Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 15, 2022 | Jun. 30, 2021 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
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 | ||
Entity Address, Address Line Two | 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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 329.7 | ||
Entity Common Stock, Shares Outstanding | 227,186,867 | ||
Auditor Name | Moss Adams LLP | ||
Auditor Location | Denver, Colorado | ||
Auditor Firm ID | 659 | ||
Entity Central Index Key | 0001411906 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 33,892,000 | $ 17,346,000 |
Prepaid expenses and other | 1,740,000 | 1,147,000 |
Total current assets | 35,632,000 | 18,493,000 |
Fixed assets, net | 2,564,000 | 3,561,000 |
Right-of-use asset, net | 629,000 | 824,000 |
Total assets | 38,825,000 | 22,878,000 |
Current liabilities | ||
Accounts payable and accrued expenses | 4,811,000 | 1,550,000 |
Lease liability-current portion | 311,000 | 284,000 |
Total current liabilities | 5,122,000 | 1,834,000 |
Lease liability-long-term | 614,000 | 925,000 |
Warrant derivative liability | 5,805,000 | 2,607,000 |
Total liabilities | 11,541,000 | 5,366,000 |
Commitments and contingencies (Note 8) | ||
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 - 227,325,381 as of December 31, 2021 and 193,378,996 as of December 31, 2020 | 23,000 | 19,000 |
Additional paid-in capital | 244,863,000 | 218,020,000 |
Accumulated deficit | (217,602,000) | (200,527,000) |
Total stockholders' equity | 27,284,000 | 17,512,000 |
Total liabilities and stockholders' equity | $ 38,825,000 | $ 22,878,000 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
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 | 227,325,381 | 193,378,996 |
Common Stock, shares outstanding | 227,325,381 | 193,378,996 |
Statements of Operations
Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expenses | ||
Research and development | $ 11,900,000 | $ 9,172,000 |
General and administrative | 8,671,000 | 6,662,000 |
Total operating expenses | 20,571,000 | 15,834,000 |
Other income (expense) | ||
Interest income | 4,000 | 12,000 |
Paycheck Protection Program loan forgiveness | 0 | 544,000 |
Derivative gain (loss) | 3,492,000 | (543,000) |
Loss on disposal of fixed asset | 0 | (73,000) |
Total other income (expense) | 3,496,000 | (60,000) |
Net loss | $ (17,075,000) | $ (15,894,000) |
Net loss per common share: Basic | $ (0.09) | $ (0.09) |
Net loss per common share: Diluted | $ (0.10) | $ (0.09) |
Weighted average number of common shares outstanding: Basic | 199,299,072 | 172,846,773 |
Weighted average number of common shares outstanding: Diluted | 204,963,019 | 172,846,773 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) | Common StockAt The Market Equity Offering Program | Common Stock | Additional Paid-in CapitalAt The Market Equity Offering Program | Additional Paid-in Capital | Accumulated DeficitAt The Market Equity Offering Program | Accumulated Deficit | At The Market Equity Offering Program | Total |
Beginning Balance at Dec. 31, 2019 | $ 16,000 | $ 191,060,000 | $ (184,633,000) | $ 6,443,000 | ||||
Beginning Balance, Shares at Dec. 31, 2019 | 158,644,757 | |||||||
Issuance of common stock for services | $ 0 | 80,000 | 0 | 80,000 | ||||
Issuance of common stock for services (Shares) | 136,236 | |||||||
Stock-based compensation, net of forfeitures | $ 0 | 1,277,000 | 0 | 1,277,000 | ||||
Stock options exercised, net | $ 0 | (2,000) | 0 | (2,000) | ||||
Stock options exercised, net (Shares) | 11,903 | |||||||
Warrants exercised, net | $ 0 | 785,000 | 0 | 785,000 | ||||
Warrants exercised, net (Shares) | 2,486,423 | |||||||
Issuance of common stock in connection with the "at-the-market" equity offering program | $ 3,000 | $ 26,188,000 | $ 0 | $ 26,191,000 | ||||
Issuance of common stock in connection with the "at-the-market" equity offering program (Shares) | 32,099,677 | |||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (1,368,000) | 0 | (1,368,000) | ||||
Net loss | 0 | 0 | (15,894,000) | (15,894,000) | ||||
Ending Balance at Dec. 31, 2020 | $ 19,000 | 218,020,000 | (200,527,000) | 17,512,000 | ||||
Ending 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 | |||||||
Stock-based compensation, net of forfeitures | $ 0 | 2,724,000 | 0 | 2,724,000 | ||||
Stock options exercised, net | $ 0 | 120,000 | 0 | 120,000 | ||||
Stock options exercised, net (Shares) | 386,604 | |||||||
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards | $ 0 | (186,000) | 0 | $ (186,000) | ||||
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards (Shares) | (113,577) | (113,577) | ||||||
Warrants exercised, net | $ 0 | 114,000 | 0 | $ 114,000 | ||||
Warrants exercised, net (Shares) | 588,221 | |||||||
Shares issued in connection with restricted stock awards | $ 0 | 0 | 0 | 0 | ||||
Shares issued in connection with restricted stock awards (Shares) | 1,785,000 | |||||||
Issuance of common stock in connection with the "at-the-market" equity offering program | $ 1,000 | $ 10,511,000 | $ 0 | $ 10,512,000 | ||||
Issuance of common stock in connection with the "at-the-market" equity offering program (Shares) | 6,246,085 | |||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (512,000) | 0 | (512,000) | ||||
Issuance of common stock and warrants in connection with the registered direct offering | $ 3,000 | 22,497,000 | 0 | 22,500,000 | ||||
Issuance of common stock and warrants in connection with the registered direct offering (Shares) | 25,000,000 | |||||||
Offering costs related to the issuance of common stock and warrants in connection with the registered direct offering | $ 0 | (1,816,000) | 0 | (1,816,000) | ||||
Fair value related to the issuance of warrants in connection with the registered direct offering | 0 | (6,689,000) | 0 | (6,689,000) | ||||
Net loss | 0 | 0 | (17,075,000) | (17,075,000) | ||||
Ending Balance at Dec. 31, 2021 | $ 23,000 | $ 244,863,000 | $ (217,602,000) | $ 27,284,000 | ||||
Ending Balance, Shares at Dec. 31, 2021 | 227,325,381 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows used in operating activities | ||
Net loss | $ (17,075,000) | $ (15,894,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation, net of forfeitures | 2,724,000 | 1,277,000 |
Depreciation and amortization | 1,094,000 | 1,177,000 |
Loss on disposal of fixed asset | 0 | 73,000 |
Paycheck Protection Program loan forgiveness | 0 | (544,000) |
Issuance of common stock for services | 80,000 | 80,000 |
Derivative (gain) loss | (3,492,000) | 543,000 |
Changes in operating assets and liabilities | ||
(Increase) decrease in prepaid expenses and other | (593,000) | 571,000 |
Increase (decrease) in accounts payable and accrued expenses | 3,262,000 | (2,475,000) |
Decrease in lease liability | (89,000) | (81,000) |
Proceeds received under the Paycheck Protection Program | 0 | 544,000 |
Net cash used in operating activities | (14,089,000) | (14,729,000) |
Cash flows used in investing activities | ||
Purchase of fixed assets | (97,000) | (63,000) |
Net cash used in investing activities | (97,000) | (63,000) |
Cash flows from financing activities | ||
Proceeds from sale of common stock in connection with the "at-the-market" equity offering program | 10,512,000 | 26,191,000 |
Costs related to sale of common stock in connection with the "at-the-market" equity offering program | (512,000) | (1,368,000) |
Proceeds from sale of common stock and warrants in connection with the registered direct offering | 22,500,000 | 0 |
Costs related to the sale of common stock and warrants in connection with the registered direct offering | (1,816,000) | 0 |
Proceeds from warrant and stock option exercises, net | 234,000 | 783,000 |
Shares held back in settlement of tax obligation for shares issued in connection with restricted stock awards | (186,000) | 0 |
Net cash provided by financing activities | 30,732,000 | 25,606,000 |
Net change in cash and cash equivalents | 16,546,000 | 10,814,000 |
Cash and cash equivalents at beginning of period | 17,346,000 | 6,532,000 |
Cash and cash equivalents at end of period | 33,892,000 | 17,346,000 |
Non-cash transactions: | ||
Commercial insurance premium financing agreement | $ 1,016,000 | $ 1,347,000 |
Basis of Presentation
Basis of Presentation | 12 Months Ended |
Dec. 31, 2021 | |
Basis of Presentation | |
Basis of Presentation | Note 1 – Basis of Presentation The accompanying financial statements have been prepared in conformity with U.S. Generally Accepted Accounting Principles (“GAAP”). Ampio Pharmaceuticals, Inc. (“Ampio” or “the Company”) is a pre-revenue stage biopharmaceutical company, located in Englewood, CO, that is focused on the development and advancement of immunomodulatory therapies for the treatment of pain from osteoarthritis. The Company’s core activities relate to research and development and raising capital. The Company has not generated operating revenue to date. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies Impact of Global Pandemic The AP-013 study was initiated in June 2019 and was ongoing when the COVID-19 pandemic began. The Secretary of Health and Human Services declared a public health emergency (“PHE”) on January 31, 2020 and the President declared a national emergency in response to COVID-19 on March 13, 2020. The AP-013 study was impacted by the COVID-19 pandemic, as was the case with many clinical studies being conducted at that time. The study was paused in April 2020 due to patient and site safety concerns about COVID-19, the inability of sites to complete the remaining 12-week efficacy and 24-week follow-up visits, or to support doing these by remote visits, and the resulting unanimous recommendation from the study’s safety monitoring committee given the influence of the COVID-19 pandemic on the conduct of the study. The U.S. Food and Drug Administration (“FDA”) acknowledged the impact of COVID-19 on clinical trials in the “ FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, In addition, since June 2020, the Company has commenced several clinical trials to determine the safety and efficacy for new applications of Ampion (i.e., inhaled and intravenous) related to inflammation resulting from COVID-19. Given the continued evolution of the COVID-19 pandemic and the related complexities and uncertainties associated with the additional variants, the Company’s business operations could be significantly impacted and, in addition, the supply chain provided by third parties on which the Company relies, including organizations that conduct clinical trials and key suppliers which provide the raw materials for manufacturing Ampion for the ongoing clinical trials, could also be impacted. The full extent of the potential adverse impact on the Company’s business operations and related current and future product development, including, but not limited to, pre-clinical research programs, clinical trials, financing activities and the overall impact on the United States and the global economy will depend on future developments related to the pandemic, which cannot be predicted at this time. 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 at the time. Cash and Cash Equivalents The Company considers instruments purchased with an original maturity of three months or less to be cash equivalents. The Company’s investment policy is to preserve principal and maintain liquidity. 