical outcomes, including improved all-cause mortality. The trial will enroll 140 patients, comparing inhaled Ampion against the standard of care. Safety remains the primary focus, with various efficacy measurements as secondary endpoints.
Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) will present at The Microcap Rodeo Winter Wonderland Conference on February 17, 2021, at 2:30 PM EST. This virtual event highlights the company's focus on immunology-based therapies for prevalent inflammatory conditions, particularly its lead product candidate, AmpionTM. The drug is backed by a significant patent portfolio and is eligible for 12 years of FDA market exclusivity upon approval. Interested investors can access the webcast through a provided link.
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