AR-300

ENGLEWOOD, Colo., April 18, 2023 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company") today released the following letter to stockholders from its Chairman, Kevin Buchi and Chief Executive Officer, Mike Martino. Dear Ampio Stockholders: On March 28, 2023, we filed our 2022 Annual Report on Form 10-K. In this letter we would like to elaborate on two key operational points which were included in that Annual Report. Firstly, we want to elaborate on progress with the development of what we have previously called, "AR-300." We gained a considerable amount of knowledge about osteoarthritis (OA) from the company's previous clinical and in vitro studies with Ampion. In January 2022, we began work on "AR-300," a series of synthetic formulations of what we believed to be the three active pharmaceutical ingredients (APIs) that were present at low levels in Ampion. Our development efforts in the first quarter 2023 have focused on rigorously testing different formulations of these APIs at an independent, well-respected research organization, using two validated, well-published rodent models of OA, which we will highlight here. The first model, called the medial meniscal tear (MMT) model, results in pathology that highly resembles the pathology that occurs with OA in humans, and is the most common preclinical model used by industry to identify potential therapies that may inhibit cartilage degeneration associated with OA. The second model, the mono-iodoacetate (MIA) model, measures the effects of potential therapies on the pain associated with progressive stages of OA, and is also the most common preclinical model used by industry to identify potential therapies to treat the pain associated with OA. To-date, we have shown cartilage protection in the MMT model with multiple combinations of the prospective APIs, with one formulation generating especially encouraging results. Additionally, in the MIA model, several alternative formulations have demonstrated immediate and early pain reduction in the inflammatory pain phase of the model. The combination of pain reduction and prevention of cartilage degeneration provides optimism that we have a drug candidate to treat OA of the knee (OAK). Of course, we will have to demonstrate these benefits in clinical trials acceptable to regulators and payers, but we are encouraged by these results. Additionally, we want to emphasize that these are results that were never observed with Ampion, nor with the original formulations of AR-300. These results show that we are now in possession of new and unique formulations, separate and distinct from both Ampion and AR-300, that demonstrate their own therapeutic potential. Because of that, we have already taken steps to protect this new intellectual property, worldwide. Based on this progress, we have focused our ongoing efforts toward optimizing two potential formulations to take forward into development. In the third quarter of 2023, we intend to select one of these optimized formulations to move towards clinical development. Given that these formulations are unique, proprietary, and are neither Ampion nor AR-300 (or derivatives thereof), we will now refer to development of these new formulations as OA-20X program. With the data from these additional studies, we will be in position later this year to seek scientific advice meetings with the FDA, UK, and EU regulatory authorities. Secondly, we want to elaborate on our progress in implementing a hybrid, virtual organizational model. From the outset, our intent was (and remains) to retain the organizational capabilities to govern a publicly traded company, comply with related reporting requirements, lead strategy development and program selection, and identify, retain, and manage third-party contractors with specific and proven expertise in the different, related activities required to develop a drug (e.g., drug candidate selection, formulation development, GMP manufacturing, preclinical development, clinical development, regulatory, etc.) on a just-in-time, as needed basis. We believe this model positions us to drive strategic development in the most expeditious and cost-effective way. We communicated, and began implementing, this organizational strategy at the end of 2022 with a planned reduction in force, which continued into the first quarter 2023. In addition, we entered into a sublease agreement effective March 1, 2023, whereby we have subleased the entire Ampio facility in Colorado. As a result of implementing this organizational strategy, Ampio now has five full-time employees, numerous engaged consultants with industry leading expertise in osteoarthritis (OA) drug development (as outlined above) and independent labs and contract manufacturing partners, all collaborating to further the development of the OA-20x program. We expect to remain a Colorado-based company for the foreseeable future and for the time being have retained our current mailing address. We estimate that this strategy will result in annualized cost savings of approximately $4.6 million, allowing us to focus our cash investment on OA-20x development for 2023 in addition to our ongoing governance and reporting obligations as a publicly traded company and other necessary expenses. Again, this update elaborates on just two points from our recently filed Annual Report, and we encourage you to read the full Annual Report in its entirety because it contains important information. We look forward to updating you following conclusion of the third quarter 2023. Best regards, J. Kevin Buchi, Chair of the Board of Directors Michael A. Martino, Chief Executive Officer Caution Regarding Forward-Looking Statements All statements other than statements of historical facts contained in this letter, including statements regarding our anticipated future clinical developments, future financial position, and plans and objectives of management for future operations, are forward-looking statements. Words such as "may", "will", "should", "forecast", "could", "expect", "suggest", "believe", "estimate", "continue", "anticipate", "intend", "ongoing", "opportunity", "potential", "predicts", "seek", "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology, typically identify forward-looking statements. Forward-looking statements are based on certain assumptions and expectations of future events and trends that are subject to risks and uncertainties including: we are dependent on the success of our OA-20X program and we cannot be certain that any preclinical data will support its further development; there can be no assurance that we will be successful in identifying or completing any strategic alternative or that any such strategic alternative will yield value for our stockholders; we may not be able to manage third parties to provide timely, high quality, and cost-effective services to us; our history of losses and our cash resources available to execute our business plan over the next twelve months raise substantial doubt about our ability to continue as a going concern; we are involved in legal proceedings that likely will adversely affect our financial position and our pursuit of strategic alternatives; we may need additional capital to fund our future operations, the development of the OA-20X program and any strategic transaction; we are dependent on adequate protection of our patent and proprietary rights; the price of our stock has been and may continue to be extremely volatile; if we cannot continue to satisfy the NYSE American continued listing requirements and rules, our securities may be delisted, which could negatively impact the price of our securities; and other risks described in "Risk Factors" and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and subsequent periodic reports filed with the SEC. We undertake no obligation to update or revise publicly any forward-looking statements to reflect events or circumstances after the date of such statements for any reason, except as otherwise required by law. For more information, contact: Ampio Pharmaceuticals, Inc. Michael Martino Chief Executive Officer mmartino@ampiopharma.com View original content to download multimedia: SOURCE Ampio Pharmaceuticals, Inc. Company Codes: NYSE:AMPE, AMEX:AMPE