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 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 years ended December 31, 2021 and 2020, the Company has maintained balances in excess of federally insured limits. Concentration of Supplier The Company currently contracts with a limited number of suppliers to obtain each of the key components/raw materials needed to produce Ampion for clinical trials, including Human Serum Albumin, the line sets and the vials/caps and stoppers. The Company believes there are other viable suppliers that could be substituted should the suppliers for the key components/raw materials become non-competitive. Fixed Assets Fixed assets are stated at cost less accumulated depreciation and amortization. Cost includes expenditures for equipment, leasehold improvements, replacements, and renewals and the related cost required to get certain equipment in operating condition. The Company charges routine and ongoing maintenance and repairs to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in operations. The cost of property and equipment is depreciated using the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the remaining life of the lease. Impairment of Long-Lived Assets The Company performs an annual evaluation of the recoverability of the carrying value of its long-lived assets to determine if facts and circumstances indicate that the carrying value of assets may be impaired and if any adjustment is warranted. Based on the Company’s evaluation as of December 31, 2021 and 2020, no impairment existed for long-lived assets. Fair Value of Financial Instruments The Company’s financial instruments include cash and cash equivalents, accounts payable and accrued expenses, and warrant derivative liability. The carrying amounts of cash and cash equivalents, accounts payable and accrued expenses are carried at cost, which approximates fair value due to the short maturity of these instruments. The warrant derivative liability is recorded at estimated fair value based on utilization of the Black-Scholes warrant pricing model depending on facts and circumstances. See Note 8 and Note 9 Share-Based Compensation The Company accounts for share-based payments by recognizing compensation expense based upon the estimated fair value of the share-based payments on the date of grant. The Company determines the estimated fair value of the share-based payments granted using the fair market value or Black-Scholes option pricing model and recognizes compensation costs ratably over the requisite service period which approximates the vesting period using the graded method. See Note 11 Income Taxes Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The overall change in deferred tax assets and liabilities for the period measures the deferred tax expense or benefit for the period. The measurement of deferred tax assets may be reduced by a valuation allowance based on judgmental assessment of available evidence if deemed more likely than not that some or all of the deferred tax assets will not be realized. The Company has recorded a valuation allowance against all of its deferred tax assets, as management has concluded that it is more likely than not that the net deferred tax asset will not be realized through projected future taxable income, based primarily on the Company’s ongoing history of operating losses and the lack of taxable income in the foreseeable future. See Note 12 Clinical Trial Accruals The Company is currently conducting four discrete clinical trials which are at various stages of completion. The clinical trial accrual covering each of the studies involve identifying services that third parties, contracted by the Company, have performed, and estimating the associated cost incurred for these services which remain un-invoiced as of the balance sheet date. In addition, the clinical trial accrual involves the measurement of milestone achievements achieved by the patients participating in the clinical trial and the associated costs which have not been invoiced as of the balance sheet date. The Company develops an estimate of liability using its judgment based upon the facts and circumstances known at the time. Research and Development Research and development costs are expensed as incurred in the respective periods. Liquidity In December 2021, the Company finalized a registered direct offering that generated gross proceeds of $22.5 million, offset by offering-related costs of $1.8 million (see Note 10 Furthermore, in February 2020, the Company entered into a Sales Agreement (“Sales Agreement”) with two agents to implement an “at-the-market” (“ATM”) equity offering program under which the Company, at its sole discretion and subject to certain exceptions, may issue and sell from time-to-time shares of its authorized common stock. During the year ended December 31, 2021, the Company sold shares pursuant to the ATM equity offering program, which yielded gross proceeds of $10.5 million, offset by offering-related costs of $0.5 million (see Note 10 The company recognized a net loss of $17.1 million, which is primarily attributable to operating expenses of $20.6 million, partially offset by the non-cash derivative gain of $3.5 million (see Note 9 Adoption of Recent Accounting Pronouncements The Company has not adopted any recent accounting pronouncements during the year ended December 31, 2021, as none were deemed to be applicable. Recent Accounting Pronouncements In August 2020, the Financial Accounting Standard Board (the “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 This Annual Report on Form 10-K 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. |
Prepaid Expenses and Other
Prepaid Expenses and Other | 12 Months Ended |
Dec. 31, 2021 | |
Prepaid Expenses and Other | |
Prepaid Expenses and Other | Note 3 – Prepaid Expenses and Other Prepaid expenses and other balances as of December 31, 2021 and 2020 are as follows: December 31, 2021 2020 Deposits $ 884,000 $ 266,000 Unamortized commercial insurance premiums 465,000 627,000 Professional fees 235,000 — Raw materials 72,000 — Receivable 16,000 185,000 Other 68,000 69,000 Total prepaid expenses and other $ 1,740,000 $ 1,147,000 |
Fixed Assets
Fixed Assets | 12 Months Ended |
Dec. 31, 2021 | |
Fixed Assets | |
Fixed Assets | Note 4 – Fixed Assets Fixed assets balances, net of accumulated depreciation, as of December 31, 2021 and 2020 are as follows: Estimated Useful Lives December 31, (in Years) 2021 2020 Leasehold improvements 10 $ 1,649,000 $ 2,250,000 Manufacturing facility/clean room 3 - 8 677,000 998,000 Lab equipment and office furniture 5 - 8 238,000 313,000 Fixed assets, net $ 2,564,000 $ 3,561,000 Depreciation expense as of December 31, 2021 and 2020 is as follows: Year Ended December 31, 2021 2020 Depreciation and amortization expense $ 1,094,000 $ 1,177,000 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | Note 5 – Accounts Payable and Accrued Expenses Accounts payable and accrued expenses as of December 31, 2021 and 2020 is as follows: December 31, 2021 2020 Accounts payable $ 427,000 $ 186,000 Clinical trials 2,995,000 558,000 Professional fees 510,000 267,000 Accrued compensation 389,000 — Commercial insurance premium financing 269,000 386,000 Other 221,000 153,000 Accounts payable and accrued expenses $ 4,811,000 $ 1,550,000 Commercial Insurance Premium Financing Agreement In June 2021, the Company entered into an insurance premium financing agreement for $0.9 million, with a term of nine months and an annual interest rate of 3.57% . Under the terms and provisions of the agreement, the Company will be required to make principal and interest payments totaling $82,000 per month over the remaining term of the agreement. The outstanding obligation as of December 31, 2021 was $245,000 , which will be paid in full by March 2022. In addition, as of December 31, 2021, the Company had a remaining balance of $24,000 related to annual insurance premiums payable to the Company’s insurance broker, which will be paid in full by March 2022. |
Paycheck Protection Program
Paycheck Protection Program | 12 Months Ended |
Dec. 31, 2021 | |
Paycheck Protection Program | |
Paycheck Protection Program | Note 6 – Paycheck Protection Program In April 2020, the Company received proceeds of $544,000 via a loan from KeyBank National Association (the “Lender”) that was issued under the Paycheck Protection Program (the “PPP”) established under the Coronavirus Aid, Relief and Economic Security Act. The term of the PPP loan was two years with an annual interest rate of 1.0% and principal and interest payments would be deferred for the first six months of the loan term, which was subsequently updated in accordance with the Paycheck Protection Program Flexibility Act of 2020. In October 2020, the Company submitted its PPP loan forgiveness application, requesting forgiveness of the full principal amount of its PPP loan. In May 2021, the Company received notification from the Lender that the Small Business Administration (the “SBA”) had authorized full forgiveness of the PPP loan. In July 2021, the Company received notification from the Lender that the SBA submitted, and the Lender has received, proceeds representing the full pay-off of the loan balance. As such, the Company’s loan balance of $544,000 is considered to be paid off in full. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 – Commitments and Contingencies Commitments and contingencies as of December 31, 2021 are described below and summarized in the following table: Total 2022 2023 2024 2025 2026 Thereafter Key clinical research trial obligations $ 4,444,000 $ 4,444,000 $ — $ — $ — $ — $ — Employment agreements 4,021,000 1,764,000 1,260,000 997,000 — — — $ 8,465,000 $ 6,208,000 $ 1,260,000 $ 997,000 $ — $ — $ — Key Clinical Research Trial Obligations Osteoarthritis of the Knee AP-013 study In December 2020, the Company entered into an initial contract with a clinical research organization (“CRO”) in reference to the AP-013 study totaling $1.4 million. The contractual provisions required a retainer of $315,000, which will be applied to study expenses as further defined by the contract. The CRO will refund any unused portion of the retainer. The initial contract was increased by $300,000 due to additional procedures performed at the request of the Company during the close-out phase of the study. The Company had an outstanding future contractual commitment of $120,000 (net of the $315,000 deposit) as of December 31, 2021. 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, which will be applied to future study expenses as further defined by the contract. Due to the unpredictable nature of the ongoing COVID-19 pandemic, and the Company’s difficulty to recruit and enroll patients impacted by Long-COVID in accordance with the terms and provisions of the study protocol, the Company needed to secure additional CRO resources and sites to complete the trial, which resulted in a contractual amendment of $1.0 million. As such, the revised contractual amount for the AP-018 study is $1.3 million. The CRO will refund any unused portion of the retainer. The Company had an outstanding future contractual commitment of $100,000 (net of the $105,000 deposit) as of December 31, 2021. 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, which has been, and will continue to be, applied to study expenses as further defined by the contract. Due to the unpredictable nature of the ongoing COVID-19 pandemic, and the Company’s difficulty with the enrollment of patients for the treatment of COVID-19 given the unplanned variability of the virus, vaccine rates and mutations in the virus in certain geographies, the contractual amount was amended by $1.9 million to account for additional study sites, investigator payments and enrollment delays. As such, the revised contractual commitment for the AP-019 study is $4.4 million. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. The Company had an outstanding future contractual commitment of $2.8 million (net of the $200,000 deposit) as of December 31, 2021. 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 a retainer of $345,000, which has been, and will continue to be, applied to study expenses as further defined by the contract. Due to the unpredictable nature of the ongoing COVID-19 pandemic, and the Company’s difficulty with the enrollment of patients for the treatment of COVID-19 given the unplanned variability of the virus, vaccine rates and mutations in the virus in certain geographies, the contractual amount was amended by $0.7 million to account for additional study sites, investigator payments and enrollment delays. As such, the revised contractual commitment for the AP-017 study is $2.5 million. In the event of premature termination, the Company will pay for services rendered and expenses incurred through the date of termination. The CRO will refund any unused portion of the retainer. Employment Agreements The Company has three employment agreements that expire in October 2024 and one employment agreement that expires in November 2022. These employment agreements call for base salaries ranging from $335,000 to $550,000 and discretionary bonus and severance payments ranging from $167,000 to $275,000. These employment agreements supersede and replace the Company’s prior employment agreements. Amounts noted above do not assume the continuation of employment beyond the initial contractual terms of each employee’s existing employment agreements. 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)” 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 presented in the balance sheet as of December 31, 2021: Facility Lease Payments 2022 2023 2024 2025 2026 Thereafter Remaining Facility Lease Payments $ 999,000 $ 355,000 $ 364,000 $ 280,000 $ — $ — $ — Less: Discount Adjustment (74,000) Total lease liability $ 925,000 Lease liability-current portion $ 311,000 Long-term lease liability $ 614,000 The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of December 31, 2021: ROU Asset Balance as of December 31, 2020 $ 824,000 Amortization (195,000) Balance as of December 31, 2021 $ 629,000 The Company recorded lease expense in the respective periods is as follows: Year Ended December 31, 2021 2020 Lease expense $ 275,000 $ 264,000 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2021 | |
