UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


	☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the ~~Quarterly Period Ended:~~quarterly period ended: ~~June 30, 2021~~March 31, 2022


	☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-35182

cid:image001.jpg@01CDF343.4BBAE3B0

AMPIO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)


Delaware	26-0179592
(State or other jurisdiction of incorporation or organization)	(IRS Employer Identification No.)

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

(720) 437-6500

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol	Name of each exchange on which registered:
Common ~~Stock,~~stock, par value $0.0001 per share	AMPE	NYSE American

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large Accelerated Filer	☐	Accelerated Filer	☐

Non-Accelerated Filer	☒	Smaller reporting company	☒

		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of ~~July 30, 2021,~~May 6, 2022, there were ~~200,457,957~~227,186,867 outstanding shares of common stock, par value $0.0001 per share, of the registrant.

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AMPIO PHARMACEUTICALS, INC.

FOR THE QUARTER ENDED ~~JUNE 30, 2021~~MARCH 31, 2022

INDEX

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains statements reflecting assumptions, expectations, projections, intentions or beliefs about future events that are intended as forward-looking statements. All statements included or incorporated by reference in this report, other than statements of historical fact, that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements appear in a number of places, including “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements represent our reasonable judgment about the future based on various factors and using numerous assumptions and are subject to known and unknown risks, uncertainties and other factors that could cause our actual results and financial position to differ materially from those contemplated by such statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts, and use words such as “anticipate,” “forecast,” “suggest,” believe,” “continue,” “ongoing,” “opportunity,” “predicts”, “seek,” “believe,” “could,” “estimate,” “expect,” “future,” “intend,” “may,” “should,” “plan,” “potential,” “project,” “will,” “would” and other words of similar meaning, or the negatives of such terms or other variations. These include, but are not limited to, statements relating to the following:

●

projected operating or financial results, including anticipated cash flows used in operations;

●

expectations regarding clinical trials for Ampion, capital expenditures, research and development expenses and other payments;

●

our beliefs and assumptions relating to our liquidity position, including, but not limited to, our ability to obtain near-term additional financing;

●

our beliefs, assumptions and expectations about the regulatory approval pathway for Ampion including, but not limited to, our ability to obtain regulatory approval for Ampion in a timely manner, or at all; and

●

our ability to identify strategic partners and enter into beneficial license, co-development, collaboration or similar arrangements.

Any or all of our forward-looking statements may turn out to be wrong. They may be affected by inaccurate assumptions or by known or unknown risks, uncertainties and other factors including, among others:

●

the results of the independent internal investigation we announced on May 16, 2022, as well as the time and expense associated with the investigation and related matters;

●

the actual and perceived effectiveness of Ampion, and how Ampion compares to competitive products;

●

the progress and results of clinical trials for Ampion and additional costs or delays associated therewith;

●

our ability to ~~continue as a going concern;~~receive regulatory approval for and sell the products that we are developing for the treatment of severe osteoarthritis of the knee (“OAK”) or COVID-19;

●

the fact that we have incurred significant losses since inception, expect to incur net losses for at least the next several years and may never achieve or sustain profitability;

●

our ability to fund our operations, including our ability to access ~~sufficient~~ funding through our “at-the-market” equity offering or through other equity or debt offerings;

●

our ability to retain key employees, consultants, and advisors and to attract, retain and motivate qualified personnel;

●

~~the progress and results of clinical trials for~~ ~~Ampion and additional costs or delays associated therewith~~;

●

~~the significant competition in the search for a treatment for COVID-19;~~

●

our ability to enroll hospitalized patients in our Phase I and II trials of Ampion for the treatment of COVID-19 given the unplanned variability of the virus, vaccine rates and mutations in the virus in certain geographies;

●

~~our ability to receive regulatory approval for and sell the products that we are developing for the treatment of COVID-19;~~

●

our reliance on third parties to conduct our clinical trials resulting in costs or delays that prevent us from successfully commercializing Ampion;

●

competition for patients in conducting clinical trials, delaying product development and straining our limited financial resources;

●

the risk and costs associated with our decision to suspend enrollment in the Phase III clinical trial for treatment of severe Osteoarthritis of the Knee due to considerations relating to the COVID-19 pandemic;

●

our ability to navigate the regulatory approval process in the U.S. and other countries, and our success in obtaining required regulatory approvals for Ampion on a timely basis;

●

our need to rely on third party manufacturers if we receive regulatory approval for Ampion but do not have redundant manufacturing capabilities;

●

commercial developments for products that compete with Ampion;

●

the ~~actual and perceived effectiveness of Ampion, and how Ampion compares to competitive products;~~

~~Table of Contents~~

●

~~the~~ rate and degree of market acceptance and clinical utility of Ampion or any of our other product candidates for which we receive marketing approval;

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●

the possibility that, even if Ampion is approved for commercialization, the ~~FDA~~U.S. Food and Drug Administration (“FDA”) may impose limitations on its use or reduce the approved indications on the product label;

●

expenses and costs we will incur to comply with FDA post-approval requirements if we, or our collaborators, obtain marketing approval for Ampion;

●

government restrictions on pricing reimbursement, as well as other healthcare payor cost-containment initiatives;

●

our ability to obtain approval to develop, manufacture and sell our products ~~internationally;~~in global markets;

●

our ability to realize the investment we made in our manufacturing facility if Ampion does not receive marketing approval;

●

adverse effects and the unpredictable nature of the ~~recent and~~ ongoing COVID-19 pandemic;

●

the strength, enforceability and duration of our intellectual property protection, and the eligibility of our patent portfolio for FDA market exclusivity;

●

our success in avoiding infringement of the intellectual property rights of others;

●

adverse developments in our research and development activities;

●

potential liability if any of our product candidates cause illness, injury or death, or adverse publicity from any such events;

●

our ability to operate our business efficiently, manage capital expenditures and costs (including general and administrative expenses) and obtain financing when required; and

●

our expectations with respect to future licensing, partnering or other strategic activities.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the expectations, estimates, projections, beliefs and assumptions of our management, based on information currently available to management, all of which are subject to change. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, changes in circumstances and other factors that are difficult to predict and many of which are outside our control, any of which could cause our actual results and the timing of certain events to differ materially and adversely from those expressed or implied by such forward-looking statements. Additional factors that could cause or contribute to such differences include, but are not limited to, those described in the section entitled “Risk Factors” in Part I, Item 1A of the Form 10-K. These risks are not exhaustive. Other sections of this Annual Report include additional factors that could adversely impact our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

In addition, there may be other factors that could cause our actual results to be materially different from the results referenced in the forward-looking statements, some of which are included elsewhere in this report, including, but not limited to, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March ~~3, 2021~~29, 2022 (the ~~“2020~~“2021 Annual Report”), particularly in the “Risk Factors” sections of each report, that could cause actual results or events to differ materially from the forward-looking statements that we make herein. Many of these factors will be important in determining our actual future results. Consequently, no forward-looking statement should be relied upon. Our actual future results may vary materially from those expressed or implied in any forward-looking statements. All forward-looking statements contained in this report are qualified in their entirety by this cautionary statement. Forward-looking statements speak only as of the date they are made, and we disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of this report, except as otherwise required by applicable law.

This Quarterly Report on Form 10-Q includes trademarks for Ampion^®, which are protected under applicable intellectual property laws and are our property. Solely for convenience, our trademarks and trade names referred to in this Quarterly Report on Form 10-Q may appear without the ^® or ^TM symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights to these trademarks and trade names.

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

AMPIO PHARMACEUTICALS, INC.

Condensed Balance Sheets

(unaudited)


	June 30,		December 31,		March 31,		December 31,
	2021		2020		2022		2021

Assets
Current assets
Cash and cash equivalents	$	20,549,000	$	17,346,000	$	28,837,000	$	33,892,000
Prepaid expenses and other		2,358,000		1,147,000		1,070,000		1,740,000
Total current assets		22,907,000		18,493,000		29,907,000		35,632,000

Fixed assets, net		3,074,000		3,561,000		2,302,000		2,564,000
Right-of-use asset		728,000		824,000
Right-of-use asset, net						577,000		629,000
Total assets	$	26,709,000	$	22,878,000	$	32,786,000	$	38,825,000

Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable and accrued expenses	$	2,937,000	$	1,550,000	$	5,208,000	$	4,811,000
Lease liability-current portion		298,000		284,000		318,000		311,000
Total current liabilities		3,235,000		1,834,000		5,526,000		5,122,000

Lease liability-long-term		773,000		925,000		533,000		614,000
Warrant derivative liability		2,340,000		2,607,000		4,474,000		5,805,000
Total liabilities		6,348,000		5,366,000		10,533,000		11,541,000

Commitments and contingencies (Note 7)
Commitments and contingencies (Note 5)

Stockholders’ equity
Preferred Stock, par value $0.0001; 10,000,000 shares authorized; NaN issued		—		—		—		—
Common Stock, par value $0.0001; 300,000,000 shares authorized; shares issued and outstanding - 200,070,419 as of June 30, 2021 and 193,378,996 as of December 31, 2020		20,000		19,000
Common Stock, par value $0.0001; 300,000,000 shares authorized; shares issued and outstanding - 227,186,867 as of March 31, 2022 and 227,325,381 as of December 31, 2021						23,000		23,000
Additional paid-in capital		228,091,000		218,020,000		245,468,000		244,863,000
Accumulated deficit		(207,750,000)		(200,527,000)		(223,238,000)		(217,602,000)
Total stockholders’ equity		20,361,000		17,512,000		22,253,000		27,284,000

Total liabilities and stockholders’ equity	$	26,709,000	$	22,878,000	$	32,786,000	$	38,825,000

The accompanying notes are an integral part of these financial statements.

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AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Operations

(unaudited)


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
	2021		2020		2021		2020		2022		2021

Operating expenses
Research and development	$	2,273,000	$	1,118,000	$	4,568,000	$	5,373,000	$	3,687,000	$	2,296,000
General and administrative		1,400,000		1,482,000		2,923,000		3,249,000		3,283,000		1,523,000
Total operating expenses		3,673,000		2,600,000		7,491,000		8,622,000		6,970,000		3,819,000

Other income (expense)
Other income
Interest income		1,000		0		2,000		12,000		3,000		1,000
Paycheck Protection Program loan forgiveness		—		544,000		—		544,000
Derivative gain (loss)		116,000		(675,000)		267,000		156,000
Total other income (expense)		117,000		(131,000)		269,000		712,000
Derivative gain										1,331,000		151,000
Total other income										1,334,000		152,000

Net loss	$	(3,556,000)	$	(2,731,000)	$	(7,222,000)	$	(7,910,000)	$	(5,636,000)	$	(3,667,000)

Net loss per common share:
Basic	$	(0.02)	$	(0.02)	$	(0.04)	$	(0.05)	$	(0.02)	$	(0.02)
Diluted	$	(0.02)	$	(0.02)	$	(0.04)	$	(0.05)	$	(0.03)	$	(0.02)

Weighted average number of common shares outstanding:
Basic		196,179,371		166,392,893		195,785,398		162,723,309		226,083,328		195,387,047
Diluted		201,448,038		166,392,893		200,985,349		163,906,257		226,110,693		200,752,267

The accompanying notes are an integral part of these financial statements.

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AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Stockholders’ Equity

(unaudited)


					Additional				Total					Additional				Total
		Common Stock			Paid-in		Accumulated		Stockholders'		Common Stock			Paid-in		Accumulated		Stockholders'
		Shares	Amount		Capital		Deficit		Equity		Shares	Amount		Capital		Deficit		Equity
Balance at December 31, 2019		158,644,757	$	16,000	$	191,060,000	$	(184,633,000)	$	6,443,000

Balance at December 31, 2020											193,378,996	$	19,000	$	218,020,000	$	(200,527,000)	$	17,512,000
Issuance of common stock for services		136,236		0		80,000		0		80,000	54,052		0		80,000		0		80,000
Stock-based compensation, net of forfeitures		—		0		213,000		0		213,000
Issuance of common stock in connection with the "at-the-market" equity offering program		1,241,126		0		682,000		0		682,000
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program		—		0		(246,000)		0		(246,000)
Net loss		—		0		0		(5,179,000)		(5,179,000)

Balance at March 31, 2020		160,022,119	$	16,000	$	191,789,000	$	(189,812,000)	$	1,993,000

Stock-based compensation, net of forfeitures		—		0		64,000		0		64,000
Share-based compensation, net of forfeitures											—		0		166,000		0		166,000
Stock options exercised, net		1,314		0		0		0		0	129,500		0		33,000		0		33,000
Warrants exercised		250,000		0		100,000		0		100,000
Issuance of common stock in connection with the "at-the-market" equity offering program		13,068,517		1,000		7,230,000		0		7,231,000
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program		—		0		(314,000)		0		(314,000)
Net loss		—		0		0		(2,731,000)		(2,731,000)

Balance at June 30, 2020		173,341,950	$	17,000	$	198,869,000	$	(192,543,000)	$	6,343,000


Balance at December 31, 2020		193,378,996		19,000		218,020,000		(200,527,000)		17,512,000

Issuance of common stock for services		54,052		0		80,000		0		80,000
Stock-based compensation, net of forfeitures		—		0		166,000		0		166,000
Stock options exercised, net		129,500		0		33,000		0		33,000
Shares held back in settlement of tax obligation and exercise cost		(28,562)		0		(40,000)		0		(40,000)
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards											(28,562)				(40,000)		0		(40,000)
Warrants exercised, net		306,705		0		114,000		0		114,000	306,705		0		114,000		0		114,000
Issuance of common stock in connection with the "at-the-market" equity offering program		1,848,437		0		2,705,000		0		2,705,000	1,848,437		0		2,705,000		0		2,705,000
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program		—		0		(126,000)		0		(126,000)	—		0		(126,000)		0		(126,000)
Net loss		—		0		0		(3,667,000)		(3,667,000)	—		0		0		(3,667,000)		(3,667,000)

Balance at March 31, 2021		195,689,128	$	19,000	$	220,952,000	$	(204,194,000)	$	16,777,000	195,689,128	$	19,000	$	220,952,000	$	(204,194,000)	$	16,777,000

Stock-based compensation, net of forfeitures		—		0		67,000		0		67,000
Stock options exercised, net		314,162		0		127,000		0		127,000
Shares held back in settlement of tax obligation and exercise cost		(28,802)		0		0		0		0
Warrants exercised, net		29,158		0		0		0		0
Issuance of common stock in connection with the "at-the-market" equity offering program	��	4,066,773		1,000		7,266,000		0		7,267,000
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program		—		0		(321,000)		0		(321,000)
Balance at December 31, 2021											227,325,381		23,000		244,863,000		(217,602,000)		27,284,000
Share-based compensation, net of forfeitures											—		0		716,000		0		716,000
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards											(138,514)		0		(79,000)		0		(79,000)
Offering costs related to the issuance of common stock and warrants in connection with the registered direct offering											—		0		(32,000)		0		(32,000)
Net loss		—		0		0		(3,556,000)		(3,556,000)	—		0		0		(5,636,000)		(5,636,000)

Balance at June 30, 2021		200,070,419	$	20,000	$	228,091,000	$	(207,750,000)	$	20,361,000
Balance at March 31, 2022											227,186,867	$	23,000	$	245,468,000	$	(223,238,000)	$	22,253,000

The accompanyingnotes are an integral part of these financial statements.

