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AMPE Ampio Pharmaceuticals

Document And Entity Information

Document And Entity Information - shares3 Months Ended
Mar. 31, 2021Apr. 26, 2021
Document And Entity Information [Abstract]
Document Type10-Q
Document Quarterly Reporttrue
Document Period End DateMar. 31,
2021
Document Transition Reportfalse
Entity File Number001-35182
Entity Registrant NameAMPIO PHARMACEUTICALS, INC.
Entity Incorporation, State or Country CodeDE
Entity Tax Identification Number26-0179592
Entity Address, Address Line One373 Inverness Parkway, Suite 200
Entity Address, City or TownEnglewood
Entity Address, State or ProvinceCO
Entity Address, Postal Zip Code80112
City Area Code720
Local Phone Number437-6500
Title of 12(b) SecurityCommon Stock, par value $0.0001 per share
Trading SymbolAMPE
Security Exchange NameNYSEAMER
Entity Current Reporting StatusYes
Entity Interactive Data CurrentYes
Entity Filer CategoryNon-accelerated Filer
Entity Small Businesstrue
Entity Emerging Growth Companyfalse
Entity Shell Companyfalse
Entity Common Stock, Shares Outstanding195,689,128
Entity Central Index Key0001411906
Current Fiscal Year End Date--12-31
Document Fiscal Year Focus2021
Document Fiscal Period FocusQ1
Amendment Flagfalse

Condensed Balance Sheets

Condensed Balance Sheets - USD ($)Mar. 31, 2021Dec. 31, 2020
Current assets
Cash and cash equivalents $ 15,804,000 $ 17,346,000
Prepaid expenses and other1,798,000 1,147,000
Total current assets17,602,000 18,493,000
Fixed assets, net3,348,000 3,561,000
Right-of-use asset776,000 824,000
Total assets21,726,000 22,878,000
Current liabilities
Accounts payable and accrued expenses1,351,000 1,550,000
Lease liability-current portion291,000 284,000
Total current liabilities1,642,000 1,834,000
Lease liability-long-term851,000 925,000
Warrant derivative liability2,456,000 2,607,000
Total liabilities4,949,000 5,366,000
Commitments and contingencies (Note 7)
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 - 195,689,128 as of March 31, 2021 and 193,378,996 as of December 31, 202019,000 19,000
Additional paid-in capital220,952,000 218,020,000
Accumulated deficit(204,194,000)(200,527,000)
Total stockholders' equity16,777,000 17,512,000
Total liabilities and stockholders' equity $ 21,726,000 $ 22,878,000

Condensed Balance Sheets (Paren

Condensed Balance Sheets (Parenthetical) - $ / sharesMar. 31, 2021Dec. 31, 2020
Condensed Balance Sheets
Preferred Stock, par value $ 0.0001 $ 0.0001
Preferred Stock, shares authorized10,000,000 10,000,000
Preferred Stock, shares issued0 0
Common Stock, par value $ 0.0001 $ 0.0001
Common Stock, shares authorized300,000,000 300,000,000
Common Stock, shares issued195,689,128 193,378,996
Common Stock, shares outstanding195,689,128 193,378,996

Condensed Statements of Operati

Condensed Statements of Operations - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Operating expenses
Research and development $ 2,296,000 $ 4,254,000
General and administrative1,523,000 1,767,000
Total operating expenses3,819,000 6,021,000
Other income
Interest income1,000 11,000
Derivative gain151,000 831,000
Total other income152,000 842,000
Net loss $ (3,667,000) $ (5,179,000)
Net loss per common share: Basic $ (0.02) $ (0.03)
Net loss per common share: Diluted $ (0.02) $ (0.04)
Weighted average number of common shares outstanding: Basic195,387,047 159,053,722
Weighted average number of common shares outstanding: Diluted200,752,267 160,557,777

Condensed Statements of Stockho

Condensed Statements of Stockholders' Equity - USD ($)Common Stock [Member]At The Market Equity Offering ProgramCommon Stock [Member]Additional Paid-in CapitalAt The Market Equity Offering ProgramAdditional Paid-in CapitalAccumulated DeficitAt The Market Equity Offering ProgramAccumulated DeficitAt The Market Equity Offering ProgramTotal
Beginning Balance at Dec. 31, 2019 $ 16,000 $ 191,060,000 $ (184,633,000) $ 6,443,000
Beginning Balance, shares at Dec. 31, 2019158,644,757
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 $ 0 213,000 0 213,000
Issuance of common stock $ 0 $ 682,000 $ 0 $ 682,000
Issuance of common stock (Shares)1,241,126
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program0 (246,000)0 (246,000)
Net loss0 0 (5,179,000)(5,179,000)
Ending Balance at Mar. 31, 2020 $ 16,000 191,789,000 (189,812,000)1,993,000
Ending Balance, shares at Mar. 31, 2020160,022,119
Beginning Balance at Dec. 31, 2020 $ 19,000 218,020,000 (200,527,000)17,512,000
Beginning Balance, shares at Dec. 31, 2020193,378,996
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 $ 0 166,000 0 166,000
Stock options exercised, net $ 0 33,000 0 33,000
Stock options exercised, net (Shares)129,500
Shares held back in settlement of tax obligation and exercise cost $ 0 (40,000)(40,000)
Shares held back in settlement of tax obligation and exercise cost (Shares)(28,562)
Warrants exercised, net $ 0 114,000 0 114,000
Warrants exercised, net (Shares)306,705
Issuance of common stock $ 0 $ 2,705,000 $ 0 $ 2,705,000
Issuance of common stock (Shares)1,848,437
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program $ 0 (126,000)0 (126,000)
Net loss0 0 (3,667,000)(3,667,000)
Ending Balance at Mar. 31, 2021 $ 19,000 $ 220,952,000 $ (204,194,000) $ 16,777,000
Ending Balance, shares at Mar. 31, 2021195,689,128

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Cash flows used in operating activities
Net loss $ (3,667,000) $ (5,179,000)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation, net of forfeitures166,000 213,000
Depreciation and amortization294,000 295,000
Issuance of common stock for services80,000 80,000
Derivative gain(151,000)(831,000)
Changes in operating assets and liabilities
(Increase) decrease in prepaid expenses and other(651,000)698,000
(Decrease) increase in accounts payable and accrued expenses(199,000)189,000
Decrease in lease liability(19,000)(18,000)
Net cash used in operating activities(4,147,000)(4,553,000)
Cash flows used in investing activities
Purchase of fixed assets(81,000)0
Net cash used in investing activities(81,000)0
Cash flows from financing activities
Proceeds from sale of common stock in connection with "at-the-market" equity offering program2,705,000 682,000
Costs related to sale of common stock in connection with the "at-the-market" equity offering program(126,000)(246,000)
Proceeds from warrant exercises114,000 0
Other(7,000)0
Net cash provided by financing activities2,686,000 436,000
Net change in cash and cash equivalents(1,542,000)(4,117,000)
Cash and cash equivalents at beginning of period17,346,000 6,532,000
Cash and cash equivalents at end of period $ 15,804,000 $ 2,415,000

The Company and Summary of Sign

The Company and Summary of Significant Accounting Policies3 Months Ended
Mar. 31, 2021
The Company and Summary of Significant Accounting Policies
The Company and Summary of Significant Accounting PoliciesNote 1 – The Company and Summary of Significant Accounting Policies Ampio Pharmaceuticals, Inc. (“Ampio” or the “Company”) is a biopharmaceutical company focused on the development and advancement of immunology-based therapies for prevalent inflammatory conditions. Basis of Presentation ​ The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions of the SEC on Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the financial position and of the results of operations and cash flows of the Company for the periods presented. ​ These financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2020 included in the Company’s 2020 Annual Report. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The information as of and for the three months ended March 31, 2021 is unaudited. The balance sheet at December 31, 2020 was derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements. Impact of Global Pandemic ​ In January 2020, the World Health Organization (“WHO”) announced a global health emergency because of the novel coronavirus (“COVID-19”). In March 2020, the WHO declared the outbreak of COVID-19, a global pandemic. COVID-19 has, and continues, to adversely impact the United States and global economies. In April 2020, and pursuant to the U.S. Food and Drug Administration (“FDA”), independent Safety Monitoring Committee (“SMC”), and Institutional Review Board guidance covering ongoing clinical trials in the presence of the COVID-19 pandemic, the Company and the clinical research organization (“CRO”) paused all ongoing conduct associated with the Phase III clinical trial (the “AP-013 study”) of Ampion for the treatment of Osteoarthritis of the Knee (“OAK”). In March 2021, the Company submitted a detailed proposal to the FDA in response to the FDA’s guidance regarding the status of the AP-013 study. In April 2021, the Company received a response to the proposal from the FDA, which provides guidance and flexibility on how to maintain the Special Protocol Assessment (“SPA”), while allowing the Company to evaluate and consider several paths for moving forward. The Company is evaluating the FDA’s response and will continue to maintain an ongoing active dialog with the FDA with respect to the AP-013 study to reach agreement on the path forward considering the ongoing pandemic. The AP-013 study data will continue to remain paused and blinded to ensure clinical trial integrity and compliance with the SPA issued by the FDA in June 2019 until agreement is reached with the FDA. ​ In addition, since June 2020, the Company has commenced several clinical trials to determine the safety and efficacy for new applications of Ampion (i.e., inhaled and intravenous) related to COVID-19 infection. Given the continued evolution of the COVID-19 pandemic and the related complexities and uncertainties associated with the additional variants, the Company’s business operations could be significantly impacted and, in addition, the business operations of third parties on which the Company relies, including organizations that conduct clinical trials and key suppliers which provide the raw materials for manufacturing Ampion for the ongoing clinical trials could also be impacted. The full extent of the potential adverse impact on the Company’s business operations and related product development, including, but not limited to, clinical trials, financing activities and the overall impact on the United States and the global economy will depend on future developments, which cannot be predicted at this time due to the continued uncertainty of the COVID-19 pandemic. ​ Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company has no off-balance-sheet concentrations of credit risk, such as foreign exchange contracts, option contracts or foreign currency hedging arrangements. The Company consistently maintains its cash and cash equivalent balances in the form of bank demand deposits, United States federal government backed treasury securities and fully liquid money market fund accounts with financial institutions that management believes are creditworthy. The Company periodically monitors its cash positions with, and the credit quality of, the financial institutions with which it invests. During the three months ended March 31, 2021, and as consistent with prior reporting periods, the Company maintained balances in excess of federally insured limits. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and related disclosures in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions primarily include the Company’s projected liquidity and resulting going concern position and the projected useful lives and potential impairment of fixed assets. The Company develops these estimates using its judgment based upon the facts and circumstances known at the time. Adoption of Recent Accounting Pronouncements The Company has not adopted any recent accounting pronouncements during the three months ended March 31, 2021. Recent Accounting Pronouncements In August 2020, 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 Quarterly Report on Form 10-Q does not discuss recent pronouncements that are not anticipated to have a current and/or future impact on or are unrelated to the Company’s financial condition, results of operations, cash flows or disclosures.

