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Ampio Pharmaceuticals(AMPE) - 2022 Q2 - Quarterly Report

Cautionary Note Regarding Forward-Looking Statements This section warns that forward-looking statements involve known and unknown risks and uncertainties that could materially alter actual results - Forward-looking statements necessarily involve known and unknown risks and uncertainties which may cause actual performance, financial results, or other business outcomes to differ materially67 - Key areas of forward-looking statements include projected operating/financial results, expectations regarding clinical trial costs, beliefs about liquidity position, strategic alternatives process, and ability to identify strategic partners8 - Risks include time/expense of internal investigation, ability to regain NYSE American listing compliance, funding operations, substantial doubt about going concern, potential for strategic alternatives to fail or incur unexpected costs, and ability to retain key employees8 PART I – FINANCIAL INFORMATION This part presents Ampio Pharmaceuticals' unaudited financial statements, management's discussion, market risk disclosures, and controls for Q2 2022 Item 1. Financial Statements (unaudited) This section provides the unaudited condensed financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows Condensed Balance Sheets The condensed balance sheets show the Company's financial position, reflecting decreases in total assets, stockholders' equity, and total liabilities Condensed Balance Sheet Summary | Metric | June 30, 2022 | December 31, 2021 | | :----------------------------- | :-------------- | :---------------- | | Cash and cash equivalents | $22,890,000 | $33,892,000 | | Total current assets | $24,644,000 | $35,632,000 | | Total assets | $27,215,000 | $38,825,000 | | Total current liabilities | $5,082,000 | $5,122,000 | | Warrant derivative liability | $1,588,000 | $5,805,000 | | Total liabilities | $7,118,000 | $11,541,000 | | Total stockholders' equity | $20,097,000 | $27,284,000 | Condensed Statements of Operations The condensed statements of operations show continued net losses, with a decrease for the three months ended June 30, 2022 Condensed Statements of Operations Summary | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,743,000 | $2,273,000 | $5,430,000 | $4,568,000 | | General and administrative | $3,245,000 | $1,400,000 | $6,528,000 | $2,923,000 | | Total operating expenses | $4,988,000 | $3,673,000 | $11,958,000 | $7,491,000 | | Derivative gain | $2,886,000 | $116,000 | $4,217,000 | $267,000 | | Net loss | $(2,070,000) | $(3,556,000) | $(7,706,000) | $(7,222,000) | | Net loss per common share (Basic) | $(0.01) | $(0.02) | $(0.03) | $(0.04) | | Net loss per common share (Diluted) | $(0.02) | $(0.02) | $(0.05) | $(0.04) | Condensed Statements of Stockholders' Equity The condensed statements of stockholders' equity detail changes in common stock, paid-in capital, and accumulated deficit, reflecting net losses Stockholders' Equity Summary | Metric | Balance at Dec 31, 2021 | Balance at Jun 30, 2022 | | :------------------------------------ | :---------------------- | :---------------------- | | Common Stock (Shares) | 227,325,381 | 226,286,867 | | Common Stock (Amount) | $23,000 | $23,000 | | Additional Paid-in Capital | $244,863,000 | $245,382,000 | | Accumulated Deficit | $(217,602,000) | $(225,308,000) | | Total Stockholders' Equity | $27,284,000 | $20,097,000 | - Net loss for the six months ended June 30, 2022, was $(7,706,000), contributing to the accumulated deficit17 - Share-based compensation, net of forfeitures, added $716,000 to additional paid-in capital for the six months ended June 30, 202217 Condensed Statements of Cash Flows The condensed statements of cash flows show increased cash used in operating activities and a net cash outflow from financing activities Cash Flow Summary | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(10,891,000) | $(6,475,000) | | Net cash used in investing activities | $0 | $(81,000) | | Net cash (used in) provided by financing activities | $(111,000) | $9,759,000 | | Net change in cash and cash equivalents | $(11,002,000) | $3,203,000 | | Cash and cash equivalents at end of period | $22,890,000 | $20,549,000 | Notes to Condensed Financial Statements These notes provide