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AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Cash Flows

(unaudited)


	Six Months Ended June 30,				Three Months Ended March 31,
	2021		2020		2022		2021

Cash flows used in operating activities
Net loss	$	(7,222,000)	$	(7,910,000)	$	(5,636,000)	$	(3,667,000)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation, net of forfeitures		233,000		277,000
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation, net of forfeitures						716,000		166,000
Depreciation and amortization		568,000		591,000		262,000		294,000
Paycheck Protection Program loan forgiveness		0		(544,000)
Issuance of common stock for services		80,000		80,000		0		80,000
Derivative gain		(267,000)		(156,000)
Changes in operating assets and liabilities
Increase in prepaid expenses and other		(1,211,000)		(229,000)
Derivative (gain) loss						(1,331,000)		(151,000)
Changes in operating assets and liabilities:
(Increase) decrease in prepaid expenses and other						670,000		(651,000)
Increase (decrease) in accounts payable and accrued expenses		1,386,000		(1,758,000)		397,000		(199,000)
Decrease in lease liability		(42,000)		(38,000)		(22,000)		(19,000)
Proceeds received under the Paycheck Protection Program		0		544,000
Net cash used in operating activities		(6,475,000)		(9,143,000)		(4,944,000)		(4,147,000)

Cash flows used in investing activities
Purchase of fixed assets		(81,000)		0		0		(81,000)
Net cash used in investing activities		(81,000)		0		0		(81,000)

Cash flows from financing activities
Proceeds from sale of common stock in connection with "at-the-market" equity offering program		9,972,000		7,913,000
Proceeds from sale of common stock in connection with the "at-the-market" equity offering program						0		2,705,000
Costs related to sale of common stock in connection with the "at-the-market" equity offering program		(447,000)		(560,000)		0		(126,000)
Proceeds from warrant and stock option exercises, net		234,000		100,000
Net cash provided by financing activities		9,759,000		7,453,000
Proceeds from sale of common stock and warrants in connection with the registered direct offering						0		114,000
Costs related to the sale of common stock and warrants in connection with the registered direct offering						(32,000)		0
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards						(79,000)		0
Other						0		(7,000)
Net cash (used in) provided by financing activities						(111,000)		2,686,000

Net change in cash and cash equivalents		3,203,000		(1,690,000)		(5,055,000)		(1,542,000)

Cash and cash equivalents at beginning of period		17,346,000		6,532,000		33,892,000		17,346,000
Cash and cash equivalents at end of period	$	20,549,000	$	4,842,000	$	28,837,000	$	15,804,000

Non-cash transactions:
Commercial insurance premium financing agreement	$	1,016,000	$	1,347,000

The accompanying notes are an integral part of these financial statements.

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AMPIO PHARMACEUTICALS, INC.

Notes to Condensed Financial Statements

(unaudited)

Note 1 – The Company and Summary of Significant Accounting Policies

Ampio Pharmaceuticals, Inc. (“Ampio” or the “Company”) is a pre-revenue stage biopharmaceutical company focused on the research, development and advancement of ~~immunology-based~~immunomodulatory therapies for ~~prevalent inflammatory conditions.~~the treatment of pain from osteoarthritis.

Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States for interim financial information and with the instructions of the SEC on Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the financial position and of the results of operations and cash flows of the Company for the periods presented.

These financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, ~~2020~~2021 included in the Company’s ~~2020~~2021 Annual Report. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The information as of and for the three ~~and six~~ months ended ~~June 30, 2021~~March 31, 2022 is unaudited. The balance sheet at December 31, ~~2020~~2021 was derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements.

~~Impact of Global Pandemic~~

In January 2020, the Secretary of Health and Human Services (“HHS”) declared a public health emergency and the World Health Organization (“WHO”) announced a global health emergency because of the novel Coronavirus Disease 2019 (“COVID-19”). In March 2020, the WHO declared the outbreak of COVID-19, a global pandemic. Since the declaration of the outbreak, COVID-19 has adversely impacted and continues to adversely impact the United States and global economies. In April 2020, and pursuant to the U.S. Food and Drug Administration (“FDA”), independent Safety Monitoring Committee (“SMC”), and Institutional Review Board guidance covering ongoing clinical trials in the presence of the COVID-19 pandemic, the Company and the clinical research organization (“CRO”) paused all ongoing conduct associated with the Phase III clinical trial (the “AP-013 study”) of Ampion for the treatment of Osteoarthritis of the Knee (“OAK”). In March 2021, the Company submitted a detailed proposal to the FDA in response to the FDA’s guidance regarding the status of the AP-013 study. In April 2021, the Company received a response to the proposal from the FDA, which provides guidance and flexibility on how to maintain the Special Protocol Assessment (“SPA”), while allowing the Company to evaluate and consider several paths for moving forward. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, the Company is evaluating its options to analyze the clinical trial data from the AP-013 study.

In addition, since June 2020, the Company has commenced several clinical trials to determine the safety and efficacy for new applications of Ampion (i.e., inhaled and intravenous) related to COVID-19 infection. Given the continued evolution of the COVID-19 pandemic and the related complexities and uncertainties associated with the additional variants, the Company’s business operations could be significantly impacted and, in addition, the business operations of third parties on which the Company relies, including organizations that conduct clinical trials and key suppliers which provide the raw materials for manufacturing Ampion for the ongoing clinical trials could also be impacted. The full extent of the potential adverse impact on the Company’s business operations and related current and future product development, including, but not limited to, clinical trials, financing activities and the overall impact on the United States and the global economy will depend on future developments related to the pandemic, which cannot be predicted at this time.

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Concentrations of Credit Risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company has no off-balance-sheet concentrations of credit risk, such as foreign exchange contracts, option contracts or foreign currency hedging arrangements. The Company consistently maintains its cash and cash equivalent balances in the form of bank demand deposits, United States federal government backed treasury securities and fully liquid money market fund accounts with financial institutions that management believes are creditworthy. The Company periodically monitors its cash positions with, and the credit quality of, the financial institutions with which it invests. During the three ~~and six~~ months ended ~~June 30, 2021,~~March 31, 2022, and as consistent with prior reporting periods, the Company maintained balances in excess of federally insured limits.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and related disclosures in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.

Significant items subject to such estimates and assumptions primarily include the Company’s projected current and long-term liquidity, ~~and resulting going concern position,~~the clinical trial accrual, ~~and the~~ projected useful lives and potential impairment of fixed assets. The Company develops these estimates using its judgment based upon the facts and circumstances known to it at the time.

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Liquidity / Going Concern

We are a pre-revenue stage biopharmaceutical company that has incurred an accumulated deficit of $223.2 million as of March 31, 2022. We expect to generate continued operating losses for the foreseeable future as the Ampio board of directors is considering strategic alternatives for Ampio and Ampion, which may include the continued development and advancement of Ampion, capital raising, licensing and other partnering opportunities, positioning the Company for a strategic transaction or other alternative(s).

As of March 31, 2022, we had $28.8 million of cash and cash equivalents. Based on our current cash position and projection of operating expenses and capital expenditures, we believe we will have sufficient liquidity to fund operations into the second half of 2023. Our cash resources and our capital needs are based upon management estimates as to future operations and expense, which involve significant judgment. Additionally, given that the Ampio board of directors is considering strategic alternatives, our forecasts regarding the sufficiency of our liquidity is based upon maintaining our current operations. Accordingly, we may exhaust our available cash and cash equivalents earlier than presently anticipated and may require more capital more quickly than presently anticipated.

Additional financing may not be available in the amount or at the time we need it or may not be available on acceptable terms or at all. We may obtain future additional financing by incurring indebtedness or from an offering of our equity securities or either of these. If we raise additional 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. If we raise additional equity financing, new investors may demand rights, preferences, or privileges senior to those of existing holders of common stock.

Based on the above, these existing and ongoing factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying unaudited interim financial statements were prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

These financial statements do not include any separate adjustments relating to the recovery of recorded assets or the classification of liabilities, which adjustments may be necessary in the future should the Company be unable to continue as a going concern.

Adoption of Recent Accounting Pronouncements

The Company has not adopted any recent accounting pronouncements during the ~~six~~three months ended ~~June 30, 2021.~~March 31, 2022, as none were deemed to be applicable.

Recent Accounting Pronouncements

In August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU 2020-06, “Debt (Subtopic 470-20); Debt with Conversion and Other Options and Derivatives and Hedging (Subtopic 815-40) Contracts in Entity’s Own Equity”. The updated guidance is part of the FASB’s simplification initiative, which aims to reduce unnecessary complexity in U.S. GAAP. Consequently, more convertible debt instruments will be reported as single liability instruments with no separate accounting for embedded conversion features. The ASU 2020-06 also removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for the exception. In addition, ASU 2020-06 also simplifies the diluted net income per share calculation in certain areas. The updated guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years, with early adoption permitted for periods beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on the Company’s financial ~~statements.~~statements and has decided to wait to implement ASU 2020-06 until its effective date.

This Quarterly Report on Form 10-Q does not discuss recent pronouncements that are not anticipated to have a current and/or future impact on or are unrelated to the Company’s financial condition, results of operations, cash flows or disclosures.

~~Note 2 - Going Concern~~

As of and for the six months ended June 30, 2021, the Company had cash and cash equivalents of $20.5 million and a net loss of $7.2 million, respectively. The net loss is primarily attributable to operating expenses of $7.5 million, partially offset by the non-cash derivative gain of $0.3 million (see ~~Note 9~~). The Company used $6.5 million to fund its business operations for the six-month period ended June 30, 2021 and ended the period with an accumulated deficit and stockholders’ equity of $207.8 million and $20.4 million, respectively. As a clinical stage biopharmaceutical company, the Company has not generated any operating revenues or profits since the inception of business operations. In addition, the Company is subject to all of the risks and uncertainties typically associated with biopharmaceutical companies that

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devote substantially all of their efforts and resources to research and development, as well as clinical trials, and do not yet have commercialized products. These existing and projected on-going factors continue to raise substantial doubt about the Company’s ability to continue as a going concern.

In February 2020, the Company entered into a Sales Agreement (“Sales Agreement”) with 2 agents to implement an “at-the-market” (“ATM”) equity offering program under which the Company, from time to time and at its sole discretion, may issue and sell shares of its authorized common stock. During the six months ended June 30, 2021, the Company sold shares pursuant to the ATM equity offering program, which yielded gross proceeds of approximately $10.0 million, which was offset by offering related costs of $0.4 million (see ~~Note 10~~).

~~The Company has prepared an updated projection covering the period from July 1, 2021 through August 31, 2022 based on the requirements of ASC 205-40, “~~~~Going Concern~~”, which reflects cash requirements for fixed, recurring base level business expenses such as payroll, legal and accounting, patents and overhead, and incremental costs supporting the existing and projected clinical development programs. The Company continues to assess the impact of the COVID-19 pandemic and the impact that it may have on the Company’s current and projected future studies. The Company anticipates using the ATM equity offering program to raise additional funds in the near term, as needed, while also considering supplementing the funds raised with separate private or public equity offering(s). Based on the Company’s current cash position, projection of operating expenses, current and projected capacity under the ATM and/or other equity financing opportunities, the Company believes it will have sufficient liquidity to fund operations through the fourth quarter of 2022. This projection is based on many assumptions that may prove to be incorrect. Despite the prior access and use of the ATM equity offering program in a manner to provide sufficient ongoing liquidity to the Company, the ATM is not considered to represent a source of committed capital. As such, it is possible that the Company could exhaust its available cash and cash equivalents earlier than presently anticipated. In addition, given the ongoing continued uncertainty of the COVID-19 pandemic, its effect on the Company’s business operations and ability to raise capital remains uncertain and subject to change. While the Company believes that the studies currently being conducted will be successful, the Company expects to raise additional capital in both the near and long-term to enable it to support its business operations, including specifically (i) clinical development of Ampion, (ii) Biologics License Application (“BLA”) preparation and submission, (iii) existing base business operations and (iv) commercial development activities for Ampion. The Company will continue to closely monitor and evaluate the overall capital markets to determine the appropriate timing and funding level for any such capital raising activities, which will primarily depend on stock price and existing market conditions relative to the timing of the Company’s liquidity needs. However, the Company cannot currently provide any assurance that it will be successful in satisfying its future liquidity needs in a manner that will be sufficient to fund its base level of operations and any incremental expenses related to the further development of Ampion for OAK, therapeutic treatment of COVID-19 and other indications as they arise.

The accompanying unaudited interim financial statements were prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any separate adjustments relating to the recovery of recorded assets or the classification of liabilities, which adjustments may be necessary in the future should the Company be unable to continue as a going concern.

