10-Q

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: March 31, 2022

or

☐ 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

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, 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 May 6, 2022, there were 227,186,867 outstanding shares of common stock, par value $0.0001 per share, of the registrant.

AMPIO PHARMACEUTICALS, INC.

FOR THE QUARTER ENDED MARCH 31, 2022

INDEX

		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	26
Item 4.	Controls and Procedures	27
	PART II-OTHER INFORMATION
Item 1.	Legal Proceedings	27
Item 1A.	Risk Factors	27
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	27
Item 3.	Defaults Upon Senior Securities	27
Item 4.	Mine Safety Disclosures	28
Item 5.	Other Information	28
Item 6.	Exhibits	29
SIGNATURES		30

2

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 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 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;

● 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;

● 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 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 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 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 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 29, 2022 (the “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.

4

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

AMPIO PHARMACEUTICALS, INC.

Condensed Balance Sheets

(unaudited)

	March 31,		December 31,
	2022		2021
Assets
Current assets
Cash and cash equivalents	$	28,837,000	$	33,892,000
Prepaid expenses and other		1,070,000		1,740,000
Total current assets		29,907,000		35,632,000
Fixed assets, net		2,302,000		2,564,000
Right-of-use asset, net		577,000		629,000
Total assets	$	32,786,000	$	38,825,000
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable and accrued expenses	$	5,208,000	$	4,811,000
Lease liability-current portion		318,000		311,000
Total current liabilities		5,526,000		5,122,000
Lease liability-long-term		533,000		614,000
Warrant derivative liability		4,474,000		5,805,000
Total liabilities		10,533,000		11,541,000
Commitments and contingencies (Note 5)
Stockholders’ equity
Preferred Stock, par value $0.0001; 10,000,000 shares authorized; none issued		—		—
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		245,468,000		244,863,000
Accumulated deficit		(223,238,000)		(217,602,000)
Total stockholders’ equity		22,253,000		27,284,000
Total liabilities and stockholders’ equity	$	32,786,000	$	38,825,000

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

5

AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Operations

(unaudited)

	Three Months Ended March 31,
	2022		2021
Operating expenses
Research and development	$	3,687,000	$	2,296,000
General and administrative		3,283,000		1,523,000
Total operating expenses		6,970,000		3,819,000
Other income
Interest income		3,000		1,000
Derivative gain		1,331,000		151,000
Total other income		1,334,000		152,000
Net loss	$	(5,636,000)	$	(3,667,000)
Net loss per common share:
Basic	$	(0.02)	$	(0.02)
Diluted	$	(0.03)	$	(0.02)
Weighted average number of common shares outstanding:
Basic		226,083,328		195,387,047
Diluted		226,110,693		200,752,267

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

6

AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Stockholders’ Equity

(unaudited)

				Additional				Total
	Common Stock			Paid-in		Accumulated		Stockholders'
	Shares	Amount		Capital		Deficit		Equity
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		—		80,000		—		80,000
Share-based compensation, net of forfeitures	—		—		166,000		—		166,000
Stock options exercised, net	129,500		—		33,000		—		33,000
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards	(28,562)				(40,000)		—		(40,000)
Warrants exercised, net	306,705		—		114,000		—		114,000
Issuance of common stock in connection with the "at-the-market" equity offering program	1,848,437		—		2,705,000		—		2,705,000
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program	—		—		(126,000)		—		(126,000)
Net loss	—		—		—		(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
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	—		—		716,000		—		716,000
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards	(138,514)		—		(79,000)		—		(79,000)
Offering costs related to the issuance of common stock and warrants in connection with the registered direct offering	—		—		(32,000)		—		(32,000)
Net loss	—		—		—		(5,636,000)		(5,636,000)
Balance at March 31, 2022	227,186,867	$	23,000	$	245,468,000	$	(223,238,000)	$	22,253,000

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

7

AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Cash Flows

(unaudited)

	Three Months Ended March 31,
	2022		2021
Cash flows used in operating activities
Net loss	$	(5,636,000)	$	(3,667,000)
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		262,000		294,000
Issuance of common stock for services		—		80,000
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		397,000		(199,000)
Decrease in lease liability		(22,000)		(19,000)
Net cash used in operating activities		(4,944,000)		(4,147,000)
Cash flows used in investing activities
Purchase of fixed assets		—		(81,000)
Net cash used in investing activities		—		(81,000)
Cash flows from financing activities
Proceeds from sale of common stock in connection with the "at-the-market" equity offering program		—		2,705,000
Costs related to sale of common stock in connection with the "at-the-market" equity offering program		—		(126,000)
Proceeds from sale of common stock and warrants in connection with the registered direct offering		—		114,000
Costs related to the sale of common stock and warrants in connection with the registered direct offering		(32,000)		—
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards		(79,000)		—
Other		—		(7,000)
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)
Cash and cash equivalents at beginning of period		33,892,000		17,346,000
Cash and cash equivalents at end of period	$	28,837,000	$	15,804,000

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

8

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 immunomodulatory therapies for 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, 2021 included in the Company’s 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 months ended March 31, 2022 is unaudited. The balance sheet at December 31, 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.

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 months ended 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, the clinical trial accrual, 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.

9

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 three months ended 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 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.

10

Note 2 – Prepaid Expenses and Other

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

	March 31, 2022		December 31, 2021
Deposits	$	565,000	$	884,000
Unamortized commercial insurance premiums		212,000		465,000
Professional fees		87,000		235,000
Maintenance service contracts		63,000		—
Clinical trial inventory		—		72,000
Other receivable		19,000		16,000
Other		124,000		68,000
Total prepaid expenses and other	$	1,070,000	$	1,740,000

Note 3 – 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
	Useful Lives
	(in Years)	March 31, 2022		December 31, 2021
Leasehold improvements	10	$	6,075,000	$	6,075,000
Manufacturing facility/clean room	3 - 8		2,984,000		2,984,000
Lab equipment and office furniture	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		$	2,302,000	$	2,564,000

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

	Three Months Ended March 31,
	2022		2021
Depreciation and amortization expense	$	262,000	$	294,000

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Note 4 – Accounts Payable and Accrued Expenses

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

	March 31, 2022		December 31, 2021
Accounts payable	$	1,582,000	$	427,000
Clinical trials		2,919,000		2,995,000
Professional fees		302,000		510,000
Accrued compensation		292,000		389,000
Commercial insurance premium financing		—		269,000
Other		113,000		221,000
Accounts payable and accrued expenses	$	5,208,000	$	4,811,000

Commercial Insurance Premium Financing Agreement

In June 2021, the Company entered into an insurance premium financing agreement for $916,000, with a term of nine months and an annual interest rate of 3.57%. Under the terms and provisions of the agreement, the Company was required to make principal and interest payments totaling $82,000 per month over the remaining term of the agreement. The outstanding obligation for the Company’s annual insurance premiums were paid in full as of March 31, 2022.

Note 5 - Commitments and Contingencies

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 an initial retainer of $315,000, which was applied to study expenses as further defined by the contract during the first three months ended March 31, 2022. The Company entered into a change order to the initial contract in April 2022 totaling $0.7 million which reflects the estimated final costs to close out the study with expected completion in the next three to 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 1 study for at-home treatment utilizing inhaled Ampion to treat patients with Long-COVID, or prolonged respiratory symptoms due to COVID-19 (the “AP-018 study”). The contractual provisions required an initial retainer of $105,000 to be applied to future study expenses as further defined by the contract. Subsequent to March 2021, the Company agreed to a contractual amendment of $1.0 million. As of March 31, 2022, the contract is substantially complete and any future services to be performed are deemed to be minimal.

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In June 2021, the Company entered into a contract with a CRO totaling $2.5 million in reference to a multicenter Phase 2 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 to be applied to study expenses as further defined by the contract. The contractual amount was later amended by $0.9 million. As such, the revised contractual commitment for the AP-019 study is $3.4 million as of 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 finalization of the study. The CRO will refund any unused portion of the retainer. As of March 31, 2022, the Company expects to spend $0.5 million related to future services expected to be performed under this contract and accordingly, does not expect any refund of any unused portion of 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 2 clinical trial utilizing IV Ampion in the treatment of patients with complications arising from 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 three employment agreements that expire in October 2024 and in November 2021, the Company entered into one 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 four 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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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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There was no warrant activity during the three months ended March 31, 2022:

		Weighted		Weighted Average
	Number of	Average		Remaining
	Warrants	Exercise Price		Contractual Life
Outstanding as of December 31, 2020	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	—	$	—
Warrants expired	—	$	—
Outstanding as of March 31, 2022	18,302,897	$	1.02	3.99

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

					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

The total value for the warrant derivative liability as of March 31, 2022 is approximately $4.5 million (see Note 7).

Note 7 - 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.

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

	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
Balance as of December 31, 2021	$	5,805,000
Warrant issuances		—
Warrant exercises		—
Change in fair value		(1,331,000)
Balance as of March 31, 2022	$	4,474,000

Note 8 - Common Stock

Authorized Shares

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

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

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	March 31, 2022
Authorized shares		300,000,000
Common stock outstanding		227,186,867
Options outstanding		9,010,312
Warrants outstanding		18,302,897
Reserved for issuance under 2019 Stock and Incentive Plan		2,984,023
Available shares		42,515,901

ATM Equity Offering Program

In February 2020, the Company entered into a Sales Agreement with two 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 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 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, 2022 and 2021:

		Three Months Ended March 31,
		2022		2021
Total shares of common stock sold		—		1,848,437
Gross proceeds	$	—	$	2,705,000
Commissions earned by placement agents		—		(109,000)
Issuance fees		—		(17,000)
Net proceeds	$	—	$	2,579,000

Common Stock Issued for Services

The Company issued an aggregate of 54,052 shares of common stock under the Ampio Pharmaceuticals, Inc. 2019 Stock and Incentive Plan (the “2019 Plan”), valued at an aggregate of $80,000 as partial compensation for the services of four non-employee directors, during the three months ended 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 9 - 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, 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 March 31, 2022:

	2019 Plan
Total shares reserved for equity awards		10,000,000
Options granted, net of forfeitures during previous fiscal years		(3,933,471)
Options granted during fiscal 2022		(1,598,323)
Restricted stock awards, net of settlement granted during fiscal 2021		(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		138,514
Remaining shares available for future equity awards		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 outstanding options that were issued in accordance with the 2010 Plan and the 2019 Plan:

Outstanding Options by Plan	March 31, 2022
2010 Plan		3,561,518
2019 Plan		5,448,794
Outstanding as of March 31, 2022		9,010,312

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

	Number of	Weighted		Weighted Average
	Options	Average		Remaining
Range of Exercise Prices	Outstanding	Exercise Price		Contractual Lives
Up to $0.50	1,767,823	$	0.45	9.22
$0.51 - $1.00	4,697,345	$	0.69	6.81
$1.01 - $1.50	937,000	$	1.19	9.45
$1.51 and above	1,608,144	$	2.46	6.48
Total	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 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

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

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table summarizes stock-based compensation expense (stock options and common stock issued for services) for the three months ended March 31, 2022 and 2021:

	Three Months Ended March 31,
	2022		2021
Research and development expenses
Share-based compensation	$	47,000	$	46,000
General and administrative expenses
Issuance of common stock for services (see Note 8)		—		80,000
Share-based compensation		669,000		120,000
Total share-based compensation	$	716,000	$	246,000
Unrecognized share-based compensation expense related to stock options as of March 31, 2022	$	996,000
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 10 - 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 months ended March 31, 2022 and 2021:

	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 March 31,
	2022	2021
Warrants to purchase shares of common stock	18,275,532	2,939,996
Outstanding stock options	9,010,312	1,510,485
Restricted stock awards	1,101,000	—
Total potentially dilutive shares of common stock	28,386,844	4,450,481

Item 2. 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 2021 Annual Report.

Executive Summary

We are a pre-revenue stage biopharmaceutical company focused on the research, development and advancement of immunomodulatory therapies for 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.

Ampion is our lead product candidate. We have been studying Ampion for the potential treatment of multiple inflammatory conditions (e.g., osteoarthritis of the knee or OAK, osteoarthritis of the hand, and COVID-19 inflammation in the lung).

During 2021 and continuing into the first quarter of 2022, we have been primarily engaged in clinical development of Ampion. We have conducted four discrete clinical trials in the United States and 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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As of March 31, 2022, we had one clinical trial outstanding with patient enrollment, AP-019, and the other clinical studies were in various stages of completion. In May 2022, we terminated enrollment of the AP-019 study, as no beneficial effect of nebulized Ampion could be documented. We continued to recognize patient enrollment and study costs throughout the first quarter 2022. Clinical trial accrual amounts were $2.9 million as of March 31, 2022 as compared to $3.0 million as of December 31, 2021.

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

Known Trends or Future Events; Outlook

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.

We had approximately 42.5 million shares of common stock authorized and available for future issuance as of March 31, 2022 and our ability to raise 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 program.

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. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable and appropriate under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The methods, estimates, and judgments used by us in applying these critical accounting policies have a significant impact on the results we report in our financial statements.

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

Newly Issued Accounting Pronouncements

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

RESULTS OF OPERATIONS

Results of Operations – March 31, 2022 Compared to March 31, 2021

We recognized a net loss for the three months ended March 31, 2022 (“2022 quarter”) of $5.6 million compared to a net loss of $3.7 million for the three months ended March 31, 2021 (“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 $3.8 million, partially offset by the non-cash derivative gain of $0.2 million. The decrease in our stock price from $0.57 as of December 31, 2021 to $0.47 as of March 31, 2022 caused the valuation of the warrant liability to decrease resulting in a derivative gain during the 2022 quarter. Operating expenses increased $3.2 million from the 2021 quarter to the 2022 quarter primarily due to a $1.4 million increase in research and development costs, as well as a $1.8 million increase in general and administrative costs, both of which are further explained below.

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 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

2022 Quarter Compared to 2021 Quarter

Research and development costs increased by approximately $1.4 million, or 61%, for the 2022 quarter compared to the 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 expense increased $1.2 million, or 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 resulting in a decrease in costs of $0.4 million.

Salaries and benefits

Salaries and benefit expense increased $151,000, or 24%, for the 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 beginning of the 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 $145,000, or 126%, for the 2022 quarter compared with the 2021 quarter as a result of the 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 provide research services. The costs directly related to these agreements was $83,000 in the 2022 quarter. In addition, the Company initiated a series of animal studies to support the dosing and 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 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

2022 Quarter Compared to 2021 Quarter

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

Professional fees

Professional fees increased $924,000, or 193%, for the 2022 quarter compared to the 2021 quarter due primarily to an increase in costs related to (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.

Salaries and benefits

Salaries and benefit expense increased $395,000, or 167%, for the 2022 quarter compared with the 2021 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 interim Chairman and Chief Executive Officer and (iv) annual option grants issued to non-Section 16 employees in the 2022 quarter.

Cash Flows

Cash flows for the respective periods are as follows:

	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 three months ended March 31, 2022 our operating activities used approximately $4.9 million in cash and cash equivalents, which was less than our reported net loss of $5.6 million. The difference is primarily a result of 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 $0.5 million.

Net Cash Used in Investing Activities

During the three months ended 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.

Net Cash Provided by (used in) Financing Activities

During the three months ended 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 $2.7 million from the sale of approximately 1.8 million shares of common stock pursuant to the ATM equity offering program, which was partially offset by offering related costs of $126,000. In addition, we also received proceeds of $114,000 from investor warrant exercises representing 284,000 shares of common stock.

Liquidity and Capital Resources

Since inception, we have not generated operating revenue or profits. 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. During the three months ended March 31, 2022, the Company had no activity in its ATM equity offering program.

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 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 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.

We had approximately 42.5 million shares of common stock authorized and available for future issuance as of March 31, 2022 and our ability to raise 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 program.

In the event that we are unable to obtain additional capital through equity capital raises, partnering/licensing transactions 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 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). 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 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.

Not applicable.

Item 1A. Risk Factors.

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 2021 Annual Report and other reports that we have filed with the SEC, which could materially affect our business, financial condition or future results.

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

During the three months ended March 31, 2022, we did not issue any 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 vesting of 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	$	-

Item 3. Defaults Upon Senior Securities.

None.

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Item 4. Mine Safety Disclosures.

Not Applicable.

Item 5. Other Information.