detailed information supporting the condensed financial statements, covering accounting policies, balance sheet items, commitments, and subsequent events - Ampio Pharmaceuticals, Inc. is a pre-revenue biopharmaceutical company historically focused on immunomodulatory therapies for osteoarthritis pain23 - The Company's board is considering strategic alternatives, including potential acquisition of a product/pipeline or a reverse merger23 - Financial statements are unaudited and prepared in accordance with GAAP for interim information, requiring management estimates and assumptions2427 - The Company maintains cash and cash equivalents in bank demand deposits, U.S. federal government-backed treasury securities, and money market funds, with balances often exceeding federally insured limits26 Note 1 – The Company and Summary of Significant Accounting Policies This note describes Ampio Pharmaceuticals as a pre-revenue biopharmaceutical company exploring strategic alternatives, outlining financial statement basis and credit risk Liquidity / Going Concern The Company has an accumulated deficit of $225.3 million and expects continued losses, raising substantial doubt about its ability to continue as a going concern - Accumulated deficit reached $225.3 million as of June 30, 2022, with expectations of continued operating losses30 Cash and Cash Equivalents | Metric | June 30, 2022 | | :---------------------- | :-------------- | | Cash and cash equivalents | $22,900,000 | - The Company estimates sufficient liquidity to fund operations and strategic alternatives into the second half of 2023, based on current cash and expense projections32 - Substantial doubt exists about the Company's ability to continue as a going concern, and future financing may be difficult due to depressed stock price and NYSE American listing compliance issues3334 - The Company implemented a reduction in force on August 2, 2022, terminating 10 of 18 employees (approximately 55.5%) to conserve cash resources31 Recent Accounting Pronouncements The Company evaluated ASU 2020-06, simplifying convertible debt accounting, and plans to defer its implementation until December 15, 2023 - FASB issued ASU 2020-06 to simplify accounting for convertible debt instruments and diluted net income per share calculation3839 - The Company has evaluated ASU 2020-06 and decided to defer its implementation until its effective date for fiscal years beginning after December 15, 202339 Note 2 – Prepaid Expenses and Other This note details prepaid expenses and other current assets, showing a slight increase driven by unamortized commercial insurance premiums Prepaid Expenses and Other Summary | Item | June 30, 2022 | December 31, 2021 | | :------------------------------ | :-------------- | :---------------- | | Deposits | $365,000 | $884,000 | | Unamortized commercial insurance premiums | $1,124,000 | $465,000 | | Professional fees | $110,000 | $235,000 | | Maintenance service contracts | $43,000 | $0 | | Clinical trial inventory | $0 | $72,000 | | Other | $112,000 | $84,000 | | Total prepaid expenses and other | $1,754,000 | $1,740,000 | Note 3 – Fixed Assets This note breaks down fixed assets, net of accumulated depreciation, showing a decrease due to ongoing depreciation Fixed Assets Summary | Item | June 30, 2022 | December 31, 2021 | | :-------------------------- | :-------------- | :---------------- | | Fixed assets, gross | $10,798,000 | $10,798,000 | | Accumulated depreciation | $(8,752,000) | $(8,234,000) | | Fixed assets, net | $2,046,000 | $2,564,000 | Depreciation and Amortization Expense | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Depreciation and amortization expense | $256,000 | $274,000 | $518,000 | $568,000 | Note 4 – Accounts Payable and Accrued Expenses This note details accounts payable and accrued expenses, which remained stable, with decreased clinical trial accruals and increased insurance premium financing Accounts Payable and Accrued Expenses Summary | Item | June 30, 2022 | December 31, 2021 | | :-------------------------------- | :-------------- | :---------------- | | Accounts payable | $718,000 | $427,000 | | Clinical trials | $2,161,000 | $2,995,000 | | Professional fees | $1,028,000 | $510,000 | | Accrued compensation | $11,000 | $389,000 | | Commercial insurance premium financing | $757,000 | $269,000 | | Other | $82,000 | $221,000 | | Accounts payable and accrued expenses | $4,757,000 | $4,811,000 | - In June 2022, the Company entered into an insurance premium financing agreement for $1,159,000 at 3.975% annual interest, with an outstanding obligation of $757,000 as of June 30, 202244 Note 5 - Commitments and Contingencies This note outlines contractual commitments for clinical trials, employment agreements, related party research, and a facility lease, highlighting recent terminations - AP-013 OAK study: Estimated final costs to close out the study are $0.7 million, with an outstanding future contractual commitment of $0.3 million as of June 30, 202245 - AP-018 (inhaled COVID-19) and AP-017 (IV COVID-19) studies are substantially complete with minimal future obligations4648 - AP-019 (inhaled COVID-19) study enrollment was terminated on May 3, 2022, due to no documented beneficial effect, and is substantially complete with no future contractual commitment47 - The Company has employment agreements with its CFO (term ending Oct 2024, $335k salary) and CEO (term ending Nov 2022, $550k salary), including severance provisions49 - Related party research agreements with Trauma Research, LLC and Dr. David Bar-Or were terminated effective September 5, 2022, and November 4, 2022, respectively, with remaining obligations estimated at $21,000 and $62,00050 Facility Lease Payments | Lease Payment Category | Amount | | :--------------------- | :------- | | Remaining Facility Lease Payments | $823,000 | | Less: Discount Adjustment | $(50,000) | | Total lease liability | $773,000 | | Lease liability-current portion | $325,000 | | Long-term lease liability | $448,000 | Note 6 – Warrants This note details outstanding warrants, which decreased to 15,977,050 as of June 30, 2022, due to expirations, with a weighted average exercise price of $1.06 Warrants Summary | Metric | December 31, 2021 | June 30, 2022 | | :-------------------------------- | :---------------- | :-------------- | | Number of Warrants Outstanding | 18,302,897 | 15,977,050 | | Weighted Average Exercise Price | $1.02 | $1.06 | | Weighted Average Remaining Contractual Life (years) | 4.24 | 4.30 | - 2,325,847 warrants expired on June 1, 20225354 - As of June 30, 2022, 0.8 million warrants were equity-classified and 15.2 million were liability-classified53 Note 7 - Fair Value Considerations This note explains the Company's Level 3 warrant derivative liability, valued using the Black-Scholes model, which significantly decreased to $1.588 million - The Company's warrant derivative liability is measured at fair value using Level 3 unobservable inputs, primarily valued with the Black-Scholes warrant pricing model5759 Warrant Derivative Liability | Metric | December 31, 2021 | June 30, 2022 | | :----------------------- | :---------------- | :-------------- | | Warrant derivative liability | $5,805,000 | $1,588,000 | - The change in fair value of derivative instruments resulted in a gain of $(1,331,000) for Q1 2022 and $(2,886,000) for Q2 202260 Note 8 - Common Stock This note outlines the common stock structure, including authorized and outstanding shares, shares reserved for equity plans, and no ATM sales activity in H1 2022 Common Stock Structure | Item | June 30, 2022 | | :------------------------------------------ | :-------------- | | Authorized shares | 300,000,000 | | Common stock outstanding | 226,286,867 | | Options outstanding | 6,549,116 | | Warrants outstanding | 15,977,050 | | Reserved for issuance under 2019 Stock and Incentive Plan | 4,747,773 | | Available shares | 46,439,194 | - The ATM equity offering program had no sales of common stock during the three and six months ended June 30, 2022, compared to $7.267 million and $9.972 million in gross proceeds for the respective periods in 202165 - No common stock was issued for services to non-employee directors during the six months ended June 30, 2022, compared to 54,052 shares valued at $80,000 in 202166 Note 9 - Equity This note details equity compensation plans, summarizing stock option and restricted stock award activity, showing decreases in outstanding options and nonvested awards Equity Awards Summary (2019 Plan) | Metric | June 30, 2022 | | :------------------------------------------ | :-------------- | | Total shares reserved for equity awards (2019 Plan) | 10,000,000 | | Remaining shares available for future equity awards | 4,747,773 | Nonvested Restricted Stock Awards | Metric | December 31, 2021 | June 30, 2022 | | :-------------------------------- | :---------------- | :-------------- | | Nonvested Restricted Stock Awards | 1,468,000 | 201,000 | Stock Options Summary | Metric | December 31, 2021 | June 30, 2022 | | :-------------------------------- | :---------------- | :-------------- | | Outstanding Stock Options | 7,506,989 | 6,549,116 | | Exercisable Stock Options | N/A | 4,588,107 | - Share-based compensation expense for the six months ended June 30, 2022, was $630,000, with unrecognized expense of $667,000 for stock options and $201,728 for restricted stock awards71 Note 10 - Earnings Per Share This note details basic and diluted EPS calculations, showing net losses for both periods, with potentially dilutive shares excluded due to their anti-dilutive effect Earnings Per Share Summary | Metric | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | | :-------------------------------------- | :------------------------------- | :----------------------------- | | Net loss available to common stockholders | $(4,956,000) | $(11,923,000) | | Basic weighted-average common shares outstanding | 226,085,867 | 226,084,605 | | Diluted weighted-average shares outstanding | 226,085,867 | 226,084,605 | | Earnings per share – basic | $(0.01) | $(0.03) | | Earnings per share – diluted | $(0.02) | $(0.05) | Potentially Dilutive Shares | Potentially Dilutive Shares | June 30, 2022 (3 Months) | June 30, 2022 (6 Months) | | :-------------------------------------- | :----------------------- | :----------------------- | | Warrants to purchase common stock | 15,977,050 | 15,977,050 | | Outstanding stock options | 6,549,116 | 6,549,116 | | Restricted stock awards | 201,000 | 201,000 | | Total potentially dilutive shares | 22,727,166 | 22,727,166 | - All potentially dilutive shares were excluded from diluted net loss per share calculations due to their anti-dilutive effect7274 Note 11 – Subsequent Events This note discloses significant post-June 30, 2022 events, including a 55.5% employee reduction in force and termination of related party agreements - On August 2, 2022, the Company committed to a reduction in force, terminating 10 of 18 employees (55.5%) by August 31, 202275 - Expected charges related to the reduction in force include up to $425,000 for severance and termination benefits in Q3 2022, and up to $355,000 for retention and severance arrangements through Q4 202276 - The Company terminated personal services and research services agreements with Dr. David Bar-Or and Trauma Research LLC, effective September 5, 2022, and November 4, 2022, respectively77 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. This section provides management's perspective on the Company's financial condition and results, highlighting its pre-revenue stage, accumulated deficit, and strategic review Executive Summary Ampio Pharmaceuticals, Inc. is a pre-revenue biopharmaceutical company with a $225.3 million accumulated deficit, now exploring strategic alternatives for its lead product, Ampion - Ampio is a pre-revenue biopharmaceutical company with an accumulated deficit of $225.3 million as of June 30, 202279 - Ampion is the lead product candidate, studied for osteoarthritis of the knee (OAK) and COVID-19 inflammation81 - The Company conducted four clinical trials (AP-013, AP-017, AP-019, AP-018) for Ampion, all of which completed enrollment and were in various stages of completion as of June 30, 202281 - The board is considering strategic alternatives for Ampio and Ampion, including potential acquisition of a product/pipeline or a reverse merger82 Accounting Policies The financial statements adhere to GAAP, requiring management estimates, with no substantial changes to significant accounting policies since the 2021 Annual Report - Financial statements are prepared in accordance with GAAP, requiring management estimates and judgments83 - Significant accounting policies and estimates have not substantially changed from the 2021 Annual Report84 Results of Operations This section analyzes the Company's financial performance for the three and six months ended June 30, 2022, detailing changes in net loss, operating expenses, and derivative