Note 32 – Prepaid Expenses and Other

Prepaid expenses and other balances as of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020~~2021 are as follows:



	June 30, 2021		December 31, 2020		March 31, 2022		December 31, 2021

Deposits	$	1,236,000	$	266,000	$	565,000	$	884,000
Unamortized commercial insurance premiums		981,000		627,000		212,000		465,000
Annual maintenance service contracts		63,000		—
Receivable		30,000		185,000
Professional fees						87,000		235,000
Maintenance service contracts						63,000		—
Clinical trial inventory						—		72,000
Other receivable						19,000		16,000
Other		48,000		69,000		124,000		68,000
Total prepaid expenses and other	$	2,358,000	$	1,147,000	$	1,070,000	$	1,740,000

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Note 43 – Fixed Assets

Fixed assets are recorded based on acquisition cost and once placed in service, are depreciated utilizing the straight-line method over their estimated economic useful lives. Leasehold improvements are accreted over the shorter of the estimated economic life or related lease term. Fixed assets, net of accumulated depreciation and amortization, consist of the following:


	Estimated					Estimated
	Useful Lives	June 30,		December 31,		Useful Lives
	(in Years)	2021		2020		(in Years)	March 31, 2022		December 31, 2021

Leasehold improvements	10	$	1,950,000	$	2,250,000	10	$	6,075,000	$	6,075,000
Manufacturing facility/clean room	3 - 8		834,000		998,000	3 - 8		2,984,000		2,984,000
Lab equipment and office furniture	5 - 8		290,000		313,000	5 - 8		1,739,000		1,739,000
Fixed assets, gross								10,798,000		10,798,000
Accumulated depreciation								(8,496,000)		(8,234,000)
Fixed assets, net		$	3,074,000	$	3,561,000		$	2,302,000	$	2,564,000

Depreciation and amortization expense for the respective periods is as follows:


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
	2021		2020		2021		2020		2022		2021

Depreciation and amortization expense	$	274,000	$	296,000	$	568,000	$	591,000	$	262,000	$	294,000

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Note 54 – Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses as of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020~~2021 are as follows:



	June 30, 2021		December 31, 2020		March 31, 2022		December 31, 2021

Accounts payable	$	170,000	$	186,000	$	1,582,000	$	427,000
Clinical trials		1,525,000		558,000		2,919,000		2,995,000
Professional fees						302,000		510,000
Accrued compensation						292,000		389,000
Commercial insurance premium financing		808,000		386,000		—		269,000
Professional fees		380,000		267,000
Other		54,000		153,000		113,000		221,000
Accounts payable and accrued expenses	$	2,937,000	$	1,550,000	$	5,208,000	$	4,811,000

~~Note 6 – Paycheck Protection Program~~Commercial Insurance Premium Financing Agreement

In ~~April 2020,~~June 2021, the Company ~~received proceeds of $544,000 via~~entered into an insurance premium financing agreement for $916,000, with a loan from KeyBank National Association (the “Lender”) that was issued under the Paycheck Protection Program (the “PPP”) established under the Coronavirus Aid, Relief and Economic Security Act. The term of ~~the PPP loan is two years with~~nine months and an annual interest rate of ~~1.0%~~3.57%. Under the terms and provisions of the agreement, the Company was required to make principal and interest payments ~~will be deferred~~totaling $82,000 per month over the remaining term of the agreement. The outstanding obligation for the ~~first six months~~Company’s annual insurance premiums were paid in full as of ~~the loan term, which was subsequently updated in accordance with the Paycheck Protection Program Flexibility Act of 2020.~~March 31, 2022.

In October 2020, the Company submitted its PPP loan forgiveness application, requesting forgiveness of the full principal amount of its PPP loan. In May 2021, the Company received notification from the Lender that the Small Business Administration (the “SBA”) had authorized full forgiveness of the PPP loan. In July 2021, the Company received notification from the Lender that the SBA submitted, and the Lender has received, proceeds representing the full pay-off of the loan balance. As such, the Company’s loan balance is considered to be paid off in full.

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Note 75 - Commitments and Contingencies

~~Commitments and contingencies are described below and summarized by the following table:~~

Total

2021

2022

2023

2024

2025

Thereafter
Key clinical research trial obligations

$
3,896,000

$
2,768,000

$
1,128,000

$
0

$
0

$
0

$
0
Employment agreements

830,000

351,000

466,000

13,000

0

0

0
Commercial insurance premium financing agreement

808,000

539,000

269,000

0

0

0

0
Statistical analysis and programming consulting services

326,000

163,000

163,000

0

0

0

0

$
5,860,000

$
3,821,000

$
2,026,000

$
13,000

$
0

$
0

$
0

Key Clinical Research Trial Obligations

Please see Part II, Item 5 of this Form 10-Q for information regarding an internal investigation relating to our clinical studies.

Osteoarthritis of the Knee

AP-013 study

In December 2020, the Company entered into an initial contract with a CRO in reference to the AP-013 study database totaling $1.4 million. The contractual provisions required aan initial retainer of $315,000, which ~~will be~~was applied to ~~future~~ study expenses as further defined by the ~~contract. In~~contract during the ~~event of premature termination, the~~first three months ended March 31, 2022. The Company ~~will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. In March 2021, the Company submitted~~entered into a ~~detailed proposal~~change order to the ~~FDA~~initial contract in ~~response~~April 2022 totaling $0.7 million which reflects the estimated final costs to close out the ~~FDA’s guidance regarding~~study with expected completion in the ~~status of the AP-013 study, which was paused as a result of the COVID-19 pandemic. In April 2021, the Company received a response~~next three to the proposal from the FDA. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, the Company is evaluating its options to analyze the clinical trial data from the AP-013 study. The Company had an outstanding future contractual commitment of $382,000 (net of deposit) as of June 30, 2021.five months.

Inhaled treatment for COVID-19 patients

AP-018 study and AP-019 study

In March 2021, the Company entered into a contract with a CRO totaling $318,000 in reference to a Phase I1 study for at-home treatment utilizing inhaled Ampion to treat patients with ~~Post-Acute Sequelae of SARS-CoV-2 infection (“PASC”) commonly referred to as “Long-COVID”,~~Long-COVID, or prolonged respiratory symptoms due to COVID-19 (the “AP-018 study”). The contractual provisions required an initial retainer of $105,000 ~~which will~~to be applied to future study expenses as further defined by the contract. ~~In the event of premature termination,~~Subsequent to March 2021, the Company ~~will pay for~~agreed to a contractual amendment of $1.0 million. As of March 31, 2022, the contract is substantially complete and any future services ~~rendered and expenses incurred through the date~~to be performed are deemed to be minimal.

Table of ~~termination. The CRO will refund any unused portion of the retainer. The Company had an outstanding future contractual commitment of $130,000 (net of deposit) as of June 30, 2021.~~Contents

In June 2021, the Company entered into a contract with a CRO totaling $2.5 million in reference to a multicenter Phase II2 clinical trial, using inhaled Ampion in the treatment of respiratory distress due to COVID-19 (the “AP-019 study”). The contractual provisions required an initial retainer of $300,000 ~~which will~~to be applied to ~~future~~ study expenses as further defined by the contract. InThe contractual amount was later amended by $0.9 million. As such, the ~~event~~revised contractual commitment for the AP-019 study is $3.4 million as of ~~premature termination,~~March 31, 2022. Enrollment of the AP-019 study was terminated on May 3, 2022, as no beneficial effect of nebulized Ampion could be documented. The Company will pay for contractually obligated services rendered and expenses incurred through the date of ~~termination.~~finalization of the study. The CRO will refund any unused portion of the retainer. ~~The~~As of March 31, 2022, the Company ~~had an outstanding~~expects to spend $0.5 million related to future ~~contractual commitment~~services expected to be performed under this contract and accordingly, does not expect any refund of ~~$2.2 million (net~~any unused portion of ~~deposit) as of June 30, 2021.~~the retainer.

Intravenous (“IV”) treatment for COVID-19 patients

AP-017 study

In December 2020, the Company entered into a contract with a CRO totaling $1.8 million in reference to a multicenter Phase II2 clinical trial utilizing IV Ampion in the treatment of patients ~~suffering from~~with complications arising from ~~COVID-~~COVID-19 (the “AP-017 study”). The contractual provisions required an initial retainer of $345,000 to be applied to study expenses as further defined by the contract. The Company stopped the trial after an interim enrollment of 35 subjects, which resulted in a favorable contractual adjustment of $0.5 million to reflect the lower study enrollment. As such, the revised contractual commitment for the AP-017 study is $1.3 million as of March 31, 2022. The Company has an outstanding future commitment of $324,000 as of March 31, 2022, which reflects future services related to finalizing the study.

Employment Agreements

In October 2021, the Company entered into 3 employment agreements that expire in October 2024 and in November 2021, the Company entered into 1 employment agreement that expires in November 2022. These employment agreements call for initial base salaries ranging from $335,000 to $550,000. The employment agreements provide that the employee is entitled to a discretionary bonus. Additionally, the employee is entitled to a severance payment in the event the Company terminates employee’s employment without Cause, or employee terminates his or her employment with Good Reason.

Related Party Research Agreements

In February 2022, the Company entered into a sponsored research agreement with Trauma Research, LLC, an entity owned by one of the Company’s directors. The agreement totals $400,000 for research activities to be performed over the next year. In addition, the Company also entered into an agreement with that director to provide research services. The agreement totals $250,000, which is to be paid in 4 equal installments payable quarterly over the one-year term. As of March 31, 2022, commitments for future services expected to be rendered for the research and research service agreements total $358,000 and $208,000, respectively.

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19 (the AP-017 study”). The contractual provisions required a retainer of $345,000, which will be applied to future study expenses as further defined by the contract. The contract currently accounts for 120 patients; however, based on the revised protocol, the number of patients has increased to 200. The Company is in ongoing discussions with the CRO to amend the contractual amount to account for the additional patients expected to be enrolled. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer.~~The Company had an outstanding future contractual commitment of $1.2 million (net of deposit) as of June 30, 2021.~~

~~Employment Agreements~~

On December 14, 2019, the Company entered into a three-year employment agreement with Mr. Macaluso, Chief Executive Officer, which became effective January 10, 2020, immediately following the expiration of his prior employment agreement. The employment agreement provides for an annual salary of $300,000 and term ending January 10, 2023, subject to certain automatic renewal provisions.

~~On September 16, 2019, the Company entered into a~~ two-year employment agreement with Ms. Cherevka, Chief Operating Officer, which by its terms cancelled the previous employment agreement on such date. The employment agreement provides for an annual salary of $280,000 and a term ending September 16, 2021, subject to certain automatic renewal provisions.

The Company entered into an employment agreement with Mr. Daniel Stokely, Chief Financial Officer, on July 9, 2019, which provided for an annual salary of $285,000 and a term beginning July 31, 2019 and lasting for three years, subject to certain automatic renewal provisions.

~~Amounts noted above do not assume the continuation of employment beyond the contractual terms of each employee’s existing employment agreements.~~

~~Commercial Insurance Premium Financing Agreement~~

In June 2021, the Company entered into an insurance premium financing agreement for $0.9 million, with a term of nine months and an annual interest rate of 3.57%. Under the terms and provisions of the agreement, the Company will be required to make principal and interest payments totaling $82,000 per month over the remaining term of the agreement. The outstanding obligation as of June 30, 2021 was $734,000, which will be paid in full by March 2022. In addition, as of June 30, 2021, the Company had a remaining balance of $74,000 related to annual insurance premiums payable to the Company’s insurance broker, which will be paid in full by March 2022.Facility Lease

~~Statistical Analysis and Programming Consulting Services~~

In May 2019, the Company entered into a statistical analysis and programming consulting services agreement for $578,000. As of June 30, 2021, the Company had incurred cumulative costs totaling $252,000 against the contract and, as such, had an outstanding obligation of $326,000, which is expected to be settled by fiscal 2022.

~~Facility Lease~~

In December 2013, the Company entered into a 125-month non-cancellable operating lease for office space and a manufacturing facility. The effective date of the lease was May 1, 2014. The initial base rent of the lease was $23,000 per month. The total base rent over the term of the lease is approximately $3.3 million, which includes rent abatements and leasehold incentives. The Company adopted the FASB issued ASC 842, “Leases (Topic 842)” effective January 1, 2019. With the adoption of ASC 842, the Company recorded an operating right-of-use (“ROU”) asset and an operating lease liability on its balance sheet. The ROU asset represents the Company’s right to use the underlying asset for the lease term and the lease obligation represents the Company’s commitment to make the lease payments arising from the lease. ROU lease assets and obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term. As the Company’s lease does not provide an implicit rate, the Company used an estimated incremental borrowing rate of 5.75% based on the information available at the commencement date in determining the present value of the lease payments. Lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. The lease liability is classified both as current in part and long-term on the balance sheet.

The following table provides a reconciliation of the Company’s remaining undiscounted payments for its facility lease and the carrying amount of the lease liability disclosed on the balance sheet as of March 31, 2022:


	Facility Lease Payments		2022		2023		2024		2025		2026		Thereafter

Remaining Facility Lease Payments	$	912,000	$	268,000	$	364,000	$	280,000	$	—	$	—	$	—
Less: Discount Adjustment		(61,000)
Total lease liability	$	851,000

Lease liability-current portion	$	318,000

Long-term lease liability	$	533,000

The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of March 31, 2022:


	ROU Asset

Balance as of December 31, 2021	$	629,000
Amortization		(52,000)
Balance as of March 31, 2022	$	577,000

The Company recorded lease expense in the respective periods is as follows:


	Three Months Ended March 31,
	2022		2021

Lease expense	$	81,000	$	73,000

Note 6 – Warrants

The Company has issued both equity (“placement agent”) and liability (“investor”) classified warrants in conjunction with previous equity raises. The Company had a total of 1.1 million equity-classified warrants and 17.2 million liability-classified warrants outstanding as of March 31, 2022.

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determining the present value of the lease payments. Lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. The lease liability is classified both as current in part and long-term in part on the balance sheet based on the projected settlement of the liability.

Facility Lease Payments

Remainder of
2021

2022

2023

2024

2025

Thereafter

Remaining Facility Lease Payments

$
1,173,000

$
174,000

$
355,000

$
364,000

$
280,000

$
—

$
—
Less: Discount Adjustment

(102,000)

Total lease liability

$
1,071,000

Lease liability-current portion

$
298,000

Long-term lease liability

$
773,000

~~The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of June 30, 2021:~~

ROU Asset

Balance as of December 31, 2020

$
824,000
Amortization

(96,000)
Balance as of June 30, 2021

$
728,000

~~The Company recorded lease expense in the respective periods is as follows:~~

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020


Lease expense

$
67,000

$
66,000

$
140,000

$
132,000

~~Note 8 – Warrants~~

The Company has issued both equity (“placement agent”) and liability (“investor”) classified warrants in conjunction with previous equity raises. The Company had a total of 1.6 million equity-classified warrants and 2.2 million liability-classified warrants outstanding as of June 30, 2021.