Warrants. | |
Warrants | Note 8 – Warrants The Company has issued both equity (“placement agent”) and liability classified (“investor”) warrants in conjunction with equity raises. The Company had a total of 1.1 million equity-classified warrants and 17.2 million liability-classified warrants outstanding as of December 31, 2021. The following table summarizes the Company’s warrant activity: Weighted Weighted Average Number of Average Remaining Warrants Exercise Price Contractual Life Outstanding as of December 31, 2019 7,116,524 $ 0.57 3.41 Warrant exercised (2,985,800) $ 0.42 — 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 Warrants exercised (812,827) $ 0.58 — Warrants expired (15,000) $ 0.94 — Outstanding as of December 31, 2021 18,302,897 $ 1.02 4.24 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 4.96 August 2018 public offering $ 0.40 Investor 153,400 1.61 June 2017 registered direct offering $ 0.76 Investor 2,026,915 0.42 June 2019 public offering $ 0.50 Placement agent 823,650 2.46 June 2017 registered direct offering $ 0.76 Placement agent 298,932 0.42 Outstanding as of December 31, 2021 18,302,897 $ 1.02 4.24 In connection with the December 2021 registered direct offering, the Company issued investor warrants to purchase an aggregate of 15.0 million shares of common stock at an exercise price of $1.10 with a term of five years and are immediately exercisable (see Note 10 Assumptions for warrants issued December 15, 2021: December 31, 2021 At Issuance Exercise Price $ 1.10 $ 1.10 Volatility 101 % 100 % Equivalent term (years) 4.96 5.00 Risk-free interest rate 1.25 % 1.26 % Number of warrants 15,000,000 15,000,000 Derivative liability $ 5,597,000 $ 6,689,000 In connection with the August 2018 confidentially marketed public offering, the Company issued investor warrants to purchase an aggregate of 20.0 million shares of common stock at an exercise price of $0.40 with a term of five years . Due to certain derivative features, these warrants were accounted for under liability accounting and are recorded at fair value each reporting period. As of December 31, 2021 and 2020, these warrants had a fair value of $52,000 and $606,000 , respectively. Significant assumptions, using the Black-Scholes valuation model, as of December 31, 2021, December 31, 2020, and at issuance were as follows: December 31, Assumptions for warrants issued August 13, 2018: 2021 2020 Exercise Price $ 0.40 $ 0.40 Volatility 107 % 131 % Equivalent term (years) 1.61 2.61 Risk-free interest rate 0.60 % 0.15 % Number of warrants 153,400 437,500 Derivative liability $ 52,000 $ 606,000 In connection with the June 2017 registered direct offering, the Company issued investor warrants to purchase an aggregate of 11.0 million shares of common stock at an exercise price of $0.76 with a term of five years . Due to certain derivative features, these warrants are accounted for under liability accounting and are recorded at fair value each reporting period. As of December 31, 2021 and 2020, these warrants had a fair value of December 31, Assumptions for warrants issued June 2, 2017: 2021 2020 Exercise Price $ 0.76 $ 0.76 Volatility 92 % 90 % Equivalent term (years) 0.42 1.42 Risk-free interest rate 0.15 % 0.11 % Number of warrants 2,026,915 2,026,915 Derivative liability $ 156,000 $ 2,001,000 During the year ended December 31, 2021, the Company issued 284,100 shares of its common stock as a result of the exercise of investor warrants with an exercise price of $0.40. The Company received proceeds of $114,000 during the period related to these investor warrant exercises. In addition, former placement agents elected to exercise 528,727 of their warrants utilizing the net exercise option, where the total number of shares of common stock issued was reduced to cover the exercise price and, as such, the Company issued 304,121 shares of common stock. The Company did not receive any cash related to the exercise of placement agent warrants. A total of 15,000 placement agent warrants also expired during the year ended December 31, 2021. The total value for the warrant derivative liability as of December 31, 2021 is approximately $5.8 million (see Note 9 During the year ended December 31, 2020, the Company issued 2.0 million shares of its common stock as a result of the exercise of investor warrants with an exercise price of $0.40 and received proceeds of $785,000 related to these investor warrant exercises. In addition, former placement agents elected to exercise 1.0 million of their warrants utilizing the net exercise option, where the total number of shares of common stock issued was reduced to cover the exercise price and, as such, the Company issued 524,000 shares of common stock. The Company did not receive any cash related to the exercise of placement agent warrants. |
Fair Value Considerations
Fair Value Considerations | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Considerations | |
Fair Value Considerations | Note 9 – 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 are 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 December 31, 2021 and 2020, by level within the fair value hierarchy: Fair Value Measurements Using Level 1 Level 2 Level 3 Total December 31, 2021 Liabilities: Warrant derivative liability $ — $ — $ 5,805,000 $ 5,805,000 December 31, 2020 Liabilities: Warrant derivative liability $ — $ — $ 2,607,000 $ 2,607,000 The recurring warrant derivative liability was valued using the Black-Scholes valuation methodology because that model embodies all the relevant assumptions that address the features underlying these instruments. The significant assumptions in valuing the warrant derivative liability as of December 31, 2021, December 31, 2020, and at issuance are disclosed in Note 8 The following table sets forth a reconciliation of changes in the fair value of financial liabilities classified as Level 3 in the fair valued hierarchy: Derivative Instruments Balance as of December 31, 2020 $ 2,607,000 Warrant issuances 6,689,000 Warrant exercises (347,000) Change in fair value (3,144,000) Balance as of December 31, 2021 $ 5,805,000 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2021 | |
Common Stock. | |
Common stock | N Authorized Shares The Company had 300.0 million authorized shares of common stock as of December 31, 2021 and 2020. The following table summarizes the Company’s remaining authorized shares available for future issuance: December 31, 2021 Authorized shares 300,000,000 Common stock outstanding 227,325,381 Options outstanding 7,506,989 Warrants outstanding 18,302,897 Reserved for issuance under 2019 Stock and Incentive Plan 4,417,332 Available shares 42,447,401 Registered Direct Offering In December 2021, the Company completed a registered direct offering whereby it issued 25.0 million shares of its common stock at a price of $0.90 per share, along with investor warrants to purchase up to 15.0 million shares of common stock, generating gross proceeds of $22.5 million. In connection with this offering, the Company entered into a Placement Agent Agreement with the placement agent. Pursuant to the Placement Agent Agreement, the placement agent received a 7% commission of $1.6 million, and $75,000 as compensation for other costs related to the offering. Additionally, the Placement Agent Agreement contained certain restrictions that prevents the Company from conducting an equity financing and utilizing the at-the-market equity offering program in the near term. The Company also incurred expenses related to legal, accounting, and other registration costs of $167,000 . The shares and warrants were offered and sold pursuant to the Company’s shelf registration statement. The investor warrants issued in connection with the registered direct offering have an exercise price of $1.10 per share and are immediately exercisable with a term of five years from issuance. Based on the terms of the warrant and related securities law, the contract does not meet the criteria within Accounting Standards Codification (“ASC”) 815 “ Derivatives and Hedging ” to permit the company to settle in unregistered shares. Therefore, the Company could be forced to cash settle the warrants. Based on this derivative feature, these warrants must be accounted for as a liability at fair value under ASC 815. On the date of issuance, these warrants were valued at $6.7 million, using the Black-Scholes valuation model (see Note 8 ) and represents a reduction in additional paid-in capital at the time of issuance. ATM Equity Offering Program Sales Agreement In February 2020, the Company entered into a Sales Agreement with two agents to implement an 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. In connection with the registered direct offering that the Company completed in December 2021, the Company is prohibited from utilizing the ATM equity offering program until May 15, 2022. The following table summarizes the Company’s sales and related issuance costs incurred under the Sales Agreement as of December 31, 2021: Year Ended December 31, 2021 2020 Total shares of common stock sold 6,246,085 32,099,677 Gross proceeds $ 10,512,000 $ 26,191,000 Commissions earned by placement agents (422,000) (1,050,000) Issuance fees (90,000) (318,000) Net proceeds $ 10,000,000 $ 24,823,000 Issuance of Common Stock for Services The Company issued 54,052 and 136,236 shares of common stock under the Ampio Pharmaceuticals, Inc. 2019 Stock and Incentive Plan (the “2019 Plan”), each valued at $80,000, as partial compensation for the services of non-employee directors, during the years ended December 31, 2021 and 2020, respectively. |
Equity Instruments
Equity Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Equity Instruments | |
