EDGAR 10-K Filing

Company CIK: 1411906
Filing Year: 2023
Filename: 1411906_10-K_2023_0001558370-23-004723.json

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ITEM 1. BUSINESS
Item 1.Business.
Overview
We are a pre-revenue stage biopharmaceutical company. Until May 2022 we were focused on the clinical development of Ampion® and preclinical development of AR-300, a novel, proprietary, small molecule formulation that has (i) demonstrated anti-inflammatory properties in vitro and (ii) protection of cartilage in preclinical rat meniscal tear studies.
Subsequently, we have shifted nearly all of our focus towards the preclinical development of AR-300 and we are currently conducting studies to evaluate the efficacy of AR-300 in osteoarthritis-related pain. If the preclinical data is compelling, we would plan to initially target clinical development of AR-300 for the treatment of osteoarthritis of the knee (OAK). Osteoarthritis is widely regarded as being typified by cartilage loss. Substances that protect articular cartilage during the course of osteoarthritis have been termed chondroprotective. Clinical demonstration of cartilage protection and pain management in the knee could position AR-300 for administration early in the current OAK treatment paradigm which we believe is a potentially large and attractive market opportunity.
The development of AR-300 to date has been based, in part, on our extensive drug discovery and clinical development experience obtained during the development of Ampion for the treatment of OAK. It is important to note, however, that AR-300 is not Ampion, rather it is a novel and unique formulation in preclinical development. We currently expect to have preclinical pain and chondroprotection results for AR-300 in the first half of 2023.
In addition, and given the overall risks associated with preclinical drug development, we continue to opportunistically identify and evaluate strategic opportunities that would allow us to acquire or license later stage assets and/or merge with companies that have those assets as part of the strategic alternatives process that we announced in May 2022. In 2022, we evaluated more than a dozen potential strategic alternatives with the assistance of our legal, clinical and regulatory, and financial advisors consistent with our strategic alternatives process.
On November 9, 2022, the Company effected a 15-to-1 reverse stock split. The Company has retroactively applied the reverse stock split made effective on November 9, 2022 to share and per share amounts in the consolidated financial statements as of December 31, 2022 and December 31, 2021. Additionally, pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately, with any fractional shares rounded up to the next whole share. The Company also retroactively applied such adjustments in the notes to the consolidated financial statements as of December 31, 2022 and December 31, 2021. The reverse stock split did not reduce the number of authorized shares of common stock and preferred stock and did not alter the par value.
Government Regulation
FDA Approval Process
If Ampio determines that pain and chondroprotection data from the AR-300 preclinical studies justify moving forward with the clinical development of AR-300, it is our intent to approach FDA in INTERACT (Initial Targeted Engagement for Regulatory Advice) and pre-IND meeting later in 2023 to discuss the development plan for the drug, which we believe will be regulated as a small molecule formulation, and will require additional, IND-enabling preclinical studies, a Phase 1 safety study, at least one Phase 2 proof of efficacy study, and likely two randomized, controlled Phase 3 studies. Based on current input from our clinical and regulatory advisor, we believe this regulatory process could comprise five-to-seven years and require an incremental investment over and above Ampio’s general operating expense during that period.
Intellectual Property Summary
We will be able to protect our proprietary intellectual property rights from unauthorized use by third parties only to the extent that such rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. We seek to protect our trade secrets and proprietary know-how through confidentiality and nondisclosure agreements and other controls over confidential information. If we do not adequately protect our trade secrets and proprietary know-how, our competitive position and business prospects could be materially harmed.
The following describes our patents and patent applications relating to AR-300 and Ampion®.
AR-300
We own a number of United States provisional patent applications covering AR-300, as well as its uses, formulations, and manufacturing processes. We expect that these provisional patent applications, which are the patent rights we consider most significant in relation to our business as a whole, will be consolidated and filed as a single PCT (Patent Cooperation Treaty) application in the second quarter of 2023. One or more national phase applications will be filed from this PCT application approximately eighteen (18) months later, in the third quarter of 2024.
Because we are currently focused on the preclinical development of AR-300, we anticipate filing additional patent applications in the future, covering new discoveries, formulations and/or research advancements in or relating to AR-300, as we determine appropriate.
Patents covering AR-300 may extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. Generally speaking, patents to issue from the above-mentioned PCT application will exist for a period of twenty years from the filing date of the PCT application, or until the second quarter of 2043. The scope of protection afforded by a patent can also vary from country to country and depends on the patent type, the scope of its patent claims and the availability of legal remedies. Patent term extensions (PTE) may be available in some countries to compensate for a loss of patent term due to delay in a product’s approval due to the regulatory requirements.
Reliable patent protection and enforcement around the world are among the key factors we consider for continued business and R&D investment. The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (WTO-TRIPS) requires participant countries to provide patent and other intellectual property-related protection for pharmaceutical products by law, with an exemption provided for least developed countries until 2033. While some countries have made improvements, we may face patent grant, enforcement and other intellectual property challenges in many countries.
Ampion
Globally, we own a large number of issued patents and pending patent applications covering Ampion®, our proprietary biological pharmaceutical product, as well as its uses, formulations, and manufacturing processes. Given the decision to focus available resources on the research and development of AR-300, we made the decision starting in 2023 to significantly limit or discontinue much of the existing patent portfolio covering Ampion®. Those members of the existing Ampion® patent estate that we expect to continue to maintain will be based on the relative importance of technologies
covered by patents, the geographic jurisdiction of patents, and remaining patent term. We believe that this strategy will significantly reduce the overall number of patents and minimize the economic impact of the Ampion® patent estate on the Company.
Human Capital Resources
As we move forward with the development of AR-300, we believe it is crucial that we have just-in-time access to specific best-in-class expertise at each unique stage of the drug’s development, including the following: (i) expertise in planning, executing, and evaluating preclinical development, (ii) planning and executing the Phase 1 safety study, (iii) planning and executing the Phase 2 and 3 clinical studies, (iv) interfacing with regulatory authorities, and (v) maintaining, analyzing, and presenting data required to support regulatory filings and decisions. In addition, we continue to be a public-reporting company and, as such, require the resources to comply with our public reporting and stock exchange obligations.
Accordingly, we have implemented a hybrid organizational model whereby we retain the organizational competencies to govern and comply with the public reporting requirements and select and manage specific third-party independent contractors with proven industry expertise in formulation development, preclinical development, GMP manufacturing, clinical development, regulatory and legal on an as needed basis. We believe this model will position us best to develop AR-300 in the most expeditious and cost-effective manner, and effectively control the fixed costs associated with building an all-employee organization.
We began implementing this model toward the end of 2022 and have continued implementation into the first quarter of 2023. As of December 31, 2022, we had eight full-time employees focused on research, manufacturing, project management, accounting and finance, administrative support, information technology (“IT”), and corporate governance. As of February 1, 2023, we had five employees focused on project management, accounting and finance, IT, and corporate governance. Consistent with our outsourcing philosophy, we have contracted with third-party firms to provide medical/clinical oversight, financial and accounting control, assistance with transferring manufacturing methods, and administrative support, and have engaged third-party firms with specific orthopedic expertise to assist with designing and implementing preclinical, clinical and regulatory development plans for AR-300.
Available Information
We file annual reports, quarterly reports, proxy statements and other documents with the SEC under the Exchange Act. The SEC maintains a website that contains reports, proxy and information statements, and other information regarding issuers, including Ampio, that file electronically with the SEC. These filings are available through the SEC’s website at https://www.sec.gov.
Ampio also makes available free of charge through its website, http://www.ampiopharma.com, its annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed or furnished pursuant to the Exchange Act as soon as reasonably practicable after the Company electronically files such material with, or furnishes it to, the SEC. Information found on our website is not incorporated by reference into this Annual Report.

