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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: June 30, 2023

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

Graphic

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.)

9800 Mount Pyramid Court, Suite 400

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

(Registrant’s telephone number, including area code): (720) 437-6500

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 August 7, 2023, there were 15,101,490 outstanding shares of common stock, par value $0.0001 per share, of the registrant.

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 other than statements of historical facts contained in this Quarterly Report, including statements regarding our anticipated future clinical developments, future financial position, and plans and objectives of management for future operations, are forward-looking statements. Words such as “may”, “will”, “should”, “forecast”, “could”, “expect”, “suggest”, “believe”, “estimate”, “continue”, “anticipate”, “intend”, “ongoing”, “opportunity”, “potential”, “predicts”, “seek”, “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology, typically identify forward-looking statements. Such forward-looking statements include, but are not limited to, statements relating to the following:

projected operating or financial results, including anticipated cash flows used in operations or the effect of any actions we may take to reduce expenses and preserve cash and cash equivalents;
potential outcomes of preclinical trials for OA.201, any future capital expenditures, research and development expenses and other payments relating to OA.201, and any capital raising activities to fund OA.201 research and development related expenses;
our strategic alternatives process, including any potential interested counterparty, transaction structure, timing and transaction expense associated with any strategic alternative and the potential success of any strategic alternative(s);
the expense, time and/or outcome of any legal proceeding; and
our ability to identify strategic partners for OA.201 or any other potential product and the execution of beneficial license, co-development, collaboration or similar arrangements.

We undertake no obligation to update or revise publicly any forward-looking statements to reflect events or circumstances after the date of such statements for any reason, except as otherwise required by law.

Forward-looking statements are based on certain assumptions and expectations of future events and trends that are subject to risks and uncertainties. Actual future results and trends may differ materially from historical results or those reflected in any such forward-looking statements depending on a variety of factors.

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 for the year ended December 31, 2022, other similar sections of our subsequent reports. Additionally, other sections of this Quarterly Report include additional factors that could adversely impact the business and financial performance expressed or implied in any forward-looking statements, including, but not limited to, “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” For additional information concerning factors that may cause actual results to vary materially from those stated in the forward-looking statements, see our reports on Forms 10-K, 10-Q and 8-K filed with the SEC from time to time.

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.

3

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

AMPIO PHARMACEUTICALS, INC.

Condensed Balance Sheets

(unaudited)

June 30, 

December 31, 

    

2023

    

2022

Assets

 

  

 

  

Current assets

 

  

 

  

Cash and cash equivalents

$

6,953,000

$

12,653,000

Insurance recovery receivable

1,380,000

Prepaid expenses and other

 

816,000

 

676,000

Total current assets

 

9,149,000

 

13,329,000

Fixed assets, net

 

 

184,000

Right-of-use asset, net

75,000

Total assets

$

9,149,000

$

13,588,000

Liabilities and Stockholders’ Equity

 

  

 

  

Current liabilities

 

  

 

  

Accounts payable and accrued expenses

$

2,141,000

$

852,000

Lease liability-current portion

 

354,000

 

340,000

Total current liabilities

 

2,495,000

 

1,192,000

Lease liability-long-term

 

94,000

 

274,000

Warrant derivative liability

 

 

44,000

Asset retirement obligation

289,000

Total liabilities

 

2,589,000

 

1,799,000

Commitments and contingencies (Note 5)

 

  

 

  

Mezzanine equity:

Preferred Stock, par value $0.0001; 10,000,000 shares authorized; shares issued and outstanding - 15,103 and none as of June 30, 2023 and December 31, 2022, respectively

 

 

Stockholders’ equity

 

  

 

  

Common Stock, par value $0.0001; 300,000,000 shares authorized; shares issued and outstanding - 15,102,877 as of June 30, 2023 and December 31, 2022

 

2,000

 

2,000

Additional paid-in capital

 

245,802,000

 

245,726,000

Accumulated deficit

 

(239,244,000)

 

(233,939,000)

Total stockholders’ equity

 

6,560,000

 

11,789,000

Total liabilities and stockholders’ equity

$

9,149,000

$

13,588,000

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

4

AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Operations

(unaudited)

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2023

    

2022

    

2023

    

2022

    

Operating expenses

 

  

 

  

 

  

 

  

 

Research and development

$

344,000

$

1,743,000

$

868,000

$

5,430,000

General and administrative

 

1,216,000

 

3,245,000

 

5,036,000

 