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 that it does not consider data from AP-013 to be 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 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 Registrant (incorporated by reference to Registrant’s Form 8-K filed March 30, 2010).
3.2	Certificate of Amendment to Certificate of Incorporation of the Registrant (incorporated by reference to the Registrant’s Form 8-K filed March 30, 2010).
3.3	Plan of Conversion of Chay Enterprises, Inc. to a Delaware corporation (incorporated by reference to the Registrant’s Form 8-K filed December 18, 2019).
3.4	Certificate of Amendment to the Certificate of Incorporation of the Registrant (incorporated by reference to the Registrant’s Form 8-K filed December 18, 2019).
3.5	Amended and Restated Bylaws of the Registrant (incorporated by reference to the Registrant’s Form 10-Q filed November 14, 2018).
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*	Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
32.1#	Certificate of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 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 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 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 A. Martino
	Michael A. Martino
	Chairman and Chief Executive Officer
	(principal executive officer)
	Date: May 16, 2022
By:	/s/ Daniel G. Stokely
	Daniel G. Stokely
	Chief Financial Officer and Secretary
	(principal financial and accounting officer)
	Date: May 16, 2022

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EX-10.1

Exhibit 10.1

RESEARCH SERVICES AGREEMENT

This Research Services Agreement ("Agreement") is made on February 4, 2022 ("Effective Date"), and entered into by and between Ampio Pharmaceuticals, Inc., a Delaware corporation, having its address at 373 Inverness Parkway, Suite 200 Englewood, Colorado 80112 ("Company") and Trauma Research LLC, a Colorado limited liability company, having its address at 900 East Oxford Lane, Englewood, Colorado 80110 ("Contractor"). Company and Contractor may individually be referred to herein as "Party" and collectively as the "Parties".

1.Engagement of Services. The Parties may enter into one or more research project assignments (the form of which is attached to this Agreement as Exhibit A) (each executed research project assignment, a "Research Project Assignment"). Upon execution, each Research Project Assignment will be binding on the Parties and incorporated herein. Contractor will render the research services set forth in each Research Project Assignment (the "Services") by the completion dates set forth therein.

2.Compensation. During the Term, Company will pay Contractor the fees set forth in each Research Project Assignment for Services rendered pursuant to this Agreement and to any such Research Project Assignment (the "Contractor Services Fee"). Contractor will be reimbursed only for expenses which are expressly provided for in a Research Project Assignment or which have been approved in advance in writing by Company, within thirty (15) days of receipt of Contractor's invoice, provided Contractor has furnished such documentation for authorized expenses as Company may reasonably request. Upon termination of this Agreement for any reason other than Contractor's uncured breach of this Agreement, Contractor will be paid only for those Contractor Services Fees on the basis stated in the Research Project Assignment(s) for work which has been timely and properly completed prior to such termination. Contractor will be entitled to no further payments from Company in the event this Agreement is terminated due to Contractor's uncured breach of this Agreement.

3.Research Projects.

3.1The Services will be under the direction of Dr. David Bar-Or (the "Principal Investigator") and will be conducted at one or more other suitable facilities selected by Contractor. The Principal Investigator shall properly supervise all persons performing services in connection with the Services and shall ensure that they comply with the terms of this Agreement and any requirements identified in the Research Project Assignment.

3.2Company's designated representative for consultation and communications with the Principal Investigator shall be Mike Martino or such other person as Company may from time to time designate in writing to Contractor and to the Principal Investigator.

3.3During the Term, Company's representatives may consult informally with the Principal Investigator and other Contractor representatives regarding the Services, both personally and by telephone. Access to work carried on by Contractor in the course of these consultations shall be under the reasonable control of the Principal Investigator but shall be made available on a reasonable basis for observation of the work.

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3.4The Principal Investigator will make up to four oral reports each year during the Term as requested by Company's designated representative. Within ninety (90) days after termination of this Agreement, the Principal Investigator shall prepare a final report summarizing all activities undertaken and accomplishments achieved through the performance of the Services.

4.Records. Contractor will keep accurate financial and scientific records directly relating to the Services, which fully and properly reflect all work done and results achieved in the performance of the Services (including all data in the form required by applicable laws and regulations), and will make such records available to Company or its authorized representative throughout the Term and for a period of one year following termination of the Agreement, or for such longer period required by law during normal business hours upon reasonable notice. Prior to destroying or otherwise disposing of any such records, Contractor will provide Company a reasonable opportunity to take possession of the records at Company's own expense.

5.Independent Contractor Relationship. The Parties' relationship hereunder is that of independent contractors. Nothing in this Agreement is intended to, or should be construed to, create a partnership, agency, joint venture or employment relationship between the Parties. Contractor shall control the manner and means of performing Contractor's obligations hereunder, including retention of third parties to act on Contractor's behalf, such as the staff at the Swedish Department, Swedish Laboratory, and St. Anthony Department ("Contractor's Agents"), provided, however, that Contractor shall cause Contractor's Agents to observe the provisions of Section 6 of this Agreement and Contractor shall be responsible for the performance of Contractor's Agents. Contractor will not be entitled to any of the benefits that Company may make available to its employees, including, but not limited to, group health or life insurance, profit­ sharing or retirement benefits.   Contractor is not authorized to make any representation, contract or commitment on behalf of Company unless specifically requested or authorized in writing to do so by a Company manager. Contractor is solely responsible for, and will file, on a timely basis, all tax returns and payments required to be filed with, or made to, any federal, state or local tax authority with respect to the performance of services and receipt of fees under this Agreement. Contractor is solely responsible for, and must maintain adequate records of, expenses incurred in the course of performing services under this Agreement. No part of Contractor's compensation will be subject to withholding by Company for the payment of any social security, federal, state or any other employee payroll taxes. While on the Company's premises or using the Company's equipment, Contractor shall comply with all applicable policies of Company relating to business and office conduct, health and safety, and use of Company's facilities, supplies, information technology, equipment, networks, and other resources.

6.Confidential Information.

6.1Definition of Confidential Information. "Confidential Information" as used in this Agreement shall mean any and all technical and non-technical information including patent, copyright, trade secret, and proprietary information, techniques, sketches, drawings, models, inventions, know-how, processes, apparatus, equipment, algorithms, software programs, software source documents, and formulae related to the current, future and proposed products and services of the Company, its suppliers and customers, and includes, without limitation, its respective information concerning research, experimental work, development, design details and specifications, engineering, financial information, procurement requirements, purchasing,

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manufacturing, customer lists, business forecasts, sales and merchandising and marketing plans and information. All data or results from the performance of the Services shall be Confidential Information and exclusively owned by Company. Confidential Information also includes proprietary or confidential information of any third party who may disclose such information to Company or to Contractor while conducting Company's business or performing its respective services hereunder.

6.2Nondisclosure and Nonuse Obligations. Contractor will use the Confidential Information solely to perform its obligations pursuant to the Services, solely for the benefit of Company. Contractor agrees that it shall treat all Confidential Information with the same degree of care as it treats its own like confidential information, but in all cases using no less than reasonable care. Contractor agrees that it may disclose Confidential Information only to those of its employees who need to know such information for purposes of carrying out the Research Project Assignment(s) and who have previously agreed , either as a condition of employment or in order to obtain the Confidential Information, to be bound by terms and conditions substantially similar to those of this Agreement. Contractor will immediately give notice to Company of any unauthorized use or disclosure of the Confidential Information. Contractor agrees to assist Company in remedying any such unauthorized use or disclosure of the Confidential Information. If, in connection with providing services hereunder, Contractor desires to disclose Confidential Information to third parties, Contractor may do so only with the prior written consent of Company and after providing Company with a copy of an executed confidentiality agreement binding such third party to terms at least as stringent as the confidentiality terms contained in this Section 6.

6.3Exclusions from Nondisclosure and Nonuse Obligations.Contractor' s obligations under Section 6.2 with respect to any portion of Confidential Information shall terminate when Contractor can document that: (a) it was in the public domain at or subsequent to the time it was communicated to Contractor by Company through no fault of Contractor; (b) it was rightfully in Contractor's possession free of any obligation of confidence at or subsequent to the time it was communicated to Contractor by Company; (c) it was developed by employees or agents of Contractor independently of and without reference to any information communicated to Contractor by Company;

6.4Authorized Disclosure. This Agreement shall not restrict Contractor from disclosing Confidential Information to the extent required by applicable law or as requested by any judicial, regulatory, law enforcement, or governmental authority, provided, however, that Contractor shall, to the extent legally permissible, give notice of such requirement or request to Company so that Company may seek (at Company' s expense) a protective order or other appropriate relief.

6.5Disclosure of Third Party Information. Neither Party shall communicate any information to the other Party in violation of the proprietary rights of any third party.

6.6Publication and Academic Rights. Contractor shall not issue any press releases or make any public presentation or announcement with respect to the existence of this Agreement or the details hereof, without the prior, written consent of Company; provided, however that such restriction shall not apply to disclosures or reporting within Contractor's organization or where required by law. Neither Party shall use the other Party's name or the name of its officers, directors,

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or employees in any advertising, sales, promotional, or publicity materials without the prior, written consent of the other Party. The results of the Services may be published in scientific literature and may also be used in submissions to regulatory authorities. It is the intention of the Parties that Company and the Principal Investigator will publish or present the results of the Services together, unless specific permission is obtained in advance from Company for Contractor to publish separate results. For publication of separate results by Contractor, Contractor must provide Company with a copy of materials for publication or presentation thirty (30) days prior to submission so that Company may: (a) review such materials for accuracy of background information, (b) determine that such publication will not compromise Company's ongoing patent rights or any Confidential Information, and (c) take necessary action to protect Company patent rights.

7.Ownership Rights in Company Property.

7.1Company shall be the sole and exclusive owner of Company Property. "Company Property" means (a) all materials (including, without limitation, all documents, data, reports, drawings, analyses, equipment, products, prototypes, services and other work) furnished to Contractor by Company, produced by Contractor before the Effective Date for or with Company, or produced after the Effective Date by Contractor in the performance of this Agreement or pursuant to any Research Project Assignment; and (b) all copyrights, patents, trade secrets, inventions, and other proprietary or intellectual property rights produced before or after the Effective Date. by Contractor in the performance of this Agreement or pursuant to any Research Project Assignment or the performance of any Services. The term "Company Property" does not include any general know-how, methodology, processes, products, devices or experience of Contractor gained prior to performance of the Services or from experience gained parallel to performance of the Services from unrelated sources. To the fullest extent permitted by law, all Company Property produced before or after the Effective Date shall be deemed to be "Works for Hire" for the benefit of Company, as U.S. federal and international copyright law defines that term. To the extent Company Property may not be considered Works for Hire, Contractor hereby irrevocably and unconditionally sells, assigns, and transfers all of its rights, title, and interest in Company Property to Company, without additional consideration. Contractor shall promptly execute and deliver all documents and instruments reasonably requested by Company to evidence such transfers and Contractor shall be reimbursed for reasonable expenses incurred in order to comply with this obligation. Further, Contractor hereby irrevocably waives and releases in favor of Company any unassignable rights, including any "moral" rights, that Contractor or any of its employees, officers, or agents may have in or to any Company Property.

7.2Contractor unconditionally grants to Company a non-exclusive, perpetual , irrevocable , worldwide, fully-paid right and license, with the right to sublicense through multiple levels of sublicensees , under any copyrights, patents, trade secrets, inventions, and other intellectual property or proprietary rights of Contractor used or incorporated into or otherwise necessary to exploit any Company Property, to: (a) reproduce, create derivative works of, distribute, publicly perform, publicly display, transmit, and otherwise use the Company Property in any medium or format, whether now known or hereafter discovered, (b) use, make, have made, sell, offer to sell, import, and otherwise exploit the Company Property, and (c) exercise any and all other present or future rights in the Company Property without restriction.

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7.3Contractor represents and warrants that its employees, agents (including the Principal Investigator), and any other persons performing the Services for or in connection with Contractor are contractually obliged to convey to Company all right, title, and interest in and to Company Property and that all third parties given access to Confidential Information or Company Property by Contractor will have entered into a confidentiality, non-disclosure, and invention assignment agreement the terms of which are at least as protective of the Confidential Information and Company Property as those in this Agreement.

8.Return of Company's Property. Contractor agrees to promptly deliver the original and any copies of the Company Property to Company at any time upon Company's request. Upon termination  of this Agreement  by any Party for any reason, Contractor agrees to promptly deliver to Company or destroy, at Company's option, the original and any copies  of  the  Company Property.  Contractor agrees to certify in writing that Contractor has so returned or destroyed all such Company Property if Company so requests.

9.Materials Transfer.

9.1It is contemplated that Company will, during the course of the Services, provide Contractor various chemical and biological materials, including,  without limitation, compounds, cell lines, tissue and fluid samples, and associated know-how and data owned by or proprietary to Company (or proprietary to a third party from which such materials were obtained) ("Company Material"). Company shall provide any Company Material necessary for. performance of the Services pursuant to a separate Material Transfer Agreement to be entered into by the Parties. Company shall be free, in its sole discretion, to distribute Company Material provided to the Contractor to others and to use it for its own purposes.

9.2Company Material shall be used by the Principal Investigator solely in connection with the Services and not for any other purpose  without the prior written consent of Company, which consent shall not be unreasonably withheld.  Contractor  shall not distribute,  release, or  in any way disclose Company Material to any person or entity other than laboratory personnel under the Principal Investigator's direct supervision. Except as expressly  provided  by the  Research Project Assignment, Contractor shall not reverse engineer, decompile, decode, disassemble, or otherwise attempt to determine the specific formula or composition of any Company Material.

9.3Contractor shall ensure that no one will be allowed to take or send Company Material to any other location, unless written permission is obtained from Company. Company Material is made available by Contractor and Company for investigational use only in laboratory animals or in vitro experiments. Neither Company Material, nor any chemical or  biological materials treated therewith or derived therefrom, will be used in human beings.

9.4This Agreement and the resulting transfer of Company Material constitute a license to use Company Material solely for purposes of the Services. Except as otherwise provided in this Agreement, the Receiving Party agrees that nothing pursuant to this Section 9 shall be deemed to grant any rights under any patents. At the request of Company, Contractor will return all unused Company Material, whether or not during the Term.

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9.5Any Company Material provided is experimental in nature and shall be provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. THERE IS NO REPRESENTATION OR WARRANTY THAT THE USE OF COMPANY MATERIAL WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.

9.6In no event shall Company be liable for any use by Contractor of Company Material or any loss, claim, damage or liability , of whatsoever kind or nature, which may arise from or in connection with this Agreement or the use, handling or storage of Company Material.

9.7Contractor will use Company Material in compliance with all laws, governmental regulations and guidelines applicable to Company Material.

10. Term and Termination .

10.1Term. This Agreement is effective as of the Effective Date set forth above and will continue until terminated as set forth below ("Term").

10.2Termination by Company. Company may terminate this Agreement, with or without cause, at any time upon ninety (90) days prior written notice to Contractor.

10.3Termination by Contractor. Contractor may terminate this Agreement, with or without cause, at any time upon ninety (90) days' prior written notice to Company.

10.4Survival. Sections 4, 5, 6, 7, 9.5, 10, 11, 13, and 17-23 will survive any termination or expiration of this Agreement.

11.Notices. Any notice which a Party is required or permitted to give to another Party shall be given by personal delivery or registered or certified mail, return receipt requested, addressed to the other Party at the appropriate address set forth in this Section 11 below, or at such other address as another Party may from time to time designate in writing. The date of personal delivery or the date of mailing of any such notice shall be deemed to be the date of delivery thereof.

Ifto Company:	373 Inverness Parkway, Suite 200
	Englewood, CO 80112
	Attn: Michael A. Martino, CEO
If to Contractor:	900 East Oxford Lane
	Englewood, CO 80110
	Attn: Dr. David Bar-Or

12. Re12resentations and Warranties.

12.1Quality. Contractor represents and warrants to Company that the Services performed under this Agreement shall be performed with the degree of skill and care that is required by current, good and sound professional procedures and practices, and in conformance with generally accepted professional standards prevailing at the time the work is performed so as

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to ensure that the Services performed are correct and appropriate for the purposes contemplated in this Agreement and related Research Project Assignments.

12.2Compliance. Contractor represents and warrants to Company that in the course of performing the Services and in connection with all activities hereunder, Contractor will comply with applicable laws, rules, regulations, guidelines, and generally accepted standards, including, but not limited to, regulations of the U.S. Food and Drug Administration ("FDA") and Contractor has not been, will not be, and will not use in any capacity the services of any person who has been debarred or disqualified by the FDA pursuant to the Generic Drug Enforcement Act of 1992 or any other equivalent of successor statutes, rules, or regulations. Contractor agrees to immediately notify Company in writing if Contractor or any such person has been debarred or disqualified or proceedings have been initiated with respect to such debarment or disqualification, whether such disbarment or initiation of proceedings occurs during or after the performance of the Services. Company shall have the right to terminate this Agreement upon receipt of notice from Contractor that Contractor received notice of action or threat of action with respect to debarment or becomes debarred as set forth in this Section 12.2. Further, Contractor agrees to abide by, at all times during the Term, the "Ampio Pharmaceuticals, Inc. Code of Business Conduct and Ethics," a copy of which is attached hereto as Exhibit B, and the "Ampio Pharmaceuticals, Inc. Insider Trading Policy," a copy of which is attached hereto as Exhibit C.

