Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 30, 2021 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-35182 | |
Entity Registrant Name | AMPIO PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-0179592 | |
Entity Address, Address Line One | 373 Inverness Parkway, Suite 200 | |
Entity Address, City or Town | Englewood | |
Entity Address, State or Province | CO | |
Entity Address, Postal Zip Code | 80112 | |
City Area Code | 720 | |
Local Phone Number | 437-6500 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | AMPE | |
Security Exchange Name | NYSEAMER | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 200,457,957 | |
Entity Central Index Key | 0001411906 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets | ||
Cash and cash equivalents | $ 20,549,000 | $ 17,346,000 |
Prepaid expenses and other | 2,358,000 | 1,147,000 |
Total current assets | 22,907,000 | 18,493,000 |
Fixed assets, net | 3,074,000 | 3,561,000 |
Right-of-use asset | 728,000 | 824,000 |
Total assets | 26,709,000 | 22,878,000 |
Current liabilities | ||
Accounts payable and accrued expenses | 2,937,000 | 1,550,000 |
Lease liability-current portion | 298,000 | 284,000 |
Total current liabilities | 3,235,000 | 1,834,000 |
Lease liability-long-term | 773,000 | 925,000 |
Warrant derivative liability | 2,340,000 | 2,607,000 |
Total liabilities | 6,348,000 | 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 - 200,070,419 as of June 30, 2021 and 193,378,996 as of December 31, 2020 | 20,000 | 19,000 |
Additional paid-in capital | 228,091,000 | 218,020,000 |
Accumulated deficit | (207,750,000) | (200,527,000) |
Total stockholders' equity | 20,361,000 | 17,512,000 |
Total liabilities and stockholders' equity | $ 26,709,000 | $ 22,878,000 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Condensed Balance Sheets | ||
Preferred Stock, par value | $ 0.0001 | $ 0.0001 |
Preferred Stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred Stock, shares issued | 0 | 0 |
Common Stock, par value | $ 0.0001 | $ 0.0001 |
Common Stock, shares authorized | 300,000,000 | 300,000,000 |
Common Stock, shares issued | 200,070,419 | 193,378,996 |
Common Stock, shares outstanding | 200,070,419 | 193,378,996 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating expenses | ||||
Research and development | $ 2,273,000 | $ 1,118,000 | $ 4,568,000 | $ 5,373,000 |
General and administrative | 1,400,000 | 1,482,000 | 2,923,000 | 3,249,000 |
Total operating expenses | 3,673,000 | 2,600,000 | 7,491,000 | 8,622,000 |
Other income (expense) | ||||
Interest income | 1,000 | 0 | 2,000 | 12,000 |
Paycheck Protection Program loan forgiveness | 544,000 | 0 | 544,000 | |
Derivative gain (loss) | 116,000 | (675,000) | 267,000 | 156,000 |
Total other income (expense) | 117,000 | (131,000) | 269,000 | 712,000 |
Net loss | $ (3,556,000) | $ (2,731,000) | $ (7,222,000) | $ (7,910,000) |
Net loss per common share: Basic | $ (0.02) | $ (0.02) | $ (0.04) | $ (0.05) |
Net loss per common share: Diluted | $ (0.02) | $ (0.02) | $ (0.04) | $ (0.05) |
Weighted average number of common shares outstanding: Basic | 196,179,371 | 166,392,893 | 195,785,398 | 162,723,309 |
Weighted average number of common shares outstanding: Diluted | 201,448,038 | 166,392,893 | 200,985,349 | 163,906,257 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member]At The Market Equity Offering Program | Common Stock [Member] | 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 | $ 191,060 | $ (184,633) | $ 6,443 | ||||
Beginning Balance, Shares at Dec. 31, 2019 | 158,644,757 | |||||||
Issuance of common stock for services | $ 0 | 80 | 0 | 80 | ||||
Issuance of common stock for services (Shares) | 136,236 | |||||||
Stock-based compensation, net of forfeitures | $ 0 | 213 | 0 | 213 | ||||
Issuance of common stock | $ 0 | $ 682 | $ 0 | $ 682 | ||||
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 program | 0 | (246) | 0 | (246) | ||||
Net loss | 0 | 0 | (5,179) | (5,179) | ||||
Ending Balance at Mar. 31, 2020 | $ 16 | 191,789 | (189,812) | 1,993 | ||||
Ending Balance, Shares at Mar. 31, 2020 | 160,022,119 | |||||||
Beginning Balance at Dec. 31, 2019 | $ 16 | 191,060 | (184,633) | 6,443 | ||||
Beginning Balance, Shares at Dec. 31, 2019 | 158,644,757 | |||||||
Net loss | (7,910) | |||||||
Ending Balance at Jun. 30, 2020 | $ 17 | 198,869 | (192,543) | 6,343 | ||||
Ending Balance, Shares at Jun. 30, 2020 | 173,341,950 | |||||||
Beginning Balance at Mar. 31, 2020 | $ 16 | 191,789 | (189,812) | 1,993 | ||||
Beginning Balance, Shares at Mar. 31, 2020 | 160,022,119 | |||||||
Stock-based compensation, net of forfeitures | $ 0 | 64 | 0 | 64 | ||||
Stock options exercised, net | $ 0 | 0 | 0 | 0 | ||||
Stock options exercised, net (Shares) | 1,314 | |||||||
Warrants exercised, net | $ 0 | 100 | 0 | 100 | ||||
Warrants exercised, net (Shares) | 250,000 | |||||||
Issuance of common stock | $ 1 | 7,230 | 0 | 7,231 | ||||
Issuance of common stock (Shares) | 13,068,517 | |||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (314) | 0 | (314) | ||||
Net loss | 0 | 0 | (2,731) | (2,731) | ||||
Ending Balance at Jun. 30, 2020 | $ 17 | 198,869 | (192,543) | 6,343 | ||||
Ending Balance, Shares at Jun. 30, 2020 | 173,341,950 | |||||||
Beginning Balance at Dec. 31, 2020 | $ 19 | 218,020 | (200,527) | 17,512 | ||||
Beginning Balance, Shares at Dec. 31, 2020 | 193,378,996 | |||||||
Issuance of common stock for services | $ 0 | 80 | 0 | 80 | ||||
Issuance of common stock for services (Shares) | 54,052 | |||||||
Stock-based compensation, net of forfeitures | $ 0 | 166 | 0 | 166 | ||||
Stock options exercised, net | $ 0 | 33 | 0 | 33 | ||||
Stock options exercised, net (Shares) | 129,500 | |||||||
Shares held back in settlement of tax obligation and exercise cost | $ 0 | (40) | 0 | (40) | ||||
Shares held back in settlement of tax obligation and exercise cost (Shares) | (28,562) | |||||||
Warrants exercised, net | $ 0 | 114 | 0 | 114 | ||||
Warrants exercised, net (Shares) | 306,705 | |||||||
Issuance of common stock | $ 0 | 2,705 | 0 | 2,705 | ||||
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) | 0 | (126) | ||||
Net loss | 0 | 0 | (3,667) | (3,667) | ||||
Ending Balance at Mar. 31, 2021 | $ 19 | 220,952 | (204,194) | 16,777 | ||||
Ending Balance, Shares at Mar. 31, 2021 | 195,689,128 | |||||||
Beginning Balance at Dec. 31, 2020 | $ 19 | 218,020 | (200,527) | 17,512 | ||||
Beginning Balance, Shares at Dec. 31, 2020 | 193,378,996 | |||||||
Net loss | (7,222) | |||||||
Ending Balance at Jun. 30, 2021 | $ 20 | 228,091 | (207,750) | 20,361 | ||||
Ending Balance, Shares at Jun. 30, 2021 | 200,070,419 | |||||||
Beginning Balance at Mar. 31, 2021 | $ 19 | 220,952 | (204,194) | 16,777 | ||||
Beginning Balance, Shares at Mar. 31, 2021 | 195,689,128 | |||||||
Stock-based compensation, net of forfeitures | $ 0 | 67 | 0 | 67 | ||||
Stock options exercised, net | $ 0 | 127 | 0 | 127 | ||||