6,528,000

Loss on sale of fixed assets

56,000

Total operating expenses

 

1,560,000

 

4,988,000

 

5,960,000

 

11,958,000

Other income

 

  

 

  

 

  

 

  

Interest income

 

98,000

 

32,000

 

202,000

 

35,000

Rental income

91,000

121,000

Loss on derecognition of ARO asset

(6,000)

Gain on elimination of ARO obligation

294,000

Derivative gain

 

 

2,886,000

 

 

4,217,000

Total other income

 

189,000

 

2,918,000

 

611,000

 

4,252,000

Net loss

$

(1,371,000)

$

(2,070,000)

$

(5,349,000)

$

(7,706,000)

Net loss per common share:

 

  

 

  

 

  

 

  

Basic

$

(0.09)

$

(0.14)

$

(0.35)

$

(0.51)

Diluted

$

(0.09)

$

(0.33)

$

(0.35)

$

(0.79)

Weighted average number of common shares outstanding:

Basic

 

15,093,944

15,072,392

15,093,919

15,072,307

Diluted

15,093,944

15,072,392

15,093,919

15,072,307

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

5

AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Mezzanine Equity and Stockholders’ Equity

(unaudited)

Mezzanine Equity

Additional

Total

Series D Preferred

Common Stock

Paid-in

Accumulated

Stockholders'

    

Shares

    

Amount

Shares

    

Amount

    

Capital

Deficit

    

Equity

Balance at December 31, 2021

 

$

15,172,111

$

2,000

$

244,884,000

$

(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

(9,234)

(79,000)

(79,000)

Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program

(32,000)

(32,000)

Net loss

 

 

 

 

(5,636,000)

 

(5,636,000)

Balance at March 31, 2022

15,162,877

2,000

245,489,000

(223,238,000)

22,253,000

Share-based compensation, net of forfeitures

423,000

423,000

Restricted stock award forfeitures

(60,000)

(509,000)

(509,000)

Net loss

(2,070,000)

(2,070,000)

Balance at June 30, 2022

$

15,102,877

$

2,000

$

245,403,000

$

(225,308,000)

$

20,097,000

Balance at December 31, 2022

$

15,102,877

$

2,000

$

245,726,000

$

(233,939,000)

$

11,789,000

Reclassification of warrant derivative upon adoption of ASU 2020-06

44,000

44,000

Share-based compensation, net of forfeitures

23,000

23,000

Net loss

(3,978,000)

(3,978,000)

Balance at March 31, 2023

15,102,877

2,000

245,749,000

(237,873,000)

7,878,000

Share-based compensation, net of forfeitures

53,000

53,000

Issuance of Series D preferred stock dividend

15,103

Net loss

(1,371,000)

(1,371,000)

Balance at June 30, 2023

15,103

$

15,102,877

$

2,000

$

245,802,000

$

(239,244,000)

$

6,560,000

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

6

AMPIO PHARMACEUTICALS, INC.

Condensed Statements of Cash Flows

(unaudited)

    

Six Months Ended June 30, 

    

    

2023

    

2022

    

Cash flows used in operating activities

Net loss

$

(5,349,000)

$

(7,706,000)

Adjustments to reconcile net loss to net cash used in operating activities:

Share-based compensation, net of forfeitures

 

76,000

 

630,000

Depreciation and amortization

 

122,000

 

518,000

Loss on sale of fixed assets

56,000

Loss on derecognition of ARO asset

6,000

Gain on elimination of ARO obligation

(294,000)

Accretion of asset retirement obligation

5,000

Derivative gain

 

 

(4,217,000)

Changes in operating assets and liabilities:

Increase in insurance recovery receivable

(1,380,000)

Increase in prepaid expenses and other

 

(140,000)

 

(15,000)

(Decrease) increase in accounts payable and accrued expenses

 

1,289,000

 

(53,000)

Decrease in lease liability

 

(91,000)

 

(48,000)

Net cash used in operating activities

 

(5,700,000)

 

(10,891,000)

Net cash used in investing activities

 

 

Cash flows used in financing activities

Costs related to the sale of common stock and warrants in connection with the registered direct offering

(32,000)

Funding of tax obligation relative to shares withheld in connection with restricted stock awards

(79,000)

Net cash used in financing activities

 

 

(111,000)

Net change in cash and cash equivalents

 

(5,700,000)

 

(11,002,000)

Cash and cash equivalents at beginning of period

 

12,653,000

 