12.3General. Contractor represents and warrants to the Company that: (a) Contractor has the right to enter into this Agreement, to grant the rights granted herein, and to perform fully all of Contractor's obligations in this Agreement; (b) Contractor entering into this Agreement with the Company and Contractor's performance of the Services do not and will not conflict with or result in any breach or default under any other agreement to which Contractor is subject; (c) the Company will receive good and valid title to all Company Property, free and clear of all encumbrances and liens of any kind; and (d) Contractor has the right to bind Swedish and St. Anthony, to control the activities of the Swedish Department, Swedish Laboratory, and St. Anthony Department, and that Contractor has agreements in place with Swedish and St. Anthony that are not inconsistent with this Agreement.

12.4IP Infringement. Contractor represents to Company that the material, products, services, or other work assignments to be furnished, produced or performed under this Contract will not infringe any copyright, patent, trade secret, or license, or otherwise violate the intellectual property or proprietary rights, of any person or entity, to the best of its knowledge. Contractor agrees to indemnify, defend, and hold Company and its officers, directors, employees, and agents harmless from and against any and all liabilities, costs and damages arising out of any such infringement (whether or not known to Contractor) and from any suit, demand or claim made against Company alleging any such infringement. Contractor further agrees to pay any judgment or reasonable settlement offer resulting from such suit, demand or claim, and to pay all damages and attorney's fees. If there is such a claim, Contractor agrees to either procure for Company the right to continue using the material, replace them with non-infringing material, or modify them so that they become non-infringing.

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13.Indemnification.

13.1By Company. Company agrees to indemnify, defend, and hold harmless Contractor and its trustees, directors, officers, employees, agents, and contractors (collectively, the "Contractor Indemnitees") from damages finally awarded or finally paid in settlement in respect ofliability and losses (including reasonable attorney's fees and expenses) they suffer as the result of third-party claims, demands, costs, or judgments ("Losses"), to the extent such Losses arise out of: (i) personal injury of a third party directly resulting from use of the Company Materials by Contractor in accordance a Research Project Assignment, directions of Company, and applicable law; (ii) negligence, recklessness, or willful misconduct on the part of any Company Indemnitee (defined below); or (iii) a material breach of this Agreement by Company. Company's indemnification obligation shall not apply to the extent any Losses are indemnifiable by Contractor pursuant to Section 13.2 below.

13.2By Contractor. Contractor agrees to indemnify, defend, and hold harmless Company, its stockholders, directors, officers, employees, agents, and contractors ("Company Indemnitees") from third party Losses they suffer to the extent such Losses arise out of: (i) a failure by any Contractor Indemnitee to adhere to a Research Project Assignment, terms of this Agreement, or applicable law; (ii) negligence, recklessness, or willful misconduct on the part of any Contractor Indemnitee; or (iii) a material breach of this Agreement by Contractor.

14.Insurance. Company shall maintain, at its sole cost and expense, business and general liability coverage for the acts and omissions of itself, its officers, directors, employees and agents, including, but not limited to, covering claims, liabilities, damages and judgments which may arise out of its sponsorship of the Services. All such insurance shall be issued upon such forms and in such amounts that are reasonable and customary in the health care industry. Written documentation of this insurance coverage will be provided to Contractor upon request.

15.Conflicts of Interest. Contractor shall exercise reasonable care and diligence to prevent any actions or conditions that could result in a conflict with any Company interest. During the Term, Contractor shall not accept any employment or engage in any consulting work that creates a conflict of interest with Company or in any way compromises the services to be performed under this Agreement. Company understands that Contractor, alone or with other researchers, may be involved in conducting research on behalf of other sponsors.

16.Waiver. The failure of any Party to insist on strict compliance with any of the terms, covenants, or conditions of this Agreement by the other Party shall not be deemed a waiver of that term, covenant or condition nor shall any waiver or relinquishment of any right or power at any one time or times be deemed a waiver or relinquishment of that right or power for all or any other times

17.Governing Law. This Agreement shall be governed by the laws of the State of Colorado.

18.Assignment. This Agreement may be assigned by Company in connection with an acquisition (by whatever means), including by merger with, or the sale of substantially all of its related business to, another. This Agreement may otherwise be assigned by Company only with the consent of Contractor, not to be unreasonably withheld. Contractor may not assign the Services or any portion of this Agreement without the prior written consent of Company.

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19.Entire Agreement. This Agreement constitutes the entire agreement between the Parties relating to this subject matter and supersedes all prior or contemporaneous oral or written agreements concerning such subject matter. The terms of this Agreement will govern all Research Project Assignments and Services undertaken by Contractor for Company. This Agreement may only be changed by mutual agreement of authorized representatives of the Parties in writing.

20.Defend Trade Secrets Act of 2016. Contractor acknowledges receipt of the following notice under 18 U.S.C § 1833(6)(1): "An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (a) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal."

21.Non-Solicitation. Each Party agrees that it will not, directly or indirectly, in any manner, other than for the benefit of the other Party or with the other Party's prior written consent, during the Term and for a period of twelve (12) months after the termination or expiration of this Agreement, regardless of reason (the "Restricted Period"): (a) offer to hire, induce or attempt to induce any officer, employee or agent of the other Party or any of its affiliates or subsidiaries to discontinue his or her relationship with the other Party or any of its affiliates or subsidiaries; (b) directly or indirectly solicit, or attempt to solicit, any employee of the other Party; or (c) (i) call upon, solicit, divert or take away any of the customers, business or prospective customers of the other Party or any of its suppliers, and/or (ii) solicit, entice or attempt to persuade any other consultant of the other Party to leave the services of the other Party for any reason. For the avoidance of doubt, nothing in this Section 21 limits or prohibits a Party from having and advertising available job openings, or interviewing and hiring personnel of the other Party to the extent they are not directly solicited and/or respond to general job openings made available by a Party. If the provisions relating to the geographic or substantive scope of the restriction or the time period of the restriction exceed the maximum areas or period of time which a court or competent jurisdiction would enforce, the Parties agree that the areas and time period shall be deemed to be the maximum areas or time period which a court of competent jurisdiction would enforce in any state in which such court shall be convened.

22.Dis.Q_ute Resolution.

22.1Except as provided below, any dispute between the Parties arising out of or relating to this Agreement, or the breach, termination or validity of this Agreement, shall be finally settled by binding arbitration conducted expeditiously in accordance with the J.A.M.S./Endispute Comprehensive Arbitration Rules and Procedures. The arbitration shall be governed by the United States Arbitration Act, 9 U.S.C. Sections 1 16, and judgment upon the award rendered by the arbitrators may be entered by any court having jurisdiction thereof. The place of arbitration shall be Denver, Colorado.

22.2The arbitration shall commence within 60 days of the date on which a written demand for arbitration is filed by either Party hereto. In connection with the arbitration proceeding, the arbitrator shall have the power to order the production of documents by each Party and any third-party witnesses. In addition, each Party may take up to three depositions as of right,

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and the arbitrator may in his or her discretion allow additional depositions upon good cause shown by the moving Party. However, the arbitrator shall not have the power to order the answering of interrogatories or the response to requests for admission. In connection with any arbitration, each Party to the arbitration shall provide to the other, no later than seven business days before the date of the arbitration, the identity of all persons that may testify at the arbitration and a copy of all documents that may be introduced at the arbitration or considered or used by a Party's witness or expert. The arbitrator's decision and award shall be made and delivered within six months of the selection of the arbitrator. The arbitrator's decision shall set forth a reasoned basis for any award of damages or finding of liability. The arbitrator shall not have power to award damages in excess of actual compensatory damages and shall not multiply actual damages or award punitive damages, and each Party hereby irrevocably waives any claim to such damages.

22.3Each Party covenants and agrees that such Party will participate in the arbitration in good faith. This Section 22 applies equally to requests for temporary, preliminary or permanent injunctive relief, except that in the case of temporary or preliminary injunctive relief any Party may proceed in court without prior arbitration for the limited purpose of avoiding immediate and irreparable harm.

22.4Each Party (a) hereby irrevocably submits to the jurisdiction of any United States District Court of competent jurisdiction for the purpose of enforcing the award or decision in any such proceeding, (b) hereby waives, and agrees not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above named courts, that its property is exempt or immune from attachment or execution (except as protected by applicable law), that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court, and (c) hereby waives and agrees not to seek any review by any court of any other jurisdiction which may be called upon to grant an enforcement of the judgment of any such court. Each Party hereby consents to service of process by registered mail at the address to which notices are to be given. Each Party agrees that its, his or her submission to jurisdiction and its, his or her consent to service of process by mail is made for the express benefit of each other Party. Final judgment against any Party in any such action, suit or proceeding may be enforced in other jurisdictions by suit, action or proceeding on the judgment, or in any other manner provided by or pursuant to the laws of such other jurisdiction.

23.Counterparts. This Agreement may be signed in one or more counterparts.

[Signature Page Follows]

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.

COMPANY:		CONTRACTOR:
Ampio Pharmaceuticals, Inc.		Trauma Research LLC
By:	/s/ Michael A. Martino	By:
Name:	Michael A.Martino	Name:	David Bar-Or
Title:	Chairman & CEO

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EXHIBIT A

RESEARCH PROJECT ASSIGNMENT

This Research Project Assignment (this “Research Project Assignment”), entered into in furtherance of that certain Research Services Agreement dated February 4, 2022 by and between Ampio Pharmaceuticals, Inc. ("Company") and Trauma Research LLC ("Contractor") (the"Agreement"), is effective as of February 4, 2022 (the "Research Project Assignment Effective Date") by and between Company and Contractor. This Research Project Assignment is governed by the terms of the Agreement. Any item in this Research Project Assignment that is inconsistent with that Agreement is invalid.

Ampio Pharmaceuticals and TR LLC Research Collaboration:

Research Program Plan

TR: David Bar-Or, MD, Melissa A. Hausburg, PhD, Jason S. Williams, PhD

Ampio FTE: Gregory W. Thomas, Raphael Bar-Or, Kristen Hirter, MS

Executive Summary

In vitro research will be conducted withAmpion (AR-100 and AR-300) to investigate 1) chondrogenesis to support disease modifying osteoarthritis drug (DMOAD) applications; 2) inflammasome mechanism of action to support target indications and development application outside of osteoarthritis (OA). These goals will be supported by A) in vitro work; B) RNA (transcriptomics), proteins (proteomics), and metabolites (metabolomics); C) bioinformatics with the aim to deliver a pre-clinical research program that supports effective transition into clinical development.

Ampion has been clinically shown to reduce pain and early studies support a delay total knee replacement in OA of the knee (OAK) patients. In vitro studies to support the hypothesis that Ampion promotes chondrogenesis and cartilage repair will support the development of the Ampion program.

Further, Ampion decreases proinflammatory mediators in multiple cell types, and may act by inhibiting inflammasome(s), a multiprotein complex that when aberrantly activated is associated with inflammatory disorders. Investigation of this pathway has far reaching therapeutic implications to potentially expand target indications outside of OA. In vitro studies will support the development of the Ampion program outside of OA.

Research report(s) will be delivered on a rolling basis within 4-6 weeks of completed work, and a full report summarizing all work performed will be presented quarterly. Pass through costs are estimated and will be purchased by theTR team using a specific job code assigned by Ampio Finance.

TABLE OF CONTENTS

EXECUTIVE SUMMARY	12
1.INVESTIGATION OF THE EFFECTS OF AMPION ON CHONDROCYTE BIOLOGY	16
Background	16
Aims	16
Materials and Methodology	16
Budget and Timelines	23
2.INVESTIGATION OF INFLAMMASOME INHIBITION BY AMPION	24
Background	24
Aims	24
Materials and Methodology	24
Budget and Tinielines	25
3.PROTEOMICS & METABOLOMICS ANALYSIS	27
Background	27
Aims	27
Materials and Methodology	27
Budget and Timeline	29
4.BIOINFORMATICS	31
Background	31
Aims	32
Resources and Materials	33
Methodology	34
Budget and Timeline	35
5.BUDGET SUMMARY	36
6.BUDGET APPROVAL	37

1.Investigation of the Effects of Am pion on Chondrocyte Biology

Background

The pathology of osteoarthritis (OA) involves a complex series of cellular events that results in the gradual loss of cartilage, fibrosis or stiffening of the synovial membrane, and osteophyte or bone spur formation. The bulk of the functional activity and structural framework of synovial joints is controlled by cells known as chondrocytes. Under normal circumstances, these cells regulate the turnover of extracellular matrix (ECM) and maintain tissue homeostasis. However, mechanical forces, aging, and underlying chronic inflammation drive differential changes and apoptosis of chondrocytes, resulting in degenerative joint conditions.

Current treatment options, such as corticosteroids and NSAIDs, attempt to address pain and inflammation but may prove detrimental with prolonged use. To evaluate Ampion treatment as an avenue for disease modification, a series of in vitro investigations designed to focus on drug effects on chondrocyte biology will be performed.

Aims

1.Develop and confirm models that will mimic articular cartilage chondrocyte biology.

2.Investigate the use of Ampion treatment in the preservation of cartilage and in chondrogenesis or recapitulation of cartilage.

Materials and Methodology

1.   Chondrocyte/Chondrogenesis modeling

a.Rationale.

To achieve our project objectives, it is imperative that a model assess the expression of chondrocyte cellular markers and function. In vitro human chondrocyte models, derived from both normal and OA tissue, will be used to mimic cartilage biology and later

challenged by inflammatory and/or mechanical activation to exhibit signs of disease. One of the challenges of chondrocyte cell culture is a well-known and rapid "de­ differentiation" of these cells following removal from the body. As a result, they need to be carefully recapitulated to their original state. Thus, several protocol options will be evaluated to confirm they are exhibiting the requisite functional dynamics. These will include but are not limited to expansion of cells into working cell banks followed by:

1) culturing in the presence of chondrogenic growth factors,

2) Three-dimensional (3D) culture techniques, and

3) temporal analysis of said cultures.

These models will be tested in the cells in the presence of Ampion (AR-100 and AR-300) with specific metrics in mind.

b.Materials and reagents.

i. Commercially available chondrocytes derived from normal and/or OA knee tissue and companion growth mediums.

ii. Chondrocyte differentiation mediums.

iii. 3D cell culturing matrix.

iv. Consumable cell culture ware including plates, pipets, etc.

v. Recombinant cytokines for differentiation of cells.

c.Methodologies.

i.    Banking of cells.

1.All purchased cells will be expanded following standard or recommended protocols and then working banks of cells prepared for experiments. These banks will consist of individual use vials stored in liquid nitrogen.

ii.Monolayer culture of chondrocytes.

1. The simplest model for evaluation will be the culturing of chondrocytes in monolayers on standard tissue culture plastics.

2. Banked cells will be cultured using basal medium formulations as controls and compared to mediums containing chondrogenic signals (i.e., TGFP)

3. Pros.

a.This model will allow for the highest throughput for drug testing.

4. Cons.

a. Evidence suggests that this model may result in the highest level of variability, which will be captured and documented in research reports.

b. The cells will also be subject to dedifferentiation artifacts and poor chondrogenic properties using this method.

iii.Micromass culturing.

1. To improve chondrocyte function, high density chondrocyte "pellets" will be cultured in tissue culture plates and/or low binding tubes.

2. These cultures will be conducted and evaluated for 7 to 21 days.

3. Pros.

a. Following this method, cells will be easy to handle, process, and manipulate as free-floating pellets in culture.

4. Cons.

a. Some critical markers or chondrocyte functions may take up to 21 days for appreciable detection.

iv.3D cultures.

1. Chondrocytes will be cultured 3 dimensionally by placing in alginate and collagen gels.

2. As with micromass, these cultures will be performed for 7 to 21 days.

3. Pros.

a. Evidence suggests that 3D culturing represents the best model for establishing chondrocyte characteristics.

4. Cons.

a. Some critical functional markers may take up to 21 days for full expression.

b. Gels must be degraded prior to cellular analysis.

c. Gel components may not be suitable for mass spec analysis.

2.Chondrocyte models and drug interventions

a. Rationale.

The chondrocyte culturing phase listed above will be utilized to identify techniques deemed suitable for in-house "bioassay" use. It is important to note here that these bioassays will not be rigorously validated following USP standards. Instead, we will use this phase to identify metrics that prove 1) repeatable and 2) provide enough dynamic range for meaningful drug testing and statistical analysis. To expedite the drug discovery process, these experiments will be conducted using appropriate controls as well as Ampion (AR-100 and/ or AR-300 as appropriate).

b.Materials and reagents.

i. Consumable cell culture ware including glass plates, coverslips, etc.

ii. Immunostaining antibodies and reagents.

iii. Recombinant cytokines for activation of cells.

iv. qPCR plates and reagents

c.Methodologies

i. Validation or confirmation of chondrocyte function and markers in models.