Stock options exercised, net (Shares) | 314,162 | |||||||
Shares held back in settlement of tax obligation and exercise cost | $ 0 | 0 | 0 | 0 | ||||
Shares held back in settlement of tax obligation and exercise cost (Shares) | (28,802) | |||||||
Warrants exercised, net | $ 0 | 0 | 0 | 0 | ||||
Warrants exercised, net (Shares) | 29,158 | |||||||
Issuance of common stock | $ 1 | $ 7,266 | $ 0 | $ 7,267 | ||||
Issuance of common stock (Shares) | 4,066,773 | |||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (321) | 0 | (321) | ||||
Net loss | 0 | 0 | (3,556) | (3,556) | ||||
Ending Balance at Jun. 30, 2021 | $ 20 | $ 228,091 | $ (207,750) | $ 20,361 | ||||
Ending Balance, Shares at Jun. 30, 2021 | 200,070,419 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows used in operating activities | ||
Net loss | $ (7,222) | $ (7,910) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation, net of forfeitures | 233 | 277 |
Depreciation and amortization | 568 | 591 |
Paycheck Protection Program loan forgiveness | 0 | (544) |
Issuance of common stock for services | 80 | 80 |
Derivative gain (loss) | (267) | (156) |
Changes in operating assets and liabilities | ||
Increase in prepaid expenses and other | (1,211) | (229) |
Increase (decrease) in accounts payable and accrued expenses | 1,386 | (1,758) |
Decrease in lease liability | (42) | (38) |
Proceeds received under the Paycheck Protection Program | 0 | 544 |
Net cash used in operating activities | (6,475) | (9,143) |
Cash flows used in investing activities | ||
Purchase of fixed assets | (81) | 0 |
Net cash used in investing activities | (81) | 0 |
Cash flows from financing activities | ||
Proceeds from sale of common stock in connection with "at-the-market" equity offering program | 9,972 | 7,913 |
Costs related to sale of common stock in connection with the "at-the-market" equity offering program | (447) | (560) |
Proceeds from warrant and stock option exercises, net | 234 | 100 |
Net cash provided by financing activities | 9,759 | 7,453 |
Net change in cash and cash equivalents | 3,203 | (1,690) |
Cash and cash equivalents at beginning of period | 17,346 | 6,532 |
Cash and cash equivalents at end of period | 20,549 | 4,842 |
Non-cash transactions: | ||
Commercial insurance premium financing agreement | $ 1,016 | $ 1,347 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
The Company and Summary of Significant Accounting Policies | |
The Company and Summary of Significant Accounting Policies | Note 1 – The Company and Summary of Significant Accounting Policies Ampio Pharmaceuticals, Inc. (“Ampio” or the “Company”) is a 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 generally accepted accounting principles (“GAAP”) in the United States for interim financial information and with the instructions of the SEC on Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the financial position and of the results of operations and cash flows of the Company for the periods presented. These financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 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 and six months ended June 30, 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 Secretary of Health and Human Services (“HHS”) declared a public health emergency and the World Health Organization (“WHO”) announced a global health emergency because of the novel Coronavirus Disease 2019 (“COVID-19”). In March 2020, the WHO declared the outbreak of COVID-19, a global pandemic. Since the declaration of the outbreak, COVID-19 has adversely impacted 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. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, the Company is evaluating its options to analyze the clinical trial data from the AP-013 study. 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 current and future 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 related to the pandemic, which cannot be predicted at this time. 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 and six months ended June 30, 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, clinical trial accrual 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 six months ended June 30, 2021. Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU 2020-06, “ Debt (Subtopic 470-20); Debt with Conversion and Other Options and Derivatives and Hedging (Subtopic 815-40) Contracts in Entity’s Own Equity 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 Concern | 6 Months Ended |
Jun. 30, 2021 | |
Going Concern | |
Going Concern | Note 2 - Going Concern As of and for the six months ended June 30, 2021, the Company had cash and cash equivalents of $20.5 million and a net loss of $7.2 million, respectively. The net loss is primarily attributable to operating expenses of $7.5 million, partially offset by the non-cash derivative gain of $0.3 million (see Note 9 devote substantially all of their efforts and resources to research and development, as well as clinical trials, and do not yet have commercialized products. These existing and projected on-going factors continue to raise substantial doubt about the Company’s ability to continue as a going concern. 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, from time to time and at its sole discretion, may issue and sell shares of its authorized common stock. During the six months ended June 30, 2021, the Company sold shares pursuant to the ATM equity offering program, which yielded gross proceeds of approximately $10.0 million, which was offset by offering related costs of $0.4 million (see Note 10 The Company has prepared an updated projection covering the period from July 1, 2021 through August 31, 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 Other | 6 Months Ended |
Jun. 30, 2021 | |
Prepaid Expenses and Other | |
Prepaid Expenses and Other | Note 3 – Prepaid Expenses and Other Prepaid expenses and other balances as of June 30, 2021 and December 31, 2020 are as follows: June 30, 2021 December 31, 2020 Deposits $ 1,236,000 $ 266,000 Unamortized commercial insurance premiums 981,000 627,000 Annual maintenance service contracts 63,000 — Receivable 30,000 185,000 Other 48,000 69,000 Total prepaid expenses and other $ 2,358,000 $ 1,147,000 |
Fixed Assets
Fixed Assets | 6 Months Ended |
Jun. 30, 2021 | |
Fixed Assets | |
Fixed Assets | Note 4 – Fixed Assets Fixed assets are recorded based on acquisition cost and, once placed in service, are depreciated utilizing the straight-line method over their estimated economic useful lives. Leasehold improvements are accreted over the shorter of the estimated economic life or related lease term. Fixed assets, net of accumulated depreciation and amortization, consist of the following: Estimated Useful Lives June 30, December 31, (in Years) 2021 2020 Leasehold improvements 10 $ 1,950,000 $ 2,250,000 Manufacturing facility/clean room 3 - 8 834,000 998,000 Lab equipment and office furniture 5 - 8 290,000 313,000 Fixed assets, net $ 3,074,000 $ 3,561,000 Depreciation and amortization expense for the respective periods is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Depreciation and amortization expense $ 274,000 $ 296,000 $ 568,000 $ 591,000 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 6 Months Ended |