ENGLEWOOD, Colo., Jan. 17, 2023 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company") today released the following letter to stockholders from its Chairman, Kevin Buchi and Chief Executive Officer, Mike Martino. Dear Fellow Ampio Stockholders: 2022 was a challenging year for our company. We continue to receive update requests from individual stockholders. Rather than responding to those individual requests, we are issuing this letter to update all stockholders. Going forward, we will provide periodic updates with our regular quarterly and annual filings with the SEC. The following are the relevant updates we can provide at this time: Consistent with prior communications, we have completed clinical trial reports for all legacy Ampion trials and submitted those reports to the appropriate agencies for review and ultimate publication on ClinicalTrials.gov. We have also informed the FDA that we have discontinued development of Ampion and have withdrawn the 3 Investigational New Drug (INDs) applications we held: intra-articular injection for Osteoarthritis, intravenous and nebulized COVID. These actions conclude all development efforts on Ampion. Also consistent with prior communications, we have continued to focus on reducing operating costs, including, but not limited to, reducing personnel expense to correspond to the conclusion of the development efforts relating to Ampion. We plan to provide an update in our 2022 Form 10-K regarding our other efforts to reduce our operating costs and cash burn. As communicated in our Form 10-Q for the third quarter 2022, filed on November 14, 2022, the Ampio board and management team are focused on a two-pronged approach to increase stockholder value as part of our strategic alternatives process, as follows: AR-300 is a novel, proprietary (patents pending), small molecule formulation that has demonstrated promising anti-inflammatory properties in vitro in preclinical animal studies and protection of cartilage in preclinical rat meniscal tear studies. We are currently conducting studies to evaluate the efficacy of AR-300 in osteoarthritis pain. If the preclinical data are compelling, we would plan to initially target clinical development of AR-300 for the treatment of osteoarthritis of the knee (OAK,) which we continue to believe represents an attractive market opportunity. Clinical demonstration of cartilage protection and pain management in the knee could position AR-300 for administration early in the current OAK treatment paradigm. The development of AR-300 to date has been based, in part, on our extensive drug discovery and clinical development experience during the development of Ampion for the treatment of OAK. However, AR-300 is not Ampion, it is a new and unique formulation in preclinical development. Given that, we cannot make assurances about the success of the ongoing preclinical studies nor provide guidance on the clinical development program until we have the data from the studies underway. We expect to have preclinical pain and chondroprotection results in the first half of 2023. Given the risks associated with preclinical drug development, we continue to opportunistically identify and evaluate strategic opportunities to acquire or license later stage assets and/or merge with companies that have those assets. To-date, we have evaluated more than a dozen such opportunities. However, finding attractive and affordable assets and/or merger partners has been challenging due to competition from the high number of companies with failed clinical trials that are pursuing the same strategy, in addition to our circumstances regarding our cash balance, the uncertainty around our continued listing on a major exchange, and the potential risks associated with ongoing legal and regulatory matters. Again, we will provide updates in our future SEC filings to the extent that there are any significant developments. In our last Form 10-Q, we disclosed stockholder litigation and an SEC investigation. We will provide updates on these ongoing matters in our SEC filings to the extent that there are material developments. As noted above, the fact that these matters are pending is an additional challenge to our strategic alternatives process. These are the updates we can provide at this time. We expect to provide additional detail and further updates in our 2022 Form 10-K, which we expect to the end of Q1 2023. Until then, while we know that patience is a difficult ask, we nonetheless do appreciate any patience and support you can provide as we attempt to navigate these difficult circumstances. Best regards, J. Kevin Buchi Chairman of the Board Michael A. Martino Chief Executive Officer Caution Regarding Forward-Looking Statements This letter to Ampio stockholders contains forward-looking statements concerning possible or anticipated future financial performance, operations, business activities or plans. These statements are typically preceded by the words "believes," "expects," "anticipates," "intends" or similar expressions. For these forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in federal securities laws. Shareholders and the investing public should understand that these forward-looking statements are subject to risks and uncertainties which could affect our actual results and cause actual results to differ materially from those indicated in the forward-looking statements. We describe these risks and uncertainties in our Annual Report on Form 10-K filed with the SEC and subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. They include, but are not limited to: AR-300 is a pre-clinical stage formulation and there is no assurance that AR-300 will demonstrate safety and efficacy in preclinical studies to support continued development; we may not be successful in securing a later stage asset or in completing any transaction as part of our strategic alternatives process; there can be no assurance that we will continue to meet all of the requirements for continued listing on the NYSE American or that our common stock will continue to trade on the NYSE American; we may be unable to fund our operations and complete transactions as part of our strategic alternatives process without additional capital; and we are involved in legal proceedings that have and likely will adversely affect our financial position and our pursuit of strategic alternatives. The forward-looking statements included in the letter to Ampio stockholders speaks only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. For more information, contact: Ampio Pharmaceuticals, Inc. Michael Martino Chief Executive Officer mmartino@ampiopharma.com Company Codes: NYSE:AMPE, AMEX:AMPE