Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 31, 2020 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2020 | |
Entity Registrant Name | AMPIO PHARMACEUTICALS, INC. | |
Trading Symbol | AMPE | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 185,055,000 | |
Entity Central Index Key | 0001411906 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-35182 | |
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 | |
Security Exchange Name | NYSEAMER |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 9,361,000 | $ 6,532,000 |
Prepaid expenses and other | 1,475,000 | 1,718,000 |
Total current assets | 10,836,000 | 8,250,000 |
Fixed assets, net | 3,838,000 | 4,748,000 |
Right-of-use asset | 870,000 | 1,003,000 |
Total assets | 15,544,000 | 14,001,000 |
Current liabilities | ||
Accounts payable and accrued expenses | 1,641,000 | 4,025,000 |
Lease liability-current portion | 278,000 | 259,000 |
Total current liabilities | 1,919,000 | 4,284,000 |
Lease liability-long-term | 999,000 | 1,210,000 |
Warrant derivative liability | 1,901,000 | 2,064,000 |
Total liabilities | 4,819,000 | 7,558,000 |
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 - 183,938,000 as of September 30, 2020 and 158,645,000 as of December 31, 2019 | 18,000 | 16,000 |
Additional paid-in capital | 206,618,000 | 191,060,000 |
Accumulated deficit | (195,911,000) | (184,633,000) |
Total stockholders' equity | 10,725,000 | 6,443,000 |
Total liabilities and stockholders' equity | $ 15,544,000 | $ 14,001,000 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
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 | 183,938,000 | 158,645,000 |
Common Stock, shares outstanding | 183,938,000 | 158,645,000 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Operating expenses | ||||
Research and development | $ 1,655,000 | $ 3,428,000 | $ 7,027,000 | $ 7,129,000 |
General and administrative | 1,647,000 | 1,745,000 | 4,896,000 | 4,301,000 |
Total operating expenses | 3,302,000 | 5,173,000 | 11,923,000 | 11,430,000 |
Other income (expense) | ||||
Interest income | 0 | 8,000 | 12,000 | 53,000 |
Paycheck protection program funding | 0 | 0 | 544,000 | 0 |
Derivative gain (loss) | 7,000 | (2,054,000) | 163,000 | (1,233,000) |
Loss on disposal of asset | (73,000) | (73,000) | 0 | |
Total other (expense) income | (66,000) | (2,046,000) | 646,000 | (1,180,000) |
Net loss | $ (3,368,000) | $ (7,219,000) | $ (11,277,000) | $ (12,610,000) |
Net loss per common share: Basic | $ (0.02) | $ (0.05) | $ (0.07) | $ (0.10) |
Net loss per common share: Diluted | $ (0.02) | $ (0.05) | $ (0.07) | $ (0.10) |
Weighted average number of common shares outstanding: Basic | 178,622,000 | 142,208,000 | 168,062,000 | 122,895,000 |
Weighted average number of common shares outstanding: Diluted | 178,622,000 | 142,208,000 | 169,354,000 | 122,895,000 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) | Common Stock [Member]Public offering | Common Stock [Member]At The Market Equity Offering Program | Common Stock [Member] | Additional Paid-in CapitalPublic offering | Additional Paid-in CapitalAt The Market Equity Offering Program | Additional Paid-in Capital | Accumulated DeficitPublic offering | Accumulated DeficitAt The Market Equity Offering Program | Accumulated Deficit | Public offering | At The Market Equity Offering Program | Total |
Beginning Balance at Dec. 31, 2018 | $ 11,000 | $ 176,228,000 | $ (171,003,000) | $ 5,236,000 | ||||||||
Beginning Balance, shares at Dec. 31, 2018 | 110,942,000 | |||||||||||
Issuance of common stock for services | $ 0 | 60,000 | 0 | 60,000 | ||||||||
Issuance of common stock for services (Shares) | 136,000 | |||||||||||
Stock-based compensation, net of forfeitures | $ 0 | 28,000 | 0 | 28,000 | ||||||||
Warrants exercised, net | $ 0 | 20,000 | 0 | 20,000 | ||||||||
Warrants exercised, net (Shares) | 50,000 | |||||||||||
Net (loss) income | $ 0 | 0 | (5,812,000) | (5,812,000) | ||||||||
Ending Balance at Mar. 31, 2019 | $ 11,000 | 176,336,000 | (176,815,000) | (468,000) | ||||||||
Ending Balance, shares at Mar. 31, 2019 | 111,128,000 | |||||||||||
Beginning Balance at Dec. 31, 2018 | $ 11,000 | 176,228,000 | (171,003,000) | 5,236,000 | ||||||||
Beginning Balance, shares at Dec. 31, 2018 | 110,942,000 | |||||||||||
Settlement of employee tax liability related to stock option exercise, net | 0 | |||||||||||
Net (loss) income | (12,610,000) | |||||||||||
Ending Balance at Sep. 30, 2019 | $ 14,000 | 187,737,000 | (183,613,000) | 4,138,000 | ||||||||
Ending Balance, shares at Sep. 30, 2019 | 142,208,000 | |||||||||||
Beginning Balance at Mar. 31, 2019 | $ 11,000 | 176,336,000 | (176,815,000) | (468,000) | ||||||||
Beginning Balance, shares at Mar. 31, 2019 | 111,128,000 | |||||||||||
Stock-based compensation, net of forfeitures | $ 0 | 73,000 | 0 | 73,000 | ||||||||
Warrants exercised, net | $ 0 | 330,000 | 0 | 330,000 | ||||||||
Warrants exercised, net (Shares) | 825,000 | |||||||||||
Issuance of common stock | $ 3,000 | $ 0 | $ 11,997,000 | $ 142,000 | $ 0 | $ 0 | $ 12,000,000 | $ 142,000 | ||||
Issuance of common stock (Shares) | 30,000,000 | 255,000 | ||||||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (144,000) | 0 | (144,000) | ||||||||
Offering costs related to the issuance of common stock in connection with the public offering | 0 | (1,243,000) | 0 | (1,243,000) | ||||||||
Net (loss) income | 0 | 0 | 421,000 | 421,000 | ||||||||
Ending Balance at Jun. 30, 2019 | $ 14,000 | 187,491,000 | (176,394,000) | 11,111,000 | ||||||||
Ending Balance, shares at Jun. 30, 2019 | 142,208,000 | |||||||||||
Stock-based compensation, net of forfeitures | $ 0 | 246,000 | 0 | 246,000 | ||||||||
Net (loss) income | 0 | 0 | (7,219,000) | (7,219,000) | ||||||||
Ending Balance at Sep. 30, 2019 | $ 14,000 | 187,737,000 | (183,613,000) | 4,138,000 | ||||||||
Ending Balance, shares at Sep. 30, 2019 | 142,208,000 | |||||||||||
Beginning Balance at Dec. 31, 2019 | $ 16,000 | 191,060,000 | (184,633,000) | 6,443,000 | ||||||||
Beginning Balance, shares at Dec. 31, 2019 | 158,645,000 | |||||||||||
Issuance of common stock for services | $ 0 | 80,000 | 0 | 80,000 | ||||||||
Issuance of common stock for services (Shares) | 136,000 | |||||||||||
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) | 1,241,000 | |||||||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | 0 | (246,000) | 0 | (246,000) | ||||||||
Net (loss) income | 0 | 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, 2020 | 160,022,000 | |||||||||||
Beginning Balance at Dec. 31, 2019 | $ 16,000 | 191,060,000 | (184,633,000) | 6,443,000 | ||||||||
Beginning Balance, shares at Dec. 31, 2019 | 158,645,000 | |||||||||||
Settlement of employee tax liability related to stock option exercise, net | $ 2,000 | |||||||||||
Stock options exercised, net (Shares) | 20,000 | |||||||||||
Issuance of common stock (Shares) | 276,000 | |||||||||||
Net (loss) income | $ (11,277,000) | |||||||||||
Ending Balance at Sep. 30, 2020 | $ 18,000 | 206,618,000 | (195,911,000) | 10,725,000 | ||||||||
Ending Balance, shares at Sep. 30, 2020 | 183,938,000 | |||||||||||
Beginning Balance at Mar. 31, 2020 | $ 16,000 | 191,789,000 | (189,812,000) | 1,993,000 | ||||||||
Beginning Balance, shares at Mar. 31, 2020 | 160,022,000 | |||||||||||
Stock-based compensation, net of forfeitures | $ 0 | 64,000 | 0 | 64,000 | ||||||||
Stock options exercised, net | $ 0 | 0 | 0 | 0 | ||||||||
Stock options exercised, net (Shares) | 1,000 | |||||||||||
Warrants exercised, net | $ 0 | 100,000 | 0 | 100,000 | ||||||||
Warrants exercised, net (Shares) | 250,000 | |||||||||||
Issuance of common stock | $ 1,000 | 7,230,000 | 0 | 7,231,000 | ||||||||
Issuance of common stock (Shares) | 13,069,000 | |||||||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (314,000) | 0 | (314,000) | ||||||||
Net (loss) income | 0 | 0 | (2,731,000) | (2,731,000) | ||||||||
Ending Balance at Jun. 30, 2020 | $ 17,000 | 198,869,000 | (192,543,000) | 6,343,000 | ||||||||
Ending Balance, shares at Jun. 30, 2020 | 173,342,000 | |||||||||||
Stock-based compensation, net of forfeitures | $ 0 | 477,000 | 0 | 477,000 | ||||||||
Settlement of employee tax liability related to stock option exercise, net | $ 0 | (2,000) | 0 | (2,000) | ||||||||
Settlement of employee tax liability related to stock option exercise, net (Shares) | 3,000 | |||||||||||
Warrants exercised, net | $ 0 | 365,000 | 0 | 365,000 | ||||||||
Warrants exercised, net (Shares) | 1,188,000 | |||||||||||
Issuance of common stock | $ 1,000 | $ 7,222,000 | $ 0 | $ 7,223,000 | ||||||||
Issuance of common stock (Shares) | 9,405,000 | |||||||||||
Offering costs related to the issuance of common stock in connection with the "at-the-market" equity offering program | $ 0 | (313,000) | 0 | (313,000) | ||||||||
Net (loss) income | 0 | 0 | (3,368,000) | (3,368,000) | ||||||||
Ending Balance at Sep. 30, 2020 | $ 18,000 | $ 206,618,000 | $ (195,911,000) | $ 10,725,000 | ||||||||
Ending Balance, shares at Sep. 30, 2020 | 183,938,000 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities | ||
Net loss | $ (11,277,000) | $ (12,610,000) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation, net of forfeitures | 754,000 | 347,000 |
Depreciation and amortization | 885,000 | 975,000 |
Loss on disposal of fixed asset | 73,000 | 0 |
Paycheck Protection Program funding that offsets qualified expenses | (544,000) | 0 |
Issuance of common stock for services | 80,000 | 60,000 |
Derivative (gain) loss | (163,000) | 1,233,000 |
Changes in operating assets and liabilities | ||
Decrease (increase) in prepaid expenses and other | 243,000 | (1,390,000) |
(Decrease) increase in accounts payable and accrued expenses | (2,385,000) | 805,000 |
Decrease in lease liability | (59,000) | (52,000) |
Proceeds received under the Paycheck Protection Program | 544,000 | 0 |
Net cash used in operating activities | (11,849,000) | (10,632,000) |
Cash flows used in investing activities | ||
Purchase of fixed assets | (48,000) | (14,000) |
Net cash used in investing activities | (48,000) | (14,000) |
Cash flows from financing activities | ||
Proceeds from sale of common stock in connection with "at-the-market" equity offering program | 15,136,000 | 142,000 |
Costs related to sale of common stock in connection with the "at-the-market" equity offering program | (873,000) | (144,000) |