Jun. 30, 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 June 30, 2021 and December 31, 2020 are as follows: June 30, 2021 December 31, 2020 Accounts payable $ 170,000 $ 186,000 Clinical trials 1,525,000 558,000 Commercial insurance premium financing 808,000 386,000 Professional fees 380,000 267,000 Other 54,000 153,000 Accounts payable and accrued expenses $ 2,937,000 $ 1,550,000 |
Paycheck Protection Program
Paycheck Protection Program | 6 Months Ended |
Jun. 30, 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 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. 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 is considered to be paid off in full. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 - Commitments and Contingencies Commitments and contingencies are described below and summarized by the following table: Total 2021 2022 2023 2024 2025 Thereafter Key clinical research trial obligations $ 3,896,000 $ 2,768,000 $ 1,128,000 $ — $ — $ — $ — Employment agreements 830,000 351,000 466,000 13,000 — — — Commercial insurance premium financing agreement 808,000 539,000 269,000 — — — — Statistical analysis and programming consulting services 326,000 163,000 163,000 — — — — $ 5,860,000 $ 3,821,000 $ 2,026,000 $ 13,000 $ — $ — $ — Key Clinical Research Trial Obligations Osteoarthritis of the Knee AP-013 study In December 2020, the Company entered into an initial contract with a CRO in reference to the AP-013 study database totaling $1.4 million. The contractual provisions required a retainer of $315,000, which will be applied to future study expenses as further defined by the contract. 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. 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. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, the Company is evaluating its options to analyze the clinical trial data from the AP-013 study. The Company had an outstanding future contractual commitment of $382,000 (net of deposit) as of June 30, 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 I study for at-home treatment utilizing inhaled Ampion to treat patients with Post-Acute Sequelae of SARS-CoV-2 infection (“PASC”) commonly referred to as “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. 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 $130,000 (net of deposit) as of June 30, 2021. In June 2021, the Company entered into a contract with a CRO totaling $2.5 million in reference to a multicenter Phase II 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 will be applied to future study expenses as further defined by the contract. 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 $2.2 million (net of deposit) as of June 30, 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 II clinical trial utilizing IV Ampion in the treatment of patients suffering from complications arising from COVID- 19 (the AP-017 study”). The contractual provisions required a retainer of $345,000, which will be applied to future study expenses as further defined by the contract. The contract currently accounts for 120 patients; however, based on the revised protocol, the number of patients has increased to 200. The Company is in ongoing discussions with the CRO to amend the contractual amount to account for the additional patients expected to be enrolled. 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 On December 14, 2019, the Company entered into a 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 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 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. 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 June 30, 2021 was $734,000, which will be paid in full by March 2022. In addition, as of June 30, 2021, the Company had a remaining balance of $74,000 related to annual insurance premiums payable to the Company’s insurance broker, which will be paid in full by March 2022. Statistical Analysis and Programming Consulting Services In May 2019, the Company entered into a statistical analysis and programming consulting services agreement for $578,000. As of June 30, 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 by fiscal 2022. Facility Lease In December 2013, the Company entered into a 125-month “Leases (Topic 842)” determining the present value of the lease payments. Lease expense is recognized on a straight-line basis over the lease term, subject to any changes in the lease or expectations regarding the terms. The lease liability is classified both as current in part and long-term in part on the balance sheet based on the projected settlement of the liability. The following table provides a reconciliation of the Company’s remaining undiscounted payments for its facility lease and the carrying amount of the lease liability disclosed on the balance sheet as of June 30, 2021: Facility Lease Payments Remainder of 2022 2023 2024 2025 Thereafter Remaining Facility Lease Payments $ 1,173,000 $ 174,000 $ 355,000 $ 364,000 $ 280,000 $ — $ — Less: Discount Adjustment (102,000) Total lease liability $ 1,071,000 Lease liability-current portion $ 298,000 Long-term lease liability $ 773,000 The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of June 30, 2021: ROU Asset Balance as of December 31, 2020 $ 824,000 Amortization (96,000) Balance as of June 30, 2021 $ 728,000 The Company recorded lease expense in the respective periods is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Lease expense $ 67,000 $ 66,000 $ 140,000 $ 132,000 |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2021 | |
Warrants | |
Warrants | Note 8 – Warrants The Company has issued both equity (“placement agent”) and liability (“investor”) classified warrants in conjunction with previous equity raises. The Company had a total of 1.6 million equity-classified warrants and 2.2 million liability-classified warrants outstanding as of June 30, 2021. The following table summarizes the Company’s warrant activity during the six months ended June 30, 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 (357,126) $ 0.42 — Outstanding as of June 30, 2021 3,773,598 $ 0.68 1.49 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 0.92 Placement agent warrants at $0.76 422,233 0.92 Placement agent warrants at $0.94 150,000 0.16 Investor warrants at $0.40 153,400 2.12 Placement agent warrants at $0.50 1,021,050 2.97 Outstanding as of June 30, 2021 3,773,598 $ 0.68 1.49 During the six months ended June 30, 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 73,026 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 51,763 shares of common stock. 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 June 30, 2021 is approximately $2.3 million (see Note 9 |