1.Chondrocyte phenotypes will be established using markers as follows.

a.    Proposed chondrocyte phenotype analysis.

i. Catabolic: MMP expression and ROS generating enzymes.

ii. Anabolic: Col2al, TGFB, BMP, IGF-1.

iii. Hypertrophic: Col IO and Runx2

iv. De-differentiated: Coll

b.     Additional markers of importance.

i. Proteolytic enzymes including but not limited to MMP-1, MMP-3, and MMP-13.

ii. SOX9.

iii. Aggrecan.

c.    Analyze and quantify by RTPCR using primer pairs and/or commercially available arrays from above.

d.    Analyze and quantify by immunostaining, western blot, and/or in-cell western blot using select antibodies from above.

2. Cellular secretomic and proteomic analysis to be performed via Trauma Research mass spec core center.

3. Integrity and/or make up of ECM in cultures will also be performed using proteomic analysis via Trauma Research mass spec analysis and Alcian blue staining.

4. Compare marker expression versus de-differentiated cells and/or saline controls. Appropriate positive and negative controls to also be identified and used for comparative analysis (NSAIDs, dexamethasone, etc.).

ii. Exploration of immuno- or mechano-stimulation of models.

1. Following marker development and confirmation, the models will then be challenged using pro-inflammatory cytokines and/or mechanical stress using TR pressure chamber.

2. Expression of proven markers will then be evaluated between Ampion and control treatment groups.

3.Mesenchymal stem cell modeling

a. Rationale.

Models for chondrogenesis and/or chondrocyte biology can also be derived from primary stem cell culture. Following these methods, in vitro chondrocytes can be generated from mesenchymal stem cells and will be mentioned here as an alternative approach to above. These cells will be explored following chondrocyte modeling described above.

b. Materials and reagents.

1.    Bone marrow-derived mesenchymal stem cells (BMMSC).

11.  Passage and differentiation mediums.

111.Culture ware and staining/testing material listed above.

c. Methodologies.

1.    In brief, micromass culture of BMMSC would be conducted for 21 days to generate chondrocyte-like cells.

11.  Metrics and markers would be established as described above.

4.Synoviocyte modeling

a.Rationale.

One of the most abundant cell types present in synovial joints are synoviocytes. These cells comprise the synovial lining and function to produce synovial fluid, which provides lubrication for the joint as well as nutrition for chondrocytes. Two distinct types of synoviocytes exist: type A macrophage-like and type B fibroblast-like. Since these cells interact directly with chondrocytes and can contribute to OA pathology, we also propose that cocultures of these cells should also be conducted after establishment of the model above.

b.Material and Reagents.

i. Primary synovial cells. Commercially available sources exist which should include both type A and type B cells.

ii. Companion expansion mediums.

iii. Tissue culture plate inserts.

iv. Cytokines for cellular activation.

c.Methodologies.

1. Coculture of synoviocytes with chondrocytes.

1. To evaluate potential interaction between chondrocytes and synoviocytes, coculturing of these cell types can be performed in the presence of Ampion with the metrics described above quantified.

2. To achieve this, cell culture inserts containing chondrocyte gels or pellets will be added to plate wells with established synoviocyte monolayers.

3. Activating cytokines (. i.e., IL-1 and/or TNFa) can then be added to either side of the insert.

4. Conditioned mediums, RNA, and total protein extracts can then be evaluated at select time points.

ii. Culture of chondrocytes with synoviocyte conditioned mediums.

1. As an alternative approach, conditioned mediums from synoviocytes can be placed on chondrocyte cultures.

Budget and Timelines

Chondrocytes

The methods listed above will be evaluated, in concert, to determine the most appropriate model for in-house use. All appropriate positive and negative controls will be identified and tested in addition to saline and drug treatment groups in early development to expedite the generation of preliminary data. Due to the extended time needed for these culturing techniques, this phase will take approximately 3-4 months to determine the approach. An additional 3-4 months will be required to gather replicates for statistical analysis.

BMMSC & Synoviocytes

Stem cell methodologies are provided as an alternative approach to the chondrocyte culture techniques mentioned above. If the initial chondrocyte culturing experiments do not appear to meet investigational requirements, the budget listed above can be pivoted to BMMSC reagents with no foreseen adjustment.

The synoviocyte proposal is highly dependent on the success of the chondrocyte model characterization and will be performed as necessary.

2. Investigation of Inflammasome Inhibition by Ampion

Background

Inflammasomes are multiprotein inflammatory complexes that can activate caspases to produce cytokines and induced pyroptosis. Moreover, these key inflammatory features are intimately associated with the release of IL-1β and IL-18 during infection, inflammation, and autoimmune conditions. Thus, targeting of this pathway has far reaching therapeutic implications.

We have previously demonstrated that Ampion exhibits an ability to inhibit the release of IL-lβ from PBMC and THP-1 activated cells using LPS or TLR7/8 agonists, respectively. To explore the expansion of Ampion outside of OA, a deeper investigation into inflammasome signaling will be investgiated.

Aims

1. To establish specific inflammasomes and pathways (ie; canonical vs non-canonical) responsible for the observed inhibition IL-1β release by Ampion in immune cells to support target indication expansion of Ampion.

Materials and Methodology

1. Cell culture models to employ.

a. Monocytic cell lines including immature and differentiated THP-1 and U937 cells.

b. Primary monocytes

c. Monocyte-derived macrophages and or dendritic cells.

d. Neutrophils

e. Epithelial cells

2. Differentiation protocols

a. PMA

b. M-CSF or GM-CSF for MO differentiation followed by 1) IFNy = Ml, 2) IL-4 and/or IL-13 = M2 or dendritic

3. Transcriptome

a. qPCR arrays and/or select targets

4. Proteomics and Metabolomics

5. Western blot

a. Targets: Caspase 5, Caspase 1, NLRP (NLRP3 and NLRP12) species, AIM2, etc.

b. Performed using standard protocols and/or in-cell.

c. Pull downs to determine complexes affected by Ampion

6. Immunostaining

a. Evaluate localization of inflammasome complex proteins in the cell. For example, tubulin together with NLRP3 to establish if increased acetylation correlates with lack of perinuclear localization.

7. siRNA knockdown

a. Knock down of target inflammasome proteins to determine impact on Ampion activity.

8. ELISA for IL-Iβ

a. Determine secreted IL- I β levels from each model with and without Ampion

Budget and Timelines

Investigation into Ampion-mediated inhibition of the inflammasome will include optimizing culture and treatment conditions of inflammatory cell types including several distinct cell types contribute to chronic inflammation in the knee, such as chondrocytes, synoviocytes, and immune cells. The work will likely follow a similar budget and timeline when compared to the chondrogenesis project.

3. Proteomics & Metabolomics Analysis

Background

The sum of all proteins in a tissue or cell is referred to as the proteome. Proteomics studies proteins and their quantities, structure, modifications, and functional roles in biochemical processes. Proteins are the final effector of cell behavior and cellular homeostasis, and proteomics offers a glimpse into how these processes are being regulated. Additionally, as many diseases tend to manifest at the protein level it is vital to understand how the proteome differs or changes in healthy vs disease or in responding to pharmaceutical treatment.

Metabolomics can be considered the most current state of metabolic function, as metabolite changes can occur on the timescale of seconds to minutes. Quantifying metabolites and other small molecules allow a look into what metabolic pathways are active. For example, what sugars and amino acids are being consumed by cells and the byproducts being produced allude to which energy pathways the cells are using are make energy. After drug treatment, metabolomics can be used to reveal how a drug is altering cellular metabolism, as well as how the drug is being metabolized.

Aims

1.   Support the two objectives: 1) chondrogenesis to support disease modifying osteoarthritis drug (DMOAD) applications; and 2) inflammasome mechanism of action to support target indications and development application outside of OA by identifying proteins and metabolites that change as a result of Ampion treatment by quantification using Liquid Chromatography-Mass Spectrometry (LC-MS).

Materials and Methodology

1. Equipment and consumables

a. Acquity UPLC BEH C18 Column

b. Acquity UPLC BEH Amide Column

c. Bead Beater

d. 10kd Molecular weight cut off filters (Microcon or Vivacon)

e. Top14 Depletion columns (if there will be any exposure to albumin or blood)

f. Pierce Rapid Gold BCA Protein Assay Kit

g. Pierce C18 spin tips

h. Waters Autosampler Vials

i. 1.5ml and 2.0ml low protein binding tubes

j. Glass Beads 0.5mm-1.0mm

2. Reagents

a. All Reagents for LC-MS need to be of ultra-pure grade, this includes ReagentPlus, and Optima grade for liquid solvents.

b. Heavy labeled metabolite standards.

c. Sequencing Grade Trypsin

3. Software

a. Masslynx

b. Mascot Server

c. Mascot Distiller and Daemon

d. Scaffold Elements

4. Proteomics

a. Sample Prep

i. All Samples will be processed according to optimized FASP (filter-aided sample preparation) protocols. This involves capturing proteins on molecular weight cut-off filters. Captured proteins are then denatured and extensively washed before being digested overnight with the enzyme, trypsin.

11. Peptides collected post-digest will be desalted, washed, and cleaned up using C18 resin spin tips. Cleaned peptides will then then be eluted into waters autosampler vials for injection on LC-MS.

b. LC-MS Analysis and data analysis

i. Peptides will be injected onto Waters Acquity UPLC BEH column and run with a 3-hour gradient.

11.  RAW data files for each sample will then be searched for identifications using MASCOT server and the program Mascot Daemon.

m. Excel reports from Daemon will be used to move forward with protein reports and data analysis using the following but not limited to:

1. MetaboAnalyst

2. Ingenuity Pathway Analysis

2. Metabolomics

a. Sample Prep

i. All samples will be processed according to an optimized metabolite extraction protocol. Hydrophilic metabolites will be extracted from cells and tissues using a polar lysis buffer (50/30/20 MeOH/ACN/H2O)

b. LC-MS analysis and data analysis

i.   Metabolites will be injected onto the Waters Acquity UPLC BEH column and run with a 10 min method

11.  RAW data files for each sample will be searched using Scaffold Elements Program

111.  Data analysis and reports can be done and generated in Scaffold Elements.

Budget and Timeline

Reagent quality for LC-MS must be stringent due to the sensitivity of this technique will be billed to Ampio as a pass-through cost. Further, the costs associated with proteomics and metabolomics center on the type ofreagents necessary to answer the research question. For example, proteins or metabolites that have been labeled with heavy atoms are used for standards when quantifying specific proteins/metabolites. However, for semi-quantification, it is not necessary to have a heavy standard, so it depends on where the initial results lead Ampio. Running LC-MS, processing the data, and interpreting results will require significant time from a highly trained TR scientist.

As the TR Omics group will be processing samples handed off from other arms of the research group, the timeline will be impacted by the receipt of samples. Once samples are in hand, sample prep for proteomics generally takes 2 days. Metabolomics sample prep can be done and analyzed in one day. Proteomics LC-MS run time is 3 hours per sample. Metabolomics run time is 10-30 minutes per sample. Once these data are obtained, processing, analyses, report writing, and figure generation will be delivered within 4-6 weeks of the completed experiment.

The Omics team will deliver protein and metabolite identification reports, corresponding raw data, and team-guided figures to aid visualization of report results, which will be summerzied in a research report. These data will help guide the research team in several ways: 1) elucidate proteins and metabolites that are differentially regulated in chondrocyte biology

downstream of Ampion treatment, 2) uncover protein and metabolic pathways that are regulated by or changing with Ampion treatment in chondrocytes and other cells associated with joint inflammation, 3) identify possible targets for future drug development, and 4) understanding how Ampion is affecting the proteome and influencing cellular metabolism .

4. Bioinformatics

Background

Ampion has been clinically shown to reduce pain and delay total knee replacement in OAK patients. In vitro studies in OA chondrocytes and mesenchymal stem cells support the hypothesis that Ampion promotes chondrogenesis and cartilage repair; however, these studies focused on a small number of select genes and proteins. Consequently, a broader understanding of the ability of Ampion to promote chondrogenesis is warranted. Comprehensive and unbiased bioinformatic analyses empower our ability to discover complex biological systems such as the promotion of chondrogenesis driven by Ampion. Increased chondrogenesis in OAK patients would be considered a modification of this disease, and by characterizing the effects of Ampion with bioinformatics, a comprehensive understanding may support the idea that Ampion is both a symptomatic treatment and a disease modifying biologic in OA patients.

As a biologic, Ampion contains several known and unknown components. An efficient method to test the therapeutic implications of Ampion is to describe cellular changes in gene expression (transcriptomics), protein (proteomics), and metabolic pathways (metabolomics) that are regulated by Ampion. These 'omics' datasets are very large and difficult to interpret because building connections between tens to thousands of molecules and how they relate to cellular processes is humanly impossible.

To aid in these types of analyses, the fields of biology and computational sciences joined to form bioinformatics. Ingenuity Pathway Analysis (IPA) is a bioinformatics software that contains a vast 'knowledgebase' of biologically relevant connections between biomolecules, chemicals, and drugs. Unlike other online bioinformatics software, the IPA knowledgebase has been hand curated by scientists from published literature and thus not only contains biologically relevant connections but the consequences of their regulation. For example, molecule A regulates

100 different genes with the potential to change cellular behavior. With treatment, molecule A is activated, and 40 genes increase, which is reflected in the dataset. IPA analyzes the dataset and predicts the cellular consequences (increased/decreased proliferation, anti-/pro-inflammation, etc) of increased expression of those specific genes.

The limited historical omics data featuring Ampion compared to control treatment has shown that between different cell types analyzed, Ampion regulates unique target molecules. By expanding our knowledge of Ampion target molecules through omics dataset generation, we will investigate opportunities for further development of other disease indications in the future.

Remarkably, the public domain of omics datasets featuring human disease-states or animal models of human disease has greatly expanded. Thousands of datasets are available to download, process and analyze. Many of these datasets have been published from peer-reviewed manuscripts.

The overarching purpose of the bioinformatics division of the Ampio research program is to make biologically relevant connections between Ampion regulated molecules in cells or tissues and how that relates to Ampion's therapeutic potential by comparing to public omics datasets of disease.

Aims

1.Process for IPA upload historical data generated by Ampio Pharmaceuticals.

2.Analyze and interpret historical data generated by Ampio Pharmaceuticals.

3. Provide guidance on experimental design of future Ampio Pharmaceutical omics datasets.

4. Process Ampio Pharmaceutical historic or future raw data with Qiagen CLC genomics workbench or R programming software to generate datasets for upload into IPA.

5. Analyze Ampion datasets in IPA and report results.

6.Compare Ampion datasets to each other in varying cell types and conditions.

7.Interpret IPA findings of future omics datasets generated by Ampio Pharmaceuticals.

8.Acquire and analyze with Qiagen CLC genomics workbench or R programming software datasets of human disease or, if necessary, animal models of human disease and prepare them for upload to IPA and comparison to Ampion datasets.

9.Compare Ampion omic datasets to public datasets of human disease or, if necessary, animal models of human disease.

10. Produce and deposit to the M drive at Ampio Pharmaceuticals research reports with all data, programming scripts, IPA summaries, and graphs of interest to disseminate findings.

11. Compose and revise manuscripts based on findings of scientific importance.

12. Publish manuscripts that further drug development of Ampion in peer-reviewed journals.

Resources and Materials

● PhD scientists trained in omics dataset generation, analysis, and interpretation

● Computing resources including high-speed internet, server support, computers, monitors, and other computer peripherals

● Licenses of Qiagen software (IPA and CLC genomics workbench)

● R programming and related software

● Historical data from experiments comparing Ampion to control treatment with full experimental design and details. Data not received in IPA upload format will require processing

● Raw omics data from future experiments comparing Ampion to control treatment with full experimental design and details

· Network access to M drive

● Fees related to publication of manuscripts, color figures, and manuscript open access

Methodology

Raw omics data analyses

The CLC genomics workbench will be used to process raw RNA sequencing (FASTQ) files through a workflow that includes sequence trimming, quality control, genomic alignment, and quantification of reads. Statistical analyses of omics (transcriptomics, proteomics, and metabolomics) count data will be performed in R programming software [1] with the DESeq2 [2] package. To determine differences in target molecule regulation by Ampion log2 fold-changes, p­ values, and adjusted p-values will be calculated. Genes with an adjusted p-value < 0.05 will be considered differentially expressed.