Proceeds from sale of common stock in connection with the public offering | 0 | 12,000,000 |
Costs related to sale of common stock in connection with the public offering | 0 | (1,243,000) |
Proceeds from warrant exercises | 465,000 | 350,000 |
Settlement of employee tax liability related to stock option exercise, net | (2,000) | 0 |
Net cash provided by financing activities | 14,726,000 | 11,105,000 |
Net change in cash and cash equivalents | 2,829,000 | 459,000 |
Cash and cash equivalents at beginning of period | 6,532,000 | 7,585,000 |
Cash and cash equivalents at end of period | 9,361,000 | 8,044,000 |
Non-cash transactions: | ||
Commercial insurance premium financing agreement | 1,347,000 | 0 |
Initial lease liability arising from the adoption of ASC 842 | 0 | 1,704,000 |
Initial recognition of right-of-use asset arising from the adoption of ASC 842 | $ 0 | $ 1,168,000 |
The Company and Summary of Sign
The Company and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
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 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, 2019 included in the Company’s 2019 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 nine months ended September 30, 2020 is unaudited. The balance sheet at December 31, 2019 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 a new strain 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 significantly affect 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 regulatory 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 of Ampion for the treatment of OAK, also known as the “AP-013 study”. Due to the increases in reported COVID-19 cases, the Company has determined that the AP-013 study will remain paused. However, the FDA recently provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. The Company is reviewing this guidance and continues to have ongoing discussions with the CRO to determine the best approach for the AP-013 study. Since the filing of its Form 10-Q covering the three-month period ending June 30, 2020, the Company has been conducting clinical trials related to potential new applications of Ampion (i.e. inhaled and intravenous) related to the COVID-19 infection. The outbreak has and may continue to spread, which could materially impact the Company’s business operations and, in addition, those 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. The full extent of potential impacts on the Company’s business and product development, including clinical trials, financing activities and the global economy will depend on future developments, which cannot be predicted due to the uncertain nature of the continued COVID-19 pandemic, government mandated shut downs, and its adverse effects, including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others. These effects could have a material adverse impact on the Company’s business, operations, financial condition and results of operations. 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 September 30, 2020, 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 future liquidity and resulting going concern position, warrant derivative liability and related periodic gains and losses, stock-based compensation, the projected useful lives and potential impairment of fixed assets, and the valuation allowance related to deferred tax assets. The Company develops these estimates using its judgment based upon the facts and circumstances known at the time. Adoption of Recent Accounting Pronouncements In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework (Topic 820) Recent Accounting Pronouncements The Company reviewed the recent accounting pronouncements and determined that none of the recent accounting pronouncements were applicable. 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 | 9 Months Ended |
Sep. 30, 2020 | |
Going Concern | |
Going Concern | Note 2 - Going Concern As of and for the nine months ended September 30, 2020, the Company had cash and cash equivalents of $9.4 million and a net loss of $11.3 million, respectively. The net loss is primarily attributable to operating expenses of $11.9 million, partially offset by the receipt of Paycheck Protection Program (“PPP”) proceeds of $0.5 million (see Note 6 Note 9 $11.9 $196.0 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 nine months ended September 30, 2020, the Company sold shares pursuant to the ATM equity offering program, which yielded gross proceeds of $15.1 million (see Note 10 The Company has prepared an updated projection covering the period from October 1, 2020 through September 30, 2021 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 | 9 Months Ended |
Sep. 30, 2020 | |
Prepaid Expenses and Other | |
Prepaid Expenses and Other | Note 3 – Prepaid Expenses and Other Prepaid expenses and other balances as of September 30, 2020 and December 31, 2019 are as follows: September 30, 2020 December 31, 2019 Unamortized commercial insurance premiums $ 970,000 $ 502,000 Deposits 214,000 1,162,000 BLA consulting services refund 182,000 - Receivable 14,000 14,000 Other 95,000 40,000 Total prepaid expenses and other $ 1,475,000 $ 1,718,000 |
Fixed Assets
Fixed Assets | 9 Months Ended |
Sep. 30, 2020 | |
Fixed Assets | |
Fixed Assets | Note 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 consist of the following: Estimated Weighted Average Net Book Value Net Book Value Useful Lives Remaining Useful December 31, Accumulated September 30, in Years Lives in Years 2019 Additions Disposals Depreciation 2020 Leasehold improvements 10 4 $ 2,850,000 $ — $ — $ (450,000) $ 2,400,000 Manufacturing facility/clean room 3 - 8 3 1,550,000 9,000 (73,000) (370,000) 1,116,000 Lab equipment and office furniture 5 - 8 3 348,000 39,000 — (65,000) 322,000 Fixed assets, net $ 4,748,000 $ 48,000 $ (73,000) $ (885,000) $ 3,838,000 Depreciation and amortization expense for the respective periods is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Depreciation and amortization expense $ 294,000 $ 320,000 $ 885,000 $ 975,000 |
Accounts Payable and Accrued Ex
Accounts Payable and Accrued Expenses | 9 Months Ended |
Sep. 30, 2020 | |
Accounts Payable and Accrued Expenses | |
Accounts Payable and Accrued Expenses | Note 5 – Accounts Payable and Accrued Expenses Accounts payable and accrued expenses as of September 30, 2020 and December 31, 2019 are as follows: September 30, 2020 December 31, 2019 Accounts payable $ 398,000 $ 151,000 Commercial insurance premium financing agreement 721,000 21,000 Clinical trials 225,000 3,288,000 Professional fees 181,000 317,000 Other 116,000 176,000 Accrued incentive compensation — 72,000 Accounts payable and accrued expenses $ 1,641,000 $ 4,025,000 |
Paycheck Protection Program
Paycheck Protection Program | 9 Months Ended |
Sep. 30, 2020 | |
Paycheck Protection Program | |
Paycheck Protection Program | Note 6 – Paycheck Protection Program In response to the COVID-19 pandemic, the PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) and administered by the U.S. Small Business Administration (“SBA”). Companies who met the eligibility requirements set forth by the PPP could qualify for PPP loans provided by local lenders, which supports payroll, rent and utility expenses (“qualified expenses”). If the loan proceeds are fully utilized to pay qualified expenses over the covered period, as further defined by the PPP, the full principal amount of the PPP loan may qualify for loan forgiveness, subject to potential reduction based on the level of full-time employees maintained by the organization during the covered period as compared to a baseline period. In April 2020, the Company received proceeds of $544,000 under the PPP provided by KeyBank National Association (the “Lender”). Based on the term and conditions of the loan agreement, 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 has been updated according to the Paycheck Protection Program Flexibility Act of 2020 (“Flexibility Act”). In June 2020, the Flexibility Act was signed into law, which amended the CARES Act. The Flexibility Act changed key provisions of the PPP, including, but not limited to, (i) provisions relating to the maturity of PPP loans, (ii) the deferral period covering of PPP loan payments and (iii) the process for measurement of loan forgiveness. More specifically, the Flexibility Act provides a minimum maturity of five years for all PPP loans made on or after June 5, 2020, the date of the enactment of the Flexibility Act, and permits lenders and borrowers to extend the maturity date of earlier PPP loans by mutual agreement. As of the date of this filing, the Company has not approached the Lender to request an extension of the maturity date from two years to five years. The Flexibility Act also provides that if a borrower does not apply for forgiveness of a loan within 10 months after the last day of the measurement period (the “covered period”), the PPP loan is no longer deferred and the borrower must begin paying principal and interest. Therefore, the Company’s deferral period for principal and interest payments was updated from six months according to the terms and conditions of the loan agreement to ten months. In addition, the Flexibility Act extended the length of the covered period from eight weeks to 24 weeks from receipt of proceeds, while allowing borrowers that received PPP loans before June 5, 2020 to determine, at their sole discretion, a covered period of either eight weeks or 24-weeks. After reviewing the applicable terms and conditions of the Flexibility Act, the Company has elected to extend the length of the covered period from eight weeks to the lesser of (i) the period whereby qualified expenses equal loan proceeds or (ii) 24 weeks. The Company has performed initial calculations of its PPP loan forgiveness eligibility according to the terms and conditions of the SBA’s Loan Forgiveness Application (Revised June 16, 2020) and, based on such calculations, expects that the PPP loan will be forgiven in full over a period of less than 24 weeks. In addition, the Company has determined that it is probable that the Company will meet all the conditions of the PPP loan forgiveness program. As such, the Company has determined that the PPP loan should be accounted for as a government grant which analogizes with International Accounting Standards (“IAS”) 20, Accounting for Government Grants and Disclosure of Government Assistance September 30, 2020 PPP loan proceeds $ 544,000 Qualified expenses eligible for forgiveness (544,000) PPP loan balance $ — In October 2020, the Company submitted the PPP loan forgiveness application, which has been approved by the Lender. In accordance with the terms and conditions of the Flexibility Act, the Lender has 60 days from receipt of the completed application to issue a decision to the SBA. If the Lender determines that the borrower is entitled to forgiveness of some or all of the amount applied for under the statue and applicable regulations, the Lender must request payment from the SBA at the time the Lender issues its decision to the SBA. 