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ITEM 1A. RISK FACTORS
Item 1A.
Risk Factors.
You should carefully consider the following risk factors and all other information contained herein as well as the information included in this Annual Report and other reports and filings made with the SEC in evaluating our business and prospects. Risks and uncertainties, in addition to those we describe below, that are not presently known to us or that we currently believe are immaterial may also impair our business operations. If any of the following risks occur, our business and financial results could be harmed, and the price of our common stock could decline. You should also refer to the other information contained in this Annual Report, including our Consolidated Financial Statements and the related Notes.
Risks Related to the Development of AR-300, Strategic Alternatives and Our Business
We are dependent on the success of our AR-300 technology and we cannot be certain that any preclinical data will support its further development.
AR-300 is a novel, proprietary (patents pending), small molecule formulation that has demonstrated promising anti-inflammatory properties in vitro 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. We expect to have preclinical pain and chondroprotection results in the first half of 2023. The future development of AR-300 will depend on the success and level of positive data from the current and near-term preclinical studies. At this time, AR-300 is our only potential product in development. We do not have any products that are approved for commercial sale and may never be able to develop marketable products. In 2022, we generated no revenue from any source other than interest income.
If the results from the preclinical studies of AR-300 are sufficiently positive, any future product candidate from a formulation of AR-300 will require additional development, including further preclinical studies, as well as clinical trials, optimization of their formulation, and regulatory clearances, before they can be commercialized. Positive results obtained during early development do not necessarily mean later development will succeed. If AR-300 fails to demonstrate sufficiently positive data at any time or we determine there are other barriers to successful commercialization, we may abandon development of AR-300.
We believe that sufficiently positive pre-clinical data for AR-300 is a condition to future capital raising to fund AR-300 development. If our available cash resources are insufficient to fund our expenses (including relating to legal proceedings) and the development of AR-300 and/or completion of a strategic transaction, we may implement further cost reduction and other cash-focused measures to manage liquidity and we may pursue a plan of liquidation or dissolution of Ampio or seek bankruptcy protection. If we decided to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of the Company’s current liquidity position and pending legal matters, it is unlikely that cash would be available for distributions to stockholders.
We may explore strategic alternatives but 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.
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. 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.
The process of exploring strategic alternatives is time consuming, and our board of directors has not set a timetable for the conclusion of its review of strategic alternatives. Our review of strategic options and alternatives could result in, among other things, a sale, merger, reverse merger, consolidation or business combination, asset divestiture, partnering, licensing or other collaboration agreements, or potential acquisitions, recapitalizations or restructurings, or in one or more transactions. There can be no assurance that the exploration of strategic alternatives is the correct strategy to pursue or that it will result in the identification or consummation of any transaction. Certain potential strategic transaction alternatives, if available and achieved, could result in substantial dilution to existing stockholders and have a material adverse effect on the market price of Ampio’s common stock.
Additionally, in light of our current stock price and ongoing legal matters, there can be no assurance that we will have sufficient capital resources to fund any strategic transaction, if available. If we raise additional funds through the issuance of equity securities, including as part of a strategic transaction, it could result in substantial dilution to our existing stockholders, increased fixed payment obligations, and any issued securities may have rights senior to those of the Company’s shares of common stock.
We also cannot assure that any potential transaction or other strategic alternative, if identified, evaluated and consummated, will provide greater value to our stockholders or otherwise successfully address the challenges associated with our dependence upon a single preclinical asset for our business. Any potential transaction would be dependent upon a number
of factors that may be beyond our control, including, among other factors, market conditions, industry trends, the interest of third parties in our business or preclinical development progress, and the availability of financing to potential buyers on reasonable terms.
We rely on third parties for critical resources, including AR-300 development, and we may not be able to manage these third parties to provide timely, high quality, and cost-effective services to us.
As of December 31, 2022, we had eight full-time employees and as of February 1, 2023, we had five full-time employees. These employees are focused on project management, accounting & finance, IT, and corporate governance. As part of our AR-300 development strategy, we have determined to outsource and contract with independent organizations, advisors and consultants to provide specific services, such as orthopedic expertise to assist with designing and implementing preclinical, clinical and regulatory development plans for AR-300. We have also determined to contract with third parties for other business-related functions such as finance and accounting and administrative support. We believe that we will be able to obtain support and relevant expertise from the third party resources at an overall lower cost profile than hiring our own employees as well as benefit from greater range of expertise from third party resources than may be found in any number of employees. However, there can be no assurance that our strategy of using third parties will result in these intended benefits.
We currently rely, and for the foreseeable future will continue to rely, in substantial part on third parties to provide critical services to us. We cannot assure you that the services of these third parties will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. If the cost of these services increase for any reason, or if these third parties are unable or unwilling provide services to us, we may have to find another third party to provide these services which could result in interruptions, increased costs, delays, in other challenges in the development of AR-300, in the execution of strategic alternatives or strategic transactions, in our ability to fulfill our SEC reporting obligation or comply with the continued listing requirements of NYSE American, or in the proper functioning of other business functions. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided by third-party service providers is compromised for any reason, we may similarly suffer from interruptions, increased costs, delays and from the other challenges described above. We cannot assure you that we will be able to manage our existing third-party service providers or find other competent outside contractors and consultants on economically reasonable terms, or at all.
Risks Related to Our Financial Position and Capital Requirements
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.
In 2022, we experienced net losses of $16.3 million, had no revenue other than interest income, and used $21.1 million in cash to fund our operations. Due to the current level of liquidity at December 31, 2022 and the projected shortfall to cover operating expenses requiring cash for a period of 12 months from the report date of the annual report, management has expressed substantial doubt as to our ability to continue as a going concern.
As of December 31, 2022, our source of liquidity consisted of $12.7 million of cash and cash equivalents. While we implemented cost reductions in 2022, our finite cash resources available to execute our business plan present the risk that we will not have sufficient cash available in the amount or at the time we need it to fund our ongoing operations and execute our business plan involving the development of AR-300 and strategic alternatives over the next twelve months.
Our capital needs are based upon management estimates as to future expense and potential future capital raising activity, which involve significant judgment particularly given that we are pursuing a strategic alternatives process and cannot predict the duration or expense associated with this process. Additionally, the expense associated with and outcome of any legal proceeding is not possible to determine at this time. We cannot assure you that additional financing will be available in the amount or at the time we need it, or that it will be available on acceptable terms or at all. We believe that positive pre-clinical data for AR-300 is a condition to future capital raising to fund further development of AR-300 and an identifiable, attractive strategic transaction is a condition to future capital raising to fund that strategic transaction.
If our available cash resources are insufficient to fund our expenses (including relating to legal proceedings) and the development of AR-300 and/or completion of a strategic transaction, we may implement further cost reduction and other cash-focused measures to manage liquidity and we may pursue a plan of liquidation or dissolution of Ampio or seek
bankruptcy protection. If we decided to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of the Company’s current liquidity position and pending legal matters, it is unlikely that cash would be available for distributions to stockholders.
We are involved in legal proceedings that likely will adversely affect our financial position and our pursuit of strategic alternatives.
We are involved in and may in the future be involved in legal proceedings. Regardless of whether any claims against us are valid or whether we are liable, litigation claims or regulatory proceedings are expensive and time consuming to defend against, require us to advance potentially substantial amounts to director and officer defendants for their defense of the claims, and will result in the diversion of management attention and resources from our business and strategic goals. Insurance may not be available at all or in sufficient amounts to cover any liabilities with respect to these or other matters. The outcome of any legal proceeding is not possible to determine at this time. If we are liable in any legal proceeding, such proceeding could result in injunctions or other equitable relief, settlements, penalties, fines or damages that could materially adversely affect our results of operations, cash position and the conduct of our business and pursuit of strategic alternatives. The uncertainty relating to any legal proceedings may also impair our ability to raise capital. Given our limited cash resources, significant liabilities resulting from legal proceedings could force us to implement further cost reduction and other cash-focused measures to manage liquidity, including potential termination of our strategic alternatives process, and the Company may pursue a plan of liquidation or dissolution of the Company or seek bankruptcy protection, any of which could cause the value of any investment in the Company to decline to zero. If we decided to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of the Company’s current liquidity position and pending legal matters, it is unlikely that cash would be available for distributions to stockholders.
We may need additional capital to fund our future operations, the development of AR-300 and any strategic transaction.