Equity Instruments | Note 11 – Equity Instruments In December 2019, the Company’s Board of Directors and stockholders approved the adoption of the 2019 Plan, under which shares were reserved for future issuance of equity related awards classified as option awards/grants, 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 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 December 31, 2021: 2019 Plan Total shares reserved for equity awards 10,000,000 Options granted during previous fiscal years (2,067,471) Options granted during fiscal 2021 (1,866,000) Restricted stock awards granted during fiscal 2021 (1,785,000) Forfeited, expired and/or cancelled equity awards 5,500 Shares forfeited to settle exercise price and tax obligation 130,303 Remaining shares available for future equity awards 4,417,332 Options The Company’s stock option activity is summarized in the table below: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Price Contractual Life Intrinsic Value Outstanding December 31, 2019 6,000,332 $ 1.33 5.40 $ — Granted 1,923,471 $ 0.90 Exercised (32,500) $ 0.33 Forfeited (100,000) $ 1.70 Expired and/or cancelled (1,691,652) $ 1.87 Outstanding as of December 31, 2020 6,099,651 $ 1.04 7.36 $ — Granted 1,866,000 $ 1.21 Exercised (443,662) $ 0.55 Forfeited, expired and/or cancelled (15,000) $ 5.76 Outstanding as of December 31, 2021 7,506,989 $ 1.12 7.21 $ 91,000 Exercisable as of December 31, 2021 6,333,656 $ 1.02 6.73 $ 88,000 Of the 443,662 stock options that were exercised during the year ended December 31, 2021, 8,000 stock options were cash exercised whereby the Company received proceeds to cover the option holder’s exercise price and tax obligations totaling $6,000. In addition, 302,734 stock options were exercised as cashless exercises whereby the Company received proceeds to cover the option holders’ exercise price totaling $154,000. The remaining 132,928 stock options were net exercised whereby the total number of shares of common stock issued was reduced by 57,058 shares to cover the option holders’ exercise price and tax obligations. The Company submitted the tax obligations totaling $40,000 on behalf of the option holders. The shares of common stock that are held back upon a net exercise of a stock option to settle the option holder’s obligation associated with the exercise price and tax obligations are added back to the reserve for shares available for future equity awards under the 2019 Plan. Outstanding options that were issued in accordance with the 2010 Plan and 2019 Plan are summarized in the table below: Outstanding Options by Plan December 31, 2021 2010 Plan 3,630,018 2019 Plan 3,876,971 Outstanding as of December 31, 2021 7,506,989 Stock options outstanding at December 31, 2021 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 $0.50 494,500 $ 0.44 7.66 $0.51 - $1.00 4,452,345 $ 0.70 6.80 $1.01 - $1.50 937,000 $ 1.19 9.69 $1.51 and above 1,623,144 $ 2.45 6.77 Total 7,506,989 $ 1.12 7.21 Restricted Stock Awards In connection with the three employment agreements that expire October 2024 (see Note 7 remaining shares of restricted stock awards vesting annually on January 1st until 2025. The 2019 Plan allows the restricted stock award grantee to authorize the Company to withhold shares of common stock to settle the tax obligation at such time the shares vest. The shares of restricted stock that vested immediately were subject to statutory tax withholdings and all three employees authorized the Company to withhold shares of common stock to settle the tax obligation, which resulted in a forfeiture of 113,577 shares of restricted stock and 1.7 million net shares of restricted stock being issued during the year ended December 31, 2021. The restricted stock awards activity at December 31, 2021 is summarized in the table below: Weighted Average Grant-Date Aggregate Awards Fair Value Intrinsic Value Granted 1,785,000 $ 1.64 Vested (203,423) $ 1.64 $ — Shares forfeited to settle tax obligation (113,577) $ 1.64 Unvested at December 31, 2021 1,468,000 $ 1.64 Share-based Compensation 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 and modified during the period ended December 31, 2021 and December 31, 2020, using the following assumptions: Year Ended December 31, 2021 2020 Expected volatility 113% - 127 % 121% - 134 % Risk free interest rate 0.78% - 1.38 % 0.19% - 1.67 % Expected term (years) 5.00 - 6.50 3.00 - 6.00 Based on these assumptions, the Company recognized $1.4 million of share-based compensation related to options as of December 31, 2021. The Company also computes the fair value for all restricted stock awards based on the stock price on the grant date and recognizes share-based compensation ratably over the requisite service period which approximates the vesting period. The Company recognized $1.3 million of share-based compensation relating to restricted stock awards as of December 31, 2021. As such, the Company recognized a total of $2.7 million of share-based compensation for options and restricted stock awards as of December 31, 2021, which is further explained in the table below. Share-based compensation expense related to the fair value of stock options and restricted stock awards is included in the statements of operations as research and development expenses and general and administrative expenses as set forth in the table below. The Company determined the fair value as of the date of grant for options using the Black-Scholes option pricing model and expenses the fair value ratably over the vesting period. The following table summarizes stock-based compensation for the years ended December 31, 2021 and December 31, 2020: Year Ended December 31, 2021 2020 Research and development expenses Share-based compensation $ 46,000 $ 401,000 General and administrative expenses Issuance of common stock for services (see Note 10 80,000 80,000 Share-based compensation 2,678,000 876,000 Total share-based compensation $ 2,804,000 $ 1,357,000 Unrecognized share-based compensation expense related to stock options as of December 31, 2021 868,000 Weighted average remaining years to vest for stock options 1.24 Unrecognized share-based compensation expense related to restricted stock awards as of December 31, 2021 1,572,000 Weighted average remaining years to vest for restricted stock awards 3.01 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | Note 12 – Income Taxes Income tax expense (benefit) resulting from applying statutory rates in jurisdictions in which the Company is taxed (Federal and State of Colorado) differs from the income tax provision (benefit) in the Company’s financial statements. The following table reflects the reconciliation for the respective periods: Years Ended December 31, 2021 2020 (Benefit) expense at federal statutory rate (21.0) % (21.0) % State, net of federal income tax impact (4.4) % (2.9) % Stock-based compensation 0.1 % 4.7 % Registered offering gain/warrant expense (4.6) % 0.4 % Paycheck Protection Program funding 0.0 % (0.7) % Change in state deferred tax rate 0.0 % 0.7 % Expiration of tax attribute carryforwards 1.1 % 1.5 % Other 2.1 % 0.0 % Change in valuation allowance 26.7 % 17.3 % Effective tax rate 0.0 % 0.0 % Deferred income taxes arise from temporary differences in the recognition of certain items for income tax and financial reporting purposes. The approximate tax effects of significant temporary differences which comprise the deferred tax assets and liabilities are as follows for the respective periods: Years Ended December 31, 2021 2020 Long-term deferred income tax assets (liabilities): Accrued liabilities $ 96,000 $ — Interest expense carryforward 73,000 — ROU asset (155,000) (203,000) Lease liability 228,000 298,000 Net operating loss carryforward 47,858,000 43,515,000 Share-based compensation 1,050,000 1,030,000 Unrealized loss on trading security 772,000 772,000 Property and equipment 113,000 9,000 Warrants 96,000 152,000 Other 1,000 1,000 Less: Valuation allowance (50,132,000) (45,574,000) Total long-term deferred income tax assets (liabilities) $ — $ — As of December 31, 2021, Ampio has approximately $194.6 million in net operating loss (“NOL”) carryforwards that, subject to limitation, may be available in future tax years to offset taxable income. These net operating loss carryforwards expire from 2022 through 2037. Approximately $63.5 million of the NOL carryforward carries forward indefinitely. Under the provisions of the Internal Revenue Code, substantial changes in the Company’s ownership may result in limitations on the amount of NOL carryforwards that can be utilized in future years. The Company has provided a full valuation allowance against its deferred tax assets as it has determined that it is not more likely than not that recognition of such deferred tax assets will be utilized in the foreseeable future. The amount of income taxes and related income tax positions taken are subject to audits by federal and state tax authorities. The Company has adopted accounting guidance for uncertain tax positions which provides that in order to recognize an uncertain tax benefit, the taxpayer must be more likely than not of sustaining the position, and the measurement of the benefit is calculated as the largest amount that is more than 50% likely to be realized upon recognition of the benefit. The Company believes that it has no material uncertain tax positions and has fully reserved against its future tax benefit with a valuation allowance and does not expect significant changes in the amount of unrecognized tax benefits to occur within the next twelve months. The Company’s policy is to record a liability for the difference between benefits that are both recognized and measured pursuant to GAAP and tax positions taken or expected to be taken on the tax return. Then, to the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. The Company reports tax-related interest and penalties as a component of income tax expense. During the periods reported, management of the Company has concluded that no significant tax position requires recognition. The Company files income tax returns in the United States federal and various state jurisdictions. The Company is no longer subject to income tax examinations for federal income taxes before 2018 or for Colorado before 2017. Net operating loss carryforwards are subject to examination in the year they are utilized regardless of whether the tax year in which they are generated has been closed by statute. The amount subject to disallowance is limited to the NOL utilized. Accordingly, the Company may be subject to examination for prior NOL’s generated as such NOL’s are utilized. |
Earnings Per Share
Earnings Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share | |
Earnings Per Share | Note 13 – 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, warrants for the shares of common stock and restricted stock awards. 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 year ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Net loss $ (17,075,000) $ (15,894,000) Less: decrease in fair value of investor warrants (3,492,000) — Loss available to common stockholders $ (20,567,000) $ (15,894,000) Basic weighted-average common shares outstanding 199,299,072 172,846,773 Add: dilutive effect of equity instruments 5,663,947 — Diluted weighted-average shares outstanding 204,963,019 172,846,773 Earnings per share – basic $ (0.09) $ (0.09) Earnings per share – diluted $ (0.10) $ (0.09) The potentially dilutive shares of common stock that have been excluded from the calculation of net loss per share because of the anti-dilutive effect as of December 31, 2021 and 2020 are as follows: Year Ended December 31, 2021 2020 Warrants to purchase shares of common stock 12,638,950 4,130,724 Outstanding stock options 7,506,989 6,099,651 Restricted stock awards 1,468,000 — Total potentially dilutive shares of common stock 21,613,939 10,230,375 |
Litigation
Litigation | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Litigation | Note 14 – Litigation From time to time, the Company may be a party to litigation arising in the ordinary course of business. As of December 31, 2021, the Company is not a party to any ongoing lawsuits. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2021 | |
Employee Benefit Plan | |
Employee Benefit Plan | Note 15 – Employee Benefit Plan The Company has a 401(k) plan that allows participants to contribute a portion of their salary, subject to eligibility requirements and annual IRS limits. However, as of December 31, 2021, the Company does not match employee contributions. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events | |