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 through the date of payment, not later than 90 days after the Lender issues its decision to the SBA. Although the Company believes it is probable that the PPP loan will be forgiven, the Company cannot currently provide any objective assurance that it will obtain forgiveness in whole or in part. 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 August 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. The Company may prepay the PPP loan at any time without penalty and the loan agreement evidencing the PPP loan contains customary events of default relating to, among other things, payment defaults, or breaches of representations and warranties, or other provisions of the loan agreement. The occurrence of an event of default may trigger an acceleration of the maturity date for all amounts outstanding, collection of all amounts owing from the Company and/or the Lender filing suit and obtaining a judgment against the Company. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
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 (1) 2020 2021 2022 2023 2024 Thereafter Key clinical research trial obligations $ 2,915,000 $ 675,000 $ 2,240,000 $ — $ — $ — $ — BLA consulting services 1,143,000 — 457,000 686,000 — — — Statistical analysis and programming consulting services 318,000 30,000 288,000 — — — — Employment agreements 1,478,000 216,000 783,000 466,000 13,000 — — Commercial insurance premium financing agreement 721,000 474,000 247,000 — — — — $ 6,575,000 $ 1,395,000 $ 4,015,000 $ 1,152,000 $ 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 August 2021 under the PPP loan if it is not forgiven by the SBA (see Note 6 ). Key Clinical Research Trial Obligations AP-013 study In March 2019, the Company entered into a contract with a CRO in connection with the AP-013 study totaling $6.2 million and covering an initial clinical trial size of 724 patients, which was increased by $4.1 million in January 2020 as a result of an increase in the number of participating patients to 1,034, resulting in the CRO contract commitment totaling $10.3 million. In April 2020, and pursuant to the FDA guidance covering ongoing clinical trials in the presence of the COVID-19 pandemic, the Company and the CRO paused all ongoing conduct associated with the AP-013 study. Increases in COVID-19 cases across certain regions of the United States continue to be reported on a consistent basis. Due to the continued increase in reported cases, the Company has determined that the AP-013 study will remain paused. However, the FDA recently provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. The Company is reviewing this guidance and continues to have ongoing discussions with the CRO to determine the best approach for the AP-013 study. From the inception of this contract through September 30, 2020, the Company incurred and accrued cumulative costs totaling $8.2 million against the contract. This contract had an outstanding obligation for future costs and services totaling $2.1 million as of September 30, 2020. However, this obligation assumes that the Company will continue the AP-013 study at the same point the study was paused, and that the completion of the study will be consistent with the parameters as contained in the existing contract, which may not be the case. The Company continues to explore all viable options to enable it to complete the AP-013 study; however, it is possible that the COVID-19 pandemic may prevent completion of the AP-013 study at this time or at all. Due to the uncertainty resulting from the COVID-19 pandemic, the future contractual commitment amount related to the AP-013 study may change. The following table provides further detail of the Company’s current contractual obligations for the conduct of the AP-013 study, which does not reflect any changes related to the potential impact of COVID-19, as such impacts are unknown and cannot be reasonably estimated at the date of this filing: September 30, 2020 Original contract (based on 724 patients) $ 6,180,000 Amendment to contract (based on 1,034 patients) 4,075,000 Total contract $ 10,255,000 Initial deposit (included in original contract amount) $ 861,000 Amendment to deposit 699,000 Expenses incurred applied to deposit (1,386,000) Remaining deposit (applied to future expenses) $ 174,000 Expenses incurred/accrued (includes expenses applied to deposit) $ 8,182,000 Total future commitment $ 2,073,000 Inhaled treatment for COVID-19 patients In May 2020, the Company entered into a contract with a CRO in connection with a pre-clinical inhaled safety study for Ampion totaling $207,000. In August 2020, the Company finalized contract negotiations to increase the contract to $250,000 as a result of additional pre-study work and reporting. In September 2020, the safety study was completed and, as such, the Company had no outstanding future commitment as of September 30, 2020. The data from the safety study was submitted to the FDA to support the Investigational New Drug (“IND”) application covering inhaled Ampion treatment for COVID-19 patients, which was granted in September 2020. 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 Company expects to commence the AP-014 study during the fourth quarter of fiscal 2020 and, as such, had an outstanding future commitment of $836,000 as of September 30, 2020. In October 2020, the Company entered into a contract with a regional hospital group in connection with the FDA approved IND application for the AP-014 study totaling $30,000. As noted above, the Company expects to commence the AP-014 study during the fourth quarter of fiscal 2020. Intravenous (“IV”) treatment for COVID-19 patients In June 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 (the “AP-016 study”) totaling $43,000. In September 2020, the AP-016 study was completed. However, the Company will continue to monitor the patients enrolled in the AP-016 study for a 90-day period subsequent to the completion of the study and costs are expected to be minimal during this period. In July 2020, the Company entered into a contract with a regional hospital group in connection with the FDA approved IND application for the AP-016 study totaling $50,000. As noted above, the Company completed the AP-016 study in September 2020 and, as such, had no outstanding future commitment as of September 30, 2020. 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 recorded 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 contract negotiations to provide a refund of the deposit totaling $182,000 due to the pause of the AP-013 study and the delay in filing of the BLA. The Company is required to provide a deposit totaling $364,000 once the work commences related to the preparation of the related BLA for Ampion. The Company had incurred cumulative costs totaling $79,000 against this contract and, as such, had outstanding future obligations totaling $1.1 million as of September 30, 2020, which will be settled at such time future services are provided to the Company primarily related to the development and filing of the Ampion BLA. Given the uncertainty surrounding the COVID-19 pandemic and the resulting impact on the AP-013 study, at 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 late fiscal 2021, 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 September 30, 2020, the Company had incurred cumulative costs totaling $260,000 against the contract and, as such, had an outstanding obligation of $318,000. 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. The employment agreement, as amended in July 2020, allowed for reimbursement of reasonable commuting and relocation expenses, including the employee portion of taxes, for up to one year. The commuting and relocation expenses were substantially incurred as of September 30, 2020 with the residual expected to be incurred during the fourth quarter of fiscal 2020. 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 July 2020, the Company entered into an insurance premium financing agreement for $1.0 million, with a term of nine months and an annual interest rate of 3.37%. Under the terms and provisions of the agreement, the Company will be required to make principal and interest payments totaling $116,000 per month over the remaining term of the agreement. The outstanding obligation as of September 30, 2020 was $683,000, which will be paid in full by March 2021. In addition, as of September 30, 2020, the Company had a remaining balance of $38,000 related to annual insurance premiums payable to the Company’s insurance broker, which will be paid in full by June 2021. 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)” lease term and the lease obligation represents the Company’s commitment to make the lease payments arising from the lease. ROU lease assets and obligations are recognized at the commencement date based on the present value of remaining lease payments over the lease term. As the Company’s lease does not provide an implicit rate, the Company used an estimated incremental borrowing rate 5.75% based on the information available at the commencement date in 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 as current or long-term on the balance sheet. 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 September 30, 2020: Facility Lease Payments Remainder of 2021 2022 2023 2024 Thereafter Remaining Facility Lease Payments $ 1,429,000 $ 85,000 $ 345,000 $ 355,000 $ 364,000 $ 280,000 $ — Less: Discount Adjustment (152,000) Total lease liability $ 1,277,000 Lease liability-current portion $ 278,000 Long-term lease liability $ 999,000 The following table provides a reconciliation of the Company’s remaining ROU asset for its facility lease presented in the balance sheet as of September 30, 2020: ROU Asset Balance as of December 31, 2019 $ 1,003,000 Amortization (133,000) Balance as of September 30, 2020 $ 870,000 The Company recorded lease expense in the respective periods is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Lease expense $ 66,000 $ 65,000 $ 198,000 $ 196,000 |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2020 | |