As of December 31, 2022, we had $12.7 million of cash and cash equivalents which we expect can fund our operations through the fourth quarter of 2023. Our future capital requirements will depend on, and could increase significantly as a result of, many factors including:
● progress in and the costs of our AR-300 preclinical studies and any future clinical trials and research and development relating to AR-300;
● costs relating to the exploration of strategic alternatives and costs associated with pursuit of any strategic transaction, including any consideration we may pay to acquire or license later stage assets and/or merge with companies that have those assets or other transaction or series of transactions;
● the costs of defending lawsuits and other claims such as those described in Part I, Item 3. “Legal Proceedings” and any amounts paid to resolve those legal matters;
● the costs involved in filing, prosecuting, enforcing, and defending patent claims and other intellectual property rights;
● efforts to cure any future non-compliance with the minimum stockholders’ equity or other requirement of the NYSE American; and
● the costs of sustaining our corporate overhead requirements, including D&O insurance, and hiring and retaining necessary personnel or third parties.
Our capital needs are based upon management estimates as to future expense and potential future capital raising activity, which involve significant judgment particularly given that we are in the middle of the strategic alternatives process and cannot predict the duration or expense associated with this process. Additionally, the expense associated with and outcome of any legal proceeding is not possible to determine at this time.
We cannot assure you that additional financing will be available in the amount or at the time we need it, or that it will be available on acceptable terms or at all. We believe that positive pre-clinical data for AR-300 is a condition to pursue future capital raising to fund AR-300 and an identifiable, attractive strategic transaction is a condition to pursue future capital raising to fund that strategic transaction. We may obtain future additional financing by incurring indebtedness or from an offering of our equity securities or any of these.
If we raise equity financing, our stockholders may experience significant dilution of their ownership interests and the value of shares of our common stock could decline. Our efforts to raise additional funds from the sale of equity may be hampered by the currently depressed trading price of our common stock, by pending legal matters, and by our prior non-compliance or any future non-compliance with the continued listing requirements of the NYSE American. If we raise additional equity financing, new investors may demand rights, preferences or privileges senior to those of existing holders of common stock. Our efforts to raise funds by incurring indebtedness may be hampered by our limited assets to secure debt and the absence of any revenue to support debt service payments. Any financing would likely have covenants that would affect the manner in which we conduct our business, including by restricting our ability to incur indebtedness or sell additional equity securities.
If we cannot timely raise any needed funds, we may implement further cost reduction and other cash-focused measures to manage liquidity and we may pursue a plan of liquidation or dissolution of Ampio or seek bankruptcy protection. If we decided to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of the Company’s current liquidity position and pending legal matters, it is unlikely that cash would be available for distributions to stockholders.
Risks Related to Our Intellectual Property
We are dependent on adequate protection of our patent and proprietary rights.
We rely on patents, trade secrets, trademarks, copyrights, know-how, and contractual provisions to establish and protect our intellectual property rights. We own a number of United States provisional patent applications covering AR-300, our proprietary small molecule pharmaceutical product, as well as its uses, formulations, and manufacturing processes. We anticipate filing additional patent applications in the future, covering new discoveries, formulations and/or research advancements in or relating to AR-300, as needs arise. If we do not diligently pursue our intellectual property rights or they are invalidated or circumvented, our development of AR-300 and any future commercialization of any formulation of AR-300 will be adversely affected. We must successfully defend these rights against third-party challenges.
However, these legal means afford us only limited protection and may not adequately protect our rights or remedies to gain or keep any advantages we may have over other companies seeking to commercialize product candidates similar or identical to AR-300. If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent or other legal protections of our intellectual property rights, our ability to prevent our competitors from commercializing product candidates similar or identical to AR-300 would be adversely affected.
Additionally, competitors, many of which have substantial resources and may make substantial investments in competing products and product candidates, may apply for and obtain patents that will prevent, limit, or interfere with our ability to develop, manufacture or market any product relating to AR-300. Further, while we do not believe that our claimed intellectual property interferes with the rights of others, third parties may nonetheless assert patent infringement claims against us in the future.
Costly litigation may be necessary to enforce patents issued or licensed to us, to protect trade secrets or “know-how” we own, to defend us against claimed infringement of the rights of others or to determine the ownership, scope, or validity of our proprietary rights and the rights of others.
Any claim of infringement against us may involve significant liabilities to third parties, could require us to seek licenses from third parties, and could prevent us from manufacturing, selling, or using any products that we may develop. The occurrence of this litigation or the effect of an adverse determination in any of this type of litigation could have a material adverse effect on our business and financial condition.
Risks Related to Our Common Stock
The price of our stock has been extremely volatile and may continue to be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
The price of our common stock has been extremely volatile and may continue to be so, particularly as we confront and attempt to address the risks relating to AR-300, our strategic alternatives process, our capital resources, and the other risk factors described in this section. Additionally, the stock market in general and the market for pre-revenue stage biopharmaceutical companies have experienced extreme volatility that has often been unrelated to the operating performance of a particular company. The following factors, in addition to the other risk factors described in this section, may also have a significant impact on the market price of our common stock:
● any actual or perceived adverse developments in the preclinical studies for AR-300, any clinical trials involving AR-300, or the general development of AR-300;
● uncertainties relating to the strategic alternatives or any strategic transaction, including actual or perceived adverse developments in this process or the announcement or pendency of any transaction;
● any announcements of developments with, or comments by, the FDA or other regulatory authorities that may impact Ampio or the potential regulatory path for AR-300;
● developments in any legal proceeding in which we are or may become involved;
● any announcements concerning our retention or loss of key employees;
● our continued compliance with NYSE American listing requirements and any action taken by the NYSE American relating to our common stock;
● announcements of patent issuances or denials, infringement claims or other intellectual property related developments;
● announcements of the introduction of new competitive products by other companies;
● future issuances of common stock or other securities;
● sales of stock by our stockholders holding a significant position in the Company;
● economic and other external factors beyond our control; and
● public confidence in the securities markets and regulation by or of the securities market.
A significant drop in the price of our stock could expose us to the risk of securities class action lawsuits, which could result in substantial costs and divert management’s attention and resources, which could adversely affect our business.
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.
Currently, our common stock is listed on the NYSE American. In order to maintain our listing on the NYSE American, we must continue to satisfy the applicable continued listing requirements and rules, including such rules and requirements relating to minimum share price, minimum stockholders’ equity and a minimum number of public stockholders.
The NYSE American may delist the securities of any issuer if, in its opinion, the issuer’s financial condition and/or operating results appear unsatisfactory; if it appears that the extent of public distribution or the aggregate market value of the security has become so reduced as to make continued listing on the NYSE American inadvisable; if the issuer sells or disposes of principal operating assets or ceases to be an operating company; if an issuer fails to comply with the NYSE American’s listing requirements; if an issuer's common stock sells at what the NYSE American considers a “low selling price” (generally trading below $0.20 per share for an extended period of time); maintaining minimum stockholders’ equity at least $6.0 million; or if any other event occurs or any condition exists which makes continued listing on the NYSE American, in its opinion, inadvisable.
If the NYSE American delists our securities, we could face significant consequences, including:
● a limited availability for market quotations for our securities;
● reduced liquidity with respect to our securities;
● a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in reduced trading;
● activity in the secondary trading market for our common stock;
● reduced opportunities for strategic alternatives;
● limited amount of news and analyst coverage; and
● a decreased ability to issue additional securities or obtain additional financing in the future.
While we continue to monitor our compliance with the NYSE American continued listing requirements, there can be no assurance that we will be able to continue to comply with the NYSE American listing requirements.
The market for the Company’s common stock may be thinly traded and stockholders may be unable to sell at or near ask prices or at all.
The Company’s common stock may be thinly traded on the NYSE American, meaning that the number of persons interested in purchasing the Company’s shares at or near ask prices at any given time may be relatively small or non-existent. Consequently, there may be periods of several days or more when trading activity in the Company’s shares is minimal or non-existent. The Company cannot assure investors that a broader or more active public trading market for the Company’s common stock will develop or be sustained or that current trading levels will be maintained.
Anti-takeover provisions in our charter and bylaws and in Delaware law could prevent or delay a change in control of Ampio.
Provisions of our certificate of incorporation and bylaws may discourage, delay, or prevent a merger or acquisition that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions include:
● requiring supermajority stockholder voting to effect certain amendments to our certificate of incorporation and bylaws;
● restricting the ability of stockholders to call special meetings of stockholders; and
● establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings.
If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us, our business, our market or our competitors. Coverage by securities and industry analysts and initiation of coverage in the future is uncertain at this time. If securities or industry analysts do not cover our company, the trading price for our stock could continue to be negatively impacted. Additionally, if any analyst downgrades our stock, our stock price would likely decline.Click or tap here to enter text.