Going Concern

Going Concern3 Months Ended
Mar. 31, 2021
Going Concern
Going ConcernNote 2 - Going Concern As of and for the three months ended March 31, 2021, the Company had cash and cash equivalents of $15.8 million and a net loss of $3.7 million, respectively. The net loss is primarily attributable to operating expenses of $3.8 million, partially offset by the non-cash derivative gain of $151,000 (see Note 9 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, may issue and sell from time to time shares of its authorized common stock. During the three months ended March 31, 2021, the Company sold shares pursuant to the ATM equity offering program, which yielded gross proceeds of $2.7 million, which was offset by offering related costs of $126,000 (see Note 10 ​ The Company has prepared an updated projection covering the period from May 1, 2021 through April 30, 2022 based on the requirements of ASC 205-40, “ Going Concern ​ The accompanying unaudited interim financial statements were prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These financial statements do not include any separate adjustments relating to the recovery of recorded assets or the classification of liabilities, which adjustments may be necessary in the future should the Company be unable to continue as a going concern.

Prepaid Expenses and Other

Prepaid Expenses and Other3 Months Ended
Mar. 31, 2021
Prepaid Expenses and Other
Prepaid Expenses and OtherNote 3 – Prepaid Expenses and Other Prepaid expenses and other balances as of March 31, 2021 and December 31, 2020 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2021 ​ December 31, 2020 ​ ​ ​ ​ ​ Deposits ​ $ 1,311,000 ​ $ 266,000 Unamortized commercial insurance premiums ​ ​ 295,000 ​ ​ 627,000 Annual maintenance service contracts ​ ​ 77,000 ​ ​ — Receivable ​ ​ 26,000 ​ ​ 185,000 Other ​ ​ 89,000 ​ ​ 69,000 Total prepaid expenses and other ​ $ 1,798,000 ​ $ 1,147,000 ​

Fixed Assets

Fixed Assets3 Months Ended
Mar. 31, 2021
Fixed Assets
Fixed AssetsNote 4 – Fixed Assets Fixed assets are recorded based on acquisition cost and, once placed in service, are depreciated on the straight-line method over their estimated economic useful lives. Leasehold improvements are accreted over the shorter of the estimated economic life or related lease term. Fixed assets, net of accumulated depreciation and amortization, consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Estimated ​ ​ ​ ​ ​ ​ Useful Lives ​ March 31, ​ December 31, ​ in Years 2021 2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ Leasehold improvements 10 ​ $ 2,100,000 ​ $ 2,250,000 Manufacturing facility/clean room 3 - 8 ​ ​ 931,000 ​ ​ 998,000 Lab equipment and office furniture 5 - 8 ​ 317,000 ​ 313,000 Fixed assets, net ​ ​ ​ $ 3,348,000 ​ $ 3,561,000 ​ Depreciation and amortization expense for the respective periods is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ ​ 2021 2020 ​ ​ ​ ​ ​ ​ ​ ​ Depreciation and amortization expense ​ $ 294,000 ​ $ 295,000 ​ ​

Accounts Payable and Accrued Ex

Accounts Payable and Accrued Expenses3 Months Ended
Mar. 31, 2021
Accounts Payable and Accrued Expenses
Accounts Payable and Accrued ExpensesNote 5 – Accounts Payable and Accrued Expenses Accounts payable and accrued expenses as of March 31, 2021 and December 31, 2020 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2021 ​ December 31, 2020 ​ ​ ​ ​ ​ Accounts payable ​ $ 126,000 ​ $ 186,000 Clinical trials ​ ​ 1,050,000 ​ ​ 558,000 Professional fees ​ 78,000 ​ 267,000 Other insurance premium ​ 32,000 ​ 386,000 Other ​ ​ 65,000 ​ ​ 153,000 Accounts payable and accrued expenses ​ $ 1,351,000 ​ $ 1,550,000 ​

Paycheck Protection Program

Paycheck Protection Program3 Months Ended
Mar. 31, 2021
Paycheck Protection Program
Paycheck Protection ProgramNote 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 is two years with an annual interest rate of 1.0% and principal and interest payments will 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 (the “Flexibility Act”). ​ In October 2020, the Company submitted its PPP loan forgiveness application, requesting forgiveness of the full principal amount of its PPP loan of $544,000, which the Company believes to consist of qualified expenses as defined by the Flexibility Act. The loan forgiveness application has been approved by the Lender and submitted to the SBA for final review. According to the Flexibility Act, the SBA will, subject to any SBA review of the loan or loan application, remit the appropriate forgiveness amount to the Lender, plus any interest accrued thereon through the date of payment, not later than 90 days after the Lender issues its decision to the SBA. As of the date of this filing, the Company has not been notified by the Lender of the SBA’s response to the PPP loan forgiveness application, but the Lender has confirmed that repayment of the loan will be deferred until the SBA provides a response. Based on the PPP loan forgiveness application calculation, and the Lender approving the loan forgiveness application, the Company continues to assert that it is probable the PPP loan qualifies for forgiveness in full by the SBA and such forgiveness will be provided by the SBA in due course. However, without formal approval from the SBA, the Company cannot provide certainty that it will obtain forgiveness in whole or in part. ​ The Company believes that it is not likely or probable, but pursuant to the Flexibility Act, the Company’s PPP loan agreement will be amended in the event that no amount or less than all of the PPP loan is forgiven. In addition, starting in September 2021, the Company will be required to make principal and interest payments totaling $23,000 per month or an adjusted amount based on the loan amendment over the remaining term of the PPP loan until such time as the loan is fully settled.