Warrants | |
Warrants | Note 8 – Warrants The Company has issued equity-classified warrants and liability warrants in conjunction with previous equity raises. The Company had a total of 2.2 million equity-classified warrants and 3.2 million liability warrants outstanding as of September 30, 2020. The following table summarizes the Company’s warrant activity during the nine months ended September 30, 2020: Weighted Weighted Average Number of Average Remaining Warrants Exercise Price Contractual Life Outstanding as of December 31, 2019 7,116,000 $ 0.57 3.41 Warrants issued — $ — Warrants exercised (1,668,000) $ 0.42 Warrants expired — $ — Outstanding as of September 30, 2020 5,448,000 $ 0.61 2.52 During the nine months ended September 30, 2020, the Company issued 1.2 million 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 $465,000 during the nine months ended September 30, 2020 related to these investor warrant exercises. In addition, former placement agents elected to exercise 506,000 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 276,000 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 September 30, 2020 is approximately $1.9 million. See Note 9 |
Fair Value Considerations
Fair Value Considerations | 9 Months Ended |
Sep. 30, 2020 | |
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 are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources not affiliated with the Company. Unobservable inputs are inputs that reflect the Company’s assumptions of what market participants would use in pricing the asset or liability based on the best information available in the circumstances. The hierarchy is broken down into three levels based on reliability of the inputs as follows: Level 1: Inputs that reflect unadjusted quoted prices in active markets that are accessible to the Company for identical assets or liabilities; Level 2: Inputs that include quoted prices for similar assets and liabilities in active or inactive markets or that are observable for the asset or liability either directly or indirectly; and Level 3: Unobservable inputs that are supported by little or no market activity. The Company’s financial instruments include cash and cash equivalents, accounts payable and accrued expenses, and warrant derivative liability. Warrants are recorded at estimated fair value utilizing the Black-Scholes warrant pricing model. The Company’s assets and liabilities which are measured at fair value are classified in their entirety based on the lowest level of input that is significant to their fair value measurement. The Company’s policy is to recognize transfers in and/or out of the fair value hierarchy as of the date in which the event or change in circumstances caused the transfer. The Company has consistently applied the valuation techniques in all periods presented. The following table presents the Company’s financial assets and liabilities that were accounted for at fair value on a recurring basis as of September 30, 2020 and December 31, 2019, by level within the fair value hierarchy: Fair Value Measurements Using Level 1 Level 2 Level 3 Total September 30, 2020 Liabilities: Warrant derivative liability $ — $ — $ 1,901,000 $ 1,901,000 December 31, 2019 Liabilities: Warrant derivative liability $ — $ — $ 2,064,000 $ 2,064,000 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, 2019 $ 2,064,000 Warrant exercises (912,000) Change in fair value 749,000 Balance as of September 30, 2020 $ 1,901,000 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Common stock | Note 10 - Common Stock Authorized Shares The Company had 300.0 million authorized shares of common stock as of September 30, 2020 and December 31, 2019. The following table summarizes the Company’s remaining authorized shares available for future issuance: September 30, 2020 Authorized shares 300,000,000 Common stock outstanding 183,938,000 Options outstanding 5,484,000 Warrants outstanding 5,448,000 Reserved for issuance under 2019 Stock and Incentive Plan 8,643,000 Available shares 96,487,000 Shelf Registration In March 2017, the Company filed a shelf registration statement on Form S-3 (the “Prior Shelf Registration Statement”) with the SEC to register the offering by the Company, from time to time, of up to $100.0 million of the Company’s common stock, preferred stock, debt securities, warrants and units, as well as, the sale by selling stockholders of 5.0 million shares of common stock. The Prior Shelf Registration Statement was declared effective by the SEC in April 2017 and was terminated in May 2020. In April 2020, the Company filed a shelf registration statement on Form S-3 (the “New Shelf Registration Statement”) with the SEC to register the offering by the Company, from time to time, of up to $100.0 million of the Company’s common stock, preferred stock, debt securities, warrants and units, which was declared effective by the SEC in May 2020. The Company had $88.4 million remaining under the New Shelf Registration Statement as of September 30, 2020. However, the Company’s ability to issue and sell securities under the New Shelf Registration Statement may be limited, based on many factors including, but not limited to, the Company’s stock price and related volatility, the trading volume of the Company’s common stock, and the number of remaining authorized shares available for the Company to issue. ATM Equity Offering Program Sales Agreement In February 2020, the Company entered into a Sales Agreement with two agents to implement an ATM equity offering program under which the Company, from time to time and at its sole discretion, may offer and sell shares of its common stock having an aggregate offering price up to $50.0 million to the public through the agents until (i) each agent declines to accept the terms for any reason, (ii) the entire amount of shares has been sold, or (iii) the Company suspends or terminates the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, the agents shall use their commercially reasonable efforts to sell shares from time to time, based upon the Company’s instructions as documented on a purchase notification form. If an agent declines to accept the purchase notification form, the agent must promptly notify the Company and the other agent then has the ability to accept or decline the purchase notification form. The Company has no obligation to sell any shares and may, at any time and in its sole discretion, suspend sales under the Sales Agreement or terminate the Sales Agreement in accordance with its terms. The Sales Agreement includes customary indemnification rights in favor of the agents, and provides that the agents will be entitled to an aggregate fixed commission of 4.0% of the gross proceeds (2.0% to each agent) to the Company from any shares sold pursuant to the Sales Agreement. The following table summarizes the Company’s sales and related issuance costs incurred under the Sales Agreement as of September 30, 2020: Three months ended Three months ended Three months ended March 31, 2020 June 30, 2020 September 30, 2020 Total Total shares of common stock sold 1,241,000 13,069,000 9,405,000 23,715,000 Average price per share $ 0.58 $ 0.54 $ 0.78 $ 0.64 Gross Proceeds $ 682,000 $ 7,231,000 $ 7,223,000 $ 15,136,000 Commissions earned by placement agents (27,000) (290,000) (290,000) (607,000) Issuance / subsequent recurring fees (219,000) (24,000) (23,000) (266,000) Net Proceeds $ 436,000 $ 6,917,000 $ 6,910,000 $ 14,263,000 Common Stock Issued for Services The Company issued 136,000 and 136,000 shares of common stock valued at $80,000 and $60,000, as partial compensation for the services of non-employee directors, during the nine months ended September 30, 2020 and 2019, respectively. |
Equity
Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity | |
Equity | Note 11 - Equity Options In December 2019, the Company’s Board of Directors and stockholders approved the adoption of the Ampio Pharmaceuticals, Inc. 2019 Stock and Incentive Plan (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 September 30, 2020: 2019 Plan Total shares reserved for equity awards 10,000,000 Options granted during fiscal 2019 (144,000) Options granted during fiscal 2020 (1,218,000) Add back: expired, forfeited and/or cancelled equity awards 5,000 Remaining shares available for future equity awards 8,643,000 The following table summarizes the Company’s stock option activity under both the 2010 Plan and 2019 Plan during the nine months ended September 30, 2020: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Price Contractual Life Intrinsic Value Outstanding as of December 31, 2019 6,000,000 $ 1.33 5.40 $ — Granted 1,218,000 $ 0.67 Exercised (20,000) $ 0.54 Forfeited (100,000) $ 1.70 Expired and/or cancelled (1,614,000) $ 0.87 Outstanding as of September 30, 2020 5,484,000 $ 1.11 7.26 $ 1,435,000 Exercisable as of September 30, 2020 5,335,000 $ 1.12 7.21 $ 1,388,000 Of the 1.2 million stock options that were granted during the nine months ended September 30, 2020, 604,000 stock options were reissued as replacements for 711,000 stock options that were cancelled. The value of the reissued stock options was estimated using the Black-Scholes option pricing model and totaled $277,000. The 100,000 stock options that were forfeited and approximately 1.6 million stock options that expired and/or were cancelled during the nine months ended September 30, 2020 were issued under the 2010 Plan, which was cancelled as noted above. Therefore, these forfeited and expired and/or cancelled stock options were not added back to the 2019 Plan. The 20,000 stock options that were exercised were processed as a net exercise, 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 on behalf of the option holders and did not receive any cash proceeds from the net exercise. Stock options outstanding as of September 30, 2020 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 $0.50 704,000 $ 0.44 8.77 $0.51 - $1.00 4,092,000 $ 0.61 7.01 $1.01 - $1.50 50,000 $ 1.03 9.85 $1.51 and above 638,000 $ 4.48 2.87 5,484,000 $ 1.11 7.26 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 September 30, 2020, using the following assumptions: Expected volatility 120.80% - 201.90 % Risk free interest rate 0.19% - 1.67 % Expected term (years) 3.00 - 5.51 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 nine months ended September 30, 2020 and 2019: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expenses Stock-based compensation $ 72,000 $ 46,000 $ 142,000 $ 77,000 General and administrative expenses Issuance of common stock for services — — 80,000 60,000 Stock-based compensation 405,000 209,000 612,000 278,000 Total stock-based compensation $ 477,000 $ 255,000 $ 834,000 $ 415,000 Unrecognized expense as of September 30, 2020 $ 28,000 Weighted average remaining years to vest 0.24 |