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ITEM 1B. UNRESOLVED STAFF COMMENTS
Item 1B.
Unresolved Staff Comments.
None.

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ITEM 2. PROPERTIES
Item 2.Properties.
We maintain our headquarters, research laboratories, and manufacturing facilities in leased space located in Englewood, Colorado, for monthly minimum lease payments of approximately $30,000. The lease expires in September 2024.
Effective March 1, 2023, the Company entered into a sublease agreement with the consent of the Landlord pursuant to which the Company will sublease the Premises for a term commencing on March 1, 2023 and continuing until the expiration of the Lease on September 30, 2024. However, the address of the Company’s principal executive offices continues to be 373 Inverness Parkway, Suite 200, Englewood, Colorado 80112.

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ITEM 3. LEGAL PROCEEDINGS
Item 3. Legal Proceedings.
From time to time, the Company may be a party to litigation arising in the ordinary course of business. In addition, as of December 31, 2022, Ampio was involved in the following material pending legal proceedings:
Kain v. Ampio Pharmaceuticals, Inc., et al., 22-cv-2105
On August 17, 2022, a putative Ampio shareholder filed a securities fraud class action against the Company, its current CEO Michael A. Martino and two former executives, Michael Macaluso and Holli Cherevka, in the United States District Court for the District of Colorado, captioned Kain v. Ampio Pharmaceuticals, Inc., et al., 22-cv-2105. The Complaint alleges that Ampio and the individual defendants made various false and misleading statements regarding the efficacy, clinical trials and FDA communications relating to Ampio’s lead product, Ampion, and its treatment of severe osteoarthritis of the knee in violation of Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Rule 10b-5 promulgated thereunder. The Complaint also asserts control person liability against the individual defendants under Section 20 of the Exchange Act.
The Complaint relies largely on Ampio’s announcement on May 16, 2022, that it had formed a special Board committee to investigate the statistical analysis of Ampio’s AP-013 clinical trial and the unauthorized provision of Ampion to various individuals who were not participating in clinical trials, and Ampio’s further announcement on August 3, 2022, that the investigation had revealed that various employees were aware that the AP-013 trial did not demonstrate efficacy for Ampion’s primary endpoints and did not fully and timely report the results of the trial and the timing of unblinding data from the trial. Based on the Company’s reports, the Complaint asserts that various statements made by the Company during the Class Period were false and misleading because they: (i) inflated Ampio’s ability to successfully obtain FDA approval for Ampion; (ii) inflated the results of the AP-013 clinical trial and failed to disclose the timing of unblinding the data from the study; and (iii) overstated the Company’s business, operations and prospects.
The Complaint seeks an unspecified amount of compensatory damages as well as attorneys’ fees and costs. On October 17, 2022, six putative shareholders filed motions seeking to be named lead plaintiff. On November 7, 2022, two of the movants filed oppositions to each other’s motions; the remaining movants either withdrew their motions or filed non-oppositions to another putative shareholder’s motion. The Court has not yet ruled on the competing motions for appointment of lead plaintiff. In the interim, the Court approved the parties’ joint motion to stay proceedings, and all deadlines are deferred until after a decision on the lead plaintiff motion(s).
Ampio intends to defend itself vigorously against this action.
Maresca v. Martino, et al., 22-cv-2646-KLM
On October 7, 2022, putative Ampio shareholder Robert Maresca filed a Verified Shareholder Derivative Complaint in the United States District Court for the District of Colorado, captioned Maresca v. Martino, et al., 22-cv-2646-KLM. The derivative complaint, brought on behalf of the Company, asserts claims against a number of current and former executives and directors of the Company, namely Michael A. Martino, Michael Macaluso, Holli Cherevka, David Bar-Or, David Stevens, J. Kevin Buchi, Philip H. Coelho and Richard B. Giles.
Based largely on the same allegations as the Kain securities fraud class action complaint (including Ampio’s reports in May and August, 2022, regarding its internal investigation and findings), the Complaint asserts that the individual defendants caused the Company to make false or misleading statements in its SEC filings by “hyp[ing Ampio’s] ability to successfully file a BLA for Ampion;” “exaggerate[ing] results of the AP-013 study;” “misstat[ing] the true timing of
unblinding of data from the AP-013 study;” and “fail[ing] to maintain internal controls.” The Complaint also asserts that the defendants failed to exercise due care and comply with the Company’s policies and procedures designed to ensure Board and Audit Committee oversight of the business operations and that ethical business practices were maintained. It also contends that two of the defendants (Cherevka and Coelho) sold Company stock while in possession of material non-public information at artificially inflated prices in violation of the Company’s insider trading restrictions. The Complaint asserts that the individuals should not have received compensation while violating their duties to the Company. The Complaint also alleges that the defendants caused the Company to repurchase its own stock at artificially inflated prices, causing damage to the Company itself.
The Complaint asserts six causes of action on behalf of the Company and against the individual defendants: (1) violations of Section 14(a) of the Exchange Act based on purportedly false and misleading statements in the Company’s proxy statements; (2) violations of Section 10(b) of the Exchange Act and Rule 10b-5 promulgated thereunder; (3) control person liability under Section 20(a) of the Exchange Act; (4) breach of fiduciary duty; (5) unjust enrichment; and (6) waste of corporate assets. The Complaint seeks an unspecified amount of compensatory and restitution damages to be paid to Ampio, together with pre- and post-judgment interest, as well as injunctive relief imposing certain corporate governance reforms and attorneys’ fees and costs.
On November 2, 2022, the Company and plaintiff (together with plaintiff in a second derivative action -- the Marquis action, discussed below) filed a joint motion to consolidate the two derivative actions and appoint the lawyers representing the two plaintiffs as co-lead counsel. That same day, the Company and plaintiff filed a stipulation providing the Company additional time to answer, move or otherwise respond to the Complaint.
On January 10, 2023, after the Company received additional extensions of time to respond, the Court granted consolidation of the Maresca and Marquis actions but denied appointment of co-lead counsel for plaintiffs without prejudice. On January 11, 2023, Plaintiffs renewed their motion for appointment of co-lead counsel. On January 12, 2023, the Court granted the renewed motion and appointed co-lead counsel for plaintiffs.
On January 17, 2023, the parties filed a joint stipulated motion seeking a temporary stay of the consolidated derivative actions, subject to various conditions, until the earlier of: (1) the dismissal of the Kain action; (2) a defendant filing an answer in the Kain action; or (3) another derivative action being filed that is not stayed for the same duration. On January 25, 2023, the Court granted the motion for temporary stay. Accordingly, all deadlines are deferred until the stay is terminated.
Ampio intends to defend itself vigorously against this action.
Marquis v. Martino, et al., 22-cv-2803-KLM
On October 25, 2022, putative shareholder Samantha Marquis filed a derivative complaint in the United States District Court for the District of Colorado, captioned Marquis v. Martino, et al., 22-cv-2803-KLM. The Complaint, filed on behalf of Ampio, asserts that various current and former officers and directors of Ampio - namely, Michael Martino, Michael Macaluso, Holli Cherevka, David Bar-Or, David Stevens, Kevin Buchi, Philip Coelho, and Richard Giles, breached their fiduciary duties as directors and/or officers and violated Section 14(a) of the Exchange Act by causing the Company to file false and misleading proxy statements. The Complaint focuses on the Company’s alleged failure to timely report that the results of the AP-013 trial for Ampion were unfavorable, failing to show efficacy on the co-primary endpoints of pain and function, and the Company’s alleged failure to disclose the results of and timing of unblinding the study data. The Complaint asserts that the individual defendants breached their fiduciary duties by making or causing the Company to make materially false and misleading statements regarding Ampio’s business, operations and prospects and by failing to maintain adequate internal controls. Based on these allegations, the Complaint asserts two causes of action on behalf of the Company: (1) violations of Section 14(a) of the Exchange Act against all defendants other than Cherevka; and (2) breach of fiduciary duty against all defendants. Based on these claims, the Complaint seeks judgment in favor of the Company and against the individual defendants in an unspecified amount of compensatory and restitution damages, together with pre- and post-judgment interest and costs of the action including reasonable attorneys’ and experts’ fees as well as a mandatory injunction requiring Ampio and the defendants to reform and improve the corporate governance and internal controls of the Company.
On November 2, 2022, the Company and plaintiff (together with plaintiff in the previously filed Maresca action, discussed above) filed a joint motion to consolidate the two derivative actions and appoint the lawyers representing the two plaintiffs as co-lead counsel.
On January 10, 2023, the Court granted consolidation of the Maresca and Marquis actions but denied appointment of co-lead counsel for plaintiffs without prejudice. On January 11, 2023, Plaintiffs renewed their motion for appointment of co-lead counsel. On January 12, 2023, the Court granted the renewed motion and appointed co-lead counsel for plaintiffs.
On January 17, 2023, the parties filed a joint stipulated motion seeking a temporary stay of the consolidated derivative actions, subject to various conditions, until the earlier of: (1) the dismissal of the Kain action; (2) a defendant filing an answer in the Kain action; or (3) another derivative action being filed that is not stayed for the same duration. On January 25, 2023, the Court granted the motion for temporary stay. Accordingly, all deadlines are deferred until the stay is terminated.
Ampio intends to defend itself vigorously against this action.
McCann v. Martino, et al., 2023cv30287
On January 27, 2023, putative shareholder John McCann filed a derivative complaint in the District Court, City & County of Denver, State of Colorado, captioned McCann v. Martino, et al., 2023cv30287. The Complaint, filed on behalf of Ampio, asserts that various current and former officers and directors of Ampio - namely, Michael Martino, J. Kevin Buchi, David Stevens, Elizabeth Jobes, Holli Cherevka, David Bar-Or, Philip H. Coelho, and Richard B. Giles, breached their fiduciary duties as directors and/or officers by allowing the Company to issue false and misleading statements, The Complaint focuses on the Company’s alleged failure to timely report that the results of the AP-013 trial for Ampion were unfavorable, failing to show efficacy on the co-primary endpoints of pain and function, and the Company’s alleged failure to disclose the results of and timing of unblinding the study data. The Complaint asserts that the individual defendants breached their fiduciary duties by allowing the Company to make materially false and misleading statements regarding Ampio’s business, operations and prospects and by failing to maintain adequate internal controls. Based on these allegations, the Complaint asserts five causes of action on behalf of the Company: (1) breach of fiduciary duty against the current directors; (2) gross mismanagement against the current directors; (3) waste of corporate assets against the current directors; (4) unjust enrichment against all defendants; and (5) breach of fiduciary duty by insider trading against defendants Cherevka and Coelho. Based on these claims, the Complaint seeks judgment in favor of the Company and against the individual defendants in an unspecified amount of compensatory damages, costs of the action including reasonable attorneys’ and experts’ fees as well as a mandatory injunction requiring Ampio to reform and improve the corporate governance and internal procedures of the Company.
Defendant Cherevka was served and by order dated February 9, 2023, obtained an extension of time to respond to the Complaint through March 31, 2023. On March 2, 2023, the parties filed a joint stipulated motion seeking a temporary stay of the action, subject to various conditions, until the earlier of: (1) the dismissal of the Kain action; (2) a defendant filing an answer in the Kain action; or (3) another derivative action being filed that is not stayed for the same duration. On March 3, 2023, the Court granted the motion for temporary stay. Accordingly, all deadlines are deferred until the stay is terminated.
Ampio intends to defend itself vigorously against this action.
SEC Investigation
On October 12, 2022, the Securities and Exchange Commission, or SEC, entered an order directing private investigation and designating officers to take testimony to determine whether we or any other entities or persons have engaged in, or are about to engage in, any violations of the securities laws. The SEC has since issued subpoenas to the Company and numerous current and former officers, directors, employees and consultants of the Company. We intend to cooperate fully with the SEC.