Subsequent Events | Note 16 – Subsequent Events 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Impact of Global Pandemic | Impact of Global Pandemic The AP-013 study was initiated in June 2019 and was ongoing when the COVID-19 pandemic began. The Secretary of Health and Human Services declared a public health emergency (“PHE”) on January 31, 2020 and the President declared a national emergency in response to COVID-19 on March 13, 2020. The AP-013 study was impacted by the COVID-19 pandemic, as was the case with many clinical studies being conducted at that time. The study was paused in April 2020 due to patient and site safety concerns about COVID-19, the inability of sites to complete the remaining 12-week efficacy and 24-week follow-up visits, or to support doing these by remote visits, and the resulting unanimous recommendation from the study’s safety monitoring committee given the influence of the COVID-19 pandemic on the conduct of the study. The U.S. Food and Drug Administration (“FDA”) acknowledged the impact of COVID-19 on clinical trials in the “ FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, In addition, since June 2020, the Company has commenced several clinical trials to determine the safety and efficacy for new applications of Ampion (i.e., inhaled and intravenous) related to inflammation resulting from COVID-19. Given the continued evolution of the COVID-19 pandemic and the related complexities and uncertainties associated with the additional variants, the Company’s business operations could be significantly impacted and, in addition, the supply chain provided by third parties on which the Company relies, including organizations that conduct clinical trials and key suppliers which provide the raw materials for manufacturing Ampion for the ongoing clinical trials, could also be impacted. The full extent of the potential adverse impact on the Company’s business operations and related current and future product development, including, but not limited to, pre-clinical research programs, clinical trials, financing activities and the overall impact on the United States and the global economy will depend on future developments related to the pandemic, which cannot be predicted at this time. |
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 at the time. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers instruments purchased with an original maturity of three months or less to be cash equivalents. The Company’s investment policy is to preserve principal and maintain liquidity. |
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 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 years ended December 31, 2021 and 2020, the Company has maintained balances in excess of federally insured limits. |
Concentration of Supplier | Concentration of Supplier The Company currently contracts with a limited number of suppliers to obtain each of the key components/raw materials needed to produce Ampion for clinical trials, including Human Serum Albumin, the line sets and the vials/caps and stoppers. The Company believes there are other viable suppliers that could be substituted should the suppliers for the key components/raw materials become non-competitive. |
Fixed Assets | Fixed Assets Fixed assets are stated at cost less accumulated depreciation and amortization. Cost includes expenditures for equipment, leasehold improvements, replacements, and renewals and the related cost required to get certain equipment in operating condition. The Company charges routine and ongoing maintenance and repairs to expense as incurred. When assets are sold, retired, or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in operations. The cost of property and equipment is depreciated using the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized over the remaining life of the lease. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company performs an annual evaluation of the recoverability of the carrying value of its long-lived assets to determine if facts and circumstances indicate that the carrying value of assets may be impaired and if any adjustment is warranted. Based on the Company’s evaluation as of December 31, 2021 and 2020, no impairment existed for long-lived assets. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments include cash and cash equivalents, accounts payable and accrued expenses, and warrant derivative liability. The carrying amounts of cash and cash equivalents, accounts payable and accrued expenses are carried at cost, which approximates fair value due to the short maturity of these instruments. The warrant derivative liability is recorded at estimated fair value based on utilization of the Black-Scholes warrant pricing model depending on facts and circumstances. See Note 8 and Note 9 |
Share-Based Compensation | Share-Based Compensation The Company accounts for share-based payments by recognizing compensation expense based upon the estimated fair value of the share-based payments on the date of grant. The Company determines the estimated fair value of the share-based payments granted using the fair market value or Black-Scholes option pricing model and recognizes compensation costs ratably over the requisite service period which approximates the vesting period using the graded method. See Note 11 |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that includes the enactment date. The overall change in deferred tax assets and liabilities for the period measures the deferred tax expense or benefit for the period. The measurement of deferred tax assets may be reduced by a valuation allowance based on judgmental assessment of available evidence if deemed more likely than not that some or all of the deferred tax assets will not be realized. The Company has recorded a valuation allowance against all of its deferred tax assets, as management has concluded that it is more likely than not that the net deferred tax asset will not be realized through projected future taxable income, based primarily on the Company’s ongoing history of operating losses and the lack of taxable income in the foreseeable future. See Note 12 |
Clinical Trial Accrual | Clinical Trial Accruals The Company is currently conducting four discrete clinical trials which are at various stages of completion. The clinical trial accrual covering each of the studies involve identifying services that third parties, contracted by the Company, have performed, and estimating the associated cost incurred for these services which remain un-invoiced as of the balance sheet date. In addition, the clinical trial accrual involves the measurement of milestone achievements achieved by the patients participating in the clinical trial and the associated costs which have not been invoiced as of the balance sheet date. The Company develops an estimate of liability using its judgment based upon the facts and circumstances known at the time. |
Research and Development | Research and Development Research and development costs are expensed as incurred in the respective periods. |
Liquidity | Liquidity In December 2021, the Company finalized a registered direct offering that generated gross proceeds of $22.5 million, offset by offering-related costs of $1.8 million (see Note 10 Furthermore, in February 2020, the Company entered into a Sales Agreement (“Sales Agreement”) with two agents to implement an “at-the-market” (“ATM”) equity offering program under which the Company, at its sole discretion and subject to certain exceptions, may issue and sell from time-to-time shares of its authorized common stock. During the year ended December 31, 2021, the Company sold shares pursuant to the ATM equity offering program, which yielded gross proceeds of $10.5 million, offset by offering-related costs of $0.5 million (see Note 10 The company recognized a net loss of $17.1 million, which is primarily attributable to operating expenses of $20.6 million, partially offset by the non-cash derivative gain of $3.5 million (see Note 9 |
Adoption of Recent Accounting Pronouncements | Adoption of Recent Accounting Pronouncements The Company has not adopted any recent accounting pronouncements during the year ended December 31, 2021, as none were deemed to be applicable. Recent Accounting Pronouncements In August 2020, the Financial Accounting Standard Board (the “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 This Annual Report on Form 10-K 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. |
Prepaid Expenses and Other (Tab
Prepaid Expenses and Other (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Prepaid Expenses and Other | |
Schedule Of Prepaid Expenses and other balances | December 31, 2021 2020 Deposits $ 884,000 $ 266,000 Unamortized commercial insurance premiums 465,000 627,000 Professional fees 235,000 — Raw materials 72,000 — Receivable 16,000 185,000 Other 68,000 69,000 Total prepaid expenses and other $ 1,740,000 $ 1,147,000 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fixed Assets | |
Schedule of Fixed Assets | Estimated Useful Lives December 31, (in Years) 2021 2020 Leasehold improvements 10 $ 1,649,000 $ 2,250,000 Manufacturing facility/clean room 3 - 8 677,000 998,000 Lab equipment and office furniture 5 - 8 238,000 313,000 Fixed assets, net $ 2,564,000 $ 3,561,000 |
Schedule Of Depreciation expense | Year Ended December 31, 2021 2020 Depreciation and amortization expense $ 1,094,000 $ 1,177,000 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | December 31, 2021 2020 Accounts payable $ 427,000 $ 186,000 Clinical trials 2,995,000 558,000 Professional fees 510,000 267,000 Accrued compensation 389,000 — Commercial insurance premium financing 269,000 386,000 Other 221,000 153,000 Accounts payable and accrued expenses $ 4,811,000 $ 1,550,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Commitments and Contingencies | Commitments and contingencies as of December 31, 2021 are described below and summarized in the following table: Total 2022 2023 2024 2025 2026 Thereafter Key clinical research trial obligations $ 4,444,000 $ 4,444,000 $ — $ — $ — $ — $ — Employment agreements 4,021,000 1,764,000 1,260,000 997,000 — — — $ 8,465,000 $ 6,208,000 $ 1,260,000 $ 997,000 $ — $ — $ — |
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 presented in the balance sheet as of December 31, 2021: Facility Lease Payments 2022 2023 2024 2025 2026 Thereafter Remaining Facility Lease Payments $ 999,000 $ 355,000 $ 364,000 $ 280,000 $ — $ — $ — Less: Discount Adjustment (74,000) Total lease liability $ 925,000 Lease liability-current portion $ 311,000 Long-term lease liability $ 614,000 |
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 December 31, 2021: ROU Asset Balance as of December 31, 2020 $ 824,000 Amortization (195,000) Balance as of December 31, 2021 $ 629,000 The Company recorded lease expense in the respective periods is as follows: Year Ended December 31, 2021 2020 Lease expense $ 275,000 $ 264,000 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of Company's warrant activity | The following table summarizes the Company’s warrant activity: Weighted Weighted Average Number of Average Remaining Warrants Exercise Price Contractual Life Outstanding as of December 31, 2019 7,116,524 $ 0.57 3.41 Warrant exercised (2,985,800) $ 0.42 — 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 Warrants exercised (812,827) $ 0.58 — Warrants expired (15,000) $ 0.94 — Outstanding as of December 31, 2021 18,302,897 $ 1.02 4.24 |
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 4.96 August 2018 public offering $ 0.40 Investor 153,400 1.61 June 2017 registered direct offering $ 0.76 Investor 2,026,915 0.42 June 2019 public offering $ 0.50 Placement agent 823,650 2.46 June 2017 registered direct offering $ 0.76 Placement agent 298,932 0.42 Outstanding as of December 31, 2021 18,302,897 $ 1.02 4.24 |
2017 public offering | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of assumptions for warrants issued | December 31, Assumptions for warrants issued June 2, 2017: 2021 2020 Exercise Price $ 0.76 $ 0.76 Volatility 92 % 90 % Equivalent term (years) 0.42 1.42 Risk-free interest rate 0.15 % 0.11 % Number of warrants 2,026,915 2,026,915 Derivative liability $ 156,000 $ 2,001,000 |