33,892,000

Cash and cash equivalents at end of period

$

6,953,000

$

22,890,000

Non-cash transactions:

Commercial insurance premium financing agreement

$

703,000

$

1,159,000

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

7

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 that until May 2022 was engaged with the development of Ampion and early development of AR-300, a synthetic version of Ampion and subsequently, a small molecule pre-clinical stage development asset which was designed to leverage the key attributes of Ampion, which was referred to previously as the OA-20X program and is now referred to as the OA.201 program. As part of the OA.201 program, we have been focusing our ongoing efforts toward optimizing two potential small molecule formulations to take forward into development. In the third quarter of 2023, we intend to select one of these optimized formulations to move towards clinical development. Given that these formulations are unique, proprietary, and are neither Ampion nor AR-300 (or derivatives thereof), we now refer to development of these new formulations as the OA.201 program.

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.

On November 9, 2022, the Company effected a 15-to-1 reverse stock split. The Company has retroactively applied the reverse stock split made effective on November 9, 2022 to share and per share amounts in the condensed financial statements for the three and six months ended June 30, 2023 and June 30, 2022. Additionally, pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately, with any fractional shares rounded up to the next whole share. The Company also retroactively applied such adjustments in the notes to the condensed financial statements for the three and six months ended June 30, 2023 and June 30, 2022. The reverse stock split did not reduce the number of authorized shares of common stock and preferred stock and did not alter the par value.

These financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”). The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The information as of and for the three and six months ended June 30, 2023 and June 30, 2022 is unaudited. The balance sheet at December 31, 2022 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. As of and subsequent to March 31, 2023, the Company no longer holds balances in excess of federally insured limits.

8

Use of Estimates

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

Significant items subject to such estimates and assumptions primarily include the Company’s projected current and long-term liquidity and insurance recovery receivable related to attorney’s fees for the Class Action Lawsuit and the Shareholder Derivative Actions to be covered and paid by our directors’ and officers’ insurance carrier, after satisfaction of our $2.5 million retention. 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 $239.2 million as of June 30, 2023. We expect to generate continued operating losses for the foreseeable future as we are pursuing the continued development and advancement of the OA.201 program and sourcing the requisite liquidity primarily through capital raising efforts.

As of June 30, 2023, we had $7.0 million of cash and cash equivalents and an insurance recovery receivable of $1.4 million, of which $1.0 million was received in early third-quarter 2023. Based on our current cash / liquidity position and current projection of operating expenses and capital expenditures, we believe we will have sufficient liquidity to fund operations into the first quarter of 2024. Our cash resources and our capital needs are based upon management estimates as to future operations and expense and the timing of collection of the insurance recovery receivable, which involve significant judgment. If we are able to successfully optimize a small molecule formulation to take forward into development, we intend to fund that future development of the OA.201 program through an offering of our equity securities. We may also seek to raise equity capital in order to attempt to cure potential non-compliance with the minimum stockholders’ equity requirement of the NYSE American in future reporting periods. 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 require a greater amount of capital than presently anticipated or may require capital more quickly than presently anticipated, or both.

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. 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

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

9

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 adopted ASU 2020-06 effective January 1, 2023. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial statements.

Recent Accounting Pronouncements

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

Note 2 – Current Assets, Excluding Cash and Cash Equivalents

The Company recorded an insurance recovery receivable of $1,380,000 on its balance sheet, as of June 30, 2023, owing from the Company’s insurance carrier to the Company with respect to amounts advanced by the Company in excess of the Company’s previously paid $2.5 million self-insured retention for defense costs relating to currently pending lawsuits and the SEC investigation that we expect to be covered and paid by our directors’ and officers’ insurance. As of June 30, 2023, we have previously paid and accrued to our financial statements covered expenses totaling $2.5 million, the full amount of the self-insured retention.

Prepaid expenses and other balances as of June 30, 2023 and December 31, 2022 are as follows:

    

    

June 30, 2023

December 31, 2022

Unamortized commercial insurance premiums

$

696,000

$

610,000

Deposits

34,000

34,000

Professional fees

48,000

19,000

Other

38,000

13,000

Total prepaid expenses and other

$

816,000

$

676,000

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. Effective March 1, 2023, the Company entered into a sublease of its existing facility and in connection with that sublease, entered into a bill of sale with the subtenant for all of the Company’s existing fixed assets (see Note 5).