In silica pathway analysis

Calculated differential gene expression values will be uploaded into Ingenuity Pathway Analysis (IPA) software (Qiagen Digital Insights, Redwood City, CA, USA). Expression Core Analyses will be run based on Expression Log Ratios with an adjusted p-value < 0.05 using the Ingenuity Knowledge Base as reference. Using the default node setting, a graphical summary will be generated by IPA that reflects the overall top regulated entities for each individual analysis. Further, IPA analyses will be used to computationally infer upstream regulators that are predicted to have similar or opposite actions to the effect of Ampion. Z-scores will be calculated, where z > 0 predicts activation or similar regulation, and z < 0 predicts the converse; an absolute value of 2 will be used as a significance cutoff. Additional analyses including but not limited to Analysis Match, Network Analysis, and Enrichment analyses will be performed as deemed necessary.

Budget and Timeline

Bioinformatics analysis of the effect of Ampion on transcription in immunostimulated PBMCs is currently underway. The manuscript entitled "LMWF5A (Ampion) Demonstrates an Anti-Inflammatory Mode of Action and Similar Drug Targets to Dexamethasone in Activated PBMC" is under peer review at Molecular Biology Reports. These data will also be used to draw connections between Ampion and chondrogenesis. Direct analysis of omics data from inflammasome and chondrocyte experiments will be dependent on timing of raw data receipt.

Depending on the level of processing of raw data per each experiment, final upload into IPA may take up to 3-4 weeks for a part-time scientist. Full IPA analysis is an ongoing process depending on what data show and the areas of interest that arise. Analysis and manuscript completion may take up to 3-6 months for a part-time scientist. Research report(s) will be delivered within 4-6 weeks of completed work, and a full report summarizing all work will be presented quarterly.

Dataset analyses will be deposited to the M drive server at Ampio Pharmaceuticals. The format will be a research report and include all files that are required to repeat the analyses.

These files may include but are not limited to original data, programming scripts, IPA summaries, and graphs of interest.

Results and findings that are determined to contribute to the drug development of Ampion will be written into manuscripts and submitted to peer-reviewed journals with Sponsor approval. Upon receipt ofreviewed manuscripts, TR will address, if necessary, reviewer's comments and revise the manuscripts.

5.Budget Summary

Investigation	Timeline	Cost
1. Chondrocytes / Chondrogenesis		$100,000
2. Inflammasome		$50,00
3. Proteomics & Metabolomics		$50,00
4. Bioinformatics		$50,00
Totals	12 months	$250,000
Pass-through estimate		$150,000

Payment terms: Trauma Research, LLC (TRLLC) will invoice Ampio $20,833.33 per month, representing the monthly Investigation Fee, for a period of twelve (12) months which represents the Investigation Period. The payment of the invoice shall be due and payable within fifteen (15) days upon receipt of the invoice. In addition, TRLLC shall invoice Ampio for pass-through costs incurred related to the investigational work as further defined in the Research Program Plan. The invoice for pass-through costs shall have reasonable support for such costs and not exclude any mark-up I overhead charge and shall be due and payable upon receipt invoice.

Deliverables: Research report(s) will be delivered on a rolling basis within 4-6 weeks of completed work, and a full report summarizing all work performed in to date will be presented quarterly. It is anticipated this work will result in 2 peer-reviewed publications.

Expected start date: 31 January 2022

Expected termination date: 31 January 2023

Sponsor provides: Test articles and 2 FTE resources

TR provides: As described

Pass-through costs: An estimated budget for reagents, consumables, and the potential of out­

sourced testing (i.e. ELISA array analysis) is provided. TR will be responsible for ordering and billing pass-through costs.

6. Budget Approval

Approval to proceed as described:

COMPANY:		CONTRACTOR:
Ampio Pharmaceuticals, Inc.		Trauma Research LLC
By:	/s/ Michael A. Martino	By:
Name:	Michael A. Martino	Name:	David Bar-Or
Title:	Chairman & CEO	Title:	Director

EX-10.2

Exhibit 10.2

PERSONAL SERVICES AGREEMENT

This Personal Services Agreement ("Agreement") is made on February 4, 2022 ("Effective Date") and entered into by and between Ampio Pharmaceuticals, Inc., a Delaware corporation, having its address at 373 Inverness Parkway, Suite 200 Englewood, Colorado 80112 ("Company") and Dr. David Bar-Or, an individual residing at 900 East Oxford Lane, Englewood CO 80113 (the "Principal Investigator"). Company and Principal Investigator may individually be referred to herein as a "Party" and collectively as the "Parties".

1. Engagement of Services.

1.1Company and Contractor may enter into one or more research project assignments (each executed research project assignment, a "Research Project Assignment") pursuant to that certain Research Services Agreement, dated of even date herewith, by and between the Company and the Contractor (the "Contractor Agreement"). Upon execution, each Research Project Assignment will be binding on Company and Contractor and incorporated herein. The Principal Investigator agrees to oversee and direct the research services set forth in each Research Project Assignment (the "Contractor Services") by the completion dates set forth therein.

1.2Principal Investigator is skilled in: (a) the design, development, preparation, review, and evaluation of research proposals, including project names and research hypotheses; (b) research and development activities, including_ the development of intellectual property; (c) managing research projects, including as to timelines and budgets, and (d) providing scientific input and guidance to ensure scientific integrity of research projects and, during the Term, Principal Investigator will provide all such skills and expertise to Company, including proposing Research Project Assignments pursuant to the Contractor Agreement suitable for Company, overseeing and directing all Contractor Services to ensure they are of a type and kind suitable and sufficient for Company, overseeing development and prosecution of Company's intellectual property rights (both ongoing and newly developed), providing input and guidance with respect to Company's development programs (both with Contractor and other research and development activities), and overseeing and serving as chair of the technology committee of Company's board (all of the foregoing services, including any other advisory or consulting services requested by Company, collectively the "Principal Investigator Services"). For the avoidance of doubt, the specific Principal Investigator Services to be provided by Principal Investigator will be as specified by Company from time to time.

2.Compensation. During the Term, Company will pay Principal Investigator U.S. two hundred and fifty thousand dollars ($250,000) annually (the "Principal Investigator Services Fee") for Principal Investigator Services rendered pursuant to this Agreement. Each annual Principal Investigator Services Fee will be paid in four equal payments of U.S. sixty two thousand five hundred dollars ($62,500), payable quarterly during the Term. The Principal Investigator Service Fee is in lieu of board fees Principal Investigator may be entitled to as a board member of Company, all of which are hereby waived by Principal Investigator. For the avoidance of doubt, options or shares awarded to board members are excluded from the foregoing waiver. Company shall have no obligation to pay any Principal Investigator Service Fees (or any portion thereof) following termination of this Agreement for any reason.

3. Research Projects.

3.1Contractor will furnish the laboratory facilities necessary to carry out the Contractor Services pursuant to the Contractor Agreement. The Contractor Services will be under the direction of Principal Investigator and will be conducted at one or more other suitable facilities selected by Contractor. The Principal Investigator shall properly supervise all persons performing services in connection with the Contractor Services and shall ensure that they comply with the terms of this Agreement, the Contractor Agreement and any requirements identified in the applicable Research Project Assignment or required by Company.

3.2Company's designated representative for consultation and communications with the Principal Investigator shall be Michael Martino or such other person as Company may from time to time designate in writing to Principal Investigator. Principal Investigator shall also provide updates with respect to the Principal Investigator Services and the Contractor Services to the board and CEO of Company and other officers and directors of Company at Company's reasonable request.

3.3During the Term, Company's representatives may consult informally with Principal Investigator regarding the Principal Investigator Services and the Contractor Services, both personally and by telephone . Access to work carried on by Contractor in the course of these consultations shall be under the reasonable control of Principal Investigator but shall be made available on a reasonable basis for observation of the work.

3.4Principal Investigator will make up to four oral reports each year during the Term as requested by Company's designated representative. Within ninety (90) days after termination of this Agreement, Principal Investigator shall prepare a final report summarizing all activities undertaken and accomplishments achieved through the performance of the Principal Investigator Services.

4.Records. Principal Investigator will keep accurate scientific records directly relating to the Principal Investigator Services and will make such records available to Company or its authorized representative throughout the Term and for a period of one year following termination of the Agreement. Prior to destroying or otherwise disposing of any such records, Principal Investigator will provide Company a reasonable opportunity to take possession of the records at Company's own expense.

5.Independent Contractor Relationship. The Parties' relationship hereunder is that of independent contractors. Nothing in this Agreement is intended to, or should be construed to, create a partnership , agency, joint venture or employment relationship among the Parties. Principal Investigator shall control the manner and means of performing Principal Investigator's obligations hereunder. Principal Investigator will not be entitled to any of the benefits that Company may make available to its employees, including , but not limited to, group health or life insurance , profit­ sharing or retirement benefits. Principal Investigator is not authorized to make any representation, contract or commitment on behalf of Company unless specifically requested or authorized in writing to do so by a Company manager. Principal Investigator is not authorized to execute a Research Project Assignment on behalf of Company. Principal Investigator is solely responsible for, and will file, on a timely basis, all tax returns and payments required to be filed with, or made

to, any federal, state or local tax authority with respect to the performance of services and receipt of fees under this Agreement. Principal Investigator is solely responsible for, and must maintain adequate records of, expenses incurred in the course of performing services under this Agreement. No part of Principal Investigator's compensation will be subject to withholding by Company for the payment of any social security, federal, state or any other employee payroll taxes. While on the Company's premises or using the Company's equipment, Principal Investigator shall comply with all applicable policies of Company relating to business and office conduct, health and safety, and use of Company's facilities, supplies, information technology, equipment, networks, and other resources.

6. Confidential Information.

6.1Definition of Confidential Information. "Confidential Information" as used in this Agreement shall mean any and all technical and non-technical information including patent, copyright, trade secret, and proprietary information, techniques, sketches, drawings, models, inventions, know-how, processes, apparatus, equipment, algorithms, software programs, software source documents, and formulae related to the current, future and proposed products and services of the Company, its suppliers and customers, and includes, without limitation, its respective information concerning research,  experimental work,  development,   design  details  and speci fications, engineering, financial information, procurement requirements, purchasing, manufacturing, customer lists, business forecasts, sales and merchandising and marketing plans and information. All data or results from the performance of the Contractor Services and Principal Investigator Services shall be Confidential Information and exclusively owned by Company. Confidential Information also includes proprietary or confidential information of any third party who may disclose such information to Company or to Contractor or Principal Investigator while conducting Company's business or performing their respective services hereunder.

6.2Nondisclosure and Nonuse Obligations. Principal Investigator will use the Confidential Information solely to perform his obligations pursuant to the Principal Investigator Services, solely for the benefit of Company. Principal Investigator agrees that he shall treat all Confidential Information with the same degree of care as he treats his own like confidential information, but in all cases using no less than reasonable care. Principal Investigator agrees that he may disclose Confidential Information only to those of Contractor's employees who need to know such information for purposes of carrying out their respective services and who have previously agreed, either as a condition of employment or in order to obtain the Confidential Information, to be bound by terms and conditions substantially similar to those of this Agreement. Principal Investigator will immediately give notice to Company of any unauthorized use or disclosure of the Confidential Information. Principal Investigator agrees to assist Company in remedying any such unauthorized use or disclosure of the Confidential Information. If, in connection with providing services hereunder, Principal Investigator desires to disclose Confidential Information to third parties, he may do so only with the prior written consent of Company and after providing Company with a copy of an executed confidentiality agreement binding such third party to terms at least as stringent as the confidentiality terms contained in this Section 6.

6.3Exclusions from Nondisclosure and Nonuse Obligations. Principal Investigator's obligations under Section 6.2 with respect to any portion of Confidential Information shall

terminate when Principal Investigator can document that: (a) it was in the public domain at or subsequent to the time it was communicated to Principal Investigator by Company through no fault of Contractor or Principal Investigator; (b) it was rightfully in Principal Investigator's possession free of any obligation of confidence at or subsequent to the time it was communicated to Principal Investigator by Company; or (c) it was developed by Principal Investigator or by employees or agents of Contractor independently of, and without reference to, any information communicated to Contractor or Principal Investigator by Company.

6.4Authorized Disclosure. This Agreement shall not restrict Principal Investigator from disclosing Confidential Information to the extent required by applicable law or as requested by any judicial, regulatory, law enforcement, or governmental authority; provided, however, that Principal Investigator shall, to the extent legally permissible, give notice of such requirement or request to Company so that Company may seek (at Company's expense) a protective order or other appropriate relief.

6.5Disclosure of Third Party Information. No Party shall communicate any information to any other Party in violation of the proprietary rights of any third party.

6.6Publication and Academic Rights. Principal Investigator shall not issue any press releases or make any public presentation or announcement with respect to the existence of this Agreement or the details hereof, without the prior, written consent of Company; provided , however, that such restriction shall not apply to disclosures or reporting within Contractor's organization or where required by law. No Party shall use any other Party's name or the name of its officers, directors, or employees in any advertising, sales, promotional, or publicity materials without the prior, written consent of such other Party. The results of the Contractor Services and Principal Investigator Services may be published in scientific literature and may also be used in submissions to regulatory authorities. It is the intention of the Parties that Company and Principal Investigator will publish or present the results of the Contractor Services and Principal Investigator Services together, unless specific permission is obtained by Contractor or Principal Investigator in advance from Company for Contractor or Principal Investigator, as applicable, to publish separate results. For publication of separate results by Contractor or Principal Investigator, Contractor or Principal Investigator, as applicable, must provide Company with a copy of materials for publication or presentation thirty (30) days prior to submission so that Company may: (a) review such materials for accuracy of background information; (b) determine that such publication will not compromise Company's ongoing patent rights or any Confidential Information; and (c) take necessary action to protect Company patent rights.

7. Ownership Rights in Company Property.

7.1Company shall be the sole and exclusive owner of Company Property. "Company Property" means (a) all materials (including, without limitation, all documents, data, reports, drawings, analyses, equipment, products, prototypes, services and other work) furnished to Contractor or Principal Investigator by Company, produced by Contractor or Principal Investigator before the Effective Date for or with Company, or produced after the Effective Date by Contractor or Principal Investigator in the performance of this Agreement, the Contractor Agreement or pursuant to any Research Project Assignment or the performance of any Contractor Services or Principal Investigator Services; and (b) all copyrights, patents, trade secrets, inventions, and other

proprietary or intellectual property rights produced before or after the Effective Date by Contractor or Principal Investigator in the performance of this Agreement, the Contractor Agreement or pursuant to any Research Project Assignment or the performance of any Contractor Services or Principal Investigator Services. The term "Company Property" does not include any general know­ how, methodology, processes, products, devices or experience of Contractor or Principal Investigator gained prior to performance of the Contractor Services or Principal Investigator Services, as applicable, or from experience gained parallel to performance of the Contactor Services or Principal Investigator Services from umelated sources. To the fullest extent permitted by law, all Company Property produced before or after the Effective Date shall be deemed to be "Works for Hire" for the benefit of Company, as U.S. federal and international copyright law defines that term. To the extent Company Property may not be considered Works for Hire, Principal Investigator hereby irrevocably and unconditionally sells, assigns, and transfers all of his rights , title, and interest in Company Property to Company , without additional consideration. Principal Investigator shall promptly execute and deliver all documents and instruments reasonably requested by Company to evidence such transfers and Principal Investigator shall be reimbursed for reasonable expenses incurred in order to comply with this obligation. Further, Principal Investigator hereby irrevocably waives and releases in favor of Company any unassignable rights, including any "moral rights", that Principal Investigator may have in or to any Company Property.

7.2Principal Investigator unconditionally grants to Company a non-exclusive, perpetual, irrevocable, worldwide, fully-paid right and license, with the right to sublicense through multiple levels of sublicensees, under any copyrights, patents, trade secrets, inventions, and other intellectual property or proprietary rights of Principal Investigator, used or incorporated into or otherwise necessary to exploit any Company Property, to: (a) reproduce , create derivative works of, distribute, publicly perform, publicly display, transmit, and otherwise use the Company Property in any medium or format, whether now known or hereafter discovered; (b) use, make, have made, sell, offer to sell, import, and otherwise exploit the Company Property; and (c) exercise any and all other present or future rights in the Company Property without restriction.

7.3Principal Investigator represents and warrants that all third parties given access to Confidential Information or Company Property by Principal Investigator will have entered into a confidentiality, non-disclosure, and invention assignment agreement the terms of which are at least as protective of the Confidential Information and Company Property as those in this Agreement.

8.Return of Company' s Property. Principal Investigator agrees to promptly deliver the original and any copies of the Company Property to Company at any time upon Company's request. Upon termination of this Agreement by any Party for any reason, Principal Investigator agrees to promptly deliver to Company or destroy, at Company's option, the original and any copies of the Company Property. Principal Investigator agrees to certify in writing that Principal Investigator has so returned or destroyed all such Company Property if Company so requests .