Fair Value Considerations
Fair Value Considerations | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Considerations [Abstract] | |
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 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 June 30, 2021 and December 31, 2020, by level within the fair value hierarchy: Fair Value Measurements Using Level 1 Level 2 Level 3 Total June 30, 2021 Liabilities: Warrant derivative liability $ — $ — $ 2,340,000 $ 2,340,000 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 80,000 Balance as of June 30, 2021 $ 2,340,000 |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Common stock | Note 10 - Common Stock Authorized Shares The Company had 300.0 million authorized shares of common stock as of June 30, 2021 and December 31, 2020. The following table summarizes the Company’s remaining authorized shares available for future issuance: June 30, 2021 Authorized shares 300,000,000 Common stock outstanding 200,070,419 Options outstanding 5,686,989 Warrants outstanding 3,773,598 Reserved for issuance under 2019 Stock and Incentive Plan 7,918,755 Available shares 82,550,239 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 and June 30, 2021: Three months ended Three months ended Total Total shares of common stock sold 1,848,437 4,066,773 5,915,210 Gross proceeds $ 2,705,000 $ 7,267,000 $ 9,972,000 Commissions earned by placement agents (109,000) (291,000) (400,000) Issuance fees (17,000) (30,000) (47,000) Net proceeds $ 2,579,000 $ 6,946,000 $ 9,525,000 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 six months ended June 30, 2021 and 2020, respectively. |
Equity
Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity | |
Equity | Note 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 June 30, 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 six months ended June 30, 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 (443,662) $ 0.55 Forfeited, expired and/or cancelled (5,000) $ 1.75 Outstanding as of June 30, 2021 5,686,989 $ 1.08 6.92 $ 4,661,000 Exercisable as of June 30, 2021 5,413,989 $ 1.09 6.80 $ 4,471,000 Of the 443,662 stock options that were exercised during the six months ended June 30, 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 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. The following table summarizes the outstanding options that were issued in accordance with the 2010 Plan and the 2019 Plan: Outstanding Options by Plan June 30, 2021 2010 Plan 3,640,018 2019 Plan 2,046,971 Outstanding as of June 30, 2021 5,686,989 Stock options outstanding as of June 30, 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 8.17 $0.51 - $1.00 4,152,345 $ 0.71 7.14 $1.01 - $1.50 187,000 $ 1.39 9.38 $1.51 and above 853,144 $ 3.23 4.59 Total 5,686,989 $ 1.08 6.92 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 June 30, 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 and six months ended June 30, 2021 and 2020: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development expenses Stock-based compensation $ — $ 11,000 $ 46,000 $ 71,000 General and administrative expenses Issuance of common stock for services — — 80,000 80,000 Stock-based compensation 67,000 53,000 187,000 206,000 Total stock-based compensation $ 67,000 $ 64,000 $ 313,000 $ 357,000 Unrecognized expense as of June 30, 2021 $ 98,000 Weighted average remaining years to vest 1.12 |
Earnings Per Share
Earnings Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share | |
Earnings Per Share | Note 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 and six months ended June 30, 2021 and 2020: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Net loss $ (3,556,000) $ (2,731,000) $ (7,222,000) $ (7,910,000) Less: decrease in fair value of investor warrants (116,000) — (267,000) (156,000) Loss available to common stockholders $ (3,672,000) $ (2,731,000) $ (7,489,000) $ (8,066,000) Basic weighted-average common shares outstanding 196,179,371 166,392,893 195,785,398 162,723,309 Add: dilutive effect of equity instruments 5,268,667 — 5,199,951 1,182,948 Diluted weighted-average shares outstanding 201,448,038 166,392,893 200,985,349 163,906,257 Earnings per share – basic $ (0.02) $ (0.02) $ (0.04) $ (0.05) Earnings per share – diluted $ (0.02) $ (0.02) $ (0.04) $ (0.05) 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 June 30, Six Months Ended June 30, 2021 2020 2021 2020 Outstanding stock options 1,437,657 6,866,524 1,466,319 5,917,367 Warrants to purchase shares of common stock 2,754,263 5,374,832 2,794,317 5,141,041 Total potentially dilutive shares of common stock 4,191,920 12,241,356 4,260,636 11,058,408 |
Litigation
Litigation | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Litigation | Note 13 – Litigation From time to time, the Company may be a party to litigation arising in the ordinary course of business. As of June 30, 2021, the Company is not a party to any ongoing lawsuits. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events | |
Subsequent Events | Note 14 – Subsequent Events In July 2021, the Company received additional gross proceeds of $0.5 million from the sale of 330,875 shares of common stock in an ATM offering pursuant to the Sales Agreement, which was offset by offering related costs of $22,000. |
The Company and Summary of Si_2
The Company and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
The Company and Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the United States for interim financial information and with the instructions of the SEC on Quarterly Reports on Form 10-Q and Article 8 of Regulation S-X. Accordingly, such financial statements do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the financial position and of the results of operations and cash flows of the Company for the periods presented. These financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto for the year ended December 31, 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 and six months ended June 30, 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 | Impact of Global Pandemic In January 2020, the Secretary of Health and Human Services (“HHS”) declared a public health emergency and the World Health Organization (“WHO”) announced a global health emergency because of the novel Coronavirus Disease 2019 (“COVID-19”). In March 2020, the WHO declared the outbreak of COVID-19, a global pandemic. Since the declaration of the outbreak, COVID-19 has adversely impacted 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. In May 2021, the FDA issued updated statistical guidance for the industry. At this time, the Company is evaluating its options to analyze the clinical trial data from the AP-013 study. 