Fixed assets, net of accumulated depreciation, consist of the following:

Estimated

Useful Lives

    

 (in Years)

    

June 30, 2023

December 31, 2022

Leasehold improvements

 

10

$

$

4,965,000

Manufacturing facility/clean room

 

3 - 8

 

 

2,803,000

Lab equipment and office furniture

 

5 - 8

 

 

1,661,000

Fixed assets, gross

9,429,000

Accumulated depreciation

(9,245,000)

Fixed assets, net

$

$

184,000

10

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

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2023

    

2022

    

2023

    

2022

    

Depreciation and amortization expense

$

$

256,000

$

122,000

$

518,000

Note 4 – Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses as of June 30, 2023 and December 31, 2022 are as follows:

    

June 30, 2023

December 31, 2022

    

Professional fees

$

596,000

$

157,000

Accounts payable

 

627,000

 

97,000

Preclinical and clinical trials

271,000

89,000

Commercial insurance premium financing

 

545,000

 

189,000

Accrued severance

1,000

143,000

Property taxes

74,000

Franchise taxes

9,000

78,000

Other

92,000

25,000

Accounts payable and accrued expenses

$

2,141,000

$

852,000

Commercial Insurance Premium Financing Agreement

In June 2023, the Company entered into an insurance premium financing agreement for $703,000, with a term of nine months, annual interest rate of 8.00% and made a down payment of $171,000. Under the terms and provisions of the agreement, the Company is required to make principal and interest payments totaling $59,000 per month over the remaining term of the agreement.

Note 5 - Commitments and Contingencies

Employment Agreements

As of June 30, 2023, the Company is a party to an employment agreement dated October 11, 2021 with Daniel Stokely to serve in the capacity as the Company’s Chief Financial Officer with an initial base salary of $335,000 and an initial term ending in October 2024.

As of June 30, 2023, the Company is a party to an employment agreement with Michael A. Martino, Chief Executive Officer, dated November 22, 2021 and amended August 30, 2022 with an initial base salary of $550,000. The amendment on August 30, 2022 extended the term to November 22, 2023. All other terms and conditions of Mr. Martino’s employment agreement remain unchanged. Under these employment agreements, each executive is entitled to a severance payment in the event the Company terminates employee’s employment without cause, or employee terminates his employment with good reason.

11

Related Party Research Agreements

On February 4, 2022, the Company entered into a sponsored research services agreement with Trauma Research, LLC, an entity owned by one of the Company’s former directors. The agreement totaled $400,000 for research activities to be performed over the next two years. In addition, the Company also entered into a personal services agreement dated February 4, 2022 with that individual to provide research services. The agreement payments totaled $250,000, which were to be paid in four equal installments payable quarterly over the one-year term. On August 5, 2022, the Company delivered notice of termination of the personal services agreement, effective September 5, 2022, and during September paid the remaining obligation of $21,000. On August 5, 2022, the Company delivered notice of termination of the research services agreement, effective November 4, 2022, and paid the remaining obligation of $63,000. There are no related party agreements in effect as of June 30, 2023.

Facility Lease

The Company is a party to a Lease Agreement (the “Lease”) with Beta Investors Group, LLC (successor by assignment to NCWP – Inverness Business Park, LLC) (the “Landlord”) dated December 13, 2013 pursuant to which the Company has leased office and manufacturing space in Suite 200 and Suite 204 in the building located at 373 Inverness Parkway, Englewood, Colorado (the “Premises”). The lease was a 125-month non-cancellable operating lease for office space and a manufacturing facility, set to expire September 2024 with the right to renew for an additional 60 months. 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.

Effective March 1, 2023, the Company entered into a sublease agreement whereby the Company subleased the Premises for a term commencing on March 1, 2023 and continuing until the expiration for the Lease on September 30, 2024. The subtenant will pay to the Company rent and other amounts assessed by the Landlord against the Company under the Lease. The subtenant is also responsible for utilities and insurance under the sublease agreement. Under the terms and conditions of the sublease agreement, the Company was fully released of its obligation under the Lease to dismantle and remove certain components of leasehold improvements at the end of the lease term. Accordingly, the Company derecognized its asset retirement obligation (“ARO”) in the amount of $294,000 which resulted in the recognition of a non-cash gain totaling $288,000 gain, net of $6,000 loss on the derecognition of the ARO asset.

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 June 30, 2023:

    

Facility Lease Payments

    

2023

    

2024

    

2025

    

2026

    

2027

    

Thereafter

Remaining Facility Lease Payments

$

464,000

$

184,000

$

280,000

$

$

$

$

Less: Discount Adjustment

 

(16,000)

Total lease liability

$

448,000

Lease liability-current portion

$

354,000

Long-term lease liability

$

94,000

The Right-of-Use (ROU) asset was fully amortized as of March 31, 2023 and remains fully amortized as of June 30, 2023.

