ENGLEWOOD, Colo., Oct. 5, 2023 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (the 'Company), a pre-revenue stage biopharmaceutical company focused on development of a potential treatment for osteoarthritis as part of its OA-201 program, today announced that it has selected Ascendia Pharmaceuticals, Inc.

ENGLEWOOD，Colo。，2023年10月5日/PRNewswire/-Ampio Pharmaceuticals，Inc。（NYSE American:AMPE）（'公司）是一家收入前期的生物制药公司，专注于开发骨关节炎的潜在治疗方法作为其OA-201计划的一部分，今天宣布它已选择Ascendia Pharmaceuticals，Inc。

('Ascendia') to provide services to support the clinical development of OA-201, a novel therapeutic for the treatment of symptomatic osteoarthritis pain. OA-201 consists of a natural metabolite, formulated as an injectable small molecule product which has demonstrated an active reduction in pain and cartilage degradation in relevant pre-clinical studies..

（'Ascendia'）提供服务以支持OA-201的临床开发，OA-201是一种治疗症状性骨关节炎疼痛的新型治疗方法。OA-201由天然代谢物组成，配制成可注射的小分子产品，在相关的临床前研究中证明了疼痛和软骨退化的积极减少。。

Ascendia, a specialty contract development and manufacturing organization (CDMO) leader, will provide Ampio with a range of services including formulation development, process development and optimization. Ascendia will also provide scale-up, GLP supply and method validation, culminating in cGMP manufacturing of the product to support future Phase 1, 2 and 3 clinical trials.

Ascendia是专业合同开发和制造组织（CDMO）负责人，将为Ampio提供一系列服务，包括配方开发，流程开发和优化。Ascendia还将提供放大，GLP供应和方法验证，最终产品的cGMP制造，以支持未来的1,2和3期临床试验。

Any future clinical trials to be conducted by Ampio will require Food & Drug Administration (FDA) approval of an Investigational New Drug Application (IND)..

Ampio未来进行的任何临床试验都需要食品和药物管理局（FDA）批准研究性新药申请（IND）。。

'After evaluation of many CDMO service providers, we are very pleased to have selected Ascendia given its strong and broad level of integrated in-house capabilities which we believe will provide a solid platform supporting the continued clinical development of OA-201 for inclusion in future clinical trials,' said Michael A.

“在对许多CDMO服务提供商进行评估之后，我们非常高兴地选择了Ascendia，因为它具有强大而广泛的集成内部功能水平，我们相信这将为OA-201的持续临床开发提供一个坚实的平台，以纳入未来的临床试验，“Michael a.说。

Martino, Ampio's Chief Executive Officer..

Martino，Ampio的首席执行官。。

Ampio was advised throughout this process by the Bruder Consulting & Venture Group (BCVG,) who Ampio have engaged to assist in the design and execution of its preclinical, clinical, and manufacturing plans and programs. 'We are pleased to collaborate with Scott Bruder, MD, PhD, and his team and realize the benefits of their cumulative years of experience in developing and evaluating drugs and devices in the osteoarthritis space,' said Martino.

Ampio在整个过程中由Bruder Consulting＆Venture Group（BCVG，）提供建议，Ampio已参与协助设计和执行其临床前，临床和制造计划和计划我们很高兴与Scott Bruder，医学博士，博士和他的团队合作，并意识到他们多年来在骨关节炎领域开发和评估药物和设备的经验的好处，“马蒂诺说。

'This engagement is a direct application of our virtual organization strategy aimed at keeping internal, fixed costs low while at the same time accessing the best talent to help us achieve our goals.'.

“这种参与是我们虚拟组织战略的直接应用，旨在保持内部固定成本低，同时获取最佳人才来帮助我们实现目标。”。

About Ampio Pharmaceuticals, Inc.

关于Ampio制药公司。

Located in Englewood, Colorado, Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) is focused on development of a potential treatment for osteoarthritis as part of its OA-201 program. The OA-201 development program is seeking to advance Ampio's unique and proprietary small molecule formulation to take forward through pain and chondroprotection pre-clinical studies and the next phases of drug development.

Ampio Pharmaceuticals，Inc.（NYSE American:AMPE）位于科罗拉多州恩格尔伍德，致力于开发骨关节炎的潜在治疗方法，作为其OA-201计划的一部分。OA-201开发计划正在寻求推进Ampio独特和专有的小分子制剂，以通过疼痛和软骨保护临床前研究以及药物开发的下一阶段。

Ampio's primary strategy is to address the large and attractive opportunity for treatment of osteoarthritis of the knee (OAK) and other joints..

Ampio的主要策略是解决治疗膝关节（OAK）和其他关节骨关节炎的巨大而有吸引力的机会。。

About Ascendia Pharmaceuticals, Inc.