Commitments and Contingencies

Commitments and Contingencies3 Months Ended
Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Commitments and ContingenciesNote 7 - Commitments and Contingencies Commitments and contingencies are described below and summarized by the following table: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total (1) 2021 2022 2023 2024 2025 Thereafter Key clinical research trial obligations ​ $ 1,708,000 ​ $ 1,708,000 ​ $ — ​ $ — ​ $ — ​ $ — ​ $ — BLA consulting services ​ ​ 1,140,000 ​ ​ — ​ ​ 1,140,000 ​ ​ — ​ ​ — ​ ​ — ​ ​ — Statistical analysis and programming consulting services ​ ​ 326,000 ​ ​ 326,000 ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — Employment agreements ​ ​ 1,046,000 ​ ​ 567,000 ​ ​ 466,000 ​ ​ 13,000 ​ ​ — ​ ​ — ​ ​ — ​ ​ $ 4,220,000 ​ $ 2,601,000 ​ $ 1,606,000 ​ $ 13,000 ​ $ — ​ $ — ​ $ — ​ (1) Not included in the commitments and contingencies table above are the monthly principal and interest payments of $23,000 that would be due beginning in September 2021 and continuing for a period of 24 months in the event the loan is not forgiven by the SBA (see Note 6 ). ​ Key Clinical Research Trial Obligations Osteoarthritis of the Knee ​ ​ ​ AP-013 study In December 2020, the Company entered into an initial contract with a CRO in connection with the AP-013 study database totaling $1.4 million. The contract required a retainer of $465,000, which the Company funded during the three months ended March 31, 2021. In March 2021, the Company submitted a detailed proposal to the FDA in response to the FDA’s guidance regarding the status of the AP-013 study, which was paused as a result of the COVID-19 pandemic. In April 2021, the Company received a response to the proposal from the FDA. The Company is evaluating the FDA’s response and will continue to maintain an ongoing active dialog with the FDA with respect to the AP-013 study to reach agreement on the path forward considering the ongoing pandemic. Until agreement with the FDA is reached, the AP-013 study data will continue to remain paused and blinded to ensure clinical trial integrity. Depending on the FDA’s response, the future contractual commitment amount and timing of disbursement may change. The Company had an outstanding future commitment of $347,000 (net of deposit) as of March 31, 2021. ​ Inhaled treatment for COVID-19 patients AP-014 study and AP-018 study In September 2020, the Company entered into a contract with a CRO in connection with the FDA approved IND application covering inhaled Ampion treatment for COVID-19 infected patients hospitalized for respiratory distress (the “AP-014 study”) totaling $836,000. The contract scope reflected an initial estimate of ten study sites. However, the Company was able to finalize enrollment of the AP-014 study with only three sites. Based on the reduction in study sites, the revised estimate for the AP-014 study was reduced to $530,000. In addition, the contract required an initial retainer of $232,000, which has been funded and will be applied to the study expenses as further defined by the contract. In March 2021, the Company entered into a new contract with a CRO in connection with a randomized, double-blinded, placebo-controlled Phase I study to evaluate the safety and efficacy of Ampion in patients with Long-COVID, or prolonged respiratory symptoms due to COVID-19 (“the AP-018 study”). Due to the reduction of the AP-014 contractual amount, the Company requested, and the CRO approved, that $105,000 of the AP-014 retainer be transferred to the AP-018 study retainer (see additional information below). Due to the transfer of a portion of the retainer to the AP-018 study, the remaining retainer balance for the AP-014 study is $127,000. As of March 31, 2021, the Company had incurred cumulative costs totaling $496,000 against the contract for the AP-014 study and, as such, had an outstanding obligation of $0 (net of deposit). As noted above, in March 2021, the Company entered into a contract with a CRO totaling $318,000 for the AP-018 study for at-home treatment with inhaled Ampion for patients with Long-COVID, or prolonged respiratory symptoms due to COVID-19. The contract required an initial retainer of $105,000, which will be applied to future study expenses as further defined by the contract. The Company expects to commence enrollment of the AP-018 study during the second quarter of 2021 and, as such, had an outstanding future commitment of $213,000 (net of deposit) as of March 31, 2021. Intravenous (“IV”) treatment for COVID-19 patients AP-017 study In December 2020, the Company entered into a contract with a CRO in connection with the FDA approved IND application covering IV Ampion treatment for COVID-19 patients for an expanded global Phase II study (the “AP-017 study”) totaling $1.8 million. The contract required an initial retainer of $495,000, which the Company funded during the three months ended March 31, 2021 and which will be applied to future study expenses as further defined by the contract. The Company expects to commence enrollment in the AP-017 study during the second quarter of 2021 and, as such, had an outstanding future commitment of $1.1 million (net of deposit) as of March 31, 2021. BLA Consulting Services In March 2018, the Company entered into a BLA consulting services agreement for $1.2 million. This contract required a deposit, of which $182,000 was funded and classified within the “prepaid expenses and other” line item on the balance sheet. In June 2020, the Company finalized contract negotiations to increase the contract by a nominal amount to incorporate the review of the IND applications for inhaled and IV Ampion treatment. In September 2020, the Company finalized an amendment to the existing contract, which resulted in a refund of the initial deposit and requires the Company to provide a future deposit totaling $364,000 at such time the work commences related to the preparation of the related BLA for Ampion. The Company has incurred cumulative costs totaling $82,000 against this contract and, as such, had outstanding future obligations totaling $1.1 million as of March 31, 2021, which will be settled at such time as future services are provided to the Company primarily related to the development and filing of the Ampion BLA. Due to the pause of the AP-013 study, as of the date of this filing, the Company estimates the incurrence of the remaining costs associated with the preparation of the BLA filing will be postponed until early 2022, if not later. Statistical Analysis and Programming Consulting Services In May 2019, Ampio entered into a statistical analysis and programming consulting services agreement for $578,000. As of March 31, 2021, the Company had incurred cumulative costs totaling $252,000 against the contract and, as such, had an outstanding obligation of $326,000, which is expected to be settled over the duration of 2021. Employment Agreements On December 14, 2019, the Company entered into a new three-year employment agreement with Mr. Macaluso, Chief Executive Officer, which became effective January 10, 2020, immediately following the expiration of his prior employment agreement. The new employment agreement provides for an annual salary of $300,000 and term ending January 10, 2023, subject to certain automatic renewal provisions. On September 16, 2019, the Company entered into a new two-year employment agreement with Ms. Cherevka, Chief Operating Officer, which by its terms cancelled the previous employment agreement on such date. The new employment agreement provides for an annual salary of $280,000 and a term ending September 16, 2021, subject to certain automatic renewal provisions. The Company entered into an employment agreement with Mr. Daniel Stokely, Chief Financial Officer, on July 9, 2019, which provided for an annual salary of $285,000 and a term beginning July 31, 2019 and lasting for three years, subject to certain automatic renewal provisions. Amounts noted above do not assume the continuation of employment beyond the contractual terms of each employee’s existing employment agreements. 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 March 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Facility Lease Payments Remainder of 2022 2023 2024 2025 Thereafter ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Remaining Facility Lease Payments ​ $ 1,259,000 ​ $ 260,000 ​ $ 355,000 ​ $ 364,000 ​ $ 280,000 ​ $ — ​ $ — Less: Discount Adjustment ​ (117,000) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total lease liability ​ $ 1,142,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Lease liability-current portion ​ $ 291,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Long-term lease liability ​ $ 851,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of March 31, 2021: ​ ​ ​ ​ ​ ​ ROU Asset ​ ​ ​ Balance as of December 31, 2020 ​ $ 824,000 Amortization ​ ​ (48,000) Balance as of March 31, 2021 ​ $ 776,000 ​ ​ The Company recorded lease expense in the respective periods is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ ​ 2021 2020 ​ ​ ​ ​ ​ ​ ​ ​ Lease expense ​ $ 73,000 ​ $ 67,000 ​ ​

Warrants

Warrants3 Months Ended
Mar. 31, 2021
Warrants
WarrantsNote 8 – Warrants The Company has issued both equity (“placement agent”) and liability classified (“investor”) warrants in conjunction with previous equity raises. The Company had a total of 1.6 million equity-classified warrants and 2.2 million liability-classified warrants outstanding as of March 31, 2021. ​ The following table summarizes the Company’s warrant activity during the three months ended March 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Weighted Average ​ ​ Number of ​ Average ​ Remaining ​ ​ Warrants ​ Exercise Price ​ Contractual Life ​ ​ ​ ​ ​ ​ ​ ​ Outstanding as of December 31, 2020 ​ 4,130,724 ​ $ 0.66 ​ 2.05 Warrants exercised ​ (316,174) ​ $ 0.41 ​ — Outstanding as of March 31, 2021 3,814,550 ​ $ 0.68 1.75 ​ ​ The following table summarizes the Company’s outstanding warrants between placement agent and investor warrant classifications: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Weighted Average ​ ​ Number of ​ Average ​ Remaining ​ ​ Warrants ​ Exercise Price ​ Contractual Life ​ ​ ​ ​ ​ ​ ​ ​ Investor warrants at $0.76 ​ 2,026,915 ​ ​ ​ ​ 1.17 Placement agent warrants at $0.76 ​ 431,685 ​ ​ ​ ​ 1.17 Placement agent warrants at $0.94 ​ 150,000 ​ ​ ​ ​ 0.42 Investor warrants at $0.40 ​ 153,400 ​ ​ ​ ​ 2.37 Placement agent warrants at $0.50 ​ 1,052,550 ​ ​ ​ ​ 3.22 Outstanding as of March 31, 2021 3,814,550 ​ $ 0.68 1.75 ​ During the three months ended March 31, 2021, the Company issued 284,000 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 three months ended March 31, 2021 related to these investor warrant exercises. In addition, former placement agents elected to exercise 32,000 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 the Company issued 23,000 shares of common stock as a result. The Company did not receive any cash related to the exercise of placement agent warrants. The total value for the warrant derivative liability as of March 31, 2021 is approximately $2.5 million (see Note 9