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 current and future 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 related to the pandemic, which cannot be predicted at this time. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company has no off-balance-sheet concentrations of credit risk, such as foreign exchange contracts, option contracts or foreign currency hedging arrangements. The Company consistently maintains its cash and cash equivalent balances in the form of bank demand deposits, United States federal government backed treasury securities and fully liquid money market fund accounts with financial institutions that management believes are creditworthy. The Company periodically monitors its cash positions with, and the credit quality of, the financial institutions with which it invests. During the three and six months ended June 30, 2021, and as consistent with prior reporting periods, the Company maintained balances in excess of federally insured limits. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses, and related disclosures in the financial statements and accompanying notes. The Company bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions primarily include the Company’s projected liquidity and resulting going concern position, clinical trial accrual 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 | Adoption of Recent Accounting Pronouncements The Company has not adopted any recent accounting pronouncements during the six months ended June 30, 2021. Recent Accounting Pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU 2020-06, “ Debt (Subtopic 470-20); Debt with Conversion and Other Options and Derivatives and Hedging (Subtopic 815-40) Contracts in Entity’s Own Equity 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) | 6 Months Ended |
Jun. 30, 2021 | |
Prepaid Expenses and Other | |
Schedule Of Prepaid Expenses and other balances | June 30, 2021 December 31, 2020 Deposits $ 1,236,000 $ 266,000 Unamortized commercial insurance premiums 981,000 627,000 Annual maintenance service contracts 63,000 — Receivable 30,000 185,000 Other 48,000 69,000 Total prepaid expenses and other $ 2,358,000 $ 1,147,000 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fixed Assets | |
Schedule of Fixed Assets | Estimated Useful Lives June 30, December 31, (in Years) 2021 2020 Leasehold improvements 10 $ 1,950,000 $ 2,250,000 Manufacturing facility/clean room 3 - 8 834,000 998,000 Lab equipment and office furniture 5 - 8 290,000 313,000 Fixed assets, net $ 3,074,000 $ 3,561,000 |
Schedule Of Depreciation expense | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Depreciation and amortization expense $ 274,000 $ 296,000 $ 568,000 $ 591,000 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | June 30, 2021 December 31, 2020 Accounts payable $ 170,000 $ 186,000 Clinical trials 1,525,000 558,000 Commercial insurance premium financing 808,000 386,000 Professional fees 380,000 267,000 Other 54,000 153,000 Accounts payable and accrued expenses $ 2,937,000 $ 1,550,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Commitments and Contingencies | Total 2021 2022 2023 2024 2025 Thereafter Key clinical research trial obligations $ 3,896,000 $ 2,768,000 $ 1,128,000 $ — $ — $ — $ — Employment agreements 830,000 351,000 466,000 13,000 — — — Commercial insurance premium financing agreement 808,000 539,000 269,000 — — — — Statistical analysis and programming consulting services 326,000 163,000 163,000 — — — — $ 5,860,000 $ 3,821,000 $ 2,026,000 $ 13,000 $ — $ — $ — |
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 disclosed on the balance sheet as of June 30, 2021: Facility Lease Payments Remainder of 2022 2023 2024 2025 Thereafter Remaining Facility Lease Payments $ 1,173,000 $ 174,000 $ 355,000 $ 364,000 $ 280,000 $ — $ — Less: Discount Adjustment (102,000) Total lease liability $ 1,071,000 Lease liability-current portion $ 298,000 Long-term lease liability $ 773,000 |
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 June 30, 2021: ROU Asset Balance as of December 31, 2020 $ 824,000 Amortization (96,000) Balance as of June 30, 2021 $ 728,000 The Company recorded lease expense in the respective periods is as follows: Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Lease expense $ 67,000 $ 66,000 $ 140,000 $ 132,000 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Warrants | |
Summary of Company's warrant activity | The following table summarizes the Company’s warrant activity during the six months ended June 30, 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 (357,126) $ 0.42 — Outstanding as of June 30, 2021 3,773,598 $ 0.68 1.49 |
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 Warrants Exercise Price Contractual Life Investor warrants at $0.76 2,026,915 0.92 Placement agent warrants at $0.76 422,233 0.92 Placement agent warrants at $0.94 150,000 0.16 Investor warrants at $0.40 153,400 2.12 Placement agent warrants at $0.50 1,021,050 2.97 Outstanding as of June 30, 2021 3,773,598 $ 0.68 1.49 |
Fair Value Considerations (Tabl
Fair Value Considerations (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Considerations [Abstract] | |
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 June 30, 2021 and December 31, 2020, by level within the fair value hierarchy: Fair Value Measurements Using Level 1 Level 2 Level 3 Total June 30, 2021 Liabilities: Warrant derivative liability $ — $ — $ 2,340,000 $ 2,340,000 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 value hierarchy: Derivative Instruments Balance as of December 31, 2020 $ 2,607,000 Warrant exercises (347,000) Change in fair value 80,000 Balance as of June 30, 2021 $ 2,340,000 |
Common Stock (Tables)
Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Schedule of remaining authorized Shares | June 30, 2021 Authorized shares 300,000,000 Common stock outstanding 200,070,419 Options outstanding 5,686,989 Warrants outstanding 3,773,598 Reserved for issuance under 2019 Stock and Incentive Plan 7,918,755 Available shares 82,550,239 |
Schedule of sale of stock under sales agreement | Three months ended Three months ended Total Total shares of common stock sold 1,848,437 4,066,773 5,915,210 Gross proceeds $ 2,705,000 $ 7,267,000 $ 9,972,000 Commissions earned by placement agents (109,000) (291,000) (400,000) Issuance fees (17,000) (30,000) (47,000) Net proceeds $ 2,579,000 $ 6,946,000 $ 9,525,000 |
Equity (Tables)
Equity (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Stock Options Outstanding and Exercisable | Stock options outstanding as of June 30, 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 8.17 $0.51 - $1.00 4,152,345 $ 0.71 7.14 $1.01 - $1.50 187,000 $ 1.39 9.38 $1.51 and above 853,144 $ 3.23 4.59 Total 5,686,989 $ 1.08 6.92 |