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ITEM 4. MINE SAFETY DISCLOSURE
Item 4.Mine Safety Disclosures.
Not applicable.
PART II

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ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock currently trades on the NYSE American under the ticker symbol “AMPE.”
Holders of Common Stock
As of March 22, 2023, there were approximately 191 registered holders of our common stock. A substantially greater number of holders of our common stock are “street name” or beneficial holders, whose shares are held of record by banks, brokers, and other financial institutions.
Dividend Policy
We have never paid cash dividends and have no plans to pay cash dividends in the near future. We intend to utilize all current and future available sources of liquidity to develop and commercialize AR-300. If we issue any preferred stock and/or obtain financing from a bank in the future, the terms of those financings may contain restrictions on our ability to pay dividends in the near or long term.
Equity Compensation Plan Information
Information regarding our equity compensation plans is incorporated by reference from Part III, Item 12 “Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”

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ITEM 6. SELECTED FINANCIAL DATA
Item 6.[Reserved]

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing elsewhere in this report. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business and related financings, includes forward-looking statements that involve risks and uncertainties. You should read the “Risk Factors” section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Critical Accounting Policies, Estimates and Judgments
Our financial statements were prepared in accordance with GAAP. The preparation of the financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses incurred during the reporting period. On an on-going basis, management evaluates its estimates and judgments. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable and appropriate under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The methods, estimates, and judgments used by us in applying these critical accounting policies have a significant impact on the results we report in our financial statements. Additional information regarding our critical accounting policies and estimates is contained in Notes 2, 6, 8 and 10 to the Financial Statements. We consider the following accounting policies to be those that are most important to the portrayal of our financial condition and that require a higher degree of judgment.
Clinical Trial Accrual
As part of the process of preparing our financial statements, we are required to estimate our expenses resulting from our obligations under contracts with various vendors, which primarily include clinical and pre-clinical research organizations, consultants and clinical site/investigatory agreements in connection with our active and ongoing clinical trials over the reporting period. The financial terms of these contracts are subject to negotiations, subsequent amendment(s) as a result of change in scope of work and often results in payments that do not match the periods over which materials and/or services are provided under such contracts. Our key objective is to reflect the appropriate trial expenses in the financial statements by matching those expenses with the period in which services are performed, materials are received and efforts are expended. We account for these expenses according to the progress of the trials as measured by subject enrollment and progression/timing of various aspects of the trials. We determine accrual estimates by taking into account discussions with applicable personnel and outside service providers as to the progress or state of the trials, or the services completed. During the course of a clinical trial, we adjust the clinical expense recognition if actual results differ from estimates. We make estimates of our accrued expenses as of each balance sheet date based on the facts and circumstances known to us at that time. Our clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the reporting of amounts that are too high or too low for any particular period. To date, there have not been any material adjustments to our prior estimates of accrued research and development expenses. As of December 31, 2022 all of the clinical trials related to Ampion have been completed and, as such, we do not expect to incur any significant future costs related to these trials.
Share-Based Compensation
We account for share-based payments by recognizing compensation expense based upon the estimated fair value of the share-based payments on the date of grant. We determine the estimated fair value of the share-based payments granted using the fair market value of the stock in the case of restricted stock awards or Black-Scholes option pricing model in the case of stock options and recognize compensation costs ratably over the requisite service period which approximates the vesting period using the graded method. To calculate the fair value of the options, certain assumptions are made regarding components of the model, including the fair value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield and expected option life. Changes to the assumptions could cause significant adjustments to the valuation. We calculate our volatility assumptions using the actual changes in the market value of our stock. Forfeitures are recognized as they occur. Our historical option exercises do not provide a reasonable basis to estimate an expected term due to the lack of sufficient data. Therefore, we estimate the expected term by using the simplified method. The simplified method calculates the expected term as the average of the vesting term plus the contractual life of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. The assumptions used in determining the fair value of share-based awards represent our best estimates, but the estimates involve inherent uncertainties and the application of our judgment. As a result, if factors change and we use significantly different assumptions or estimates, our share-based compensation expense could be materially different in the future.
Impairment of Long-Lived Assets
Fixed assets are amortized or depreciated over their estimated useful life on a straight-line basis. We monitor conditions related to these assets to determine whether events and circumstances warrant a revision to the remaining amortization or depreciation period. Management performs an annual evaluation of the recoverability of the carrying value of its long-lived assets or whenever our management concludes events or changes in circumstances indicate that the carrying amount may not be recoverable. When we determine that the useful lives of assets are shorter than we had originally estimated, we accelerate the rate of depreciation over the assets’ new, shorter useful lives. During the year ended December 31, 2022, management determined that there were impairment indicators; the fair value of the long-lived assets were determined based on Level 3 fair value measurements and resulted in an impairment loss of $1.6 million.
Derivative Warrant Liabilities
Warrants issued pursuant to equity offerings that are potentially exercisable resulting in a variable number of shares being issued are considered derivative liabilities and therefore are measured at fair value. The Company uses the Black-Scholes pricing model to estimate fair value at each exercise and period end date. The key assumptions used in the model are the expected future volatility in the price of the Company’s shares and the expected life of the warrants. The impact of changes in key assumptions is described in Note 8.
Recent Accounting Pronouncements
Information regarding recently issued and relevant accounting standards (adopted and not adopted as of December 31, 2022) is contained in Note 2 to the Financial Statements.
Results of Operations-Year Ended December 31, 2022 Compared to December 31, 2021
We recognized a net loss for the year ended December 31, 2022 (the “2022 period”) of $16.3 million compared to the net loss recognized of $17.1 million for the year ended December 31, 2021 (the “2021 period”). The net loss during the 2022 period was primarily attributable to operating expenses of $22.3 million, that included a $1.9 million impairment loss related to long-lived and ROU assets; partially offset by the non-cash derivative gain and interest income of $5.8 million and $0.2 million, respectively. The net loss during fiscal 2021 was attributable to operating expenses of $20.6 million, partially offset by non-cash derivative gain of $3.5 million. Operating expenses increased $1.7 million, or 9%, from the 2021 period to the 2022 period primarily due to a (i) $2.8 million, or 32%, increase in general and administrative costs, (ii) recognition of $1.9 million impairment loss associated with the Company’s long-lived and ROU assets; partially offset by (iii) a $3.0 million reduction in research and development costs.
Research and Development
Research and development costs decreased by approximately $3.0 million, or 25%, for the 2022 period compared to the 2021 period. Categories of research and development costs are summarized as follows and exclude an allocation of general and administrative expenses:
Year Ended December 31,
Clinical trial and sponsored research expenses
$
2,991,000
$
5,787,000
Salaries and benefits
2,755,000
2,981,000
Depreciation
1,031,000
1,070,000
Laboratory
890,000
779,000
Professional fees
780,000
335,000
Operations/manufacturing
308,000
816,000
Share-based compensation
139,000
46,000
Other
22,000
86,000
Total research and development
$
8,916,000
$
11,900,000
Clinical trial and sponsored research expenses
The clinical trial and sponsored research expenses decreased by approximately $2.8 million or 48%, primarily due to a decrease in certain Ampion clinical trial costs (i.e., AP-017, AP-018 and AP-019) totaling $1.7 million. These studies commenced in late 2020 through the first half of 2021 but were substantially completed from a patient enrollment perspective in early 2022. In addition, clinical trial costs related to Ampion clinical trial AP-013 decreased $1.1 million as the study was completed with an analysis of the results filed with the FDA in late first quarter 2022 with modest costs related to final close-out of the study throughout the remainder of the 2022 period. All clinical trials were completed in 2022.
Salaries and benefits
Salaries and benefits expenses decreased $0.2 million, or 8%, for the 2022 period compared with the 2021 period primarily due to the reduction in force (“RIF”) communicated in August 2022 which resulted in a reduction of 11 full-time equivalents (“FTEs”) with 9 FTEs separated in August 2022 and 2 FTEs in January 2023. As a result of the RIF and the termination of two executive officers, 2022 had a weighted average 11 FTEs which was 27% lower than a weighted average 15 FTEs for 2021. The reduction of salary and benefits cost for 2022 resulting from lower average FTEs and the lack of incentive compensation accrued in 2022 was partially offset by severance and related benefits related to the RIF totaling approximately $0.7 million. Accordingly, we have implemented a hybrid organizational model whereby we retain the organizational competencies to govern and comply with the public reporting requirements and select and manage specific third-party independent contractors with proven industry expertise in formulation development, preclinical development, GMP manufacturing, clinical development, regulatory and legal on an as needed basis. We believe this model will position us best to develop AR-300 in the most expeditious and cost-effective manner, and effectively control the fixed costs associated with building an all-employee organization.
Professional Fees
Professional fees expense increased $0.4 million, or 133% for the 2022 period compared with the 2021 period as a result of the engagement of Chief Medical Officer, serving in the capacity as a consultant which commenced in the fourth quarter 2021 and continued throughout the 2022 period. In addition, we incurred incremental costs in the 2022 period associated with additional third-party biostatisticians and other consultants in connection with finalizing and closing out the prior Ampion clinical studies (i.e., AP-013, AP-017, AP-018 and AP-019).
Operations/Manufacturing