~~The following table summarizes the Company’s~~There was no warrant activity during the ~~six~~three months ended ~~June 30, 2021:~~March 31, 2022:


		Weighted		Weighted Average		Weighted		Weighted Average
	Number of	Average		Remaining	Number of	Average		Remaining
	Warrants	Exercise Price		Contractual Life	Warrants	Exercise Price		Contractual Life

Outstanding as of December 31, 2020	4,130,724	$	0.66	2.05	4,130,724	$	0.66	2.05
Warrants issued in connection with the registered direct offering					15,000,000	$	1.10	4.96
Warrant exercised					(812,827)	$	0.58	—
Warrants expired					(15,000)
Outstanding as of December 31, 2021					18,302,897	$	1.02	4.24
Warrants issued in connection with the registered direct offering					—	$	—
Warrants exercised	(357,126)	$	0.42	—	—	$	—
Outstanding as of June 30, 2021	3,773,598	$	0.68	1.49
Warrants expired					—	$	—
Outstanding as of March 31, 2022					18,302,897	$	1.02	3.99

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The following table summarizes the Company’s outstanding warrants between placement agent and investor warrant classifications:

Weighted

Weighted Average

Number of

Average

Remaining

Warrants

Exercise Price

Contractual Life

Investor warrants at $0.76

2,026,915

0.92
Placement agent warrants at $0.76

422,233

0.92
Placement agent warrants at $0.94

150,000

0.16
Investor warrants at $0.40

153,400

2.12
Placement agent warrants at $0.50

1,021,050

2.97
Outstanding as of June 30, 2021

3,773,598

$
0.68

1.49


					Weighted		Weighted Average
				Number of	Average		Remaining
Date	Exercise Price		Type	Warrants	Exercise Price		Contractual Life

December 2021 registered direct offering	$	1.10	Investor	15,000,000			4.71
August 2018 public offering	$	0.40	Investor	153,400			1.37
June 2017 registered direct offering	$	0.76	Investor	2,026,915			0.17
June 2019 public offering	$	0.50	Placement agent	823,650			2.22
June 2017 registered direct offering	$	0.76	Placement agent	298,932			0.17
Outstanding as of March 31, 2022				18,302,897	$	1.02	3.99

During the six months ended June 30, 2021, the Company issued 284,100 shares of its common stock as a result of the exercise of investor warrants with an exercise price of $0.40. The Company received proceeds of $114,000 during the period related to these investor warrant exercises. In addition, former placement agents elected to exercise 73,026 of their warrants utilizing the net exercise option, where the total number of shares of common stock issued was reduced to cover the exercise price and, as such, the Company issued 51,763 shares of common stock. The Company did not receive any cash related to the exercise of placement agent warrants.

The total value for the warrant derivative liability as of ~~June 30, 2021~~March 31, 2022 is approximately ~~$2.3~~$4.5 million (see Note 97).

Note 97 - Fair Value Considerations

Authoritative guidance defines fair value as the price that would be received upon the sale of an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the measurement date. The guidance establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs reflect inputs that market participants would use in pricing the asset or liability based on market data obtained from sources not affiliated with the Company. Unobservable inputs are inputs that reflect the Company’s assumptions of what market participants would use in pricing the asset or liability based on the best information available in the circumstances. The hierarchy is broken down into three levels based on reliability of the inputs as follows:


	Level 1:	Inputs that reflect unadjusted quoted prices in active markets that are accessible to the Company for identical assets or liabilities;

	Level 2:	Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and

	Level 3:	Unobservable inputs that are supported by little or no market activity.

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The Company’s financial instruments include cash and cash equivalents, accounts payable and accrued expenses, and warrant derivative liability. Warrants are recorded at estimated fair value utilizing the Black-Scholes warrant pricing model.

The Company’s assets and liabilities which are measured at fair value are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. The Company’s policy is to recognize transfers in and/or out of the fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. The Company has consistently applied the valuation techniques in all periods presented.

~~Table of Contents~~

The following table presents the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020,~~2021, by level within the fair value hierarchy:

Fair Value Measurements Using


Level 1

Level 2

Level 3

Total
June 30, 2021








Liabilities:








Warrant derivative liability

$
0

$
0

$
2,340,000

$
2,340,000

December 31, 2020








Liabilities:








Warrant derivative liability

$
0

$
0

$
2,607,000

$
2,607,000


	Fair Value Measurements Using
	Level 1		Level 2		Level 3		Total
March 31, 2022
Liabilities:
Warrant derivative liability	$	—	$	—	$	4,474,000	$	4,474,000

December 31, 2021
Liabilities:
Warrant derivative liability	$	—	$	—	$	5,805,000	$	5,805,000

The warrant derivative liability for both periods presented was valued using the Black-Scholes valuation methodology because that model embodies all the relevant assumptions that address the features underlying these instruments.

The following table sets forth a reconciliation of changes in the fair value of financial liabilities classified as Level 3 in the fair value hierarchy:


	Derivative Instruments		Derivative Instruments

Balance as of December 31, 2020	$	2,607,000
Balance as of December 31, 2021			$	5,805,000
Warrant issuances				—
Warrant exercises		(347,000)		—
Change in fair value		80,000		(1,331,000)
Balance as of June 30, 2021	$	2,340,000
Balance as of March 31, 2022			$	4,474,000

Note 108 - Common Stock

Authorized Shares

The Company had 300.0 million authorized shares of common stock as of ~~June 30, 2021~~March 31, 2022 and December 31, ~~2020.~~2021.

The following table summarizes the Company’s remaining authorized shares available for future issuance:

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	~~June 30, 2021~~March 31, 2022

Authorized shares		300,000,000

Common stock outstanding		~~200,070,419~~227,186,867
Options outstanding		~~5,686,989~~9,010,312
Warrants outstanding		~~3,773,598~~18,302,897
Reserved for issuance under 2019 Stock and Incentive Plan		~~7,918,755~~2,984,023

Available shares		~~82,550,239~~42,515,901

ATM Equity Offering Program

In February 2020, the Company entered into a Sales Agreement with 2 agents to implement an ~~ATM~~“at the market” (ATM) equity offering program under which the Company, from time to time and at its sole discretion, may offer and sell shares of its common stock having an aggregate offering price up to $50.0 million to the public through the agents until (i) each agent declines to accept the terms for any reason, (ii) the entire amount of shares has been sold, or (iii) the Company suspends or terminates the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, the agents shall use their

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commercially reasonable efforts to sell shares from time to time, based upon the Company’s instructions as documented on a purchase notification form. If an agent declines to accept the purchase notification form, the agent must promptly notify the Company and the other agent then has the ability to accept or decline the purchase notification form. The Company has no obligation to sell any shares and may, at any time and in its sole discretion, suspend sales under the Sales Agreement or terminate the Sales Agreement in accordance with its terms. The Sales Agreement includes customary indemnification rights in favor of the agents and provides that the agents will be entitled to an aggregate fixed commission of 4.0% of the gross proceeds (2.0% to each agent) to the Company from any shares sold pursuant to the Sales Agreement.

The following table summarizes the Company’s sales and related issuance costs incurred under the Sales Agreement during the three months ended March 31, ~~2021~~2022 and ~~June 30,~~ 2021:


								Three Months Ended March 31,
	Three months ended March 31, 2021		Three months ended June 30, 2021		Total			2022		2021

Total shares of common stock sold		1,848,437		4,066,773		5,915,210		—		1,848,437

Gross proceeds	$	2,705,000	$	7,267,000	$	9,972,000	$	—	$	2,705,000
Commissions earned by placement agents		(109,000)		(291,000)		(400,000)		—		(109,000)
Issuance fees		(17,000)		(30,000)		(47,000)		—		(17,000)
Net proceeds	$	2,579,000	$	6,946,000	$	9,525,000	$	—	$	2,579,000

Common Stock Issued for Services

The Company issued an aggregate of 54,052 ~~and 136,236~~ shares of common stock under the Ampio Pharmaceuticals, Inc. 2019 Stock and Incentive Plan (the “2019 Plan”), ~~each~~ valued at an aggregate of $80,000 as partial compensation for the services of four non-employee directors, during the ~~six~~three months ended ~~June 30, 2021 and 2020, respectively.~~March 31, 2021. During the three months ended March 31, 2022, the Company did not issue any shares of common stock as partial compensation for the services of non-employee directors.

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Note 119 - Equity

Options

In December 2019, the Company’s Board of Directors and stockholders approved the adoption of the 2019 Plan, under which shares were reserved for future issuance of equity related awards classified as option ~~awards/grants,~~awards, restricted stock awards and other equity related awards. The 2019 Plan permits grants of equity awards to employees, directors and consultants. The stockholders approved a total of 10.0 million shares to be reserved for issuance under the 2019 Plan. The Company’s previous 2010 Stock and Incentive Plan (the “2010 Plan”) was cancelled concurrently with the adoption of the 2019 Plan.

The following table summarizes the activity of the 2019 Plan and the shares available for future equity awards as of ~~June 30, 2021:~~March 31, 2022:


	2019 Plan

Total shares reserved for equity awards		10,000,000
Options granted, net of forfeitures during previous fiscal years		~~(2,067,471)~~(3,933,471)
Options granted during fiscal 2022		(1,598,323)
Restricted stock awards, net of settlement granted during fiscal 2021		~~(36,000)~~(1,785,000)
Restricted stock awards, net of settlement granted during fiscal 2022		0
Forfeited, expired and/or cancelled equity awards, prior year		5,500
Forfeited, expired and/or cancelled equity awards, during 2022		26,500
Shares forfeited to settle exercise price and tax obligation during fiscal 2021		130,303
Shares forfeited to settle exercise price and tax obligation during 2022		~~22,226~~138,514
Remaining shares available for future equity awards		~~7,918,755~~2,984,023

The following table summarizes the Company’s restricted stock awards activity during the three months ended March 31, 2022:


		Weighted
		Average Grant-Date			Aggregate
	Awards	Fair Value			Intrinsic Value
Nonvested as of December 31, 2021	1,468,000	$	1.64
Granted	—
Vested	(367,000)	$	1.64	$	—
Nonvested as of March 31, 2022	1,101,000	$	1.64

Of the vested restricted stock awards reported above, the Company withheld 138,514 common shares which represented the fair value of the tax settlement.

The following table summarizes the Company’s stock option activity during the three months ended March 31, 2022:


		Weighted		Weighted Average
	Number of	Average		Remaining		Aggregate
	Options	Exercise Price		Contractual Life		Intrinsic Value
Outstanding as of December 31, 2021	7,506,989	$	1.04	7.36	$	—
Granted	1,598,323	$	0.48
Exercised	—	$	—
Forfeited, expired and/or cancelled	(95,000)	$	0.89
Outstanding as of March 31, 2022	9,010,312	$	1.01	7.50	$	36,000
Exercisable as of March 31, 2022	6,624,442	$	1.12	6.69	$	17,000

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~~The following table summarizes the Company’s stock option activity during the six months ended June 30, 2021:~~

Weighted

Weighted Average


Number of

Average

Remaining

Aggregate

Options

Exercise Price

Contractual Life

Intrinsic Value
Outstanding as of December 31, 2020

6,099,651

$
1.04

7.36

$
—
Granted

36,000

$
1.76

Exercised

(443,662)

$
0.55

Forfeited, expired and/or cancelled

(5,000)

$
1.75

Outstanding as of June 30, 2021

5,686,989

$
1.08

6.92

$
4,661,000
Exercisable as of June 30, 2021

5,413,989

$
1.09

6.80

$
4,471,000

Of the 443,662 stock options that were exercised during the six months ended June 30, 2021, 8,000 stock options were cash exercised whereby the Company received proceeds to cover the option holder’s exercise price and tax obligations totaling $6,000. In addition, 302,734 stock options were exercised as cashless exercises whereby the Company received proceeds to cover the option holders’ exercise price totaling $154,000. The remaining 132,928 stock options were net exercised whereby the total number of shares of common stock issued was reduced to cover the option holders’ exercise price and tax obligations. The Company submitted the tax obligations totaling $40,000 on behalf of the option holders. The shares of common stock that are held back upon a net exercise of a stock option to settle the option holder’s obligation associated with the exercise price and tax obligations are added back to the reserve for shares available for future equity awards under the 2019 Plan.

The following table summarizes the outstanding options that were issued in accordance with the 2010 Plan and the 2019 Plan:


Outstanding Options by Plan	~~June 30, 2021~~March 31, 2022
2010 Plan		~~3,640,018~~3,561,518
2019 Plan		~~2,046,971~~5,448,794
Outstanding as of ~~June 30, 2021~~March 31, 2022		~~5,686,989~~9,010,312

Stock options outstanding as of ~~June 30, 2021~~March 31, 2022 are summarized in the table below:


	Number of	Weighted		Weighted Average	Number of	Weighted		Weighted Average
	Options	Average		Remaining	Options	Average		Remaining
Range of Exercise Prices	Outstanding	Exercise Price		Contractual Lives	Outstanding	Exercise Price		Contractual Lives
Up to $0.50	494,500	$	0.44	8.17	1,767,823	$	0.45	9.22
$0.51 - $1.00	4,152,345	$	0.71	7.14	4,697,345	$	0.69	6.81
$1.01 - $1.50	187,000	$	1.39	9.38	937,000	$	1.19	9.45
$1.51 and above	853,144	$	3.23	4.59	1,608,144	$	2.46	6.48
Total	5,686,989	$	1.08	6.92	9,010,312	$	1.01	7.50

The Company computes the fair value for all options granted or modified using the Black-Scholes option pricing model. 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. The Company calculates its volatility assumption using the actual changes in the market value of its stock. Forfeitures are recognized as they occur. The Company’s historical option exercises do not provide a reasonable basis to estimate an expected term due to the lack of sufficient data. Therefore, the Company estimates 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 Company computed the fair value of options granted/modified during the period ended ~~June 30, 2021,~~March 31, 2022, using the following assumptions:


	Three Months Ended March 31,
	2022		2021

Expected volatility	117% - 119	%	127.17	%
Risk free interest rate	1.26% - 1.94	%	0.78	%
Expected term (years)	5.45 - 6.51		5.0

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~~Expected volatility~~	~~127.17~~	%
~~Risk free interest rate~~	~~0.78~~	%
~~Expected term (years)~~	~~5.00~~

Stock-based compensation expense related to the fair value of stock options is included in the statements of operations as research and development expenses or general and administrative expenses as set forth in the table below. The following table summarizes stock-based compensation expense (stock options and common stock issued for services) for the three ~~and six~~ months ended ~~June 30, 2021~~March 31, 2022 and ~~2020:~~2021:


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
	2021		2020		2021		2020		2022		2021
Research and development expenses
Stock-based compensation	$	—	$	11,000	$	46,000	$	71,000
Share-based compensation									$	47,000	$	46,000

General and administrative expenses
Issuance of common stock for services		0		0		80,000		80,000
Stock-based compensation		67,000		53,000		187,000		206,000
Issuance of common stock for services (see Note 8)										0		80,000
Share-based compensation										669,000		120,000

Total stock-based compensation	$	67,000	$	64,000	$	313,000	$	357,000
Total share-based compensation									$	716,000	$	246,000

Unrecognized expense as of June 30, 2021	$	98,000
Unrecognized share-based compensation expense related to stock options as of March 31, 2022									$	996,000

Weighted average remaining years to vest		1.12
Weighted average remaining years to vest for stock options										2.04

Unrecognized share-based compensation expense related to restricted stock awards as of March 31, 2022										1,339,000

Weighted average remaining years to vest for restricted stock awards										2.76

Note 1210 - Earnings Per Share

Basic earnings per share is computed by dividing net loss available to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted earnings per share is based on the treasury stock method and computed by dividing net loss available to common stockholders by the diluted weighted-average shares of common stock outstanding during each period. The Company’s potentially dilutive shares include stock options and warrants for the shares of common stock. The potentially dilutive shares are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when the effect is dilutive. The investor warrants are treated as equity in the calculation of diluted earnings per share in both the computation of the numerator and denominator, if dilutive. The following table sets forth the calculations of basic and diluted earnings per share for the three ~~and six~~ months ended ~~June 30, 2021~~March 31, 2022 and ~~2020:~~2021:

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020
Net loss

$
(3,556,000)

$
(2,731,000)

$
(7,222,000)

$
(7,910,000)
Less: decrease in fair value of investor warrants

(116,000)

—

(267,000)

(156,000)
Loss available to common stockholders

$
(3,672,000)

$
(2,731,000)

$
(7,489,000)

$
(8,066,000)

Basic weighted-average common shares outstanding

196,179,371

166,392,893

195,785,398

162,723,309
Add: dilutive effect of equity instruments

5,268,667

—

5,199,951

1,182,948
Diluted weighted-average shares outstanding

201,448,038

166,392,893

200,985,349

163,906,257
Earnings per share – basic

$
(0.02)

$
(0.02)

$
(0.04)

$
(0.05)
Earnings per share – diluted

$
(0.02)

$
(0.02)

$
(0.04)

$
(0.05)


	Three Months Ended March 31,
	2022		2021
Net loss	$	(5,636,000)	$	(3,667,000)
Less: decrease in fair value of investor warrants		(1,331,000)		(151,000)
Loss available to common stockholders	$	(6,967,000)	$	(3,818,000)

Basic weighted-average common shares outstanding		226,083,328		195,387,047
Add: dilutive effect of equity instruments		27,365		5,365,220
Diluted weighted-average shares outstanding		226,110,693		200,752,267
Earnings per share – basic	$	(0.02)	$	(0.02)
Earnings per share – diluted	$	(0.03)	$	(0.02)

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The potentially dilutive shares of common stock that have been excluded from the calculation of net loss per share because of their anti-dilutive effect are as follows:


	Three Months Ended June 30,		Six Months Ended June 30,		Three Months Ended March 31,
	2021	2020	2021	2020	2022	2021
Warrants to purchase shares of common stock					18,275,532	2,939,996
Outstanding stock options	1,437,657	6,866,524	1,466,319	5,917,367	9,010,312	1,510,485
Warrants to purchase shares of common stock	2,754,263	5,374,832	2,794,317	5,141,041
Restricted stock awards					1,101,000	—
Total potentially dilutive shares of common stock	4,191,920	12,241,356	4,260,636	11,058,408	28,386,844	4,450,481

~~Note 13 – Litigation~~

~~From time to time, the Company may be a party to litigation arising in the ordinary course of business. As of June 30, 2021, the Company is not a party to any ongoing lawsuits.~~

~~Note 14 – Subsequent Events~~

In July 2021, the Company received additional gross proceeds of $0.5 million from the sale of 330,875 shares of common stock in an ATM offering pursuant to the Sales Agreement, which was offset by offering related costs of $22,000.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

~~MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~

This discussion should be read in conjunction with our historical financial statements. The following discussion and analysis contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. For additional information regarding these risks and uncertainties, please see “Cautionary Note Regarding Forward-Looking Statements”, above, Part II, Item 1A of this Quarterly Report on Form 10-Q, “Risk Factors,” and the risk factors included in our ~~2020~~2021 Annual ~~Report and other reports that we have filed with the SEC.~~Report.

~~EXECUTIVE SUMMARY~~Executive Summary

We are a pre-revenue stage biopharmaceutical company focused on the research, development and advancement of ~~immunology-based~~immunomodulatory therapies for ~~prevalent inflammatory conditions.~~the treatment of pain from osteoarthritis. We have not generated operating revenue to date, and our operations have been substantially funded through equity raises, which have occurred from time to time since inception.

~~The biopharmaceutical market, both domestic and globally,~~

Ampion is ~~a highly competitive industry with strict regulations that are unpredictable in nature, time intensive and costly.~~our lead product candidate. We ~~are committed to offering a compelling therapeutic option~~have been studying Ampion for ~~patients most in need~~the potential treatment of ~~new treatments for~~multiple inflammatory conditions ~~including, but not limited to,~~(e.g., osteoarthritis of the knee or OAK, osteoarthritis of the hand, and COVID-19 inflammation in the ~~treatment of serious complications arising from the COVID-19 pandemic, including Long-COVID~~lung).

~~Moving forward,~~During 2021 and continuing into the first quarter of 2022, we ~~will continue to place a disciplined focus on maintaining our business operations~~have been primarily engaged in ~~a manner that is streamlined~~clinical development of Ampion. We have conducted four discrete clinical trials in the United States and efficient while continuing to allocate a requisite level of our liquidity, human capital and other operational resources towards the advancement of key immunology-based therapies with the ultimate goal of achieving FDA marketing approval and subsequent commercialization of Ampion for these conditions.abroad as follows:


Study Name		Title
AP-013		A Randomized, Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee
AP-017		A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Intravenous Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation
AP-019		A Randomized, Double-Blinded, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress Due to COVID-19
AP-018		A Randomized, Double-Blinded, Placebo-Controlled Phase 1 Study to Evaluate the Safety and Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms due to COVID-19 (Long-COVID)

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~~Overview~~

~~We maintain an Internet website at www.ampiopharma.com. Information on or linked to our website is not incorporated by reference into this Quarterly Report on Form 10-Q. Filings~~As of March 31, 2022, we had one clinical trial outstanding with patient enrollment, AP-019, and the ~~SEC can also be obtained at the SEC’s website, www.sec.gov.~~

~~Ampion, our lead product candidate, is~~other clinical studies were in ~~the process~~various stages of advancing through clinical trials in the United States. Ampion is currently in development as an intra-articular injection treatment for severe OAK, an IV treatment for COVID-19 patients, and an inhaled treatment for COVID-19 and Long-COVID. Pre-clinical and discovery work is also underway for additional applications and indications for Ampion.

In June 2019, we commenced the AP-013 study titled “A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults with Pain Due to Severe Osteoarthritis of the Knee”. In April 2020, due to the impact of COVID-19, we paused the ongoing conduct of the AP-013 study. During fiscal 2020 and fiscal 2021, the FDA provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were impacted by the pandemic. In March 2021, we submitted a detailed proposal to the FDA in response to the FDA’s recent guidance regarding the status of the AP-013 study.completion. In May ~~2021, the FDA issued updated statistical guidance for the industry. At this time,~~2022, we are evaluating our options to analyze the clinical trial data from the AP-013 study. However, due to the significant uncertainty surrounding the continuation and overall impact of the pandemic, it is possible that the continuation of the pandemic may prevent completion of the AP-013 study at this time or at all. In addition, the current uncertainty resulting from the pandemic may result in a significant change to the future contractual commitment related to the AP-013 study.

In October 2020, we commenced a study (the “AP-014 study”) titled “A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults with Respiratory Distress Secondary to COVID-19 Infection”. In March 2021, we finalized the enrollment of 40 patients, who were randomized 1:1, Ampion in addition to the Standard of Care (“SOC”) versus SOC alone. Patients were randomized to receive inhaled Ampion for five days. The study met its primary end-point and demonstrated the safety and tolerability of inhaled Ampion in COVID-19 patients. Additionally, a reduction in mortality was observed by nearly 80% of patients with Ampion treatment compared to SOC alone. It was also noted that Ampion treated patients required less hospital time and were stable or showed improvement on a scale of clinical improvement compared to patients treated with SOC alone. This data was presented to the FDA for guidance as a potential Emergency Use Authorization (“EUA”) therapy. The FDA provided guidance and recommended the Company proceed to a Phase II study in COVID-19 patients.

In December 2020, we initiated the multicentered AP-017 study in the United States and Israel for IV Ampion therapy in patients with COVID-19. The preliminary results of the AP-014 study were shared with the FDA, at which point the FDA recommended updates to the protocol for the AP-017 study, which were implemented in the study titled “A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Intravenous Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation”. In June 2021, due to the ongoing turmoil in the region, we decided to pause the AP-017 study in Israel. However, we plan to continue conducting the AP-017 study in the United States.

In March 2021, we initiated the AP-018 study titled “A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms due to COVID-19 (Long-COVID)”. An increasing number of people with COVID-19 are experiencing lingering effects of COVID-19 and continue to have prolonged respiratory complications months after the onset of the disease, also known as PASC, Long-COVID, and/or long-hauler syndrome. This study aims to evaluate the safety of Ampion and the clinical outcomes in patients with Long-COVID.

In April 2021, we initiated the multicentered AP-019 study titled “A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress Due to COVID-19”, following the strong top-line results achieved from the AP-014 study. In June 2021, we announced randomization and dosing of patients in the AP-019 study in the United States. In June 2021, we also received approval to expandterminated enrollment of the AP-019 study, as no beneficial effect of nebulized Ampion could be documented. We continued to ~~India.~~

~~Table of Contents~~

~~In April 2021, we provided an update on the continued research~~recognize patient enrollment and discovery for Ampion applications. Laboratory results suggest Ampion’s suitability for addressing kidney diseases and provides further evidence that it is a platform biologic for treatment of a wide variety of inflammatory and autoimmune diseases.

We believe the immunomodulatory action and anti-inflammatory effects of Ampion may provide a treatment for individuals with inflammatory conditions including, but not limited to, severe OAK and the widespread inflammation associated with COVID-19 infection.

Our therapeutic product pipeline is the result of more than two decades of research at leading hospital-based research centers. Significant discoveries in both scientific and clinical research have been published in peer-reviewed journals, highlighting the depth of research supporting Ampion’s therapeutic capabilities. Ampion is backed by an extensive and robust United States and global patent portfolio with intellectual property protection extending through 2037. In addition, Ampion is eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act of 2009.

~~AMPION~~

We have developed a novel biologic drug, Ampion, which contains a blood-derived cyclized peptide and small molecules that target multiple pathways in the innate immune response characteristic of inflammatory disease. ~~In vitro~~ studies have shown that Ampion represses the transcription of proteins responsible for inflammation, while activating anti-inflammatory proteins responsible for signaling tissue growth and healing. Ampion achieves its biological effect by targeting the over production of inflammatory cytokines, which is common in multiple inflammatory diseases like osteoarthritis and respiratory disease, and other inflammatory conditions. Ampion has been shown to uniquely reduce inflammation along multiple pathways, unlike other anti-inflammatory therapies that target only one mechanism.

~~Ampion has been developed for use, and has been cleared by the FDA for investigation, by multiple routes of administration.~~

●

Intra-articular injection places Ampion right where it is needed to locally treat inflammation. The osteoarthritis trials are evaluating the safety and efficacy of intra-articular injection into the joint.

●

Inhalation provides direct application of Ampion to locally treat inflammation in the lungs. Certain COVID-19 clinical trials are evaluating the safety and efficacy of Ampion inhalation in the lungs of COVID-19 patients with respiratory illness, which is supported by strong top-line results achieved from the AP-014 study.

●

Intravenous provides systemic application of Ampion to broadly treat inflammation throughout the body. An additional COVID-19 clinical trial is evaluating the safety and efficacy of Ampion IV treatment in COVID-19 patients with respiratory illness.

~~Table of Contents~~

We believe that the Ampion mechanism of action provides a therapeutic effect by interrupting the dysregulated immune system responsible for the disease, damage, and pain attributed to many inflammatory and degenerative conditions. Ampion is considered a platform drug which is potentially useful for several inflammatory diseasesstudy costs throughout the ~~body.~~

~~Ampion for Osteoarthritis~~

~~Ampion targets the cellular pathways in the innate immune response correlated with pain, inflammation, and joint damage from osteoarthritis. As described above, i~~~~n vitro~~ ~~studies have shown that Ampion represses the transcription~~first quarter 2022. Clinical trial accrual amounts were $2.9 million as of inflammatory cytokines responsible for inflammation, while activating anti-inflammatory proteins responsible for tissue growth and healing. We believe that this mechanism of action interrupts the disease process responsible for the pain and disability associated with OAK while providing a market expansion potentialMarch 31, 2022 as ~~a disease modifying biologic drug.~~

We are currently developing Ampion as an intra-articular injection to treat the signs and symptoms of severe OAK, which continues to be a growing epidemic in the United States and other countries worldwide. OAK is a progressive disease characterized by gradual degradation and loss of cartilage due to inflammation of the soft tissue and bony structures of the knee joint. Progression of the most severe form of OAK leaves patients with little or no treatment options other than a total knee arthroplasty. The FDA has asserted that severe OAK is an “unmet medical need” with no existing licensed therapy available. While we believe that Ampion could successfully treat this “unmet medical need”, our ability to market this product is subject to FDA approval.

~~Ampion Development for Osteoarthritis~~

Since our inception, we have conducted multiple clinical trials and have advanced through late-stage clinical trials in the United States, initially under the guidance of the FDA’s Office of Blood Research and Review and most recently under the guidance of the FDA’s Office of Tissues and Advanced Therapies.

Study AP-003-A was a multicenter, randomized, double-blind Phase III trial of 329 patients who were randomized 1:1 to receive Ampion or saline control via intra-articular injection. The study showed a statistically significant reduction in pain compared to ~~the control, with~~$3.0 million as of December 31, 2021.

Please see Part II, Item 5 of this Form 10-Q for information regarding an average of greater than 40% reduction in pain from baseline at 12 weeks with Ampion treatment. Patients who received Ampion also showed a significant improvement in function and quality of life at 12 weeks compared to patients who received the saline control at 12 weeks. Quality of life was assessed using Patient Global Assessment. Furthermore, the trial included severely diseased patients, defined radiographically as Kellgren Lawrence Grade 4 (“KL 4”). From this patient population, those patients who received Ampion had a significantly greater reduction in pain than those who received the saline control. Ampion was well tolerated with minimal adverse events reported in either the Ampion or saline treated groups. There were no drug-related serious adverse events in either group.

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In 2018, the FDA reiterated and confirmed that our successful pivotal Phase III clinical trial, AP-003-A, was adequate and well-controlled, provided evidence of the effectiveness of Ampion and can contribute to the substantial evidence of effectiveness necessary for the approval of a BLA. The FDA provided guidance that we should complete an additional Phase III trial of KL 4 severe OAK patients with concurrent controls that would be carried out under an SPA to obtain FDA concurrence on the trial design prior to initiation of the trial.

We received an SPA agreement in June 2019 from the FDA for a Phase III clinical protocol in reference to the AP-013 study. The SPA agreement for the AP-013 study finalized patient enrollment at 1,034 patients, with a sample size assessment at an interim analysis of 724 patients to allow an adjustment up to 1,551 patients if deemed necessary. In the SPA agreement, the FDA agreed that the design and planned analysis of the AP-013 study adequately addressed the objectives necessary to support a regulatory submission. According to the FDA’s guidance regarding SPAs (published in April 2018), an SPA documents the FDA’s agreement that the design and planned analysis of a study can address objectives in support of a regulatory submission; however, the final determinations for marketing application approval are made after a complete review of the marketing application and are based on the entire data in the application. Following the receipt of the SPA agreement, we initiated the AP-013 study, identified and engaged clinical sites for the clinical trial, and initiated dosing of patients at those sites.