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 June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development expenses Stock-based compensation $ — $ 11,000 $ 46,000 $ 71,000 General and administrative expenses Issuance of common stock for services — — 80,000 80,000 Stock-based compensation 67,000 53,000 187,000 206,000 Total stock-based compensation $ 67,000 $ 64,000 $ 313,000 $ 357,000 Unrecognized expense as of June 30, 2021 $ 98,000 Weighted average remaining years to vest 1.12 |
Employee Stock Option | |
Stock Option Activity | The following table summarizes the Company’s stock option activity during the six months ended June 30, 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 (443,662) $ 0.55 Forfeited, expired and/or cancelled (5,000) $ 1.75 Outstanding as of June 30, 2021 5,686,989 $ 1.08 6.92 $ 4,661,000 Exercisable as of June 30, 2021 5,413,989 $ 1.09 6.80 $ 4,471,000 The following table summarizes the outstanding options that were issued in accordance with the 2010 Plan and the 2019 Plan: Outstanding Options by Plan June 30, 2021 2010 Plan 3,640,018 2019 Plan 2,046,971 Outstanding as of June 30, 2021 5,686,989 |
2019 Stock plan | |
Stock Option Activity | The following table summarizes the activity of the 2019 Plan and the shares available for future equity awards as of June 30, 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) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share | |
Schedule for the calculations of basic and diluted earnings per share | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Net loss $ (3,556,000) $ (2,731,000) $ (7,222,000) $ (7,910,000) Less: decrease in fair value of investor warrants (116,000) — (267,000) (156,000) Loss available to common stockholders $ (3,672,000) $ (2,731,000) $ (7,489,000) $ (8,066,000) Basic weighted-average common shares outstanding 196,179,371 166,392,893 195,785,398 162,723,309 Add: dilutive effect of equity instruments 5,268,667 — 5,199,951 1,182,948 Diluted weighted-average shares outstanding 201,448,038 166,392,893 200,985,349 163,906,257 Earnings per share – basic $ (0.02) $ (0.02) $ (0.04) $ (0.05) Earnings per share – diluted $ (0.02) $ (0.02) $ (0.04) $ (0.05) |
Potentially dilutive securities, excluded | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Outstanding stock options 1,437,657 6,866,524 1,466,319 5,917,367 Warrants to purchase shares of common stock 2,754,263 5,374,832 2,794,317 5,141,041 Total potentially dilutive shares of common stock 4,191,920 12,241,356 4,260,636 11,058,408 |
Going Concern (Detail)
Going Concern (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Feb. 29, 2020item | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Cash and cash equivalents | $ 20,549,000 | $ 20,549,000 | $ 17,346,000 | ||||||
Net loss | (3,556,000) | $ (2,731,000) | (7,222,000) | $ (7,910,000) | |||||
Working capital | 6,500,000 | 6,500,000 | |||||||
Operating expenses | 3,673,000 | 2,600,000 | 7,491,000 | 8,622,000 | |||||
Derivative gain (loss) | 116,000 | (675,000) | 267,000 | 156,000 | |||||
Accumulated deficit | (207,750,000) | (207,750,000) | (200,527,000) | ||||||
Stockholders' equity | $ 20,361,000 | $ 6,343,000 | 20,361,000 | $ 6,343,000 | $ 16,777,000 | $ 17,512,000 | $ 1,993,000 | $ 6,443,000 | |
ATM equity offering program | |||||||||
Gross proceeds | 10,000,000 | ||||||||
Offering related costs | $ 400,000 | ||||||||
Sale Agreement (ATM) | |||||||||
Number of agents | item | 2 |
Prepaid Expenses and Other (Det
Prepaid Expenses and Other (Detail) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Prepaid Expenses and Other | ||
Deposits | $ 1,236,000 | $ 266,000 |
Unamortized commercial insurance premiums | 981,000 | 627,000 |
Annual maintenance service contracts | 63,000 | |
Receivable | 30,000 | 185,000 |
Other | 48,000 | 69,000 |
Total prepaid expenses and other | $ 2,358,000 | $ 1,147,000 |
Fixed Assets (Detail)
Fixed Assets (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Fixed assets, net | $ 3,074,000 | $ 3,561,000 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives in Years | 10 years | |
Fixed assets, gross | $ 1,950,000 | 2,250,000 |
Manufacturing facility/ clean room | ||
Property, Plant and Equipment [Line Items] | ||
Fixed assets, gross | $ 834,000 | 998,000 |
Manufacturing facility/ clean room | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Lives in Years | 3 years | |
Manufacturing facility/ clean room | 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 | $ 290,000 | $ 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 and
Fixed Assets - Depreciation and Amortization Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Fixed Assets | ||||
Depreciation and amortization expense | $ 274,000 | $ 296,000 | $ 568,000 | $ 591,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Detail) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 170,000 | $ 186,000 |
Clinical trials | 1,525,000 | 558,000 |
Commercial insurance premium financing | 808,000 | 386,000 |
Professional fees | 380,000 | 267,000 |
Other | 54,000 | 153,000 |
Accounts payable and accrued expenses | $ 2,937,000 | $ 1,550,000 |
Paycheck Protection Program - A
Paycheck Protection Program - Additional Information (Detail) - PPP | 1 Months Ended |
Apr. 30, 2020USD ($) | |
Debt Instrument [Line Items] | |
PPP loan proceeds | $ 544,000 |
Interest rate (as a percentage) | 1.00% |
Term of agreement (in years) | 6 months |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Commitments and Contingencies (Detail) | Jun. 30, 2021USD ($) |
Commitment And Contingencies [Line Items] | |
2021 | $ 3,821,000 |
2022 | 2,026,000 |
2023 | 13,000 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 5,860,000 |
Key Clinical Research Trial Obligations | |
Commitment And Contingencies [Line Items] | |
2021 | 2,768,000 |
2022 | 1,128,000 |
2023 | 0 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 3,896,000 |
Employment Agreements | |
Commitment And Contingencies [Line Items] | |
2021 | 351,000 |
2022 | 466,000 |
2023 | 13,000 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 830,000 |
Commercial Insurance Premium Financing Agreement | |
Commitment And Contingencies [Line Items] | |
2021 | 539,000 |
2022 | 269,000 |
2023 | 0 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | 808,000 |
Statistical analysis and programming consulting services | |
Commitment And Contingencies [Line Items] | |
2021 | 163,000 |
2022 | 163,000 |
2023 | 0 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Total | $ 326,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | |||||
Jun. 30, 2021 | Apr. 30, 2020 | Dec. 31, 2013 | Mar. 31, 2021 | Dec. 31, 2020 | May 31, 2019 | |
Commitments and Contingencies [Line Items] | ||||||
Contractual obligation | $ 5,860,000 | |||||
Facility Lease Incremental Borrowing Rate | 5.75% | |||||
Newly Leased Office Space and Manufacturing Facility [Member] | ||||||
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 | $ 3,896,000 | |||||
New CRO | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | $ 1,400,000 | |||||
Contractual deposit Commitment | 315,000 | |||||