Fair Value Considerations

Fair Value Considerations3 Months Ended
Mar. 31, 2021
Fair Value Considerations [Abstract]
Fair Value ConsiderationsNote 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 reflect inputs that market participants would use in pricing the asset or liability based on market data obtained from sources not affiliated with the Company. Unobservable inputs are inputs that reflect the Company’s assumptions of what market participants would use in pricing the asset or liability based on the best information available in the circumstances. The hierarchy is broken down into three levels based on reliability of the inputs as follows: Level 1: Inputs that reflect unadjusted quoted prices in active markets that are accessible to the Company for identical assets or liabilities; Level 2: Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and Level 3: Unobservable inputs that are supported by little or no market activity. ​ The Company’s financial instruments include cash and cash equivalents, accounts payable and accrued expenses, and warrant derivative liability. Warrants are recorded at estimated fair value utilizing the Black-Scholes warrant pricing model. The Company’s assets and liabilities which are measured at fair value are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. The Company’s policy is to recognize transfers in and/or out of the fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. The Company has consistently applied the valuation techniques in all periods presented. The following table presents the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of March 31, 2021 and December 31, 2020, by level within the fair value hierarchy: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements Using ​ Level 1 Level 2 Level 3 Total March 31, 2021 ​ ​ ​ ​ ​ Liabilities: ​ ​ ​ ​ Warrant derivative liability ​ $ — ​ $ — ​ $ 2,456,000 ​ $ 2,456,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2020 ​ ​ ​ ​ Liabilities: ​ ​ ​ ​ Warrant derivative liability ​ $ — ​ $ — ​ $ 2,607,000 ​ $ 2,607,000 ​ The warrant derivative liability for both periods presented was valued using the Black-Scholes valuation methodology because that model embodies all the relevant assumptions that address the features underlying these instruments. The following table sets forth a reconciliation of changes in the fair value of financial liabilities classified as Level 3 in the fair value hierarchy: ​ ​ ​ ​ ​ Derivative Instruments ​ ​ ​ ​ Balance as of December 31, 2020 ​ $ 2,607,000 Warrant exercises ​ (347,000) Change in fair value ​ 196,000 Balance as of March 31, 2021 ​ $ 2,456,000 ​

Common Stock

Common Stock3 Months Ended
Mar. 31, 2021
Equity [Abstract]
Common stockNote 10 - Common Stock Authorized Shares The Company had 300.0 million authorized shares of common stock as of March 31, 2021 and December 31, 2020. The following table summarizes the Company’s remaining authorized shares available for future issuance: ​ ​ ​ ​ ​ March 31, 2021 ​ ​ ​ Authorized shares ​ 300,000,000 ​ ​ ​ Common stock outstanding ​ 195,689,128 Options outstanding ​ 6,001,151 Warrants outstanding ​ 3,814,550 Reserved for issuance under 2019 Stock and Incentive Plan ​ 7,918,755 ​ ​ ​ Available shares ​ 86,576,416 ​ ATM Equity Offering Program 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. The following table summarizes the Company’s sales and related issuance costs incurred under the Sales Agreement during the three months ended March 31, 2021: ​ ​ ​ ​ ​ ​ ​ Sales Agreement ​ ​ ​ ​ Total shares of common stock sold ​ ​ 1,848,437 ​ ​ ​ ​ Gross proceeds ​ $ 2,705,000 Commissions earned by placement agents ​ ​ (109,000) Issuance fees ​ ​ (17,000) Net proceeds ​ $ 2,579,000 ​ Common Stock Issued for Services The Company issued 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 three months ended March 31, 2021 and 2020, respectively.

Equity

Equity3 Months Ended
Mar. 31, 2021
Equity
EquityNote 11 - Equity Options In December 2019, the Company’s Board of Directors and stockholders approved the adoption of the 2019 Plan, under which shares were reserved for future issuance of equity related awards classified as option awards/grants, restricted stock awards and other equity related awards. The 2019 Plan permits grants of equity awards to employees, directors and consultants. The stockholders approved a total of 10.0 million shares to be reserved for issuance under the 2019 Plan. The Company’s previous 2010 Stock and Incentive Plan (the “2010 Plan”) was cancelled concurrently with the adoption of the 2019 Plan. The following table summarizes the activity of the 2019 Plan and the shares available for future equity awards as of March 31, 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 ​ ​ (36,000) Forfeited, expired and/or cancelled equity awards ​ 22,226 Remaining shares available for future equity awards ​ ​ 7,918,755 ​ The following table summarizes the Company’s stock option activity during the three months ended March 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Weighted Average ​ ​ ​ ​ Number of ​ Average ​ Remaining ​ ​ Aggregate ​ ​ Options ​ Exercise Price ​ Contractual Life ​ ​ Intrinsic Value Outstanding as of December 31, 2020 6,099,651 ​ $ 1.04 7.36 $ — Granted 36,000 ​ $ 1.76 ​ ​ ​ Exercised (129,500) ​ $ 0.48 ​ ​ ​ Forfeited, expired and/or cancelled (5,000) ​ $ 1.75 ​ ​ ​ Outstanding as of March 31, 2021 6,001,151 ​ $ 1.06 7.14 $ 5,109,000 Exercisable as of March 31, 2021 5,692,151 ​ $ 1.06 7.00 $ 4,906,000 ​ Of the 129,500 stock options that were exercised, 8,000 were cash exercised, where the Company received proceeds to cover the option holder’s exercise price and tax obligations totaling $6,000. In addition, 60,000 stock options were exercised as cashless exercises, where the Company received proceeds to cover the option holders’ exercise price totaling $27,000. The remaining 61,500 stock options were net exercised, where the total number of shares of common stock issued was reduced to cover the option holders’ exercise price and tax obligations. The Company submitted the tax obligations totaling $40,000 on behalf of the option holders and did not receive any cash proceeds from the net stock option exercises. Shares of common stock that are held back upon exercise of a stock option to cover the option holder’s exercise price and tax obligations are added back to the shares of stock available for issuance under the 2019 Plan. The following table summarizes the outstanding options that were issued in accordance with the 2010 Plan and the 2019 Plan: ​ ​ ​ ​ Outstanding Options by Plan ​ March 31, 2021 ​ ​ ​ ​ 2010 Plan ​ ​ 3,938,180 2019 Plan ​ ​ 2,062,971 Outstanding as of March 31, 2021 ​ ​ 6,001,151 ​ Stock options outstanding as of March 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 $0.50 602,000 ​ $ 0.44 8.31 $0.51 - $1.00 4,346,007 ​ $ 0.70 7.31 $1.01 - $1.50 ​ 194,000 ​ $ 1.38 ​ 9.62 $1.51 and above 859,144 ​ $ 3.22 4.88 Total 6,001,151 ​ $ 1.06 7.14 ​ The Company computes the fair value for all options granted or modified using the Black-Scholes option pricing model. To calculate the fair value of the options, certain assumptions are made regarding components of the model, including the fair value of the underlying common stock, risk-free interest rate, volatility, expected dividend yield and expected option life. Changes to the assumptions could cause significant adjustments to the valuation. The Company calculates its volatility assumption using the actual changes in the market value of its stock. Forfeitures are recognized as they occur. The Company’s historical option exercises do not provide a reasonable basis to estimate an expected term due to the lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method. The simplified method calculates the expected term as the average of the vesting term plus the contractual life of the options. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. The Company computed the fair value of options granted/modified during the period ended March 31, 2021, using the following assumptions: ​ ​ ​ ​ ​ Expected volatility 127.17 % Risk free interest rate 0.78 % Expected term (years) 5.00 ​ Stock-based compensation expense related to the fair value of stock options is included in the statements of operations as research and development expenses or general and administrative expenses as set forth in the table below. The following table summarizes stock-based compensation expense (stock options and common stock issued for services) for the three months ended March 31, 2021 and 2020: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2021 2020 Research and development expenses ​ ​ Stock-based compensation ​ $ 46,000 ​ $ 59,000 ​ ​ ​ ​ ​ ​ ​ General and administrative expenses ​ ​ Issuance of common stock for services ​ 80,000 ​ 80,000 Stock-based compensation ​ 120,000 ​ 154,000 ​ ​ ​ ​ ​ ​ ​ Total stock-based compensation ​ $ 246,000 ​ $ 293,000 ​ ​ ​ ​ ​ ​ ​ Unrecognized expense as of March 31, 2021 ​ ​ 165,000 ​ ​ ​ ​ ​ ​ ​ ​ Weighted average remaining years to vest ​ ​ 1.29 ​ ​

Earnings Per Share

Earnings Per Share3 Months Ended
Mar. 31, 2021
Earnings Per Share
Earnings Per ShareNote 12 - Earnings Per Share Basic earnings per share is computed by dividing net loss available to common stockholders by the weighted-average number of shares of common stock outstanding during each period. Diluted earnings per share is based on the treasury stock method and computed by dividing net loss available to common stockholders by the diluted weighted-average shares of common stock outstanding during each period. The Company’s potentially dilutive shares include stock options and warrants for the shares of common stock. The potentially dilutive shares are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when the effect is dilutive. The investor warrants are treated as equity in the calculation of diluted earnings per share in both the computation of the numerator and denominator, if dilutive. The following table sets forth the calculations of basic and diluted earnings per share for the three months ended March 31, 2021 and 2020: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2021 2020 Net loss ​ $ (3,667,000) ​ $ (5,179,000) Less: decrease in fair value of investor warrants ​ ​ (151,000) ​ ​ (831,000) Loss available to common stockholders ​ $ (3,818,000) ​ $ (6,010,000) ​ ​ ​ ​ ​ ​ ​ Basic weighted-average common shares outstanding ​ ​ 195,387,047 ​ ​ 159,053,722 Add: dilutive effect of equity instruments ​ ​ 5,365,220 ​ ​ 1,504,055 Diluted weighted-average shares outstanding ​ ​ 200,752,267 ​ ​ 160,557,777 Earnings per share – basic ​ $ (0.02) ​ $ (0.03) Earnings per share – diluted ​ $ (0.02) ​ $ (0.04) ​ The potentially dilutive shares of common stock that have been excluded from the calculation of net loss per share because of their anti-dilutive effect are as follows: ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2021 2020 Outstanding stock options 1,510,485 ​ 5,948,013 Warrants to purchase shares of common stock 2,939,996 ​ 5,904,288 Total potentially dilutive shares of common stock 4,450,481 ​ 11,852,301 ​