In January 2020, the Secretary of HHS declared COVID-19 a public health emergency in the United States and the WHO announced a global health emergency because of COVID-19. The CDC indicated that older adults, age 65 years and older, are at higher risk for severe illness as a result of COVID-19. The AP-013 study focuses on individuals with the most severely diseased OAK, which represents an underserved patient population typically excluded from clinical studies because of the intractable nature of their condition. The AP-013 study population is comprised of elderly patients with an average age of 65 years old and a maximum age of 87 years. Therefore, guidance from the CDC indicates the AP-013 study population is the highest risk demographic for developing severe illness during the current COVID-19 pandemic. In March 2020, and most recently updated on January 27, 2021, the FDA acknowledged the impact of COVID-19 on clinical trials in published guidance, “~~FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic~~”, which outlines the FDA’s recommendations for ensuring clinical trial participant safety and adherence to good clinical practice guidelines and protocol requirements for clinical trials during the outbreak. In concurrence with the FDA guidance, the SMC for the AP-013 study recognized the impact of COVID-19 on the clinical trial. In April 2020, we paused ongoing conduct of the AP-013 study. In March 2021, we submitted a detailed proposal to the FDA in response to the FDA’s guidance regarding the status of the AP-013 study. In April 2021, we received a responseinternal investigation relating to our ~~proposal from the FDA. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, we are evaluating our options to analyze the~~ clinical trial data from the AP-013 study. During this period, the AP-013 study will remain paused and blinded to ensure clinical trial integrity and compliance with the SPA. However, due to the significant uncertainty surrounding the continuation and overall impact from the pandemic, it is possible that the continuation of the pandemic may prevent completion of the AP-013 study at this time or at all. In addition, the current uncertainty resulting from the pandemic may result in a significant change to the future contractual commitment related to the AP-013 study.

~~Ampion for COVID-19~~

The COVID-19 pandemic has resulted in millions of cases and deaths worldwide with figures continuing to reflect significant expansion of the pandemic. The COVID-19 infection is an acute respiratory illness caused by a novel coronavirus (SARS-COV-2). Once infected, the COVID-19 virus moves into a patient’s respiratory tract where the lungs may become inflamed, making breathing difficult and requiring treatment with oxygen. Complications of severe COVID-19 infection include, but are not limited to, Acute Respiratory Distress Syndrome (“ARDS”), Acute Lung Injury (“ALI”), PASC, pneumonia, sepsis and septic shock, cardiomyopathy and arrhythmia, acute kidney injury and prolonged hospitalization for other complications (i.e., secondary bacterial infection). We believe that it is imperative that effective therapeutic treatments are identified and developed to address the full spectrum of clinical features of COVID-19 infection, from the need for oxygen to the progression to ARDS.

~~Nonclinical~~ ~~in vitro~~ studies show Ampion decreases the production of inflammatory cytokines associated with the hyperactive inflammatory response present during COVID-19 infection. Elevated levels of inflammatory cytokines are correlated with COVID-19 severity and may also trigger additional complications including pneumonia, ALI and/or

~~Table of Contents~~

~~ARDS, which is a leading cause of mortality in COVID-19. By targeting and reducing the production of these inflammatory cytokines, Ampion may improve the clinical outcome for patients with COVID-19.~~

Due to its mode of action, Ampion may be a viable treatment option for those infected with COVID-19 to improve clinical outcomes and decrease the progression and severity of associated COVID-19 inflammatory conditions (i.e., COVID-19 pneumonia, ALI, ARDS, and ultimately mortality). Accordingly, Ampion may provide an early intervention option for COVID-19 patients.

~~As an immunomodulatory agent, we believe that Ampion may be effective in improving the clinical course and outcome of COVID-19 patients.~~

~~Ampion Development for Treating COVID-19 Induced Inflammation~~

Ampion is in development as a novel biologic drug that regulates multiple therapeutic targets in the innate immune system responsible for the inflammation, tissue damage and pathogenesis associated with dysregulated immune disorders. Due to its mode of action, Ampion may be a viable treatment option for those infected with COVID-19 to improve clinical outcomes and slow the progression and severity associated critical COVID-19 inflammatory conditions (i.e., progression to respiratory failure, the need for assisted breathing and ultimately mortality).

Ampion is currently in development as an IV treatment for COVID-19 patients. In May 2020, we submitted an Investigational New Drug (“IND”) application for the IV treatment of adults with COVID-19. In June 2020, we received FDA agreement to proceed with human trials utilizing an IV Ampion treatment for COVID-19 patients, and we commenced the Phase I AP-016 study in July 2020. In September 2020, we announced the results of the AP-016 study, which met its primary endpoint and found Ampion to be safe and well-tolerated with no remarkable difference in the incidence, frequency, and severity of adverse events between IV Ampion and SOC. Secondary efficacy endpoints from the study suggest Ampion may improve the clinical outcome for patients with COVID-19 as measured by the ordinal scale of clinical improvement as recommended by the WHO, and by the National Early Warning Score, as recommended by the National Institute for Health and Care Excellence in its guidelines for the management of COVID-19 patients in critical care. Following these results, in December 2020, the Company initiated a multicenter study, the AP-017 study, in the United States and Israel for IV Ampion therapy in patients with COVID-19. In discussions with the FDA for EUA of Ampion for COVID-19 patients, the FDA recommended study updates to protocol AP-017, which were implemented in the study titled “A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Intravenous Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation”. In June 2021, due to the ongoing turmoil in the region, we decided to pause the AP-017 study in Israel. However, we plan to continue conducting the AP-017 study in the United States. We commenced enrollment of the AP-017 study in the United States during the third quarter of 2021.

Ampion is currently in development as an inhaled treatment for COVID-19 patients. In August 2020, we submitted preclinical safety data to support the IND application for inhalation treatment of adults with respiratory distress due to COVID-19 infection. In September 2020, we received FDA agreement to proceed with human trials utilizing inhaled Ampion as a treatment for COVID-19 patients and, in October 2020, we commenced the AP-014 study. In April 2021, we announced the results from the AP-014 study. The AP-014 study not only met its primary endpoint, but the final data showed a greater improvement in all-cause mortality in COVID-19 patients with Ampion treatment over patients treated using SOC. Specifically, mortality in the SOC group was 24%, while in the group treated with Ampion, mortality was only 5%, representing an almost 80% improvement.

~~Other key findings from the study continue to show a positive outcome for patients treated with Ampion including:~~

●

~~Patients who received Ampion required less hospitalization time. The average hospital length of stay was four days less for the Ampion group compared to the patients receiving SOC.~~

●

Patients treated with Ampion were either stable or showed improvement on a scale of clinical improvement compared to patients treated using SOC. By day five, 89% of patients who received Ampion were stable or had improvement compared to 77% of patients who received SOC. This trend in improvement with Ampion treatment is noted as early as day two and continues to day five.

~~Table of Contents~~

●

~~Ampion treatment was safe and well-tolerated in all patients. There were no remarkable adverse events with Ampion treatment, and no drug-related serious adverse events were reported.~~

In March 2021, we initiated the AP-018 study titled, “A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms due to COVID-19 (Long-COVID)”. An increasing number of people with COVID-19 are experiencing lingering effects of COVID-19 and continue to have prolonged respiratory complications months after the onset of the disease, also known as PASC, Long-COVID, and/or long-hauler syndrome. This study aims to evaluate the safety of Ampion and the clinical outcomes in patients with Long-COVID. We commenced enrollment of the AP-018 study during the third quarter of 2021.

We continue to communicate on a regular basis with the FDA to advance the development of these programs. As an immunomodulatory agent, with anti-inflammatory effects, we believe Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improving the clinical course and outcome for patients.

Due to the global pandemic and the need for new treatments, regulatory authorities are applying emergency approval programs. These programs include the EUA program in the United States. We may seek an EUA from the FDA for the use of Ampion for COVID-19 patients. If we decide to apply for an EUA and it is granted, a separate regulatory process will be needed in order to obtain a full marketing authorization (i.e., non-emergency authorization) for the use of Ampion in COVID-19 patients.

~~Recent Financing Activities~~

~~Information regarding our recent financing activities is contained in~~ ~~Note 10~~ ~~to the Financial Statements.~~studies.

Known Trends or Future Events; Outlook

We are a pre-revenue stage biopharmaceutical company that has incurred an accumulated deficit of ~~$207.8~~$223.2 million as of ~~June 30, 2021.~~March 31, 2022. We expect to generate continued operating losses for the foreseeable future as ~~we continue~~ the ~~ongoing~~Ampio board of directors is considering strategic alternatives for Ampio and Ampion, which may include the continued development and advancement of ~~immunological-based therapies with the ultimate goal of achieving FDA marketing approval and subsequent commercialization of~~ Ampion, ~~for the indications previously discussed. In addition, while working in parallel with the continued advancement of immunology-based therapies for Ampion, we continue to actively explore~~capital raising, licensing and other partnering opportunities, ~~with both domestic and global-based organizations in order to further leverage and maximize~~positioning the ~~value of Ampion to our stockholders.~~

~~We plan to maintain an ongoing dialog with the FDA to explore all viable options to complete the AP-013 study under an amended SPA agreement, as~~Company for a ~~result of the COVID-19 pandemic and the related adverse impact on the study. It remains possible that the ongoing COVID-19 pandemic may prevent completion of the study over the near term~~strategic transaction or at all. While the potential economic impact brought by, and the duration of, COVID-19 may be difficult to assess or predict, a continued widespread pandemic could result in significant disruption of global financial markets, reducing our ability to access capital in a timely and effective manner. In addition, a recession or market correction resulting from the spread of COVID-19 could have a material adverse impact on our ability to raise requisite financing to support our business operations, which would adversely impact the value of our common stock.other alternative(s).

As of ~~June 30, 2021,~~March 31, 2022, we had ~~$20.5~~$28.8 million of cash and cash equivalents. During the six months ended June 30, 2021, we sold approximately 5.9 million shares of common stock pursuant to the ATM equity offering program, which yielded gross proceeds of approximately $10.0 million; offset by offering related costs of $0.4 million. We anticipate the continued use of the ATM equity offering program in a disciplined manner based on near-term liquidity needs and may seek to supplement the funds raised with separate private or public equity offering(s). Based on our current cash position and projection of ~~operations~~operating expenses and ~~expected access to equity financing,~~capital expenditures, we believe we will have sufficient liquidity to fund operations ~~through~~into the ~~fourth quarter~~second half of ~~2022. This projection~~2023. Our cash resources and our capital needs are based upon management estimates as to future operations and expense, which involve significant judgment. Additionally, given that the Ampio board of directors is considering strategic alternatives, our forecasts regarding the sufficiency of our liquidity is based ~~on many assumptions that~~upon maintaining our current operations. Accordingly, we may prove to be incorrect. Despite the prior access and use of the ATM equity offering program in a manner to provide sufficient ongoing liquidity to the Company, the ATM is not considered to represent a source of committed capital. As such, it is possible that the Company could exhaust ~~its~~our available cash and cash equivalents earlier than presently ~~anticipated. In addition, as the global pandemic continues, its effect on the Company’s operations~~anticipated and ~~ability to raise~~may require more capital ~~through the~~

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ATM equity offering program, or otherwise, remains uncertain and subject to change. These existing and on-going factors continue to raise substantial doubt about our ability to continue as a going concern (see ~~Note 2~~ ~~to the Financial Statements).~~more quickly than presently anticipated.

~~Our shelf registration statement, which was declared effective~~Additional financing may not be available in the amount or at the time we need it or may not be available on acceptable terms or at all. We may obtain future additional financing by incurring indebtedness or from an offering of our equity securities or either of these. If we raise additional equity financing, our stockholders may experience significant dilution of their ownership interests and the ~~SEC in May 2020, provides us with the ability to sell up to an aggregate amount of $100.0 million~~value of shares of our common stock ~~preferred stock, debt securities, warrants and units, or any combination thereof, less any sales~~could decline. Our efforts to raise additional funds from the ~~ATM~~sale of equity offering program that occurred prior to May 6, 2020, which was the effective date of the shelf registration statement. We had $67.3 million remaining under the shelf registration statement as of June 30, 2021. However, we cannot be certain that we will be able to secure additional financing or that any funding, or securities offered pursuant to the shelf registration statement or otherwise, will be adequate to execute our business strategy. Even if we are able to obtain additional financing, such additional financing may be ~~costly and may require us to agree to covenants or other provisions that favor~~hampered by the currently depressed trading price of our common stock. If we raise additional equity financing, new investors ~~over~~may demand rights, preferences, or privileges senior to those of existing ~~stockholders.~~

June 30, 2021

Authorized shares

300,000,000

Common stock outstanding

200,070,419
Options outstanding

5,686,989
Warrants outstanding

3,773,598
Shares reserved for issuance under 2019 Stock and Incentive Plan

7,918,755
Available shares

82,550,239

Effective registration statement
$
100,000,000
ATM activity (May 6, 2020 - June 30, 2021)

(32,672,000)
Remaining amount on registration statement
$
67,328,000

Average stock price immediately preceding June 30, 2021:

30 day
$
1.78
60 day
$
1.81
90 day
$
1.79

holders of common stock.

~~Even though we~~We had approximately ~~82.6~~42.5 million shares of common stock authorized and available for future issuance as of ~~June 30, 2021,~~March 31, 2022 and our ability to raise additional funds by issuing equity securities ~~pursuant to~~may be limited by our authorized and available common stock. Additionally, we are limited in the amount of equity securities we may sell under our current shelf registration statement ~~is limited by~~to the ~~$67.3~~$44.3 million remaining, of which ~~$13.8~~$13.3 million is currently reserved for the ATM equity offering program. Based on the table above, the average stock price could represent a range of our ability to draw down on the residual shelf capacity. In addition, we, at our discretion, may file a new shelf registration statement to register the issuance and sale of any remaining shares of common stock that are authorized for issuance and/or any other equity or debt securities that may be issued by the Company.

ACCOUNTING POLICIES

Significant Accounting Policies and Estimates

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, including those related to recoverability of long-lived assets and the ability for the Company to continue as a going concern.~~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

~~Table of Contents~~

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. ~~Our significant accounting policies and estimates are included in our 2020 Annual Report.~~

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Our significant accounting policies and estimates have not changed substantially from those previously disclosed in our ~~2020~~2021 Annual Report.