Earnings Per Share
Earnings Per Share | 9 Months Ended |
Sep. 30, 2020 | |
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 nine months ended September 30, 2020 and 2019: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Net (loss) income $ (3,368,000) $ (7,219,000) $ (11,277,000) $ (12,610,000) Less: decrease in fair value of investor warrants — — (163,000) — Loss available to common stockholders $ (3,368,000) $ (7,219,000) $ (11,440,000) $ (12,610,000) Basic weighted-average common shares outstanding 178,622,000 142,208,000 168,062,000 122,895,000 Add: dilutive effect of equity instruments — — 1,292,000 — Diluted weighted-average shares outstanding 178,622,000 142,208,000 169,354,000 122,895,000 Earnings per share – basic $ (0.02) $ (0.05) $ (0.07) $ (0.10) Earnings per share – diluted $ (0.02) $ (0.05) $ (0.07) $ (0.10) The potentially dilutive shares of common stock that have been excluded from the calculation of net loss per share because of the anti-dilutive effect are as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Outstanding stock options 5,484,000 5,914,000 4,567,000 5,914,000 Warrants to purchase shares of common stock 5,448,000 23,508,000 5,073,000 23,508,000 Total potentially dilutive shares of common stock 10,932,000 29,422,000 9,640,000 29,422,000 |
Litigation
Litigation | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Litigation | Note 13 – Litigation On August 25, 2018, a purported stockholder of the Company commenced a putative class action lawsuit in the United States District Court for the Central District of California (the “Court”), captioned Shi v. Ampio Pharmaceuticals, Inc., et al., Case No. 18-cv-07476 (the “Securities Class Action”). The plaintiff in the Securities Class Action alleged that the Company and certain of its current and former officers had violated the federal securities laws by misrepresenting and/or omitting material information regarding the AP-003 Phase III clinical trial of Ampion. The plaintiff asserted claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Securities and Exchange Commission Rule 10b-5, on behalf of a putative class of purchasers of the Company’s common stock from December 14, 2017 through August 7, 2018. The plaintiff in the Securities Class Action sought unspecified damages, pre-judgment and post-judgment interest, and attorneys’ fees and costs. On September 27, 2019, the Court presiding over the Securities Class Action issued an order appointing a Lead Plaintiff and Lead Counsel, pursuant to the Private Securities Litigation Reform Act. The Lead Plaintiff filed an amended complaint in late 2019. The Company filed a motion to dismiss the amended complaint on February 10, 2020. On March 26, 2020, the Lead Plaintiff filed a brief in opposition to the Company’s motion to dismiss. The Company filed a reply to the Lead Plaintiff’s brief in opposition on April 27, 2020. On June 19, 2020, the Court granted the Company’s motion to dismiss and dismissed the Securities Class Action with prejudice. The plaintiff did not file a notice of appeal, and the case is now concluded. On September 10, 2018, a purported stockholder of the Company brought a derivative action in the United States District Court for the Central District of California, captioned Cetrone v. Macaluso, et al., Case No. 18-cv-07855 (the “Cetrone Action”), alleging primarily that the directors and officers of Ampio had breached their fiduciary duties in connection with alleged misstatements and omissions regarding the AP-003 Phase III clinical trial of Ampion. The plaintiff sought unspecified damages, certain governance reforms, pre-judgment and post-judgment interest, attorneys’ fees and costs. On October 5, 2018, a purported stockholder of the Company brought a derivative action in the United States District Court for the District of Colorado, Theise v. Macaluso, et al., Case No. 18-cv-02558 (the “Theise Action”), which closely paralleled the allegations in the Cetrone Action. A second derivative action was filed in the United States District Court for the District of Colorado and was consolidated with the Theise Action under the caption In re: Ampio Pharmaceuticals Inc. Stockholder Derivative Actions, Case No. 18-cv-02558. The plaintiffs sought unspecified damages, pre-judgment and post-judgment interest, attorneys’ fees and costs. On August 28, 2020, the District Court for the Central District of California dismissed the Cetrone Action in its entirety and without prejudice, pursuant to a Stipulation of Dismissal between the parties. On August 31, 2020, the United States District Court for the District of Colorado similarly dismissed the Theise Action in its entirety and without prejudice, pursuant to a Stipulation of Dismissal between the parties. As of September 30, 2020, each of the Securities Class Action, the Cetrone Action and the Theise Action have been dismissed. As of the date hereof, 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) | 9 Months Ended |
Sep. 30, 2020 | |
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 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, 2019 included in the Company’s 2019 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 nine months ended September 30, 2020 is unaudited. The balance sheet at December 31, 2019 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 World Health Organization (“WHO”) announced a global health emergency because of a new strain 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 significantly affect 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 regulatory 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 of Ampion for the treatment of OAK, also known as the “AP-013 study”. Due to the increases in reported COVID-19 cases, the Company has determined that the AP-013 study will remain paused. However, the FDA recently provided guidance specifically designed to assist the pharmaceutical industry with viable options for evaluating data from clinical trials which were adversely impacted by the pandemic. The Company is reviewing this guidance and continues to have ongoing discussions with the CRO to determine the best approach for the AP-013 study. Since the filing of its Form 10-Q covering the three-month period ending June 30, 2020, the Company has been conducting clinical trials related to potential new applications of Ampion (i.e. inhaled and intravenous) related to the COVID-19 infection. The outbreak has and may continue to spread, which could materially impact the Company’s business operations and, in addition, those 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. The full extent of potential impacts on the Company’s business and product development, including clinical trials, financing activities and the global economy will depend on future developments, which cannot be predicted due to the uncertain nature of the continued COVID-19 pandemic, government mandated shut downs, and its adverse effects, including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others. These effects could have a material adverse impact on the Company’s business, operations, financial condition and results of operations. |
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 months ended September 30, 2020, 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 future liquidity and resulting going concern position, warrant derivative liability and related periodic gains and losses, stock-based compensation, the projected useful lives and potential impairment of fixed assets, and the valuation allowance related to deferred tax 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 In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement - Disclosure Framework (Topic 820) Recent Accounting Pronouncements The Company reviewed the recent accounting pronouncements and determined that none of the recent accounting pronouncements were applicable. 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) | 9 Months Ended |
Sep. 30, 2020 | |
Prepaid Expenses and Other | |
Schedule Of Prepaid Expenses and other balances | September 30, 2020 December 31, 2019 Unamortized commercial insurance premiums $ 970,000 $ 502,000 Deposits 214,000 1,162,000 BLA consulting services refund 182,000 - Receivable 14,000 14,000 Other 95,000 40,000 Total prepaid expenses and other $ 1,475,000 $ 1,718,000 |
Fixed Assets (Tables)
Fixed Assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fixed Assets | |
Schedule of 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 consist of the following: Estimated Weighted Average Net Book Value Net Book Value Useful Lives Remaining Useful December 31, Accumulated September 30, in Years Lives in Years 2019 Additions Disposals Depreciation 2020 Leasehold improvements 10 4 $ 2,850,000 $ — $ — $ (450,000) $ 2,400,000 Manufacturing facility/clean room 3 - 8 3 1,550,000 9,000 (73,000) (370,000) 1,116,000 Lab equipment and office furniture 5 - 8 3 348,000 39,000 — (65,000) 322,000 Fixed assets, net $ 4,748,000 $ 48,000 $ (73,000) $ (885,000) $ 3,838,000 |
Schedule Of Depreciation expense | Depreciation and amortization expense for the respective periods is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Depreciation and amortization expense $ 294,000 $ 320,000 $ 885,000 $ 975,000 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounts Payable and Accrued Expenses | |