Litigation

Litigation3 Months Ended
Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
LitigationNote 13 – Litigation From time to time, the Company may be a party to litigation arising in the ordinary course of business. As of March 31, 2021, the Company is not a party to any ongoing lawsuits. ​

The Company and Summary of Si_2

The Company and Summary of Significant Accounting Policies (Policies)3 Months Ended
Mar. 31, 2021
The Company and Summary of Significant Accounting Policies
Basis of PresentationBasis of Presentation ​ The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions of the SEC on Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the financial position and of the results of operations and cash flows of the Company for the periods presented. ​ These financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 2020 included in the Company’s 2020 Annual Report. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The information as of and for the three months ended March 31, 2021 is unaudited. The balance sheet at December 31, 2020 was derived from the audited financial statements at that date but does not include all of the information and footnotes required by GAAP for complete financial statements.
Impact of Global PandemicImpact of Global Pandemic ​ In January 2020, the World Health Organization (“WHO”) announced a global health emergency because of the novel coronavirus (“COVID-19”). In March 2020, the WHO declared the outbreak of COVID-19, a global pandemic. COVID-19 has, and continues, to adversely impact the United States and global economies. In April 2020, and pursuant to the U.S. Food and Drug Administration (“FDA”), independent Safety Monitoring Committee (“SMC”), and Institutional Review Board guidance covering ongoing clinical trials in the presence of the COVID-19 pandemic, the Company and the clinical research organization (“CRO”) paused all ongoing conduct associated with the Phase III clinical trial (the “AP-013 study”) of Ampion for the treatment of Osteoarthritis of the Knee (“OAK”). In March 2021, the Company submitted a detailed proposal to the FDA in response to the FDA’s guidance regarding the status of the AP-013 study. In April 2021, the Company received a response to the proposal from the FDA, which provides guidance and flexibility on how to maintain the Special Protocol Assessment (“SPA”), while allowing the Company to evaluate and consider several paths for moving forward. The Company is evaluating the FDA’s response and will continue to maintain an ongoing active dialog with the FDA with respect to the AP-013 study to reach agreement on the path forward considering the ongoing pandemic. The AP-013 study data will continue to remain paused and blinded to ensure clinical trial integrity and compliance with the SPA issued by the FDA in June 2019 until agreement is reached with the FDA. ​ In addition, since June 2020, the Company has commenced several clinical trials to determine the safety and efficacy for new applications of Ampion (i.e., inhaled and intravenous) related to COVID-19 infection. Given the continued evolution of the COVID-19 pandemic and the related complexities and uncertainties associated with the additional variants, the Company’s business operations could be significantly impacted and, in addition, the business operations of third parties on which the Company relies, including organizations that conduct clinical trials and key suppliers which provide the raw materials for manufacturing Ampion for the ongoing clinical trials could also be impacted. The full extent of the potential adverse impact on the Company’s business operations and related product development, including, but not limited to, clinical trials, financing activities and the overall impact on the United States and the global economy will depend on future developments, which cannot be predicted at this time due to the continued uncertainty of the COVID-19 pandemic.
Concentrations of Credit RiskConcentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company has no off-balance-sheet concentrations of credit risk, such as foreign exchange contracts, option contracts or foreign currency hedging arrangements. The Company consistently maintains its cash and cash equivalent balances in the form of bank demand deposits, United States federal government backed treasury securities and fully liquid money market fund accounts with financial institutions that management believes are creditworthy. The Company periodically monitors its cash positions with, and the credit quality of, the financial institutions with which it invests. During the three months ended March 31, 2021, and as consistent with prior reporting periods, the Company maintained balances in excess of federally insured limits.
Use of EstimatesUse 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 liquidity and resulting going concern position and the projected useful lives and potential impairment of fixed assets. The Company develops these estimates using its judgment based upon the facts and circumstances known at the time.
Adoption of Recent Accounting PronouncementsAdoption of Recent Accounting Pronouncements The Company has not adopted any recent accounting pronouncements during the three months ended March 31, 2021. Recent Accounting Pronouncements In August 2020, 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 Quarterly Report on Form 10-Q does not discuss recent pronouncements that are not anticipated to have a current and/or future impact on or are unrelated to the Company’s financial condition, results of operations, cash flows or disclosures.

Prepaid Expenses and Other (Tab

Prepaid Expenses and Other (Tables)3 Months Ended
Mar. 31, 2021
Prepaid Expenses and Other
Schedule Of Prepaid Expenses and other balances​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2021 ​ December 31, 2020 ​ ​ ​ ​ ​ Deposits ​ $ 1,311,000 ​ $ 266,000 Unamortized commercial insurance premiums ​ ​ 295,000 ​ ​ 627,000 Annual maintenance service contracts ​ ​ 77,000 ​ ​ — Receivable ​ ​ 26,000 ​ ​ 185,000 Other ​ ​ 89,000 ​ ​ 69,000 Total prepaid expenses and other ​ $ 1,798,000 ​ $ 1,147,000

Fixed Assets (Tables)

Fixed Assets (Tables)3 Months Ended
Mar. 31, 2021
Fixed Assets
Schedule of Fixed Assets​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Estimated ​ ​ ​ ​ ​ ​ Useful Lives ​ March 31, ​ December 31, ​ in Years 2021 2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ Leasehold improvements 10 ​ $ 2,100,000 ​ $ 2,250,000 Manufacturing facility/clean room 3 - 8 ​ ​ 931,000 ​ ​ 998,000 Lab equipment and office furniture 5 - 8 ​ 317,000 ​ 313,000 Fixed assets, net ​ ​ ​ $ 3,348,000 ​ $ 3,561,000
Schedule Of Depreciation expense​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ ​ 2021 2020 ​ ​ ​ ​ ​ ​ ​ ​ Depreciation and amortization expense ​ $ 294,000 ​ $ 295,000 ​

Accounts Payable and Accrued _2

Accounts Payable and Accrued Expenses (Tables)3 Months Ended
Mar. 31, 2021
Accounts Payable and Accrued Expenses
Schedule of accounts payable and accrued expenses​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2021 ​ December 31, 2020 ​ ​ ​ ​ ​ Accounts payable ​ $ 126,000 ​ $ 186,000 Clinical trials ​ ​ 1,050,000 ​ ​ 558,000 Professional fees ​ 78,000 ​ 267,000 Other insurance premium ​ 32,000 ​ 386,000 Other ​ ​ 65,000 ​ ​ 153,000 Accounts payable and accrued expenses ​ $ 1,351,000 ​ $ 1,550,000

Commitments and Contingencies (

Commitments and Contingencies (Tables)3 Months Ended
Mar. 31, 2021
Commitments and Contingencies Disclosure [Abstract]
Summary of Commitments and ContingenciesCommitments and contingencies are described below and summarized by the following table: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total (1) 2021 2022 2023 2024 2025 Thereafter Key clinical research trial obligations ​ $ 1,708,000 ​ $ 1,708,000 ​ $ — ​ $ — ​ $ — ​ $ — ​ $ — BLA consulting services ​ ​ 1,140,000 ​ ​ — ​ ​ 1,140,000 ​ ​ — ​ ​ — ​ ​ — ​ ​ — Statistical analysis and programming consulting services ​ ​ 326,000 ​ ​ 326,000 ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — Employment agreements ​ ​ 1,046,000 ​ ​ 567,000 ​ ​ 466,000 ​ ​ 13,000 ​ ​ — ​ ​ — ​ ​ — ​ ​ $ 4,220,000 ​ $ 2,601,000 ​ $ 1,606,000 ​ $ 13,000 ​ $ — ​ $ — ​ $ — ​ (1) Not included in the commitments and contingencies table above are the monthly principal and interest payments of $23,000 that would be due beginning in September 2021 and continuing for a period of 24 months in the event the loan is not forgiven by the SBA (see Note 6 ).
Summary of reconciliation of the Company's undiscounted payments for its facility lease and the carrying amount of the lease liabilityThe 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 March 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Facility Lease Payments Remainder of 2022 2023 2024 2025 Thereafter ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Remaining Facility Lease Payments ​ $ 1,259,000 ​ $ 260,000 ​ $ 355,000 ​ $ 364,000 ​ $ 280,000 ​ $ — ​ $ — Less: Discount Adjustment ​ (117,000) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total lease liability ​ $ 1,142,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Lease liability-current portion ​ $ 291,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Long-term lease liability ​ $ 851,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​
Lease ExpenseThe following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of March 31, 2021: ​ ​ ​ ​ ​ ​ ROU Asset ​ ​ ​ Balance as of December 31, 2020 ​ $ 824,000 Amortization ​ ​ (48,000) Balance as of March 31, 2021 ​ $ 776,000 ​ ​ The Company recorded lease expense in the respective periods is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ ​ 2021 2020 ​ ​ ​ ​ ​ ​ ​ ​ Lease expense ​ $ 73,000 ​ $ 67,000 ​