Newly Issued Accounting Pronouncements

Information regarding the recently issued accounting standards (adopted and not adopted as of ~~June 30, 2021)~~March 31, 2022) is contained in Note 1 to the Financial Statements.

RESULTS OF OPERATIONS

Results of Operations – ~~June 30, 2021~~March 31, 2022 Compared to ~~June 30, 2020~~March 31, 2021

We recognized a net loss for the three months ended ~~June 30, 2021~~March 31, 2022 (“~~2021~~2022 quarter”) of ~~$3.6~~$5.6 million compared to a net loss of ~~$2.7~~$3.7 million for the three months ended ~~June 30, 2020~~March 31, 2021 (“~~2020~~2021 quarter”). The net loss during the 2022 quarter was primarily attributable to operating expenses of $7.0 million, partially offset by a non-cash derivative gain of $1.3 million. The net loss during the 2021 quarter was primarily attributable to operating expenses of ~~$3.7 million;~~$3.8 million, partially offset by the non-cash derivative gain of ~~$0.1~~$0.2 million. The net loss during the 2020 quarter was primarily attributable to operating expenses of $2.6 million and the non-cash derivative loss of $0.7 million; partially offset by the gain realized from the PPP loan forgiveness of $0.5 million. The modest increasedecrease in our stock price ~~during the 2020 quarter~~from $0.57 as of December 31, 2021 to $0.47 as of March 31, 2022 caused the valuation of the warrant liability to ~~increase~~decrease resulting in a derivative ~~loss recorded.~~gain during the 2022 quarter. Operating expenses increased ~~$1.1~~$3.2 million from the ~~2020~~2021 quarter to the ~~2021~~2022 quarter primarily due to a ~~$1.2~~$1.4 million increase in research and development costs, ~~partially offset by~~as well as a ~~$0.1~~$1.8 million ~~decrease~~increase in general and administrative costs, both of which are further explained below.

We recognized a net loss for the six months ended June 30, 2021 (“2021 period”) of $7.2 million compared to a net loss of $7.9 million for the six months ended June 30, 2020 (“2020 period”). The net loss during the 2021 period was primarily attributable to operating expenses of $7.5 million, partially offset by the non-cash derivative gain of $0.3 million. The modest increase in our stock price during the 2021 period would have normally caused an increase in the warrant liability, resulting in a derivative loss to be recognized. However, during the six months ended June 30, 2021, we had 284,100 investor warrants exercised, which caused the warrant liability to decrease, offsetting the derivative loss from the increase in stock price and resulting in the recognition of a net derivative gain. The net loss during the 2020 period was primarily attributable to operating expenses of $8.6 million, partially offset by the gain realized from the expected PPP loan forgiveness of $0.5 million and non-cash derivative gain of $0.2 million. The outstanding amount of investor warrants decreased due to warrant exercises, causing the valuation of the warrant liability to decrease, which resulted in a non-cash derivative gain; partially offset by a modest appreciation in our stock price during the 2020 period. The operating expenses decreased $1.1 million from the 2020 period to the 2021 period primarily due to a $0.8 million decrease in research and development costs and a $0.3 million decrease in general and administrative costs, both of which are further explained below.

~~Table of Contents~~

Operating Expenses

Research and Development

Research and development costs (benefits) are summarized as follows and exclude an allocation of general and administrative expenses:

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020

Clinical trial and sponsored research expenses

$
808,000

$
(82,000)

$
1,575,000

$
2,928,000

Salaries and benefits

613,000

652,000

1,235,000

1,349,000

Depreciation

268,000

293,000

557,000

586,000

Laboratory

266,000

95,000

381,000

187,000

Operations / manufacturing

228,000

67,000

617,000

101,000

Professional fees

72,000

16,000

107,000

41,000

Equipment rental and repair

11,000

11,000

44,000

33,000

Regulatory / FDA

7,000

55,000

6,000

77,000

Stock-based compensation

—

11,000

46,000

71,000

Total research and development

$
2,273,000

$
1,118,000

$
4,568,000

$
5,373,000


	Three Months Ended March 31,
	2022		2021
Clinical trial and sponsored research expenses	$	1,925,000	$	769,000
Salaries and benefits		772,000		621,000
Depreciation		256,000		289,000
Operations/manufacturing		205,000		389,000
Laboratory		260,000		115,000
Professional fees		194,000		35,000
Equipment rental and repair		15,000		33,000
Regulatory / FDA		13,000		(1,000)
Share-based compensation		47,000		46,000
Total research and development	$	3,687,000	$	2,296,000

~~2021~~2022 Quarter Compared to ~~2020~~2021 Quarter

Research and development costs increased by approximately ~~$1.2~~$1.4 million, or ~~103%~~61%, for the ~~2021~~2022 quarter compared to the ~~2020~~2021 quarter. Research and development costs with variances above $75,000 and 10% compared with the previous quarter are further explained below.

~~Clinical trial and sponsored research expenses~~

The clinical trial and sponsored research expenses increased by approximately $0.9 million, or 1,085%, primarily due to the initiation of the AP-013 study database contract in December 2020 to ensure the validity and accuracy of the study data prior to submission to the FDA. It is important to note that the AP-013 study was paused in April 2020 and remains paused through the current period as a result of the pandemic. During the 2020 quarter, we reviewed the clinical trial accrual assumptions for the AP-013 study and adjusted those assumptions accordingly based on discussions with the CRO, resulting in a favorable accrual adjustment of $0.5 million. In addition, during the 2021 quarter, we incurred costs associated with the various COVID-19 studies of $0.4 million, all of which were initiated subsequent to the 2020 quarter.

~~Laboratory~~

Laboratory expenses increased $171,000, or 180%, for the 2021 quarter compared with the 2020 quarter as a result of continued effort and incremental spend associated with research and discovery searching for novel applications to further leverage the Ampion platform technology.

~~Operations / manufacturing~~

Operations / manufacturing expenses increased $161,000, or 240%, for the 2021 quarter compared with the 2020 quarter as a result of the current period production of clinical trial products to be utilized in the current and upcoming clinical trials.

~~2021 Period Compared to 2020 Period~~

Research and development costs decreased by approximately $0.8 million, or 15%, for the 2021 period compared to the 2020 period. Research and development costs with variances above $175,000 and 10% compared with the previous period are further explained below.

~~Table of Contents~~

Clinical trial and sponsored research expenses

The clinical trial and sponsored research ~~expenses decreased by approximately $1.4~~expense increased $1.2 million, or ~~46%~~150%, primarily due to the study related costs associated with the AP-018 and AP-019 COVID-19 studies whereby the interim enrollment was completed for the AP-019 study and the Phase 1 AP-018 study was substantially completed in the 2022 quarter resulting in a cost increase of $1.6 million. These studies did not commence until early/mid second-half 2021 resulting in no costs in the 2021

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quarter. This increase was partially offset by a decrease in costs associated with the AP-013 study ~~being temporarily paused~~resulting in ~~April 2020~~a decrease in costs of $0.4 million.

Salaries and ~~continuing through~~benefits

Salaries and benefit expense increased $151,000, or 24%, for the ~~current period~~2022 quarter compared with the 2021 quarter as a result of (i) modest increase in health and medical benefits and (ii) market-based compensation adjustments effective at the ~~pandemic. The pause~~beginning of the AP-013 study resulted in a reduction of ongoing patient enrollment and study monitoring expenses totaling $2.8 million; partially offset by $0.4 million of expenses associated with the current COVID-19 studies, as well as the $1.0 million of expenses related to the AP-013 study database contract, which were initiated subsequent to the 2020 period.

~~Laboratory~~

Laboratory expenses increased $194,000, or 104%, for the 2021 period compared with the 2020 period as a result of continued effort and incremental spend associated with searching for novel applications to further leverage the Ampion platform technology.2022 quarter.

Operations / manufacturing

Operations / manufacturing expenses decreased $184,000, or 47%, as a result of no clinical trial product manufacturing in the 2022 quarter compared to the 2021 quarter.

Laboratory

Laboratory expenses increased ~~$516,000,~~$145,000, or ~~511%~~126%, for the ~~2021~~2022 quarter compared with the ~~2020~~2021 quarter as a result of the ~~current period production of clinical trial products~~Company entering into, in February 2022, a sponsored research agreement with Trauma Research, LLC and a separate agreement with the director that owns this company to ~~be utilized~~provide research services. The costs directly related to these agreements was $83,000 in the ~~current~~2022 quarter. In addition, the Company initiated a series of animal studies to support the dosing and ~~upcoming clinical trials.~~biological effects of our drug in vivo in fourth quarter 2021 and into the 2022 quarter which resulted in $57,000 of incremental costs during the 2022 quarter.

Professional Fees

Professional fees expense increased $159,000, or 454%, for the 2022 quarter compared with the 2021 quarter as a result of the Company entering into an agreement with Dr. Howard Levy in October 2021 to serve in the capacity as the Company’s Chief Medical Officer. In addition, the Company incurred incremental costs during the 2022 quarter related to review of the AP-013 study information and related documents supporting the briefing book which was submitted to the FDA during the period.

General and Administrative

General and administrative expenses are summarized as follows:

Three Months Ended June 30,

Six Months Ended June 30,


2021

2020

2021

2020

Professional fees

$
517,000

$
614,000

$
997,000

$
1,355,000

Insurance

330,000

319,000

669,000

592,000

Salaries and benefits

240,000

275,000

477,000

512,000

Stock-based compensation

67,000

53,000

267,000

286,000

Facilities

128,000

120,000

256,000

247,000

Director fees

68,000

60,000

159,000

143,000

Other

34,000

22,000

71,000

48,000

Travel and meetings

10,000

16,000

15,000

60,000

Depreciation

6,000

3,000

12,000

6,000

Total general and administrative

$
1,400,000

$
1,482,000

$
2,923,000

$
3,249,000


	Three Months Ended March 31,
	2022		2021
Professional fees	$	1,403,000	$	479,000
Insurance		254,000		340,000
Salaries and benefits		632,000		237,000
Stock-based compensation		669,000		200,000
Facilities		136,000		128,000
Director fees		105,000		92,000
Depreciation		6,000		5,000
Other		78,000		42,000
Total general and administrative	$	3,283,000	$	1,523,000

~~2021~~2022 Quarter Compared to ~~2020~~2021 Quarter

General and administrative costs ~~decreased $82,000,~~increased $1.8 million, or 6%116%, for the ~~2021~~2022 quarter compared to the ~~2020~~2021 quarter. General and administrative costs with variances above $75,000 and 10% are ~~further~~ explained below.

Professional fees

Professional fees ~~decreased $97,000,~~increased $924,000, or ~~16%~~193%, for the ~~2021~~2022 quarter compared to the ~~2020~~2021 quarter due primarily to ~~a decrease~~an increase in ~~litigation~~costs related ~~legal costs which are directly attributable~~ to ~~the dismissal of the securities class action and derivative cases during the third quarter of 2020.~~

~~2021 Period Compared to 2020 Period~~

General and administrative costs decreased $326,000, or 10%, for the 2021 period compared to the 2020 period. General and administrative costs with variances above $175,000 and 10% are further explained below.(i) investor / public relations outreach activities, (ii) third-party market research studies, (iii)

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technical accounting services and (iv) legal services associated with certain FDA regulatory matters and indemnification payments related to legal services incurred by a former advisor relating to an SEC investigation of the former advisor.

~~Professional fees~~Salaries and benefits

~~Professional fees decreased $358,000,~~Salaries and benefit expense increased $395,000, or ~~26%~~167%, for the 2022 quarter compared with the 2021 ~~period~~quarter as a result of (i) incremental headcount in the 2022 quarter and, (ii) market-based compensation adjustments effective at the beginning of the 2022 quarter.

Stock-based compensation

Stock-based compensation expense increased $469,000, or 235%, for the 2022 quarter compared with the 2021 quarter as a result of non-cash expense in the 2022 quarter associated with (i) the vesting of restricted stock awards issued to certain officers in October 2021, (ii) issuance of option grants to newly elected Board members in fourth quarter 2021 and 2022 quarter, (iii) issuance of option grants to the ~~2020 period due primarily~~interim Chairman and Chief Executive Officer and (iv) annual option grants issued to ~~a decrease~~non-Section 16 employees in ~~litigation related legal costs which are directly attributable to~~ the ~~dismissal of the securities class action and derivative cases during the third quarter of 2020.~~2022 quarter.

Cash Flows

Cash flows for the respective periods are as follows:

Six Months Ended June 30,

2021

2020
Net cash used in operating activities

$
(6,475,000)

$
(9,143,000)
Net cash used in investing activities

(81,000)

—
Net cash provided by financing activities

9,759,000

7,453,000
Net change in cash and cash equivalents

$
3,203,000

$
(1,690,000)


	Three Months Ended March 31,
	2022		2021
Net cash used in operating activities	$	(4,944,000)	$	(4,147,000)
Net cash used in investing activities		—		(81,000)
Net cash (used in) provided by financing activities		(111,000)		2,686,000
Net change in cash and cash equivalents	$	(5,055,000)	$	(1,542,000)

Net Cash Used in Operating Activities

During the ~~six~~three months ended ~~June 30, 2021,~~March 31, 2022 our operating activities used approximately ~~$6.5~~$4.9 million in cash and cash equivalents, which was less than our reported net loss of ~~$7.2~~$5.6 million. The difference is primarily a result of ~~periodic~~a decrease in working capital, excluding cash and cash equivalents, totaling $1.1 million and non-cash charges related to depreciation and amortization and stock-based compensation totaling $1.0 million, partially offset by a non-cash adjustment of $1.3 million related to the warrant derivative gain.

During the three months ended March 31, 2021 our operating activities used approximately $4.1 million in cash and cash equivalents, which was more than our reported net loss of $3.7 million. The difference is primarily a result of an increase in working capital, excluding cash and cash equivalents, totaling $0.8 million and non-cash adjustment for the warrant derivative gain totaling $0.2 million, partially offset by recurring non-cash charges related to depreciation and amortization, stock-based compensation and issuance of common stock for services totaling ~~$0.9 million and an increase in working capital of $0.1 million; partially off-set by the non-cash adjustment for the warrant derivative gain totaling $0.3~~$0.5 million.

During the six months ended June 30, 2020, our operating activities used approximately $9.1 million in cash and cash equivalents, which was more than our net loss of $7.9 million primarily as a result of a decrease in working capital, excluding cash and cash equivalents, totaling $1.5 million and non-cash adjustments for the warrant derivative and PPP funding totaling $0.7 million; partially off-set by non-cash charges related to depreciation and amortization, stock-based compensation and issuance of common stock for services totaling $1.0 million.

Net Cash Used in Investing Activities

During the ~~six~~three months ended ~~June 30,~~March 31, 2022, there was no change in cash related to investing activities. During the three months ended March 31, 2021, $81,000 in cash and cash equivalents was used to acquire manufacturing machinery and equipment.