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

Three Months Ended June 30, 

Six Months Ended June 30, 

    

2023

    

2022

    

2023

    

2022

    

Lease expense

$

14,000

$

70,000

$

101,000

$

151,000

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Note 6 – Warrants

The Company adopted ASU 2020-06 effective January 1, 2023 using the modified retrospective method, and accordingly reclassified its “investor” liability classified warrants to accumulated deficit. The Company’s “placement agent” warrants were previously classified as equity. The Company had a total of 1.1 million equity-classified warrants as of June 30, 2023.

    

    

Weighted

    

Weighted Average

Number of

Average

Remaining

Warrants

Exercise Price

Contractual Life

Outstanding as of December 31, 2022

1,065,137

$ 15.94

3.80

Outstanding as of June 30, 2023

 

1,065,137

$ 15.94

 

3.30

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

$ 16.50

Investor

1,000,000

3.46

August 2018 public offering

$ 6.00

Investor

10,227

0.12

June 2019 public offering

$ 7.50

Placement agent

54,910

0.97

Outstanding as of June 30, 2023

 

1,065,137

$ 15.94

 

3.30

There was no warrant derivative liability as of June 30, 2023. The total value for the warrant derivative liability as of December 31, 2022 was approximately $44,000 (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.

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.

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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.

As noted previously, the Company early adopted ASU 2020-06 resulting in the reclassification of the warrant derivative liability to stockholder’s equity, effective January 1, 2023.

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

    

Fair Value Measurements Using

    

Level 1

    

Level 2

    

Level 3

    

Total

December 31, 2022

 

  

 

  

 

  

 

  

Liabilities:

 

  

 

  

 

  

 

  

Warrant derivative liability

$

$

$

44,000

$

44,000

The warrant derivative liability for the December 31, 2022 period presented was valued using the Black-Scholes valuation methodology as we believe that model embodies all the relevant assumptions (including trading volatility, estimated terms and risk-free interest rates) that address the features underlying these instruments.

Due to the implementation of ASU 2020-06, effective January 1, 2023 the fair value of financial liabilities classified as Level 3 in the fair value hierarchy was reduced by $44,000. There were no financial liabilities classified as Level 1, 2 or 3 as of June 30, 2023.

Note 8 - Common Stock

Authorized Shares

The Company had 300.0 million authorized shares of common stock as of June 30, 2023 and December 31, 2022.

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

June 30, 2023

Authorized shares

300,000,000

Common stock outstanding

15,102,877

Options outstanding

254,388

Warrants outstanding

1,065,137

Reserved for issuance under 2019 Stock and Incentive Plan

484,372

Available shares for future issuance

283,093,226

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. 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 shelf registration

14

statement associated with the ATM equity offering program expired on May 6, 2023. Therefore, there was no activity under the Sales Agreement for the three months ended June 30, 2023.

Note 9 – Mezzanine Equity and Stockholders’ Equity

Preferred Stock

On May 24, 2023, the Board declared a dividend of one one-thousandth of a share (1/1000th) of Series D Preferred Stock, par value $0.0001 per share (“Series D Preferred Stock”), for each outstanding share of common stock of the Company, par value $0.0001 per shares (the “Common Stock”) to stockholders of record at 5:00 p.m. Eastern Time on June 8, 2023 (the “Record Date”). The Certificate of Designation of Series D Preferred Stock (the “Certificate of Designation”) was filed with the Delaware Secretary of State and became effective on May 25, 2023.

The dividend was based on the number of shares of common stock on June 8, 2023 and resulted in 15,103 Series D Preferred shares being issued. Each whole share of Series D Preferred Stock entitles the holder thereof to 1,000,000 votes per share, and each fraction of a share of Series D Preferred Stock has a ratable number of votes. Thus, each one-thousandth of a share of Series D Preferred Stock is entitled to 1,000 votes. The outstanding shares of Series D Preferred Stock are entitled to vote together with the outstanding shares of common stock as a single class exclusively with respect to any proposal to adopt an amendment to the Company’s Amended and Restated Certificate of Incorporation, as amended (the “Certificate of Incorporation”), to effect a reverse stock split of the outstanding shares of Common Stock at a ratio determined in accordance with the terms of such amendment (the “Reverse Stock Split”), and (ii) any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split (the “Adjournment Proposal”). The Reverse Stock Split and Adjournment Proposal were presented at the 2023 Annual Meeting of Stockholders held on Thursday, July 27, 2023.