Warrants (Tables)

Warrants (Tables)3 Months Ended
Mar. 31, 2021
Warrants
Summary of Company's warrant activityThe following table summarizes the Company’s warrant activity during the three months ended March 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Weighted Average ​ ​ Number of ​ Average ​ Remaining ​ ​ Warrants ​ Exercise Price ​ Contractual Life ​ ​ ​ ​ ​ ​ ​ ​ Outstanding as of December 31, 2020 ​ 4,130,724 ​ $ 0.66 ​ 2.05 Warrants exercised ​ (316,174) ​ $ 0.41 ​ — Outstanding as of March 31, 2021 3,814,550 ​ $ 0.68 1.75
Schedule of stockholders equity note warrants or rights classified as equity and liabilityThe following table summarizes the Company’s outstanding warrants between placement agent and investor warrant classifications: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Weighted Average ​ ​ Number of ​ Average ​ Remaining ​ ​ Warrants ​ Exercise Price ​ Contractual Life ​ ​ ​ ​ ​ ​ ​ ​ Investor warrants at $0.76 ​ 2,026,915 ​ ​ ​ ​ 1.17 Placement agent warrants at $0.76 ​ 431,685 ​ ​ ​ ​ 1.17 Placement agent warrants at $0.94 ​ 150,000 ​ ​ ​ ​ 0.42 Investor warrants at $0.40 ​ 153,400 ​ ​ ​ ​ 2.37 Placement agent warrants at $0.50 ​ 1,052,550 ​ ​ ​ ​ 3.22 Outstanding as of March 31, 2021 3,814,550 ​ $ 0.68 1.75

Fair Value Considerations (Tabl

Fair Value Considerations (Tables)3 Months Ended
Mar. 31, 2021
Fair Value Considerations [Abstract]
Schedule of Fair Value, Assets and Liabilities Measured on Recurring BasisThe following table presents the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of March 31, 2021 and December 31, 2020, by level within the fair value hierarchy: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements Using ​ Level 1 Level 2 Level 3 Total March 31, 2021 ​ ​ ​ ​ ​ Liabilities: ​ ​ ​ ​ Warrant derivative liability ​ $ — ​ $ — ​ $ 2,456,000 ​ $ 2,456,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2020 ​ ​ ​ ​ Liabilities: ​ ​ ​ ​ Warrant derivative liability ​ $ — ​ $ — ​ $ 2,607,000 ​ $ 2,607,000
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input ReconciliationThe following table sets forth a reconciliation of changes in the fair value of financial liabilities classified as Level 3 in the fair value hierarchy: ​ ​ ​ ​ ​ Derivative Instruments ​ ​ ​ ​ Balance as of December 31, 2020 ​ $ 2,607,000 Warrant exercises ​ (347,000) Change in fair value ​ 196,000 Balance as of March 31, 2021 ​ $ 2,456,000

Common Stock (Tables)

Common Stock (Tables)3 Months Ended
Mar. 31, 2021
Equity [Abstract]
Schedule of remaining authorized Shares​ ​ ​ ​ ​ March 31, 2021 ​ ​ ​ Authorized shares ​ 300,000,000 ​ ​ ​ Common stock outstanding ​ 195,689,128 Options outstanding ​ 6,001,151 Warrants outstanding ​ 3,814,550 Reserved for issuance under 2019 Stock and Incentive Plan ​ 7,918,755 ​ ​ ​ Available shares ​ 86,576,416
Schedule of sale of stock under sales agreement​ ​ ​ ​ ​ ​ ​ Sales Agreement ​ ​ ​ ​ Total shares of common stock sold ​ ​ 1,848,437 ​ ​ ​ ​ Gross proceeds ​ $ 2,705,000 Commissions earned by placement agents ​ ​ (109,000) Issuance fees ​ ​ (17,000) Net proceeds ​ $ 2,579,000

Equity (Tables)

Equity (Tables)3 Months Ended
Mar. 31, 2021
Summary of Stock Options Outstanding and ExercisableStock options outstanding as of March 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 $0.50 602,000 ​ $ 0.44 8.31 $0.51 - $1.00 4,346,007 ​ $ 0.70 7.31 $1.01 - $1.50 ​ 194,000 ​ $ 1.38 ​ 9.62 $1.51 and above 859,144 ​ $ 3.22 4.88 Total 6,001,151 ​ $ 1.06 7.14
Assumptions Used in Computing Fair Value of All Options Granted​ ​ ​ ​ ​ Expected volatility 127.17 % Risk free interest rate 0.78 % Expected term (years) 5.00
Summary of Stock-Based Compensation Expense​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2021 2020 Research and development expenses ​ ​ Stock-based compensation ​ $ 46,000 ​ $ 59,000 ​ ​ ​ ​ ​ ​ ​ General and administrative expenses ​ ​ Issuance of common stock for services ​ 80,000 ​ 80,000 Stock-based compensation ​ 120,000 ​ 154,000 ​ ​ ​ ​ ​ ​ ​ Total stock-based compensation ​ $ 246,000 ​ $ 293,000 ​ ​ ​ ​ ​ ​ ​ Unrecognized expense as of March 31, 2021 ​ ​ 165,000 ​ ​ ​ ​ ​ ​ ​ ​ Weighted average remaining years to vest ​ ​ 1.29 ​
Employee Stock Option
Stock Option ActivityThe following table summarizes the Company’s stock option activity during the three months ended March 31, 2021: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Weighted Average ​ ​ ​ ​ Number of ​ Average ​ Remaining ​ ​ Aggregate ​ ​ Options ​ Exercise Price ​ Contractual Life ​ ​ Intrinsic Value Outstanding as of December 31, 2020 6,099,651 ​ $ 1.04 7.36 $ — Granted 36,000 ​ $ 1.76 ​ ​ ​ Exercised (129,500) ​ $ 0.48 ​ ​ ​ Forfeited, expired and/or cancelled (5,000) ​ $ 1.75 ​ ​ ​ Outstanding as of March 31, 2021 6,001,151 ​ $ 1.06 7.14 $ 5,109,000 Exercisable as of March 31, 2021 5,692,151 ​ $ 1.06 7.00 $ 4,906,000 The following table summarizes the outstanding options that were issued in accordance with the 2010 Plan and the 2019 Plan: ​ ​ ​ ​ Outstanding Options by Plan ​ March 31, 2021 ​ ​ ​ ​ 2010 Plan ​ ​ 3,938,180 2019 Plan ​ ​ 2,062,971 Outstanding as of March 31, 2021 ​ ​ 6,001,151
2019 Stock plan
Stock Option ActivityThe following table summarizes the activity of the 2019 Plan and the shares available for future equity awards as of March 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 ​ ​ (36,000) Forfeited, expired and/or cancelled equity awards ​ 22,226 Remaining shares available for future equity awards ​ ​ 7,918,755

Earnings Per Share (Tables)

Earnings Per Share (Tables)3 Months Ended
Mar. 31, 2021
Earnings Per Share
Schedule for the calculations of basic and diluted earnings per share​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2021 2020 Net loss ​ $ (3,667,000) ​ $ (5,179,000) Less: decrease in fair value of investor warrants ​ ​ (151,000) ​ ​ (831,000) Loss available to common stockholders ​ $ (3,818,000) ​ $ (6,010,000) ​ ​ ​ ​ ​ ​ ​ Basic weighted-average common shares outstanding ​ ​ 195,387,047 ​ ​ 159,053,722 Add: dilutive effect of equity instruments ​ ​ 5,365,220 ​ ​ 1,504,055 Diluted weighted-average shares outstanding ​ ​ 200,752,267 ​ ​ 160,557,777 Earnings per share – basic ​ $ (0.02) ​ $ (0.03) Earnings per share – diluted ​ $ (0.02) ​ $ (0.04)
Potentially dilutive securities, excluded​ ​ ​ ​ ​ ​ Three Months Ended March 31, ​ 2021 2020 Outstanding stock options 1,510,485 ​ 5,948,013 Warrants to purchase shares of common stock 2,939,996 ​ 5,904,288 Total potentially dilutive shares of common stock 4,450,481 ​ 11,852,301

Going Concern (Detail)

Going Concern (Detail)1 Months Ended3 Months Ended
Feb. 29, 2020itemMar. 31, 2021USD ($)Mar. 31, 2020USD ($)Dec. 31, 2020USD ($)Dec. 31, 2019USD ($)
Cash and Cash Equivalents, at Carrying Value $ 15,804,000 $ 17,346,000
Net Income (Loss) Attributable to Parent(3,667,000) $ (5,179,000)
Operating Expenses3,819,000 6,021,000
Gain (Loss) on Derivative Instruments, Net, Pretax151,000 831,000
Net Cash Provided by (Used in) Operating Activities(4,147,000)(4,553,000)
Retained Earnings (Accumulated Deficit)(204,194,000)(200,527,000)
Stockholders' deficit16,777,000 $ 1,993,000 $ 17,512,000 $ 6,443,000
ATM equity offering program
Gross proceeds2,700,000
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs $ 126,000
Sale Agreement (ATM)
Number of agents | item2