~~During the six months ended June 30, 2020, $0 in cash and cash equivalents was used to acquire manufacturing machinery and equipment.~~

Net Cash Provided by (used in) Financing Activities

During the ~~six~~three months ended ~~June 30,~~March 31, 2022, 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 138,514 common shares 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.

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During the three months ended March 31, 2021, we received gross proceeds of ~~approximately $10.0~~$2.7 million from the sale of approximately ~~5.9~~1.8 million shares of common stock pursuant to the ATM equity offering program, which was partially offset by ~~offering-related~~offering related costs of ~~$0.4 million.~~$126,000. In addition, we also received proceeds of ~~$234,000~~$114,000 from investor warrant exercises ~~and stock option exercises.~~

~~During the six months ended June 30, 2020, we received gross proceeds of $7.9 million from the sale of 14.3 million~~representing 284,000 shares of common stock pursuant to the ATM equity offering program, which was partially offset by offering-related costs of $0.6 million. In addition, we also received proceeds of $100,000 from investor warrant exercises.stock.

~~Table of Contents~~

Liquidity and Capital Resources

Since inception, we have not generated operating revenue or profits. ~~Over this period, we have~~We expect to generate continued ~~to be focused on research~~operating losses for the foreseeable future as the Ampio board of directors is considering strategic alternatives for Ampio and ~~clinical~~Ampion, which may include the continued development ~~activities for the~~and advancement of Ampion, ~~towards multiple BLA submissions; all of which has required~~capital raising, licensing and other partnering opportunities, positioning the Company for a ~~substantial amount of capital.~~ strategic transaction or other alternative(s).

As of ~~June 30, 2021, we do not have a fixed and determinable committed source of liquidity to meet our expected obligations over the next twelve months. Specifically,~~March 31, 2022, we had ~~$20.5~~$28.8 million of cash and cash ~~equivalents as of June 30, 2021.~~equivalents. During the three months ended March 31, 2022, the Company had no activity in its ATM equity offering program.

~~Although the ATM and/or other equity financing programs are not committed sources~~Based on our current cash position and projection of ~~liquidity, based on expected access to the ATM, consistent with previous periods,~~operating expenses and ~~potential for future equity financing programs,~~capital expenditures, we ~~project that~~believe we will have sufficient liquidity to fund operations ~~through fourth quarter~~into the second half of ~~2022.~~2023. Our ~~projection~~cash resources and our capital needs are based upon management estimates as to future operations and expense, which involve significant judgment. Additionally, given that the Ampio board of directors is considering strategic alternatives, our forecasts regarding the sufficiency of our liquidity are based upon maintaining our current operations. Accordingly, we may exhaust our available cash and cash equivalents earlier than presently anticipated and may require more capital more quickly than presently anticipated.

Additional financing may not be available in the amount or at the time we need it, or may not be available on ~~many assumptions that~~acceptable terms or at all. We may ~~prove~~obtain future additional financing by incurring indebtedness or from an offering of our equity securities or either of these. If we raise additional 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 ~~incorrect. In addition,~~hampered by the currently depressed trading price of our common stock. If we raise additional equity financing, new investors may demand rights, preferences or privileges senior to those of existing holders of common stock.

We had approximately 42.5 million shares of common stock authorized and available for future issuance as ~~the global pandemic continues in an unpredictable manner, its effect on~~of March 31, 2022 and our ~~business operations and~~ ability to raise ~~capital through~~additional funds by issuing equity securities may be limited by our authorized and available common stock. Additionally, we are limited in the amount of equity securities we may sell under our current shelf registration statement to the $44.3 million remaining, of which $13.3 million is currently reserved for the ATM equity offering or otherwise, remains highly uncertain and subject to change. While we believe the studies currently being conducted will be successful, we anticipate that we will seek to raise additional capital investments in both the near and long-term to enable us to primarily support (i) clinical development of Ampion, (ii) BLA preparation and submission, (iii) existing base business operations and (iv) commercial development activities for Ampion. We intend to continue our close evaluation of the overall capital markets to determine the appropriate timing and funding level for any such capital raising activities, which will primarily depend on our stock price and existing market conditions relative to our need for funds at such time.

The audit report on our financial statements for the fiscal year ended December 31, 2020 contains an explanatory paragraph indicating that there was substantial doubt about our ability continue as a going concern. In order to address the going concern, we have prepared a projection through August 31, 2022. Our projection reflects cash requirements for fixed, recurring base business expenses such as payroll, legal and accounting, patents and overhead, and incremental costs supporting our current and projected clinical development programs.

In May 2020, the shelf registration statement was declared effective by the SEC and, as of June 30, 2021, we had approximately $67.3 million available for issuance under the shelf registration statement with approximately 82.6 million authorized shares of common stock remaining available for issuance.program.

In the event that we are unable to obtain ~~funding~~additional capital through equity capital raises, ~~and/or~~ partnering/licensing transactions ~~in the future when deemed appropriate,~~or other strategic transaction, or a combination of these, we will likely be required to delay, reduce the scope of or eliminate our development, manufacturing and/or regulatory programs for Ampion ~~and/or our future commercialization efforts~~ and/or suspend operations for a period of time until we are able to secure additional funding. If we are not successful in raising sufficient funds to pay for further development and licensing of Ampion, we may choose to license or otherwise relinquish greater, or all, rights to Ampion at an earlier stage of development or on less favorable terms than we would otherwise choose. This could lead to impairment or other charges, which could materially affect our balance sheet and operating results.

Off Balance Sheet Arrangements

We do not have off-balance sheet arrangements, financings or other relationships with unconsolidated entities or other persons, also known as “variable interest entities”.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act, and are not required to provide the information required under this item.

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Item 4. Controls and Procedures.

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 Securities Exchange Act of 1934, or 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 Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”), as appropriate, to allow timely decisions regarding required disclosure.

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of senior management, including the CEO and the CFO, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15(b) and ~~15d-15(b)~~15d-15(b). Based upon this evaluation, the CEO and the CFO concluded that our disclosure controls and procedures as of the end of the period covered by this report were ~~effective.~~not effective due to the matters identified as part of the Company’s decision announced on May 16, 2022 to conduct an internal investigation, to be overseen by an independent special committee, as described in Part II, Item 5 of this Quarterly Report on Form 10-Q.

Changes in Internal Control over Financial Reporting

There were no changes in our internal controls over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II – OTHER INFORMATION

Item 1. Legal Proceedings.

~~Information regarding our Legal Proceedings is contained in~~ ~~Note 13~~ ~~to the Financial Statements.~~Not applicable.

Item 1A. Risk Factors.

~~We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control.~~ In addition to the other information set forth in this Quarterly Report on Form 10-Q, including Part II, Item 5, you should carefully consider the factors in Part I, “Item 1A. Risk Factors” in our ~~2020~~2021 Annual Report and other reports that we have filed with the SEC, which could materially affect our business, financial condition or future results. ~~Except as set forth below, during the period covered by this Quarterly Report on Form 10-Q, there have been no material changes in our risk factors as previously disclosed.~~

~~Our pursuit of Ampion as a COVID-19 therapeutic treatment is at an early stage. We may be unable to produce a~~

~~drug that successfully treats the virus in a timely manner, if at all.~~

Since June 2020, we have commenced several clinical trials to determine the safety and efficacy for application of Ampion (i.e., inhaled and intravenous), as a therapeutic treatment for COVID-19. Our development of a COVID-19 treatment is in its early stages, and we may be unable to produce a drug that successfully treats COVID-19 related illness in a timely manner, if at all. We are also committing financial resources and personnel to the development of these COVID-19 treatments which may cause delays in or otherwise negatively impact our other development programs, despite uncertainties surrounding the longevity and extent of COVID-19 as a global health concern. Our business could be negatively impacted by our allocation of significant resources to a global health threat that is unpredictable and could rapidly dissipate or against which our treatments, if developed, may not be partially or fully effective. In addition, conducting a clinical trial of a COVID-19 treatment is challenging in the current environment due to a number of factors, including a large number of competitive clinical trials seeking to enroll COVID-19 patients, the high workload of hospital staff, variability in vaccination rates among the population, mutations of the COVID-19 virus and related illness in certain geographies, and the difficulty of enrolling patients in intensive care or similar environments. These challenges may delay our clinical trials and may increase the costs of, or otherwise adversely affect, our clinical trials which could materially impact our business, financial condition, and results of operations.

~~Table of Contents~~

Item 2. Unregistered Sales of Securities and Use of Proceeds.

During the three months ended ~~June 30, 2021,~~March 31, 2022, we issued 29,158 shares of common stock to former placement agents as a result of net exercises of placement agent warrants, with exercise prices ranging from $0.50 to $0.76 per share of common stock, where the total number of shares of common stock to be issued were reduced to cover the exercise price. We did not ~~receive~~issue any ~~cash~~unregistered securities.

During the three months ended March 31, 2022, we did not repurchase any securities, other than 138,514 shares from employees for tax withholding purposes related to ~~the exercise~~vesting of ~~the placement agent warrants.~~restricted stock grants.


	Total Number	Average
	Of	Price Paid
Period	Shares Purchased	Per Share
January 1, 2022 to January 31, 2022	138,514	$	0.57
February 1, 2022 to February 28, 2022	0	$	-
March 1, 2022 to March 31, 2022	0	$	-

~~The issuance of the above securities was exempt from the registration requirements under Rule 4(2) of the Securities Act of 1933, as amended, and/or Rule 506 as promulgated under Regulation D.~~

Item 3. Defaults Upon Senior Securities.

None.

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Item 4. Mine Safety Disclosures.

Not Applicable.

Item 5. Other Information.

~~The~~On May 16, 2022, the Company issued a press release attached hereto as Exhibit 99.1 announcing that an independent special committee of the Board of Directors (the “Committee”), with the assistance of independent legal counsel, is in the process of conducting an internal investigation that relates to, among other matters, Ampio’s AP-013 clinical trial and other clinical trials. FDA has communicated to the Company ~~has set the date of the 2021 Annual Meeting of Stockholders for August 14, 2021 at 9:00 a.m. Mountain Time~~that it does not consider data from AP-013 to be ~~held entirely virtually by means of remote communication. For additional information, please see~~sufficient to demonstrate efficacy as a second pivotal trial for Ampion. Further analysis subsequent to that communication from FDA suggests that data from AP-013 will not be sufficient to support regulatory approval in the US or other countries. Management’s recent analyses also indicate no clinically meaningful treatment effect signals from the Company’s ~~definitive proxy statement which was filed with the SEC on June 30, 2021.~~three COVID-19 clinical trials, AP-017, AP-018, or AP-019.

Additionally, in the press release issued on May 16, 2022, Ampio disclosed that the Committee also is overseeing a review of unauthorized use of Ampion by individuals not participating in clinical trials. Ampion is an investigational drug not approved by FDA. Ampio instituted safeguards to cease this practice and engaged independent outside counsel to conduct a thorough review, which is ongoing The Company is currently in the process of working to ensure that the issue has been resolved, that appropriate mitigation measures have been implemented, and that this information is provided to FDA.

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Item 6. Exhibits.

The exhibits listed on the “Exhibit Index” set forth below are filed or furnished with this Quarterly Report on Form 10-Q or incorporated by reference as set forth therein.


Exhibit Number		Description
3.1		Certificate of Incorporation of the ~~Company~~Registrant (incorporated by reference to ~~Exhibit 3.3 from~~ Registrant’s Form 8-K filed on March 30, 2010).
3.2		Certificate of Amendment to Certificate of Incorporation of the ~~Company~~Registrant (incorporated by reference to ~~Exhibit 3.4 from~~the Registrant’s Form 8-K filed on March 30, 2010).
3.3		Plan of Conversion of Chay Enterprises, Inc. to a Delaware corporation (incorporated by reference to ~~Exhibit 2.1 from~~the Registrant’s Form 8-K filed ~~on March 30, 2010)~~December 18, 2019).
3.4		Certificate of Amendment ofto the Certificate of Incorporation of the ~~Company~~Registrant (incorporated by reference to ~~Exhibit 3.1 from~~the Registrant’s Form 8-K filed on December 18, 2019).
3.5		Amended and Restated Bylaws of the Registrant ~~as currently in effect~~ (incorporated by reference to ~~Exhibit 3.1 from~~the Registrant’s Form 10-Q filed on November 14, 2018).
~~31.1~~10.1*		Research Services Agreement between the Registrant and Trauma Research LLC, dated February 4, 2022.*
10.2*		Personal Services Agreement between the Registrant and Dr. Bar-Or, dated February 4, 2022.*
31.1*		Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.**
~~31.2~~31.2*		Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.**
~~32.1~~32.1#		Certificate of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of ~~2002.~~2002.##
99.1*		Press Release of Ampio Pharmaceuticals, Inc. Issued May 16, 2022.*
101		XBRL (eXtensible Business Reporting Language). The following financial statements from Ampio Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the quarter ended ~~June 30, 2021,~~March 31, 2022, formatted in Inline XBRL: (i) the Condensed Balance Sheets, (ii) the Condensed Statements of Operations, (iii) the Condensed Statements of Stockholders’ Equity (Deficit), (iv) the Condensed Statements of Cash Flows, and (v) the Notes to Financial Statements.
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

* Filed herewith.

~~# Furnished~~#Furnished herewith.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	AMPIO PHARMACEUTICALS, INC.

	By:	/s/ Michael ~~Macaluso~~A. Martino
		Michael ~~Macaluso~~A. Martino
		Chairman and Chief Executive Officer
		(principal executive officer)
		Date: ~~August 4, 2021~~May 16, 2022

	By:	/s/ Daniel G. Stokely
		Daniel G. Stokely
		Chief Financial Officer and Secretary
		(principal financial and accounting officer)
		Date: ~~August 4, 2021~~May 16, 2022

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		Page
	PART I-FINANCIAL INFORMATION

Item 1.	Financial Statements (unaudited)	5

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	3326

Item 4.	Controls and Procedures	3427

	PART II-OTHER INFORMATION

Item 1.	Legal Proceedings	3427

Item 1A.	Risk Factors	3427

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	3527

Item 3.	Defaults Upon Senior Securities	3527

Item 4.	Mine Safety Disclosures	3528

Item 5.	Other Information	3528

Item 6.	Exhibits	3529

SIGNATURES		3630


	Facility Lease Payments		Remainder of 2021		2022		2023		2024		2025		Thereafter

Remaining Facility Lease Payments	$	1,173,000	$	174,000	$	355,000	$	364,000	$	280,000	$	—	$	—
Less: Discount Adjustment		(102,000)
Total lease liability	$	1,071,000

Lease liability-current portion	$	298,000

Long-term lease liability	$	773,000