Operations/manufacturing expense decreased by $0.5 million or 62% as all studies were completed during the 2022 period and, as such, the purchase of supplies to manufacture clinical trial product was not necessary.
General and Administrative
General and administrative expenses increased $2.8 million, or 32%, for the 2022 period compared to the 2021 period. Categories of general and administrative expenses are summarized as follows:
Year Ended December 31,
Professional fees
$
6,896,000
$
2,517,000
Salaries and benefits
1,485,000
1,141,000
Insurance
1,124,000
1,186,000
Share-based compensation
814,000
2,758,000
Facilities
538,000
512,000
Director fees
312,000
350,000
Other
297,000
207,000
Total general and administrative
$
11,466,000
$
8,671,000
Professional fees
Professional fees increased $4.4 million, or 174%, for the 2022 period compared to the 2021 period due primarily to legal costs incurred related to investigations coordinated and conducted by the independent special committee of the Ampio Board of Directors (the “Special Committee”) and which focused primarily on (i) the statistical analysis of Ampio’s AP-013 clinical trial and (ii) the unauthorized provision of Ampion. In addition, the increase is also attributable to incremental legal costs associated with an SEC investigation and class action / derivative lawsuits initiated in the second half of 2022. Legal costs will continue to be incurred by the Company to defend itself vigorously against these actions. Finally, we incurred an increase in costs associated with the evaluation and assessment of strategic opportunities and outsourced accounting, market research studies and public and investor relation services which were focused primarily on a special stockholders meeting and the approval of the reverse stock split effected on November 9, 2022.
Salaries and benefits
Salaries and benefit expense increased $0.3 million, or 30%, for the 2022 period compared with the 2021 period as a result of market-based compensation adjustments for the Chief Executive Officer and Chief Financial Officer effective in October 2021 which was partially offset by a lower weighted average incremental headcount during the 2022 period due primarily to the termination of the employment of one executive officer in May 2022.
Share-based Compensation
Share-based compensation expense decreased $1.9 million, or 71%, primarily due to stock option and restricted stock award adjustments related to forfeitures and cancellations of unvested stock options / restricted stock awards resulting from the employee terminations / board resignations during the 2022 period and whereby the expense was previously recognized.
Impairment of Long-lived Fixed and ROU Assets
In accordance with ASC Topic 360, Property, Plant and Equipment, the Company assesses all of its long-lived assets for impairment when impairment indicators are identified. Based on the assessment performed on September 30, 2022, the Company recorded a non-cash impairment related to its long-lived assets which was triggered by the Company’s announcement during the third quarter reporting period that it was discontinuing further development of its lead development asset, Ampion. Since the carrying value of the long-lived assets exceeded its undiscounted cash flows, an impairment loss, calculated as the difference between carrying value and fair value, was necessary. Accordingly, the Company recorded a $1.6 million impairment loss for the year ended December 31, 2022 through a direct reduction to the cost basis of the affected assets in its balance sheet.
In addition, the Company performed an assessment of potential impairment of the ROU asset consistent with the approach applied to other long-lived assets. ROU assets are reviewed for recoverability whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. If the carrying amount of an asset exceeds its estimated future undiscounted cash flows, an impairment loss is recorded for the excess of the asset’s carrying amount over its fair value. Accordingly, the Company recorded a $0.3 million impairment loss on the ROU asset for the year ended December 31, 2022.
There were no impairment charges for the year ended December 31, 2021.
Cash Flows
Cash flows for the respective periods are as follows:
Year Ended December 31,
Net cash used in operating activities
$
(21,128,000)
$
(14,089,000)
Net cash used in investing activities
-
(97,000)
Net cash (used in) provided by financing activities
(111,000)
30,732,000
Net change in cash and cash equivalents
$
(21,239,000)
$
16,546,000
Net Cash Used in Operating Activities
During the 2022 period, our operating activities used approximately $21.1 million in cash and cash equivalents, which was more than our reported net loss of $16.3 million. The difference of approximately $4.8 million is attributable to a non-cash adjustment of $5.8 million related to the warrant derivative gain and a decrease in accounts payable and accrued expenses of $4.0 million, partially offset by non-cash charges related to impairment loss, depreciation, accretion, amortization and stock-based compensation totaling $3.9 million and decreases in prepaid expenses and other of $1.1 million.
During the 2021 period, our operating activities used approximately $14.1 million in cash and cash equivalents, which was less than our reported net loss of $17.1 million. The difference is primarily a result of periodic non-cash charges
related to depreciation and amortization and share-based compensation totaling $3.9 million and an increase in working capital of $2.6 million; partially offset by the non-cash adjustment for the warrant derivative gain totaling $3.5 million.
Net Cash Used in Investing Activities
During the 2022 period, there was no change in cash related to investing activities. During the 2021 period, $97,000 in cash and cash equivalents was used to acquire manufacturing machinery and equipment.
Net Cash Used in (Provided by) Financing Activities
During the 2022 period, we settled a tax liability of $79,000 related to the vesting of restricted stock awards. As a result of the settlement, the Company withheld 9,234 common shares for taxes which represented the fair value of the tax settlement. In addition, the Company paid $32,000 in offering costs related to the registered direct offering which was finalized in December 2021.
During the 2021 period, we received gross proceeds of $22.5 million in connection with a registered direct offering, which was partially offset by offering-related costs of $1.8 million. We also received approximately $10.5 million from the sale of approximately 0.4 million shares of common stock pursuant to the ATM equity offering program, which was partially offset by offering-related costs of $0.5 million. In addition, we received proceeds of $0.2 million from investor warrant exercises and stock option exercises which was offset by the shares held back in the settlement of tax obligations related to the restricted stock awards totaling $0.2 million.
Contractual Obligations and Commitments
Our contractual obligations as of December 31, 2022 primarily consist of employment agreements and a non-cancellable operating lease arrangement for our office and manufacturing facility. As of December 31, 2022, the value of our obligations under the operating lease was $614,000. For a more detailed description of our contractual obligations see Note 6 to the Financial Statements.
Liquidity and Capital Resources
Since inception, we have not generated revenue, profits or operating cash flow. Over this period, we have continued to be focused on research and pre-clinical / clinical development all of which has required raising a substantial amount of capital. We have completed the clinical trial reports for all legacy Ampion trials and have concluded any further development efforts on Ampion. We have shifted nearly all of our focus towards the preclinical development of AR-300 and we are currently conducting studies to evaluate the efficacy of AR-300 in osteoarthritis-related pain.
The Company’s sources of liquidity are its cash and cash equivalents, which were $12,653,000 on December 31, 2022. We expect to use cash in operations for the continued development of AR-300, as well as opportunistically identifying and evaluating strategic opportunities as part of the strategic alternatives process. Based on our current projection we expect our cash balance at December 31, 2022 to support existing business operations through the fourth quarter of 2023. These projections are based on assumptions that may prove to be incorrect. As such, it is possible that we could exhaust our available cash and cash equivalents earlier than presently anticipated.
If we determine to move forward with the clinical development of AR-300, we believe the development and regulatory process could comprise five-to-seven years and require an incremental investment over and above Ampio’s general operating expense during that period. We intend to fund future AR-300 clinical development expense through an offering of our equity securities. We may also seek to raise equity capital in order to attempt to cure non-compliance with the minimum stockholders’ equity requirement of the NYSE American. Such additional liquidity is subject to market conditions and other factors, including limitations that may apply to the Company under applicable SEC and NYSE American regulations and challenges associated with raising sufficient capital to meet the Company’s financing needs in light of the Company’s current stock price and related constraints. Should we require additional financing, financing may not be available in the amount or at the time we need it and/or may not be available on acceptable terms or at all.
Although we have implemented cash-focused measures to manage liquidity such as the RIF and implementation of our outsourcing philosophy and the recent sublease of our office and manufacturing facility, we continue to expect cash used
by operating activities for 2023 to be negatively impacted by general and administrative expense, driven by higher professional fees including incremental legal and other costs associated with an SEC investigation and class action / derivative lawsuits.
Based on management's sensitivity analysis of liquidity requirements, we expect we will be able to maintain current operations and meet anticipated capital expenditure requirements through the fourth quarter 2023 based upon our cash resources and our ability to delay or discontinue development of AR-300 in order to limit expenses consistent with the availability of our cash resources. However, it is possible that we could exhaust our available cash and cash equivalents earlier than presently anticipated due to a number of factors, including unexpected expense associated with legal matters, strategic alternatives or transactions, compliance with our reporting requirements, efforts to raise capital for AR-300 and maintain our listing on the NYSE American. Our lack of revenue or cash inflows and our cash resources on December 31, 2022 raise substantial doubt as to our ability to continue as a going concern.
Management’s plans to address the doubt regarding the Company’s ability to continue as a going concern include active monitoring of our operating expenses and use of our outsourcing philosophy to minimize expenses associated with AR-300. Management expects to manage future expense associated with AR-300 clinical development to align with the timing and amount of expense with future capital raising activities. If our available cash resources are insufficient to fund our expenses (including relating to legal proceedings) and the development of AR-300 and/or completion of a strategic transaction, we may implement further cost reduction and other cash-focused measures to manage liquidity and we may pursue a plan of liquidation or dissolution of Ampio or seek bankruptcy protection. If we decided to cease operations and dissolve and liquidate our assets, it is unclear to what extent we would be able to pay our obligations. In such a circumstance and in light of the Company’s current liquidity position and pending legal matters, it is unlikely that cash would be available for distributions to stockholders.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 8. Financial Statements and Supplementary Data.
The Financial Statements and Supplementary Data required by this item are in Item 15 of Part IV, “Index to Financial Statements” at page of this annual report on Form 10-K and are incorporated herein by reference.