2018 public offerings | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of assumptions for warrants issued | December 31, Assumptions for warrants issued August 13, 2018: 2021 2020 Exercise Price $ 0.40 $ 0.40 Volatility 107 % 131 % Equivalent term (years) 1.61 2.61 Risk-free interest rate 0.60 % 0.15 % Number of warrants 153,400 437,500 Derivative liability $ 52,000 $ 606,000 |
2021 public offering | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of assumptions for warrants issued | Assumptions for warrants issued December 15, 2021: December 31, 2021 At Issuance Exercise Price $ 1.10 $ 1.10 Volatility 101 % 100 % Equivalent term (years) 4.96 5.00 Risk-free interest rate 1.25 % 1.26 % Number of warrants 15,000,000 15,000,000 Derivative liability $ 5,597,000 $ 6,689,000 |
Fair Value Considerations (Tabl
Fair Value Considerations (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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 December 31, 2021 and 2020, by level within the fair value hierarchy: Fair Value Measurements Using Level 1 Level 2 Level 3 Total December 31, 2021 Liabilities: Warrant derivative liability $ — $ — $ 5,805,000 $ 5,805,000 December 31, 2020 Liabilities: Warrant derivative liability $ — $ — $ 2,607,000 $ 2,607,000 |
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 valued hierarchy: Derivative Instruments Balance as of December 31, 2020 $ 2,607,000 Warrant issuances 6,689,000 Warrant exercises (347,000) Change in fair value (3,144,000) Balance as of December 31, 2021 $ 5,805,000 |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Common Stock. | |
Schedule of remaining authorized Shares | December 31, 2021 Authorized shares 300,000,000 Common stock outstanding 227,325,381 Options outstanding 7,506,989 Warrants outstanding 18,302,897 Reserved for issuance under 2019 Stock and Incentive Plan 4,417,332 Available shares 42,447,401 |
Schedule of sale of stock under sales agreement | Year Ended December 31, 2021 2020 Total shares of common stock sold 6,246,085 32,099,677 Gross proceeds $ 10,512,000 $ 26,191,000 Commissions earned by placement agents (422,000) (1,050,000) Issuance fees (90,000) (318,000) Net proceeds $ 10,000,000 $ 24,823,000 |
Equity Instruments (Tables)
Equity Instruments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Schedule of Stock Options Outstanding and Exercisable | Number of Weighted Weighted Average Options Average Remaining Range of Exercise Prices Outstanding Exercise Price Contractual Lives Up to $0.50 494,500 $ 0.44 7.66 $0.51 - $1.00 4,452,345 $ 0.70 6.80 $1.01 - $1.50 937,000 $ 1.19 9.69 $1.51 and above 1,623,144 $ 2.45 6.77 Total 7,506,989 $ 1.12 7.21 |
Schedule of restricted stock awards activity | Weighted Average Grant-Date Aggregate Awards Fair Value Intrinsic Value Granted 1,785,000 $ 1.64 Vested (203,423) $ 1.64 $ — Shares forfeited to settle tax obligation (113,577) $ 1.64 Unvested at December 31, 2021 1,468,000 $ 1.64 |
Schedule of Assumptions Used in Computing Fair Value of All Options Granted | Year Ended December 31, 2021 2020 Expected volatility 113% - 127 % 121% - 134 % Risk free interest rate 0.78% - 1.38 % 0.19% - 1.67 % Expected term (years) 5.00 - 6.50 3.00 - 6.00 |
Schedule of Stock-Based Compensation Expense | Year Ended December 31, 2021 2020 Research and development expenses Share-based compensation $ 46,000 $ 401,000 General and administrative expenses Issuance of common stock for services (see Note 10 80,000 80,000 Share-based compensation 2,678,000 876,000 Total share-based compensation $ 2,804,000 $ 1,357,000 Unrecognized share-based compensation expense related to stock options as of December 31, 2021 868,000 Weighted average remaining years to vest for stock options 1.24 Unrecognized share-based compensation expense related to restricted stock awards as of December 31, 2021 1,572,000 Weighted average remaining years to vest for restricted stock awards 3.01 |
Employee Stock Option | |
Schedule of stock option activity | Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Price Contractual Life Intrinsic Value Outstanding December 31, 2019 6,000,332 $ 1.33 5.40 $ — Granted 1,923,471 $ 0.90 Exercised (32,500) $ 0.33 Forfeited (100,000) $ 1.70 Expired and/or cancelled (1,691,652) $ 1.87 Outstanding as of December 31, 2020 6,099,651 $ 1.04 7.36 $ — Granted 1,866,000 $ 1.21 Exercised (443,662) $ 0.55 Forfeited, expired and/or cancelled (15,000) $ 5.76 Outstanding as of December 31, 2021 7,506,989 $ 1.12 7.21 $ 91,000 Exercisable as of December 31, 2021 6,333,656 $ 1.02 6.73 $ 88,000 Outstanding Options by Plan December 31, 2021 2010 Plan 3,630,018 2019 Plan 3,876,971 Outstanding as of December 31, 2021 7,506,989 |
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 December 31, 2021: 2019 Plan Total shares reserved for equity awards 10,000,000 Options granted during previous fiscal years (2,067,471) Options granted during fiscal 2021 (1,866,000) Restricted stock awards granted during fiscal 2021 (1,785,000) Forfeited, expired and/or cancelled equity awards 5,500 Shares forfeited to settle exercise price and tax obligation 130,303 Remaining shares available for future equity awards 4,417,332 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of Effective Income Tax Rate Reconciliation | Years Ended December 31, 2021 2020 (Benefit) expense at federal statutory rate (21.0) % (21.0) % State, net of federal income tax impact (4.4) % (2.9) % Stock-based compensation 0.1 % 4.7 % Registered offering gain/warrant expense (4.6) % 0.4 % Paycheck Protection Program funding 0.0 % (0.7) % Change in state deferred tax rate 0.0 % 0.7 % Expiration of tax attribute carryforwards 1.1 % 1.5 % Other 2.1 % 0.0 % Change in valuation allowance 26.7 % 17.3 % Effective tax rate 0.0 % 0.0 % |
Schedule of Deferred Tax Assets and Liabilities | Years Ended December 31, 2021 2020 Long-term deferred income tax assets (liabilities): Accrued liabilities $ 96,000 $ — Interest expense carryforward 73,000 — ROU asset (155,000) (203,000) Lease liability 228,000 298,000 Net operating loss carryforward 47,858,000 43,515,000 Share-based compensation 1,050,000 1,030,000 Unrealized loss on trading security 772,000 772,000 Property and equipment 113,000 9,000 Warrants 96,000 152,000 Other 1,000 1,000 Less: Valuation allowance (50,132,000) (45,574,000) Total long-term deferred income tax assets (liabilities) $ — $ — |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share | |
Schedule for the calculations of basic and diluted earnings per share | Year Ended December 31, 2021 2020 Net loss $ (17,075,000) $ (15,894,000) Less: decrease in fair value of investor warrants (3,492,000) — Loss available to common stockholders $ (20,567,000) $ (15,894,000) Basic weighted-average common shares outstanding 199,299,072 172,846,773 Add: dilutive effect of equity instruments 5,663,947 — Diluted weighted-average shares outstanding 204,963,019 172,846,773 Earnings per share – basic $ (0.09) $ (0.09) Earnings per share – diluted $ (0.10) $ (0.09) |
Schedule of potentially dilutive securities, excluded | Year Ended December 31, 2021 2020 Warrants to purchase shares of common stock 12,638,950 4,130,724 Outstanding stock options 7,506,989 6,099,651 Restricted stock awards 1,468,000 — Total potentially dilutive shares of common stock 21,613,939 10,230,375 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Impairment of Long-Lived Assets (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Summary of Significant Accounting Policies | ||
Impairment of long-lived assets | $ 0 | $ 0 |
Going Concern (Detail)
Going Concern (Detail) | 1 Months Ended | 12 Months Ended | ||
Feb. 29, 2020item | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Cash and cash equivalents | $ 33,892,000 | $ 17,346,000 | ||
Net loss | (17,075,000) | (15,894,000) | ||
Working capital | 14,100,000 | |||
Operating expenses | 20,571,000 | 15,834,000 | ||
Derivative gain (loss) | 3,492,000 | (543,000) | ||
Accumulated deficit | (217,602,000) | (200,527,000) | ||
Stockholders' equity | 27,284,000 | $ 17,512,000 | $ 6,443,000 | |
Gross proceeds | 22,500,000 | |||
Offering related costs | 1,800,000 | |||
ATM equity offering program | ||||
Gross proceeds | 10,500,000 | |||
Offering related costs | $ 500,000 | |||
Sale Agreement (ATM) | ||||
Number of agents | item | 2 |
Prepaid Expenses and Other (Det
Prepaid Expenses and Other (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Prepaid Expenses and Other | ||
Deposits | $ 884,000 | $ 266,000 |
Unamortized commercial insurance premiums | 465,000 | 627,000 |
Professional fees | 235,000 | |
Raw materials | 72,000 | |
Receivable | 16,000 | 185,000 |
Other | 68,000 | 69,000 |
Total prepaid expenses and other | $ 1,740,000 | $ 1,147,000 |
Fixed Assets (Detail)
Fixed Assets (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives in Years | 10 years | |
Fixed assets, net | $ 2,564,000 | $ 3,561,000 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives in Years | 10 years | |
Fixed assets, gross | $ 1,649,000 | 2,250,000 |
Manufacturing facility/clean room [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 677,000 | 998,000 |
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 | $ 238,000 | $ 313,000 |
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 |
Fixed Assets - Depreciation Exp
Fixed Assets - Depreciation Expenses (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fixed Assets | ||
Depreciation and amortization expense | $ 1,094,000 | $ 1,177,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 427,000 | $ 186,000 |
Clinical trials | 2,995,000 | 558,000 |
Professional fees | 510,000 | 267,000 |
Accrued compensation | 389,000 | 0 |
Commercial insurance premium financing | 269,000 | 386,000 |
Other | 221,000 | 153,000 |
Accounts payable and accrued expenses | $ 4,811,000 | $ 1,550,000 |
Accounts Payable and Accrued _4
Accounts Payable and Accrued Expenses - Commercial Insurance Premium Financing Agreement (Detail) - USD ($) | 1 Months Ended | ||
Jun. 30, 2021 | Apr. 30, 2020 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||
Contractual obligation | $ 8,465,000 | ||
PPP | |||
Debt Instrument [Line Items] | |||
Term of agreement (in years) | 6 months | ||
Interest rate (as a percentage) | 1.00% | ||
Commercial Insurance Premium Financing Agreement | |||
Debt Instrument [Line Items] | |||
Financing agreement amount | $ 900,000 | ||
Term of agreement (in years) | 9 months | ||
Interest rate (as a percentage) | 3.57% | ||
Principal and interest payments per month | $ 82,000 | ||
Contractual obligation | 245,000 | ||
Insurance premiums | $ 24,000 |
Paycheck Protection Program - A
Paycheck Protection Program - Additional Information (Detail) - PPP - USD ($) | 1 Months Ended | |
Oct. 31, 2020 | Apr. 30, 2020 | |
Debt Instrument [Line Items] | ||
PPP loan proceeds | $ 544,000 | |
Interest rate (as a percentage) | 1.00% | |
Term of agreement (in years) | 6 months | |
Debt Instrument, Decrease, Forgiveness | $ 544,000 |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Commitments and Contingencies (Detail) | Dec. 31, 2021USD ($) |
Commitment And Contingencies [Line Items] | |
2022 | $ 6,208,000 |
2023 | 1,260,000 |
2024 | 997,000 |
2025 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 8,465,000 |
Key Clinical Research Trial Obligations | |
Commitment And Contingencies [Line Items] | |
2022 | 4,444,000 |
2023 | 0 |
2024 | 0 |
2025 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 4,444,000 |
Employment Agreements | |
Commitment And Contingencies [Line Items] | |
2022 | 1,764,000 |
2023 | 1,260,000 |
2024 | 997,000 |
2025 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | $ 4,021,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | |||||
Dec. 31, 2013 | Dec. 31, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies [Line Items] | ||||||
Contractual obligation | $ 8,465,000 | |||||
Facility Lease Incremental Borrowing Rate | 5.75% | |||||
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 | |||||
Key Clinical Research Trial Obligations | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contractual obligation | $ 4,444,000 | |||||
New CRO | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | $ 1,400,000 | |||||
Contractual deposit Commitment | 315,000 | |||||