9.Materials Transfer. It is contemplated that Company will, during the course of the Contractor Services, provide Contractor various chemical and biological materials, including, without limitation, compounds, cell lines , tissue and fluid samples, and associated know-how and data owned by or proprietary to Company (or proprietary to a third party from which such materials were obtained) ("Company Material"). Principal Investigator acknowledges and agrees that

Company will not be providing any Company Material to Principal Investigator, and Company Material shall not be used by the Principal Investigator for any purpose outside of the agreed Research Project Assignment.

10. Term and Termination.

10.1Term. This Agreement is effective as of the Effective Date set forth above and will terminate upon termination of the Contractor Agreement (the "Term").

10.2Termination by Company. Company may terminate this Agreement, with or without cause, at any time upon thirty (30) days prior written notice to Principal Investigator.

10.3Termination by Principal Investigator. Principal Investigator may terminate this Agreement, with or without cause, at any time upon thirty (30) days' prior written notice to Company.

10.4Survival. Sections 4, 5, 6, 7, 10, 11, 13, and 16-22 will survive any termination or expiration of this Agreement.

11.Notices. Any notice which a Party is required or permitted to give to another Party shall be given by personal delivery or registered or certified mail, return receipt requested, addressed to the other Party at the appropriate address set forth in this Section 11 below, or at such other address as another Party may from time to time designate in writing. The date of personal' delivery or the date of mailing of any such notice shall be deemed to be the date of delivery thereof.

Ifto Company:373 Inverness Parkway, Suite 200

Englewood, CO 80112 Attn: Michael Martino

If to Principal Investigator:Dr. David Bar-Or

900 East Oxford Lane Englewood, CO 80113

12. Representations and Warranties by Principal Investigator.

12.1Quality. Principal Investigator represents and warrants to Company that the Principal Investigator Services performed under this Agreement shall be performed with the degree of skill and care that is required by current, good and sound professional procedures and practices, and in conformance with generally accepted professional standards prevailing at the time the work is performed so as to ensure that the Principal Investigator Services performed are correct and appropriate for the purposes contemplated in this Agreement.

12.2Compliance. Principal Investigator represents and warrants to Company that he has not been and will not be debarred or disqualified by the FDA pursuant to the Generic Drug Enforcement Act of 1992 or any other equivalent of successor statutes, rules, or regulations.

Principal Investigator agrees to immediately notify Company in writing if Principal Investigator becomes debarred or disqualified or proceedings have been initiated with respect to such debarment or disqualification, whether such disbarment or initiation of proceedings occurs during or after the performance of the Principal Investigator Services. Company shall have the right to terminate this Agreement upon receipt of notice from Principal Investigator that Principal Investigator received notice of action or threat of action with respect to debarment or becomes debarred as set forth in this Section 12.2. Further, Principal Investigator agrees to abide by, at all times during the Term, the "Ampio Pharmaceuticals, Inc. Code of Business Conduct and Ethics," a copy of which is attached hereto as Exhibit B, and the "Ampio Pharmaceuticals, Inc. Insider Trading Policy," a copy of which is attached hereto as Exhibit C.

12.3General. Principal Investigator represents and warrants to Company that: (a) Principal Investigator has the right to enter into this Agreement, to grant the rights granted herein, and to perform fully all of Principal Investigator's obligations in this Agreement; (b) Principal Investigator entering into this Agreement with the Company and Principal Investigator's performance of the Principal Investigator Services do not and will not conflict with or result in any breach or default under any other agreement to which Principal Investigator is subject; and (c) Company will receive good and valid title to all Company Property, free and clear of all encumbrances and liens of any kind.

13. Indemnification.

13.1By Company. Company agrees to indemnify, defend, and hold harmless Principal Investigator from damages finally awarded or finally paid in settlement in respect of liability and losses (including reasonable attorney's fees and expenses) he suffers as the result of third-party claims, demands, costs, or judgments ("Losses"), to the extent such Losses arise out of: (a) personal injury of a third party directly resulting from use of the Company Materials by Contractor in accordance a Research Project Assignment, directions of Company, and applicable law; (b) negligence, recklessness, or willful misconduct on the part of any Company lndemnitee (defined below); or (c) a material breach of this Agreement by Company. Company's indemnification obligation shall not apply to the extent any Losses are indemnifiable by Principal Investigator pursuant to Section 13.2.

13.2By Principal Investigator. Principal Investigator agrees to indemnify, defend, and hold harmless Company, its stockholders, directors, officers, employees, and agents ("Company Indemnitees") from third party Losses they suffer to the extent such Losses arise out of: (a) a failure by Principal Investigator to adhere to the terms of this Agreement or applicable law; (b) Principal Investigator's negligence, recklessness, or willful misconduct; or (c) a material breach of this Agreement by Principal Investigator.

14.Conflicts oflnterest. Principal Investigator shall exercise reasonable care and diligence to prevent any actions or conditions that could result in a conflict with any Company interest. During the Term, Principal Investigator shall not accept any employment or engage in any consulting work, including through Contractor, that creates a conflict of interest with Company or in any way compromises the services to be performed under this Agreement. Principal Investigator shall immediately notify Company of any and all violations or potential violations of this clause upon becoming aware of such violation.

15.Waiver. The failure of any Party to insist on strict compliance with any of the terms, covenants, or conditions of this Agreement by the other Parties shall not be deemed a waiver of that term, covenant or condition nor shall any waiver or relinquishment of any right or power at any one time or times be deemed a waiver or relinquishment of that right or power for all or any other times

16. Governing Law. This Agreement shall be governed by the laws of the State of Colorado.

17.Assignment. This Agreement may be assigned by Company in connection with an acquisition (by whatever means), including by merger with, or the sale of substantially all of its related business to, another. This Agreement may otherwise be assigned by Company only with the consent of Principal Investigator, not to be unreasonably withheld. Principal Investigator may not assign the Principal Investigator Services or any portion of this Agreement without the prior written consent of Company.

18.Entire Agreement. This Agreement constitutes the entire agreement among the Parties relating to this subject matter and supersedes all prior or contemporaneous oral or written agreements concerning such subject matter. The terms of this Agreement will govern all Principal Investigator Services undertaken by Principal Investigator for Company. This Agreement may only be changed by mutual agreement of authorized representatives of the Parties in writing.

19.Defend Trade Secrets Act of 2016. Principal Investigator acknowledges receipt of the following notice under 18 U.S.C § 1833(b)(1): "An individual shall not be held criminally or civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that (a) is made (i) in confidence to a Federal, State, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (b) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal."

20.Non-Solicitation. In view of Principal Investigator's access to Company's trade secrets, Confidential Information, proprietary know-how and knowledge of Company resulting from Principal Investigator's relationship with Company hereunder, Principal Investigator further agrees that he will not, directly or indirectly, in any manner, other than for the benefit of Company or with Company's prior written consent, during the Term and for a period of twelve (12) months after the termination or expiration of this Agreement, regardless of reason (the "Restricted Period"): (a) offer to hire, induce or attempt to induce any officer, employee or agent of Company or any of its affiliates or subsidiaries to discontinue his or her relationship with Company or any of its affiliates or subsidiaries; (b) directly or indirectly solicit, or attempt to solicit, any employee of Company; or (c) (i) call upon, solicit, divert or take away any of the customers, business or prospective customers of Company or any of its suppliers, and/or (ii) solicit, entice or attempt to persuade any other consultant of Company to leave the services of Company for any reason. Principal Investigator acknowledges and agrees that if Principal Investigator violates any of the provisions of this Section 20, the running of the Restricted Period will be extended by the time during which the Principal Investigator engaged in such violation(s). Principal Investigator agrees that the restrictions imposed by the provisions of this covenant are fair and reasonable and are reasonably required for the protection of Company. If the provisions relating to the geographic or substantive scope of the restriction or the time period of the restriction exceed the maximum areas

or period of time which a court or competent jurisdiction would enforce, the Parties agree that the areas and time period shall be deemed to be the maximum areas or time period which a court of competent jurisdiction would enforce in any state in which such court shall be convened.

21. DisQ_ute Resolution.

21.1Except as provided below, any dispute among any of the Parties arising out of or relating to this Agreement, or the breach, termination or validity of this Agreement, shall be finally settled by binding arbitration conducted expeditiously in accordance with the J.A.M.S./Endispute Comprehensive Arbitration Rules and Procedures. The arbitration shall be governed by the United States Arbitration Act, 9 U.S.C. Sections 1 16, and judgment upon the award rendered by the arbitrators may be entered by any court having jurisdiction thereof. The place of arbitration shall be Denver, Colorado.

21.2The arbitration shall commence within 60 days of the date on which a written demand for arbitration is filed by any Party hereto. In connection with the arbitration proceeding, the arbitrator shall have the power to order the production of documents by each Party and any third-party witnesses. In addition, each Party may take up to three depositions as of right, and the arbitrator may in his or her discretion allow additional depositions upon good cause shown by the moving Party. However, the arbitrator shall not have the power to order the answering of interrogatories or the response to requests for admission. In connection with any arbitration, each Party to the arbitration shall provide to the other(s), no later than seven business days before the date of the arbitration, the identity of all persons that may testify at the arbitration and a copy of all documents that may be introduced at the arbitration or considered or used by a Party's witness or expert. The arbitrator's decision and award shall be made and delivered within six months of the selection of the arbitrator. The arbitrator's decision shall set forth a reasoned basis for any award of damages or finding of liability. The arbitrator shall not have power to award damages in excess of actual compensatory damages and shall not multiply actual damages or award punitive damages, and each Party hereby irrevocably waives any claim to such damages.

21.3Each Party covenants and agrees that such Party will participate in the arbitration in good faith. This Section 21 applies equally to requests for temporary, preliminary or permanent injunctive relief, except that in the case of temporary or preliminary injunctive relief any Party may proceed in court without prior arbitration for the limited purpose of avoiding immediate and irreparable harm.

21.4Each Party: (a) hereby irrevocably submits to the jurisdiction of any United States District Court of competent jurisdiction for the purpose of enforcing the award or decision in any such proceeding; (b) hereby waives, and agrees not to assert, by way of motion, as a defense, or otherwise, in any such suit, action or proceeding, any claim that it is not subject personally to the jurisdiction of the above named courts, that its property is exempt or immune from attachment or execution (except as protected by applicable law), that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter hereof may not be enforced in or by such court; and (c) hereby waives and agrees not to seek any review by any court of any other jurisdiction which may be called upon to grant an enforcement of the judgment of any such court. Each Party hereby consents to service of process by registered mail at the address to which notices are to be given. Each Party

agrees that its, his or her submission to jurisdiction and its, his or her consent to service of process by mail is made for the express benefit of each other Party. Final judgment against any Party in any such action, suit or proceeding may be enforced in other jurisdictions by suit, action or proceeding on the judgment, or in any other manner provided by or pursuant to the laws of such other jurisdiction.

22. Counterparts. This Agreement may be signed in one or more counterparts.

[Signature Page Follows]

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.

COMPANY:
Ampio Pharmaceuticals, Inc.
By:	/s/ Michael A. Martino
Name:	Michael A. Martino
Title:	Chairman & CEO
PRINCIPAL INVESTIGATOR:
Dr. David Bar-Or
By:
Residence:	900 East Oxford Lane
	Englewood Colorado 80113

EX-31.1

Exhibit 31.1

AMPIO PHARMACEUTICALS, INC.

Certification by Chief Executive Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Michael A. Martino, certify that:

1. I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2022 of Ampio Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 16, 2022		/s/ Michael A. Martino
	By:	Michael A. Martino
	Title:	`Chief Executive Officer
``

EX-31.2

Exhibit 31.2

AMPIO PHARMACEUTICALS, INC.

Certification by Chief Financial Officer

Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Daniel G. Stokely, certify that:

1. I have reviewed this quarterly report on Form 10-Q for the quarter ended March 31, 2022 of Ampio Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Ay
Date: May 16, 2022		/s/ Daniel G. Stokely
	By:	Daniel G. Stokely
	Title:	Chief Financial Officer

EX-32.1

Exhibit 32.1

AMPIO PHARMACEUTICALS, INC.

Certification Pursuant to 18 U.S.C. Section 1350, as Adopted

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the filing of the quarterly report on Form 10-Q for the quarter ended March 31, 2022 (the “Report”) by Ampio Pharmaceuticals, Inc. (the “Company”), each of the undersigned hereby certifies:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Ay 10
Dated: May 16, 2022	/s/ Michael A. Martino
	Michael A. Martino
	Chief Executive Officer
Dated: May 16, 2022	/s/ Daniel G. Stokely
	Daniel G. Stokely
	Chief Financial Officer

EX-99.1

Exhibit 99.1

Ampio Independent Committee to Conduct Investigation

Englewood, CO – May 16, 2022 – Ampio Pharmaceuticals, Inc. (NYSE American: AMPE) (“Ampio” or the “Company”) today announced that an independent special committee of the Ampio 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 that it does not consider data from AP-013 to be 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 three COVID-19 clinical trials, AP-017, AP-018, or AP-019.

The Ampio Board of Directors also has begun a process to consider 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).

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.

The Company does not intend to make further public comment on the Committee’s work during the pendency of the investigation. The Committee cannot predict the duration or outcome of the investigation.

About Ampio Pharmaceuticals, Inc.

Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies for the potential treatment of multiple inflammatory conditions (e.g., osteoarthritis of the knee (OAK) and other joints). Ampio's lead drug is Ampion™.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” or “estimate” or comparable terminology are intended to identify forward-looking statements. Forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements.

Such forward-looking statements include, for example, statements about: the expected scope of the internal investigation and the initiatives that may be pursued as part of a consideration of strategic alternatives. The risks and uncertainties that could cause actual results to differ materially from those expressed or implied in these forward-looking statements include the risk factors described in the Ampio’s Annual Report on Form 10-K for the year ended December 31, 2021, and other factors set forth in Ampio’s filings with the Securities and Exchange Commission, as well as (a) our cash resources available to continue our operations and implement one or more strategic alternatives, including our ability to raise capital through an equity or debt financing; (b) the expenses and costs we will incur in connection with the internal investigation, any related litigation and compliance with FDA and SEC requirements; and (c) the actual and perceived effectiveness of Ampion, and how Ampion compares to competitive products.

The forward-looking statements in this press release speak only as of the date of this press release. Except as required by law, Ampio assumes no obligation to update or revise these forward-looking statements for any reason, except as required by law.