Schedule of accounts payable and accrued expenses | September 30, 2020 December 31, 2019 Accounts payable $ 398,000 $ 151,000 Commercial insurance premium financing agreement 721,000 21,000 Clinical trials 225,000 3,288,000 Professional fees 181,000 317,000 Other 116,000 176,000 Accrued incentive compensation — 72,000 Accounts payable and accrued expenses $ 1,641,000 $ 4,025,000 |
Paycheck Protection Program (Ta
Paycheck Protection Program (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
PPP | |
Debt Instrument [Line Items] | |
Schedule of balance of the PPP loan | September 30, 2020 PPP loan proceeds $ 544,000 Qualified expenses eligible for forgiveness (544,000) PPP loan balance $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Commitments and Contingencies | Commitments and contingencies are described below and summarized by the following table: Total (1) 2020 2021 2022 2023 2024 Thereafter Key clinical research trial obligations $ 2,915,000 $ 675,000 $ 2,240,000 $ — $ — $ — $ — BLA consulting services 1,143,000 — 457,000 686,000 — — — Statistical analysis and programming consulting services 318,000 30,000 288,000 — — — — Employment agreements 1,478,000 216,000 783,000 466,000 13,000 — — Commercial insurance premium financing agreement 721,000 474,000 247,000 — — — — $ 6,575,000 $ 1,395,000 $ 4,015,000 $ 1,152,000 $ 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 August 2021 under the PPP loan if it is not forgiven by the SBA (see Note 6 ). |
Schedule of further detail of the CRO contract | September 30, 2020 Original contract (based on 724 patients) $ 6,180,000 Amendment to contract (based on 1,034 patients) 4,075,000 Total contract $ 10,255,000 Initial deposit (included in original contract amount) $ 861,000 Amendment to deposit 699,000 Expenses incurred applied to deposit (1,386,000) Remaining deposit (applied to future expenses) $ 174,000 Expenses incurred/accrued (includes expenses applied to deposit) $ 8,182,000 Total future commitment $ 2,073,000 |
Summary of reconciliation of the Company's undiscounted payments for its facility lease and the carrying amount of the lease liability | The following table provides a reconciliation of the Company’s remaining undiscounted payments for its facility lease and the carrying amount of the lease liability presented in the balance sheet as of September 30, 2020: Facility Lease Payments Remainder of 2021 2022 2023 2024 Thereafter Remaining Facility Lease Payments $ 1,429,000 $ 85,000 $ 345,000 $ 355,000 $ 364,000 $ 280,000 $ — Less: Discount Adjustment (152,000) Total lease liability $ 1,277,000 Lease liability-current portion $ 278,000 Long-term lease liability $ 999,000 |
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 September 30, 2020: ROU Asset Balance as of December 31, 2019 $ 1,003,000 Amortization (133,000) Balance as of September 30, 2020 $ 870,000 The Company recorded lease expense in the respective periods is as follows: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Lease expense $ 66,000 $ 65,000 $ 198,000 $ 196,000 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Warrants | |
Summary of Company's warrant activity | The following table summarizes the Company’s warrant activity during the nine months ended September 30, 2020: Weighted Weighted Average Number of Average Remaining Warrants Exercise Price Contractual Life Outstanding as of December 31, 2019 7,116,000 $ 0.57 3.41 Warrants issued — $ — Warrants exercised (1,668,000) $ 0.42 Warrants expired — $ — Outstanding as of September 30, 2020 5,448,000 $ 0.61 2.52 |
Fair Value Considerations (Tabl
Fair Value Considerations (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020 and December 31, 2019, by level within the fair value hierarchy: Fair Value Measurements Using Level 1 Level 2 Level 3 Total September 30, 2020 Liabilities: Warrant derivative liability $ — $ — $ 1,901,000 $ 1,901,000 December 31, 2019 Liabilities: Warrant derivative liability $ — $ — $ 2,064,000 $ 2,064,000 |
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, 2019 $ 2,064,000 Warrant exercises (912,000) Change in fair value 749,000 Balance as of September 30, 2020 $ 1,901,000 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Schedule of remaining authorized Shares | September 30, 2020 Authorized shares 300,000,000 Common stock outstanding 183,938,000 Options outstanding 5,484,000 Warrants outstanding 5,448,000 Reserved for issuance under 2019 Stock and Incentive Plan 8,643,000 Available shares 96,487,000 |
Schedule of sale of stock under sales agreement | Three months ended Three months ended Three months ended March 31, 2020 June 30, 2020 September 30, 2020 Total Total shares of common stock sold 1,241,000 13,069,000 9,405,000 23,715,000 Average price per share $ 0.58 $ 0.54 $ 0.78 $ 0.64 Gross Proceeds $ 682,000 $ 7,231,000 $ 7,223,000 $ 15,136,000 Commissions earned by placement agents (27,000) (290,000) (290,000) (607,000) Issuance / subsequent recurring fees (219,000) (24,000) (23,000) (266,000) Net Proceeds $ 436,000 $ 6,917,000 $ 6,910,000 $ 14,263,000 |
Equity (Tables)
Equity (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Summary of Stock Options Outstanding and Exercisable | The following table summarizes the Company’s stock option activity under both the 2010 Plan and 2019 Plan during the nine months ended September 30, 2020: Weighted Weighted Average Number of Average Remaining Aggregate Options Exercise Price Contractual Life Intrinsic Value Outstanding as of December 31, 2019 6,000,000 $ 1.33 5.40 $ — Granted 1,218,000 $ 0.67 Exercised (20,000) $ 0.54 Forfeited (100,000) $ 1.70 Expired and/or cancelled (1,614,000) $ 0.87 Outstanding as of September 30, 2020 5,484,000 $ 1.11 7.26 $ 1,435,000 Exercisable as of September 30, 2020 5,335,000 $ 1.12 7.21 $ 1,388,000 Of the 1.2 million stock options that were granted during the nine months ended September 30, 2020, 604,000 stock options were reissued as replacements for 711,000 stock options that were cancelled. The value of the reissued stock options was estimated using the Black-Scholes option pricing model and totaled $277,000. The 100,000 stock options that were forfeited and approximately 1.6 million stock options that expired and/or were cancelled during the nine months ended September 30, 2020 were issued under the 2010 Plan, which was cancelled as noted above. Therefore, these forfeited and expired and/or cancelled stock options were not added back to the 2019 Plan. The 20,000 stock options that were exercised were processed as a net exercise, 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 on behalf of the option holders and did not receive any cash proceeds from the net exercise. Stock options outstanding as of September 30, 2020 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 $0.50 704,000 $ 0.44 8.77 $0.51 - $1.00 4,092,000 $ 0.61 7.01 $1.01 - $1.50 50,000 $ 1.03 9.85 $1.51 and above 638,000 $ 4.48 2.87 5,484,000 $ 1.11 7.26 |
Assumptions Used in Computing Fair Value of All Options Granted | 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 September 30, 2020, using the following assumptions: Expected volatility 120.80% - 201.90 % Risk free interest rate 0.19% - 1.67 % Expected term (years) 3.00 - 5.51 |
Summary of Stock-Based Compensation Expense | Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expenses Stock-based compensation $ 72,000 $ 46,000 $ 142,000 $ 77,000 General and administrative expenses Issuance of common stock for services — — 80,000 60,000 Stock-based compensation 405,000 209,000 612,000 278,000 Total stock-based compensation $ 477,000 $ 255,000 $ 834,000 $ 415,000 Unrecognized expense as of September 30, 2020 $ 28,000 Weighted average remaining years to vest 0.24 |
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 September 30, 2020: 2019 Plan Total shares reserved for equity awards 10,000,000 Options granted during fiscal 2019 (144,000) Options granted during fiscal 2020 (1,218,000) Add back: expired, forfeited and/or cancelled equity awards 5,000 Remaining shares available for future equity awards 8,643,000 |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share | |
Schedule for the calculations of basic and diluted earnings per share | Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Net (loss) income $ (3,368,000) $ (7,219,000) $ (11,277,000) $ (12,610,000) Less: decrease in fair value of investor warrants — — (163,000) — Loss available to common stockholders $ (3,368,000) $ (7,219,000) $ (11,440,000) $ (12,610,000) Basic weighted-average common shares outstanding 178,622,000 142,208,000 168,062,000 122,895,000 Add: dilutive effect of equity instruments — — 1,292,000 — Diluted weighted-average shares outstanding 178,622,000 142,208,000 169,354,000 122,895,000 Earnings per share – basic $ (0.02) $ (0.05) $ (0.07) $ (0.10) Earnings per share – diluted $ (0.02) $ (0.05) $ (0.07) $ (0.10) |
Potentially dilutive securities, excluded | Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Outstanding stock options 5,484,000 5,914,000 4,567,000 5,914,000 Warrants to purchase shares of common stock 5,448,000 23,508,000 5,073,000 23,508,000 Total potentially dilutive shares of common stock 10,932,000 29,422,000 9,640,000 29,422,000 |
Going Concern (Detail)
Going Concern (Detail) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Oct. 31, 2020USD ($)shares | Feb. 29, 2020item | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)shares | Sep. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Cash and Cash Equivalents, at Carrying Value | $ 9,361,000 | $ 9,361,000 | $ 6,532,000 | |||||||||
Net Income (Loss) Attributable to Parent | (3,368,000) | $ (7,219,000) | $ (11,277,000) | $ (12,610,000) | ||||||||
Stock Issued During Period, Shares, New Issues | shares | 276,000 | |||||||||||
Operating Expenses | 3,302,000 | 5,173,000 | $ 11,923,000 | 11,430,000 | ||||||||
Proceeds received under the Paycheck Protection Program | 544,000 | 0 | ||||||||||
Gain (Loss) on Derivative Instruments, Net, Pretax | 7,000 | (2,054,000) | 163,000 | (1,233,000) | ||||||||
Net Cash Provided by (Used in) Operating Activities | (11,849,000) | (10,632,000) | ||||||||||
Retained Earnings (Accumulated Deficit) | (195,911,000) | (195,911,000) | (184,633,000) | |||||||||