All shares of Series D Preferred Stock that were not present in person or by proxy at the Annual Meeting of Stockholders as of immediately prior to the opening of the polls at such meeting (the “Initial Redemption Time”) were automatically redeemed in whole, but not in part, by the Company at the Initial Redemption Time without further action on the part of the Company or the holder of shares of Series D Preferred Stock (the “Initial Redemption”). The outstanding shares of Series D Preferred Stock that were not redeemed pursuant to an Initial Redemption were redeemed in whole, but not in part, automatically upon the approval by the Corporation’s stockholders of the Reverse Stock Split at the 2023 Annual Meeting of Stockholders held on Thursday, July 27, 2023. Accordingly, as of July 27, 2023, all outstanding shares of Series D Preferred Stock were redeemed.

Each share of Series D Preferred Stock was redeemed in consideration for the right to receive an amount equal to $0.01 in cash for each ten whole shares of Series D Preferred Stock that are “beneficially owned” by the “beneficial owner” (as such terms are defined in the Certificate of Designation thereof as of immediately prior to the applicable redemption time, payable upon receipt by the Company of a written request submitted by the applicable holder to the corporate secretary of the Company (each a “Redemption Payment Request”) following the applicable Redemption Time. From July 27, 2023 to the date hereof, there have been no Redemption Payment Requests.

The Series D Preferred Stock was not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Series D Preferred Stock had no stated maturity and it was not subject to any sinking fund. The Series D Preferred Stock was not subject to any restriction on the redemption or repurchase of shares by the Company while there is any arrearage in the payment of dividends or sinking fund installments.

The Company was not solely in control of the redemption of the shares of Series D Preferred Stock since the holders had the option of deciding whether to vote in respect of the Reverse Stock Split, which determines whether a given holder’s shares of Series D Preferred Stock are redeemed in the Initial Redemption or the Subsequent Redemption. Since the redemption of the Series D preferred Stock was not solely in the control of the Company, the shares of Series D Preferred Stock are classified within the mezzanine equity in the Company’s condensed consolidated balance sheet as of June 30, 2023. The shares of Series D Preferred Stock are measured at redemption value and is immaterial to the Company’s financial statements.

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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 (“RSAs”) and other equity related awards as further defined under the 2019 Plan. The 2019 Plan permits grants of equity awards to employees, directors and consultants. The stockholders approved a total of 666,667 shares to be reserved for issuance under the 2019 Plan. The Company’s previous 2010 Stock and Incentive Plan (the “2010 Plan”) was cancelled concurrently with the adoption of the 2019 Plan.

The following table summarizes the activity of the 2019 Plan and the shares available for future equity awards as of June 30, 2023:

    

2019 Plan

Total shares reserved for equity awards as of December 31, 2022

441,300

Forfeited, expired and/or cancelled equity option awards

13,737

Remaining shares available for future equity awards as of March 31, 2023

455,037

Forfeited, expired and/or cancelled equity option awards

29,335

Remaining shares available for future equity awards as of June 30, 2023

484,372

The following table summarizes the Company’s restricted stock awards activity during the three months ended June 30, 2023:

    

    

Weighted

    

Average Grant-Date

Aggregate

Awards

Fair Value

Intrinsic Value

Nonvested as of December 31, 2022

 

13,400

$

24.60

 

Vested

 

(4,467)

$

24.60

 

$

Nonvested as of March 31, 2023

8,933

$

24.60

Granted

Forfeited

Vested

Nonvested as of June 30, 2023

8,933

$

24.60

The following table summarizes the Company’s stock option activity:

    

    

Weighted

    

Weighted Average

    

Number of

Average

Remaining

Aggregate

Options

Exercise Price

Contractual Life

Intrinsic Value

Outstanding as of December 31, 2022

 

297,460

$

14.97

 

6.41

 

$

Forfeited, expired and/or cancelled

 

(13,737)

$

6.83

 

 

Outstanding as of March 31, 2023

283,723

$

15.36

6.58

$

Forfeited, expired and/or cancelled

(29,335)

$

9.61

Outstanding as of June 30, 2023

254,388

$

15.87

 

7.08

 

$

Exercisable as of June 30, 2023

 

234,684

$

15.94

6.96

 

$