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.

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ITEM 9A. CONTROLS AND PROCEDURES
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as such terms are defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure.
As of the end of the period covered by the Quarterly Report on Form 10-Q for the period ending March 31, 2022, the CEO and the CFO concluded that our disclosure controls and procedures were not effective due to the maters identified as part of the Company’s decision announced on May 16, 2022, to conduct internal investigations to be overseen by the Special Committee. The Special Committee concluded its investigation and the results and findings are further described in the announcement made on August 3, 2022. The Company has taken the following actions based in part upon the investigations and the findings of the Special Committee:
● Terminated the employment of two executive officers;
● Restructured the Board of Directors through resignation of certain directors;
● Separated the role of Chair of the Board and Chief Executive Officer;
● Re-constituted the Company’s Disclosure Committee with additional subject matter experts;
● Enhanced Company policies and procedures including those related to inventory management and distribution; and
● Conducted company-wide training regarding use of clinical trial stage pre-development drugs.
Due to sufficient passage of time to demonstrate operating effectiveness of the changes and improvements that were implemented subsequent to March 31, 2022, and the results of the evaluation performed under the supervision and with the participation of senior management, including the CEO and the CFO, the company’s design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15(b) and 15d-15(b) were deemed effective as of the end of the period covered by this report.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal controls over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act). Our management assessed the effectiveness of our internal controls over financial reporting as of December 31, 2022. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013). Our management has concluded that, as of December 31, 2022, our internal controls over financial reporting are effective based on these criteria.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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ITEM 9B. OTHER INFORMATION
Item 9B. Other Information.
None.