Stockholders' deficit | $ 10,725,000 | $ 4,138,000 | 10,725,000 | 4,138,000 | $ 6,343,000 | $ 1,993,000 | $ 6,443,000 | $ 11,111,000 | $ (468,000) | $ 5,236,000 | ||
Gross proceeds | 0 | $ 12,000,000 | ||||||||||
ATM equity offering program | ||||||||||||
Gross proceeds | $ 15,100,000 | |||||||||||
Sale Agreement (ATM) | ||||||||||||
Stock Issued During Period, Shares, New Issues | shares | 1,100,000 | |||||||||||
Adjustments to Additional Paid in Capital, Stock Issued, Issuance Costs | $ 40,000 | |||||||||||
Number of agents | item | 2 | |||||||||||
Gross proceeds | $ 1,000,000 |
Prepaid Expenses and Other (Det
Prepaid Expenses and Other (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Prepaid Expenses and Other | ||
Unamortized commercial insurance premiums | $ 970,000 | $ 502,000 |
Deposits | 214,000 | 1,162,000 |
BLA consulting services refund | 182,000 | |
Receivable | 14,000 | 14,000 |
Other | 95,000 | 40,000 |
Total prepaid expenses and other | $ 1,475,000 | $ 1,718,000 |
Fixed Assets (Detail)
Fixed Assets (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | ||
Additions | $ 48,000 | |
Disposals | (73,000) | |
Less accumulated depreciation and amortization Fixed assets net | (885,000) | |
Fixed assets, net | $ 3,838,000 | $ 4,748,000 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 10 years | |
Weighted Average Remaining Useful Life | 4 years | |
Fixed assets, gross | $ 2,400,000 | 2,850,000 |
Less accumulated depreciation and amortization Fixed assets net | $ (450,000) | |
Manufacturing facility/ clean room | ||
Property, Plant and Equipment [Line Items] | ||
Weighted Average Remaining Useful Life | 3 years | |
Fixed assets, gross | $ 1,116,000 | 1,550,000 |
Additions | 9,000 | |
Disposals | (73,000) | |
Less accumulated depreciation and amortization Fixed assets net | $ (370,000) | |
Manufacturing facility/ clean room | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 3 years | |
Manufacturing facility/ clean room | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 8 years | |
Lab equipment and office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Weighted Average Remaining Useful Life | 3 years | |
Fixed assets, gross | $ 322,000 | $ 348,000 |
Additions | 39,000 | |
Less accumulated depreciation and amortization Fixed assets net | $ (65,000) | |
Lab equipment and office furniture | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 5 years | |
Lab equipment and office furniture | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated useful lives | 8 years |
Fixed Assets - Depreciation and
Fixed Assets - Depreciation and Amortization Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Fixed Assets | ||||
Depreciation and Amortization Expense | $ 294,000 | $ 320,000 | $ 885,000 | $ 975,000 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Expenses (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Accounts Payable and Accrued Expenses | ||
Accounts payable | $ 398,000 | $ 151,000 |
Commercial insurance premiums financing agreement | 721,000 | 21,000 |
Clinical trial | 225,000 | 3,288,000 |
Professional fees | 181,000 | 317,000 |
Other | 116,000 | 176,000 |
Accrued incentive compensation | 72,000 | |
Accounts payable and accrued expenses | $ 1,641,000 | $ 4,025,000 |
Paycheck Protection Program - A
Paycheck Protection Program - Additional Information (Detail) - PPP - USD ($) | 1 Months Ended | 9 Months Ended | |
Nov. 30, 2020 | Apr. 30, 2020 | Sep. 30, 2020 | |
Debt Instrument [Line Items] | |||
Debt Instrument, Interest Rate, Stated Percentage | 1.00% | ||
Minimum | |||
Debt Instrument [Line Items] | |||
Debt Instrument, Term | 2 years | ||
Maximum | |||
Debt Instrument [Line Items] | |||
Debt Instrument, Term | 5 years | ||
Lender | |||
Debt Instrument [Line Items] | |||
Proceeds from Issuance of Debt | $ 544,000 | ||
Principal and interest payments per month | $ 23,000 | $ 23,000 |
Paycheck Protection Program - B
Paycheck Protection Program - Balance of PPP loan (Detail) - PPP | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Debt Instrument [Line Items] | |
PPP loan proceeds | $ 544,000 |
Qualified expenses | $ (544,000) |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Commitments and Contingencies (Detail) | Sep. 30, 2020USD ($) |
Commitment And Contingencies [Line Items] | |
2020 | $ 1,395,000 |
2021 | 4,015,000 |
2022 | 1,152,000 |
2023 | 13,000 |
2024 | 0 |
Thereafter | 0 |
Total | 6,575,000 |
Key Clinical Research Trial Obligations | |
Commitment And Contingencies [Line Items] | |
2020 | 675,000 |
2021 | 2,240,000 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | 2,915,000 |
BLA consulting services | |
Commitment And Contingencies [Line Items] | |
2021 | 457,000 |
2022 | 686,000 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | 1,143,000 |
Statistical analysis and programming consulting services | |
Commitment And Contingencies [Line Items] | |
2020 | 30,000 |
2021 | 288,000 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | 318,000 |
Employment Agreements | |
Commitment And Contingencies [Line Items] | |
2020 | 216,000 |
2021 | 783,000 |
2022 | 466,000 |
2023 | 13,000 |
2024 | 0 |
Thereafter | 0 |
Total | 1,478,000 |
Insurance premium financing agreement and commitments | |
Commitment And Contingencies [Line Items] | |
2020 | 474,000 |
2021 | 247,000 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
Thereafter | 0 |
Total | $ 721,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 9 Months Ended | |||||||||||
Nov. 30, 2020USD ($) | Jul. 31, 2020USD ($) | Jan. 31, 2020USD ($)item | Mar. 31, 2019USD ($)item | Dec. 31, 2013USD ($) | Sep. 30, 2020USD ($) | Oct. 31, 2020USD ($) | Aug. 31, 2020USD ($) | Jun. 30, 2020USD ($) | May 31, 2020USD ($) | Apr. 30, 2020 | May 31, 2019USD ($) | Mar. 31, 2018USD ($) | |
Commitments and Contingencies [Line Items] | |||||||||||||
Contractual obligation | $ 6,575,000 | ||||||||||||
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 | ||||||||||||
Total base rent over the term of the lease | $ 3,300,000 | ||||||||||||
Key Clinical Research Trial Obligations | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contractual obligation | $ 2,915,000 | ||||||||||||
CRO | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | $ 10,300,000 | $ 6,200,000 | 10,255,000 | ||||||||||
Amount Incurred Against Contract Obligation | 8,182,000 | ||||||||||||
Contractual obligation | 2,073,000 | ||||||||||||
Number Of Patients | item | 1,034 | 724 | |||||||||||
Increase in existing contract | $ 4,100,000 | ||||||||||||
Inhaled treatment for COVID 19 patients | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | 836,000 | $ 250,000 | $ 207,000 | ||||||||||
Contractual obligation | 836,000 | ||||||||||||
Intravenous treatment for COVID 19 patients | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | $ 43,000 | ||||||||||||
Regional Hospital Group, AP-016 Study | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | $ 50,000 | ||||||||||||
Contractual obligation | 0 | ||||||||||||
Regional Hospital Group, AP-014 Study | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | $ 30,000 | ||||||||||||
BLA consulting services | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | 1,100,000 | $ 1,200,000 | |||||||||||
Amount Incurred Against Contract Obligation | 79,000 | ||||||||||||
Prepaid consulting services deposits | 364,000 | $ 182,000 | |||||||||||
Refund of deposits | 182,000 | ||||||||||||
Statistical analysis and programming consulting services | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Contract amount | $ 578,000 | ||||||||||||
Amount Incurred Against Contract Obligation | 260,000 | ||||||||||||
Contractual obligation | 318,000 | ||||||||||||
Insurance premium financing agreement and commitments | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Term of agreement (in years) | 9 months | ||||||||||||
Interest rate (as a percentage) | 3.37% | ||||||||||||
Contract amount | $ 1,000,000 | ||||||||||||
Contractual obligation | 683,000 | ||||||||||||
Principal and interest payments | $ 116,000 | ||||||||||||
Insurance premiums | 38,000 | ||||||||||||
PPP | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Interest rate (as a percentage) | 1.00% | ||||||||||||
PPP | Lender | |||||||||||||
Commitments and Contingencies [Line Items] | |||||||||||||
Principal and interest payments | $ 23,000 | $ 23,000 |
Commitments and Contingencies_3
Commitments and Contingencies - CRO contract (Detail) | Sep. 30, 2020USD ($)person | Jan. 31, 2020USD ($) | Mar. 31, 2019USD ($) |
Commitments and Contingencies [Line Items] | |||
Total | $ 6,575,000 | ||
Original Contract, Number Of Patients | person | 724 | ||
Amended Contract, Number Of Patients | person | 1,034 | ||
CRO | |||
Commitments and Contingencies [Line Items] | |||
Original contract | $ 6,180,000 | ||
Amendment to contract | 4,075,000 | ||
Total Contract | 10,255,000 | $ 10,300,000 | $ 6,200,000 |
Initial deposit (included in original contract amount) | 861,000 | ||
Amendment to deposit | 699,000 | ||
Expenses incurred applied to deposit | (1,386,000) | ||
Remaining Deposit | 174,000 | ||
Expenses incurred/accrued (includes expenses applied to deposit) | 8,182,000 | ||
Total | $ 2,073,000 |
Commitments and Contingencies_4
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_5
Commitments and Contingencies - Summary of Reconciliation of Company's Undiscounted Payments for Facility Lease and Carrying Amount of Lease Liability (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
Remainder of 2020 | $ 85,000 | |
2021 | 345,000 | |
2022 | 355,000 | |
2023 | 364,000 | |
2024 | 280,000 | |
Remaining Facility Lease Payments | 1,429,000 | |
Less: Discount Adjustment | (152,000) | |
Total lease liability | 1,277,000 | |
Lease liability - current portion | 278,000 | $ 259,000 |
Long-term lease liability | $ 999,000 | $ 1,210,000 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Balance as of December 31, 2019 | $ 1,003,000 | |||
Amortization | (133,000) | |||
Balance as of September 30, 2020 | $ 870,000 | 870,000 | ||
Lease expense | $ 66,000 | $ 65,000 | $ 198,000 | $ 196,000 |
Warrants - (Detail)
Warrants - (Detail) - USD ($) | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Class of Warrant or Right [Line Items] | |||
Warrant derivative liability | $ 1,901,000 | $ 2,064,000 | |
Proceeds from warrant exercises | $ 465,000 | $ 350,000 | |