Contractual obligation | 120,000 | |||||
Increase in existing contract | 300,000 | |||||
Intravenous treatment for COVID 19 patients | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | 1,800,000 | |||||
Contractual deposit Commitment | 1,400,000 | $ 345,000 | ||||
Contractual amendment | 700,000 | |||||
Contractual obligation | 200,000 | |||||
Revised contract amount | 2,500,000 | |||||
Regional Hospital Group, AP-018 Study | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | $ 318,000 | |||||
Contractual deposit Commitment | 100,000 | $ 105,000 | ||||
Contractual amendment | 1,000,000 | |||||
Contractual obligation | 105,000 | |||||
Revised contract amount | 1,300,000 | |||||
Regional Hospital Group, AP-019 Study | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | $ 2,500,000 | |||||
Contractual deposit Commitment | 2,800,000 | $ 300,000 | ||||
Contractual amendment | 1,900,000 | |||||
Contractual obligation | 200,000 | |||||
Revised contract amount | $ 4,400,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Employment Agreements (Detail) | 12 Months Ended |
Dec. 31, 2021USD ($)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 |
Employment Agreements, Bonus And Severance Payments | 167,000 |
Maximum | |
Related Party Transaction [Line Items] | |
Annual Salary | 550,000 |
Employment Agreements, Bonus And Severance Payments | $ 275,000 |
Commitments and Contingencies_4
Commitments and Contingencies - Summary of Reconciliation of Company's Undiscounted Payments for Facility Lease and Carrying Amount of Lease Liability (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2022 | $ 355,000 | |
2023 | 364,000 | |
2024 | 280,000 | |
2025 | 0 | |
2025 | 0 | |
Thereafter | 0 | |
Remaining Facility Lease Payments | 999,000 | |
Less: Discount Adjustment | (74,000) | |
Total lease liability | 925,000 | |
Lease liability - current portion | 311,000 | $ 284,000 |
Long-term lease liability | $ 614,000 | $ 925,000 |
Commitments and Contingencies_5
Commitments and Contingencies - Lease Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Balance as of December 31, 2020 | $ 824,000 | |
Amortization | (195,000) | |
Balance as of December 31, 2021 | 629,000 | $ 824,000 |
Lease expense | $ 275,000 | $ 264,000 |
Warrants - Warrants Activity (D
Warrants - Warrants Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Warrants Outstanding | |||
Class of Warrant or Right, Outstanding | 18,302,897 | 4,130,724 | 7,116,524 |
Number of Warrants Outstanding, Beginning Balance | 4,130,724 | 7,116,524 | |
Number of Warrants, Warrants exercised | (812,827) | (2,985,800) | |
Number of Warrants, Warrants expired | (15,000) | ||
Number of Warrants Outstanding, Ending Balance | 18,302,897 | 4,130,724 | 7,116,524 |
Warrants, Weighted Average Exercise Price | |||
Weighted Average Exercise Price, Outstanding Beginning Balance | $ 0.66 | $ 0.57 | |
Weighted Average Exercise Price, Warrants exercised | 0.58 | 0.42 | |
Weighted Average Exercise Price, Warrants Expired | 0.94 | ||
Weighted Average Exercise Price, Outstanding Ending Balance | $ 1.02 | $ 0.66 | $ 0.57 |
Weighted Average Remaining Contractual Life | |||
Weighted Average Remaining Contractual Life, Warrants Outstanding | 4 years 2 months 26 days | 2 years 18 days | 3 years 4 months 28 days |
Registered Direct Offering | |||
Number of Warrants Outstanding | |||
Number of Warrants, Warrants issued | 15,000,000 | ||
Warrants, Weighted Average Exercise Price | |||
Weighted Average Exercise Price, Warrants issued | $ 1.10 | ||
Weighted Average Exercise Price, Outstanding Ending Balance | $ 1.10 | ||
Weighted Average Remaining Contractual Life | |||
Weighted Average Remaining Contractual Life, Warrants Outstanding | 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 |
Warrants - Warrants Activity Cl
Warrants - Warrants Activity Classified as Equity and Liability (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Warrants Outstanding, Ending Balance | 18,302,897 | 4,130,724 | 7,116,524 |
Exercise price | $ 1.02 | $ 0.66 | $ 0.57 |
Weighted Average Remaining Contractual Life, Warrants Outstanding | 4 years 2 months 26 days | 2 years 18 days | 3 years 4 months 28 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 11 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 7 months 9 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 | 5 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 5 months 15 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 | 5 months 1 day |
Warrants - Narrative (Detail)
Warrants - Narrative (Detail) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 15, 2021 | Dec. 31, 2019 | Aug. 31, 2018 | Jun. 30, 2017 | |
Class of Warrant or Right [Line Items] | ||||||
Exercise price | $ 1.02 | $ 0.66 | $ 0.57 | |||
Number of Warrants, Warrants expired | (15,000) | |||||
Warrant derivative liability | $ 5,805,000 | $ 2,607,000 | ||||
Investor Warrants | ||||||
Class of Warrant or Right [Line Items] | ||||||
Common shares issued for warrant exercised | 284,100 | 2,000,000 | ||||
Exercise price | $ 0.40 | $ 0.40 | ||||
Proceeds from warrant exercises | $ 114,000 | $ 785,000 | ||||
Number Of Warrants Exercised By Placement Agents | 528,727 | 1,000,000 | ||||
Stock Issued On Exercise Of Warrants By Placement Agents | 304,121 | 524,000 | ||||
Confidentially Marketed Public Offering | 2018 public offerings | ||||||
Class of Warrant or Right [Line Items] | ||||||
Exercise price | $ 0.40 | |||||
Warrants to purchase common stock, shares | 20,000,000 | |||||
Warrant, Term | 1 year 7 months 9 days | 2 years 7 months 9 days | 5 years | |||
Warrants outstanding, Fair value | $ 52,000 | $ 606,000 | ||||
Warrant derivative liability | $ 52,000 | $ 606,000 | ||||
Registered Direct Offering | ||||||
Class of Warrant or Right [Line Items] | ||||||
Exercise price | $ 1.10 | |||||
Warrants to purchase common stock, shares | 15,000,000 | |||||
Warrant, Term | 5 years | |||||
Registered Direct Offering | 2017 public offering | ||||||
Class of Warrant or Right [Line Items] | ||||||
Exercise price | $ 0.76 | |||||
Warrants to purchase common stock, shares | 11,000,000 | |||||
Warrant, Term | 5 months 1 day | 1 year 5 months 1 day | 5 years | |||
Warrants outstanding, Fair value | $ 156,000 | $ 2,000,000 | ||||
Warrant derivative liability | $ 156,000 | $ 2,001,000 | ||||
Registered Direct Offering | 2021 public offering | ||||||
Class of Warrant or Right [Line Items] | ||||||
Exercise price | $ 1.10 | |||||
Warrants to purchase common stock, shares | 15,000,000 | |||||
Warrant, Term | 4 years 11 months 15 days | 5 years | ||||
Fair value of warrants | $ 5,600,000 | |||||
Warrant derivative liability | $ 5,597,000 | $ 6,689,000 |
Warrants - Assumptions for Warr
Warrants - Assumptions for Warrants Issued (Detail) | Dec. 31, 2021USD ($)$ / sharesshares | Dec. 15, 2021USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019shares | Aug. 31, 2018 | Jun. 30, 2017 |
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Number of shares | shares | 18,302,897 | 4,130,724 | 7,116,524 | |||
Derivative liability | $ | $ 5,805,000 | $ 2,607,000 | ||||
Registered Direct Offering | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants term (Years) | 5 years | |||||
2018 public offerings | Confidentially Marketed Public Offering | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants term (Years) | 1 year 7 months 9 days | 2 years 7 months 9 days | 5 years | |||
Number of shares | shares | 153,400 | 437,500 | ||||
Derivative liability | $ | $ 52,000 | $ 606,000 | ||||
2018 public offerings | Confidentially Marketed Public Offering | Exercise Price | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | $ / shares | 0.40 | 0.40 | ||||
2018 public offerings | Confidentially Marketed Public Offering | Volatility | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | 1.07 | 1.31 | ||||
2018 public offerings | Confidentially Marketed Public Offering | Risk-free interest rate | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | 0.0060 | 0.0015 | ||||
2017 public offering | Registered Direct Offering | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants term (Years) | 5 months 1 day | 1 year 5 months 1 day | 5 years | |||
Number of shares | shares | 2,026,915 | 2,026,915 | ||||
Derivative liability | $ | $ 156,000 | $ 2,001,000 | ||||
2017 public offering | Registered Direct Offering | Exercise Price | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | $ / shares | 0.76 | 0.76 | ||||
2017 public offering | Registered Direct Offering | Volatility | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | 0.92 | 0.90 | ||||
2017 public offering | Registered Direct Offering | Risk-free interest rate | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | 0.0015 | 0.0011 | ||||
2021 public offering | Registered Direct Offering | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants term (Years) | 4 years 11 months 15 days | 5 years | ||||
Number of shares | shares | 15,000,000 | 15,000,000 | ||||
Derivative liability | $ | $ 5,597,000 | $ 6,689,000 | ||||
2021 public offering | Registered Direct Offering | Exercise Price | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | $ / shares | 1.10 | 1.10 | ||||
2021 public offering | Registered Direct Offering | Volatility | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | 101 | 100 | ||||
2021 public offering | Registered Direct Offering | Risk-free interest rate | ||||||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||||||
Warrants and Rights Outstanding, Measurement Input | 1.25 | 1.26 |
Fair Value Considerations - Fin
Fair Value Considerations - Financial Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
LIABILITIES | ||
Warrant derivative liability | $ 5,805,000 | $ 2,607,000 |
Fair Value, Inputs, Level 1 [Member] | ||
LIABILITIES | ||
Warrant derivative liability | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
LIABILITIES | ||
Warrant derivative liability | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
LIABILITIES | ||
Warrant derivative liability | $ 5,805,000 | $ 2,607,000 |
Fair Value Considerations - Set
Fair Value Considerations - Sets Forth a Reconciliation of Changes (Detail) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Abstract] | |
Balance as of December 31, 2020 | $ 2,607,000 |
Warrants issuances | 6,689,000 |
Warrants exercises | (347,000) |
Change in fair value | (3,144,000) |
Balance as of December 31, 2021 | $ 5,805,000 |
Common Stock - Summarizes the C
Common Stock - Summarizes the Company's remaining authorized shares available (Detail) - shares | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Common Stock. | |||
Authorized shares | 300,000,000 | 300,000,000 | |
Common stock outstanding | 227,325,381 | 193,378,996 | |
Options Outstanding | 7,506,989 | ||
Warrants Outstanding | 18,302,897 | 4,130,724 | 7,116,524 |
Reserved for issuance under 2019 Stock and Incentive Plan | 4,417,332 | ||
Available Shares | 42,447,401 |
Common Stock - Registered Direc
Common Stock - Registered Direct Offering Narrative (Detail) - USD ($) $ / shares in Units, shares in Millions | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Components of common Stock [Line Items] | ||||
Gross proceeds | $ 22,500,000 | |||
Exercise price (Dollars per share) | $ 1.02 | $ 1.02 | $ 0.66 | $ 0.57 |
Registered Direct Offering | ||||
Components of common Stock [Line Items] | ||||
Issuance of common stock in connection with the public offering (in shares) | 25 | |||
Stock price (in dollars per share) | $ 0.90 | $ 0.90 | ||
Warrants to purchase common stock, shares | 15 | 15 | ||
Proceeds from issuance of common stock | $ 22,500,000 | |||
Percentage of commission | 7.00% | 7.00% | ||
Underwriter commission | $ 1,600,000 | |||
Compensation for other costs relating To offering | 75,000 | |||
Costs associated with the offering | $ 167,000 | |||
Exercise price (Dollars per share) | $ 1.10 | $ 1.10 | ||
Warrants term (Years) | 5 years | 5 years | ||
Warrants Outstanding | $ 6,700,000 | $ 6,700,000 |
Common Stock - Sales Agreement
Common Stock - Sales Agreement (Detail) | 1 Months Ended | 12 Months Ended | |