Contractual obligation | 382,000 | |||||
Intravenous treatment for COVID 19 patients | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | 1,800,000 | |||||
Contractual deposit Commitment | $ 345,000 | |||||
Contractual obligation | 1,200,000 | |||||
Regional Hospital Group, AP-018 Study | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | $ 318,000 | |||||
Contractual deposit Commitment | $ 105,000 | |||||
Contractual obligation | 130,000 | |||||
Regional Hospital Group, AP-019 Study [Member] | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | 2,500,000 | |||||
Contractual deposit Commitment | 300,000 | |||||
Contractual obligation | 2,200,000 | |||||
Statistical analysis and programming consulting services | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contract amount | $ 578,000 | |||||
Contractual obligation | 326,000 | |||||
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% | |||||
Commercial Insurance Premium Financing Agreement | ||||||
Commitments and Contingencies [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 | 734,000 | |||||
Insurance premiums | $ 74,000 |
Commitments and Contingencies_3
Commitments and Contingencies - Employment Agreements (Detail) - USD ($) | Dec. 14, 2019 | Sep. 16, 2019 | Jul. 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 ($) | Jun. 30, 2021 | Dec. 31, 2020 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
Remainder of 2021 | $ 174,000 | |
2022 | 355,000 | |
2023 | 364,000 | |
2024 | 280,000 | |
Remaining Facility Lease Payments | 1,173,000 | |
Less: Discount Adjustment | (102,000) | |
Total lease liability | 1,071,000 | |
Lease liability - current portion | 298,000 | $ 284,000 |
Long-term lease liability | $ 773,000 | $ 925,000 |
Commitments and Contingencies_5
Commitments and Contingencies - Lease Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Balance as of December 31, 2020 | $ 824,000 | |||
Amortization | (96,000) | |||
Balance as of June 30, 2021 | $ 728,000 | 728,000 | ||
Lease expense | $ 67,000 | $ 66,000 | $ 140,000 | $ 132,000 |
Warrants - Warrants Activity (D
Warrants - Warrants Activity (Detail) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Number of Warrants Outstanding | ||
Class of Warrant or Right, Outstanding | 3,773,598 | 4,130,724 |
Number of Warrants Outstanding, Beginning Balance | 4,130,724 | |
Number of Warrants, Warrants exercised | (357,126) | |
Number of Warrants Outstanding, Ending Balance | 3,773,598 | 4,130,724 |
Warrants, Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Outstanding Beginning Balance | $ 0.66 | |
Weighted Average Exercise Price, Warrants exercised | 0.42 | |
Weighted Average Exercise Price, Outstanding Ending Balance | $ 0.68 | $ 0.66 |
Weighted Average Remaining Contractual Life | ||
Weighted Average Remaining Contractual Life, Warrants Outstanding | 1 year 5 months 26 days | 2 years 18 days |
Equity based-warrants | ||
Number of Warrants Outstanding | ||
Class of Warrant or Right, Outstanding | 1,600,000 | |
Number of Warrants Outstanding, Ending Balance | 1,600,000 | |
Liability warrants | ||
Number of Warrants Outstanding | ||
Class of Warrant or Right, Outstanding | 2,200,000 | |
Number of Warrants Outstanding, Ending Balance | 2,200,000 |
Warrants - Warrants Activity Cl
Warrants - Warrants Activity Classified as Equity and Liability (Detail) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Warrants Outstanding, Ending Balance | 3,773,598 | 4,130,724 |
Exercise price | $ 0.68 | $ 0.66 |
Weighted Average Remaining Contractual Life, Warrants Outstanding | 1 year 5 months 26 days | 2 years 18 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 | 11 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 Balance | 422,233 | |
Exercise price | $ 0.76 | |
Weighted Average Remaining Contractual Life, Warrants Outstanding | 11 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 Balance | 150,000 | |
Exercise price | $ 0.94 | |
Weighted Average Remaining Contractual Life, Warrants Outstanding | 1 month 28 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 | 2 years 1 month 13 days | |
Placement agent warrants at $0.50 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of Warrants Outstanding, Ending Balance | 1,021,050 | |
Exercise price | $ 0.50 | |
Weighted Average Remaining Contractual Life, Warrants Outstanding | 2 years 11 months 19 days |
Warrants - Narrative (Detail)
Warrants - Narrative (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Class of Warrant or Right [Line Items] | ||
Exercise price | $ 0.68 | $ 0.66 |
Warrant derivative liability | $ 2,340,000 | $ 2,607,000 |
Investor Warrants [Member] | ||
Class of Warrant or Right [Line Items] | ||
Common shares issued for warrant exercised | 284,100 | |
Exercise price | $ 0.40 | |
Proceeds from warrant exercises | $ 114,000 | |
Number Of Warrants Exercised By Placement Agents | 73,026 | |
Stock Issued On Exercise Of Warrants By Placement Agents | 51,763 |
Fair Value Considerations - Fin
Fair Value Considerations - Financial Assets and Liabilities (Detail) - USD ($) | Jun. 30, 2021 | Dec. 31, 2020 |
LIABILITIES | ||
Warrant derivative liability | $ 2,340,000 | $ 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 | $ 2,340,000 | $ 2,607,000 |
Fair Value Considerations - Set
Fair Value Considerations - Sets Forth a Reconciliation of Changes (Detail) | 6 Months Ended |
Jun. 30, 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 value | 80,000 |
Balance as of June 30, 2021 | $ 2,340,000 |
Common Stock (Summarizes the Co
Common Stock (Summarizes the Company's remaining authorized shares available - (Detail) - shares | Jun. 30, 2021 | Dec. 31, 2020 |
Equity [Abstract] | ||
Authorized shares | 300,000,000 | 300,000,000 |
Common stock outstanding | 200,070,419 | 193,378,996 |
Options Outstanding | 5,686,989 | |
Warrants Outstanding | 3,773,598 | 4,130,724 |
Reserved for issuance under 2019 Stock and Incentive Plan | 7,918,755 | |
Available Shares | 82,550,239 |
Common Stock (Sales Agreement)
Common Stock (Sales Agreement) (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Feb. 29, 2020USD ($)item | Jun. 30, 2021USD ($)shares | Mar. 31, 2021USD ($)shares | Jun. 30, 2021USD ($)shares | |
Class of Stock [Line Items] | ||||
Total shares of common stock sold | shares | 4,066,773 | 1,848,437 | ||
Gross Proceeds | $ 7,267 | $ 2,705 | ||
Commissions earned by placement agents | (291) | (109) | ||
Issuance fees | (30) | (17) | ||
Net Proceeds | $ 6,946 | $ 2,579 | ||
Sale Agreement (ATM) | ||||
Class of Stock [Line Items] | ||||
Number of agents | item | 2 | |||
Maximum aggregate offering price of equity securities | $ 50,000 | |||
Percentage of commission | 4.00% | |||
Sales Agreement | ||||
Class of Stock [Line Items] | ||||
Total shares of common stock sold | shares | 5,915,210 | |||
Gross Proceeds | $ 9,972 | |||
Commissions earned by placement agents | (400) | |||
Issuance fees | (47) | |||