Investor and Media Contacts: 

Tony Russo or Nic JohnsonRusso Partnersinfo@ampiopharma.comtony.russo@russopartnersllc.comnic.johnson@russopartnersllc.com

XML

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2022	May 06, 2022
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2022
Current Fiscal Year End Date	--12-31
Document Transition Report	false
Entity File Number	001-35182
Entity Registrant Name	AMPIO PHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-0179592
Entity Address, Address Line One	373 Inverness Parkway, Suite 200
Entity Address, City or Town	Englewood
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80112
City Area Code	720
Local Phone Number	437-6500
Title of 12(b) Security	Common stock, par value $0.0001 per share
Trading Symbol	AMPE
Security Exchange Name	NYSEAMER
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		227,186,867
Entity Central Index Key	0001411906
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
Amendment Flag	false

XML

Condensed Balance Sheets - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Current assets
Cash and cash equivalents	$ 28,837,000	$ 33,892,000
Prepaid expenses and other	1,070,000	1,740,000
Total current assets	29,907,000	35,632,000
Fixed assets, net	2,302,000	2,564,000
Right-of-use asset, net	577,000	629,000
Total assets	32,786,000	38,825,000
Current liabilities
Accounts payable and accrued expenses	5,208,000	4,811,000
Lease liability-current portion	318,000	311,000
Total current liabilities	5,526,000	5,122,000
Lease liability-long-term	533,000	614,000
Warrant derivative liability	4,474,000	5,805,000
Total liabilities	10,533,000	11,541,000
Commitments and contingencies (Note 5)
Stockholders' equity
Preferred Stock, par value $0.0001; 10,000,000 shares authorized; none issued
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	245,468,000	244,863,000
Accumulated deficit	(223,238,000)	(217,602,000)
Total stockholders' equity	22,253,000	27,284,000
Total liabilities and stockholders' equity	$ 32,786,000	$ 38,825,000

XML

Condensed Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
Condensed Balance Sheets
Preferred Stock, par value	$ 0.0001	$ 0.0001
Preferred Stock, shares authorized	10,000,000	10,000,000
Preferred Stock, shares issued	0	0
Common Stock, par value	$ 0.0001	$ 0.0001
Common Stock, shares authorized	300,000,000	300,000,000
Common Stock, shares issued	227,186,867	227,325,381
Common Stock, shares outstanding	227,186,867	227,325,381

XML

Condensed Statements of Operations - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Operating expenses
Research and development	$ 3,687,000	$ 2,296,000
General and administrative	3,283,000	1,523,000
Total operating expenses	6,970,000	3,819,000
Other income
Interest income	3,000	1,000
Derivative gain	1,331,000	151,000
Total other income	1,334,000	152,000
Net loss	$ (5,636,000)	$ (3,667,000)
Net loss per common share: Basic	$ (0.02)	$ (0.02)
Net loss per common share: Diluted	$ (0.03)	$ (0.02)
Weighted average number of common shares outstanding: Basic	226,083,328	195,387,047
Weighted average number of common shares outstanding: Diluted	226,110,693	200,752,267

XML

Condensed Statements of Stockholders' Equity - USD ($)	Common Stock At The Market Equity Offering Program	Common Stock	Additional Paid-in Capital At The Market Equity Offering Program	Additional Paid-in Capital	Accumulated Deficit At The Market Equity Offering Program	Accumulated Deficit	At The Market Equity Offering Program	Total
Beginning Balance at Dec. 31, 2020		$ 19,000		$ 218,020,000		$ (200,527,000)		$ 17,512,000
Beginning Balance, Shares at Dec. 31, 2020		193,378,996
Issuance of common stock for services		$ 0		80,000		0		80,000
Issuance of common stock for services (Shares)		54,052
Share-based compensation, net of forfeitures		$ 0		166,000		0		166,000
Stock options exercised, net		$ 0		33,000		0		33,000
Stock options exercised, net (Shares)		129,500
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards				(40,000)		0		(40,000)
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards (Shares)		(28,562)
Warrants exercised, net		$ 0		114,000		0		114,000
Warrants exercised, net (Shares)		306,705
Issuance of common stock in connection with the "at-the-market" equity offering program	$ 0		$ 2,705,000		$ 0		$ 2,705,000
Issuance of common stock in connection with the "at-the-market" equity offering program (Shares)	1,848,437
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)
Net loss		0		0		(3,667,000)		(3,667,000)
Ending Balance at Mar. 31, 2021		$ 19,000		220,952,000		(204,194,000)		16,777,000
Ending Balance, Shares at Mar. 31, 2021		(195,689,128)
Beginning Balance at Dec. 31, 2021		$ 23,000		244,863,000		(217,602,000)		27,284,000
Beginning Balance, Shares at Dec. 31, 2021		227,325,381
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		$ 0		(79,000)		0		(79,000)
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards (Shares)		(138,514)
Offering costs related to the issuance of common stock in connection with the public offering		$ 0		(32,000)		0		(32,000)
Net loss		0		0		(5,636,000)		(5,636,000)
Ending Balance at Mar. 31, 2022		$ 23,000		$ 245,468,000		$ (223,238,000)		$ 22,253,000
Ending Balance, Shares at Mar. 31, 2022		227,186,867

XML

Condensed Statements of Cash Flows - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cash flows used in operating activities
Net loss	$ (5,636,000)	$ (3,667,000)
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	262,000	294,000
Issuance of common stock for services	0	80,000
Derivative gain	(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	397,000	(199,000)
Decrease in lease liability	(22,000)	(19,000)
Net cash used in operating activities	(4,944,000)	(4,147,000)
Cash flows used in investing activities
Purchase of fixed assets	0	(81,000)
Net cash used in investing activities	0	(81,000)
Cash flows from financing activities
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	0	(126,000)
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	(5,055,000)	(1,542,000)
Cash and cash equivalents at beginning of period	33,892,000	17,346,000
Cash and cash equivalents at end of period	$ 28,837,000	$ 15,804,000

XML

The Company and Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2022

The Company and Summary of Significant Accounting Policies

The Company and Summary of Significant Accounting Policies

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 immunomodulatory therapies for 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, 2021 included in the Company’s 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 months ended March 31, 2022 is unaudited. The balance sheet at December 31, 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.

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 months ended 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, the clinical trial accrual, 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.

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 three months ended 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 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.

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Prepaid Expenses and Other

3 Months Ended

Mar. 31, 2022

Prepaid Expenses and Other

Prepaid Expenses and Other

Note 2 – Prepaid Expenses and Other

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

	March 31, 2022		December 31, 2021
Deposits	$	565,000	$	884,000
Unamortized commercial insurance premiums		212,000		465,000
Professional fees		87,000		235,000
Maintenance service contracts		63,000		—
Clinical trial inventory		—		72,000
Other receivable		19,000		16,000
Other		124,000		68,000
Total prepaid expenses and other	$	1,070,000	$	1,740,000

XML

Fixed Assets

3 Months Ended

Mar. 31, 2022

Fixed Assets

Fixed Assets

Note 3 – 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
	Useful Lives
	(in Years)	March 31, 2022		December 31, 2021
Leasehold improvements	10	$	6,075,000	$	6,075,000
Manufacturing facility/clean room	3 - 8		2,984,000		2,984,000
Lab equipment and office furniture	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		$	2,302,000	$	2,564,000

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

	Three Months Ended March 31,
	2022		2021
Depreciation and amortization expense	$	262,000	$	294,000

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Accounts Payable and Accrued Expenses

3 Months Ended

Mar. 31, 2022

Accounts Payable and Accrued Expenses

Accounts Payable and Accrued Expenses

Note 4 – Accounts Payable and Accrued Expenses

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

	March 31, 2022		December 31, 2021
Accounts payable	$	1,582,000	$	427,000
Clinical trials		2,919,000		2,995,000
Professional fees		302,000		510,000
Accrued compensation		292,000		389,000
Commercial insurance premium financing		—		269,000
Other		113,000		221,000
Accounts payable and accrued expenses	$	5,208,000	$	4,811,000

Commercial Insurance Premium Financing Agreement

In June 2021, the Company entered into an insurance premium financing agreement for $916,000, with a term of nine months and an annual interest rate of 3.57%. Under the terms and provisions of the agreement, the Company was required to make principal and interest payments totaling $82,000 per month over the remaining term of the agreement. The outstanding obligation for the Company’s annual insurance premiums were paid in full as of March 31, 2022.

XML

Commitments and Contingencies

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

Note 5 - Commitments and Contingencies

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 an initial retainer of $315,000, which was applied to study expenses as further defined by the contract during the first three months ended March 31, 2022. The Company entered into a change order to the initial contract in April 2022 totaling $0.7 million which reflects the estimated final costs to close out the study with expected completion in the next three to 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 1 study for at-home treatment utilizing inhaled Ampion to treat patients with Long-COVID, or prolonged respiratory symptoms due to COVID-19 (the “AP-018 study”). The contractual provisions required an initial retainer of $105,000 to be applied to future study expenses as further defined by the contract. Subsequent to March 2021, the Company agreed to a contractual amendment of $1.0 million. As of March 31, 2022, the contract is substantially complete and any future services to be performed are deemed to be minimal.

In June 2021, the Company entered into a contract with a CRO totaling $2.5 million in reference to a multicenter Phase 2 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 to be applied to study expenses as further defined by the contract. The contractual amount was later amended by $0.9 million. As such, the revised contractual commitment for the AP-019 study is $3.4 million as of 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 finalization of the study. The CRO will refund any unused portion of the retainer. As of March 31, 2022, the Company expects to spend $0.5 million related to future services expected to be performed under this contract and accordingly, does not expect any refund of any unused portion of 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 2 clinical trial utilizing IV Ampion in the treatment of patients with complications arising from 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 three employment agreements that expire in October 2024 and in November 2021, the Company entered into one 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 four 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.

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

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Warrants

3 Months Ended

Mar. 31, 2022

Warrants.

Warrants

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.

There was no warrant activity during the three months ended March 31, 2022:

		Weighted		Weighted Average
	Number of	Average		Remaining
	Warrants	Exercise Price		Contractual Life
Outstanding as of December 31, 2020	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	—	$	—
Warrants expired	—	$	—
Outstanding as of March 31, 2022	18,302,897	$	1.02	3.99

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

					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

The total value for the warrant derivative liability as of March 31, 2022 is approximately $4.5 million (see Note 7).

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Fair Value Considerations

3 Months Ended

Mar. 31, 2022

Fair Value Considerations

Fair Value Considerations

Note 7 - 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.

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.

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

	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
Balance as of December 31, 2021	$	5,805,000
Warrant issuances		—
Warrant exercises		—
Change in fair value		(1,331,000)
Balance as of March 31, 2022	$	4,474,000

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Common Stock

3 Months Ended

Mar. 31, 2022

Common Stock.

Common stock

Note 8 - Common Stock

Authorized Shares

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

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

	March 31, 2022
Authorized shares		300,000,000
Common stock outstanding		227,186,867
Options outstanding		9,010,312
Warrants outstanding		18,302,897
Reserved for issuance under 2019 Stock and Incentive Plan		2,984,023
Available shares		42,515,901

ATM Equity Offering Program

In February 2020, the Company entered into a Sales Agreement with two 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 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 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, 2022 and 2021:

		Three Months Ended March 31,
		2022		2021
Total shares of common stock sold		—		1,848,437
Gross proceeds	$	—	$	2,705,000
Commissions earned by placement agents		—		(109,000)
Issuance fees		—		(17,000)
Net proceeds	$	—	$	2,579,000

Common Stock Issued for Services

The Company issued an aggregate of 54,052 shares of common stock under the Ampio Pharmaceuticals, Inc. 2019 Stock and Incentive Plan (the “2019 Plan”), valued at an aggregate of $80,000 as partial compensation for the services of four non-employee directors, during the three months ended 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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Equity

3 Months Ended

Mar. 31, 2022

Equity

Equity

Note 9 - 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, 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 March 31, 2022:

	2019 Plan
Total shares reserved for equity awards		10,000,000
Options granted, net of forfeitures during previous fiscal years		(3,933,471)
Options granted during fiscal 2022		(1,598,323)
Restricted stock awards, net of settlement granted during fiscal 2021		(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		138,514
Remaining shares available for future equity awards		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

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

Outstanding Options by Plan	March 31, 2022
2010 Plan		3,561,518
2019 Plan		5,448,794
Outstanding as of March 31, 2022		9,010,312

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

	Number of	Weighted		Weighted Average
	Options	Average		Remaining
Range of Exercise Prices	Outstanding	Exercise Price		Contractual Lives
Up to $0.50	1,767,823	$	0.45	9.22
$0.51 - $1.00	4,697,345	$	0.69	6.81
$1.01 - $1.50	937,000	$	1.19	9.45
$1.51 and above	1,608,144	$	2.46	6.48
Total	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 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

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 months ended March 31, 2022 and 2021:

	Three Months Ended March 31,
	2022		2021
Research and development expenses
Share-based compensation	$	47,000	$	46,000
General and administrative expenses
Issuance of common stock for services (see Note 8)		—		80,000
Share-based compensation		669,000		120,000
Total share-based compensation	$	716,000	$	246,000
Unrecognized share-based compensation expense related to stock options as of March 31, 2022	$	996,000
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

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Earnings Per Share

3 Months Ended

Mar. 31, 2022

Earnings Per Share

Earnings Per Share

Note 10 - 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 months ended March 31, 2022 and 2021:

	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)

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 March 31,
	2022	2021
Warrants to purchase shares of common stock	18,275,532	2,939,996
Outstanding stock options	9,010,312	1,510,485
Restricted stock awards	1,101,000	—
Total potentially dilutive shares of common stock	28,386,844	4,450,481

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The Company and Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2022

The Company and Summary of Significant Accounting Policies

Basis of Presentation

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, 2021 included in the Company’s 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 months ended March 31, 2022 is unaudited. The balance sheet at December 31, 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.

Concentrations of Credit Risk

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 months ended March 31, 2022, and as consistent with prior reporting periods, the Company maintained balances in excess of federally insured limits.

Use of Estimates

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, the clinical trial accrual, 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.

Liquidity / Going Concern

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

Adoption of Recent Accounting Pronouncements

The Company has not adopted any recent accounting pronouncements during the three months ended 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 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.

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Prepaid Expenses and Other (Tables)

3 Months Ended

Mar. 31, 2022

Prepaid Expenses and Other

Schedule Of Prepaid Expenses and other balances

	March 31, 2022		December 31, 2021
Deposits	$	565,000	$	884,000
Unamortized commercial insurance premiums		212,000		465,000
Professional fees		87,000		235,000
Maintenance service contracts		63,000		—
Clinical trial inventory		—		72,000
Other receivable		19,000		16,000
Other		124,000		68,000
Total prepaid expenses and other	$	1,070,000	$	1,740,000

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Fixed Assets (Tables)

3 Months Ended

Mar. 31, 2022

Fixed Assets

Schedule of Fixed Assets

	Estimated
	Useful Lives
	(in Years)	March 31, 2022		December 31, 2021
Leasehold improvements	10	$	6,075,000	$	6,075,000
Manufacturing facility/clean room	3 - 8		2,984,000		2,984,000
Lab equipment and office furniture	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		$	2,302,000	$	2,564,000

Schedule Of Depreciation expense

	Three Months Ended March 31,
	2022		2021
Depreciation and amortization expense	$	262,000	$	294,000

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Accounts Payable and Accrued Expenses (Tables)

3 Months Ended

Mar. 31, 2022

Accounts Payable and Accrued Expenses

Schedule of accounts payable and accrued expenses

	March 31, 2022		December 31, 2021
Accounts payable	$	1,582,000	$	427,000
Clinical trials		2,919,000		2,995,000
Professional fees		302,000		510,000
Accrued compensation		292,000		389,000
Commercial insurance premium financing		—		269,000
Other		113,000		221,000
Accounts payable and accrued expenses	$	5,208,000	$	4,811,000

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Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2022

Commitments and Contingencies Disclosure [Abstract]

Summary of reconciliation of the Company's undiscounted payments for its facility lease and the carrying amount of the lease liability

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

Lease Expense

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

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Warrants (Tables)

3 Months Ended

Mar. 31, 2022

Warrants.

Summary of Company's warrant activity

There was no warrant activity during the three months ended March 31, 2022:

		Weighted		Weighted Average
	Number of	Average		Remaining
	Warrants	Exercise Price		Contractual Life
Outstanding as of December 31, 2020	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	—	$	—
Warrants expired	—	$	—
Outstanding as of March 31, 2022	18,302,897	$	1.02	3.99

Schedule of stockholders equity note warrants or rights classified as equity and liability

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

					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

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Fair Value Considerations (Tables)

3 Months Ended

Mar. 31, 2022

Fair Value Considerations

Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis

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

	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

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation

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
Balance as of December 31, 2021	$	5,805,000
Warrant issuances		—
Warrant exercises		—
Change in fair value		(1,331,000)
Balance as of March 31, 2022	$	4,474,000

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Common Stock (Tables)

3 Months Ended

Mar. 31, 2022

Common Stock.