Feb. 29, 2020USD ($)item | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($)shares | |
Sale Agreement (ATM) | |||
Class of Stock [Line Items] | |||
Number of agents | item | 2 | ||
Maximum aggregate offering price of equity securities | $ 50,000,000 | ||
Percentage of commission | 4.00% | ||
Sales Agreement | |||
Class of Stock [Line Items] | |||
Total shares of common stock sold | shares | 6,246,085 | 32,099,677 | |
Gross Proceeds | $ 10,512,000 | $ 26,191,000 | |
Commissions earned by placement agents | (422,000) | (1,050,000) | |
Issuance fees | (90,000) | (318,000) | |
Net Proceeds | $ 10,000,000 | $ 24,823,000 | |
Sales Agreement Agent [Member] | Sale Agreement (ATM) | |||
Class of Stock [Line Items] | |||
Percentage of commission | 2.00% |
Common Stock - Summary of Compa
Common Stock - Summary of Company's sales under the Equity Distribution Agreement (Details) (Detail) - Sales Agreement - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Class of Stock [Line Items] | ||
Total shares of common stock sold | 6,246,085 | 32,099,677 |
Gross Proceeds | $ 10,512,000 | $ 26,191,000 |
Commissions earned by placement agents | (422,000) | (1,050,000) |
Issuance fees | (90,000) | (318,000) |
Net Proceeds | $ 10,000,000 | $ 24,823,000 |
Common Stock - Common Stock Iss
Common Stock - Common Stock Issued for Services (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Components of common Stock [Line Items] | ||
Issuance of common stock for services | $ 80,000 | $ 80,000 |
Common Stock Issued for Services | Non Employee Directors [Member] | ||
Components of common Stock [Line Items] | ||
Issuance of common stock for services (Shares) | 54,052 | 136,236 |
Issuance of common stock for services | $ 80,000 |
Equity Instruments - Activity o
Equity Instruments - Activity of Plan (Detail) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Restricted stock awards granted | (1,785,000) | |
Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options granted | (1,866,000) | (1,923,471) |
Forfeited, expired and/or cancelled equity awards | 15,000 | |
2019 Stock plan | Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total shares reserved for equity awards | 10,000,000 | 10,000,000 |
Options granted | (1,866,000) | (2,067,471) |
Restricted stock awards granted | (1,785,000) | |
Forfeited, expired and/or cancelled equity awards | 5,500 | |
Shares forfeited to settle exercise price and tax obligation | 130,303 | |
Remaining shares available for future equity awards | 4,417,332 |
Equity Instruments - Stock Opti
Equity Instruments - Stock Option Activity (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Options | |||
Number of Options, Ending Balance | 7,506,989 | ||
Employee Stock Option | |||
Number of Options | |||
Number of Options, Beginning Balance | 6,099,651 | 6,000,332 | |
Number of Options, Granted | 1,866,000 | 1,923,471 | |
Number of Options, Exercised | (443,662) | (32,500) | |
Number of Options, Forfeited | (100,000) | ||
Number of Options, Forfeited, expired and/or cancelled | (15,000) | ||
Number of Options, Expired, and/or cancelled | (1,691,652) | ||
Number of Options, Ending Balance | 7,506,989 | 6,099,651 | 6,000,332 |
Number of Options, Exercisable | 6,333,656 | ||
Weighted Average Exercise Price | |||
Weighted Average Exercise Price, Beginning Balance | $ 1.04 | $ 1.33 | |
Weighted Average Exercise Price, Granted | 1.21 | 0.90 | |
Weighted Average Exercise Price, Exercised | 0.55 | 0.33 | |
Weighted Average Exercise Price, Forfeited | 1.70 | ||
Weighted Average Exercise Price, Forfeited, expired and/or cancelled | 5.76 | ||
Weighted Average Exercise Price, Expired, and/or cancelled | 1.87 | ||
Weighted Average Exercise Price, Ending Balance | 1.12 | $ 1.04 | $ 1.33 |
Weighted Average Exercise Price, Exercisable | $ 1.02 | ||
Weighted Average Remaining Contractual Life, Outstanding | 7 years 2 months 15 days | 7 years 4 months 9 days | 5 years 4 months 24 days |
Weighted Average Remaining Contractual Life, Exercisable | 6 years 8 months 23 days | ||
Aggregate Intrinsic Value, Outstanding | $ 91,000 | ||
Aggregate Intrinsic Value, Exercisable | $ 88,000 | ||
Stock options exercised (Shares) | 443,662 | 32,500 | |
Cash exercises of stock options (Shares) | 8,000 | ||
Proceeds from cash exercises | $ 6,000 | ||
Cashless exercises of stock options (Shares) | 302,734 | ||
Proceeds from cashless exercises | $ 154,000 | ||
Stock options exercised, net (Shares) | 132,928 | ||
Stock Issued On Exercise Of Warrants By Placement Agents | 57,058 | ||
Tax obligations on behalf of option holders | $ 40,000 | ||
2010 Stock Plan | |||
Number of Options | |||
Number of Options, Ending Balance | 3,630,018 | ||
2019 Stock plan | |||
Number of Options | |||
Number of Options, Ending Balance | 3,876,971 | ||
2019 Stock plan | Employee Stock Option | |||
Number of Options | |||
Number of Options, Granted | 1,866,000 | 2,067,471 | |
Number of Options, Forfeited, expired and/or cancelled | (5,500) | ||
Number of Options, Available for grant | 4,417,332 |
Equity Instruments - Summary of
Equity Instruments - Summary of Stock Options Outstanding and Exercisable (Detail) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of Options Outstanding | shares | 7,506,989 |
Weighted Average Exercise Price | $ 1.12 |
Weighted Average Remaining Contractual Lives | 7 years 2 months 15 days |
Up to $0.50 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of Options Outstanding | shares | 494,500 |
Weighted Average Exercise Price | $ 0.44 |
Weighted Average Remaining Contractual Lives | 7 years 7 months 28 days |
Range of Exercise Prices Lower | $ 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 | 4,452,345 |
Weighted Average Exercise Price | $ 0.70 |
Weighted Average Remaining Contractual Lives | 6 years 9 months 18 days |
Range of Exercise Prices Lower | $ 0.51 |
Range of Exercise Prices Upper | $ 1 |
$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 8 months 8 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 | 1,623,144 |
Weighted Average Exercise Price | $ 2.45 |
Weighted Average Remaining Contractual Lives | 6 years 9 months 7 days |
Employee Stock Option | $1.51 and above | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of Exercise Prices Lower | $ 1.51 |
Equity Instruments - Restricted
Equity Instruments - Restricted Stock Awards (Details) | 12 Months Ended |
Dec. 31, 2021employee$ / sharesshares | |
Awards | |
Granted (Shares) | 1,785,000 |
Vested (Shares) | (203,423) |
Shares forfeited to settle tax obligation (Shares) | (113,577) |
Unvested at December 31,2021 (Shares) | 1,468,000 |
Restricted stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of employment agreements | employee | 3 |
Number of employee authorized to withhold share of common stock | employee | 3 |
Number of shares forfeiture | 113,577 |
Shares issued in connection with restricted stock awards | 1,700,000 |
Awards | |
Granted (Shares) | 1,800,000 |
Average Grant-Date Fair Value | |
Granted (Dollars per share) | $ / shares | $ 1.64 |
Vested (Dollars per share) | $ / shares | 1.64 |
Shares forfeited to settle tax obligation (Dollars per share) | $ / shares | 1.64 |
Unvested at December 31, 2021 (Dollars per share) | $ / shares | $ 1.64 |
Equity Instruments - Assumption
Equity Instruments - Assumptions Used in Computing Fair Value of All Options Granted (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, Minimum | 113.00% | 121.00% |
Expected volatility, Maximum | 127.00% | 134.00% |
Risk free interest rate, Minimum | 0.78% | 0.19% |
Risk free interest rate, Maximum | 1.38% | 1.67% |
Stock-based compensation expenses | $ 2,804,000 | $ 1,357,000 |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 5 years | 3 years |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 6 years 6 months | 6 years |
Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | $ 1,400,000 | |
Restricted stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | 1,300,000 | |
Options and Restricted stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | $ 2,700,000 |
Equity Instruments - Summary _2
Equity Instruments - Summary of Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | $ 2,804,000 | $ 1,357,000 |
Unrecognized share-based compensation expense related to stock options as of December 31, 2021 | $ 868,000 | |
Weighted average remaining years to vest for stock options | 1 year 2 months 26 days | |
Unrecognized share-based compensation expense related to restricted stock awards as of December 31, 2021 | $ 1,572,000 | |
Weighted average remaining years to vest for restricted stock awards | 3 years 3 days | |
Research and Development Expenses | Stock Based Compensation | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | $ 46,000 | 401,000 |
General and Administrative Expenses | Common Stock Issued for Services | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | 80,000 | 80,000 |
General and Administrative Expenses | Stock Based Compensation | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expenses | $ 2,678,000 | $ 876,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Effective Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Benefit at federal statutory rate | (21.00%) | (21.00%) |
State, net of federal income tax impact | (4.40%) | (2.90%) |
Stock-based compensation | 0.10% | 4.70% |
Registered offering gain / warrant expense | (4.60%) | 0.40% |
Paycheck Protection Program funding | 0.00% | 0.70% |
Change in state deferred tax rate | 0.00% | 0.70% |
Expiration of tax attribute carryforwards | 1.10% | 1.50% |
Other | 2.10% | 0.00% |
Change in valuation allowance | 26.70% | 17.30% |
Effective tax rate | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Long-term deferred income tax assets (liabilities): | ||
Accrued liabilities | $ 96,000 | |
Interest expense carryforward | 73,000 | |
ROU Asset | (155,000) | $ (203,000) |
Lease liability | 228,000 | 298,000 |
Net operating loss carryforward | 47,858,000 | 43,515,000 |
Share-based compensation | 1,050,000 | 1,030,000 |
Unrealized loss on trading security | 772,000 | 772,000 |
Property and equipment | 113,000 | 9,000 |
Warrants | 96,000 | 152,000 |
Other | 1,000 | 1,000 |
Less: Valuation allowance | (50,132,000) | (45,574,000) |
Total long-term deferred income tax assets (liabilities) | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Income Taxes [Line Items] | |
Operating Loss Carryforwards | $ 194.6 |
Operating Loss Carryforward, Carries Forward Indefinitely | $ 63.5 |
Minimum | |
Income Taxes [Line Items] | |
Percentage Of Likelihood Of Tax Benefit Being Realized | 50.00% |
Earnings Per Share (Detail)
Earnings Per Share (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share | ||
Net loss | $ (17,075,000) | $ (15,894,000) |
Less: decrease in fair value of investor warrants | (3,492,000) | |
Loss available to common stockholders | $ (20,567,000) | $ (15,894,000) |
Basic weighted-average common shares outstanding | 199,299,072 | 172,846,773 |
Add: dilutive effect of equity instruments | 5,663,947 | |
Diluted weighted-average shares outstanding | 204,963,019 | 172,846,773 |
Earnings per share - basic | $ (0.09) | $ (0.09) |
Earnings per share - diluted | $ (0.10) | $ (0.09) |
Earnings Per Share - Anti-dilut
Earnings Per Share - Anti-dilutive (Detail) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares of common stock | 21,613,939 | 10,230,375 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares of common stock | 12,638,950 | 4,130,724 |
Employee Stock Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares of common stock | 7,506,989 | 6,099,651 |
Restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive shares of common stock | 1,468,000 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event [Member] | 1 Months Ended |
Feb. 28, 2022USD ($)Yinstallment | |
Subsequent Event [Line Items] | |
Number of Installments | installment | 4 |
Term of installments | Y | 1 |
Trauma Research, LLC | |
Subsequent Event [Line Items] | |
Total research activity to be performed | $ 400,000 |
Research Agreement With Director | |
Subsequent Event [Line Items] | |
Total research activity to be performed | $ 250,000 |