关于Ascendia Pharmaceuticals，Inc。

Ascendia Pharmaceuticals, Inc. ('Ascendia') is a specialty CDMO dedicated to developing and manufacturing enhanced formulations for pre-clinical and clinical stage drug candidates and marketed drug products. Ascendia specializes in improving the solubility and bioavailability of poorly water-soluble drugs using its suite of nanotechnology platforms.

Ascendia Pharmaceuticals，Inc.（'Ascendia'）是一家专门的CDMO，致力于开发和制造用于临床前和临床阶段候选药物和市售药品的增强配方。Ascendia专门利用其纳米技术平台提高水溶性差的药物的溶解度和生物利用度。

Ascendia formulates products for injectable, oral, and topical routes of administration. The company has four technology platforms - EmulSol® for producing nano-emulsions, AmorSol® for creating amorphous solid dispersions, NanoSol® for formulating nano-particles, and LipidSol® for creating lipid nanoparticles to deliver biologics, peptides, and small molecules..

Ascendia为注射，口服和局部给药途径配制产品。该公司拥有四个技术平台-用于生产纳米乳液的EmulSol®，用于制造无定形固体分散体的AmorSol®，用于配制纳米颗粒的NanoSol®，以及用于制造脂质纳米颗粒以提供生物制剂，多肽和小分子的LipidSol®。。

About Bruder Consulting & Venture Group

关于Bruder Consulting＆Venture Group

The Bruder Consulting & Venture Group ( www.bruderconsulting.com ) is a full service strategic advisory firm with expertise in the discovery, development, clinical design and regulatory approval process of biologics, devices and combination products in the orthopaedic, wound care and plastic & reconstructive surgery markets.

Bruder Consulting＆Venture Group（www.bruderculting.com）是一家全面服务的战略咨询公司，在骨科，伤口护理和塑料等生物制品，设备和组合产品的发现，开发，临床设计和监管审批过程中拥有专业知识。重建手术市场。

As veterans of the business development, licensing, and acquisition process, BCVG has led or supported more than $2 billion of transactions in the USA and abroad..

作为商业发展，许可和收购过程的退伍军人，BCVG领导或支持了美国和国外超过20亿美元的交易。。

Caution Regarding Forward-Looking Statements

谨慎对待前瞻性陈述

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..

除本函所载历史事实陈述外的所有陈述，包括有关我们预期的未来临床发展，未来财务状况以及未来运营管理计划和目标的陈述，均为前瞻性陈述。诸如“可能”，“将会”，“应该”，“预测”，“可能”，“期望”，“建议”，“相信”，“估计”，“继续”，“预期”，“打算”，“正在进行”，“机会”，“潜力”，“预测”，“寻求”，“计划”或类似的词语，或这些术语或其他术语的否定性，通常会识别前瞻性陈述。。

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.201 program and we cannot be certain that any preclinical data will support its further development; 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 will need additional capital to fund our future operations, the OA.201 program, and any strategic transaction, as well as to assure compliance with the NYSE American minimum stockholders' equity requirement; 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..

前瞻性陈述基于对未来事件和趋势的某些假设和预期，这些假设和趋势受到风险和不确定性的影响，包括：我们依赖于OA.201计划的成功，我们无法确定任何临床前数据是否会支持其进一步发展；我们可能无法管理第三方为我们提供及时，高质量和具有成本效益的服务；我们的损失历史和我们在未来12个月内可用于执行我们业务计划的现金资源对我们继续关注的能力提出了实质性怀疑；我们参与可能对我们的财务状况和追求战略选择产生不利影响的法律诉讼；我们将需要额外的资金来资助我们未来的运营，OA.201计划和任何战略交易，并确保符合纽约证券交易所美国最低股东的股权要求；我们依赖充分保护我们的专利和专有权；我们股票的价格一直并且可能继续极度波动；如果我们不能继续满足纽约证券交易所美国的持续上市要求和规则，我们的证券可能会被脱牌，这可能会对我们证券的价格产生负面影响；以及我们在2022年12月31日结束的财政年度表格10-K年度报告和随后向SEC提交的定期报告中“风险因素”和其他地方所述的其他风险。。

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.

除法律另有要求外，我们没有义务公开更新或修改任何前瞻性陈述，以反映此类陈述之日以后的事件或情况。

For more information, contact:

欲了解更多信息，请联系：

Ampio Pharmaceuticals, Inc.Michael A. MartinoChief Executive Officermmartino@ampiopharma.com

Ampio Pharmaceuticals，Inc。Michael A.MartinoChief执行官Officermmartino@ampiopharma.com

SOURCE Ampio Pharmaceuticals, Inc.

来源Ampio制药公司。