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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Item 10. Directors, Executive Officers and Corporate Governance.
The information required by this item is to be included in our 2023 Proxy Statement as follows:
• The information relating to our directors and nominees for director is to be included in the section entitled “Proposal 1-Election of Directors;”
• The information relating to our executive officers is to be included in the section entitled “Executive Officers;”
• The information relating to our audit committee, audit committee financial expert and procedures by which shareholders may recommend nominees to our board of directors is to be included in the section entitled “Board of Directors and Committees; Corporate Governance;” and
• If required, the information regarding compliance with Section 16(a) of the Exchange Act is to be included in the section entitled “Delinquent Section 16(a) Reports.”
Such information is incorporated herein by reference to our 2023 Proxy Statement.
Our Code of Business Conduct and Ethics applies to all of our employees, directors and officers, including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions, and those of our subsidiaries. The Code of Business Conduct and Ethics is available on our website at www.ampiopharma.com under the section entitled “Investors” under “Corporate Governance.” We intend to satisfy the disclosure requirements under Item 5.05 of the SEC Form 8-K regarding an amendment to, or waiver from, a provision of our Code of Business Conduct and Ethics by posting such information on our website at the website address and location specified above.

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ITEM 11. EXECUTIVE COMPENSATION
Item 11.
Executive Compensation.
The information required by this item is to be included in our 2023 Proxy Statement under the sections entitled “Executive Compensation,” and “Non-Employee Director Compensation,” and is incorporated herein by reference.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this item with respect to equity compensation plans is to be included in our 2023 Proxy Statement under the section entitled “Equity Compensation Plan Information” and the information required by this item with respect to security ownership of certain beneficial owners and management is to be included in our 2023 Proxy Statement under the section entitled “Security Ownership of Certain Beneficial Owners and Management” and in each case is incorporated herein by reference.

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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Item 13.
Certain Relationships and Related Transactions, and Director Independence.
The information required by this item is to be included in our 2023 Proxy Statement under the sections entitled “Certain Relationships and Related Party Transactions” and “Director Independence” and is incorporated herein by reference.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Item 14.
Principal Accountant Fees and Services.
The information required by this item is to be included in our 2023 Proxy Statement under the section entitled “Proposal 2-Ratification of Appointment of Independent Registered Public Accounting Firm” and is incorporated herein by reference.
PART IV

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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
Item 15.
Exhibits and Financial Statement Schedules.
(a)(1) Financial Statements
The following documents are filed as part of this Form 10-K, as set forth on the Index to Financial Statements found on page.
●Report of Independent Registered Public Accounting Firm
●Balance Sheets as of December 31, 2022 and 2021
●Statements of Operations for the years ended December 31, 2022 and 2021
●Statements of Stockholders’ Equity for the years ended December 31, 2022 and 2021
●Statements of Cash Flows for the years ended December 31, 2022 and 2021
●Notes to Financial Statements
(a)(2) Financial Statement Schedules
Not Applicable.
(a)(3) Exhibits
Exhibit
number
Exhibit title
3.1
Certificate of Incorporation of Chay Enterprises, Inc. (Incorporated by reference to Exhibit 3.3 of the Registrant’s Form 8-K filed March 30, 2010).
3.2
Certificate of Amendment to Certificate of Incorporation of Ampio Pharmaceuticals, Inc. (f/k/a Chay Enterprises, Inc. (Incorporated by reference to Exhibit 3.4 of the Registrant’s Form 8-K filed March 30, 2010).
3.3
Certificate of Amendment to Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to the Registrant’s Form 8-K filed December 18, 2019).
3.4
Certificate of Amendment to Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to the Registrant’s Form 8-K filed November 9, 2022).
3.5
Amended and Restated Bylaws of the Registrant, as currently in effect. (Incorporated by reference to Exhibit 3.1 to the Registrant’s Form 10-Q filed November 14, 2018).
4.1
Specimen Common Stock Certificate of the Registrant. (Incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-K for the year ended December 31, 2021).
4.2
Description of Capital Stock of Ampio Pharmaceuticals, Inc. (Incorporated by reference to Exhibit 4.5 to the Registrant’s Form 10-K filed on February 21, 2020).
10.1**
2010 Stock Incentive Plan and forms of option agreements. (Incorporated by reference to Exhibit 10.7 from Registrant’s Form 8-K/A filed March 17, 2010)
10.2**
Amendment of 2010 Stock and Incentive Plan. (Incorporated by reference to Appendix A to the Registrant’s Proxy Statement on Form 14A filed October 21, 2011)
10.3**
2019 Stock Incentive Plan and forms of option agreements. (Incorporated by reference to Exhibit 10.4 to the Registrant’s Form 10-K filed on March 3, 2021)
10.4**
Form of restricted stock award agreement under the 2019 Stock Incentive Plan. (Incorporated by reference to Exhibit 10.4 to the Registrant’s Form 10-K filed on March 29, 2022)
10.5
Lease Agreement by and between Ampio Pharmaceuticals, Inc. and NCWP - Inverness Business Park, LLC, dated December 13, 2013. (Incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed December 19, 2013)
10.6**
Employment Agreement between Ampio Pharmaceuticals, Inc. and Daniel Stokely, dated October 11, 2021. (Incorporated by reference to Exhibit 10.8 to the Registrant’s Form 10-K filed on March 29, 2022)
10.7**
Employment Agreement between Ampio Pharmaceuticals, Inc. and Michael Martino, dated November 22, 2021. (Incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K Filed November 29, 2021)
10.8**
Amendment No. 1 to Employment Agreement by and between Ampio Pharmaceuticals, Inc. and Michael A. Martino, dated August 30, 2022. (Incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K filed on September 1, 2022)
10.9**
Stock Option Cancellation and Grant Agreement for Executive between Ampio Pharmaceuticals, Inc. and Daniel Stokely, dated August 20, 2019. (Incorporated by reference to Exhibit 10.2 to the Registrant's Form 8-K filed August 23, 2019)
10.10**
Form of Indemnification Agreement between Ampio Pharmaceuticals, Inc. and certain directors, executive officers and key employees. (Incorporated by reference to Exhibit 10.11 to the Registrant’s Form 10-K filed on March 29, 2022)
10.11**
Amendment to Cancellation Agreement, dated November 7, 2019, between Ampio Pharmaceuticals Inc. and Daniel Stokely. (Incorporated by reference to Exhibit 10.4 to the Registrant's Form 10-Q filed November 7, 2019)
14.1
Ampio Pharmaceuticals, Inc. Code of Business Conduct and Ethics. (Incorporated by reference to Exhibit 14.1 to the Registrant’s Form 8-K filed December 18, 2019.)
23.1*
Consent of Moss Adams LLP.
31.1*
Certificate of the Chief Executive Officer of Ampio Pharmaceuticals, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certificate of the Chief Financial Officer of Ampio Pharmaceuticals, Inc. pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*
Certificate of the Chief Executive Officer and the Chief Financial Officer of Ampio Pharmaceuticals, Inc. pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
Inline XBRL (extensible Business Reporting Language). The following materials from Ampio Pharmaceuticals, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2022 formatted in XBRL: (i) the Balance Sheets, (ii) the Statements of Operations, (iii) the Statements of Stockholders’ Equity (Deficit), (iv) the Statements of Cash Flows, and (v) the Notes to the Financial Statements.
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed herewith.
**
This exhibit is a management contract or compensatory plan or arrangement.