Prepaid Expenses and Other (Det

Prepaid Expenses and Other (Detail) - USD ($)Mar. 31, 2021Dec. 31, 2020
Prepaid Expenses and Other
Deposits $ 1,311,000 $ 266,000
Unamortized commercial insurance premiums295,000 627,000
Annual maintenance service contracts77,000
Receivable26,000 185,000
Other89,000 69,000
Total prepaid expenses and other $ 1,798,000 $ 1,147,000

Fixed Assets (Detail)

Fixed Assets (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Fixed assets, net $ 3,348,000 $ 3,561,000
Leasehold improvements
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years10 years
Fixed assets, gross $ 2,100,000 2,250,000
Manufacturing facility/ clean room
Property, Plant and Equipment [Line Items]
Fixed assets, gross $ 931,000 998,000
Manufacturing facility/ clean room | Minimum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years3 years
Manufacturing facility/ clean room | Maximum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years8 years
Lab equipment and office furniture
Property, Plant and Equipment [Line Items]
Fixed assets, gross $ 317,000 $ 313,000
Lab equipment and office furniture | Minimum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years5 years
Lab equipment and office furniture | Maximum
Property, Plant and Equipment [Line Items]
Estimated Useful Lives in Years8 years

Fixed Assets - Depreciation and

Fixed Assets - Depreciation and Amortization Expense (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Fixed Assets
Depreciation and amortization expense $ 294,000 $ 295,000

Accounts Payable and Accrued _3

Accounts Payable and Accrued Expenses (Detail) - USD ($)Mar. 31, 2021Dec. 31, 2020
Accounts Payable and Accrued Expenses
Accounts payable $ 126,000 $ 186,000
Clinical trials1,050,000 558,000
Professional fees78,000 267,000
Other insurance premium32,000 386,000
Other65,000 153,000
Accounts payable and accrued expenses $ 1,351,000 $ 1,550,000

Paycheck Protection Program - A

Paycheck Protection Program - Additional Information (Detail) - PPP - USD ($)1 Months Ended
Sep. 30, 2021Oct. 31, 2020Apr. 30, 2020
Debt Instrument [Line Items]
Proceeds from Issuance of Debt $ 544,000
Debt Instrument, Interest Rate, Stated Percentage1.00%
Debt Instrument, Term6 months
Debt Instrument, Decrease, Forgiveness $ 544,000
Forecast
Debt Instrument [Line Items]
Debt Instrument, Periodic Payment $ 23,000

Commitments and Contingencies -

Commitments and Contingencies - Summary of Commitments and Contingencies (Detail)Mar. 31, 2021USD ($)
Commitment And Contingencies [Line Items]
2021 $ 2,601,000
20221,606,000
202313,000
20240
20250
Thereafter0
Total4,220,000
Key Clinical Research Trial Obligations
Commitment And Contingencies [Line Items]
20211,708,000
20230
20240
20250
Thereafter0
Total1,708,000
BLA consulting services
Commitment And Contingencies [Line Items]
20221,140,000
20230
20240
20250
Thereafter0
Total1,140,000
Statistical analysis and programming consulting services
Commitment And Contingencies [Line Items]
2021326,000
20230
20240
20250
Thereafter0
Total326,000
Employment Agreements
Commitment And Contingencies [Line Items]
2021567,000
2022466,000
202313,000
20240
20250
Thereafter0
Total $ 1,046,000

Commitments and Contingencies_2

Commitments and Contingencies - Additional Information (Detail)1 Months Ended
Sep. 30, 2021USD ($)Mar. 31, 2021USD ($)Sep. 30, 2020USD ($)itemApr. 30, 2020Dec. 31, 2013USD ($)Dec. 31, 2020USD ($)May 31, 2019USD ($)Sep. 30, 2018USD ($)Mar. 31, 2018USD ($)
Commitments and Contingencies [Line Items]
Contractual obligation $ 4,220,000
Facility Lease Incremental Borrowing Rate5.75%
Newly Leased Office Space and Manufacturing Facility [Member]
Commitments and Contingencies [Line Items]
Non-cancellable operating lease period125 months
Lease initial base rent per month $ 23,000
Total base rent over the term of the lease $ 3,300,000
Key Clinical Research Trial Obligations
Commitments and Contingencies [Line Items]
Contractual obligation $ 1,708,000
New CRO
Commitments and Contingencies [Line Items]
Contract amount $ 1,400,000
Contractual deposit Commitment465,000
Contractual obligation347,000
Inhaled treatment for COVID 19 patients
Commitments and Contingencies [Line Items]
Contract amount $ 836,000
Contractual deposit Commitment $ 232,000
Number of estimated study sites | item10
Number of enrolled study sites | item3
Reduced contract amount $ 530,000
Intravenous treatment for COVID 19 patients
Commitments and Contingencies [Line Items]
Contract amount1,800,000
Contractual deposit Commitment $ 495,000
Contractual obligation1,100,000
Regional Hospital Group, AP-014 Study
Commitments and Contingencies [Line Items]
Contractual deposit Commitment transfered105,000
Contractual obligation0
Remaining contractual deposit commitment127,000
Amount Incurred Against Contract Obligation496,000
Regional Hospital Group, AP-018 Study
Commitments and Contingencies [Line Items]
Contract amount318,000
Contractual deposit Commitment105,000
Contractual obligation213,000
BLA consulting services
Commitments and Contingencies [Line Items]
Contract amount $ 1,200,000
Contractual deposit Commitment $ 364,000 $ 182,000
Contractual obligation1,100,000
Amount Incurred Against Contract Obligation82,000
Statistical analysis and programming consulting services
Commitments and Contingencies [Line Items]
Contract amount $ 578,000
Contractual obligation326,000
Amount Incurred Against Contract Obligation $ 252,000
PPP
Commitments and Contingencies [Line Items]
Term of agreement (in years)6 months
Interest rate (as a percentage)1.00%
PPP | Forecast
Commitments and Contingencies [Line Items]
Principal and interest payments $ 23,000
PPP | Lender
Commitments and Contingencies [Line Items]
Principal and interest payments $ 23,000

Commitments and Contingencies_3

Commitments and Contingencies - Employment Agreements (Detail) - USD ($)Dec. 14, 2019Sep. 16, 2019Jul. 09, 2019
Chief Executive Officer [Member]
Related Party Transaction [Line Items]
Term of employment agreement (in years)3 years
Annual Salary $ 300,000
Chief Operating Officer [Member]
Related Party Transaction [Line Items]
Term of employment agreement (in years)2 years
Annual Salary $ 280,000
Chief Financial Officer [Member]
Related Party Transaction [Line Items]
Term of employment agreement (in years)3 years
Annual Salary $ 285,000

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 ($)Mar. 31, 2021Dec. 31, 2020
Lessee, Operating Lease, Liability, Payment, Due [Abstract]
Remainder of 2021 $ 260,000
2022355,000
2023364,000
2024280,000
Remaining Facility Lease Payments1,259,000
Less: Discount Adjustment(117,000)
Total lease liability1,142,000
Lease liability - current portion291,000 $ 284,000
Long-term lease liability $ 851,000 $ 925,000

Commitments and Contingencies_5

Commitments and Contingencies - Lease Expense (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
Balance as of December 31, 2020 $ 824,000
Amortization(48,000)
Balance as of March 31, 2021776,000
Lease expense $ 73,000 $ 67,000

Warrants - Warrants Activity (D

Warrants - Warrants Activity (Detail) - $ / shares3 Months Ended12 Months Ended
Mar. 31, 2021Dec. 31, 2020
Number of Warrants Outstanding
Class of Warrant or Right, Outstanding3,814,550 4,130,724
Number of Warrants Outstanding, Beginning Balance4,130,724
Number of Warrants, Warrants exercised(316,174)
Number of Warrants Outstanding, Ending Balance3,814,550 4,130,724
Warrants, Weighted Average Exercise Price
Weighted Average Exercise Price, Outstanding Beginning Balance $ 0.66
Weighted Average Exercise Price, Warrants exercised0.41
Weighted Average Exercise Price, Outstanding Ending Balance $ 0.68 $ 0.66
Weighted Average Remaining Contractual Life
Weighted Average Remaining Contractual Life, Warrants Outstanding1 year 9 months2 years 18 days
Equity based-warrants
Number of Warrants Outstanding
Class of Warrant or Right, Outstanding1,600,000
Number of Warrants Outstanding, Ending Balance1,600,000
Liability warrants
Number of Warrants Outstanding
Class of Warrant or Right, Outstanding2,200,000
Number of Warrants Outstanding, Ending Balance2,200,000

