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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 conference call scheduled for April 28, 2022, at 8 AM EDT to discuss updates from the FDA regarding the company's AP-013 study. The call aims to provide insights on the firm’s lead drug, Ampion™, an immunomodulatory therapy targeting osteoarthritis pain. The drug benefits from a robust patent portfolio extending to 2037 and may qualify for 12-year FDA market exclusivity upon approval. The company emphasizes that future statements are subject to various risks and uncertainties.
Ampio Pharmaceuticals (AMPE) announced receipt of FDA responses regarding the AP-013 trial results. The FDA disagreed with the proposed switch from the intent-to-treat (ITT) to modified intent-to-treat (mITT) analysis, citing it as a significant protocol change. Furthermore, the FDA stated that AP-013 cannot serve as a second pivotal trial for Ampion due to these changes. CEO Mike Martino expressed disappointment but indicated potential pathways to salvage the trial. He suggested that a new Phase 3 trial may be the best option moving forward for gaining BLA approval.
Ampio Pharmaceuticals (AMPE) reported a net loss of $6.2 million for Q4 2021, up from $4.6 million in Q4 2020, and an annual net loss of $17.1 million compared to $15.9 million in 2020. Despite this, the company secured $34 million in cash, expected to fund operations into H2 2023. Positive Phase 3 data for its osteoarthritis treatment, Ampion, was reported, with significant reductions in pain. The company's leadership has been strengthened with key appointments, and further clarity from the FDA is anticipated regarding the Ampion Biologics Licensing Application.
Ampio Pharmaceuticals, Inc. (AMPE) will host its fourth quarter earnings and business update call on March 29, 2022, at 4:30 PM EST. The call aims to provide insights into the company's financial performance and future direction. Ampio focuses on immunomodulatory therapies for osteoarthritis pain, with its lead product, Ampion™, backed by a robust patent portfolio and potential FDA market exclusivity through the Biologics Price Competition and Innovation Act. Investors are encouraged to join the call for detailed updates.
Ampio Pharmaceuticals, Inc. (AMPE) will attend the 34th Annual ROTH Conference from March 13-15, 2022, in Laguna Niguel, California. CEO Mike Martino will engage in one-on-one meetings with investors and participate in a fireside chat on March 15 at 4:30pm ET. The conference hosts nearly 550 companies and over 5,100 attendees, focusing on small-cap firms across various sectors.
Ampio's lead drug, Ampion™, targets inflammatory conditions and may secure 12-year FDA market exclusivity upon approval.
Ampio Pharmaceuticals, Inc. (AMPE) announced promising results from its Phase 3 AP-013 study of Ampion™ for treating severe osteoarthritis of the knee. The study showed a statistically significant pain reduction (p=0.042) in the modified Intent-to-Treat population (n=618) and notable improvements in function (p=0.027) compared to saline control. These results corroborate findings from the earlier AP-003-A trial. The company has engaged with the FDA regarding next steps, anticipating further clarity on the data by mid-2022.
Ampio Pharmaceuticals (NYSE American: AMPE) announced a webinar and conference call on March 2, 2022, at 4:30 PM EST, to update on clinical progress regarding osteoarthritis of the knee. Interested participants can join via the provided webinar link. The company focuses on developing immunomodulatory therapies for inflammatory conditions, with its lead drug, Ampion™, aiming for FDA approval. Forward-looking statements in the press release discuss potential future plans and risks.
Ampio Pharmaceuticals (NYSE American: AMPE) announced the appointment of Elizabeth Varki Jobes, Esq. to its Board of Directors, expanding the board from seven to eight members. This strategic addition aims to enhance the company's governance as it prepares for discussions with the FDA regarding a Biological License Application (BLA) submission for its lead drug, Ampion. Jobes brings nearly 30 years of legal and compliance expertise from various biopharmaceutical companies, positioning Ampio favorably in its efforts to advance immunology-based therapies.
Ampio Pharmaceuticals (NYSE: AMPE) announced its participation in the H.C. Wainwright Bioconnect Virtual Conference from January 10-13, 2022. CEO Michael Martino will present a corporate overview starting at 7:00 a.m. ET on January 10, accessible via the event website. Ampio focuses on immunology-based therapies for inflammatory conditions, with its lead drug Ampion supported by a robust patent portfolio valid until 2037.
Ampio Pharmaceuticals (AMPE) announced a successful $22.5 million registered direct offering, providing approximately $21 million in net proceeds. With expectations to end 2021 with $13 million in cash, the company now holds about $34 million to support its operational plans for over a year. CEO Mike Martino highlighted the potential for Ampio to submit a Biologics License Application (BLA) for its lead drug, Ampion, and pursue partnerships for further development. The company is focused on achieving targeted FDA agreements and securing strategic collaborations in 2022.
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