Net Proceeds | $ 9,525 | |||
Sales Agreement Agent [Member] | Sale Agreement (ATM) | ||||
Class of Stock [Line Items] | ||||
Percentage of commission | 2.00% |
Common Stock (Common Stock Issu
Common Stock (Common Stock Issued for Services) (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Components of common Stock [Line Items] | ||||
Issuance of common stock for services | $ 80,000 | $ 80,000 | ||
Common Stock Issued for Services [Member] | Non Employee Directors | ||||
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 - Activity of Plan (Deta
Equity - Activity of Plan (Detail) - Employee Stock Option - shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted | (36,000) | ||
Forfeited, expired and/or cancelled equity awards | 5,000 | ||
2019 Stock plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total shares reserved for equity awards | 10,000,000 | 10,000,000 | |
Options granted | (36,000) | (2,067,471) | |
Forfeited, expired and/or cancelled equity awards | 22,226 | ||
Remaining shares available for future equity awards | 7,918,755 |
Equity - Stock Option Activity
Equity - Stock Option Activity (Detail) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | Dec. 31, 2020$ / sharesshares | |
Number of Options | ||
Number of Options, Ending Balance | 5,686,989 | |
Employee Stock Option | ||
Number of Options | ||
Number of Options, Beginning Balance | 6,099,651 | |
Number of Options, Granted | 36,000 | |
Number of Options, Exercised | (443,662) | |
Number of Options, Forfeited, expired and/or cancelled | (5,000) | |
Number of Options, Ending Balance | 5,686,989 | 6,099,651 |
Number of Options, Exercisable | 5,413,989 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Beginning Balance | $ / shares | $ 1.04 | |
Weighted Average Exercise Price, Granted | $ / shares | 1.76 | |
Weighted Average Exercise Price, Exercised | $ / shares | 0.55 | |
Weighted Average Exercise Price, Forfeited, expired and/or cancelled | $ / shares | 1.75 | |
Weighted Average Exercise Price, Ending Balance | $ / shares | 1.08 | $ 1.04 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 1.09 | |
Weighted Average Remaining Contractual Life, Outstanding | 6 years 11 months 1 day | 7 years 4 months 9 days |
Weighted Average Remaining Contractual Life, Exercisable | 6 years 9 months 18 days | |
Aggregate Intrinsic Value, Outstanding | $ | $ 4,661,000 | |
Aggregate Intrinsic Value, Exercisable | $ | $ 4,471,000 | |
Stock options exercised (Shares) | 443,662 | |
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 | |
Tax obligations on behalf of option holders | $ | $ 40,000 | |
2010 Stock Plan | ||
Number of Options | ||
Number of Options, Ending Balance | 3,640,018 | |
2019 Stock plan | ||
Number of Options | ||
Number of Options, Ending Balance | 2,046,971 | |
2019 Stock plan | Employee Stock Option | ||
Number of Options | ||
Number of Options, Granted | 36,000 | 2,067,471 |
Number of Options, Forfeited, expired and/or cancelled | (22,226) | |
Number of Options, Available for grant | 7,918,755 |
Equity - Summary of Stock Optio
Equity - Summary of Stock Options Outstanding and Exercisable (Detail) - Employee Stock Option | 6 Months Ended |
Jun. 30, 2021$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of Options Outstanding | shares | 5,686,989 |
Weighted Average Exercise Price | $ 1.08 |
Weighted Average Remaining Contractual Lives | 6 years 11 months 1 day |
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 | 8 years 2 months 1 day |
Range of Exercise Prices Upper | $ 0.50 |
$0.51 - $1.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of Options Outstanding | shares | 4,152,345 |
Weighted Average Exercise Price | $ 0.71 |
Weighted Average Remaining Contractual Lives | 7 years 1 month 20 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 | 187,000 |
Weighted Average Exercise Price | $ 1.39 |
Weighted Average Remaining Contractual Lives | 9 years 4 months 17 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 | 853,144 |
Weighted Average Exercise Price | $ 3.23 |
Weighted Average Remaining Contractual Lives | 4 years 7 months 2 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) | 6 Months Ended |
Jun. 30, 2021 | |
Equity | |
Expected volatility | 127.17% |
Risk free interest rate | 0.78% |
Expected term (years) | 5 years |
Equity - Summary of Stock-Based
Equity - Summary of Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expenses | $ 67,000 | $ 64,000 | $ 313,000 | $ 357,000 |
Unrecognized expense as of December 31, 2020 | $ 98,000 | |||
Weighted average remaining years to vest | 1 year 1 month 13 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 | 11,000 | 46,000 | 71,000 | |
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 expenses | $ 0 | 0 | 80,000 | 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 | $ 67,000 | $ 53,000 | $ 187,000 | $ 206,000 |
Earnings Per Share (Detail)
Earnings Per Share (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings Per Share | ||||
Net loss | $ (3,556,000) | $ (2,731,000) | $ (7,222,000) | $ (7,910,000) |
Less: decrease in fair value of investor warrants | (116,000) | (267,000) | (156,000) | |
Loss available to common stockholders | $ (3,672,000) | $ (2,731,000) | $ (7,489,000) | $ (8,066,000) |
Basic weighted-average common shares outstanding | 196,179,371 | 166,392,893 | 195,785,398 | 162,723,309 |
Add: dilutive effect of equity instruments | 5,268,667 | 5,199,951 | 1,182,948 | |
Diluted weighted-average shares outstanding | 201,448,038 | 166,392,893 | 200,985,349 | 163,906,257 |
Earnings per share - basic | $ (0.02) | $ (0.02) | $ (0.04) | $ (0.05) |
Earnings per share - diluted | $ (0.02) | $ (0.02) | $ (0.04) | $ (0.05) |
Earnings Per Share - Anti-dilut
Earnings Per Share - Anti-dilutive (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares of common stock | 4,191,920 | 12,241,356 | 4,260,636 | 11,058,408 |
Employee Stock Option | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total potentially dilutive shares of common stock | 1,437,657 | 6,866,524 | 1,466,319 | 5,917,367 |
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 stock | 2,754,263 | 5,374,832 | 2,794,317 | 5,141,041 |
Subsequent Events - (Detail)
Subsequent Events - (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jul. 31, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Subsequent Event [Line Items] | |||||||
Proceeds from sale of common stock in connection with "at-the-market" equity offering program | $ 9,972,000 | $ 7,913,000 | |||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 321,000 | $ 126,000 | $ 314,000 | $ 246,000 | |||
Subsequent Event | Sale Agreement (ATM) | |||||||
Subsequent Event [Line Items] | |||||||
Proceeds from sale of common stock in connection with "at-the-market" equity offering program | $ 500,000 | ||||||
Issuance of common stock (Shares) | 330,875 | ||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 22,000 |