Schedule of remaining authorized Shares

	March 31, 2022
Authorized shares		300,000,000
Common stock outstanding		227,186,867
Options outstanding		9,010,312
Warrants outstanding		18,302,897
Reserved for issuance under 2019 Stock and Incentive Plan		2,984,023
Available shares		42,515,901

Schedule of sale of stock under sales agreement

		Three Months Ended March 31,
		2022		2021
Total shares of common stock sold		—		1,848,437
Gross proceeds	$	—	$	2,705,000
Commissions earned by placement agents		—		(109,000)
Issuance fees		—		(17,000)
Net proceeds	$	—	$	2,579,000

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Equity (Tables)

3 Months Ended

Mar. 31, 2022

Schedule of restricted stock awards activity

		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

Schedule of Stock Options Outstanding and Exercisable

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

	Number of	Weighted		Weighted Average
	Options	Average		Remaining
Range of Exercise Prices	Outstanding	Exercise Price		Contractual Lives
Up to $0.50	1,767,823	$	0.45	9.22
$0.51 - $1.00	4,697,345	$	0.69	6.81
$1.01 - $1.50	937,000	$	1.19	9.45
$1.51 and above	1,608,144	$	2.46	6.48
Total	9,010,312	$	1.01	7.50

Schedule of Assumptions Used in Computing Fair Value of All Options Granted

	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

Schedule of Stock-Based Compensation Expense

	Three Months Ended March 31,
	2022		2021
Research and development expenses
Share-based compensation	$	47,000	$	46,000
General and administrative expenses
Issuance of common stock for services (see Note 8)		—		80,000
Share-based compensation		669,000		120,000
Total share-based compensation	$	716,000	$	246,000
Unrecognized share-based compensation expense related to stock options as of March 31, 2022	$	996,000
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

Employee Stock Option

Schedule of stock option activity

		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

Outstanding Options by Plan	March 31, 2022
2010 Plan		3,561,518
2019 Plan		5,448,794
Outstanding as of March 31, 2022		9,010,312

2019 Stock plan

Schedule of stock option activity

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

	2019 Plan
Total shares reserved for equity awards		10,000,000
Options granted, net of forfeitures during previous fiscal years		(3,933,471)
Options granted during fiscal 2022		(1,598,323)
Restricted stock awards, net of settlement granted during fiscal 2021		(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		138,514
Remaining shares available for future equity awards		2,984,023

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Earnings Per Share (Tables)

3 Months Ended

Mar. 31, 2022

Earnings Per Share

Schedule for the calculations of basic and diluted earnings per share

	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)

Schedule of potentially dilutive securities, excluded

	Three Months Ended March 31,
	2022	2021
Warrants to purchase shares of common stock	18,275,532	2,939,996
Outstanding stock options	9,010,312	1,510,485
Restricted stock awards	1,101,000	—
Total potentially dilutive shares of common stock	28,386,844	4,450,481

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Summary of Significant Accounting Policies - Liquidity and Going Concern (Detail) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
The Company and Summary of Significant Accounting Policies
Accumulated deficit	$ 223,238,000	$ 217,602,000
Cash and cash equivalents	$ 28,837,000	$ 33,892,000

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Prepaid Expenses and Other (Detail) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Prepaid Expenses and Other
Deposits	$ 565,000	$ 884,000
Unamortized commercial insurance premiums	212,000	465,000
Professional fees	87,000	235,000
Maintenance service contracts	63,000
Clinical trial inventory		72,000
Other receivable	19,000	16,000
Other	124,000	68,000
Total prepaid expenses and other	$ 1,070,000	$ 1,740,000

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Fixed Assets (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 10,798,000	$ 10,798,000
Accumulated depreciation	(8,496,000)	(8,234,000)
Fixed assets, net	$ 2,302,000	2,564,000
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years	10 years
Fixed assets, gross	$ 6,075,000	6,075,000
Manufacturing facility/clean room [Member]
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 2,984,000	2,984,000
Manufacturing facility/clean room [Member] | Minimum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years	3 years
Manufacturing facility/clean room [Member] | Maximum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years	8 years
Lab equipment and office furniture
Property, Plant and Equipment [Line Items]
Fixed assets, gross	$ 1,739,000	$ 1,739,000
Lab equipment and office furniture | Minimum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years	5 years
Lab equipment and office furniture | Maximum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years	8 years

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Fixed Assets - Depreciation Expenses (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Fixed Assets
Depreciation and amortization expense	$ 262,000	$ 294,000

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Accounts Payable and Accrued Expenses (Detail) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Accounts Payable and Accrued Expenses
Accounts payable	$ 1,582,000	$ 427,000
Clinical trials	2,919,000	2,995,000
Professional fees	302,000	510,000
Accrued compensation	292,000	389,000
Commercial insurance premium financing		269,000
Other	113,000	221,000
Accounts payable and accrued expenses	$ 5,208,000	$ 4,811,000

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Accounts Payable and Accrued Expenses - Commercial Insurance Premium Financing Agreement (Detail) - Commercial Insurance Premium Financing Agreement	1 Months Ended
	Jun. 30, 2021 USD ($)
Debt Instrument [Line Items]
Financing agreement amount	$ 916,000
Term of agreement (in years)	9 months
Interest rate (as a percentage)	3.57%
Principal and interest payments per month	$ 82,000

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Commitments and Contingencies - Additional Information (Detail)	1 Months Ended			3 Months Ended
	Apr. 30, 2022 USD ($)	Feb. 28, 2022 USD ($) installment	Dec. 31, 2013 USD ($)	Mar. 31, 2022 USD ($) item	Jun. 30, 2021 USD ($)	Mar. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Commitments and Contingencies [Line Items]
Contract amount	$ 700,000
Facility Lease Incremental Borrowing Rate				5.75%
Minimum
Commitments and Contingencies [Line Items]
Expected completion period for contracts	3 months
Maximum
Commitments and Contingencies [Line Items]
Expected completion period for contracts	5 months
Newly Leased Office Space and Manufacturing Facility
Commitments and Contingencies [Line Items]
Non-cancellable operating lease period			125 months
Lease initial base rent per month			$ 23,000
Rent expense			$ 3,300,000
New CRO
Commitments and Contingencies [Line Items]
Contract amount							$ 1,400,000
Contractual deposit Commitment				$ 315,000
Intravenous treatment for COVID 19 patients
Commitments and Contingencies [Line Items]
Contract amount							1,800,000
Contractual deposit Commitment							$ 345,000
Contractual amendment				$ 500,000
Number of subjects under interim enrollment | item				3
Number of subjects enrolled | item				5
Contractual obligation				$ 324,000
Revised contract amount				1,300,000
Regional Hospital Group, AP-018 Study
Commitments and Contingencies [Line Items]
Contract amount						$ 318,000
Contractual deposit Commitment						$ 105,000
Contractual amendment				1,000,000.0
Regional Hospital Group, AP-019 Study
Commitments and Contingencies [Line Items]
Contract amount					$ 2,500,000
Contractual deposit Commitment					$ 300,000
Contractual amendment				900,000
Contractual obligation				500,000
Revised contract amount				$ 3,400,000
Sponsored Research Agreement with Trauma Research, LLC
Commitments and Contingencies [Line Items]
Contract amount		$ 400,000
Contractual obligation		358,000
Research Agreement with Director to Provide Research Services
Commitments and Contingencies [Line Items]
Contract amount		$ 250,000
Number of Installments | installment		4
Term of agreement		1 year
Contractual obligation		$ 208,000

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Commitments and Contingencies - Employment Agreements (Detail)	3 Months Ended
	Mar. 31, 2022 USD ($) agreement
Agreement Expire in October 2024
Related Party Transaction [Line Items]
Number of employment agreement expires | agreement	3
Agreement Expire in November 2022
Related Party Transaction [Line Items]
Number of employment agreement expires | agreement	1
Minimum
Related Party Transaction [Line Items]
Annual Salary | $	$ 335,000
Maximum
Related Party Transaction [Line Items]
Annual Salary | $	$ 550,000

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Commitments and Contingencies - Summary of Reconciliation of Company's Undiscounted Payments for Facility Lease and Carrying Amount of Lease Liability (Detail) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Lessee, Operating Lease, Liability, Payment, Due [Abstract]
Remainder of 2021	$ 268,000
2022	364,000
2023	280,000
Remaining Facility Lease Payments	912,000
Less: Discount Adjustment	(61,000)
Total lease liability	851,000
Lease liability - current portion	318,000	$ 311,000
Long-term lease liability	$ 533,000	$ 614,000

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Commitments and Contingencies - Lease Expense (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Balance as of December 31, 2021	$ 629,000
Amortization	(52,000)
Balance as of March 31, 2022	577,000
Lease expense	$ 81,000	$ 73,000

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Warrants - Warrants Activity (Detail) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Number of Warrants Outstanding
Class of Warrant or Right, Outstanding	18,302,897	18,302,897	4,130,724
Number of Warrants Outstanding, Beginning Balance	18,302,897	4,130,724
Number of Warrants, Warrants issued		15,000,000
Number of Warrants, Warrants exercised		(812,827)
Number of Warrants, Warrants expired		(15,000)
Number of Warrants Outstanding, Ending Balance	18,302,897	18,302,897	4,130,724
Warrants, Weighted Average Exercise Price
Weighted Average Exercise Price, Outstanding Beginning Balance	$ 1.02	$ 0.66
Weighted Average Exercise Price, Warrants issued		1.10
Weighted Average Exercise Price, Warrants exercised		0.58
Weighted Average Exercise Price, Outstanding Ending Balance	$ 1.02	$ 1.02	$ 0.66
Weighted Average Remaining Contractual Life
Weighted Average Remaining Contractual Life, Warrants Outstanding	3 years 11 months 26 days	4 years 2 months 26 days	2 years 18 days
Weighted Average Remaining Contractual Life, Warrants Issued		4 years 11 months 15 days
Equity based-warrants
Number of Warrants Outstanding
Class of Warrant or Right, Outstanding	1,100,000
Number of Warrants Outstanding, Ending Balance	1,100,000
Liability warrants
Number of Warrants Outstanding
Class of Warrant or Right, Outstanding	17,200,000
Number of Warrants Outstanding, Ending Balance	17,200,000

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Warrants - Warrants Activity Classified as Equity and Liability (Detail) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance	18,302,897	18,302,897	4,130,724
Exercise price	$ 1.02	$ 1.02	$ 0.66
Weighted Average Remaining Contractual Life, Warrants Outstanding	3 years 11 months 26 days	4 years 2 months 26 days	2 years 18 days
Investor warrants $1.10
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance	15,000,000
Exercise price	$ 1.10
Weighted Average Remaining Contractual Life, Warrants Outstanding	4 years 8 months 15 days
Investor warrants at $0.40
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance	153,400
Exercise price	$ 0.40
Weighted Average Remaining Contractual Life, Warrants Outstanding	1 year 4 months 13 days
Investor warrants at $0.76
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance	2,026,915
Exercise price	$ 0.76
Weighted Average Remaining Contractual Life, Warrants Outstanding	2 months 1 day
Placement agent warrants at $0.50
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance	823,650
Exercise price	$ 0.50
Weighted Average Remaining Contractual Life, Warrants Outstanding	2 years 2 months 19 days
Placement agent warrants at $0.76
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance	298,932
Exercise price	$ 0.76
Weighted Average Remaining Contractual Life, Warrants Outstanding	2 months 1 day

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Warrants - Narrative (Detail) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Warrants.
Warrant derivative liability	$ 4,474,000	$ 5,805,000

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Fair Value Considerations - Financial Assets and Liabilities (Detail) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
LIABILITIES
Warrant derivative liability	$ 4,474,000	$ 5,805,000
Fair Value, Inputs, Level 3 [Member]
LIABILITIES
Warrant derivative liability	$ 4,474,000	$ 5,805,000

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Fair Value Considerations - Sets Forth a Reconciliation of Changes (Detail)	3 Months Ended
	Mar. 31, 2022 USD ($)
Fair Value, Assets and Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Abstract]
Balance as of December 31, 2021	$ 5,805,000
Change in fair value	(1,331,000)
Balance as of March 31, 2022	$ 4,474,000

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Common Stock - Summarizes the Company's remaining authorized shares available (Detail) - shares	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Common Stock.
Authorized shares	300,000,000	300,000,000
Common stock outstanding	227,186,867	227,325,381
Options Outstanding	9,010,312
Warrants Outstanding	18,302,897	18,302,897	4,130,724
Reserved for issuance under 2019 Stock and Incentive Plan	2,984,023
Available Shares	42,515,901

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Common Stock - Sales Agreement (Detail)	1 Months Ended	3 Months Ended
	Feb. 29, 2020 USD ($) item	Mar. 31, 2021 USD ($) shares
Class of Stock [Line Items]
Total shares of common stock sold | shares		1,848,437
Gross Proceeds		$ 2,705,000
Commissions earned by placement agents		(109,000)
Issuance fees		(17,000)
Net Proceeds		$ 2,579,000
Sale Agreement (ATM)
Class of Stock [Line Items]
Number of agents | item	2
Maximum aggregate offering price of equity securities	$ 50,000,000.0
Percentage of commission	4.00%
Sales Agreement Agent [Member] | Sale Agreement (ATM)
Class of Stock [Line Items]
Percentage of commission	2.00%

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Common Stock - Common Stock Issued for Services (Detail)	3 Months Ended
	Mar. 31, 2021 USD ($) shares
Components of common Stock [Line Items]
Issuance of common stock for services	$ 80,000
Common Stock Issued for Services | Non Employee Directors [Member]
Components of common Stock [Line Items]
Issuance of common stock for services (Shares) | shares	54,052
Issuance of common stock for services	$ 80,000

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Equity - Activity of Plan (Detail) - Employee Stock Option - shares	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted	(1,598,323)
Forfeited, expired and/or cancelled equity awards	95,000
2019 Stock plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total shares reserved for equity awards	10,000,000		10,000,000.0
Options granted	(1,598,323)	(3,933,471)
Restricted stock awards granted	0	(1,785,000)
Forfeited, expired and/or cancelled equity awards	26,500	5,500
Shares forfeited to settle exercise price and tax obligation	138,514	130,303
Remaining shares available for future equity awards	2,984,023

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Equity - Restricted Stock Awards (Details) - Restricted stock	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Awards
Unvested as of December 31, 2021	1,468,000
Vested (Shares)	(367,000)
Unvested at March 31, 2022	1,101,000
Average Grant-Date Fair Value
Unvested at December 31, 2021 (Dollars per share) | $ / shares	$ 1,640
Vested (Dollars per share) | $ / shares	1,640
Unvested at March 31, 2022 (Dollars per share) | $ / shares	$ 1,640
Number Of Common Shares Which Represented The Fair Value Of The Tax Settlement	138,514

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Equity - Stock Option Activity (Detail) - USD ($)	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Number of Options
Number of Options, Ending Balance	9,010,312
Employee Stock Option
Number of Options
Number of Options, Beginning Balance	7,506,989
Number of Options, Granted	1,598,323
Number of Options, Forfeited, expired and/or cancelled	(95,000)
Number of Options, Ending Balance	9,010,312	7,506,989
Number of Options, Exercisable	6,624,442
Weighted Average Exercise Price
Weighted Average Exercise Price, Beginning Balance	$ 1.04
Weighted Average Exercise Price, Granted	0.48
Weighted Average Exercise Price, Forfeited, expired and/or cancelled	0.89
Weighted Average Exercise Price, Ending Balance	1.01	$ 1.04
Weighted Average Exercise Price, Exercisable	$ 1.12
Weighted Average Remaining Contractual Life, Outstanding	7 years 6 months	7 years 4 months 9 days
Weighted Average Remaining Contractual Life, Exercisable	6 years 8 months 8 days
Aggregate Intrinsic Value, Outstanding	$ 36,000
Aggregate Intrinsic Value, Exercisable	$ 17,000
2010 Stock Plan
Number of Options
Number of Options, Ending Balance	3,561,518
2019 Stock plan
Number of Options
Number of Options, Ending Balance	5,448,794
2019 Stock plan | Employee Stock Option
Number of Options
Number of Options, Granted	1,598,323	3,933,471
Number of Options, Forfeited, expired and/or cancelled	(26,500)	(5,500)
Number of Options, Available for grant	2,984,023

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Equity - Summary of Stock Options Outstanding and Exercisable (Detail) - Employee Stock Option	3 Months Ended
	Mar. 31, 2022 $ / shares shares
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares	9,010,312
Weighted Average Exercise Price	$ 1.01
Weighted Average Remaining Contractual Lives	7 years 6 months
Up to $0.50
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares	1,767,823
Weighted Average Exercise Price	$ 0.45
Weighted Average Remaining Contractual Lives	9 years 2 months 19 days
Range of Exercise Prices Upper	$ 0.50
$0.51 - $1.00
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares	4,697,345
Weighted Average Exercise Price	$ 0.69
Weighted Average Remaining Contractual Lives	6 years 9 months 21 days
Range of Exercise Prices Lower	$ 0.51
Range of Exercise Prices Upper	$ 1.00
$1.01 - $1.50
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares	937,000
Weighted Average Exercise Price	$ 1.19
Weighted Average Remaining Contractual Lives	9 years 5 months 12 days
Range of Exercise Prices Lower	$ 1.01
Range of Exercise Prices Upper	$ 1.50
$1.51 and above
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares	1,608,144
Weighted Average Exercise Price	$ 2.46
Weighted Average Remaining Contractual Lives	6 years 5 months 23 days
Range of Exercise Prices Lower	$ 1.51

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Equity - Assumptions Used in Computing Fair Value of All Options Granted (Detail)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility, Minimum	117.00%
Expected volatility, Maximum	119.00%
Risk free interest rate, Minimum	1.26%
Risk free interest rate, Maximum	1.94%
Expected volatility		127.17%
Risk free interest rate		0.78%
Expected term (years)		5 years
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (years)	5 years 5 months 12 days
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term (years)	6 years 6 months 3 days

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Equity - Summary of Stock-Based Compensation Expense (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses	$ 716,000	$ 246,000
Unrecognized share-based compensation expense related to stock options as of March 31, 2022	$ 996,000
Weighted average remaining years to vest for stock options	2 years 14 days
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 years 9 months 3 days
Research and Development Expenses | Stock Based Compensation
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses	$ 47,000	46,000
General and Administrative Expenses | Common Stock Issued for Services
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses	0	80,000
General and Administrative Expenses | Stock Based Compensation
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses	$ 669,000	$ 120,000

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Earnings Per Share (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Earnings Per Share
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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Earnings Per Share - Anti-dilutive (Detail) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock	28,386,844	4,450,481
Warrant
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock	18,275,532	2,939,996
Employee Stock Option
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock	9,010,312	1,510,485
Restricted stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock	1,101,000