Warrants - Warrants Activity Cl

Warrants - Warrants Activity Classified as Equity and Liability (Detail) - $ / shares3 Months Ended12 Months Ended
Mar. 31, 2021Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance3,814,550 4,130,724
Exercise price $ 0.68 $ 0.66
Weighted Average Remaining Contractual Life, Warrants Outstanding1 year 9 months2 years 18 days
Investor warrants at $0.76
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance2,026,915
Exercise price $ 0.76
Weighted Average Remaining Contractual Life, Warrants Outstanding1 year 2 months 1 day
Placement agent warrants at $0.76
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance431,685
Exercise price $ 0.76
Weighted Average Remaining Contractual Life, Warrants Outstanding1 year 2 months 1 day
Placement agent warrants at $0.94
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance150,000
Exercise price $ 0.94
Weighted Average Remaining Contractual Life, Warrants Outstanding5 months 1 day
Investor warrants at $0.40
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance153,400
Exercise price $ 0.40
Weighted Average Remaining Contractual Life, Warrants Outstanding2 years 4 months 13 days
Placement agent warrants at $0.50
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Warrants Outstanding, Ending Balance1,052,550
Exercise price $ 0.50
Weighted Average Remaining Contractual Life, Warrants Outstanding3 years 2 months 19 days

Warrants - Narrative (Detail)

Warrants - Narrative (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020Dec. 31, 2020
Class of Warrant or Right [Line Items]
Exercise price $ 0.68 $ 0.66
Proceeds from warrant exercises $ 114,000 $ 0
Warrant derivative liability $ 2,456,000 $ 2,607,000
Investor Warrants [Member]
Class of Warrant or Right [Line Items]
Common shares issued for warrant exercised284,000
Exercise price $ 0.40
Proceeds from warrant exercises $ 114,000
Number Of Warrants Exercised By Placement Agents32,000
Stock Issued On Exercise Of Warrants By Placement Agents23,000

Fair Value Considerations - Fin

Fair Value Considerations - Financial Assets and Liabilities (Detail) - USD ($)Mar. 31, 2021Dec. 31, 2020
LIABILITIES
Warrant derivative liability $ 2,456,000 $ 2,607,000
Fair Value, Inputs, Level 1 [Member]
LIABILITIES
Warrant derivative liability0 0
Fair Value, Inputs, Level 2 [Member]
LIABILITIES
Warrant derivative liability0 0
Fair Value, Inputs, Level 3 [Member]
LIABILITIES
Warrant derivative liability $ 2,456,000 $ 2,607,000

Fair Value Considerations - Set

Fair Value Considerations - Sets Forth a Reconciliation of Changes (Detail)3 Months Ended
Mar. 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 exercises(347,000)
Change in fair value196,000
Balance as of March 31, 2021 $ 2,456,000

Common Stock (Summarizes the Co

Common Stock (Summarizes the Company's remaining authorized shares available - (Detail) - sharesMar. 31, 2021Dec. 31, 2020
Equity [Abstract]
Authorized shares300,000,000 300,000,000
Common stock outstanding195,689,128 193,378,996
Options Outstanding6,001,151
Warrants Outstanding3,814,550 4,130,724
Reserved for issuance under 2019 Stock and Incentive Plan7,918,755
Available Shares86,576,416

Common Stock (Sales Agreement)

Common Stock (Sales Agreement) (Detail)1 Months Ended3 Months Ended
Feb. 29, 2020USD ($)itemMar. 31, 2021USD ($)shares
Sale Agreement (ATM)
Class of Stock [Line Items]
Number of agents | item2
Maximum aggregate offering price of equity securities $ 50,000,000
Percentage of commission4.00%
Sales Agreement
Class of Stock [Line Items]
Total shares of common stock sold | shares1,848,437
Gross Proceeds $ 2,705,000
Commissions earned by placement agents(109,000)
Issuance fees(17,000)
Net Proceeds $ 2,579,000
Sales Agreement Agent [Member] | Sale Agreement (ATM)
Class of Stock [Line Items]
Percentage of commission2.00%

Common Stock (Common Stock Issu

Common Stock (Common Stock Issued for Services) (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Components of common Stock [Line Items]
Stock Issued During Period, Value, Issued for Services $ 80,000 $ 80,000
Common Stock Issued for Services [Member] | Non Employee Directors
Components of common Stock [Line Items]
Stock Issued During Period, Shares, Issued for Services54,052 136,236
Stock Issued During Period, Value, Issued for Services $ 80,000

Equity - Activity of Plan (Deta

Equity - Activity of Plan (Detail) - Employee Stock Option - shares3 Months Ended12 Months Ended
Mar. 31, 2021Dec. 31, 2020Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options granted(36,000)
Forfeited, expired and/or cancelled equity awards5,000
2019 Stock plan
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total shares reserved for equity awards10,000,000 10,000,000
Options granted(36,000)(2,067,471)
Forfeited, expired and/or cancelled equity awards22,226
Remaining shares available for future equity awards7,918,755

Equity - Stock Option Activity

Equity - Stock Option Activity (Detail) - USD ($)3 Months Ended12 Months Ended
Mar. 31, 2021Dec. 31, 2020
Number of Options
Number of Options, Ending Balance6,001,151
Employee Stock Option
Number of Options
Number of Options, Beginning Balance6,099,651
Number of Options, Granted36,000
Number of Options, Exercised(129,500)
Number of Options, Forfeited, expired and/or cancelled(5,000)
Number of Options, Ending Balance6,001,151 6,099,651
Number of Options, Exercisable5,692,151
Weighted Average Exercise Price
Weighted Average Exercise Price, Beginning Balance $ 1.04
Weighted Average Exercise Price, Granted1.76
Weighted Average Exercise Price, Exercised0.48
Weighted Average Exercise Price, Forfeited, expired and/or cancelled1.75
Weighted Average Exercise Price, Ending Balance1.06 $ 1.04
Weighted Average Exercise Price, Exercisable $ 1.06
Weighted Average Remaining Contractual Life, Outstanding7 years 1 month 20 days7 years 4 months 9 days
Weighted Average Remaining Contractual Life, Exercisable7 years
Aggregate Intrinsic Value, Outstanding $ 5,109,000
Aggregate Intrinsic Value, Exercisable $ 4,906,000
Stock options exercised (Shares)129,500
Cash exercises of stock options (Shares)8,000
Proceeds from cash exercises $ 6,000
Cashless exercises of stock options (Shares)60,000
Proceeds from cashless exercises $ 27,000
Stock options exercised, net (Shares)61,500
Tax obligations on behalf of option holders $ 40,000
2010 Stock Plan
Number of Options
Number of Options, Ending Balance3,938,180
2019 Stock plan
Number of Options
Number of Options, Ending Balance2,062,971
2019 Stock plan | Employee Stock Option
Number of Options
Number of Options, Granted36,000 2,067,471
Number of Options, Forfeited, expired and/or cancelled(22,226)
Number of Options, Available for grant7,918,755

Equity - Summary of Stock Optio

Equity - Summary of Stock Options Outstanding and Exercisable (Detail) - Employee Stock Option3 Months Ended
Mar. 31, 2021$ / sharesshares
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares6,001,151
Weighted Average Exercise Price $ 1.06
Weighted Average Remaining Contractual Lives7 years 1 month 20 days
Up to $0.50
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares602,000
Weighted Average Exercise Price $ 0.44
Weighted Average Remaining Contractual Lives8 years 3 months 21 days
Range of Exercise Prices Upper $ 0.50
$0.51 - $1.00
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Number of Options Outstanding | shares4,346,007
Weighted Average Exercise Price $ 0.70
Weighted Average Remaining Contractual Lives7 years 3 months 21 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 | shares194,000
Weighted Average Exercise Price $ 1.38
Weighted Average Remaining Contractual Lives9 years 7 months 13 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 | shares859,144
Weighted Average Exercise Price $ 3.22
Weighted Average Remaining Contractual Lives4 years 10 months 17 days
Range of Exercise Prices Lower $ 1.51

Equity - Assumptions Used in Co

Equity - Assumptions Used in Computing Fair Value of All Options Granted (Detail)3 Months Ended
Mar. 31, 2021
Equity
Expected volatility127.17%
Risk free interest rate0.78%
Expected term (years)5 years

Equity - Summary of Stock-Based

Equity - Summary of Stock-Based Compensation Expense (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses $ 246,000 $ 293,000
Unrecognized expense as of December 31, 2020 $ 165,000
Weighted average remaining years to vest1 year 3 months 14 days
Research and Development Expenses [Member] | Stock Based Compensation [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses $ 46,000 59,000
General and Administrative Expenses [Member] | Common Stock Issued for Services [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses80,000 80,000
General and Administrative Expenses [Member] | Stock Based Compensation [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expenses $ 120,000 $ 154,000

Earnings Per Share (Detail)

Earnings Per Share (Detail) - USD ($)3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Earnings Per Share
Net loss $ (3,667,000) $ (5,179,000)
Less: decrease in fair value of investor warrants(151,000)(831,000)
Loss available to common stockholders $ (3,818,000) $ (6,010,000)
Basic weighted-average common shares outstanding195,387,047 159,053,722
Add: dilutive effect of equity instruments5,365,220 1,504,055
Diluted weighted-average shares outstanding200,752,267 160,557,777
Earnings per share - basic $ (0.02) $ (0.03)
Earnings per share - diluted $ (0.02) $ (0.04)

Earnings Per Share - Anti-dilut

Earnings Per Share - Anti-dilutive (Detail) - shares3 Months Ended
Mar. 31, 2021Mar. 31, 2020
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock4,450,481 11,852,301
Employee Stock Option
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock1,510,485 5,948,013
Warrant to purchase shares of common stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total potentially dilutive shares of common stock2,939,996 5,904,288