gains Results of Operations – June 30, 2022 Compared to June 30, 2021 Net loss decreased to $2.1 million for the three months ended June 30, 2022, due to a derivative gain, but increased to $7.7 million for the six-month period due to higher operating expenses Net Loss and Operating Expenses | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(2,070,000) | $(3,556,000) | $(7,706,000) | $(7,222,000) | | Total operating expenses | $4,988,000 | $3,673,000 | $11,958,000 | $7,491,000 | | Non-cash derivative gain | $2,886,000 | $116,000 | $4,217,000 | $267,000 | - The decrease in net loss for the three-month period was primarily due to a $2.9 million non-cash derivative gain, resulting from a significant decrease in stock price and warrant expirations88 - The increase in net loss for the six-month period was primarily due to a $4.5 million increase in operating expenses, partially offset by a $4.2 million non-cash derivative gain89 Operating Expenses This section analyzes the Company's research and development (R&D) and general and administrative (G&A) expenses for the three and six months ended June 30, 2022, versus 2021 Research and Development R&D costs decreased by 23% for the three months ended June 30, 2022, due to clinical trial conclusions, but increased by 19% for the six-month period due to higher professional fees Research and Development Expenses | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total research and development | $1,743,000 | $2,273,000 | $5,430,000 | $4,568,000 | | Clinical trial and sponsored research expenses | $162,000 | $808,000 | $2,087,000 | $1,575,000 | | Operations/manufacturing | $75,000 | $228,000 | $280,000 | $617,000 | | Professional fees | $314,000 | $72,000 | $508,000 | $107,000 | | Share-based compensation | $95,000 | $0 | $141,000 | $46,000 | - Clinical trial and sponsored research expenses decreased by $0.6 million (80%) for the three-month period due to the conclusion of all clinical trials in May 20229192 - Professional fees in R&D increased by $0.2 million (336%) for the three-month period due to engaging a Chief Medical Officer consultant and third-party biostatisticians for study close-out95 - Clinical trial and sponsored research expenses increased by $0.5 million (33%) for the six-month period, mainly due to AP-019 study costs, partially offset by AP-013 completion98 General and Administrative G&A costs significantly increased by 132% for the three months and 123% for the six months ended June 30, 2022, driven by higher professional fees and salaries General and Administrative Expenses | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total general and administrative | $3,245,000 | $1,400,000 | $6,528,000 | $2,923,000 | | Professional fees | $2,581,000 | $517,000 | $3,984,000 | $997,000 | | Salaries and benefits | $292,000 | $240,000 | $925,000 | $477,000 | | Share-based compensation | $(181,000) | $67,000 | $488,000 | $267,000 | - Professional fees in G&A increased by $2.1 million (399%) for the three-month period and $3.0 million (300%) for the six-month period, primarily due to legal costs for internal investigations and advisory services106110 - Share-based compensation in G&A decreased by $0.3 million (370%) for the three-month period due to forfeitures from employee terminations and board resignations108 - Salaries and benefits increased by $0.4 million (94%) for the six-month period due to higher headcount and market-based compensation adjustments111 Cash Flows Operating activities used significantly more cash in H1 2022 ($10.9 million) due to a non-cash derivative gain and working capital changes, with minimal investing and net financing outflow Cash Flow Summary | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :-------------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(10,891,000) | $(6,475,000) | | Net cash used in investing activities | $0 | $(81,000) | | Net cash (used in) provided by financing activities | $(111,000) | $9,759,000 | | Net change in cash and cash equivalents | $(11,002,000) | $3,203,000 | - Operating cash outflow increased due to a $4.2 million non-cash warrant derivative gain and a decrease in working capital in 2022114 - Financing activities in 2022 included settling a $79,000 tax liability for restricted stock awards and $32,000 in offering costs; in 2021, financing provided $10.0 million from ATM equity offering and $234,000 from warrant/option exercises117118 Liquidity and Capital Resources Ampio, a pre-revenue company with $22.9 million in cash, faces substantial doubt about its going concern ability despite estimated liquidity into H2 2023 and cost-saving measures - As of June 30, 2022, the Company had $22.9 million in cash and cash equivalents and has not generated revenue since inception119 - Management estimates sufficient liquidity to fund operations and strategic alternatives into the second half of 2023124 - Substantial doubt exists about the Company's ability to continue as a going concern, and future financing may be challenging due to depressed stock price and NYSE American listing compliance issues125126 - Cost-saving measures include a reduction in force (55.5% of employees terminated) and termination of related party agreements, driven by negative conclusions regarding Ampion's continued development122123 - If strategic transactions are unsuccessful or additional capital cannot be raised, the Company may pursue further cost reductions, liquidation, or dissolution128 Off Balance Sheet Arrangements The Company does not have any off-balance sheet arrangements, financings, or relationships with unconsolidated entities - The Company has no off-balance sheet arrangements, financings, or relationships with unconsolidated entities129 Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Ampio Pharmaceuticals, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk131 Item 4. Controls and Procedures The CEO and CFO concluded that disclosure controls were ineffective as of June 30, 2022, due to prior internal investigation issues, despite implemented but untested changes - The CEO and CFO concluded that disclosure controls and procedures were not effective as of June 30, 2022, due to matters identified in internal investigations133135 - Changes implemented to improve effectiveness include reconstituting the disclosure committee, separating CEO/Board Chair roles, personnel changes, and company-wide training, but these have not been fully tested134135 - No other material changes in internal control over financial reporting occurred during the period136 PART II – OTHER INFORMATION This part covers other required disclosures, including legal proceedings, risk factors, unregistered sales of equity securities, and exhibits Item 1. Legal Proceedings. This item states that there are no applicable legal proceedings to report - Not applicable138 Item 1A. Risk Factors. This item refers readers to the risk factors detailed in the Company's 2021 Annual Report on Form 10-K and other SEC filings - Readers should carefully consider the risk factors described in Part I, 'Item 1A. Risk Factors' in the 2021 Annual Report on Form 10-K and other SEC reports139 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. This item states that there are no applicable unregistered sales of equity securities or use of proceeds to report - Not applicable140 Item 3. Defaults Upon Senior Securities. This item indicates that there were no defaults upon senior securities - None142 Item 4. Mine Safety Disclosures. This item states that mine safety disclosures are not applicable to the Company - Not Applicable143 Item 5. Other Information. This item reiterates the termination of the Personal Services Agreement and Research Services Agreement with Dr. David Bar-Or and Trauma Research LLC - The Company terminated Personal Services Agreement with Dr. David Bar-Or (former director) and Research Services Agreement with Trauma Research LLC (owned by Dr. Bar-Or), effective September 5, 2022, and November 4, 2022, respectively144 Item 6. Exhibits. This item lists the exhibits filed or furnished with this Quarterly Report on Form 10-Q, including certificates of incorporation, bylaws, and certifications - The report includes various exhibits such as Certificate of Incorporation, Amended and Restated Bylaws, and certifications from CEO and CFO pursuant to Sarbanes-Oxley Act147 SIGNATURES This section contains the signatures of the Chief Executive Officer and Chief Financial Officer, certifying the report on behalf of Ampio Pharmaceuticals, Inc - The report is signed by Michael A. Martino, Chief Executive Officer, and Daniel G. Stokely, Chief Financial Officer, on August 9, 2022152