Issuance of common stock (Shares) | 276,000 | ||
Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Exercise price | $ 0.61 | $ 0.57 | |
Warrants exercised | 1,668,000 | ||
Investor Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Exercise price | $ 0.40 | ||
Warrants exercised | 1.2 | ||
Proceeds from warrant exercises | $ 465,000 | ||
Placement Agent Warrants [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrants exercised | 506,000 |
Warrants - Warrants Activity (D
Warrants - Warrants Activity (Detail) - $ / shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Number of Warrants Outstanding | ||
Number of Warrants Outstanding, Ending Balance | 5,448,000 | |
Warrants [Member] | ||
Number of Warrants Outstanding | ||
Number of Warrants Outstanding, Beginning Balance | 7,116,000 | |
Number of Warrants, Warrants exercised | (1,668,000) | |
Number of Warrants Outstanding, Ending Balance | 5,448,000 | 7,116,000 |
Warrants, Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Outstanding Beginning Balance | $ 0.57 | |
Weighted Average Exercise Price, Warrants exercised | 0.42 | |
Weighted Average Exercise Price, Outstanding Ending Balance | $ 0.61 | $ 0.57 |
Weighted Average Remaining Contractual Life | ||
Weighted Average Remaining Contractual Life, Warrants Outstanding | 2 years 6 months 7 days | 3 years 4 months 28 days |
Equity based-warrants | ||
Number of Warrants Outstanding | ||
Number of Warrants Outstanding, Ending Balance | 2,200,000 | |
Liability warrants | ||
Number of Warrants Outstanding | ||
Number of Warrants Outstanding, Ending Balance | 3,200,000 |
Fair Value Considerations - Fin
Fair Value Considerations - Financial Assets and Liabilities (Detail) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
LIABILITIES | ||
Warrant derivative liability | $ 1,901,000 | $ 2,064,000 |
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 | $ 1,901,000 | $ 2,064,000 |
Fair Value Considerations - Set
Fair Value Considerations - Sets Forth a Reconciliation of Changes (Detail) | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Fair Value, Assets and Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Abstract] | |
Balance as of December 31, 2019 | $ 2,064,000 |
Warrants exercises | (912,000) |
Change in fair value | 749,000 |
Balance as of September 30, 2020 | $ 1,901,000 |
Common Stock (Summarizes the Co
Common Stock (Summarizes the Company's remaining authorized shares available - (Detail) - shares | Sep. 30, 2020 | Dec. 31, 2019 |
Equity [Abstract] | ||
Authorized shares | 300,000,000 | 300,000,000 |
Common stock outstanding | 183,938,000 | 158,645,000 |
Options Outstanding | 5,484,000 | 6,000,000 |
Warrants Outstanding | 5,448,000 | |
Reserved for issuance under 2019 Stock and Incentive Plan | 8,643,000 | |
Available Shares | 96,487,000 |
Common Stock (Shelf Registratio
Common Stock (Shelf Registration Narrative) (Detail) - Shelf Registration - USD ($) shares in Millions, $ in Millions | 1 Months Ended | |
Mar. 31, 2017 | Sep. 30, 2020 | |
Components of common Stock [Line Items] | ||
Common stock to be sold by directors and management in future public offerings | 5 | |
Remaining common stocks and warrants under shelf registration | $ 88.4 | |
Maximum | ||
Components of common Stock [Line Items] | ||
Common stock and warrants | $ 100 |
Common Stock (Sales Agreement N
Common Stock (Sales Agreement Narrative) (Detail) - Sale Agreement (ATM) $ in Millions | 1 Months Ended |
Feb. 29, 2020USD ($)item | |
Class of Stock [Line Items] | |
Number of agents | item | 2 |
Maximum aggregate offering price of equity securities | $ | $ 50 |
Percentage of commission | 4.00% |
Sales Agreement Agent [Member] | |
Class of Stock [Line Items] | |
Percentage of commission | 2.00% |
Common Stock (Summary of Compan
Common Stock (Summary of Company's sales under the Equity Distribution Agreement) (Detail) - Sales Agreement [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2020 | |
Class of Stock [Line Items] | ||||
Total shares of common stock sold | 9,405,000 | 13,069,000 | 1,241,000 | 23,715,000 |
Average price per share | $ 0.78 | $ 0.54 | $ 0.58 | $ 0.78 |
Weighted Average Price Per Share | $ 0.64 | |||
Gross Proceeds | $ 7,223,000 | $ 7,231,000 | $ 682,000 | $ 15,136,000 |
Commissions earned by placement agent | (290,000) | (290,000) | (27,000) | (607,000) |
Issuance / subsequent recurring fees | (23,000) | (24,000) | (219,000) | (266,000) |
Net Proceeds | $ 6,910,000 | $ 6,917,000 | $ 436,000 | $ 14,263,000 |
Common Stock (Common Stock Issu
Common Stock (Common Stock Issued for Services) (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Components of common Stock [Line Items] | ||||
Stock Issued During Period, Value, Issued for Services | $ 80,000 | $ 60,000 | ||
Common Stock Issued for Services [Member] | Non Employee Directors | ||||
Components of common Stock [Line Items] | ||||
Stock Issued During Period, Shares, Issued for Services | 136,000 | 136,000 | ||
Stock Issued During Period, Value, Issued for Services | $ 80,000 | $ 60,000 |
Equity - Activity of Plan (Deta
Equity - Activity of Plan (Detail) - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Options granted | (1,218,000) | |
Add back: options used in net exercise | 20,000 | |
2019 Stock plan | Employee Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total shares reserved for equity awards | 10,000,000 | 10,000,000 |
Options granted | (1,218,000) | (144,000) |
Add back: expired, forfeited and/or cancelled equity awards | 5,000 | |
Remaining shares available for future equity awards | 8,643,000 |
Equity - Stock Option Activity
Equity - Stock Option Activity (Detail) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Number of Options | ||
Number of Options, Beginning Balance | 6,000,000 | |
Number of Options, Granted | 1,218,000 | |
Number of Options, Exercised | (20,000) | |
Number of Options, Forfeited | (100,000) | |
Number of Options, Expired, and/or cancelled | (1,614,000) | |
Number of Options, Ending Balance | 5,484,000 | 6,000,000 |
Number of Options, Exercisable | 5,335,000 | |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price, Beginning Balance | $ 1.33 | |
Weighted Average Exercise Price, Granted | 0.67 | |
Weighted Average Exercise Price, Exercised | 0.54 | |
Weighted Average Exercise Price, Forfeited | 1.70 | |
Weighted Average Exercise Price, Expired, and/or cancelled | 0.87 | |
Weighted Average Exercise Price, Ending Balance | 1.11 | $ 1.33 |
Weighted Average Exercise Price, Exercisable | $ 1.12 | |
Weighted Average Remaining Contractual Life, Outstanding | 7 years 3 months 3 days | 5 years 4 months 24 days |
Weighted Average Remaining Contractual Life, Exercisable | 7 years 2 months 15 days | |
Aggregate Intrinsic Value, Outstanding | $ 1,435,000 | |
Aggregate Intrinsic Value, Exercisable | $ 1,388,000 | |
Number of stock options reissued | 604,000 | |
Number of stock options cancelled | 711,000 | |
Fair value of reissued stock options | $ 277,000 |
Equity - Summary of Stock Optio
Equity - Summary of Stock Options Outstanding and Exercisable (Detail) - Employee Stock Option | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of Options Outstanding | shares | 5,484,000 |
Weighted Average Exercise Price | $ 1.11 |
Weighted Average Remaining Contractual Lives | 7 years 3 months 3 days |
Up to $0.50 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of Options Outstanding | shares | 704,000 |
Weighted Average Exercise Price | $ 0.44 |
Weighted Average Remaining Contractual Lives | 8 years 9 months 7 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 | shares | 4,092,000 |
Weighted Average Exercise Price | $ 0.61 |
Weighted Average Remaining Contractual Lives | 7 years 3 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 | 50,000 |
Weighted Average Exercise Price | $ 1.03 |
Weighted Average Remaining Contractual Lives | 9 years 10 months 6 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 | 638,000 |
Weighted Average Exercise Price | $ 4.48 |
Weighted Average Remaining Contractual Lives | 2 years 10 months 13 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) | 9 Months Ended |
Sep. 30, 2020 | |
Expected volatility, Minimum | 120.80% |
Expected volatility, Maximum | 201.90% |
Risk free interest rate, Minimum | 0.19% |
Risk free interest rate, Maximum | 1.67% |
Minimum | |
Expected term (years) | 3 years |
Maximum | |
Expected term (years) | 5 years 6 months 3 days |
Equity - Summary of Stock-Based
Equity - Summary of Stock-Based Compensation Expense (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expenses | $ 477,000 | $ 255,000 | $ 834,000 | $ 415,000 |
Unrecognized expense as of September 30, 2020 | $ 28,000 | |||
Weighted average remaining years to vest | 2 months 26 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 | $ 72,000 | 46,000 | 142,000 | 77,000 |
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 | 60,000 |
General and Administrative Expenses [Member] | Stock Based Compensation [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expenses | $ 405,000 | $ 209,000 | $ 612,000 | $ 278,000 |
Earnings Per Share (Detail)
Earnings Per Share (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Earnings Per Share | ||||
Net (loss) income | $ (3,368,000) | $ (7,219,000) | $ (11,277,000) | $ (12,610,000) |
Less: decrease in fair value of investor warrants | (163,000) | |||
Loss available to common stockholders | $ (3,368,000) | $ (7,219,000) | $ (11,440,000) | $ (12,610,000) |
Basic weighted-average common share outstanding | 178,622,000 | 142,208,000 | 168,062,000 | 122,895,000 |
Add: dilutive effect of equity instruments | 1,292,000 | |||
Diluted weighted-average shares outstanding | 178,622,000 | 142,208,000 | 169,354,000 | 122,895,000 |
Earnings per share - basic | $ (0.02) | $ (0.05) | $ (0.07) | $ (0.10) |
Earnings per share - diluted | $ (0.02) | $ (0.05) | $ (0.07) | $ (0.10) |
Earnings Per Share - Narrative
Earnings Per Share - Narrative (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares | 10,932,000 | 29,422,000 | 9,640,000 | 29,422,000 |
Employee Stock Option | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares | 5,484,000 | 5,914,000 | 4,567,000 | 5,914,000 |
Warrant to purchase shares of common stock [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive shares | 5,448,000 | 23,508,000 | 5,073,000 | 23,508,000 |